Open Access. Powered by Scholars. Published by Universities.®
- Discipline
-
- Intellectual Property Law (5)
- Antitrust and Trade Regulation (3)
- Business (3)
- Litigation (3)
- Technology and Innovation (3)
-
- Civil Procedure (2)
- Economics (2)
- Entrepreneurial and Small Business Operations (2)
- Health Law and Policy (2)
- Industrial Organization (2)
- Law and Society (2)
- Social and Behavioral Sciences (2)
- Food and Drug Law (1)
- Health Economics (1)
- International Law (1)
- International Trade Law (1)
- Medical Jurisprudence (1)
- Medicine and Health Sciences (1)
- Public Health (1)
- Science and Technology Law (1)
- Institution
- Publication
- Publication Type
Articles 1 - 7 of 7
Full-Text Articles in Law
The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro
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
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
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 …
Pharmaceutical Federalism, Patricia J. Zettler
Pharmaceutical Federalism, Patricia J. Zettler
Indiana Law Journal
There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013, Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Articles & Chapters
Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …
Much Ado About The Tpp's Effect On Pharmaceuticals, Emily M. Morris
Much Ado About The Tpp's Effect On Pharmaceuticals, Emily M. Morris
Faculty Publications
The Trans-Pacific Partnership Agreement’s many provisions that were beneficial to the pharmaceutical industry have caused a good deal of controversy. Specifically, critics allege that the TPP’s provisions requiring that member states expand patentable subject matter, adjust pharmaceutical patent terms, and link regulatory marketing approval to a drug's patent status would have raised drug prices and hindered access to medicines, particularly in developing countries. Closer examination of these provisions as well as the various ways in which member states can modify or ameliorate the effects of these provisions suggests that their potential effect on drug prices and access to health care …
Patent Pacifism, Clark D. Asay
Patent Pacifism, Clark D. Asay
Faculty Scholarship
Over the last decade, much of the patent law literature has focused on the problem of “patent trolls,” or patent owners who don’t make products, but sue others that do. The basic complaint against these types of entities is that they impose a tax on innovation without providing offsetting societal benefits. Furthermore, their patent assertions have been on the rise, with a significant percentage of patent suits now attributable to them. In short, the troll phenomenon suggests a problem of excessive patent assertions.
But despite the importance of the troll phenomenon, the fact remains that most patents are never asserted, …