Recently, the U.S. Court of Appeals for the Federal Circuit issued an opinion in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 2018-1976 (Oct. 2, 2020) (“GSK”), reversing the trial court’s grant in Teva’s favor of judgment as a matter of law (JMOL).
In this patent case, GSK asserted Teva had “induced” doctors to infringe its patent, United States Reissue Patent No. RE40,000 (“the ’000 patent”). That is, Teva had “induced” doctors to use the medicinal product “carvedilol” for treating congestive heart failure. Citing the carve-out authorization in 21 U.S.C. § 355(j)(2)(A)(viii), Teva argued it could not be found to have induced prescribing physicians to infringe during at least part of the time of the alleged infringement because it “carved out” from its label for its generic carvedilol product the indication and prescribing information for treating congestive heart failure.
At trial, a jury found the patent to be infringed and assessed damages. The district court, however, granted Teva’s motion for JMOL of non-infringement. According to the district court, GSK failed to prove Teva’s alleged inducement actually caused any physician to directly infringe, as opposed to other independent factors such as publications, the past experience of prescribing physicians with GSK’s own carvedilol product, or GSK’s Coreg® (carvedilol) label and promotion of carvedilol. GSK appealed.
In a 2-1 opinion (there was a lengthy dissent), the Federal Circuit reversed the grant of JMOL and reinstated the jury verdict, holding that the verdict of patent infringement was supported by substantial evidence. According to the Federal Circuit, the district court applied an incorrect legal standard to its assessment of the evidence. Specifically, the criteria for induced infringement are met when a provider of an identical product knows of and markets the same product for intended direct infringing activity. In this regard, the Court determined, the record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides (all which the Court details in the opinion), was ample evidence to support the jury verdict of Teva’s inducement of doctors to infringe.