Corrected Brief of Amici Curiae Fifty-Seven Law, Economics, Business, Health, and Medicine Professors in Support of Cross-Appellant's Petition for Rehearing En Banc
Federal Circuit brief in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.
34 Pages Posted: 23 Dec 2020 Last revised: 4 Jan 2021
Date Written: December 16, 2020
“Skinny labels” have a funny name. But that is all that is funny about them.
When a drug can be used to treat multiple conditions, a generic can “carve out” the patented indications from its label. The resulting “skinny label” allows the generic to launch its product for uses not covered by a patent. In this case, the Federal Circuit panel majority held, contrary to the regulatory regime and Federal Circuit precedent, that this long-recognized practice of skinny labeling could form the basis for induced infringement.
The panel’s decision is far-reaching and exceptionally important. As Chief Judge Prost explained in dissent, a finding of inducement based on Teva’s skinny label “invites a claim of inducement for almost any generic that legally enters the market with a skinny label.” This brief argues that such a “nullification” of a 35-year-old law that has been an indispensable path for generics to enter the market contradicts the Federal Circuit's decisions giving effect to skinny labels and threatens to sow uncertainty for generics, undermine the balance at the heart of the Hatch-Waxman pharmaceutical regime, and increase the costs of drugs for millions of Americans.
Keywords: patent, skinny label, section viii, Hatch-Waxman Act, generics
JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38
Suggested Citation: Suggested Citation