Luke McCloud Highlighted by The Recorder for Federal Circuit Argument

June 2020

On June 3, 2020, The Recorder, one of the oldest legal newspapers in the United States, highlighted associate Luke McCloud’s argument on behalf of Williams & Connolly client Genentech Inc. before a panel of the U.S. Court of Appeals for the Federal Circuit.  In Genentech v. Amgen, a Biologics Price Competition and Innovation Act action concerning Amgen’s attempt to launch a biosimilar version of Genentech’s $3 billion blockbuster anti-cancer therapy Avastin, Genentech appealed the trial court’s denial of an injunction to prevent the launch, and moved for an injunction preventing Amgen from entering the market with its biosimilar while the appeal was pending.  More specifically, the appeal concerned Genentech’s contention that Amgen failed to comply with the BPCIA’s 180-day notice of commercial marketing requirement upon supplementing its application for FDA approval.  

According to The Recorder, in oral argument, Luke argued that by denying Genentech’s motion for a preliminary injunction and allowing commercialization without triggering the need to file a new notice, biosimilar companies would then be allowed to apply for a product that “implicates the fewest of the innovators’ patents,” give the 180-day notice, and then file supplemental applications down the line for products that infringe additional patents.  He contended that this would deprive companies like Genentech of the opportunity to settle patent disputes before a biosimilar goes to market, by creating the kind of “hurried and chaotic motions practice” the law was intended to avoid.  The publication praised Luke’s advocacy as “poised and polished.”

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