Teva Files Certiorari Petition In "Skinny" Label Case

• Published date: 10 August 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Author: Mr Richard D. Kelly

On July 11, Teva filed its petition for certiorari from the Federal Circuit's second decision in its "skinny label" litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition makes many of the same arguments that Teva made before the Federal Circuit but the inconsistency of the Federal Circuit's decision in GSK with three prior decisions standout. Its yet another example of the Federal Circuit's lack of discipline in following its own precedent. While Teva rightly complains that the decision creates uncertainty around the skinny label provisions of 21 U.S.C. ' 355(j)(2)(A)(viii), the real uncertainty is created by the Federal Circuit's unfortunate habit of ignoring its own precedent upon which parties rely in making decisions.

In finding that Teva induced infringement of GSK's patent Re. 40,000 ('000) a reissue of U.S.P. 5,760,069 ('069), the Federal Circuit pieced together disparate sections of Teva's label for carvedilol along with the FDA's determination that Teva's carvedilol product was AB substitutable for GSK's carvedilol product. Such a finding was not for all purposes but only those on the Teva label. The '000 patent claimed treating congestive heart failure in combination with other drugs for a period greater than six months. The label for GSK's carvedilol product, Coreg^', had three indications, post-MI LVD treatment, hypertension treatment, and congestive heart failure (CHF). At the time Teva launched its generic product only the CHF indication had patent protection. Teva sought approval only for the unpatented post-MI LVD and hypertension treatments and had, following the FDA's instructions omitted the portions of the GSK label related to CHF. In 2007 upon the expiration of GSK's patent to drug carvedilol Teva launched its generic product with the FDA approved label. In 2008 the '000 patent issue with substantially narrower claims than the original patent. GSK withdrew the '069 patent from the Orange Book and added the '000 patent in its place. In 2011, following GSK's delisting of certain patents from the Orange Book, including the '069 patent and U.S. Patent No. 5,902,821, the FDA instructed Teva to "revise [its] labeling to include the information associated with pa- tent '821 (delisted) and the associated Use Code (U-313)." J.A. 5557. It told Teva to submit labeling "that is identical in content to the approved [GSK Coreg'] labeling (including the package insert and any patient package insert and/or Medication Guide that may be...