West Virginia University College of Law professor S. Sean Tu recently authored an amicus brief, submitted to the Supreme Court of the United States in Teva Pharmaceuticals v. GlaxoSmithKline, No. 22-37. The brief was co-authored with Michael A. Carrier of Rutgers Law School and Charles Duan of Cornell University.
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.
This brief and others were discussed in the context of the case in an article, Justices Told Generic Drugs At Risk From Skinny Label Ruling by Ryan Davis, published by Law360 on August 15, 2022.
Find more of Professor Tu's scholarship on SSRN.