Brief of 14 Professors of Law as Amici Curiae in Support of the Petition for Rehearing En Banc in GlaxoSmithKline v. Teva Pharmaceuticals, Fed. Cir. No. 18-1976

Abstract

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit considered whether labeling and marketing materials for a generic drug could induce infringement of a patent on a method of using that drug, despite the label and those materials having carved out indications relating to that method pursuant to FDA procedures and the Hatch-Waxman Act. In an original opinion from 2020 and a revised opinion in 2021, a panel of the court affirmed a jury finding of inducement.

This brief calls on the full Federal Circuit to reconsider that decision en banc, for two reasons. First, the panel’s treatment of inducement opens up a direct conflict between patent law and the Hatch–Waxman Act amendments to the Federal Food, Drug, and Cosmetic Act. Those amendments, which enable abbreviated new drug applications (ANDAs), require a generic to use the same labeling as its equivalent brand-name product with only limited exceptions, as part of the carve-out procedure that deals specifically with inducement. By requiring ANDA applicants to make scattered revisions throughout their labels lest they induce infringement despite FDA approval of the label otherwise, the panel decision conflicts with this aspect of Hatch–Waxman. Importantly, the decision does not merely create dual tracks of liability that ANDA applicants must navigate; it creates a tension between the laws themselves insofar as one threatens to frustrate the other. Such a tension must be resolved in the process of statutory construction, which the panel decision failed to do.

Second, the panel relies on product advertisements and government submissions that a product is “equivalent” to another to find inducement of a method-of-use patent. Such a result is problematic insofar as it denies basic comparative product information to consumers. That problem is especially concerning given that statements of product equivalence are found in a range of industries beyond generic drugs, such as biosimilars, mechanical repair parts, and information and communication technology. En banc review is necessary to reevaluate the panel’s decision insofar as it potentially creates new and unexpected avenues of patent infringement in all of these fields.

Keywords: patents, intellectual property, generic drugs, ANDA, Hatch-Waxman, FDA

JEL Classification: O31, O38, K23, K32