District Court Proceedings

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

We have previously written about the Patent Trial and Appeal Board’s (“PTAB”) precedential decision in Apple Inc. v. Fintiv, Inc., which set forth six factors the PTAB will consider when assessing whether to discretionarily deny an IPR petition in light of co-pending district court litigation.  Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (March 20, 2020).  The PTAB has been applying the Fintiv factors in subsequent IPRs, many of which involve a stayed district court litigation.  The PTAB has now designated as precedential a decision instituting IPR in Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (Dec. 1, 2020).  In this IPR, although the co-pending district court case was not stayed, Sotera Wireless (“Sotera”) filed a stipulation relinquishing all potentially duplicative arguments.  The PTAB allowed the IPR to proceed, noting that the stipulation avoided duplication and prevented conflicting results, chief components of the Fintiv factors.  More detail on this decision is below.
Continue Reading One More Tool to Avoid Fintiv IPR Denial: File A Stipulation in District Court Relinquishing Potentially Duplicative Arguments

In an April 11, 2019 order, Judge Andrews of the District of Delaware ruled that a Hatch-Waxman defendant’s obviousness defenses were precluded under 35 U.S.C. § 315(e)(2) even though the barring PTAB decision issued over a year after the court had held an obviousness trial.  Novartis Pharm. Corp. v. Par Pharm., Inc., No. 14-cv-01289 (D. Del. Apr. 11, 2019), Docket No. 198.  Read on for the details.
Continue Reading Court Applies Post-Trial IPR Estoppel Where Final Judgment Didn’t Address All Obviousness Defenses

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