On Sept. 26-27, Professor Erika Lietzan participated in a symposium at New York University Law School Engelberg Center entitled “Health Care at Reasonable Cost: The Hatch-Waxman Act at 40 and Beyond.” Sept. 24 marked the 40th anniversary of this statute, which established the modern generic drug approval framework and also amended the Patent Act to give brand drug companies back a portion of the patent term that is lost while they conduct premarket testing.
This symposium convened academic and industry experts to consider whether this transformational statute has achieved its twin goals of facilitating drug competition and encouraging drug innovation. Professor Lietzan has published many articles on the Hatch-Waxman Amendments, including perhaps most importantly this article, The History and Political Economy of the Hatch-Waxman Amendments, which is now the definitive history and won the Shook Hardy Bacon Excellence in Research Award in 2019.
More recently, she published an exhaustive empirical study of the patent term restoration decisions issued since 1984, which found that longer pre-market clinical testing programs lead to shorter effective patent life, even after the U.S. Patent and Trade Office (PTO) has granted patent term restoration. The results were strongly statistically significant and contribute to a growing body of literature raising the alarm that the U.S. legal system may be systematically skewing drug research incentives away from the harder problems.
At the symposium, Professor Lietzan discussed how a recently enacted drug price “negotiation” statute, which is implemented by the Centers for Medicare and Medicaid Services (CMS), interacts with the Hatch-Waxman framework, explaining that the timing of the two frameworks are fundamentally misaligned, which may further undermine incentives to innovate.
Original source can be found here.