Teva’s ANDA carve-out does not save it from induced infringement (“when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met”) (petition for rehearing en banc denied (2/11/22))

GlaxoSmithKline LLC, et al. v. Teva Pharmaceuticals USA, Inc.

Docket No. 2018-1976, -2023


October 2, 2020

Update (2/11/22):  Petition for rehearing denied.  Judges Moore, Newman, O’Malley, Taranto, Chen and Stoll concurred to address dissents by Judges Prost, Dyk and Reyna, Judge Dyk, and Judge Reyna.  Judge Dyk wrote, e.g., “the more specific and later-enacted provisions of the HatchWaxman Act override the general infringement provisions of the Patent Act” and “[i]t is hard to see how Congress could have intended that a mandated label could be used as evidence of infringement.”  Judge Reyna wrote “that en banc consideration is warranted for issues of exceptional importance” and “may reasonably be read to mean that companies like Teva may be held liable for induced infringement despite demonstrated compliance with the statutory and regulatory requirements to carve out everything from a skinny label that the patent owner (GSK) itself designated as covered by its patent.”  The concurrence argues that “[t]he dissents advance, as bases for en banc review, legal positions that Teva has not asserted or developed” (i.e., “Teva never argued that there was a conflict between the FDA regulatory framework and patent law (as the dissents now claim); nor did it argue that the partial label was not evidence relevant to or otherwise impermissible for deciding inducement (as the dissents now suggest).”)

Brief Summary:  GSK appealed DC judgment of a matter of law (JMOL) finding no induced infringement of RE40,000 by Teva’s Coreg® (carvedilol) ANDA.  GSK’s RE40,000 issued on Jan. 8, 2008 following reexamination of US 5,760,069 (issued in 1998) directed to “[a] method of decreasing mortality caused by congestive heart failure”, RE’000 adding the limitation “wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months.”  Teva’s original 2007 ANDA label (“full label”) did not mention congestive heart failure (a “carve-out”, “skinny label”) but revised its label in 2011 to include the CHF indication as directed by the FDA.  The DC instructed the jury that “GSK must prove that Teva’s actions led physicians to directly infringe a claim of the ’000 patent” and “proof…may be based on circumstantial evidence.”  The jury found that Teva induced infringement of certain claims starting January 8, 2008 (the date the RE‘000 patent issued) to April 30, 2011 (the last day before Teva amended its label) and some during the amended label period starting May 1, 2011 and ending June 7, 2015 (the date of expiration of the ’000 patent).  The DC, however, granted Teva’s JMOL of no induced infringement by either the skinny or full labels.  The FC panel disagreed, explaining that “[p]recedent has recognized that the content of the product label is evidence of inducement to infringe” (Vanda, FC 2018) and that the DC “applied an incorrect legal standard, for precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met” (e.g., “There was ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe the designated claims for the period of the ’000 reissue patent.”)  The jury-calculated damages award was sustained, the FC panel writing that the DC “correctly instructed the jury that the availability of carvedilol from other generic producers is not a ‘non-infringing substitute’” (Micro Motion, FC 1990 (“There is precedent for finding causation despite an alternative source of supply if that source is an infringer….”)   The DC grant of JMOL was vacated and remanded for “consideration of GSK’s post-trial motion based on the verdict of willful infringement”.  Judge Prost dissented, writing, e.g., “Congress provided for skinny labels for exactly these circumstances…[a]nd Teva acted exactly as Congress intended” (“Teva’s skinny label did not even suggest using its product according to the patented method”, “there was still no inducement via the full label”).

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