The Supreme Court decided not to grant certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, which has come to be known as the "skinny label" case. That means the Federal Circuit's August 2021 decision (which was a panel rehearing of its October 2020 decision) will stand.
In its decision on rehearing, the Federal Circuit emphasized that it was not disrupting the principles that "generics could not be held liable for merely marketing and selling under a 'skinny label' omitting all patented indications" or for "merely noting (without mentioning any infringing uses) that FDA had rated a product as therapeutically equivalent to a brand-name drug." However, the court found sufficient basis to uphold the jury verdict based on findings that the labels at issue had not omitted all patented indications (based in part on information in the "Clinical Studies" section) and that Teva's marketing activities and press releases could have encouraged infringing use.
The Supreme Court decision not to review the Federal Circuit decision comes after the Solicitor General and four amicus briefs urged the Court to take action. The Solicitor General specifically took issue with aspects of the Federal Circuit decision that in effect held that the skinny label was not skinny enough. The Solicitor General emphasized that FDA regulations govern what may and may not be carved out of a skinny label under 21 U.S.C. § 355(j)(2)(A)(viii), and raised concerns that finding infringement liability based on FDA-mandated labeling could "discourage manufacturers from invoking the section viii pathway, thereby decreasing the availability of lower-cost generic drugs."
Although Teva may still pursue an equitable estoppel defense before the district court, the Supreme Court decision leaving the Federal Circuit decision intact may encourage fact-intensive, case-by-case analysis of conduct that could lead to more ANDA litigation in the skinny label context.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.