Yale Journal of Health Policy, Law, and Ethics

No Parking Here: A Review of Generic Drug 180-Day Exclusivity and Recent Reform Proposals

Victor L. Van de Wiele, Jonathan J. Darrow & Aaron S. Kesselheim

ABSTRACT.  In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) to facilitate the market entry of generic drugs after brand-name drugs’ patent exclusivity ended. To incentivize generic manufacturers to challenge brand-name manufacturers’ patents, a 180-day exclusivity accrued to the first manufacturer to successfully litigate the validity or scope of a brand-name drug patent. However, brand-name and generic manufacturers have found ways to strategically “park” the 180-day exclusivity to delay generic entry and competitive drug markets. Congress revised the statute in 2003, but concerns continued. In 2019, three Congressional bills were introduced to further revise the 180-day exclusivity framework. This Article reviews the history of the 180-day provision, evaluates what types of strategic behavior remained after 2003, and considers whether the recent legislative proposals are likely to offer improvement.

AUTHORS. Victor L. Van de Wiele, LL.B., LL.M., affiliated researcher at the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital. His work is supported by Arnold Ventures.

Jonathan J. Darrow, S.J.D., LL.M., J.D., M.B.A., Associate Professor of Law at Bentley University, an Assistant Professor of Medicine at Harvard Medical School, and an Associate Scientist at PORTAL in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital. LL.M. waived. His work is supported by ACCISS, Arnold Ventures, the Commonwealth Fund, the Greenwall Foundation, the Kaiser Permanente Institute for Health Policy, West Health, and under a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme (grant NNF17SA0027784).

Aaron S. Kesselheim, M.D., J.D., M.P.H., Professor of Medicine at Harvard Medical School and the Director of PORTAL in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital. His work is supported by Arnold Ventures and by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme (grant NNF17SA0027784).

RECOMMENDED CITATION. Victor L. Van de Wiele, Jonathan J. Darrow & Aaron S. Kesselheim, No Parking Here: A Review of Generic Drug 180-Day Exclusivity and Recent Reform Proposals, 20 YALE J. HEALTH POL’Y L. & ETHICS (2021).