Intellectual Property Law Commons^™

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane

Articles

The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the lens …

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Pharma's Nonobvious Problem, Rebecca S. Eisenberg

Articles

This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …

2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.