Congress Should Decline Ill-Advised Legislative Proposals Aimed at Evergreening of Pharmaceutical Patent Protection

The University of the Pacific Law Review, 2020

30 Pages Posted: 3 Jun 2020

See all articles by Christopher M. Holman

Christopher M. Holman

University of Missouri - Kansas City School of Law

Date Written: 2019

Abstract

There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, is aimed particularly at the oft-stated claim that drug companies are “evergreening” the patent protection on their products, thereby delaying generic market entry and the lowering of prices assumed to flow from generic competition. The present Article examines some recent legislative proposals aimed specifically at the perceived problem of pharmaceutical evergreening. To provide context, the Article begins by reviewing some of the academic literature and other commentary that would lend support to these efforts. The Article also provides this author’s own analysis and commentary of the proposed legislation, which generally concludes that the legislative proposals are largely misguided, and, if enacted, would be likely to cause more harm than good by discouraging innovation in pharmaceuticals without effectively addressing the core concerns. Instead, any legislative measures taken to address evergreening should focus directly on the misuse of patents, rather than impairing the ability of innovators to patent pharmaceutical inventions irrespective of their merit and their potential to improve the human condition.

Keywords: patents, pharmaceuticals, drugs, legislation, evergreening, prduct hopping, patent thicketing

Suggested Citation

Holman, Christopher M., Congress Should Decline Ill-Advised Legislative Proposals Aimed at Evergreening of Pharmaceutical Patent Protection (2019). The University of the Pacific Law Review, 2020, Available at SSRN: https://ssrn.com/abstract=3593954

Christopher M. Holman (Contact Author)

University of Missouri - Kansas City School of Law ( email )

5100 Rockhill Road
Kansas City, MO 64110-2499
United States

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