Fruit of One's Label: A Review of Three Key Federal Circuit Wins
March 8, 2021
Managing Intellectual Property
By Daniele M San Roman; Kyu Yun Kim; Michele C. Bosch; M. Paul P. Barker; Thomas Lee Irving
Innovative pharma has had three decisions from the US Court of Appeals for the Federal Circuit to cheer about recently: Sanofi v Watson in 2017, Vanda v West-Ward in 2018, and GSK v Teva in 2020.
Strategically-minded in-house and private practice counsel in the innovator pharma space should look to this trilogy of label-related rulings to help them create comprehensive patent prosecution and litigation strategies for their clients.
In this article, we will review each of these cases and discuss how they help the innovative pharma industry. With respect to GSK v Teva, we note that on February 9, 2021, the Federal Circuit withdrew the opinion we have discussed below and granted rehearing of the appeal on the merits.
Oral argument was held on February 23, 2021 – stay-tuned for the panel’s rehearing decision.
Click here to read the full article.
Tags
United States Court of Appeals for the Federal Circuit (CAFC), new drug application (NDA), Food and Drug Administration (FDA)
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Originally printed in Managing Intellectual Property on March 8, 2021. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.