Legal Blog

GSK v. Teva: August 2021 Panel Rehearing – Another Round on Coreg®

2014 Best Law FirmsTeva’s sales of its generic carvedilol product (generic equivalent to GSK’s Coreg®) induce infringement of GSK’s U.S. Patent RE40,000.[1] This is round two, Teva again being found to induce infringement, following a prior ruling in October 2020.[2]

This latest ruling followed Teva’s request for panel rehearing following the October 2020 ruling that found essentially the same. In the earlier ruling, sales of Teva’s generic product was found to induce infringement of the ’000 patent despite Teva ostensibly carving out the infringing use of treating congestive heart failure (CHF). In response to Teva’s request for rehearing, the Court vacated its October 2020 ruling and withdrew the opinion. The earlier ruling drew much interest, as did this latest one, with amici contending it “lacked clarity” about when approved uses are carved out of an approved label.

The background of this case has many twists and turns, but the crux of this most recent ruling, the Court cited substantial record evidence that supported the jury’s verdict that the patent was not invalid and infringed. This included the partial (and full) generic labels, Teva advertising, corporate website information, and witness testimony. Notably, GSK’s expert relied on one of the not-carved-out uses to prove that the claim elements of the carved-out use were met. The Federal Circuit reversed a grant of JMOL by Chief Judge Stark of the District of Delaware because substantial evidence supported the jury’s verdict of induced infringement.

One key takeaway here is that a generic drug manufacturer must craft a carve out carefully; in other words – it must actually carve out the use. And the generic label should be clear. While a full analysis of the carve out here is beyond the scope of this comment, submission of a section viii statement must be carefully done.

Another key takeaway, the generic must be mindful of its overt corporate conduct, including its advertising, website content, catalogs, and acts of its employees, such that these things cannot be construed as encouraging, recommending or promoting infringement (i.e., inducing).

Contrary to the fears of many, however, the Federal Circuit did not find or suggest that a true section viii carve-out constitutes evidence of inducement. Though there is more to come from this contest, including the equitable estoppel defense raised by Teva.

To read the full document, click here.


[1] GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 2021 U.S. App. LEXIS 23173, ___ F.4th ___,  (Fed. Cir., Aug. 5, 2021) (reversing district grant of JMOL of no inducement and remanding for further proceedings). GSK v Teva 08-05-2021 Fed Cir

[2] GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020) vacated and withdrawn.


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