Brief of 42 Professors of Law, Economics, Business, and Medicine as Amici Curiae in Support of the Petition

Abstract

“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.

Keywords: skinny labels, generics, Hatch Waxman, method-of-use patents

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38