Professors Rochelle Dreyfuss and Katherine Strandburg
Spring 2022
Wednesdays, 2:10-4:10 pm, Furman Hall, Room 318
Thursdays, 4:00-6:00 pm, Vanderbilt Hall, Room 208
LW.10930
3 credits
The Colloquium on Innovation Policy focuses each year on different aspects of the law’s role in promoting creativity, invention, and new technology. This year, we will examine innovation in the health care field, looking at such matters as the relationship between intellectual property, encouraging medical advances, and assuring appropriate public access to these advances; the special problem of developing countries; and competition issues related to innovation and intellectual property. We will mostly consider these questions through the lens of the COVID pandemic.
Spring 2022 Schedule of Presenters (All presentations will be held on Zoom.)
Thursday, JANUARY 27 https://nyu.zoom.us/j/96085577642
Siva Thambisetty, LSE Law School, London School of Economics and Political Science
The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic
Abstract: Addressing Vaccine Inequity examines global vaccine inequality during the COVID-19 pandemic. We critique intellectual property (IP) law under the 1995 WTO TRIPS Agreement, and specifically, the role that IP plays in enabling the inequities of production, distribution and pricing in the COVID-19 vaccine context. Given the failure of international response mechanisms, including COVAX and C-TAP, to address vaccine inequity, we argue the TRIPS waiver proposal offers a necessary and proportionate legal measure for clearing IP barriers that cannot be achieved by TRIPS flexibilities. Finally, we reflect on the waiver in the wider context of TRIPS, addressing TRIPS’ successes and failures. TRIPS Waiver is a work in progress that discusses the plea for TRIPS waiver as a plea for greater degrees of transnational private ordering to emerge to meet public health goals.
Thursday, FEBRUARY 3 https://nyu.zoom.us/j/98062745789
Ana Santos Rutschman, Center for Health Law Studies, Saint Louis University School of Law
Aligning Vaccine Innovation with Public Health Needs - Introduction and Chapter 5
Abstract: According to longstanding scientific consensus, vaccines are widely regarded as playing a fundamental role in public health. Therefore, one would reasonably expect that the dynamics of vaccine production and distribution would place a premium on incentivizing robust levels of investment in vaccine development, with the allocation of resulting vaccine occurring in ways that reflect public health priorities. Yet, that is often not the case. This book examines this disjunction from the viewpoint of the laws, policies and other market-driven forces that shape the development and distribution of vaccines. Together, these mechanisms have long led to problems of under-investment in vaccine research and production, and inequitable allocation of limited vaccine supply in ways that recurrently disadvantage lower-income populations.
Thursday, FEBRUARY 10 https://nyu.zoom.us/j/93148979767
Rachel Sachs, Visitor, NYU School of Law, Spring 2022; Washington University in St. Louis School of Law
The Accidental Innovation Policymakers
Abstract: Healthcare policymakers in the United States, particularly at the federal level, have been considering a range of proposals that would lower prices for prescription drugs. The pharmaceutical industry and many politicians have argued that these proposals would harm innovation incentives, resulting in fewer new drugs coming to market in the future. This Article identifies and explores a key problem with this argument: that it is typically deployed both accidentally and asymmetrically in nature. Specifically, this Article considers previous changes to health laws that had the impact of increasing innovation incentives by providing large new subsidies to pharmaceutical companies—chiefly the creation of Medicare Part D and the passage of the Affordable Care Act—but where policymakers appear not to have analyzed these innovation-related aspects of the new laws. By contrasting these laws with others in which policymakers explicitly centered the innovation-related impacts of their actions, such as the Hatch-Waxman Act and the Orphan Drug Act, this Article suggests that policymakers may in some cases be making innovation policy “by accident,” without knowledge of their likely results. These innovation arguments are also deployed asymmetrically by interested stakeholders, creating the potential for unbalanced policymaking over time. This Article further analyzes the implications of this accidental, asymmetric policymaking for innovation law and policy.
Wednesday, MARCH 9 https://nyu.zoom.us/j/94965395072
Christopher Morten, Science, Health, and Information Clinic, Columbia Law School
Publicizing Corporate Secrets for Public Good
Abstract: Federal regulatory agencies in the United States hold a treasure trove of valuable information essential to a functional society. Yet little of this immense and nominally “public” resource is accessible to the public. That worrying phenomenon is particularly true for the valuable information that agencies hold on powerful private actors. Corporations regularly shield vast swaths of the information they share with federal regulatory agencies from public view, claiming that the information contains legally protected trade secrets (or other proprietary “confidential commercial information”). Federal agencies themselves have largely acceded to these claims and even fueled them, by construing restrictively various doctrines of law, including trade secrecy law, freedom of information law, and constitutional law. Today, these laws—and fear of these laws—have reduced to a trickle the flow of information that the public can access. This should not and need not be the case. This article challenges the conventional wisdom that trade secrecy law restricts public agencies’ power to publicize private businesses’ secrets. In fact, federal agencies, and regulatory agencies especially, have long held and still hold statutory and constitutional authority to obtain and divulge otherwise secret information on private actors, when doing so serves the public interest. For many regulatory agencies, that authority extends even to bona fide trade secrets. In an age of “informational capitalism,” this disclosure authority makes U.S. federal regulatory agencies uniquely valuable—and perhaps uniquely dangerous. Building on recent work that explores this right in the context of drugs and vaccines, and drawing heavily from scholarship in privacy and information law, the article proposes a practical framework that regulators can use to publicize secret information in a way that maximizes public benefit and minimizes private harm. Rather than endorse unconstrained information disclosure—transparency for transparency’s sake—I instead propose controlled “information publicity,” in which regulators cultivate carefully bounded “gardens” of secret information. Within these gardens, agencies can admit only certain users and certain uses of information. Drawing on existing but largely overlooked real-world examples, I show that regulators can effectively and selectively publicize trade secret information to noncommercial users while thwarting commercial uses, thereby simultaneously protecting trade secrets’ integrity vis-à-vis competitors and unlocking new, socially valuable uses.
Thursday, March 24 https://nyu.zoom.us/j/94057361438
Michael Mattioli, Maurer School of Law, Indiana University
FDA’s Privacy Halo (Email Nicole Arzt if you plan to attend the talk and I will forward you a copy of his draft paper.)
Abstract: Do some consumers trust the words “FDA cleared” more than they should? It’s a timely question: In 2017, the US Food and Drug Administration (FDA) began permitting software makers to market smartphone apps as treatments for a range of mental health disorders, including addiction and attention deficit hyperactivity disorder. Although these novel treatments are safe and possibly effective, many of them trade on users’ privacy by liberally sharing medical data with third parties. This Article presents an original survey suggesting that the imprimatur of FDA approval on app advertisements leads consumers and prescribing doctors to ignore these data privacy risks. Rather than informing consumers, the words “FDA cleared” on mental health app ads stimulate vague and sometimes misplaced feelings of goodwill. In essence, FDA approval in this setting can improperly serve as a kind of trademark. After laying out the empirical basis for this conclusion, this Article explores its legal implications and presents a set of potential policy solutions.
Thursday, MARCH 31 https://nyu.zoom.us/j/91662296402
Nicholson Price, University of Michigan Law School
Rethinking the Role of Innovation at the FDA (Email Nicole Arzt if you plan to attend the talk and I will forward you a copy of his draft paper.)
Abstract: In multiple controversial drug approval decisions in recent years, the Food & Drug Administration (FDA) has publicly justified its decision partly on the grounds that approving the drugs in question would be necessary to support innovation in those fields going forward. To some observers, these arguments were surprising, as the agency’s determination whether a drug is “safe and effective” does not seem to depend on whether it also creates innovation incentives for pharmaceutical companies. But FDA’s use of these innovation arguments in drug approval decisions is just one small example of the ways in which the agency has come to make many other innovation-related judgments as part of its regulation of the approval of new health care technologies. In this Article, we investigate this broader set of innovation-related judgments that FDA has been making, and consider the benefits and costs of doing so. Ultimately, health policymakers could reasonably decide that FDA should have either a larger or a smaller role than it currently does in providing incentives for the development of new healthcare technologies, but they should do so thoughtfully weighing the downsides to giving FDA that role, which have been rarely considered in the literature and policy discourse. Further, we argue that whether policymakers aim to bolster or limit FDA’s role in innovation incentives, changes are needed to the agency’s structure to support its ability to make consistent judgments, relying on expert decisionmaking in doing so.
Thursday, APRIL 7 https://nyu.zoom.us/j/91746275680
John Liddicoat, University of Cambridge Faculty of Law
Repositioning Generic Drugs: Empirical Realities (Email Nicole Arzt if you plan to attend the talk and I will forward you a copy of his draft paper.)
Abstract: Commentators claim that repositioning (i.e. developing new uses for authorised drugs) slows when generics are authorised and, therefore, law reform is necessary to encourage more R&D. This study empirically examines this claim with records of clinical trials. It finds that once generics are authorised: i) commercial trials continue at “active” rates for approximately half of the drugs studied; and ii) the number of hospital and university trials actually increase. These findings cast doubt on whether additional incentives are needed. They also indicate that a more effective way to reposition drugs is for recently established government programmes to embrace IP strategies and use the hospital and university trials as an R&D pipeline.
Wednesday, APRIL 13 https://nyu.zoom.us/j/92929162733
Peter Lee, UC Davis School of Law
COVID-19 Vaccines, Technical Disclosure, and Public-Private Quid Pro Quos
Abstract: While COVID-19 vaccines have saved countless lives, their highly unequal distribution around the world has generated significant concern. Biopharmaceutical firms hold patents on these vaccines, and critics have argued for weakening these patents to increase access to these essential resources. Biopharmaceutical patentees respond that weakening patents would not increase global vaccine production because third parties cannot effectively manufacture vaccines without proprietary tacit knowledge and trade secrets. This assertion, however, appears to conflict with the traditional quid pro quo of the patent system in which inventors receive exclusive rights in exchange for disclosing their inventions. This chapter argues that this paradox—biopharmaceutical patentees have disclosed their inventions, yet those disclosures do not enable technical artisans to effectively practice them—is highly problematic. It explores the importance of tacit knowledge—uncodified, experiential knowledge held by inventors—and trade secrets to practicing and commercializing patented technologies. Patent applicants routinely do not disclose tacit knowledge and trade secrets related to practicing their inventions, and this chapter suggests modifying the patent quid pro quo to induce greater technical disclosure. It proposes resurrecting the best mode requirement of patentability and potentially extending disclosure obligations for a finite period of time after patent filing. It further argues that government agencies can leverage public research funds to promote greater technical disclosure by private innovators. Such measures can increase the disclosure of latent knowledge and codified trade secrets. However, transferring purely tacit knowledge, which is not amenable to codification, often requires direct interaction between technology generators and adopters. This chapter cautions against requiring such intensive tacit knowledge transfer as part of the patent quid pro quo. However, it suggests that additional policy levers can help motivate and facilitate such technical knowledge transfer.
Questions about the Colloquium should be addressed to Nicole Arzt at nicole.arzt@nyu.edu.