Law Commons^™

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

In FTC v. Actavis, Inc., the Supreme Court considered "reverse payment" settlements of patent infringement litigation. In such a settlement, a patentee pays the alleged infringer to settle, and the alleged infringer agrees not to enter the market for a period of time. The Court held that a reverse payment settlement violates antitrust law if the patentee is paying to avoid competition. The core insight of Actavis is the Actavis Inference: a large and otherwise unexplained payment, combined with delayed entry, supports a reasonable inference of harm to consumers from lessened competition.This paper is an effort to assist courts and …

Activating Actavis, Aaron Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

In Federal Trade Commission v. Actavis, Inc., the Supreme Court provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. The Court came down strongly in favor of an antitrust solution to the problem, concluding that “an antitrust action is likely to prove more feasible administratively than the Eleventh Circuit believed.” At the same time, Justice Breyer’s majority opinion acknowledged that the Court did not answer every relevant question. The opinion closed by “leav[ing] to the lower courts the structuring of the present rule-of-reason antitrust litigation.”This article is an effort to help courts and counsel …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to confirm …

Correlative Obligation In Patent Law: The Role Of Public Good In Defining The Limits Of Patent Exclusivity, Srividhya Ragavan

Srividhya Ragavan

In light of the recent outrageous price-spiking of pharmaceuticals, this Article questions the underlying justifications for exclusive rights conferred by the grant of a patent. Traditionally, patents are defined as property rights granted to encourage desirable innovation. This definition is a misfit as treating patents as property rights does a poor job of defining the limits of the patent rights as well as the public benefit goals of the system. This misfit gradually caused an imbalance in the rights versus duties construct within patent law. After a thorough analysis of the historical and philosophical perspectives of patent exclusivity, this Article …

Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova

Robin C Feldman

Regulatory Property: The New Ip, Robin C. Feldman

Robin C Feldman

International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston Nagan

Winston P Nagan

This Article examines the question of access to patented medicines in international law. It analyzes the extent to which international agreements may lawfully limit affordable versions of these medicines that may be available through parallel imports or compulsory licensing procedures. It considers the concept of intellectual property rights from a national and international perspective to determine how these rights must be sensitive to matters of national sovereignty when extraordinary, life-threatening diseases afflict societies in catastrophic ways. This Article suggests that viewing property (including intellectual property) as a human right requires that its scope be delimited and understood in the context …

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Yaniv Heled

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Patent Trolling--Why Bio & Pharmaceuticals Are At Risk, Robin C. Feldman, W. Nicholson Price Ii

Robin C Feldman

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Brief Of Amicus Curiae, The National Legislative Association On Prescription Drug Prices, The New Hampshire Medical Society, And Prescription Policy Choices In Support Of Defendant's Objection To Plaintiff's Motion For Preliminary Injunction, Sean Flynn

Sean Flynn

Plaintiffs in this case seek a preliminary injunction to prevent the enforcement of the New Hampshire Prescription Confidentiality Act, which protects consumers and the privacy interests of doctors in the state of New Hampshire from the increasingly common practice of using doctor-identifying information in prescription records to facilitate targeting of pharmaceutical marketing and gifts toward doctors who prescribe the most expensive drugs for their patients. This practice raises drug costs for all New Hampshire residents and compromises the professional autonomy of doctors. This brief addresses the failure of the plaintiffs to show that they are likely to succeed on the …

Brief Of Aarp And The National Legislative Association On Prescription Drug Prices As Amici Curiae In Support Of Petitioners, Sean Flynn

Sean Flynn

This brief was written in support of Vermont’s Prescription Confidentiality Law, which regulates the confidentiality of prescription records and protects them from being used by pharmaceutical companies as a “targeting tool” to identify doctors most susceptible to sales messages.

Pharmaceutical Patent Bargains: The Brazilian Experience, Bruno Meyerhof Salama, Daniel Benoliel

Bruno Meyerhof Salama

The Politics Of Patents And Drugs In Brazil And Mexico: The Industrial Bases Of Health Policies, Kenneth C. Shadlen

Ken Shadlen

After introducing pharmaceutical patents in the 1990s, Brazil subsequently adjusted the patent system to ameliorate its effects on drug prices while Mexico introduced measures that reinforce and intensify these effects. The different trajectories are due to the nature of the actors pushing for reform and subsequent patterns of coalitional formation and political mobilization. In Brazil, government demand for expensive, patented drugs made health-oriented patent reform a priority, and the existence of an autonomous local pharmaceutical sector allowed the Ministry of Health to build a supportive coalition. In Mexico, government demand made reforms less urgent, and transformations of the pharmaceutical sector …

Compulsory Licensing Of Patented Pharmaceuticals: Why A Wto Administrative Body Should Determine What Constitues A Public Health Crisis Under The Doha Declaration, Aileen M. Mcgill

Aileen M McGill

In response to concerns that patent protection for pharmaceuticals negatively affected world health, the WTO issued the Doha Declaration in 2001, allowing member nations to issue compulsory licenses for patented pharmaceuticals during a public health crisis. The terms of this Declaration allow countries to determine what constitutes a public health crisis, what terms are appropriate for compulsory licenses, and what medications they should be entitled to produce. This article argues that the Doha Declaration has not served countries most in need of inexpensive medications: least developed countries with high rates of HIV/AIDS. The terms of the Doha Declaration are too …