A New Framework for Assessing Clinical Data Transparency Initiatives

Marquette Intellectual Property Law Review Volume 18 | Issue 1 Article 1 A New Framework for Assessing Clinical Data Transparency Initiatives Erika Lietzan Follow this and additional works at: http://scholarship.law.marquette.edu/iplr Part of the Intellectual Property Commons Repository Citation Erika Lietzan, A New Framework for Assessing Clinical Data Transparency Initiatives, 18 Marq. Intellectual Property L. Rev. 33 (2014). Available at: http://scholarship.law.marquette.edu/iplr/vol18/iss1/1 This Intellectual Property Policy Forum Articles is brought to you for free and open access by the Journals at Marquette Law Scholarly Commons. It has been accepted for inclusion in Marquette Intellectual Property Law Review by an authorized administrator of Marquette Law Scholarly Commons. For more information, please contact . LIETZAN FINAL (DO NOT DELETE) 7/1/2014 1:25 PM INTELLECTUAL PROPERTY POLICY FORUM ARTICLES A NEW FRAMEWORK FOR ASSESSING CLINICAL DATA TRANSPARENCY INITIATIVES ERIKA LIETZAN* INTRODUCTION ....................................................................................... 37 I. BACKGROUND ..................................................................................... 40 II. PLACING DISCLOSURE WITHIN THE LEGAL LANDSCAPE ................. 46 A. Classification as Trade Secret ................................................ 47 B. Analytical Problems with Trade Secret Classification ........... 53 1. Trade Secret Law is Not Directly on Point ...................... 54 2. The Doctrinal Debate Collapses ...................................... 57 C. The Property Question ........................................................... 61 1. Defining the Content as Property .................................... 61 2. A Closer Look at the Right to Exclude ............................ 66 D. Implications............................................................................ 72 1. Application of Takings Principles ................................... 72 2. Public Policy Should Shape the Taking and Ancillary Legal Reform ................................................................. 77 3. Just Compensation Follows ............................................. 82 4. The International Dimension ........................................... 83 CONCLUSION ........................................................................................... 85 * Associate Professor of Law, University of Missouri School of Law. I am grateful to Sandy Baggett, Michael Carrier, Lewis Grossman, Heather Hughes, and David Lange for helpful comments on drafts of this paper. I am also grateful to Kathleen Boozang for arranging an informal audience for a draft at the Seton Hall University School of Law and to Lewis Grossman for arranging an informal audience for a draft at the American University Washington College of Law, and to the faculty who participated in those sessions. All errors and shortcomings in the article are, of course, my own. At the time this article was prepared, I was an Adjunct Professor at the George Mason University School of Law and a Partner at Covington & Burling LLP, where I specialized in the regulation of drugs and biological products, with a particular focus on aspects that have an intellectual property component. The views in this article of course should not be attributed to any client of that firm. LIETZAN FINAL (DO NOT DELETE) 34 7/1/2014 1:25 PM MARQ. INTELL. PROP. L. REV. [Vol. 18:1 LIETZAN FINAL (DO NOT DELETE) 2014] 7/1/2014 1:25 PM A NEW FRAMEWORK FOR ASSESSING CLINICAL DATA 35 ERIKA LIETZAN Erika Lietzan is an Adjunct Professor at George Mason University School of Law and a Partner at Covington & Burling LLP, where she practices food and drug law. She specializes in regulation of drugs and biological products, with a particular focus on aspects that have an intellectual property component: biosimilar regulation and policy (domestically and abroad); the Hatch-Waxman amendments; data and market exclusivities; generic (180-day) exclusivity; and patent linkage. She also specializes in the regulation of clinical trials; access issues (e.g., expanded access and treatment INDs, shortages, and importation); and issues with a constitutional law or administrative law aspect. She publishes and speaks frequently on these topics. She co-authored the definitive history of the Biologics Price Competition and Innovation Act, published in the Food and Drug Law Journal, after participating in the years-long negotiation process that led to its enactment, and her next publication will be a book chapter on FDA regulation of clinical trials (in Biotechnology and the Law, which she is also editing). Ms. Lietzan is a graduate of UNC and holds a Master's Degree in history from UCLA as well as a law degree (with high honors) from Duke Law School. She has held leadership positions within the American Bar Association (including, previously, chair of the Biotechnology Committee and now chair of the Life and Physical Sciences Division of the ABA's Section on Science & Technology). She was a member of the Board of the Directors of the Food and Drug Law Institute and is also an elected member of the American Law Institute. LIETZAN FINAL (DO NOT DELETE) 36 7/1/2014 1:25 PM MARQ. INTELL. PROP. L. REV. [Vol. 18:1 LIETZAN FINAL (DO NOT DELETE) 2014] 7/1/2014 1:25 PM A NEW FRAMEWORK FOR ASSESSING CLINICAL DATA 37 INTRODUCTION Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this data. Indeed, European authorities are moving swiftly now towards full release over industry objections and despite several lawsuits. Industry generally argues that the material is intellectual property—specifically trade secret or confidential commercial information— and that its release will help a company’s competitors, devaluing the property and reducing incentives for medical innovation. To the limited extent that they have addressed the issue, however, legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. And the tide is turning, with incremental changes in the law in the United States, coercive pressure from medical journals to release data as a condition of publication, European regulators pressing forward, and industry volunteerism to stave off the most aggressive forced disclosure proposals. This Article provides a new framework for assessing disclosure of the contents of drug applications, by filling several major gaps in the legal scholarship. The key gaps are as follows. First, scholars in the intellectual property field devote very little attention (...truncated)