In Glaxosmithkline LLC v. Teva Pharmaceuticals USA, Inc., [2018-1976, 2018-2023] (August 5, 2021), the Federal Circuit vacated the grant of JMOL in favor of Teva, and reinstated the jury’s verdict and damages award for infringement of RE40,000, and remanded for appropriate further proceedings.

The ’000 patent claims a method of decreasing mortality caused by chronic heart failure by administering carvedilol with at least one other therapeutic agent.

Teva argued it could not have induced infringement prior to 2011, because it had “carved out” the indication and prescribing information for treatment of congestive heart failure in its 2007 label under section viii, and that it could not be be liable for inducement for any time period because it did not cause others to infringe the method claimed in the ’000 patent. The jury found the ’000 patent was not invalid, that Teva induced infringement of claims 1–3 during the partial label period proir to 2011, and that Teva induced infringement of claims 1–3 and 6–9 during the full label period after 2011. The jury assessed damages based on a combination of lost profits and a reasonable royalty and found Teva’s infringement willful.

The district court granted Teva’s renewed motion for JMOL, finding that substantial evidence did not support the verdict of induced infringement because GSK failed to prove that Teva’s alleged inducement, as opposed to other factors, actually caused physicians to directly infringe by prescribing generic carvedilol for the treatment of mild to severe chronic heart failure.

The Federal Circuit agreed with GSK that substantial evidence supports that Teva actively
induced by marketing a drug with a label encouraging a patented therapeutic use. The Federal Circuit said that the labeling did not omit all patented indications or merely note (without mentioning any infringing uses) that FDA had rated a product as therapeutically equivalent to a brand-name drug. Instead, the Federal Circuit said this was a case in which substantial evidence supports a jury finding that the patented use was on the generic label at all relevant times and that, therefore, Teva failed to carve out all patented indications. The Federal Circuit address the concerns of several amici, nothing that its narrow, case-specific review of substantial evidence does not upset the careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs.

35 U.S.C. § 271(b) provides “Whoever actively induces infringement of a patent
shall be liable as an infringer.”The Federal Circuit explained that “[a] finding of inducement requires establishing “that the defendant possessed specific intent to encourage another’s infringement.” This requires a plaintiff to show that the alleged infringer’s actions induced infringing acts and that he knew or should have known his actions would induce actual infringements. The Federal Circuit said that when a plaintiff relies on a drug’s label accompanying the marketing of a drug to prove intent, the label must encourage,
recommend, or promote infringement.

The Federal Circuit found that despite Teva’s purporting to carve out the patented congestive heart failure indication, and its deletion of the indication from its pre-2011 partial label, substantial evidence supports the jury’s finding that Teva induced doctors to infringe the method of use claimed in the ’000 patent. GSK argues that substantial evidence supports
the jury’s verdict that Teva’s partial label encouraged an infringing use (via the post-MI LVD indication) and that Teva’s marketing materials encouraged prescribing carvedilol in a manner that would cause infringement of the ’000 patent, and the Federal Circuit agreed. GSK provided substantial evidence that Teva’s partial label instructed the method of use
claimed in the ’000 patent and thus was not a skinny label, because some of the labeled incidations overlapped the patented process.