The Washington Legal Foundation’s (WLF) webinar on False Claims Act (FCA) litigation highlighted several developments in case law, including that non-relator FCA cases were up significantly in fiscal year 2020. However, Jay Stephens, an attorney with Kirkland & Ellis LLP, noted that Sen. Chuck Grassley (R-Iowa) has taken aim yet again at the materiality standard for false claims as spelled out in the Supreme Court’s Escobar, a move which if successful could amplify the federal enforcement focus on life science companies.

The case of Arthrex v. Smith & Nephew at the U.S. Court of Appeals for the Federal Circuit was something of a nuclear option for the patent dispute at hand, as it raised a constitutional question regarding the appointment of administrative patent judges (APJ) at the Patent Trial and Appeal Board (PTAB). The Supreme Court has agreed to hear a consolidation of three petitions for cert arising from the Arthrex case, the outcome of which could force the reopening of a number of cases already decided by the PTAB.

The Court of Justice for the European Union (CJEU) has invalidated the EU-U.S. Privacy Shield, a mechanism designed to ensure the privacy of EU citizens’ data when conveyed to other nations in a manner consistent with the EU’s General Data Protection Regulation (GDPR). Makers of drugs and devices are not without recourse in transferring patient data to the U.S. for clinical trials conducted in Europe, but industry must revisit their standard contractual clauses to ensure those protocols provide the necessary privacy provisions, or face fines that could amount to tens of millions of euros.

The case of Fitbit Inc. v. Valencell Inc. has seen the usual number of twists and turns as it wended its way through Article III courts and an inter partes review (IPR), but a U.S. Supreme Court case that requires that all claims in an IPR be reviewed was decided during the Fitbit IPR.

Ongoing litigation between rivals Edwards Lifesciences Corp. and Abbott Laboratories is over, with the two settling all outstanding patent disputes in cases related to transcatheter mitral and tricuspid repair products. Details of the settlement remain confidential.

On Tuesday, July 7, Judge Stacey Jernigan of the U.S. Bankruptcy Court in Dallas ruled that Endologix Inc. could take an initial draw of $10 million from a Chapter 11 loan from its largest lender, Deerfield Partners. A day earlier, Endologix filed a voluntary Chapter 11 case and a consensual plan of reorganization supported by Deerfield.

The Supreme Court has declined to hear three cases that questioned the inter partes review (IPR) process for patent litigation, although the petition for cert for the Arthrex Inc. v. Smith & Nephew Inc.; Arthrocare Corp.; and the United States of America case is still pending. Should the Supreme Court pass on Arthrex, the remaining affected IPR cases will have to be relitigated at the Patent Trial and Appeal Board (PTAB), which may give those patent holders another chance to restore their patents.

The patent lawsuit between Merck & Co. and Microspherix LLC began when the latter sued Merck for infringement of patents for brachytherapy in Merck’s implantable contraceptive device, but Merck was unable to prevail in an inter partes review (IRP) or in an appeal of the IPR at the Court of Appeals for the Federal Circuit. After wading through questions about purported prior art, Merck failed to persuade the two courts that Microspherix’s non-provisional filing had strayed too far from the written description of the related provisional, thus handing Microspherix a win against its much larger rival in the market for drug delivery with microspheres.