The Federal Circuit’s August 5, 2021 ruling in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc. (link to issued opinion), is an important development in the law of “skinny” generic pharmaceutical labels and induced infringement claims. See GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) (“GSK II”) (Google Scholar link).  Read on for important aspects of the majority’s opinion and Judge Prost’s dissent.
Continue Reading Federal Circuit Issues Second GSK v. Teva Opinion On “Skinny” Label-Based Inducement

Last week, Magistrate Judge Jennifer Hall of the U.S. District Court for the District of Delaware recommended denial of two motions to dismiss and denied a motion to sever in a case involving a novel induced infringement claim against a health insurance provider. See Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., No. 20-1630-RGA-JLH, 2021 WL 3396199 (D. Del. Aug. 3, 2021) (“Amarin R. & R.”) (docket version); Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., No. 20-1630-RGA-JLH, 2021 WL 3363496 (D. Del. Aug. 3, 2021) (“Amarin Mem. Order”) (docket version). The dispute relates to Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC’s (collectively, “Hikma”) generic version of the plaintiffs’ VASCEPA® product (icosapent ethyl).  Hikma’s generic product has been on the market since November 2020. See Amarin R. & R., 2021 WL 3396199, at *3. The plaintiffs asserted three patents against Hikma and a health insurance company, Health Net, LLC (“Health Net”). Hikma and Health Net both moved to dismiss for failure to state a claim, and Health Net also moved to sever the claims against it from those against Hikma. Magistrate Judge Hall recommended that the motions to dismiss be denied, and she denied the motion to sever. Id. at *1; Amarin Mem. Order, 2021 WL 3363496, at *1.
Continue Reading Delaware Magistrate Judge: Novel Induced-Infringement Claim Against Health Insurance Provider Survives Dismissal

On April 13, 2018, the Federal Circuit issued a new decision in its recent line of cases analyzing whether generic drug labels may be evidence of induced infringement of method of treatment claims in Hatch-Waxman cases. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the Court, in upholding the District Court’s finding of induced infringement, held that proposed instructions to physicians can satisfy the specific-intent element of induced infringement. 887 F.3d 1117 (Fed. Cir. 2018) (Judges Lourie and Hughes, Chief Judge Prost dissenting on other issues). This decision follows and builds upon the Federal Circuit’s 2017 decisions in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) and Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).
Continue Reading Generic Drug Labels May Establish Specific Intent to Induce Infringement of Method of Use Claims