On Immigration, Information, and the New Jurisprudence of Federalism – Note by Nathaniel F. Sussman

Article | Immigration Law
On Immigration, Information, and the New Jurisprudence of Federalism
by Nathaniel F. Sussman*

From Vol. 93, No. 1 (November 2019)
93 S. Cal. L. Rev. 129 (2019)

Keywords: Section 1373, Anti-Commandeering Doctrine, Murphy v. NCAA

 

This Paper argues that in the wake of the Supreme Court’s 2018 decision, Murphy v. NCAA—a case completely unrelated to immigration—there is now a single best answer to the constitutional question presented in the ongoing sanctuary jurisdiction cases. The answer is that the Trump Administration’s withholding of federal grants is indeed unconstitutional, but this is because Section 1373, the statute on which the Executive’s actions are predicated, is itself unconstitutional. Specifically, this Paper argues that the expansion of the anti-commandeering doctrine under Murphy provides a tool by which the federal appellate courts can invalidate Section 1373 as an impermissible federal regulation of state and local governments. By adopting this approach, courts can surpass the comparatively surface-level questions about the Executive’s power to enforce a particular federal statute, and instead address the more central issue: the existence of Section 1373.

This argument proceeds in the following stages. Part I provides a background for each of the central concepts in this analysis. These include (1) an explanation of the anti-commandeering doctrine in its pre- and post-Murphy forms, (2) a description of Section 1373, (3) a working definition of “sanctuary jurisdictions,” and (4) a brief overview of the sanctuary jurisdiction cases decided to date. Part II argues that, in light of the Supreme Court’s decision in Murphy, there is no question that Section 1373 is subject to anti-commandeering claims. Part III then argues that, as a matter of doctrine, Section 1373 should fail to withstand such claims because it does not qualify for any exceptions to the anti-commandeering rule. Finally, Part IV argues that, aside from Supreme Court precedent, there are a series of independent, normative reasons to strike down Section 1373. This Paper concludes that Section 1373 should be held unconstitutional in its challenge before the higher federal courts, including the Supreme Court of the United States if necessary, and that such a ruling is the most desirable method of resolving the sanctuary jurisdiction cases.

*. Executive Articles Editor, Southern California Law Review, Volume 93; J.D. Candidate 2020, University of Southern California Gould School of Law; M.S. Philosophy 2017, The London School of Economics and Political Science; B.A. Political Science 2016, University of Western Ontario. I am grateful to Professor Rebecca Brown for her invaluable guidance throughout this Paper’s development.  I also thank my family, friends, and peers at USC Gould for their helpful feedback on the presentation and substance of my arguments.  Finally, I thank the fantastic team of editors at the Southern California Law Review for their diligent and thoughtful work throughout the publication process.

 

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Data Protection in the Wake of the GDPR: California’s Solution for Protecting “the World’s Most Valuable Resource” – Note by Joanna Kessler

Note | Privacy Law
Data Protection in the Wake of the GDPR: California’s Solution for Protecting “the World’s Most Valuable Resource”

by Joanna Kessler*

From Vol. 93, No. 1 (November 2019)
93 S. Cal. L. Rev. 99 (2019)

Keywords: California Consumer Privacy Act (CCPA), General Data Protection Regulation (GDPR)

This Note will argue that although the CCPA was imperfectly drafted, much of the world seems to be moving toward a standard that embraces data privacy protection, and the CCPA is a positive step in that direction. However, the CCPA does contain several ambiguous and potentially problematic provisions, including possible First Amendment and Dormant Commerce Clause challenges, that should be addressed by the California Legislature. While a federal standard for data privacy would make compliance considerably easier, if such a law is enacted in the near future, it is unlikely to offer as significant data privacy protections as the CCPA and would instead be a watered-down version of the CCPA that preempts attempts by California and other states to establish strong, comprehensive data privacy regimes. Ultimately, the United States should adopt a federal standard that offers consumers similarly strong protections as the GDPR or the CCPA. Part I of this Note will describe the elements of GDPR and the CCPA and will offer a comparative analysis of the regulations. Part II of this Note will address potential shortcomings of the CCPA, including a constitutional analysis of the law and its problematic provisions. Part III of this Note will discuss the debate between consumer privacy advocates and technology companies regarding federal preemption of strict laws like the CCPA. It will also make predictions about, and offer solutions for, the future of the CCPA and United States data privacy legislation based on a discussion of global data privacy trends and possible federal government actions.

*. Executive Senior Editor, Southern California Law Review, Volume 93; J.D. Candidate 2020, University of Southern California Gould School of Law; B.A., Sociology 2013, Kenyon College. 

 

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Unlock Your Phone and Let Me Read All Your Personal Content, Please: The First and Fifth Amendments and Border Searches of Electronic Devices – Note by Kathryn Neubauer

Note | Constitutional Law
Unlock Your Phone and Let Me Read All Your Personal
Content, Please: The First and Fifth Amendments and
Border Searches of Electronic Devices

by Kathryn Neubauer*

From Vol. 92, No. 5 (July 2019)
92 S. Cal. L. Rev. 1273 (2019)

Keywords: First Amendment, Fourth Amendment, Fifth Amendment, Border Search Exception, Technology

 

Until January 2018, under the border search exception, CBP officers were afforded the power to search any electronic device without meeting any standard of suspicion or acquiring a warrant. The border search exception is a “longstanding, historically recognized exception to the Fourth Amendment’s general principle that a warrant be obtained . . . .” It provides that suspicionless and warrantless searches at the border are not in violation of the Fourth Amendment merely because searches at the border are “reasonable simply by virtue of the fact that they occur at the border . . . .” The CBP, claiming that the border search exception applies to electronic devices, searched more devices in 2017 than ever before, with approximately a 60 percent increase over 2016 according to data released by the CBP. These “digital strip searches” violate travelers’ First, Fourth, and Fifth Amendment rights. With the advent of smartphones and the expanded use of electronic devices for storing people’s extremely personal data, these searches violate an individual’s right to privacy. Simply by travelling into the United States with a device linked to such information, a person suddenly—and, currently, unexpectedly—opens a window for the government to search through seemingly every aspect of his or her life. The policy behind these searches at the border does not align with the core principles behind our longstanding First and Fifth Amendment protections, nor does it align with the policies behind the exceptions made to constitutional rights at the border in the past.

In order to protect the privacy and rights of both citizens and noncitizens entering the United States, the procedures concerning electronic device searches need to be rectified. For instance, the border search exception should not be applied to electronic devices the same way it applies to other property or storage containers, like a backpack. One is less likely to expect privacy in the contents of a backpack than in the contents of a password- or authorization-protected devices—unlike a locked device, a backpack can be taken, can be opened easily, can fall open, and also has been traditionally subjected to searches at the border. Moreover, there are many reasons why electronic devices warrant privacy.

*. Executive Notes Editor, Southern California Law Review, Volume 92; J.D., 2019, University of Southern California Gould School of Law; B.B.A., 2014, University of Michigan. My sincere gratitude to Professor Sam Erman for his invaluable feedback on early drafts of this Note as well as to Rosie Frihart, Kevin Ganley and all the editors of the Southern California Law Review. Thank you to Brian and my family—Mark, Diane, Elisabeth, Jennifer, Alison, Rebecca, Tony, Jason, Jalal, Owen, Evelyn, Peter and Manny—for all of their love and support. Finally, a special thank you Rebecca for reading and editing countless drafts, and to Jason for bringing to my attention this important issue.

 

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Confessions of a Teenage Defendant: Why a New Legal Rule Is Necessary to Guide the Evaluation of Juvenile Confessions – Note by Hannah Brudney

Note | Criminal Law
Confessions of a Teenage Defendant: Why a New Legal Rule
Is Necessary to Guide the Evaluation of Juvenile Confessions

by Hannah Brudney*

From Vol. 92, No. 5 (July 2019)
92 S. Cal. L. Rev. 1235 (2019)

Keywords: Criminal Law, Juvenile Confessions, Civil Rights

The cases of the “Central Park Five” and Brendan Dassey are two of the highest profile criminal cases in the past three decades. Both cases unsurprisingly captured the nation’s attention and became the subjects of several documentaries. Each case forces the public to consider how police officers could mistakenly identify and interrogate an innocent suspect, how an innocent person could feel compelled to falsely confess, and how our legal system could allow the false and coerced confession of a child to be the basis of a criminal conviction. While these two cases made national headlines, they are not unique. False confessions by juveniles are a common and even inevitable occurrence given the impact of the interrogation process on children and the inadequacies of the legal standard that currently exists to protect against juvenile false confessions.

Part I of this Note will discuss the prevalence of false confessions among juvenile suspects, and explain how juveniles’ transient developmental weaknesses make them particularly vulnerable to specific coercive interrogation techniques. Part I will also emphasize the impact that a confession has on the outcome of a defendant’s trial, thereby highlighting the weight that a false confession carries.

Part II of this Note will present the existing law governing the evaluation of the voluntariness of a confession—the procedural safeguards offered by Miranda v. Arizona and the totality of the circumstances test rooted in the concern for due process. Part II will also argue that the totality of the circumstances test is insufficient to protect juveniles because it does not give binding weight to a suspect’s age, but rather considers age among several other characteristics.

Part III of this Note will propose a new legal rule to guide the evaluation of juvenile confessions. The proposed legal rule extends and expands upon the language and holding from J.D.B. v. North Carolina, and requires that age be the primary factor in courts’ evaluations of juvenile confessions. Confessions offered by children during interrogations in which coercive techniques are employed must be presumed involuntary, given the effect that manipulative interrogation techniques have on juveniles’ likelihood to falsely confess. Moreover, given that courts often have no way of knowing the circumstances of an interrogation, confessions by all juveniles should be presumed involuntary until the prosecution can prove that no coercive interrogation techniques were used. Part III also proposes a series of policy reforms that aim to reduce the prevalence of false confessions.

*. Senior Submissions Editor, Southern California Law Review, Volume 92; J.D. 2019, University of Southern California Gould School of Law; B.A. English Literature and Psychology 2014, Columbia University. I would like to thank Professor Dan Simon for his advice and guidance, as well as the members of the Southern California Law Review for their excellent editing.

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The Wild West: Application of the Second Amendment’s Individual Right to California Firearm Legislation – Note by Forrest Brown

Note | Constitutional Law
The Wild West: Application of the Second Amendment’s
Individual Right to California Firearm Legislation

by Forrest Brown*

From Vol. 92, No. 5 (July 2019)
92 S. Cal. L. Rev. 1203 (2019)

Keywords: Second Amendment

 

In its landmark District of Columbia v. Heller decision, the Supreme Court announced that the Second Amendment guarantees an individual right of the people to bear arms. Although Heller answered a long-standing question about the Second Amendment’s meaning, there remain issues to be settled. One of the most pressing—and the main topic of this Note—is the proper method of review and application of this individual right. Without guidance on these issues, several circuit courts have followed different approaches. Although opportunities to provide some clarity have come before the Supreme Court, so far, it has denied certiorari.

This Note will not opine on the merits of the individualist or collectivist approaches to the interpretation of the Second Amendment, as this question has been answered conclusively in Heller. Instead, this Note will provide a suggested framework for the application of this individual right to keep and bear arms, and will progress as follows. Part I will offer a contextual history of the Second Amendment. Part II will make the case for why clarity on this issue is so desperately needed and is punctuated by a discussion of the Second Circuit’s particularly troubling application of the right. Part III will offer a proposed framework that, if adopted by the Supreme Court, can resolve the questions posed in Part II. Part IV will apply the framework to California concealed carry regulations. Finally, Part V will apply the framework to a new California law that is likely to make its way to the Ninth Circuit soon, thus allowing the Supreme Court to clarify Second Amendment jurisprudence further.

*. Senior Submissions Editor, Southern California Law Review, Volume 92; J.D. 2019, University of Southern California Gould School of Law; B.A., Economics & Accounting 2015, University of California, Santa Barbara. My deepest appreciation goes to Professor Rebecca Brown for her guidance, the editors of the Southern California Law Review for all of their hard work, and my family and friends for their continued support.

 

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Patently Unjust: Tribal Sovereign Immunity at the U.S. Patent Office – Note by Christopher B. Phillips

From Volume 92, Number 3 (March 2019)
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Patently unjust:
Tribal Sovereign Immunity at the U.S. Patent Office

Christopher B. Phillips[*]

TABLE OF CONTENTS

Introduction

I. Sovereign Immunity

A. Tribal Sovereign Immunity

1. Kiowa Tribe of Oklahoma v. Manufacturing
Technologies, Inc.

2. Michigan v. Bay Mills Indian Community

3. Upper Skagit Indian Tribe v. Lundgren

B. State Sovereign Immunity

1. Florida Prepaid Postsecondary Education Expense
Board v. College Savings Bank

2. The Eleventh Amendment in Administrative Proceedings:
State-Owned Patents and PTAB IPR Rulings

C. Sovereign Immunity’s Purposes

1. Tribal Sovereign Immunity’s Justifications

2. State Sovereign Immunity’s Justifications

II. Reasons for the Allergan-Saint Regis Deal

A. Are These Good Deals for Participants?

B. Are Such Deals a Good Thing?

III. Decisions in the Allergan-Saint Regis IPR

A. Patent Trial and Appeal Board 2018 Decision

1. PTAB Does Not Apply Tribal Sovereign Immunity in IPRs

2. Issues with the PTAB Decision

B. The Federal Circuit Decision to Not Apply Tribal
Sovereign Immunity in an IPR Proceeding

IV. TRIBAL SOVEREIGN IMMUNITY’S UNEQUAL STATUS
WITH STATE SOVEREIGN IMMUNITY

A. The Inconsistency

1. This Inconsistency Matters and Should Be Fixed

2. Addressing the Inconsistency

CONCLUSION

Introduction

The Indian Commerce Clause of the United States Constitution grants Congress plenary power to regulate Native American tribes.[1] In the absence of congressional action, a “dual sovereign” structure exists whereby the tribes are allowed—subject to constraints imposed by Congress—to exist and regulate their own affairs independently of the states and the Federal Government.[2] As a benefit of sovereignty, tribes possess sovereign immunity—an immunity similar to the immunity granted to states under the Eleventh Amendment.[3] Sovereign immunity as a doctrine is based in the common law and allows the sovereign to avoid being sued without its consent.[4] Tribal sovereign immunity, unlike state sovereign immunity,[5] is subject to congressional abrogation, meaning Congress can decide the circumstances whereby tribes are subject to suit without their consent.[6]

In September 2017, Allergan Pharmaceuticals (“Allergan”) made news when, in the middle of a challenge to its Restasis[7] patent’s validity in Inter Partes Review (“IPR”), it assigned its patent rights in the drug to upstate New York’s Saint Regis Mohawk Tribe (“Saint Regis”).[8] After receiving the patent rights, Saint Regis quickly licensed the Restasis patent back to Allergan for an immediate payment of $13.75 million, coupled with an additional $15 million per year in royalties.[9] Because the transaction gave Saint Regis ownership of the patent, the tribe became the patent’s defender in the IPR proceeding. The tribe moved to have the IPR terminated, asserting their immunity from suit under the doctrine of tribal sovereign immunity.

An IPR is an adversarial post-grant proceeding located in the United States Patent and Trademark Office (“USPTO”); it is overseen by a panel of Administrative Patent Judges.[10] Third parties utilize this forum to challenge the validity of patents that they believe were improperly granted.[11]

The deal between Allergan and Saint Regis ignited a public relations firestorm. Critics allege that Allergan acted in bad faith. They claim Allergan “rented” Saint Regis’s sovereign immunity to gain an improper protection from IPRs.[12] Former Senator Claire McCaskill of Missouri sponsored legislation to abrogate tribal sovereign immunity by eliminating it as an IPR defense.[13] In response to criticism, Allergan and other defenders of the deal, tried to shift public focus from the deal to an IPR system that they allege inadequately protects patent owners.[14]

The deal’s critics countered by arguing that IPRs are essential to the intellectual property system because IPRs provide a forum in which disputes over patents are resolved in a quick, cost-effective manner by experts in the field.[15] The alternative to IPRs is litigation in federal district court, which can be costly. In addition, IPRs are overseen by patent law experts, while district court litigation is in front of a judge who may have no familiarity with the complexities of patent law. Moreover, IPRs provide a final check on the USPTO’s grant of a patent by reviewing the granting decision; thus, it can be viewed as a last-chance mechanism by which the USPTO can ensure it has properly granted a patent. Thus, the proceeding’s purpose is to prevent unpatentable material from gaining patent protection which can harm the patent owner’s competitors and hinder further innovation.[16]

On the other hand, the deal has upsides.[17] The tribe received much-needed funds, leading attorneys for the tribe to advocate similar deals as a solution for Saint Regis, other tribes, and state universities in need of revenue.[18] Additionally, some proponents of stronger patent rights condemn IPR proceedings as patent “death squad[s],”[19] so engaging in workarounds of this kind is necessary for patent owners to protect their hard-earned and valuable patent rights.[20]

Nearly one year after the Allergan-Saint Regis deal was announced, on July 20, 2018, the Federal Circuit decided that tribal sovereign immunity does not apply in IPRs, rejecting Saint Regis’s assertion of the doctrine.[21] Therefore, unless the Supreme Court steps in to reverse this decision, the Allergan-Saint Regis deal, and any others like it, is dead.

Part I of this Note covers the history of tribal sovereign immunity, its close relationship to state sovereign immunity, the applicability of state sovereign immunity in intellectual property disputes and administrative proceedings, and the purposes of sovereign immunity. Part II proceeds by evaluating why the Allergan-Saint Regis deal was attractive enough to its participants that they were willing to endure the negative press in order to reap its benefits—patent owners get greater protection of their patents, while tribes receive much-needed funds for little to no cost.[22] The Allergan-Saint Regis deal existed because of concerns that IPRs do not adequately protect patent owners. Congress could take the chance to address these issues, so counterproductive end-runs—even unsuccessful ones—are no longer sought out by patent owners.[23]

 Part III analyzes the various legal decisions rendered in the Allergan-Saint Regis matter. First, it reviews and evaluates the Patent Trial and Appeal Board (“PTAB”)[24] decision from February 2018, finding the it filled with legal error. Next, it evaluates the July 2018 Federal Circuit decision, again finding legal error in refusing to apply tribal sovereign immunity in IPRs. Contra these decisions, tribal sovereign immunity should apply in IPR proceedings, even if this may cause issues from a policy standpoint. These policy issues can be addressed by Congress[25] and, even so, do not outweigh the importance of maintaining tribal sovereign immunity. Therefore, the Supreme Court should take up the issue and reverse the Federal Circuit by finding that tribal sovereign immunity applies in IPRs.

In fact, the Supreme Court would likely reverse the Federal Circuit if it takes the case because its recent decisions have generally protected tribal sovereign immunity.[26] These recent decisions have been rooted in the reasons for the doctrine, such as promoting the dignity of sovereigns, protecting sovereign resources, and protecting a sovereign’s unique culture. Given these purposes, the Court has been extremely hesitant to curtail tribal sovereign immunity without clear Congressional direction to do so. Rather, the Court generally defers to Congress on the issue. Recent cases showcase the Supreme Court giving explicit direction to Congress that it must take ownership over any fixes to problems arising from the assertion of tribal sovereign immunity. Reversal is made even more likely because the Supreme Court has found that state sovereign immunity applies in administrative proceedings and patent litigation. Further, PTAB precedent allows state sovereign immunity to be invoked in IPRs, giving even more reason for the Supreme Court to find that tribal sovereign immunity applies in IPRs, thus preventing unequal treatment of the two sovereigns.

Part IV builds on this contention by evaluating how making tribal immunity inapplicable in IPRs erodes tribal sovereign immunity’s status relative to state sovereign immunity given that state sovereign immunity has typically been allowed to apply in IPRsand administrative proceedings more generally. In fact, Supreme Court jurisprudence over the past several decades has become more protective of state sovereign immunity through the Eleventh Amendment. Therefore, the Federal Circuit decision in this case leaves tribal sovereign immunity out of line with state sovereign immunity in the context of administrative proceedings. Such incongruence should be remedied. This Note argues the best remedy to this issue is for tribal immunity to be brought in line with state immunity in IPRs, thus allowing tribal sovereign immunity to apply in IPR proceedings.

I.  Sovereign Immunity

Sovereign immunity is [a] judicial doctrine which precludes bringing suit against the government without its consent. Founded on the ancient principle that the King can do no wrong, it bars holding the government or its political subdivisions liable . . . unless such immunity is expressly waived . . . .[27]

A.  Tribal Sovereign Immunity

The Indian Commerce Clause of the United States Constitution provides that Congress has the authority to regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes.”[28] By placing Indian tribes alongside states and foreign nations, the United States “recognized tribes among the family of sovereigns.”[29] Chief Justice Marshall classified tribes as “domestic dependent nations.”[30] The Court also has declared that tribes “are in many respects . . . foreign and independent nation[s],” so courts have no “power . . . to arrest the public representatives or agents of Indian nations . . . [or] compel them to pay the debts of their nation.”[31]

Today, the Supreme Court recognizes that “Indian tribes have long been recognized as possessing the common-law immunity from suit traditionally enjoyed by sovereign powers.”[32] In this respect, the Court firmly grounds tribal sovereign immunity in the “inherent powers of a limited sovereignty which has never been extinguished.”[33] In other words, tribal sovereign immunity predates the Constitution and continues to have effect. However, the enactment of the Constitution did place limitations on the immunityconsistent with tribes’ new status as domestic dependent nationsas Congress has the authority to abrogate the immunity through the Indian Commerce Clause.[34] But to do so, Congress must speak clearly, as “courts will not lightly assume that Congress in fact intends to undermine Indian self-government.”[35]

Congress’s power to abrogate tribal sovereign immunity has played a key role in the outcome of several cases. It is worth discussing two of these cases to provide a better understanding of how the Supreme Court approaches tribal sovereign immunity. This Section will conclude with a brief discussion of the Court’s most recent tribal sovereign immunity case, Upper Skagit Indian Tribe v. Lundgren. The Court in Lundgren avoided establishing any new rules for tribal sovereign immunity—the Supreme Court found that the lower courts had not yet had an opportunity to opine on legal issues of immense significance to the case, and since the Supreme Court is not generally a court of first impression, the justices remanded the case to the lower courts.[36] However, the dispute in that case concerned proceedings that could be viewed as similar to IPRs, so its various opinions and dicta are instructive.

1.  Kiowa Tribe of Oklahoma v. Manufacturing Technologies, Inc.

In Kiowa Tribe of Oklahoma v. Manufacturing Technologies, Inc., the Supreme Court held that tribal sovereign immunity can be invoked by tribes when engaged in off-reservation, commercial activity.[37] The underlying dispute in Kiowa involved stock purchased by a tribal entity from the plaintiff.[38] As part of the transaction, a promissory note was signed in the name of a tribe by which the tribe agreed to pay the plaintiff $285,000 plus interest in exchange for stock.[39] When the tribe defaulted on its payments, an action was commenced in Oklahoma state court. Once in court, the tribe moved to dismiss the case because its sovereign immunity insulated it from suit; however, both the state trial court and the Oklahoma Court of Civil Appeals ruled in favor of the creditor because they reasoned that tribal sovereign immunity should not apply to breaches of contract that involve “off-reservation commercial conduct.”[40] After the Oklahoma Supreme Court declined to hear an appeal, the United States Supreme Court granted certiorari. Justice Kennedy began the majority opinion by reviewing the general principles of tribal sovereign immunity: “[a]s a matter of federal law, an Indian tribe is subject to suit only where Congress has authorized the suit or the tribe has waived its immunity.”[41]

A key factual dispute in the case was whether the promissory note was signed on Indian territory or “beyond the Tribe’s lands;”[42] however, Justice Kennedy dismissed this issue because tribal sovereign immunity does not depend “on where the tribal activities occurred.”[43] Without Congressional abrogation of tribal sovereign immunity for off-reservation, economic conduct, the Supreme Court held for the tribe, allowing them to invoke their sovereign immunity from suit.

Justice Kennedy proceeded to lay out what the Court viewed as the shaky foundation of tribal sovereign immunity, given that it “developed almost by accident.”[44] The majority believed that “[t]here are reasons to doubt the wisdom of perpetuating the doctrine of tribal sovereign immunity because the it can economically “harm those who are unaware that they are dealing with a tribe” or have no awareness of tribal sovereign immunity.[45] However, the Court was not moved enough by these arguments to reverse, or even limit, the doctrine. Rather, the Supreme Court put the impetus on Congress to abrogate tribal sovereign immunity in situations where they find it necessary because “Congress is in a position to weigh and accommodate the competing policy concerns and reliance interests.”[46] Therefore, tribes enjoy sovereign immunity protections even when engaging in economic activity outside of reservations. The Supreme Court had the opportunity to reconsider this issue again in 2014. The result remained the same.

2.  Michigan v. Bay Mills Indian Community

When the Supreme Court decided Michigan v. Bay Mills Indian Community in 2014, it reaffirmed the basic holding from Kiowa that tribal sovereign immunity applies to commercial activity outside of Indian lands unless otherwise abrogated by Congress.[47] Michigan had asked the Supreme Court to find the federal statute at issue authorized their suit and abrogated tribal sovereign immunity, or alternatively, reverse Kiowa’s holding that tribal sovereign immunity applies to commercial activity on non-Indian lands.[48]

The Supreme Court first engaged in statutory construction and found that the statute did not clearly express a Congressional intent to abrogate tribal sovereign immunity in the context at issue.[49] The Court then noted that Michigan could have negotiated a waiver of the tribe’s immunity at the outset of their dealings and, in fact, had significant leverage to do so.[50] Therefore, this was not a situation where parties dealing with tribes were left with no recourse. It is important to remember that parties remain free to negotiate waivers of sovereign immunity, thus protecting themselves in the event future litigation is required in the matter.[51]

Next, the Bay Mills Court turned its attention to reviewing the Kiowa decision and the arguments made in favor of overruling its basic holding. The Court made four arguments under stare decisis that counted against overturning its precedent. First, the decision in Kiowa was only one decision of many in a long line of precedent upholding tribal sovereign immunity.[52] Second, the Supreme Court had relied on the Kiowa precedent as a basis for subsequent rulings. Third, the Court noted that tribes, as well as individuals and entities doing business with them, have relied on the Kiowa precedent when structuring their business dealings. Finally, the Court reiterated that the law places the power in Congress to abrogate tribal sovereign immunity—not in the Court. Therefore, in order “[t]o overcome all these reasons for [the] Court to stand pat, Michigan . . . need[ed] an ace up its sleeve.”[53]

Michigan produced no ace, leaving the Court to explain that Michigan was simply rehashing the same functional arguments promoted by Kiowa’s plaintiff—because tribal business activities have become more detached from tribal governmental interests, sovereign immunity should no longer apply to a tribe’s commercial activity.[54] In Kiowa, the Court was sympathetic to these functional arguments, but still rejected them in favor of tribal sovereign immunity; the Bay Mills Court did the same.[55]

Importantly, after the Kiowa decision, Congress expressly considered abrogating tribal sovereign immunity in the context of commercial activity on non-Indian lands, but rejected a law that overturned Kiowa’s holding.[56] Therefore, Congress had spoken directly on the issue, leading the Court to defer to Congress’s decision and uphold tribal sovereign immunity for commercial activities taking place outside of tribal land.[57] Deferring to Congress kept Bay Mills in line with Justice Kennedy’s Kiowa opinion, which rested its holding on the fact that Congress had the authority to abrogate tribal sovereign immunity and was better positioned to do so, since it could weigh the competing policy concerns. Bay Mills demonstrates the uneasiness the Supreme Court feels towards abrogating tribal sovereign immunity without clear congressional abrogation.

3.  Upper Skagit Indian Tribe v. Lundgren

In May 2018, the Supreme Court decided Upper Skagit Indian Tribe v. Lundgren.[58] The dispute concerned tribal land that the Upper Skagit Indian Tribe’s neighbors (the Lundgrens) claimed to have adverse possessed.[59] The Lundgrens “launched a quiet title lawsuit against the Upper Skagit tribe . . . after the tribe attempted to assert ownership over a strip of land . . . the Lundgrens claim[ed] belong[ed] to them.”[60] The Tribe responded to this action by invoking their sovereign immunity. Washington State courts resolved the issue in favor of the Lundgrens, holding that “the case could go forward under in rem jurisdiction,” even though the court did not have jurisdiction over the Tribe due to sovereign immunity.[61]

This state court holding created a new exception to the doctrine of tribal sovereign immunity. On review, the Supreme Court remanded the case to the state court for further review, ultimately ignoring the tribal sovereign immunity issues—though it did touch on those issues in dicta and dissenting and concurring opinions.[62] The Court remanded the case on a procedural grounds because the lower court decisions improperly interpreted a Supreme Court precedent;[63] thus, the parties in the case were asking the Supreme Court to answer a legal question that had not yet been addressed by the lower courts. Namely, the parties wanted the Court to find an “immovable property” exception to the doctrine of tribal sovereign immunity.[64] In remanding the case, the Court noted that it was the importance of the question that lead them to refrain from answering the “immovable property” exception question—“[d]etermining the limits on the sovereign immunity held by Indian tribes is a grave question; the answer will affect all tribes, not just the one before us.”[65] Therefore, whether an immovable property exception exists is an open question. Due to the similarity of the issues, the eventual resolution of this case will be instructive for the application of tribal sovereign immunity in IPRs and must be watched closely.

Justice Thomas filed a strongly worded dissent arguing that the “immovable property” exception was strongly established, thus no need to remand existed.[66] He found the idea that an entity (in this case, a tribe) could assert immunity in a suit over land situated inside another sovereign’s jurisdiction ridiculous. Further, “[a]llowing the judge-made doctrine of tribal immunity to intrude on such a fundamental aspect of state sovereignty contradicts the Constitution’s design.”[67] In making such an argument, Justice Thomas articulates a view of tribal sovereign immunity that would naturally be extended to prevent the doctrine’s assertion in IPR proceedings—since patents are historically the jurisdiction of the federal government, allowing tribal sovereign immunity there may “intrude” on the federal government’s sovereignty.[68]

B.  State Sovereign Immunity

Another set of sovereigns recognized by the Constitution is the states.[69] However, the basis for state sovereign immunity is explicitly recognized in a constitutional amendment.[70] The Eleventh Amendment says “[t]he Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.”[71]

A few years after the Eleventh Amendment’s enactment, the Supreme Court, in Hans v. Louisiana, held that the amendment imposed a broad understanding of state sovereign immunity.[72] This broad understanding of state sovereign immunity has largely been reaffirmed by the Supreme Court.[73] Thus, unlike tribal sovereign immunity, which can be abrogated by Congress, states enjoy sovereign immunity as a Constitutional right.[74]

In patent cases, the Supreme Court has held that states cannot be subject to suit for patent infringement due to their sovereign immunity.[75] The Supreme Court has not addressed whether a state is immune from a direct challenge to the validity of its patents as would occur if a state-owned patent was challenged in an IPR proceeding.[76] However, the USPTO has opined on the issue. Several 2017 PTAB decisions hold that state-owned patents are not subject to IPR challenges due to state sovereign immunity. But these holdings are subject to the condition that sovereign immunity would be deemed waived if the state had asserted the patent in litigation against the IPR petitioner. Both the Supreme Court case and these PTAB decisions are discussed in more detail below.

1.  Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank

In Florida Prepaid, the Supreme Court considered whether Congress could abrogate state sovereign immunity by allowing private suits against state entities that were infringing patents under the Patent Act.[77] At issue was the Patent Act’s clear abrogation of state sovereign immunity: “[a]ny State . . . shall not be immune, under the [E]leventh [A]mendment of the Constitution of the United States or under any other doctrine of sovereign immunity, from suit in Federal court . . . for infringement of a patent.”[78]

To address this issue, the Supreme Court first discussed its holding in Seminole Tribe of Florida v. Florida from only a few years prior. Seminole Tribe reaffirmed that Congress is not able to use its Article I powers to abrogate state sovereign immunity.[79] Rather, the only way state sovereign immunity could be abrogated is if Congress properly acted through its Fourteenth Amendment enforcement powers (“Section 5 enforcement powers”).[80] Because a patent is property for the purposes of the Fourteenth Amendment’s Due Process Clause, Congress could have theoretically used its Section 5 enforcement powers to abrogate state sovereign immunity.[81] However, since Section 5 enforcement powers are remedial, Congress can only use them when the Fourteenth Amendment’s substantive provisions are being violated and Congress needs to step in to prevent further violation of the substantive provisions.[82] Therefore, the question became whether this was a proper use of Congress’s enforcement power. After engaging in a thorough analysis under the City of Boerne v. Flores[83] Section 5 enforcement test, the Supreme Court found the Patent Act’s abrogation of state sovereign immunity was not a proper exercise of Congress’s Section 5 enforcement power.[84]

While Florida Prepaid addressed a state entity’s alleged infringement of a private party’s patent, it is instructive for its discussion of state sovereign immunity’s interplay with patent rights—allowing states to assert their sovereign immunity if made a defendant in a patent suit. A natural extension from this holding would be that state-owned patents cannot have their validity directly challenged.[85] Such a challenge to a state-owned patent’s validity would have to be in an IPR proceeding because if a state asserts their patent in an infringement suit, the suit will suffice as a waiver of the state’s sovereign immunity such that the alleged infringer would be able to challenge the patent’s validity as a defense to patent infringement.[86] Although no federal appellate court has decided if direct challenges to state-owned patents are barred by sovereign immunity, PTAB decisions in 2017 have found that state sovereign immunity protects state-owned entities from having their patents attacked in IPR proceedings.[87] A general overview of these decisions is provided in this next Section.

2.  The Eleventh Amendment in Administrative Proceedings: StateOwned Patents and PTAB IPR Rulings

Federal Maritime Commission v. South Carolina State Ports Authority (“FMC) extends a state’s Eleventh Amendment immunity beyond just Article III proceedings, covering administrative proceedings as well.[88] Additionally, in Vas-Cath, Inc. v. Curators of University of Missouri, the Federal Circuit[89] held that Eleventh Amendment immunity applies to interference proceedings[90] at the USPTO.[91] Building on this Supreme Court and Federal Circuit precedent, PTAB issued several decisions in 2017 regarding the applicability of state sovereign immunity in IPRs.[92]

In Covidien LP v. University of Florida Research Foundation, Inc.,[93] PTAB relied on FMC and Vas-Cath to hold that state sovereign immunity is a defense in IPR proceedings.[94] But to directly apply these two precedents, PTAB needed to address a few things. First, they dealt with the argument that since patents are “public rights” they can be subject to any statutory conditions—such as being subject to review in an IPR proceeding to ensure that the patent was properly granted.[95] PTAB rejected this argument outright as “unpersuasive” because there had been no “case law, or persuasive authority” holding that “a state’s Eleventh Amendment immunity may be limited or abrogated by a public rights exception.”[96] Second, PTAB also rejected the argument that sovereign immunity is irrelevant in IPRs because the “proceedings are directed to the patent itself,” and therefore, are not a private claim against the state.[97] In so deciding, PTAB asserted that the primary function of protecting a sovereign from suit is not monetary, though that is one purpose, but is according them “the respect owed . . . as joint sovereigns.”[98] This tracks recent Supreme Court decisions, the details of which are covered in Section I.C. Additionally, PTAB conceived of the IPR proceeding as a suit between parties rather than as a challenge directed solely to the patent.[99] Therefore, PTAB concluded that it is proper to apply the FMC framework in IPRs.[100]

Applying the FMC framework to IPRs, PTAB began by reaffirming the fact that “immunity applies regardless of whether a private plaintiff’s suit is for monetary damages or some other type of relief.”[101] Therefore, the “absence of monetary and injunctive relief” was irrelevant to the determination of whether state sovereign immunity could be invoked.[102] Next, PTAB considered the nature of IPRs. While noting that there were some differences in procedure and substance between IPRs and civil litigation, PTAB focused on the fact that IPRs are “adversarial” and intended to “resemble civil litigation in federal courts.”[103] Therefore, PTAB held that Eleventh Amendment immunity could be invoked in IPRs.[104]

However, PTAB went further in order to address the patent challenger’s policy argument that allowing a state to assert sovereign immunity in IPR would lead to regrettable outcomes.[105] PTAB conceded that the practical effect of the ruling would mean that states and state-owned entities no longer need to worry about having their patents challenged in the proceeding; however, the PTAB panel pointed out that exempting states from suit is exactly the point of the Eleventh Amendment.[106] The amendment, in fact, explicitly places state dignity as a sovereign above other practical considerations that may merit subjecting the state to suit.[107] Moreover, PTAB pointed out that “there is no evidence that . . . harm to the patent system . . . will come to pass.”[108]

In December 2017, PTAB convened an expanded panel of Administrative Patent Judges to hear another IPR case involving state sovereign immunity.[109] In this case, Ericsson Inc. v. Regents of the University of Minnesota,[110] PTAB’s “Chief Judge Ruschke expanded the panel from the normal three administrative patent judges to seven judges, including himself and the Deputy and Vice Chief Administrative Patent Judges” and wrote the opinion himself.[111] As such, the resulting decision can be understood as PTAB’s authoritative position on the applicability of state sovereign immunity in IPRs. The expanded panel reaffirmed the prior PTAB holdings by concluding that state sovereign immunity can be invoked in IPR proceedings.[112] In coming to this conclusion, they followed Covidien’s reasoning.[113]

However, this expanded PTAB panel placed some limits on a state’s ability to invoke its sovereign immunity. The issue before the expanded panel was whether the state-entity waived its sovereign immunity by filing a patent infringement action in federal district court against the party that had instituted the IPR proceeding.[114] The state-entity argued that waiver of sovereign immunity ought to be limited to the forum in which any waiver occurred.[115] PTAB disagreed, holding that the state waived its sovereign immunity for the purposes of subsequent IPR proceedings when it brought the patent infringement suit.[116]

This holding could prove to be a slight limitation on the usefulness of deals similar to the one between Allergan and Saint Regishowever, as will be discussed in Part III, in light of Saint Regis Mohawk Tribe v. Mylan Pharm. Inc.,[117] the deal would be between a patent owner and a state entity rather than a tribe. This is because a party who has been sued for patent infringement in district court could simply initiate IPR review of the asserted patent. The state entity would then be barred from asserting its sovereign immunity as it would be deemed waived by the commencement of the infringement suit against the party who is challenging the patent in the IPR. However, observers of the patent system believe that Ericsson’s holding on waiver could prove to be “controversial on appeal.”[118] This is because “[w]aivers of sovereign immunity . . . are typically forum specific, and [PTAB] did not cite any direct precedent for its ruling” that extended the waiver doctrine to encompass litigation in a separate forum.[119] How this issue is resolved should be watched carefully as it could have far-reaching consequences for patent owners wishing to assert sovereign immunity in IPRs.[120]

While these PTAB decisions have not authoritatively settled the question of state sovereign immunity as a defense in IPR, they provide examples of legal reasoning that may indicate how state sovereign immunity will be dealt with in IPRs if the Federal Circuit opines on the issue.[121] This is because the Federal Circuit is likely to affirm PTAB’s legal analysis.

Through January 15, 2018, the Federal Circuit has affirmed PTAB on every issue raised in cases related to the IPR process just under seventy-four percent of the time.[122] Moreover, the PTAB decisions in Covidien and Ericsson follow what the Federal Circuit held in Vas-Cath. In addition, the Supreme Court’s recent state sovereign immunity cases have viewed sovereign immunity’s primary purpose as protecting the respect due to sovereigns. Because PTAB’s decision rests on similar reasoning, it is likely PTAB will be upheld in the event the decision somehow made it to the Supreme Court.

C.  Sovereign Immunity’s Purposes

Sovereign immunity as a historical doctrine developed out of the idea that “the King c[ould] do no wrong.”[123] This was justified on the grounds that the “King” created the law within a nation or state, and therefore could not act illegally.[124] However, this justification fell out of vogue in America in the late eighteenth century and was replaced with “a rationale emphasizing the doctrine’s benefit to society.”[125] This newer strain of thought stressed that the doctrine was necessary to protect the “sovereigns funds.”[126] Sovereigns use their money to provide services to their people, and if forced to compensate every person with a claim, sovereigns would have less money to spend on providing social services, among other necessary governmental services. While the protection of sovereign funds has been mostly abandoned as a reason to protect states and the federal government via sovereign immunity,[127] it still provides a normative basis for tribal sovereign immunity.[128]

1.  Tribal Sovereign Immunity’s Justifications

Tribal sovereign immunity can be justified with a variety of functional considerations. First, it allows tribes to protect their economic interests, so they can be self-sufficient—in other words, tribal resources will be better protected. Justice Sotomayor espoused this view in her Bay Mills concurring opinion. She wrote in concurrence to provide normative reasons supporting the outcome that reasserted the doctrine of tribal sovereign immunity because she viewed the doctrine as under attack, with even the majority opinion questioning the doctrine’s normative foundations.[129]

Justice Sotomayor bolstered the argument in favor of tribal sovereign immunity with an in-depth discussion of the unique issues facing tribes and the ways sovereign immunity helps. First, she pointed out that while some tribes have become “substantial and successful commercial actors,” most tribes do not participate in “lucrative commercial activity.”[130] Furthermore, “[a] key goal of the Federal Government is to render Tribes more self-sufficient, and better positioned to fund their own sovereign functions, rather than relying on federal funding.”[131] The idea is to promote tribal self-sufficiency by allowing them space to operate in the commercial arena so they can make money to perform basic functions expected of sovereigns. These functions include providing schools, roads, police, among other services.

Promoting tribal self-sufficiency is an important goal because tribes are uniquely situated compared to the other sovereigns in the United States when it comes to raising revenue to fund their government. This is because tribes face significant hurdles in imposing taxes. “[T]ribes have no power to impose taxes on non-Indian owners of land inside the reservation even if the tribe provides significant services to the owner.”[132] Additionally, tribes are deprived “of the usual means of raising government funds” as they are significantly limited in their ability to impose property taxes.[133] Tribal governments are not allowed to impose “real property tax on trust lands, which are owned by the federal government.”[134] In some reservations, trust land is equal to all of the tribe’s land.[135] Finally, raising revenue through means such as income taxes is unrealistic because “proportionally more Indians qualify for negative income taxes,” which means they actually pay less in taxes than they receive in benefits.[136] Rather, tribes’ main source of income comes from “federal transfers, which are widely acknowledged to be inadequate . . . and . . . tribe-owned enterprises.[137] These enterprises suffer from less competitive pricing, lower productivity, and worse profitability when compared to privately owned enterprises.[138]

Given these limitations on a tribe’s ability to raise money through taxation, its funds could be significantly depleted if it is expected to pay out on every claim against it. This is especially true for tribes because they are smaller sovereigns acting within much larger sovereigns—the U.S. federal government as well as state governments. As smaller sovereigns, tribes have less money to work with and therefore can be economically crippled if they end up in a situation where they are forced to pay many judgements. To illustrate, imagine a tribe consisting of several thousand people. The tribe could be engaged in economic activity with thousands of people, and if those individuals with whom they are engaged in business have claims against them, the tribe could be wiped out. For this reason, sovereign immunity is essential to maintaining the financial well-being—and independence—of tribes which directly impacts their ability to govern themselves.

In addition to promoting self-sufficiency through stronger economic development, tribal sovereign immunity promotes “Tribal Self-Government.”[139] This idea comes from the place tribes hold in the United States. Tribes are placed alongside foreign nations and states in the United States Constitution’s Commerce Clause and are treated, in Chief Justice Marshall’s words, as “domestic dependent nations.” As this status indicates, tribes govern their own territories. Therefore, they ought to be granted the same dignity afforded to other sovereigns—namely, immunity from suit in the absence of a waiver or congressional abrogation.[140] It is a matter of respect for them to be treated like other sovereigns in the United States.[141]

Finally, tribal sovereign immunity preserves tribal cultural identity.[142] While maintaining a distinct culture in this interconnected world may be difficult, sovereign immunity assists tribes accomplish this by preventing outside forces from imposing foreign rules and values.[143] Because sovereign immunity prevents tribes from being subject to suit in non-Indian tribunals, the tribe does not need to alter its behavior to conform with outside legal and social norms, thus allowing the tribe to chart its own path regarding the law. To the extent law is influenced by culture rather than the reverse,[144] tribal sovereign immunity provides a way for tribes to control their own culture by being free from the influence of another sovereign’s laws.[145]

2.  State Sovereign Immunity’s Justifications

Like tribal sovereign immunity, state sovereign immunity rests on justifications such as protecting state resources and promoting sovereign dignity. The Eleventh Amendment was passed due to concern with protecting state resources after the Revolutionary War because most states had accumulated large debts.[146] Recently, the Supreme Court has focused on the “preeminent purpose” of promoting sovereign dignity.[147] However, because state sovereign immunity exists as a constitutional right, it is unlike tribal sovereign immunity, in which the purposes of the doctrine loom larger because Congress can abrogate it at any time.

II.  Reasons for the Allergan-Saint Regis Deal

The basic idea behind Allergan’s action is simple. The deal made Saint Regis the owner of the Restasis patent, which should leave the Tribe to defend the patent’s validity in any IPR proceeding. In defending the Restasis patent in the IPR, Saint Regis’s Motion to Terminate the proceeding argued: “[t]he tribe is a sovereign government that cannot be sued unless Congress unequivocally abrogates its immunity or the tribe expressly waives it. Neither of these exceptions apply here.”[148] Saint Regis is correct that the tribe’s sovereign immunity has not been abrogated by Congress for IPRs and that Saint Regis has not waived its immunity. In fact, in IPR decisions from 2017, PTAB validated this approach in the context of state sovereign immunity by claiming lack of jurisdiction over a proceeding involving a state-owned patent. As a result, it appeared that by slightly extending PTAB’s logic from its 2017 state sovereign immunity decisions, the Restasis patent would be safe from being challenged in the IPR. However, as will be discussed in Part III, both PTAB and the Federal Circuit disagreed and held that tribal sovereign immunity does not apply in IPR proceedings.

Even so, the motives for the Allergan-Saint Regis deal are still important to understand. As discussed in Section I.B.2, states and state-owned entities are still able to assert sovereign immunity in IPR proceedings, which could lead to patent owners seeking deals with those entities as possible protection for their patents. Therefore, it is possible—though perhaps unlikely—that these sorts of deals could proliferate.

A.  Are These Good Deals for Participants?

Yes. The deals are extremely attractive for tribes, states, and patent owners. They would allow patent owners to evade challenges to their patents in IPR proceedings, which is extremely valuable due to high invalidation rates of patents in IPRs. Independent analysis of invalidation in IPRs finds that anywhere between 62% to 92% of the patents challenged are invalidated, depending upon the technology at issue.[149] Moreover, a recent review found that fifty-eight patents had been invalidated by PTAB on the exact same grounds with which a district court had previously upheld their validity, thus demonstrating PTAB’s “slanted playing field.”[150] In addition, challenged patents represent a substantial asset for the patent owner. In Allergan’s case, the Restasis patent is valued at $1.5 billion.[151] The price of having such a valuable patent invalidated is steep. Allergan prepared for such a possibility by announcing it would layoff over 1,000 employees, costing the company an expected $125 million just in severance expenses.[152] Companies, therefore, have strong incentives to adopt measures to protect their intellectual property.[153] Paying several million dollars to “rent” a tribe’s or state’s sovereign immunity is a small price to pay to protect the patent’s validity.[154]

For tribes, deals like these provide a good way to earn much-needed money.[155] The Saint Regis Mohawk Tribe has 15,600 members and is geographically centered in upstate New York.[156] Saint Regis planned to put this money to use by enhancing government services such as “health, welfare, education, housing and other services.”[157] As discussed in Section I.C, tribes have a hard time raising revenue because they have a limited tax-base. Therefore, tribes must get creative to raise money. While casinos are a lucrative option for some tribes, a large majority of tribes have not been able to tap into casinos for any meaningful amount of revenue.[158] Providing this service to pharmaceutical and technology companies who have patents being challenged in IPRs would provide substantial revenue raising opportunities for tribes that desperately need it.[159]

B.  Are Such Deals a Good Thing?

No. In the case of Allergan and Saint Regis, the two parties use Saint Regis’s sovereign immunity to escape a procedure by which Allergan’s Restasis patent may be invalidated through a mechanism designed by Congress. This violates common notions of fairness by engaging in a “sham” transaction through which Allergan keeps a potentially improperly granted patent because they had the money to “rent” Saint Regis’s sovereign immunity. The deal acts as a loophole through which a big pharmaceutical companythat has access to expensive lawyershas exploited a process in a way that is completely unavailable to patent owners who possess fewer resources.

Arguments made on behalf of Saint Regis and Allergan, while satisfying on the surface, ultimately stumble under scrutiny. An argument supporting this deal notes that IPRs have been deemed a patent “death squad” as most patents are invalidated by the process.[160] Critics of IPRs have noted that by engaging in deals like the one between Allergan and Saint Regis, economically valuable patents may be better protected, thus stimulating more investment in research and development on products that improve people’s lives.

Yet this argument is satisfactory only to the extent that it highlights needed reforms to IPRs. While the IPR process may be flawed, those flaws should not be cured by creating an end run around the Patent Office. Doing it this way diminishes the credibility of the entire system, misallocates money by paying millions of dollars to lawyers and tribes to make the deal, and only benefits companies with resources to pay for the expensive licensing agreement and the lawyers who structure it. Therefore, any fixes to the IPR process should be done by Congress—not by private actors.[161]

Others find the deal appealing because it provides a much-needed revenue source to economically struggling tribes.[162] However, while it does enhance tribal economic independence, it accomplishes that goal by disrupting the congressionallydesigned patent system. Where tribes need to find more funding sources, steps should be taken independently of the patent system. Addressing one problem while undermining an unrelated government program is not a sustainable way to fix anything.

Furthermore, while this could boost funding for a small class of tribes, the actual benefit to most tribes will likely be marginal. Money received in these ventures could be difficult to rely on as the amount may vary dramatically over time. In fact, the appeal of such a deal could hurt early participants the most. As more sovereigns[163] recognize the upside, benefits could become more widely spread, thus leading to fewer benefits for all recipients as the funding sources are spread across a larger number of entities.[164] In addition, if the practice does not become widespread, that means tribes who need the revenue are not reaping the benefits, thus further limiting the benefit of these deals as a solution to tribal revenue issues.

As a panacea for tribal funding, then, this is a poorly targeted program. Either only a select few tribes will benefit, leaving many unable to obtain its benefits, or many will take advantage of these deals, meaning the benefit to each tribe will be small and the amount received will shrink over time as more sovereign actors take advantage of the practice. The problems faced by tribes in the financial sphere is something that should be addressed. However, promoting more deals like the one between Allergan and Saint Regis is not an efficacious solution because these deals will provide only a marginal benefit, at best.[165]

III.  Decisions in the Allergan-Saint Regis IPR

Since the deal was made in September 2017, litigation has proceeded over the applicability of tribal sovereign immunity of IPRs, resulting in opinions from both PTAB and the Federal Circuit Court of Appeals. Both opinions found tribal sovereign immunity does not apply in IPRs. As will be discussed below, a proper reading of PTAB, Federal Circuit, and Supreme Court precedent demonstrates that these decisions were incorrect.

A. Patent Trial and Appeal Board 2018 Decision

1.  PTAB Does Not Apply Tribal Sovereign Immunity in IPRs

On February 23, 2018, PTAB denied Saint Regis’s Motion to Terminate IPR proceedings due to tribal sovereign immunity.[166] After going through the history of the deal between Allergan and Saint Regis, PTAB rejected that the Supreme Court’s decision in FMC[167]which allowed state sovereign immunity to be invoked in administrative proceedings—had any bearing on the application of tribal sovereign immunity in administrative proceedings.[168] Moreover, it distinguished its own decisions allowing state sovereign immunity to be invoked in IPRs because “the immunity possessed by Indian Tribes is not co-extensive with that of the states”[169] and “there are reasons to doubt the wisdom of perpetuating the . . . doctrine.”[170]

PTAB further based its decision on Congress’s plenary control over tribal sovereign immunity and noted that the Patent Act is a generally applicable statute that places conditions on the grant of a patent, which includes the possibility of being subject to IPR proceedings.[171] PTAB relied on a variety of circuit court decisions, noting that only in limited circumstances do generally applicable laws not apply to tribes, then found that IPR proceedings do not meet these limited circumstances.[172] PTAB also relied on prior cases in which government administrative enforcement actions against tribes were deemed not to have implicated tribal sovereign immunity because “tribes cannot impose sovereign immunity to bar the federal government from exercising its trust obligations.”[173] Moreover, IPRs are not the type of suit to which an Indian tribe would traditionally enjoy immunity under the common law.”[174]

PTAB concluded this section of the opinion by noting that it does “not exercise personal jurisdiction over the patent owner,” rather, it is over “the challenged patent in an inter partes review proceeding.”[175] In a footnote, the opinion rejects characterizing the proceedings as in rem because they could find no “controlling precedent” for that proposition.[176]

Finally, PTAB concluded that even if tribal sovereign immunity applied in IPRs, the proceeding may continue because Allergan still effectively owns the patent.[177] Allergan is found to be a “patent owner” because the license from Saint Regis to Allergan “transferred ‘all substantial rights’ in the challenged patents”—including the “right to sue for infringement,” the “right to make, use, and sell products or services under the patents,” the “right to sublicense,” the “reversionary rights in patents,” the “right to litigation or licensing proceeds,” among others.[178] In addition, the “tribe is not an indispensable party” to the proceeding, thus, PTAB allowed the IPR to continue without the Tribe.[179] This decision was appealed by Saint Regis and Mohawk to the Federal Circuit.[180]

2.  Issues with the PTAB Decision

PTAB’s decision suffered from numerous flaws that should have made it a prime candidate for reversal on appeal. First, its rejection of state sovereign immunity precedent dealing with the doctrine’s applicability in administrative proceedings because tribal immunity is “not co-extensive with that of the States”[181] dramatically misunderstands the Supreme Court’s tribal sovereign immunity case law. This quote from Kiowa, when read in context, actually stands for the proposition that tribal sovereign immunity is broader than state sovereign immunity in some respects.[182] Yet PTAB relied on it for just the opposite proposition; the panel’s fundamental misunderstanding of Kiowa is evident throughout the rest of its opinion.

Other than this out-of-context quote from Kiowa, PTAB provided no reasons for holding that tribal sovereign immunity is situated differently from state sovereign immunity in IPRs or other administrative proceedings. PTAB did not attempt to distinguish other administrative adjudications that found tribal sovereign immunity applicable; rather, it dismissed them all as non-binding and simply asserted that tribal sovereign immunity is so different from state sovereign immunity that it must not apply.

The remaining arguments from PTAB hold up just as poorly under scrutiny. PTAB asserted that only in limited circumstances do generally applicable laws not apply to tribes. However, this misunderstands the issue, which is whether the tribe can assert its sovereign immunity from suit—not whether the tribe must follow a particular law. As PTAB decided in Covidien, which followed FMC and held that state sovereign immunity applies in IPR proceedings, IPRs are adversarial in nature and modeled on civil litigation.[183] Covidien explicitly found that IPRs are properly conceived of as a civil suit between two parties, rather than as an administrative enforcement proceeding.[184] PTAB’s holding in the Saint Regis case is directly at odds with its own holding in Covidien and Ericssonthe latter being PTAB’s authoritative view on state sovereign immunity in IPRs given the make-up of the expanded panel that decided it. Framing the IPR component of the Patent Act as an enforcement proceeding (rather than an adjudicative proceeding) is incorrect according to PTAB’s own decisions. Rather, as Covidien held, IPRs are modeled as a civil suit, which is the type of proceeding in which tribes historically have sovereign immunity protection.[185]

PTAB also argued its jurisdiction in IPRs is over “the challenged patent,” rather than over the tribe itself.[186] However, Covidien, again, is instructive as it reached the exact opposite conclusion when state sovereign immunity was at issue. PTAB’s Covidien decision applied state sovereign immunity because sovereign immunity’s “central purpose is to accord the States the respect owed them as joint sovereigns.”[187] Moreover, PTAB in Covidien pointed to the adversarial nature of the proceeding, the parties’ involvement in it, and the procedure imposed on PTAB’s authority to review the challenged patents as reasons the proceeding should be understood as having jurisdiction over the patent owner, rather than the patent itself.[188] PTAB in the Saint Regis case does not attempt to explain why it reaches precisely the opposite result in the tribal sovereign immunity context.[189]

PTAB reaffirmed Covidien’s basic holding in Ericsson.[190] There, PTAB convened an expanded panel in which PTAB’s Chief Judge Ruschke wrote the opinion.[191] After Ericsson, it can be reasonably concluded that the authoritative PTAB view applies state sovereign immunity in IPR proceedings for the reasons provided in Covidien. By adopting Covidien’s reasoning on the applicability of state sovereign immunity to IPRs, the Ericsson holding rests upon conclusions of law that the Saint Regis panel directly contradicts without providing any explanation.

In the Saint Regis proceeding, PTAB simply asserted that tribal immunity is different and moved on. However, tribal sovereign immunity is not different from state sovereign immunity in this context. Both doctrines promote the dignity of the sovereign, while helping protect the sovereign’s economic well-being—the latter reason being even more compelling for tribal sovereign immunity given the economic difficulties tribes experience compared to states. The better result would have been to extend Ericsson and Covidien to find that tribal sovereign immunity applies in IPRs. Unfortunately, the decision appeared to be motivated by a desire to stop deals like one between Allergan and Saint Regis from becoming an option for patent owners.[192] The main difference between the state proceedings and the tribal proceeding is that the tribal proceeding garnered significant negative press. Unfortunately, simply shutting down the Allergan-Saint Regis deal ignores the negative impacts on tribal sovereign immunity going forward.

    1.  The Federal Circuit Decision to Not Apply Tribal Sovereign Immunity in an IPR Proceeding

The Federal Circuit approached the question of whether tribal sovereign immunity applies in IPRs in much the same way as PTAB did, also finding that tribal sovereign immunity does not apply in IPRs.[193] After briefly discussing the case’s procedural history, the Federal Circuit began by laying out the rules of tribal sovereign immunity. It noted that “[g]enerally, immunity does not apply where the federal government . . . engages in an investigative action or pursues an adjudicatory agency action,” while acknowledging the FMC rule that immunity can “apply in federal agency proceedings.[194] The court described the FMC rule as allowing immunity in “adjudicative proceedings brought . . . by a private party,” but not allowing immunity in “agency-initiated enforcement proceedings.”[195] Therefore, the key question in front of the Federal Circuit was which of these two types proceedings is most analogous to IPRs.[196]

 However, answering this question was not straightforward for the Federal Circuit, as it noted IPRs are complicated, “hybrid proceeding[s]” that combine both traditional adjudicatory aspects with characteristics similar to “specialized agency proceeding[s].”[197] The Federal Circuit reviewed “several factors” that led it to determine that “IPR[s] [are] more like an agency enforcement action than a civil suit.”[198]

 First, IPRs are only instituted if the USPTO Director decides to grant review, much like a traditional enforcement action. While it is a private party that requests the review, the Director has “broad discretion in deciding whether to institute review.”[199] Therefore, IPRs are unlike the agency in FMC, which could not refuse to adjudicate private complaints. This means that a federal official is the one deciding to haul a sovereign into “court,” rather than a private party. Second, even though most IPRs are conducted in an adversarial nature between two private parties, the USPTO retains the ability to “continue review even if [a party] chooses not to participate.”[200]

 Next, the Federal Circuit pointed to the “substantial” differences between IPR procedures and the Federal Rules of Civil procedure.[201] It noted the far greater extent of discovery in district court litigation, the opportunity for live testimony at trial, and various differences in pleadings, with the Federal Rules being more liberal in allowing changes. Finally, the Federal Circuit noted that despite the USPTO having options for reexamination that are more inquisitorial than IPR proceedings—in which even the tribe acknowledged sovereign immunity would not apply under FMCthe existence of these options does not make IPRs adjudicatory proceedings. Rather “[w]hile IPR[s] present a closer case for the application of tribal immunity than reexamination, [the Federal Circuit] nonetheless conclude[d] that tribal immunity does not extend to these . . . reconsideration decisions.”[202] In deciding this, the court noted that IPRs are intended to “reexamine . . . agency decision[s].”[203]

 This decision suffers from many of the same issues that the PTAB decision suffered from, which will not be rehashed here. Further issues with the decision will be discussed in Part IV—with a particular focus on how the Federal Circuit incorrectly conceived of IPRs as agency enforcement actions rather than administrative adjudications. In addition to the faulty legal analysis, the bigger issue is the effect of this decision: tribal sovereign immunity cannot be invoked during IPRs, while state sovereign immunity can be. This creates a sort of second-class immunity for the very sovereigns that need the immunity most.

IV.  TRIBAL SOVEREIGN IMMUNITY’S UNEQUAL STATUS WITH STATE SOVEREIGN IMMUNITY

 With its decision in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals, Inc., the Federal Circuit established that tribal sovereign immunity does not apply in IPRs.[204] However, as discussed in Section I.B.2, PTAB decisions have previously found that states can invoke their sovereign immunity from suit when having their patents challenged in an IPR proceeding. The reason for this comes from inconsistent legal positions on how to conceive IPRs—that is, treating them as either adjudicatory agency actions or as agency enforcement actions. This inconsistency will be discussed below in Section IV.A.2, which contemplates how to address this inconsistency, while Section IV.A.1 argues that in addition to this inconsistency being based on legal error, this inequality in immunity is normatively undesirable for the way that it negatively impacts tribes, ultimately depriving them of a benefit bestowed on other sovereigns for no just reason.

A. The Inconsistency

 In Saint Regis, the Federal Circuit explicitly did not decide whether state sovereign immunity applies in IPRs; instead, it only explained that tribal sovereign immunity.[205] By leaving this question unanswered, prior PTAB decisions allowing states to invoke their sovereign immunity IPR proceedings were left on shaky footing.[206] This inconsistency in whether states and tribes are allowed to invoke their sovereign immunities in IPRs stems from the conception of the IPR proceeding itself as either adjudicative or enforcement-based. Currently, states can assert their sovereign immunity in IPR proceedings because IPRs are allegedly similar to adjudicative actions, while tribes may not assert their sovereign immunity in IPR proceedings because IPRs are supposedly more similar to enforcement actions.[207]

1.  This Inconsistency Matters and Should Be Fixed

  At a basic level, this inconsistency matters because it stems from an inconsistent legal position taken on the conception of IPRs—adjudicative versus enforcement—rather than a real, substantive differences between tribal and state sovereign immunity.[208]

 This inconsistent treatment of the nature of IPRs should be addressed, and the proper resolution should be that IPRs are similar to district court litigation such that, under FMC, sovereign immunity should apply.[209] First, In the USPTO’s own words, IPRs are trial proceeding[s] adjudicated before PTAB.[210] They are very similar to civil litigation in that they are an adversarial process with discovery, deadlines, and binding decisions. As discussed by PTAB in both Covidien and Ericsson, IPRs share a number of similarities with district court patent litigation.[211] IPRs are initiated by a third party, typically a competitor of the patent owner.[212] Moreover, the proceeding contains many of the safeguards for its participants that district court litigation does, including the prevention of harassment, clear pleading rules, and impartial, politically-insulated decisionmakers.[213]

 Further, the Code of Federal Regulations even provides IPR practitioners with a “trial practice” guide for when they appear “before the patent trial and appeal board,[214] further indicating the specific design of IPR practice to be modeled on civil litigation. A review of the legislative history surrounding the creation of IPRs is consistent with this. The framers of the process envisioned IPRs as adjudicative proceedings, not an enforcement proceeding.[215] Congressional intent appears to have been that “IPRs [are] to serve as a substitute for district court litigation with respect to the key issue of validity.”[216] Based on the similarities of IPR and district court litigation, the FMC framework should apply, meaning that sovereign immunity can be invoked in an IPR from a legal standpoint.[217]

 Beyond just the improper conception of IPRs adopted by PTAB and the Federal Circuit in this case, state and tribal sovereign immunity do not differ enough for this result. In fact, while there are legal differences between tribal and state sovereign immunity, any legal difference between the doctrines should actually break in favor of tribal immunity for both legal and normative reasons.

 First, tribes were not present at the original Constitutional Convention. While they were considered during the drafting of the Constitution and by the early U.S. governments in treaty discussions,[218] tribes did not have any actual input into either the drafting or the ratification of the Constitution. This is quite unlike states, which played an essential role in both drafting and ratification.[219] Given states roles in the drafting of the Constitution, a state sovereign immunity doctrine has developed which says that states can be found to have given up their immunity in some contexts in the “plan of the convention.”[220] While this is a limited doctrine in the state sovereign immunity context—state sovereign immunity case law is largely grounded in the Eleventh Amendment—it does not apply to tribes. Tribes were not present at the convention and, thus, cannot be said to have waived any immunity in the “plan of the convention.” Therefore, in many respects, tribal sovereign immunity is broader than state.[221]

 Second, the Supreme Court, in both Kiowa and Bay Mills, has made it clear that absent actual waiver by a tribe, tribal sovereign immunity does not apply only when Congress has clearly decided to abrogate it. Here, no abrogation occurred, despite former Senator Claire McCaskill introducing legislation to do so. When introducing her legislation, she expressed outrage that it was “one of the most brazen and absurd loopholes I’ve ever seen, and it should be illegal.”[222] However, since the bill was introduced in October 2017, it has not made any progress in Congress. This possibly reflects its status a low priority item for a Congress that has issues passing legislation higher on its priority list. In addition, Congress has been hesitant in the past to abrogate tribal sovereign immunity. As mentioned in Bay Mills, Congress considered abrogating tribal sovereign immunity in the context of commercial, off-reservation activity, but declined to act despite the potentially bad consequences of allowing tribes to engage in such commercial activity without the possibility of being held accountable in court. Given congressional silence in the face of knowing about the problem, courts should be wary of taking actions that fly in the face of Congress’s decision, especially given the Supreme Court’s emphasis on deferring to Congress on issues of tribal sovereign immunity.

Yet beyond these legal issues, there are normative reasons to be concerned about as well. First, courts should be wary of abrogating tribal sovereignty because they should wish to show tribes their due respect as sovereigns. Courts should not want to damage the financial health of the tribes; statistics show poor economic health in tribal territory. For example, “[f]ive of the poorest [ten] counties in the United States are in Indian country.”[223] Therefore, courts should tread lightly when considering any action that that could economically cripple a tribe, including taking away their tribal sovereign immunity in IPRs, which puts them at a disadvantage compared to states. States are still able to take advantage of their sovereign immunity in IPRs and, thus, as discussed in Section II.A, would have strong incentives to engage in these deals with patent owners.

Further, a key reason to promote the doctrine of sovereign immunity is to show the sovereign the respect that it is owed as a sovereign. Treating tribes and states differently here sends the message that tribes are lesser sovereigns than states. Given a long history of tribal oppression in the United States, effort should be made to foster respect owed to these sovereign entities. Legal rules that do the opposite should be renounced or, at least, reconsidered.

2.  Addressing the Inconsistency

 The Supreme Court should review and reverse the Federal Circuit ruling, allowing tribal sovereign immunity to apply in IPRs. In late 2018, Saint Regis appealed the Federal Circuit ruling to the Supreme Court.[224] There is a possibility that “[t]his case is headed for the Supreme Court,[225] where it will likely be reversed. This is the most desirable option available because it accomplishes several things. First, it puts tribes and states back on an even playing field when it comes to IPR sovereign immunity. This is beneficial because being able to assert sovereign immunity in an IPR proceeding is an economic benefit, as evidenced by how the Saint Regis tribe and others began to eagerly promote this service.[226] In addition, it reinstates tribes as equal sovereigns to states, thus allowing them to regain respect that is owed to them as sovereigns.

 In the absence of Supreme Court intervention, PTAB and the Federal Circuit could reverse their view on state sovereign immunity.[227] This alternative response would require PTAB to reverse course and disallow state sovereign immunity from applying in IPRs. While this is not normatively desirable, this would be the response most consistent with the Federal Circuit’s approach in Saint Regis, given how it framed IPRs as an enforcement proceeding.[228] However, the Federal Circuit’s Saint Regis opinion suffers from serious flaws in how it conceives of IPRs—it is also flawed because it largely ignores tribal sovereign immunity case law—and, therefore, its legal error should be reversed rather than extended, making this an undesirable option even though it has the benefit of putting tribes and states on an even playing field in IPRs.

CONCLUSION

In order to ensure that tribes are respected as co-sovereigns, tribal sovereign immunity should be found to apply in IPRs. There has been no congressional abrogation and state sovereign immunity has typically applied in such proceedings. As such, the Allergan-Saint Regis deal should be upheld. The Supreme Court should reverse the Federal Circuit decision preventing Saint Regis from asserting its immunity for several reasonsthe Federal Circuit misunderstood the essential adversarial nature of IPR proceedings, the Supreme Court’s jurisprudence on state and tribal sovereign immunity, and the reasons underlying the sovereign immunity doctrine. This incorrect result is fundamentally unjust, treating sovereign tribes as lesser than states for no good reason. This improper ruling calls for immediate Supreme Court intervention and reversal.

In addition, the Allergan-Saint Regis deal highlighted many issues of pressing importance. Going forward, these issues are in need of more public debateon topics such as the financial situation of tribes and issues patent owners have with IPR proceedings. Each problem requires further study, thought, and innovation to be properly solved. However, as a first step, the Supreme Court should step in and fix the errors of PTAB and the Federal Circuit, restoring the proper respect owed to tribe sovereigns.

 


[*] *. Editor-in-Chief, Southern California Law Review, Volume 92; J.D. Candidate 2019, University of Southern California Gould School of Law; M.S. Mechanical Engineering 2013, University of Minnesota; B.A. Physics 2012, Saint John’s University. I am eternally grateful to my incredible wife, Margaret, for her endless love, support, and patience over the last three years. Thank you to my parents, Jim and Teri, for all their encouragement and support. In addition, thank you to Professor Sam Erman for his guidance, time, and input as I worked through many versions of this Note. Finally, thank you to Katie Schmidt, Karen Blevins, Kevin Ganley, and the rest of the talented Southern California Law Review editors for their great work.

 [1]. U.S. Const. art. I, § 8, cl. 3; see also Matthew L.M. Fletcher, A Short History of Indian Law in the Supreme Court, Hum. Rts., Spring 2015, at 3, 3, https://papers.ssrn.com/sol3/papers.cfm?abstract
_id=2616802.

 [2]. See Gregory Ablavsky, Tribal Sovereign Immunity and Patent Law, SLS Blogs: Legal Aggregate (Sept. 13, 2017), https://law.stanford.edu/2017/09/13/tribal-sovereign-immunity-and-patent
-law (“Congress can readily use its plenary power to abrogate tribal sovereign immunity in patent law.”).

 [3]. Fletcher, supra note 1; see also U.S. Const. amend. XI. There is an academic debate over the precise contours of state sovereign immunity under the Eleventh Amendment and whether or not it actually enshrines state sovereign immunity. See, e.g., William A. Fletcher, A Historical Interpretation of the Eleventh Amendment: A Narrow Construction of an Affirmative Grant of Jurisdiction Rather Than a Prohibition Against Jurisdiction, 35 Stan. L. Rev. 1033, 1035 (1982). This Note does not opine on this issue.

 [4]. Sovereign Immunity, Black’s Law Dictionary (6th ed. 1990).

 [5]. See infra Section I.B for further discussion of state sovereign immunity’s meaning and the Supreme Court’s jurisprudence on the subject.

 [6]. Id. The differences between tribal sovereign immunity and state sovereign immunity are discussed infra Part III. However, at the outset, it is important to remember that state sovereign immunity is based on the Eleventh Amendment of the Constitution, while tribal sovereign immunity is not enshrined in a specific constitutional amendment; rather, it is federal common law. See Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751, 764–65 (1998) (Stevens, J., dissenting).

 [7]. Restasis is most commonly used to treat dry eye but can also be used to treat more serious medical conditions. See Allergan, About RESTASIS® and RESTASIS MultiDose®, Restasis, https://www.restasis.com/about-restasis-and-restasis-multidose (last visited Mar. 29, 2019); Restasis Patient Information Including Side Effects, RxList, https://www.rxlist.com/restasis-drug/patient-images-side-effects.htm (last visited Apr. 18, 2019).

 [8]. Katie Thomas, How to Protect a Drug Patent? Give It to a Native American Tribe, N.Y. Times (Sept. 8, 2017), https://www.nytimes.com/2017/09/08/health/allergan-patent-tribe.html.

 [9]. Press Release, Allergan, Allergan and Saint Regis Mohawk Tribe Announce Agreements Regarding RESTASIS® Patents (Sept. 8, 2017), https://www.allergan.com/news/news/thomson-reuters
/allergan-and-saint-regis-mohawk-tribe-announce-agr. The Restasis patent expires in 2024, and its value has been estimated at $1.5 billion. Id.; Jan Wolfe, Allergan Ruling Casts Doubt on Tribal Patent Strategy, Reuters (Oct. 17, 2017, 3:10 PM), https://www.reuters.com/article/us-allergan-patents-analysis
/allergan-ruling-casts-doubt-on-tribal-patent-strategy-idUSKBN1CM369.

 [10]. Inter Partes Review, U.S. Pat. & Trademark Off., https://www.uspto.gov/patents-application-process/appealing-patent-decisions/trials/inter-partes-review (last visited Mar. 29, 2019) [hereinafter Inter Partes Review, U.S. Pat. & Trademark Off.]; Inter Partes Review Replaces Inter Partes Reexamination, Taft, Stettinius & Hollister LLP (Oct. 5, 2012), https://www.taftlaw.com
/news-events/law-bulletins/inter-partes-review-replaces-inter-partes-reexamination.

 [11]. Inter Partes Review, U.S. Pat. & Trademark Off., supra note 10.

 [12]. Wolfe, supra note 9 (discussing a quote from Judge William Bryson of the Federal Circuit that casts the legality of “rent[ing]” a tribe’s sovereign immunity into doubt).

 [13]. S. 1948, 115th Cong. (2017).

 [14]. See infra Section II.A.

 [15]. Lawrence Hoffman, Inter Partes Review: Good or Bad for Patent Owners, Ehrlich & Fenster (Dec. 18, 2016), http://www.ipatent.co.il/inter-partes-review-good-or-bad-for-patent-owners.

 [16]. The Supreme Court affirmed the constitutionality of the IPR process in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 138 S. Ct. 1365, 1370 (2018). The case challenged IPR constitutionality because IPRs extinguish private property rights (patents) through a non-Article III venue. Id. at 137273. The precise details of this case are beyond the scope of this Note; however, the key takeaway is that IPRs are constitutional.

 [17]. For a more detailed discussion of the deal’s upsides, see infra Part II.

 [18]. See Susan Decker, Tribal Lawyer Shops Patent-Shielding Idea to State Universities, Bloomberg L. (Oct. 19, 2017, 1:11 PM), https://news.bloomberglaw.com/corporate-law/triballawyer-shops-patent-shielding-idea-to-state-universities.

 [19]. Id.

 [20]. It is important to keep in mind that while deals like this prevent patents from being invalidated by IPR, such patents may still be challenged when asserted in district court litigation. In nearly all patent litigation, the alleged infringer argues that the patent being asserted against them is invalid. In such cases, the patent owner will not be able to assert tribal sovereign immunity as they will have been deemed to have waived their immunity by entering the forum through litigation.

 [21]. Saint Regis Mohawk Tribe v. Mylan Pharm., Inc., 896 F.3d 1322, 1325 (Fed. Cir. 2018); see also Gene Quinn, Federal Circuit Rules Tribal Sovereign Immunity Cannot Be Asserted in IPRs, IPWatchdog (July 20, 2018), https://www.ipwatchdog.com/2018/07/20/federal-circuit-tribal-sovereign
-immunity-cannot-asserted-iprs/id=99504.

 [22]. States could engage in these deals in addition to tribes. Therefore, even if the Federal Circuit decision finding that tribal sovereign immunity does not apply in IPRs is upheld, Congress may still face pressure to address this issue because it could become widespread if a few cash-needy states engage in these deals.

 [23]. However, actual proposals for improving the IPR system go beyond the scope of this Note, which focuses on the application of tribal sovereign immunity to IPR proceedings.

 [24]. The Patent Trial and Appeals Board (“PTAB”) hears IPR challenges and is located inside the USPTO. 35 U.S.C. § 6(a)(b) (2012). The USPTO is part of the federal government’s executive branch.

 [25]. Many of these issues stem from issues with the IPR proceeding itself. While an evaluation of the IPR proceeding is beyond the scope of this Note, if IPRs are part of the problem, a good congressional response would be to reform the IPR proceeding, thus reducing incentives for patent owners to engage in these deals. This approach would leave tribal sovereign immunity in place as a defense in IPRs (which as this Note argues infra Parts III and IV is normatively desirable), while focusing on reforming the IPR system such that it may no longer be considered a “death trap” for patent owners.

 [26]. See infra Section I.A.

 [27]. Sovereign Immunity, supra note 4.

 [28]. U.S. Const. art. I, § 8, cl. 3.

 [29]. William Wood, It Wasn’t an Accident: The Tribal Sovereign Immunity Story, 62 Am. U. L. Rev. 1587, 1625 (2013).

 [30]. Cherokee Nation v. Georgia, 30 U.S. (5 Pet.) 1, 17 (1831).

 [31]. Wood, supra note 29, at 1641 (quoting Parks v. Ross, 52 U.S. (11 How.) 362, 374 (1850) (second alteration in original)).

 [32]. Santa Clara Pueblo v. Martinez, 436 U.S. 49, 58 (1978) (holding a tribe was immune from an action taken to enforce the Indian Civil Rights Act in federal court through declaratory and injunctive relief). Additionally, in Santa Clara Pueblo, the Supreme Court elaborated on reasons for this immunity such as the financial burdens that being subject to suit could impose on the “financially disadvantaged” tribes. Id. at 64.

 [33]. United States v. Wheeler, 435 U.S. 313, 322 (1978) (emphasis omitted).

 [34]. Id. at 323 (discussing Congress’s plenary power to regulate the conduct of tribes).

 [35]. Michigan v. Bay Mills Indian Cmty., 572 U.S. 782, 790 (2014).

 [36]. Upper Skagit Indian Tribe v. Lundgren, 138 S. Ct. 1649, 1654–55 (2018).

 [37]. Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751, 760 (1998).

 [38]. Id. at 753–54.

 [39]. Id.

 [40]. Id. at 754.

 [41]. Id.

 [42]. Id. at 753–54.

 [43]. Id. at 754.

 [44]. Id. at 756. Justice Kennedy explains this phenomenon in his opinion by arguing that Turner v. United States, 248 U.S. 354, 355 (1919), the case cited for the proposition that tribes enjoy immunity from suit, did not originally stand for this particular proposition. Rather, Justice Kennedy believes that tribal sovereign doctrine only came to exist through the Court’s subsequent decision in United States v. U.S. Fidelity & Guaranty Co., 309 U.S. 506 (1940). But see Wood, supra note 29, at 1587 (criticizing Kennedy’s historical analysis of the doctrine’s development).

 [45]. Kiowa, 523 U.S. at 758.

 [46]. Id. at 758–59.

 [47]. See Michigan v. Bay Mills Indian Cmty., 572 U.S. 782, 788–90 (2014).

 [48]. Id. at 791.

 [49]. Id. at 791–804 (evaluating Indian Gaming Regulatory Act provisions).

 [50]. Id. at 796–97. The Court explained its reasoning as follows:

If a State really wants to sue a tribe for gaming outside Indian lands, the State need only bargain for a waiver of immunity. . . . States have more than enough leverage to obtain such terms because a tribe cannot conduct class III gaming on its lands without a compact . . . and cannot sue to enforce a State’s duty to negotiate a compact in good faith . . . . So as Michigan forthrightly acknowledges, ‘a party dealing with a tribe in contract negotiations has the power to protect itself by refusing to deal absent the tribe’s waiver of sovereign immunity from suit.’ . . . And many States have taken that path.

Id. (citations omitted).

 [51]. This reasoning would not apply in the Allergan-Saint Regis case. There, waiver of sovereign immunity would not be negotiable by third parties as the third parties by definition were not present when the licensing deal was made. It is interesting though that when Allergan made this deal with Saint Regis, it secured a limited waiver of the Tribe’s immunity as it related to any potential litigation arising from the deal. See Mylan Pharm., Inc. v. Saint Regis Mohawk Tribe, No. IPR2016-01127, 2018 WL 1100950, at *10 (P.T.A.B. Feb. 23, 2018) (denying Saint Regis’s motion to terminate the proceeding).

 [52]. Bay Mills, 572 U.S. at 798 (explaining that the Kiowa Court positioned itself as simply following well-established precedent that tribal immunity does not have “any exceptions for commercial or off-reservation conduct”).

 [53]. Id. at 799.

 [54]. Id at 798–801.

 [55]. Id.

 [56]. Id. at 802–03.

 [57]. Id.

 [58]. Upper Skagit Indian Tribe v. Lundgren, 138 S. Ct. 1649 (2018).

 [59]. Andrew Westney, Justices May Cinch Immunity Loophole in Upper Skagit Case, Law360 (Feb. 1, 2018), https://www.law360.com/articles/1008098/justices-may-cinch-immunity-loophole-in-upper-skagit-case.

 [60]. Id.

 [61]. Id.

 [62]. Upper Skagit, 138 S. Ct. at 1654–55.

 [63]. See id. at 1651–53.

 [64]. See id. at 1654.

 [65]. Id.

 [66]. Id. at 1661–63 (Thomas, J., dissenting).

 [67]. Id. at 1663.

 [68]. However, as will be discussed infra Part III, neither PTAB or the Federal Circuit relied on reasoning similar to Justice Thomas’s to decide that tribal immunity does not apply in IPR.

 [69]. U.S. Const. art. I, § 8, cl. 3 (“[R]egulate commerce with foreign nations, and among the several states, and with the Indian tribes.”).

 [70]. See U.S. Const. amend. XI.

 [71]. Id.

 [72]. Hans v. Louisiana, 134 U.S. 1, 18–20 (1890) (holding that despite clear textual language to the contrary, citizens of a state are not allowed to sue the state of which they are a citizen).

 [73]. See, e.g., Seminole Tribe of Fla. v. Florida, 517 U.S. 44, 56–­57 (1996).

 [74]. As mentioned supra note 3, the specific nuances of state sovereign immunity are beyond the scope of this Note.

 [75]. See Seminole Tribe, 517 U.S. at 72.

 [76]. A holding on this issue would be instructive for the Allergan-Saint Regis case because Allergan’s patent was having its validity challenged in IPR when the deal took place.

 [77]. Fla. Prepaid Postsecondary Educ. Expense Bd. v. Coll. Sav. Bank, 527 U.S. 627, 630 (1999).

 [78]. Id. at 632 (citation omitted) (providing the statute at issue’s language, which clearly abrogated state sovereign immunity).

 [79]. Id. at 636–37 (discussing Seminole Tribe, 517 U.S. at 59).

 [80]. See Seminole Tribe, 517 U.S. at 59 (discussing Fitzpatrick v. Bitzer, 427 U.S. 445, 452–56 (1976)).

 [81]. Fla. Prepaid, 527 U.S. at 636–37 (discussing Seminole Tribe, 517 U.S. at 59–60).

 [82]. Id.

 [83]. City of Boerne v. Flores, 521 U.S. 507, 520 (1997).

 [84]. Fla. Prepaid, at 646–47. The Court evaluated the various requirements introduced in City of Boerne. See City of Boerne, 521 U.S. at 520. A deeper discussion of these requirements is beyond the scope of this Note.

 [85]. There are two ways a state’s patent could be challenged. First, the patent could be challenged in a post-grant proceeding at the Patent Office such as an IPR proceeding. Second, in a case where the state is the plaintiff, the defendant (that is, the alleged infringer) could challenge the patent’s validity during district court litigation. See David Carnes, How to Challenge a Patent, Legalzoom, https://info.legalzoom.com/challenge-patent-21969.html (last visited Mar. 31, 2019). IPRs are the only venue in which sovereign immunity could be helpful because by filing suit against an alleged infringer, the sovereign would be deemed to have waived its immunity for the purposes of that litigation.

 [86]. See Biomedical Patent Mgmt. Corp. v. California, 505 F.3d 1328, 1343 (Fed. Cir. 2007).

 [87]. Catherine Garza & Paula Heyman, Sovereign Immunity Protects State-Funded Patent Owners from Post-Grant Proceedings, Lexology: PTAB Trials Blog (Apr. 11, 2017), https://www.lexology.com/library/detail.aspx?g=d1a3c68b-efdc-4c16-bae8-d5fdd2b6feba (noting that neither the Supreme Court nor the Federal Circuit has addressed this question).

 [88]. Fed. Mar. Comm’n v. S.C. State Ports Auth. (FMC), 535 U.S. 743, 760 (2002) (holding that a state entity was immune from an adjudication at the Federal Maritime Commission because of the similarities that such proceedings have with civil litigation).

 [89]. Appeals of PTAB decisions are reviewed by the Federal Circuit. Court Jurisdiction, U.S. Court of Appeals for the Fed. Circuit, http://www.cafc.uscourts.gov/the-court/court-jurisdiction (last visited Mar. 31, 2019). The Federal Circuit has exclusive appellate jurisdiction over all patent cases that occur in federal district court. Federal Circuit decisions, along with Supreme Court decisions, are binding in the realm of patent law on PTAB and federal district courts. See id.

 [90]. In interference proceedings, the Patent Office seeks to settle a dispute over which party invented the patented product or method first. See Introduction to USPTO Patent Interference Practice, McNeely, Hare & War LLP, http://www.patentek.com/patent-interference-overview (last visited Mar. 31, 2019). This proceeding was necessary because the United States patent system granted a patent to the first inventor. However, in 2011, Congress passed the America Invents Act, which eliminated interferences as a part of patent law in the United States. Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 290 (2011). This is because the law altered the patent system to a first-to-file system, where the first entity to file for a patent is granted the patent, regardless of who invented it first. See Introduction to USPTO Patent Interference Practice, supra.

 [91]. Vas-Cath, Inc. v. Curators of the Univ. of Mo., 473 F.3d 1376, 1382 (Fed. Cir. 2007) (holding that the reasoning in FMC applied to interference proceedings because they “bear ‘strong similarities’ to civil litigation, . . . can indeed be characterized as a lawsuit”).

 [92]. Garza & Heyman, supra note 87.

 [93]. See Covidien LP v. Univ. of Fla. Research Found. Inc., No. IPR2016-1274, 2017 WL 4015009, at *1 (P.T.A.B. Jan. 25, 2017).

 [94]. Garza & Heyman, supra note 87.

 [95]. Covidien, 2017 WL 4015009, at *5.

 [96]. Id.

 [97]. Id. at *6 (presenting the argument from the party challenging the patent).

 [98]. Id. at *6 (quoting Fed. Mar. Comm’n v. S.C. State Ports Auth., 535 U.S. 743, 765 (2002)).

 [99]. Id. Note that this conception of IPR means that the ultimate disposition of Upper Skagit, discussed supra Section I.A.3., would not be applicable. That case concerns whether the “immovable property” exception applies to tribal sovereign immunity. Upper Skagit Indian Tribe v. Lundgren, 138 S. Ct. 1649, 1654 (2018). The point of that exception, as noted by Justice Thomas in dissent, is that sovereign immunity should not extend to actions over property within another sovereign’s jurisdiction. Upper Skagit, 138 S. Ct. at 1661–63 (Thomas, J., dissenting). Here, given the Patent Clause of the Constitution, exclusive jurisdiction is given to the federal government over patents. See U.S. Const. art. I, § 8, cl. 8. This means that patents are a property exclusively of federal jurisdiction, much like a physical property is exclusively within a state’s jurisdiction. Therefore, extending Justice Thomas’s view to the IPR case, would mean that sovereign immunity should not apply in IPRs due to the fact that patents are exclusively within federal jurisdiction. However, since PTAB views IPRs as adversarial in Covidien, this type of analysis is inapplicable.

 [100]. Covidien, 2017 WL 4015009, at *8. The FMC approach is used to determine whether sovereign immunity applies in administrative proceedings. IPRs are an administrative proceeding.

 [101]. Id. at *9 (emphasis omitted) (quoting FMC, 535 U.S. at 765).

 [102]. Id.

 [103]. Id. The PTAB decision extensively details all the ways that IPRs resemble civil litigation in federal courts. See id. at *9–11.

 [104]. Id. at *12.

 [105]. Id. at *11 (“Petitioner additionally argues that immunizing patents owned by alleged state entities from IPR proceedings would have harmful and far-reaching consequences.” (internal citation omitted)).

 [106]. Id. at *11.

 [107]. Id.

 [108]. Id. at *12. There is still no evidence available which shows that allowing state sovereign immunity to be asserted in IPRs causes any harm to the patent system. It seems possible, however, that this harm could surface if states begin setting up their own deals with patent owners who wish to take advantage of state sovereign immunity, much like the Allergan-Saint Regis deal. In fact, in light of the Federal Circuit’s refusal to allow tribal sovereign immunity in IPRs, it is possible patent owners may begin seeking deals with states or state-owned entities, thus, “renting” their sovereign immunity.

 [109]. Anthony Blum, PTAB Offers Clarification on Inter Partes Review and State Sovereign Immunity, Thompson Coburn LLP (Dec. 22, 2017), https://www.thompsoncoburn.com/insights/              publications/item/2017-12-22/ptab-offers-clarification-on-inter-partes-review-and-sovereign-immunity (noting that seven administrative patent judges heard this case in contrast to the usual three judges).

 [110]. Ericsson Inc. v. Regents of the Univ. of Minn., No. IPR2017-01186, 2017 WL 6517563, at

*1 (P.T.A.B. Dec. 19, 2017) (expanded panel).

 [111]. Blum, supra note 109.

 [112]. Ericsson, 2017 WL 6517563, at *2.

 [113]. Id. PTAB also utilized the FMC holding that state sovereign immunity can be invoked in administrative proceedings.

 [114]. Id.

 [115]. Id. at *2–3.

 [116]. Id. at *4.

 [117]. Saint Regis Mohawk Tribe v. Mylan Pharm., Inc., 896 F.3d 1322 (Fed. Cir. 2018).

 [118]. See, e.g., Blum, supra note 109.

 [119]. Id.

 [120]. At the time of writing, no appeals were pending on this issue.

 [121]. In Saint Regis Mohawk Tribe v. Mylan Pharmaceutical, Inc., the Federal Circuit noted that it had not opined on state sovereign immunity’s application in IPRs, saying in its decision that made tribal sovereign immunity inapplicable that “we are only deciding whether tribal immunity applies in IPR. While we recognize there are many parallels, we leave for another day the question of whether there is any reason to treat state sovereign immunity differently.” Saint Regis Mohawk Tribe v. Mylan Pharm., Inc., 896 F.3d 1322, 1329 (Fed. Cir. 2018).

 [122]. David C. Seastrunk et al., Federal Circuit PTAB Appeal Statistics – January 15, 2018, Finnegan LLP (Feb. 6, 2018) https://www.finnegan.com/en/insights/blogs/america-invents-act/federal-circuit-ptab-appeal-statistics-January-15-2018.html.

 [123]. Thomas P. McLish, Tribal Sovereign Immunity: Searching for Sensible Limits, 88 Colum. L. Rev. 173, 174 (1988) (alteration in original) (citation omitted).

 [124]. Id.

 [125]. Id.

 [126]. Id.

 [127]. Id. at 174–75 (noting a large majority of the states have either completely or partially waived their sovereign immunity from suit).

 [128]. See Michigan v. Bay Mills Indian Cmty., 572 U.S. 782, 804–07 (2014) (Sotomayor, J., concurring).

 [129]. Id.; see also supra Sections I.A.1. and I.A.2. (discussing Bay Mills and its doctrinal underpinnings in detail). Justice Sotomayor agreed with the majority opinion’s application of sovereign immunity on stare decisis grounds but concurred to provide normative justifications for the doctrine to address critics of who no longer saw it serving any purpose.

 [130]. Id. at 809 (internal quotation marks omitted) (noting that nearly half of all tribes in the United States do not operate casinos and that among the tribes that do operate casinos only a small percentage of them reap most of the profits).

 [131]. Id. at 810.

 [132]. Joseph P. Kalt & Joseph William Singer, Myths and Realities of Tribal Sovereignty: The Law and Economics of Indian Self-Rule 17 (Harvard Univ. John F. Kennedy Sch. of Gov’t Faculty Research Working Papers Series, Paper No. RWP04-016, 2004) (discussing the holding of Atkinson Trading Co. v. Shirley, 532 U.S. 645 (2001)).

 [133]. Kelly S. Croman & Jonathan B. Taylor, Why Beggar Thy Indian Neighbor? The Case for Tribal Primacy in Taxation in Indian Country 5 (Joint Occasional Papers on Native Affairs, JOPNA 2016-1, 2016), http://nni.arizona.edu/application/files/8914/6254/9090/2016_Croman_why_beggar_thy
_Indian_neighbor.pdf.

 [134]. Id.

 [135]. Id. Croman and Taylor also note that reservations are subject to state property taxes within the boundaries of the reservation unless they have been given an exemption under state law. Id.

 [136]. Id.

 [137]. Id.

 [138]. Id.

 [139]. Note, In Defense of Tribal Sovereign Immunity, 95 Harv. L. Rev. 1058, 1069 (1982). In addition, this idea can be related back to the idea that the “King” does “no wrong.” See supra Section I.C.

 [140]. Remember that tribes are “domestic dependent nations” and, as such, the scope of tribal sovereignty is limited by the sovereign on which they depend: the federal government. The limitations placed on tribal sovereign immunity give meaning to the tribe’s “dependent” status by recognizing that they are, in a sense, inferior to the federal government.

 [141]. Obviously, the dependent status of tribes still exists in the United States, but to the extent possible, tribes should be treated as a sovereign.

 [142]. See In Defense of Tribal Sovereign Immunity, supra note 139, at 1069–70.

 [143]. See id.

 [144]. While there is debate about this point, law can be conceptualized as—at least partly—reflecting the culture from which it springs. See, e.g., Iris I. Varner & Katrin Varner, The Relationship Between Culture and Legal Systems and the Impact on Intercultural Business Communication, 3 Global Advances Bus. & Comm. Conf. & J., no. 1, 2014, at 1, 2–3.

 [145]. There will be some crossover as tribes are “domestic dependent nations” that are subject to the constraints of the United States Constitution and laws passed by Congress. However, sovereign immunity still provides some level of protection in this area. Evaluating how much protection is beyond the scope of this Note.

 [146]. See Wood, supra note 29, at 1619.

 [147]. Id. at 1619–20 (noting additionally that protecting a state’s treasury was still a meaningful purpose of the Eleventh Amendment).

 [148]. Carlos Quijada, Patents and Tribal Sovereign Immunity, Univ. of Utah S.J. Quinney Coll. of Law: LABS Blog (Oct. 23, 2017), https://www.law.utah.edu/patents-and-tribal-sovereign-immunity.

 [149]. Dan Schneider & James Edwards, Open Letter from Conservatives: What’s at Stake in Oil States v. Greene’s Energy Group, IPWatchdog (Nov. 28, 2017), http://www.ipwatchdog.com
/2017/11/28/conservatives-open-letter-oil-states-v-greenes-energy-group/id=90579.

 [150]. Steve Brachmann & Gene Quinn, 58 Patents Upheld in District Court Invalidated by PTAB on Same Grounds, IPWatchdog (Jan. 8, 2018), http://www.ipwatchdog.com/2018/01/08/58-patents-upheld-district-court-invalidated-ptab/id=91902.

 [151]. Wolfe, supra note 9.

 [152]. Michael Erman, Allergan to Cut Over 1,000 Jobs as It Works to Cut Costs, Reuters (Jan. 3, 2018, 8:59 AM), https://www.reuters.com/article/us-allergan-layoffs/allergan-to-cut-over-1000-jobs-as-it-works-to-cut-costs-idUSKBN1ES1HN.

 [153]. Patents such as Restasis also represent the reward after substantial investment by the company.

 [154]. Again, while the Federal Circuit has said that tribal immunity does not apply, these numbers are emblematic of the massive economic incentive that patent owners have to engage in these types of workarounds.

 [155]. These deals help protect and grow tribal resources, which is one of the purposes of tribal sovereign immunity.

 [156]. Quijada, supra note 148.

 [157]. Saint Regis Mohawk Tribe, Frequently Asked Questions About New Research and Technology (Patent) Business 3 (2017), https://www.srmt-nsn.gov/_uploads/site_files/Office-of-Technology-Research-and-Patents-FAQ.pdf.

 [158]. See Michigan v. Bay Mills Indian Cmty., 572 U.S. 782, 809–10 (2014) (Sotomayor, J., concurring).

 [159]. Similar reasons exist for states to engage in such deals, even if, as noted in Section I.C.2, states possess stronger mechanisms for raising money. That being said, it is easy to envision poorer states engaging in such deals as another source of revenue. The biggest obstacle to states doing such a thing, it seems, would be potential political pressure. In addition, given how the Federal Circuit ruled in Saint Regis, see infra Section III.B., it is possible state sovereign immunity may no longer be found to apply in IPRs.

 [160]. See supra Section II.A.; see also Decker, supra note 18 (explaining that IPRs act as patent “death squad[s]”).

 [161]. However, as will be discussed infra Part III, these shortcomings do not justify the outcomes reached by the Federal Circuit and PTAB in the Allergan-Saint Regis case. Rather, reforms should focus on improving the patent system, while respecting tribal sovereign immunity.

 [162]. See, e.g., Saint Regis Mohawk Tribe, supra note 157, at 3; cf. Bay Mills, 572 U.S. at 809–10 (Sotomayor, J., concurring) (arguing that “not all Tribes are engaged in highly lucrative commercial activity” and that even if they were, this fact alone “would not justify the commercial-activity exception urged by the principal dissent”).

 [163]. States could do this as well. See supra Section I.B.2.

 [164]. While such benefit spreading could be a good thing, it most likely will harm sovereigns, such as Saint Regis, who pioneered these deals only to have companies go to other sovereigns who offer better deals. This could cause harm to some tribes as revenue sources dry up and previously relied upon services must go away due to lack of funding.

 [165]. This Note takes no position on how to best handle the financial situation of tribes. It just recognizes that relying on a system like the one used by Allergan and Saint Regis could be very counterproductive.

 [166]. See Mylan Pharm., Inc. v. Saint Regis Mohawk Tribe, No. IPR2016-01127, 2018 WL 1100950, at *2 (P.T.A.B. Feb. 23, 2018) (denying Saint Regis’s motion to terminate the proceeding).

 [167]. See supra Section I.B.2. for a discussion of FMC and its holdings on state sovereign immunity in administrative proceedings.

 [168]. Mylan Pharm., 2018 WL 1100950, at *34 (discussing Federal Maritime Commission v. South Carolina State Ports Authority (FMC), 535 U.S. 743 (2002), in which the Supreme Court held that state sovereign immunity could be invoked in administrative proceedings). PTAB also rejected in this portion of the opinion decisions by other administrative agencies which had found that tribal sovereign immunity could be invoked in administrative proceedings. Id. at *3 (discussing Kanj v. Viejas Band of Kumeyaay Indians, No. 06-074, 2007 WL 1266963 (U.S. Dep’t of Labor Adm. Rev. Bd. Apr. 27, 2007)), which noted that no prior cases prevented tribes from asserting sovereign immunity in administrative adjudications). It should be noted that PTAB provided no reasons for treating states and tribes differently in this context.

 [169]. Id. at *4 (citation omitted).

 [170]. Id. (citation omitted).

 [171]. Id. at *4–5.

 [172]. See, e.g., id. at *5 (discussing San Manuel Indian Bingo & Casino v. NLRB, 475 F.3d 1306, 1312–13 (D.C. Cir. 2007), which said “when a tribal government goes beyond matters of internal self-governance and enters into off-reservation business transaction[s] with non-Indians, its claim of sovereignty is at its weakest.”). This underlying idea is directly at odds with the Supreme Court’s approach in Bay Mills, which found tribal sovereign immunity is only abrogated where Congress clearly intends, even if there may be negative consequences from the immunity’s applicability. PTAB did not discuss Bay Mills in its analysis. For further discussion of Bay Mills, see Section I.A.

 [173]. Mylan Pharm., 2018 WL 1100950, at *5 (quoting Quileute Indian Tribe v. Babbitt, 18 F.3d 1456, 1459 (9th Cir. 1994)). The tribes attempted to distinguish these cases on the basis that IPRs include a third party initiating and remaining involved in the entire proceeding; however, PTAB rejected this argument. Id. at *6.

 [174]. Id. (internal quotation marks omitted). It is unclear then why PTAB thinks state sovereign immunity can be invoked in IPRs.

 [175]. Id. (discussing how patent owners are not required to participate in IPR proceedings).

 [176]. Id. at *6 n.6.

 [177]. Id. at *7–8.

 [178]. Id. at *8, *10–12.

 [179]. Id. at *13–15 (noting that the Federal Rules of Procedure do not apply to administrative proceedings).

 [180]. Kevin E. Noonan, St. Regis Mohawk Tribe and Allergan Appeal Denial of Motion to Dismiss on Sovereign Immunity Grounds, Patent Docs: Patent Law Weblog (Mar. 1, 2018, 10:04 PM), http://www.patentdocs.org/2018/03/st-regis-mohawk-tribe-and-allergan-appeal-denial-of-motion-to-dismiss-on-sovereign-immunity-grounds.html. The decision can be appealed under the collateral order doctrine which allows for immediate appeal of denials of sovereign immunity. See, e.g., Burlington N. & Santa Fe Ry. Co. v. Vaughn, 509 F.3d 1085, 1094 (9th Cir. 2007).

 [181]. See Mylan Pharm., 2018 WL 1100950, at *4 (discussing Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751, 756 (1998)).

 [182]. See Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751, 75556 (1998). The Court “noted, however, that the immunity possessed by Indian tribes is not coextensive with that of the States,” distinguishing “state sovereign immunity from tribal sovereign immunity,” because “tribes were not at the Constitutional Convention.” Id. Accordingly, the tribes were “not parties to the ‘mutuality of . . . concession’ that ‘makes the States’ surrender of immunity from suit by sister States plausible.’”

Id. (quoting Blatchford v. Native Village of Noatak, 501 U.S. 775, 782 (1991) (alteration in original)).

 [183]. Covidien LP v. Univ. of Fla. Research Found. Inc., No. IPR2016-1274, 2017 WL 4015009, at *13 (P.T.A.B. Jan. 25, 2017).

 [184]. Id.

 [185]. See Kiowa, 523 U.S. at 754–55.

 [186]. Mylan Pharm., 2018 WL 1100950, at *6.

 [187]. Covidien, 2017 WL 4015009, at *6.

 [188]. Id. at *9–11.

 [189]. Upper Skagit Indian Tribe v. Lundgren, discussed supra Section I.A.3, almost answered whether tribal sovereign immunity applies to in rem jurisdiction, where lower courts have claimed the jurisdiction is over the property instead of the tribe, thus allowing the lower courts to find tribal immunity not applicable in the proceeding. In rem jurisdiction is like IPRs because the proceeding can be construed to be about the patent itself—not the patent owner. However, the Supreme Court avoided answering whether tribal immunity applies to in rem cases, leaving the question for another day. See generally Upper Skagit Indian Tribe v. Lundgren, 138 S. Ct. 1649 (2018).

 [190]. Ericsson Inc. v. Regents of the Univ. of Minn., No. IPR2017-01186, 2017 WL 6517563, at

*2 (P.T.A.B. Dec. 19, 2017) (expanded panel).

 [191]. Blum, supra note 109.

 [192]. Which, as discussed supra Section II.B., is a valid concern. However, abrogating tribal sovereign immunity where it should not be is not the proper response. Rather, the onus should be on Congress to address the issue as they are better situated to do so.

 [193]. Saint Regis Mohawk Tribe v. Mylan Pharm., Inc., 896 F.3d 1322, 1325 (Fed. Cir. 2018).

 [194]. Id. at 1325–26.

 [195]. Id. at 1326.

 [196]. Remember, as discussed supra Section I.B.2., the PTAB had previously decided that for the purposes of state sovereign immunity, IPR should be treated as an adjudicative action rather than a traditional enforcement action.

 [197]. Saint Regis, 896 F.3d at 1326 (citation omitted).

 [198]. Id. at 1327.

 [199]. Id.

 [200]. Id. at 1328. While this is true as a rule, most often IPRs proceed as would litigation, with the patent owner arguing for patent validity and a variety of private challengers arguing the patent is invalid.

 [201]. Id.

 [202]. Id. at 1329.

 [203]. Id. (citation omitted).

 [204]. See supra Section III.B. for a discussion of the ruling.

 [205]. Saint Regis, 896 F.3d at 1329 (“In this case [the Federal Circuit] only decid[ed] whether tribal immunity applies in IPR. While [it] recognize[d] there are many parallels, [it] le[ft] for another day the question of whether there is any reason to treat state sovereign immunity differently.”).

 [206]. See Ericsson Inc. v. Regents of the Univ. of Minn., No. IPR2017-01186, 2017 WL 6517563, at *2 (P.T.A.B. Dec. 19, 2017) (expanded panel); Covidien LP v. Univ. of Fla. Research Found. Inc., No. IPR2016-1274, 2017 WL 4015009, at *12 (P.T.A.B. Jan. 25, 2017).

 [207]. For a discussion of PTAB rulings on state sovereign immunity’s applicability in IPRs, including Covidien and Ericsson, see supra Section I.B.2. In those cases, PTAB focused on the similarity between IPRs and district court litigation on its way to finding that state sovereign immunity applies. See supra Part III for further discussion of PTAB’s and the Federal Circuit’s decisions finding that tribal sovereign immunity does not apply in an IPR proceeding because of its dissimilarity to district court litigation.

 [208]. While PTAB’s original holding that tribal sovereign immunity does not apply in IPRs focused on the difference between tribal and state sovereign immunity, the Federal Circuit’s decision did not.

 [209]. For PTAB’s proper analysis of why IPR is similar to district court litigation, see supra Section I.B.2.

 [210]. Inter Partes Review, U.S. Pat. & Trademark Off., supra note 10.

 [211]. See supra Section I.B.2.

 [212]. Inter Partes Review, U.S. Pat. & Trademark Off., supra note 10 (presenting, on the government’s own website, the procedure for how this “trial proceeding” is conducted); see also Peter Harter & Gene Quinn, How IPR Gang Tackling Distorts PTAB Statistics, IPWatchdog (Apr. 5, 2017), https://www.ipwatchdog.com/2017/04/05/ipr-gang-tackling-distorts-ptab-statistics/id=81816 (explaining the process by which third parties can initiate IPR proceedings).

 [213]. See 35 U.S.C. §§ 311–314 (2012) (revealing the adversarial nature of the proceeding); 37 C.F.R. § 42.51–.52 (2018) (laying out IPR discovery procedures); Alex Chan, Are Administrative Patent Judges Properly Appointed Under the Appointments Clause?, Am. B. Ass’n (Feb. 15, 2019), https://www.americanbar.org/groups/litigation/committees/minority-trial-lawyer/articles/2019/are-administrative-patent-judges-properly-appointed-under-the-appointments-clause (“PTAB judges exercise significant independent discretion, are not removable from the competitive service except for cause.”); see also Covidien LP v. Univ. of Fla. Research Found. Inc., No. IPR2016-1274, 2017 WL 4015009, at *8–11 (P.T.A.B. Jan. 25, 2017) (“[C]onsidering the nature of inter partes review and civil litigation, [PTAB] conclude[d] that the considerable resemblance between the two is sufficient to implicate the immunity afforded to the States by the Eleventh Amendment.”).

 [214]. See 37 C.F.R. § 42 (2018) (laying out the procedure for a PTAB trial).

 [215]. See 157 Cong. Rec. S1375 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl) (“One important structural change made by the present bill is that inter partes reexamination is converted into an adjudicative proceeding in which the petitioner, rather than the [USTPO], bears the burden of showing unpatentability.”).

 [216]. Joel Sayres & Julie Wahlstrand, To Stay or Not to Stay Pending IPR? That Should Be a Simpler Question, 17 Chi.-Kent J. Intell. Prop., no. 3, 2018, at 52, 59.

 [217]. It is true that there are some dissimilarities between IPRs and civil litigation as well, but these dissimilarities are limited to procedures, rather than the main substance between them, and largely reflect the somewhat more limited nature of the IPR proceeding. It is then important to note that per PTAB, “there is no requirement that the two types of proceedings be identical for sovereign immunity to apply to an administrative proceeding.” Covidien, 2017 WL 4015009, at *11.

 [218]. See, e.g., Relations with Native Americans, Library of Cong., https://www.loc.gov
/collections/continental-congress-and-constitutional-convention-from-1774-to-1789/articles-and-essays
/to-form-a-more-perfect-union (last visited Apr. 3, 2019).

 [219]. See, e.g., The Constitutional Convention of 1787, Univ. of Mo.-Kansas City Sch. L., http://law2.umkc.edu/faculty/projects/ftrials/conlaw/convention1787.html (last visited Apr. 3, 2019).

 [220]. See, e.g., Blatchford v. Native Vill. of Noatak, 501 U.S. 775, 779 (1991) (“[A] State will therefore not be subject to suit in federal court unless it has consented to suit, either expressly or in the ‘plan of the convention.’” (citation omitted)).

 [221]. Of course, this is only true in those areas where tribal sovereign immunity has not been abrogated.

 [222]. Meg Tirrell, More Scrutiny for Allergan over Native American Tribe Deal, CNBC (Oct. 2, 2017, 6:31 PM), https://www.cnbc.com/2017/10/02/more-scrutiny-for-allergan-over-native-american-tribe-deal.html.

 [223]. Juana Summers, Looming Trump Budget Cuts Deepen Distress on Pine Ridge, CNN (May 28, 2017, 10:49 AM), https://www.cnn.com/2017/05/27/politics/indian-reservation-trump-budget/index
.html.

 [224]. Petition for Writ of Certiorari, Saint Regis Mohawk Tribe v. Mylan Pharm., Inc. (No. 18-899) (U.S. Jan. 11, 2019); St. Regis Mohawk Tribe Appeals Loss in Patent Case to Supreme Court, Indianz.com (Jan. 16, 2019), https://www.indianz.com/News/2019/01/16/st-regis-mohawk-tribe-appeals-loss-in-pa.asp.

 [225]. Gene Quinn, Federal Circuit Rules Tribal Sovereign Immunity Cannot Be Asserted in IPRs, IPWatchdog (July 20, 2018), https://www.ipwatchdog.com/2018/07/20/federal-circuit-tribal-sovereign
-immunity-cannot-asserted-iprs/id=99504.

 [226]. See, e.g., supra note 155 and accompanying text.

 [227]. This assumes that neither plan on reversing course on tribal sovereign immunity. The Federal Circuit denied a petition to rehear the case en banc. Matthew W. Johnson, PTAB Denies Stay Pending Sovereign Immunity Cert Petition, Lexology: PTAB Litig. Blog (Dec. 26, 2018), https://www.lexology.com/library/detail.aspx?g=a28cb7cc-76b1-47ea-8364-0cf8d618ba1d.

 [228]. See supra Section III.B. (discussing the Federal Circuit’s decision in the Saint Regis case).

 

An Examination of the Right to Try Act of 2017 and Industry’s Potential Path Moving Forward – Note by Sylvia Zaich

From Volume 92, Number 2 (January 2019)
DOWNLOAD PDF


 

An Examination of the Right to Try Act of 2017 and Industry’s potential Path Moving Forward

Sylvia Zaich[*]

TABLE OF CONTENTS

INTRODUCTION

I. A Brief History of the FDA and the current
Drug development process

A. The Origins of the FDA’s Regulatory Framework

B. The Drug Development Process

II. ChalLenges to the regulatory framework and
an overview of the Expanded access program

A. Prior Pre-Approval Access Challenges

1. 1970s: Laetrile, the FDCA, and Rutherford v. United States

2. 1980s–1990s: The Reagan Administration and the
HIV/AIDS Epidemic

3. 2000s: Pre-Approval Access, a Proposal, and Abigail Alliance v. Von Eschenbach

B. The Expanded Access Program

1. How a Physician Requests Expanded Access for
Individual Patient Use

2. How Companies Evaluate an Individual Patient Request

3. How the FDA Evaluates an Individual Patient Request

III. THE RIGHT-TO-TRY MOVEMENT

A. The Movement’s Rationale for Right to Try and
Success at the State Level

1. The Right-to-Try Movement’s Rationale

2. The Movement’s Success at the State Level

B. The FDA’s Response

1. Clarifying the FDA’s Use of Clinical Outcomes

2. Demystifying Manufacturers’ Eligibility Criteria

3. Increasing Awareness of Expanded Access

4. Streamlining the Individual Patient Request Process70

C. The Push for a Federal Right to Try

IV. the Right to Try Act of 2017

A. The Law

1. Who is Eligible?

2. When Would an Investigational Drug Qualify?

3. What are the Reporting Obligations?

4. When Can the FDA Use Clinical Outcomes?

B. Industry’s Potential Path Moving Forward

1. Even with the Right to Try Act, Most Companies Will
Continue to Use Expanded Access

2. Charting Industry’s Path Forward

CONCLUSION

Appendix

 

INTRODUCTION

In 2013, a petition started to circulate the Internet, urging the CEO of BioMarin Pharmaceutical to provide its investigational drug BMN-673 to then forty-five-year-old attorney Andrea Sloan, who was undergoing treatment for late stage ovarian cancer.[1] With standard treatments no longer an option, her physicians proposed trying BMN-673, one of a new class of cancer drugs called PARP inhibitors developed by BioMarin. The advanced nature of Sloan’s cancer disqualified her from enrolling in a clinical trial, so instead she and her physicians sought access to BMN-673 through the U.S. Food & Drug Administration’s (“FDA”) expanded access program, which allows pre-approval use of drugs outside of the clinical trial setting.[2]

The FDA confirmed Sloan was a candidate for expanded access use, but that confirmation did not guarantee use. That decision was left to the discretion of the company. BioMarin declined to provide BMN-673 because the drug was still in early phase of development: “It would be unethical and reckless to provide [BMN-673 to] end-stage refractory ovarian cancer patients outside a clinical trial.”[3] This decision sparked the Change.org petition that ultimately secured more than 230,000 signatures.[4] Even with this overwhelming public support, BioMarin maintained its position. A different company, which was developing a similar drug, eventually provided Sloan with access on the condition that it remain unidentified. Sloan started the treatment, but her cancer had progressed, and she died shortly thereafter.[5]

Sloan’s expanded access experience is not unique. A number of patients, with the support of their friends and families, launched similar online campaigns, seeking access to investigational medicines after becoming frustrated with companies’ unwillingness to accommodate expanded access requests for investigational drugs.[6] Some were successful; others were not. These campaigns, including Sloan’s, increased public awareness and dialogue regarding terminally ill patients’ ability to access investigational medicine and helped spark a national legislative movement promoting such individuals’ “right to try.”[7]

In 2015, Texas was the twenty-first state to adopt righttotry legislation.[8] The Texas bill was named in Andrea Sloan’s memory. These laws, despite often having bipartisan support, have been divisive, with supporters claiming that the right to try offers “real hope,[9] and critics maintaining that the right to try is merely political theatrics and ultimately will do more harm than good for individual patients.[10] Forty-one states have adopted righttotry laws since the movement first launched in 2014.[11] That success sparked a push for a federal righttotry law.

President Donald J. Trump voiced his support for such legislation in his 2018 State of the Union address: “People who are terminally ill should not have to go from country to country to seek a cure—I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”[12] That endorsement was the final nudge Congress needed. On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right to Try Act”).[13]

This Note proceeds in four parts. Part I briefly looks back at the FDA’s history and the impact of two significant drug crises in establishing the agency’s current framework before explaining the current drug development process. Part II recounts previous challenges to this regulatory framework, which ultimately led to the development of the current expanded access program. Part II also examines the current expanded access program and, more specifically, the evaluation criteria applied by three of its key decisionmakers: the treating physician; the manufacturer; and the FDA.

Part III traces the beginnings of the right to try movement, examining the rationale for the laws and exploring how social media and increased direct-to-consumer advertising of approved drugs possibly created an opening for widespread support of these laws. Part III also explores why the FDA’s efforts to address criticisms of the expanded access program were unable to dissuade enactment of the Right to Try Act. Part IV provides an overview of the Right to Try Act and how the Act differs from expanded access. Part IV further explores why, in general, mainstream industry likely will not adopt the righttotry pathway, before arguing that pharmaceutical and biotechnology companies should avoid maintaining their current positions regarding pre-approval access, and instead address some of the criticisms raised during the right-totry movement by (1) revising their existing expanded access policies and (2) improving clinical trial access.

I.  A Brief History of the FDA and the current Drug development process

To better understand the rationale for the FDA’s regulatory framework and the role it has “effectively balanc[ing] the interests of those patient populations who would benefit from having greater access to investigational drugs, with the broader interests of society in having safe and effective new therapies approved for marketing and widely available,”[14] Part I of this Note reviews how the FDA’s authority developed in response to two significant drug safety crises and provides a primer on the current drug development process.

A.  The Origins of the FDA’s Regulatory Framework

The origins of the FDA can be traced back to the 1800s, but two drug safety crises prompted the development of the agency’s current regulatory framework. The deaths of more than one hundred people from an untested drug formulation led to the enactment of the Federal Food, Drug, and Cosmetic Act of 1938 (“FDCA”), which required manufacturers to show “that any new drug was safe before it could be marketed.”[15] The initial effectiveness of the FDCA was limited. If the agency did not respond to a new drug application[16] within sixty days, the drug was automatically approved for public consumption.[17] The FDCA also did not require standardized drug testing.[18] This remained the regulatory environment—despite efforts by some to address these shortcomings—until the second drug safety crisis of the twentieth century.

In 1960, the manufacturer of the thenpopular sedative thalidomide submitted a marketing application for the drug in the United States.[19] The FDA refused to grant approval over concerns about inadequate and deficient safety data.[20] The manufacturer had distributed “more than two and a half million tablets . . . to approximately 20,000 patients” in the United States for clinical testing, but few, if any, of these individuals were actually monitored after receiving the drug.[21] The drug was eventually linked to an “epidemic of congenital malformations.”[22] The global thalidomide crisis motivated politicians to reconsider legislation that would have “tightened restrictions surrounding the surveillance and approval process for drugs.”[23]

Two years later, in 1962, Congress passed the Kefauver-Harris Amendment “to assure the safety, effectiveness, and reliability of drugs.[24] This amendment eliminated the FDCA’s de facto approval loophole and extended the review period to 180 days.[25] Even more significant, the Kefauver-Harris Amendment “laid the groundwork for the [current multi-phased] system of clinical trials”[26] by requiring a manufacturer to submit “substantial evidence” of an investigational drug’s safety and efficacy with its marketing application.[27]

B.  The Drug Development Process

A manufacturer or other protocol sponsor,[28] before conducting a clinical trial, must first submit an investigational new drug (“IND”) application.[29] The IND provides an overview of the biopharmaceutical company’s general investigational plan and clinical trial protocols for the drug.[30] The plan must provide:

(a) [t]he rationale for the drug or research study;

(b) the indication(s) to be studied;

(c) the general approach to be followed in evaluating the drug;

(d) the kinds of clinical trials to be conducted in the first year . . . ;

(e) the estimated number of patients . . . ; and

(f) any risks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug or related drugs.[31]

The IND gives the FDA the information it needs to assess the safety of the proposed phase I trials and the “scientific quality of [the proposed phase II and III trials] and the likelihood that the [trials] will yield data capable of meeting statutory standards for marketing approval.”[32]

In phase I, a manufacturer assesses the drug’s safety and determines the appropriate dosage for subsequent trials.[33] The participants are typically healthy volunteers but depending on the condition may be patient volunteers.[34] The enrollment size of these trials is small. A single phase I trial might enroll anywhere between twenty to eighty volunteers.[35] The Biotechnology Innovation Organization (“BIO”) estimates that approximately 60% of drugs advance from phase I to phase II clinical trials.[36]

In phase II, the investigational drug is tested in patient volunteers who have the disease or condition.[37] This commonly involves a randomized clinical trial in which patients are randomly assigned either the investigational drug or some other treatment—“either an inactive substance (placebo), or a different drug that is usually considered the standard of care for the disease”—without knowing which treatment they are receiving.[38] The manufacturer then compares the effectiveness of the investigational drug to the effectiveness of the alternative treatment.[39] Phase II clinical trials are also required to assess the drug’s “common short-term side effects and risks.”[40] In general, this is the stage of development with the lowest success rate”—almost 70% of drugs fail to move beyond phase II.[41]

The pre-approval development process culminates with phase III clinical trials,[42] which are intended to produce “statistically significant data about the safety, efficacy and overall benefit-risk relationship of the investigational medicine.”[43] This data is an integral component of the new drug application a manufacturer submits to the FDA.[44] To obtain statistically significant data, these studies often require a substantial number of volunteers—sometimes upwards of 5,000 volunteers depending on the disease or condition.[45]

The recruitment process throughout clinical development can take several years and be very expensive, with manufacturers often struggling to fully enroll their clinical trials.[46] The low accrual rates can be the result of strict inclusion and exclusion criteria.[47] Still, manufacturers can be resistant to making the criteria less restrictive and more inclusive,[48] perhaps because lessstandardized patients might make it harder to parse through data, extend the length or size of a clinical trial, increase the risk of adverse events potentially impacting a drug’s safety profile and potentially its approval, and make clinical development more expensive.[49]

The estimated time from discovery to FDA approval of a drug is now at least ten years. The cost of development is estimated between $10 million and $2.6 billion, with the higher estimate factoring in costs associated with investigational drugs that never advance beyond clinical development.[50] These costs are then passed on to patients, with some cancer therapies costing upwards of $375,000.[51] “The U.S. spent nearly $88 billion treating cancer in 2014, with patients paying nearly $4 billion out-of-pocket.”[52] All of that spending, however, does not necessarily translate into positive outcomes for every patient.[53]

II.  ChalLenges to the regulatory framework and an overview of the Expanded access program

A.  Prior Pre-Approval Access Challenges

The tension—highlighted most recently by the right-to-try movement—between ensuring patients have access to potentially groundbreaking medicines as soon as possible and ensuring that these therapies are both safe and effective is not nascent. There have been three significant pre-approval access challengesstarting with Rutherford v. United States in 1975to the FDA’s regulatory framework since the enactment of the Kefauver-Harris Amendment.

1.  1970s: Laetrile, the FDCA, and Rutherford v. United States

In 1975, a few individuals with terminal cancer filed a lawsuit seeking to enjoin the FDA from obstructing the interstate shipment and sale of the alternative treatment laetrile because it was not approved by the FDA.[54] The district court ordered the FDA to allow patients pre-approval access.[55] On appeal, the U.S. Court of Appeals for the Tenth Circuit referred the issue to the FDA,[56] which found laetrile was a new drug within the meaning of the FDCA and could be barred from interstate sale until the necessary safety and efficacy data was submitted for FDA review and received FDA approval.[57] The district court vacated that decision on statutory and constitutional grounds,[58] and the FDA appealed.[59] The Tenth Circuit—rather than relying on the district court’s reasoning—held instead that the FDCA’s “‘safety’ and ‘effectiveness’ terms” did not apply to individuals with terminal cancer diagnoses.[60]

The case was eventually heard by the Supreme Court, which decided in favor of the agency’s FDCA interpretation.[61] The Court held the FDCA made “no special provision for drugs used to treat terminally ill patients” based on the statute’s plain language.[62] The Court also explained that it could not imply a statutory exception because the “legislative history and consistent administrative interpretation” of the FDCA did not support one.[63]

2.  1980s–1990s: The Reagan Administration and the HIV/AIDS Epidemic

 After President Ronald Reagan’s election in 1980, his administration ushered in widespread deregulation efforts across all areas of government.[64] Those efforts included (1) amending the FDCA, which the administration viewed as unnecessarily delaying drug approvals, and (2) establishing a defined program for terminally patients seeking access to investigational drugs for treatment rather than research purposes.[65] The FDA, in response to the administration’s latter concern, proposed codifying the agency’s existing informal pre-approval access procedures.[66] Those efforts became even more urgent with the HIV/AIDS epidemic though the agency’s efforts and the administration’s initial concern regarding pre-approval access were not aimed directly at aiding individuals with HIV/AIDS.[67]

 The FDA promulgated several significant changes not only to improve patient access outside of the clinical trial setting to drugs still in clinical development, but also to reduce the length of time between discovery and final FDA approval. The latter issue being one in which the interests of activists and manufacturers aligned, as both advocated for changes to the regulatory framework.[68] First, the FDA amended its regulations in 1987 to allow widespread access to an investigational drug outside of the clinical trial setting through a “treatment protocol.”[69] The agency continued to apply an informal standard for individual requests until the Food & Drug Administration Modernization Act of 1997 codified the expanded access program, which specifically addressed the need for a formal individual patient request process.[70] Second, the FDA created the Accelerated Approval pathway[71] and introduced a striated review framework[72] to speed up the availability of promising new drugs intended for the treatment of serious diseases or conditions. Subsequent congressional action in 1997 and 2012 armed the FDA with two additional means to further reduce the time from initial development of a drug to its approval.[73]

3.  2000s: Pre-Approval Access, a Proposal, and Abigail Alliance v. Von Eschenbach

There was not another significant challenge to the drug development and approval process until an organization, seeking to improve terminally ill patients’ abilities to obtain investigational drugs, proposed a “three-tiered approval system.”[74] The first approval tier would have allowed limited marketing of investigational drugs following completion of phase I trials.[75] The organizationthe Abigail Alliance for Better Access to Developmental Drugs (the Abigail Alliance”)[76]claimed terminally ill patients with no other treatment options faced a “different risk-benefit tradeoff” and should have the option to try investigational drugs.[77] The FDA rejected this proposal, explaining that this approach “would upset the appropriate balance” by “giving almost total weight to the goal of early availability and giving little recognition to the importance of marketing drugs with reasonable knowledge . . . of their likely clinical benefit and their toxicity.”[78]

The Abigail Alliance, agency rejection in hand, filed an action against the FDA.[79] The organization sought to block the agency’s policy prohibiting the pre-approval sale of drugs to individuals with terminal conditions.[80] The Abigail Alliance argued that the FDA’s policy “violate[d] terminally ill patients’ constitutional privacy and liberty rights, as well as their due process rights to life.”[81] The district court found these claims legally unpersuasive.[82] But a United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) panel, in a 2–1 split, agreed with the group, holding that the due process clause protected the right of terminally ill patients to decide whether to use investigational drugs that the FDA had determined were safe enough for additional clinical trials after reviewing results from phase I clinical trials.[83] The panel directed the district court to determine whether the FDA’s policy was narrowly tailored to serve a compelling governmental interest.[84]

The FDA’s request for an en banc hearing was granted before a lower court could apply strict scrutiny.[85] The court en banc flatly rejected the panel’s decision.[86] The court expressed “serious doubt” about the constitutional validity of the Abigail Alliance’s articulated right: a “fundamental right of access for the terminally ill to experimental drugs.”[87] To establish its articulated right, the Abigail Alliance needed to illustrate a tradition of accessibility to drugs that were not proven to be safe or effective.[88] The en banc court found that “FDA regulation of post-phase I drugs [was] entirely consistent with [the United States’] historical tradition of prohibiting the sale of unsafe drugs.”[89] The en banc court also disputed the group’s effectiveness argument, noting the existence of “at least some drug regulation prior to [the Kefauver-Harris Amendment] address[ing] efficacy.”[90] The en banc court also dismissed the Abigail Alliance’s argument that the right to self-preservationbased on the common law doctrine of necessity, the tort of intentional interference with rescue, and the right to self-defensecreated a constitutionally protected right in this context.[91] The court concluded that the Abigail Alliance’s articulated right was not fundamental.[92] The court held that “the FDA’s policy of limiting access to investigational drugs [was] rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects.”[93]

Two years after the D.C. Circuit’s decision in Abigail Alliance, the FDA finally issued revised expanded access regulation clarifying the process by which an individual patient could request expanded access.[94] The current expanded access program is discussed in greater detail below.

B.  The Expanded Access Program

The expanded access program, as discussed, was designed to address concern that some individuals may not have an opportunity to try a promising therapy given the sometimes ten-year path to formal regulatory approval. The expanded access program allows some patients with serious or immediately life-threatening diseases to use an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.”[95] The program is available for individual patient use, intermediate-size patient use, and widespread patient use.[96] In addition to the patient, there are three other important decisionmakers. Section II.B.1 describes how a physician would initiate an expanded access request for an individual patient. Sections II.B.2 and II.B.3 then discuss the criteria used by biopharmaceutical companies and the FDA to determine eligibility in the individualpatient setting.

1.  How a Physician Requests Expanded Access for Individual Patient Use

Prior to initiating an expanded access request for a patient, the requesting physician must first conclude that “the probable risk to the person from the investigational drug is not greater than the probable risk from the disease or condition.”[97]

After this determination is made, the physician must then seek a letter of authorization (“LOA”) from the manufacturer.[98] The request must be made by a physician. The LOA allows the FDA to refer to the requested investigational drug’s IND file instead of requiring the requesting physician to obtain confidential information regarding the drug’s pharmacology, toxicology, chemistry, or manufacturing process.[99] As evidenced by Andrea Sloan’s unsuccessful request, this has been the greatest source of frustration for patients seeking expanded access use. Aside from Pfizer, most companies do not disclose how many requests they receive or grant each year.[100] This step of the process can also be lengthy as current FDA regulation does not impose a time restraint.[101] So even if a company acknowledges receipt of a request within twotothree business days,[102] the company is not required to expediently review that request, which often involves multiple parties within a company.[103]

If the company agrees to grant use and provides a LOA, the requesting physician would then submit an application form to the FDA. The FDA asks the physician to provide an overview of the patient’s clinical history, the rationale for the expanded access request, and the proposed treatment plan.[104] The FDA has up to thirty days to review the application and provide feedback.[105] A 2017 U.S. Government Accountability Office (“GAO”) report found that the FDA’s median response time was no more than nineteen days for non-emergency situations.[106]

While the FDA reviews the application, the physician must also obtain approval from his or her institution’s or hospital’s institutional review board (“IRB”).[107] The requesting physician can also request a waiver from the FDA, which would allow the expanded access request to be reviewed by either the IRB chair or another designated member.[108] The physician must also discuss the expanded access requirements with the patient and secure the patient’s informed consent to treatment.[109]

2.  How Companies Evaluate an Individual Patient Request

The expanded access regulation does not prescribe the criteria a manufacturer should use when determining whether to grant an expanded access request.[110] Industry groups Pharmaceutical Research and Manufacturers of America (“PhRMA”) and BIO, however, have each separately published guiding principles for the groups’ respective members that closely mirror the evaluation criteria used by the FDA.[111] PhRMA recommends that manufacturers consider five factors: (1) whether the individual has exhausted all available treatment options for a serious or life-threatening illness; (2) whether “[t]he investigational drug [is] under active clinical development”; (3) whether “[t]he patient is ineligible for, or otherwise unable to participate in, clinical trials”; (4) whether [t]he potential benefit to the patient [outweighs the] potential risk”; and (5) whether approving the request would interfere with the “successful completion of the clinical trial process.”[112]

A survey of twenty biopharmaceutical companies’ eligibility criteria[113] illustrates that most large companies offering expanded access have adopted criteria modeled off either PhRMA or BIO’s guidelines, with only slight variations.[114] In general, companies include criteria limiting expanded access to patients with serious or life-threatening conditions. The extent to which a patient must have tried standard treatment options and must not have other treatment options available varies. A few companies require the patient to have tried standard treatments unsuccessfully and to not have other treatment options available. Other companies just require that the patient does not have other treatment options available. The real difference in this language, however, might be just semantics.

Of the companies surveyed, one also factored in a patient’s ability to regularly travel to a treating site for observation and follow-up while receiving the investigational drug when deciding whether to grant an expanded access request.[115] Likewise, manufacturers will not consider an expanded access request unless the drug is in active development (that is, the company cannot have discontinued the program), but some companies choose to define this criterion more narrowly than BIO or PhRMA.[116] Take for examples, Merck, Amgen, and Allergan, which will not grant requests for a specific drug unless the company is actively developing the drug in the proposed intended use.[117] The criteria used by Merck and a few other companies also requires that the company have plans to submit a marketing application.[118]

Given concerns about expanded access impacting clinical trial enrollment, companies are hesitant to grant an expanded access request unless the individual is unable to participate in a clinical trial. This criterion is generally left vague, but some companies provide specific factors that they will or will not consider.[119] For example, under Genentech’s criteria, an individual who lives too far away from a clinical trial center would not be considered ineligible for a clinical trial and therefore would not qualify for expanded access based on this factor alone.[120] In contrast, Pfizer and Teva Pharmaceutical would consider geographic limitations as a factor affecting a patient’s ability to participate in a clinical trial.[121]

All of the companies surveyed included a criterion requiring the potential benefits of the drug to outweigh the potential combined risks of the treatment and the disease to the individual patient.[122] To make this risk-benefit assessment, PhRMA explains, there should be sufficiently robust preliminary safety and efficacy data, including dosing information, to determine that the preliminary benefit-risk balance is positive for the specific indication for which the request is made.”[123] While some companies keep this criterion vague to allow for greater discretion, a few companies’ criteria specifically mentions a dosing requirement.[124] Although most companies’ criteria did not distinguish between children and adults, one company’s guidelines specifically require sufficient pediatric data to determine the appropriate dosage before it will grant expanded access use for a child.[125]

Like the other criteria, almost all of the companies surveyed had some language in their expanded access guidelines addressing the clinical trial process and, more specifically, the need to ensure that pre-approval access use did not interfere with the clinical trial process.[126] A few companies specifically consider whether they have adequate drug supply for both their clinical trials and expanded access when making the determination.[127] While not specifically addressed, this criterion likely also considers the extent to which expanded access use might impact other aspects of clinical development, such as the FDA’s use of adverse events occurring during expanded access use, when reviewing an investigational drug’s marketing application.[128] A few companies also build in additional discretion by allowing their medical teams to establish additional criteria in light of a given drug’s current development and available data.[129]

As discussed, however, most companies do not disclose how many expanded access requests they receive or, of those, how many they grant.[130] This lack of disclosure makes it difficult for physicians, patients, or even the FDA to hypothesize how companies apply their criteria when reviewing an expanded access request. Two companies have made this type of information publicly available, but through different channels and with different levels of information. Pfizer, for example, discloses its overall expanded access approval rate on its website, but it does not explain the rationale for the small percentage of denials. By contrast, as part of a case study in the Journal of the American Medical Association (“JAMA”), Janssen released limited expanded access data regarding one investigational drug for a distinct period of time. That study reported the most common reason the company denied a request was an unfavorable risk-benefit profile.[131]

3.  How the FDA Evaluates an Individual Patient Request

The FDA, as mentioned, must review all expanded access requests. When reviewing an expanded access requestwhether for individual patient use, intermediate-size patient use, or widespread patient usethe FDA examines three threshold criteria: (1) patient eligibility; (2) risk-benefit analysis; and (3) impact on clinical trials.

a.  Patient Eligibility

The patient or group of patients must have a “serious or immediately life-threatening disease or condition,” in which “no comparable or satisfactory alternative therapy” is available.[132] An “immediately life-threatening disease” is defined as a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.”[133] A “serious disease” is defined as one “associated with morbidity that has substantial impact on day-to-day functioning.”[134] The FDA has previously authorized expanded access use for serious diseases like amyotrophic lateral sclerosis (“ALS”), narcolepsy, and Alzheimer’s disease.[135] In guidance from the FDA, the agency further clarifies its standard for a serious disease explaining: “short-lived and self-limiting morbidity will usually not be sufficient to qualify a condition as serious, but the morbidity need not be irreversible, provided it is persistent or recurrent.”[136] The FDA interprets no comparable or satisfactory therapy to “mean that there exists no other available therapy to treat the patient’s condition or that the patient has tried available therapies and failed to respond adequately or is intolerant to them.”[137]

b.  Risk-Benefit Analysis

The second requirement is that the “potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease.[138] This criterion acknowledges “the need for the risks and benefits of drugs to be well characterized” before the FDA will grant an expanded access request for an individual or group of patients.[139] This criterion is not intended to establish a uniform minimum approval threshold; that determination is dependent on the expanded access category and the seriousness of the disease.[140]

c.  Impact on Clinical Trials

The availability of expanded access also hinges on the FDA’s determination that “providing the investigational drug . . . will not interfere with . . . clinical investigations that could support marketing approval.[141] While it is understandable that many patients would prefer to secure an investigational drug outside of the confines of a clinical trial, especially given their randomized nature, expanded access use cannot “compromise enrollment in the trials” that would ultimately support a marketing application.[142] This criterion attempts to address concerns that expanded access would reduce individuals’ willingness to participate in clinical trials, especially given evidence that approximately 3% of adults with cancer enroll in clinical trials.[143]

* * *

The three expanded access categories each have additional category-specific criteria that the FDA must consider before granting a request (Table 1).With an individual patient expanded access request, the FDA must also conclude that “the patient cannot obtain the drug under another IND or protocol.”[144] This means that the patient is either ineligible to enroll in ongoing clinical trials based on eligibility criteria or unable to enroll for some other reason.[145]

The FDA approves most expanded access requests.[146] Between 2012 and 2015, the agency approved approximately 99% of the more than 5,000 single-patient expanded access requests it received.[147] The FDA does not just rubber-stamp these requests. The FDA made “meaningful changes in approximately 10 percent of these cases to enhance patient safety” such as adjusting dosage, increasing safety oversight, and strengthening informed consent.[148] FDA Commissioner Scott Gottlieb explained:

[t]he changes are based on the scientific and medical expertise of our staff, and informed by confidential information provided to FDA by product sponsors during the course of development. This information is often unavailable to the treating physician—and the larger medical community—and becomes available only after a drug is approved.[149]

The real question is how many expanded access requests never reach the FDA because the manufacturer declines to provide a letter of authorization.[150]

III.  THE RIGHTTOTRY MOVEMENT

In 2014, the Goldwater Institute, a conservative and libertarian public policy think tank, launched a new initiative based on patients’ right to “some choice over their own destinies.”[151] The think tank’s initial goal was to pass state laws giving terminally ill patients the right to obtain access to investigational drugs that have completed phase I clinical trials without interference from the FDA.[152] This goal was later expanded to secure the enactment of a federal law under the same premise.

Section III.A outlines and assesses the movement’s rationale for proposing a new pre-approval access pathway before briefly discussing the movement’s success at the state level. Section III.B examines the FDA’s attempts to address the movement’s claims and why those attempts by the agency were insufficient. Section III.C discusses the efforts by Senator Ron Johnson (R-Wis.) to secure enactment of federal right to try legislation.

A.  The Movement’s Rationale for Right to Try and Success at the State Level

1.  The RighttoTry Movement’s Rationale

The arguments for right to try can be distilled to three main claims: (1) the expanded access program is “so riddled with bureaucracy and delay that a patient’s chances of obtaining potentially lifesaving treatment in time are practically negligible”;[153] (2) the FDA is irreparably broken because it prevents individuals from using “potentially lifesaving medicines and treatments until those treatments receive final approval”;[154] and (3) patients with life-threatening diseases should be allowed to try an investigational drug that has already passed the FDA’s basic safety testing in phase I trials and remains within the FDA’s approval process because they are “safe.”[155]

a.  The Expanded Access Program Is Overly Bureaucratic and Slow

The Goldwater Institute specifically claimed that the expanded access program burdens people’s right to try because: (1) the FDA has “unfettered authority to deny a terminal patient access . . . for a variety of reasons, including nonmedical reasons”; (2) the application is overly burdensome and complicated for requesting physicians; and (3) the IRB review requirement prolongs and prevents access for patients undergoing treatment at non-academic centers outside of major metropolitan areas.[156]

There are two problems with the first part of this claim. First, this claim completely ignores the GAO report findings, which suggest a contrary proposition.[157] Second, this claim fails to acknowledge that sign-off from the FDA is only the last step in the process.[158] Take Andrea Sloan’s story as an example. The FDA acknowledged Sloan was an appropriate candidate for expanded access, but BioMarin would not provide BMN-673.[159] While the FDA approves nearly all of the expanded access requests it receives, the perception is that the bigger obstacle is manufacturer cooperation.[160] Most companies do not publicly disclose the number of requests received or promote the number of times the company has approved an individual patient’s request.[161] Of the company policies surveyed in Section II.B.2,[162] only Pfizer publicized information on its website about the number of requests it received and how many were approved by the company.[163] The lack of collective disclosure by manufacturers––and the inability of the FDA to require manufacturers to provide this information––leaves the public and politicians with a myopic view of the expanded access program.

The FDA has since introduced Form FDA 3926 (“Individual Patient Expanded Access – Investigational New Drug Application”) and modified the IRB review requirement addressing the second and third part of this claim, which are both discussed in greater detail in Section III.B. These changes could improve accessibility to the expanded access program over time.

 b.  The FDA Regulatory Framework Is Broken

The Goldwater Institute argued that the current regulatory framework is broken because it can take years before the FDA approves a drug. Yet instead of offering a solution to address the clinical trial process (for example, lobbying for legislation to support the use of different clinical trial designs,[164] or to incentivize companies to reconsider their rationale for certain inclusion and exclusion criteria that could provide data that more accurately reflects real-world patients[165])––which could potentially improve access to investigational drugs more broadly––the organization decided the easier path was pre-approval access legislation that cut-out the FDA. This strategy was shortsighted and arguably based on the Goldwater Institute’s overarching goal of limiting the FDA’s oversight of drugs for all patients and not just those drugs designed for the treatment of immediately life-threatening diseases.[166]

The claim that the framework is “broken” also focuses on speed to the detriment of safety and efficacy. The need for adequate safety and effectiveness data can prolong the drug approval process,[167] however, even with these requirements, the FDA is consistently faster at approving investigational drugs than other regulatory authorities. For example,

[a]mong the 289 unique novel therapeutic agents [approved between 2001 and 2010], 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States.[168]

The speed with which a drug is approved, however, should not be the only priority—safety and efficacy are still important concerns. Some argue the agency is now underemphasizing these two criteria in its aim to ensure patients can access novel drugs more quickly.[169] A JAMA study found that “nearly a third of [drugs] approved [by the FDA] from 2001 through 2010 had major safety issues years after they were widely available to patients.”[170] A patient with a life-threatening disease or condition may understandably be frustrated by the lengthy development timeline, especially when a drug is touted as a potential “breakthrough” early on in its development cycle. However, pre-approval access without FDA oversight does not directly fix this lag between development and approval; it could make it worse for everyone if patients attempt to seek pre-approval access instead of enrolling in clinical trials.[171]

 c.  Patients Should Be Allowed to Use Investigational Drugs that Have Completed Phase I Clinical Testing

Finally, the Goldwater Institute’s claim that patients should be able to try investigational drugs because completion of phase I testing renders them safe fails to acknowledge that most investigational drugs are not approved by the FDA. The “overall likelihood of [FDA] approval . . . from Phase I for all developmental candidates [between 2006 and 2015] was 9.6%.”[172] The successful completion of a phase I clinical trial also does not guarantee a drug’s safety, and in general, investigational drugs have the lowest successful transition rates at phase II.[173] Take the example of fialuridine. In 1993, five individuals enrolled in a phase II clinical trial studying the use of fialuridine in hepatitis B died, despite an earlier phase I clinical trial in which 25% of a twenty-four-patient trial were cured after receiving fialuridine for twenty-eight days.[174] This example might seem extreme, but it still illustrates the risks associated with equating successful completion of a phase I trial with a broad endorsement of safety. As discussed, an approved drug’s safety profile is also not fully understood until sometimes years after it is approved. The potential harm of an investigational drug, even to someone “facing imminent death,” still needs to be considered before allowing an individual with a serious or life-threatening disease to use the investigational drug merely on the basis of completion of phase I testing.[175]

In conclusion, the movement’s rationales for these laws were misplaced and ill-guided. There is no doubt, however, that despite these claims, the Goldwater Institute was successful in securing the support necessary to pass both state and federal legislation.

2.  The Movement’s Success at the State Level

Post-Abigail Alliance, efforts were made to enact legislation to amend the expanded access program. While these federal bills failed to make it beyond congressional committee,[176] the state righttotry bills, from the outset, gained more support. There are several possible reasons for this increased support. First, information regarding investigational drugs, especially data from medical meetings, has become more accessible with the Internet and social media.[177] This increased accessibility is good, but it also can lead to increased interest in investigational drugs—especially when a drug is deemed “revolutionary” by the medical community, even with limited safety and efficacy data.[178] Timothy Turnham, the former executive director at the Melanoma Research Foundation, explains: “There is a disconnect between what researchers think is statistically significant and what is really significant for patients . . . . Patients hear ‘progress,’ and they think that means they’re going to be cured.”[179]

Second, there has been an increase in direct-to-consumer advertising of approved specialty drugs for the treatment of conditions such as cancer and autoimmune disorders by pharmaceutical companies[180] and of specific practices areas such as oncology and organ transplantation by cancer hospitals.[181] The United States is one of only a small number of countries which allows drug company advertising to not only mention an approved drug and its intended use, but also claims about its safety and efficacy.[182] These advertisements—though meant to be scientifically accurate—can also sometimes have misleading effects on people’s perceptions of their individual health outcomes.[183] If patients’ perceptions are skewed when they see a television advertisement claiming an FDA-approved drug will give them “a chance to live longer,” it is reasonable to think that patients’ perceptions could be equally skewed about investigational drugs given that investigational drugs are often touted as “revolutionary” at medical meetings by the manufacturers, tweeted as “ground-breaking” by physicians, and reported as “life-saving” by media, as compared to the currently available treatment option.

Third, with social media, individual patients like Andrea Sloan have a more accessible, widely-used platform by which to raise awareness of their struggle to obtain these investigational drugs through expanded access.[184] In the past, publicized efforts to pressure manufacturers for expanded access were generally a coordinated effort led by advocacy groups, aimed at obtaining an investigational drug for more widespread use.[185] Individual patients were often left to phone calls and letter writing with slim chance of successfully obtaining an experimental treatment without a connection.[186] This changed with social media. The news media found these campaigns and latched onto Sloan’s and other patients’ stories with headlines like “Company Denies Drug to Dying Child” and “Merck Expands Cancer Drug Access but too Late for Denver Dad,” which only amplified the public’s frustration with expanded access.[187] The social media campaigns and media attention, in turn, increased pressure on politicians to fix the system and allow individuals access to investigational drugs.[188]

The Goldwater Institute initially targeted more conservative states like Colorado, Arizona, and Texas,[189] but the movement also gained traction and success in more liberal states like California and Oregon.[190] The state bills also often had little political opposition and were supported by members on both sides of the aisle.[191] In total, forty states adopted righttotry laws prior to the enactment of the federal Right to Try Act. With Alaska’s enactment of its own righttotry law in July 2018, that total is now forty-one states.[192]

The goal of these state-level righttotry laws, as discussed, is to enable terminally ill patients to bypass the FDA expanded access program and request pre-approval use directly from manufacturers, but there are variations in these laws’ provisions regarding, among other things, cost recovery,[193] insurance coverage,[194] and informed consent.[195] The extent to which those variations now matter given the enactment of the Right to Try Act of 2017 is still not fully clear, but as discussed below, at least some are likely still applicable.

B.  The FDA’s Response

In response to the righttotry advocates’ criticisms, the FDA further clarified and modified aspects of the expanded access program to address its perceived shortcomings. The FDA also stepped up efforts to increase awareness and understanding of the expanded access program.

1.  Clarifying the FDA’s Use of Clinical Outcomes

A major issue for manufacturerswhich face external pressure from investors, physicians, and patient groups to bring new drugs to marketconcerns the potential impact an adverse event during expanded access use could have on an investigational drug’s development and subsequent agency review.[196] This concern was likely overstated, particularly given that “clinical safety data from expanded access treatment” has only been considered in a “small number of cases” when determining an approved drug’s label,[197] and that such a criterion has never been used to deny approval.[198] Still, the potential for an adverse event was often cited as an obstacle for patients seeking expanded access use.[199]

The FDA attempted to address these concerns, even if arguably overstated, by clarifying its policy. The treating physician needs to report only “suspected [serious or unexpected] adverse reactions . . . if there is evidence to suggest a causal relationship between the drug and the adverse event.”[200] The agency also noted that given the nature of expanded access use (in other words, an investigational drug administered outside of a controlled clinical trial to a terminally ill patient with multiple comorbidities), it would be difficult to often establish the necessary causal relationship.[201]

This modification, however, did not address the other major concern raised by manufacturers: the lack of a readily available supply of the drug sought for expanded access.[202] The FDA cannot directly tackle this issue, but it could affect the drug supply indirectly through clinical trial policies promoting diversity and inclusion.[203] This, in turn, could help some patients, who are willing to participate in a clinical trial but are instead driven to seek expanded access due to their failure to satisfy clinical eligibility requirements given age or certain comorbidities.[204]

2.  Demystifying Manufacturers’ Eligibility Criteria

A long-standing frustration for patients and their physicians was biopharmaceutical companies’ lack of transparency regarding how they evaluated expanded access requests. Before the enactment of the 21st Century Cures Act (“Cures Act”), manufacturers were not required to disclose their evaluation processes.[205] A few biopharmaceutical companies released their criteria after either coming under pressure from patients’ social media campaigns, which requested expanded access, or observing the impact that such campaigns had on other, similar companies.[206] Generally, however, this information was not easily available to patients or physicians.[207]

The Cures Act now requires manufacturers to disclose how they evaluate and respond to individual patient requests for access to investigational drugs.[208] The following information must be included on a manufacturer’s website: (1) contact information; (2) expanded access request procedures; (3) individual patient eligibility criteria; (4) anticipated response time; and (5) a link or other reference to information about the clinical trials of the drug for which expanded access is sought, available on ClinicalTrials.gov.[209]

Three primary issues have impacted the Cures Act’s effectiveness. First, not all companies are in compliance with its provisions.[210] The Cures Act does not contain an enforcement mechanism to give the FDA the ability to penalize companies that do not publish policies. Second, the Cures Act does not require participation in expanded access—just that a company post its policies. Though most companies have guidelines similar to the ones previously detailed in Section II.B.2, a company is still allowed under the Cures Act to have a policy against providing expanded access, so long as that policy is available on the company’s website.[211] And even if a company’s criteria mirrors that of PhRMA’s criteria, they are still subject to interpretation by that company’s employees. This could make it difficult to determine whether a physician’s request on behalf of a patient will be approved. Third, the Cures Act does not ensure timely response—just that a company post an anticipated response time. In general, that time frame represents the estimated time to an acknowledgment rather than an estimated time to a decision.[212] The FDA seems posed to address this final issue but has not announced definite plans to institute a timing requirement.[213]

3.  Increasing Awareness of Expanded Access

The FDA has also attempted to dispel many of the misconceptions regarding expanded access and clarify the application process for physicians and patients, especially those outside of major academic medical centers. The Reagan-Udall Foundation for the FDA, for example, created the Expanded Access Navigator.[214] This website provides an overview of the application process from both a physician and patient perspective. The physician-specific section includes contact information for independent IRB committees should a physician’s institution not have its own IRB committee,[215] and a manufacturer directory listing companies’ expanded access criteria and their anticipated response time. 

4.  Streamlining the Individual Patient Request Process

a.  Form FDA 3926

Prior to the release of Form FDA 3926, a physician could spend up to one hundred hours in his or her attempt to secure expanded access use for a single patient.[216] Although a significant portion of that estimate likely included time spent negotiating with the manufacturer to obtain a LOA and coordinating with the IRB, physicians complained the application, comprised of Form FDA 1571 (“Investigational New Drug Application”) and Form FDA 1572 (“Statement of the Investigator”),[217] was unnecessarily complex and took upwards of eight hours to complete.[218]

In 2016 the FDA rolled out a streamlined application, Form FDA 3926, to ease the application process.[219] This change was meant not only to reduce the burden on physicians already familiar with requesting expanded access, but also, more importantly, to encourage doctors less familiar with the regulatory process who may have been previously dissuaded from submitting an expanded access request for their patients because of the forms’ complexities.[220] Form FDA 3926 only requires the physician to provide: (1) the patient’s initials; (2) the date of submission; (3) the type of submission; (4) clinical information; (5) treatment information; (6) a LOA; (7) the physician’s qualification statement; and (8) the physician’s name, address, and contact information.[221] The new two-page form takes forty-five minutes to complete—a time savings of more than 90%.[222] The total application process is now estimated to take thirty hours with this new estimate likely factoring in the FDA’s simplified IRB requirement.[223]

b.  IRB Review

In October 2017, the FDA announced another change to the single-patient expanded access process. A requesting physician can now seek approval from a specifically assigned IRB or the IRB chairperson, rather than waiting for a full IRB review (in other words, a committee meeting where “a majority of the members are present”).[224] This change was intended to reduce the time between when the patient and treating physician determine an investigational drug might be appropriate and when the treating physician’s IRB approves that request, as well as to remove another potential hurdle for physicians outside of major academic centers.[225]

This modification attempts to strike the appropriate balance between oversight and timeliness as it recognizes the continued need for independent confirmatory review, while also acknowledging that full IRB review may be unnecessary in the individual patient expanded access setting, given that it could cause undue delays and potentially deter some community-based physicians from using the expanded access pathway. Yet this change also has at least one limitation and two potential drawbacks. With respect to the limitation, it is difficult to know whether hospitals will adopt this modification as it is permissive not mandatory. At least a few major centers appear to be utilizing it, though further research is necessary to determine the full extent of its adoption.[226] To facilitate more widespread adoption, the FDA or the Reagan-Udall Foundation should work with those institutions effectively utilizing the less-stringent IRB review process to develop recommended criteria that other institutions could utilize.

With respect to potential concerns, first, the modification to the IRB requirement potentially reduces the amount of independent oversight. The average IRB is composed of fourteen members, so before the change, an average of seven members would need to be present to constitute a full IRB review.[227] This change places that decision in the hands of one chairperson or another designated member; this type of reduced oversight is typically reserved for research that poses “minimal risk” to the individual.[228] Second, the FDA did not establish specific eligibility criteria for this waiver. Instead, the FDA has said such a waiver is appropriate for individual patient expanded access INDs when the physician obtains concurrence by the IRB chairperson or another designated IRB member before treatment use begins.”[229] This standard again places that decision in the hands of one person; the same person who also decides whether expanded access treatment is appropriate. To address these concerns, the FDA should closely monitor incoming expanded access requests to determine if reducing the number of IRB reviewers increases the number of denied FDA requests based on patients not meeting the eligibility criteria. As an initial step, the FDA could refer institutions incorrectly utilizing the waiver to other hospitals that are correctly applying the waiver criteria, and if that appears to not resolve this potential problem, the FDA should consider changing its policy to require at least two or three IRB members or one designated IRB member and a consulting physician specializing in the patient’s disease or condition.[230]

* * *

There were arguably three reasons that these modifications did not quell the righttotry movement and those ultimately pushing for a federal law. First, the legislation—both at the state and federal level—was not aimed at improving pre-approval access for patients, but was instead meant “to weaken” the FDA.[231] Congress did not even wait to assess the impact of the modifications before voting on the Right to Try Act, even though it had authorized the agency to release a report assessing the impact of some of these modifications in 2017.[232] That report, published after the enactment of the Right to Try Act, suggests that all of the key stakeholders, patients, physicians, manufacturers, and payers, have a positive perception of the program and the FDA’s role in pre-approval access decisions.[233] The efforts to reduce some of the administrative burdens associated with expanded access appear to be well-received.[234] In 2017 (the first full year Form FDA 3926 was available and the year the Expanded Access Navigator was launched), there were 1,151 single-patient expanded access requests, which was a 12% increase from 2016 (1,025 requests).[235] Moreover, Congress did not thoroughly assess the effectiveness of the state righttotry laws before moving forward with the federal law.

Second, the slow implementation of the FDA’s modifications likely further validated for some the righttotry advocates’ argument that the FDA is too rigid and unresponsive. For example, the modifications to the application process were introduced more than two years after the righttotry movement started.[236]

Third, the modifications, aside from the clarification regarding use of clinical outcomes, also did not address the other weakness of the expanded access program—uneven manufacturer participation.[237] The movement’s supporters argued a federal righttotry law would improve manufacturer participation in pre-approval access.[238]

C.  The Push for a Federal Right to Try

Capitalizing on the success at the state level, proponents pushed for federal legislation,[239] even though (1) there was little evidence to suggest that existing state laws had a real impact on patients’ ability to secure pre-approval access,[240] and (2) the effects of the FDA’s modifications to the expanded access program were not fully evaluated.

The first proposed bill never made it out of committee,[241] but in 2016 Senator Ron Johnson (R-Wis.) started strategically laying the groundwork. As Chair of the U.S. Senate Committee on Homeland Security and Governmental Affairs, he convened a hearing to discuss how Congress could reform the regulatory framework to provide “more patients a chance to save their lives.”[242] He introduced a righttotry bill later that year,[243] but this bill was blocked by Senate Minority Leader Harry Reid (D-Nev.) who objected over the bill’s lack of bipartisan support and nonexistent review through a formal hearing process.[244] In January 2017, Senator Johnson reintroduced a federal righttotry billthe Trickett Wendler Right to Try Act of 2017 (“S. 204”).[245] On August 3, 2017, the Senate passed the bill with no opposition, thus moving the debate over right to try to the U.S. House of Representatives.[246]

The fate of S. 204 remained in limbo for several months after an October hearing before the House Committee on Energy and Commerce.[247] The momentum shifted in favor of the righttotry movement, however, after President Trump singled out the proposed righttotry law in his 2018 State of the Union address.[248] This mention was enough to reenergize efforts in the House. In March 2018, the House Committee on Energy and Commerce introduced H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, a narrower righttotry bill incorporating feedback from the FDA.[249] H.R. 5247 failed an initial vote on March 13, but a week later, on March 21, 2018, the bill passed by a vote of 267–149, mostly along partisan lines.[250]

H.R. 5247 never reached the Senate floor.[251] With the Senate at a standstill, the House renewed discussions over S. 204.[252] In spite of ongoing criticism from industry, patient groups, and physicians,[253] on May 22, 2018, the House passed S. 204 by a vote of 250–169, again on partisan lines.[254] On May 31, 2018, President Trump signed the Right to Try Act and declared the law a victory for patients.[255]

IV.  the Right to Try Act of 2017

A.  The Law

The Right to Try Act creates “national standards and rules by which investigational drugs may be provided to terminally ill patients.”[256] The federal law—like its predecessor state laws—is permissive and not mandatory. A manufacturer is not required and cannot be compelled to provide access to an investigational drug after receiving a righttotry request pursuant to the federal Right to Try Act.[257]

1.  Who is Eligible?

First, a patient may pursue a right-to-try request if they have a “life-threatening disease or condition.”[258] Senator Johnson chose this disease threshold, rather than the “immediately life-threatening disease” standard previously used in the expanded access program “because [he thought that the immediately life-threating disease definition] would exclude patients with Duchenne muscular dystrophy, an illness [he] explicitly intended to be covered.”[259] Second, the patient must have “exhausted approved treatment options” and be “unable to participate in a clinical trial involving the eligible investigational drug.”[260] A physician—but not necessarily the requesting physician—must certify the patient cannot participate in a clinical trial.[261] The physician who certifies that a patient is unable to participate in the clinical trial must be in “good standing” and cannot receive compensation from the manufacturer in direct response to the certification.[262] Third, the patient must provide “written informed consent”––a term that is undefined under the law, rather than using the existing federal regulation defining informed consent.[263]

2.  When Would an Investigational Drug Qualify?

To qualify for right to try, an investigational drug must satisfy four requirements. First, it must have completed a phase I clinical trial.[264] The Act does not specify whether the investigational drug must have completed a phase I clinical trial in the requested indication. The Act also does not preclude requests for investigational drugs that have only been tested in healthy volunteers. Second, the drug must not be approved for any other use.[265] Third, the manufacturer must either (1) have already filed a marketing application for the investigational drug with the FDA, or (2) be investigating the drug in a clinical trial that is “intended to form the primary basis of a claim of effectiveness in support of approval” and is the subject of an active IND.[266] This language is broad because, as Senator Johnson explains, the Act was not intended to enable the FDA to exclude any clinical trial as a basis for precluding access to treatments under right to try.”[267] Fourth, the drug must be in active development (that is, not discontinued) and not subject to a clinical hold.[268]

An investigational drug that meets these requirements is then exempt from certain statutory and regulatory requirements[269] as long as the providing company also complies with sections 312.6 (labeling of investigational new drugs), 312.7 (promoting investigational drugs), and 312.8 (charging for investigational new drugs) of the Code of Federal Regulations.[270]

3.  What are the Reporting Obligations?

a.  Companies              ’ Reporting Obligations

The Right to Try Act requires a company to file a yearly report of right-to-try use with Health and Human Services (“HHS”). This yearly report to HHS must include “the number of doses supplied, the number of patients treated, [and] the uses for which the drug was made available”; the manufacturer must also report “any known serious adverse events.”[271]

b.  FDA’s Reporting Obligations

The Right to Try Act also requires the publication of a yearly report summarizing right-to-try use on the FDA’s website. This yearly report must disclose how often the FDA determines a clinical outcome to be critical to deciding safety, how often a manufacturer asks the FDA to consider such outcomes, and how often the FDA does not consider clinical outcomes when reviewing the investigational drugs marketing application.[272]

4.  When Can the FDA Use Clinical Outcomes?

The Right to Try Act bars the FDA from considering a “clinical outcome” related to a patient’s use of an investigational drug “to delay or adversely affect the review or approval” of that drug––except in two situations.[273] The FDA is allowed to use a clinical outcome if it is (1) critical to the assessment of the investigational drug’s safety, and (2) the company that provided the investigational drug can also ask for a clinical outcome to be considered.[274] The Act does not define “critical.”

* * *

 

B.  Industry’s Potential Path Moving Forward

 This Section proceeds as follows. Section IV.B.1 explains why regardless of future FDA guidance, most companies are unlikely to adopt a two-pathway approach or even a single-pathway approach using just right to try, favoring continued use of the expanded access program instead. Section IV.B.2 argues that the status quo, however, is insufficient and that companies need to address some of the criticisms raised during the right-to-try movement by (1) revising their existing expanded access policies, and (2) improving clinical trial access.

1.  Even with the Right to Try Act, Most Companies Will Continue to Use Expanded Access

All along, right-to-try advocates have contended that the Right to Try Act’s provisions limiting liability and limiting the FDA’s use of outcome data would incentivize manufacturers to utilize this new pre-approval pathway.[275] Yet, as this Note explains below, these two provisions are not enough for most companies to utilize the Right to Try Act.[276]

Lack of Support from Key Stakeholders. The Right to Try Act lacks support from industry, advocacy groups, physician organizations, and the FDA. Companies, including Janssen and Bristol-Myers Squibb, have already stated that right-to-try requests will be funneled through the expanded access pathway.[277] Janssen announced prior to the enactment of the federal Right to Try Act that it would not “evaluate right-to-try requests because [the state] laws don’t allow for FDA input, which is ‘critical for ensuring patient safety.’”[278] Patient advocacy groups and physician organizations have not significantly changed their position on the Right to Try Act since its adoption.[279] The FDA has also since voiced its continued preference for use of the expanded access program in November 2018,[280] and announced in December 2018 a new program, “Project Facilitate,” which aims to further alleviate the criticisms of the expanded access program. Project Facilitate will establish a department within the FDA that (1) will field calls from physicians requesting expanded access on behalf of a patient and patients seeking single-patient expanded access for themselves; (2) complete Form FDA 3926, and if necessary forward the completed form to a patient’s treating physician for sign-off if the initial request was made by the patient; (3) forward the request to an IRB; and (4) ultimately submit the request to the company developing the requested drug, which must make a determination “within a specified time period . . . yet [to be] determined” by the FDA.[281] With industry generally reticent to act without agency guidance,[282] the November 2018 announcement and the forthcoming Project Facilitate arguably send strong signals to keep using the expanded access program.

Insufficient Incentives. The Right to Try Act’s provisions limiting a company’s liability and limiting the FDA’s use of outcome data are insufficient incentives. First, the Right to Try Act does limit a company’s potential liability but does not protect a manufacturer against any and all liability claims. As attorney James M. Beck notes, the Act still allows claims of reckless or willful misconduct, gross negligence, or intentional tort.[283] The Right to Try Act also does not foreclose claims under state or federal product liability, tort, consumer protection, or warranty law.[284] A company would also be trading more liability protection for less FDA input when it is not clear further liability protection is even necessary. As others have pointed out, there are no examples of patients suing manufacturers of investigational drugs for “treatment-related harm[s]” stemming from expanded-access use.[285] Therefore, companies––at least within the context of expanded access––should have minimal concern over potential tort claims.

Second, although the Right to Try Act limits the FDA’s use of outcome data to when it is “critical” to determining safety, in practice the FDA rarely uses expanded access data when reviewing an investigational drug unless there is evidence to suggest a causal relationship.[286] Even though the FDA’s use of outcomes is often a concern for manufacturers, the FDA has assured companies it rarely uses expanded access data, so it is unclear how the Right to Try Act’s provision further limits the FDA’s use. Furthermore, as the Act does not define “critical,” without some guidance from the FDA it is unclear whether this is the same standard as used in expanded access, a more relaxed standard, or a heightened standard given that the FDA is not involved in reviewing the righttotry request and determining proper usage, such as dosage. Finally, even if the FDA is limited in its ability to assess reported events, manufacturers may still be concerned about whether any adverse events associated with righttotry use would impact regulatory approval in other countries.[287]

Third, the Right to Try Act does not contain a significant financial incentive for industry. The Act requires companies to comply with the existing regulation, which limits cost recovery to direct costs, except under specific circumstances.[288] A two-pathway approach would require companies to allocate additional money, personnel, and drug supply to another program that is outside the drug development process. With the cost of developing a new drug estimated to be around $2.6 billion,[289] it seems unlikely that manufacturers would be willing to expend any additional resources to only recoup direct costs.[290] A publicly traded company, like Pfizer or Janssen, might have the necessary financial resources and employees but will still answer to shareholders and still have concerns about maintaining adequate supply of the drug for its clinical trials.[291] A small, private company under pressure from investors is likely to have even less motivation to redirect limited resources to a two-pathway pre-approval program, or even a single-pathway program without some financial upside.[292] Take, for example, BrainStorm Therapeutics, which announced plans to offer its therapy through right to try and would have charged patients seeking the right to try its drug potentially $300,000. The company’s nowretracted plan likely did not comply with federal regulation given that it was positioned as a “semicommercial enterprise with modest profits.”[293]

Unanswered Implementation Questions. The Right to Try Act is meant to be a parallel pathway to expanded access and not a replacement, but it would be difficult for a company to implement a pre-approval access program in which both of these programs co-exist. The Right to Try Act does not provide companies considering utilizing right to try as a parallel pathway guidance to the threshold issue: when it should use right to try and when it should use expanded access. The FDA is working to develop guidance,[294] but for now it has said that companies are in the best position to make that determination.[295] While this Note identifies two potential options, each is not without their own drawbacks and complexities. A company could (1) use right to try when an investigational drug will be used by a single patient and use expanded access when an investigational drug will be used by a larger patient population, or (2) use right to try under certain pre-defined circumstances (for example, pediatric patients or patients with exceptional safety risks) and use expanded access in all other circumstances.

 The first option—use of right to try in the single-patient setting—would be administratively easier. A company would not need to develop new policies delineating between the two pathways for individual patients. That said, this approach does have potential challenges. First, individuals with certain types of serious diseases would not qualify for the righttotry pathway, therefore limiting their pre-approval access options until the drug has sufficient evidence to support expanded access for intermediate-size or widespread treatment.[296] Take, for example, the conditions narcolepsy or rheumatoid arthritis, which the FDA has said would independently qualify as a serious disease; these conditions would not be considered lifethreatening because both are considered chronic diseases and are alone not fatal.[297] Therefore, adoption of this approach would likely be dependent on a company’s investigational drug pipeline. A company with a single drug in development might be less concerned about this issue, but a company with a large disease pipeline that targets multiple different disease areas might be.

Second, it is not clear what the patient limit should be for right to try (that is, at what point should a company stop providing pre-approval access through right to try and transition over to expanded access for intermediatesize and widespread treatment). The Right to Try Act does not provide any guidance. A company should not be able to provide five, ten, or fifteen patients at a single hospital with an investigational drug through the right to try pathway. That starts looking more like an intermediate-size expanded access protocol[298] and arguably should have FDA oversight. Without specific right-to-try guidance, a manufacturer would need to rely on expanded access guidance as a benchmark for when a company should transition from the righttotry pathway to intermediate-size or widespread use through expanded access, but even then the existing FDA guidance does not address other concerns regarding the potential applicability of the Right to Try Act’s provisions limiting liability and use of outcome data once a certain patient threshold is crossed.

The second option—use of right to try under certain pre-defined settings—would be administratively more complicated, given that it would require companies to determine those pre-defined circumstances and ensure that the criteria for those standards is clear and easy to apply. That said, some companies might consider this approach in order to allow some patients who might otherwise not be eligible for expanded access to receive the drug through right to try, given the Act’s provisions limiting liability and use of outcome data. Two such settings that a company might reasonably consider are (1) patients who have exceptional safety risks[299] and (2) patients who are children.[300] The former group is frequently ineligible for a clinical trial and likely to be denied expanded access use because of manufacturers’ concerns about potential liability or adverse events impacting clinical development.[301] The latter group—often the face of the righttotry movement[302]is also frequently ineligible for industry-sponsored clinical trials and may be denied expanded access use because of manufacturers’ concerns about inadequate clinical data to determine an adequate dosage in the pediatric setting, potential liability, or adverse events impacting clinical development.[303]

This second approach is also not without its drawbacks. First, the pre-defined settings would need to be unambiguous. Though pediatric patients can be more clearly defined by age, the term “exceptional safety risks” is not susceptible to one definition, so companies allowing pre-approval access in this setting would need to establish a specific standard and make sure it is clearly communicated internally and externally. Second, with pediatric patients[304] and patients who are terminally ill,[305] there are also ethical considerations requiring companies to adopt more rigorous informed consent requirements and procedures. Take pediatric patients, for example, cases in which “[p]arents or other surrogates technically provide ‘informed permission’ for diagnosis and treatment, with the assent of the child whenever appropriate.”[306] Third, companies would also still need to refer back to the state righttotry laws to ensure their pre-defined settings are compliant. Oregon, for example, limits the right to try pathway to individuals who are at least eighteen years old.[307] This could increase the complexities of implementation. Fourth, the drawbacks relating to the first option likely would also impact the second option.

The practical complexities of operating a two-pathway approach, stemming from presently unanswered legal questions regarding the Right to Try Act and concerns that might arise from utilizing Right to Try in specific patient settings, make companies unlikely to use right to try even if the FDA provides guidance.

State Right-to-Try Laws. The applicability of state righttotry laws is also still uncertain.[308] While the Right to Try Act creates a national standard,[309] it does not explicitly preempt these state laws.[310] Senator Ron Johnson has previously stated that the Right to Try Act was meant to be the “federal counterpart” to the state righttotry laws.[311] With forty-one statelevel righttotry laws, implementation and compliance would be complicated. A company would likely need to comply with at least some of the provisions of the state righttotry laws in addition to the Right to Try Act’s provisions.

Take, for example, the California state statute’s criteria for patient eligibility, which requires a person to have: (1) “an immediately life-threatening disease or condition”; (2) “considered all other treatment options currently approved”; (3) “not been accepted to participate in the nearest clinical trial to his or her home . . . within one week of completion of the clinical trial application process, or, in the treating physician’s medical judgment, it is unreasonable for the patient to participate in that clinical trial”; (4) “received a recommendation from his or her primary physician and a consulting physician”; (5) “given written informed consent”; (6) documentation . . . attesting that the patient has met the requirements . . . .[312]

The first requirement limiting patient eligibility is narrower than the Right to Try Act.[313] The second requirement is arguably broader, because it would allow a patient to rely on the pathway after considering, but not exhausting, all treatment options. The first part of the third requirement could possibly supplement the Right to Try Act’s clinical trial requirement if it was interpreted as requiring proof of non-acceptance, but it is likely more accurately interpreted as allowing a patient to make a request within one week of not receiving a response, which is broader than the Right to Try Act. The second part of that requirement is clearly broader, however, than the federal law, as the Right to Try Act requires a physician to certify that a patient cannot participate in a clinical trial, and not just that it would be unreasonable for a patient to participate in a clinical trial; the California law uses a different standard. The fourth requirement supplements the Right to Try Act because it requires confirmation from a second physician.[314] The fifth requirement also supplements the federal law because, whereas the federal law leaves “informed consent” undefined, California defines “informed consent” in another part of the statute.[315] The sixth requirement mirrors the federal law.[316]

Although a company could theoretically challenge state right to try laws as preempted by the federal provision, this is not an issue that an individual company, or companies collectively, are likely to challenge, particularly given the high costs of litigation and limited financial incentive of success on the merits.[317] This issue could also impact patient’s actual interest[318] and healthcare providers’ willingness to offer such treatments.[319]

External Regulatory Challenges. The adoption of the Right to Try Act by industry seems less likely given that companies already face “challenges particularly related to . .