This week, West Virginia College of Law professor Sean Tu published an op-ed in the Los Angeles Times with co-authors Michael A. Carrier and Charles Duan. The op-ed, titled "Prevent a legal catch-22 that could push thousands of generic drugs off the market" appeared on September 21, 2022 and follows the filing of an amicus curiae brief by the authors in Teva Pharmaceuticals v. GlaxoSmithKline, No. 22-37. The United States Supreme Court will hear arguments in the case this forthcoming Ocobter 2022 term.
A summary of Brief of 42 Professors of Law, Economics, Business, and Medicine as Amici Curiae in Support of the Petition follows:
“Skinny labels” allow generics to reach the market quickly by disclaiming a drug's patented uses. This brief supporting Teva's cert petition argues that the Federal Circuit’s opinion:
(1) undermines the Hatch-Waxman Act by removing the certainty of the skinny-label route, subjecting all generics to unexpected lawsuits, and
(2) creates a conflict since the Hatch-Waxman Act requires a generic drug to use the same labeling as its patented counterpart but the Federal Circuit now requires editing of the label to avoid inducement.
We also explain the importance of this case, as the significant increase in method-of-use patents could be used against a wide array of generic drugs, threatening consumers with higher payments and adverse health effects.
Find more of Professor Tu's scholarship on SSRN.