In a split decision delivered June 21, the U.S. Supreme Court resolved the dilemma created by the constitutional non-reviewability of decisions rendered by the Patent Trial and Appeal Board (PTAB). The Supreme Court’s solution is to make those PTAB decisions reviewable by the director of the Patent and Trademark Office (PTO), although the PTO director’s discretion regarding which PTAB cases should be reviewed may itself prove highly controversial in the months and years to come.
In denying cert to Abbvie Inc. v. FTC June 21, the U.S. Supreme Court may have strengthened an FTC tool for going after biopharma companies that try to protect their patents. The high court’s refusal to hear the case reinforces a September decision by the U.S. Court of Appeals for the Third Circuit that the biopharma industry has said will make it more difficult for drug companies to pursue patent infringement cases in keeping with Hatch-Waxman.
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
The U.S. Supreme Court, in a 7-2 opinion dismissing a challenge to the Affordable Care Act (ACA), removed a threat to the future of the Biologics Price Competition and Innovation Act (BPCIA) and the biosimilars pathway it created.
It looks like the two biosimilars referencing Amgen Inc.’s Enbrel (etanercept) will have to wait out the rest of the decade before launching in the U.S. The U.S. Supreme Court declined May 17 to hear Sandoz Inc.’s appeal of last year’s split Federal Circuit ruling affirming the validity of two patents protecting etanercept and its manufacturing methods
The Supreme Court heard the case of Minerva Surgical Inc. v. Hologic Inc., which takes up the question of assignor estoppel for patents, but the discussions that peppered the April 21 hearing lent little clarity as to how the nine justices will decide the case.
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 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 U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.
