Here is a report on recent news and commentary related to the Supreme Court’s decision yesterday in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. We highlight:
- an article discussing how the Supreme Court’s decision “may make generic drugmakers less vulnerable to patent lawsuits involving so-called ‘skinny labels'”;
- an article similarly reporting how the Supreme Court’s decision “is expected to strengthen legal protections for generic manufacturers that launch products using the Hatch-Waxman Act’s ‘carve-out’ process”;
- a blog post suggesting the Supreme Court’s decision “scolded” the Federal Circuit “for its recent approach” and “has potentially far-reaching implications for the induced infringement standard across sectors”; and
- an article emphasizing that “all nine justices” joined Justice Jackson’s opinion in this “closely watched pharmaceutical patent dispute.”
Blake Brittain wrote an article for Reuters discussing how the Supreme Court’s decision “may make generic drugmakers less vulnerable to patent lawsuits involving so-called ‘skinny labels.'” Brittain highlights how, “in the court’s ruling reversing the Federal Circuit’s decision, [Justice] Jackson wrote that Amarin failed to show ‘more than a sheer possibility’ that Hikma’s statements induced infringement of its patents.” Brittain also notes that Hikma “and the Trump administration both argued that allowing lawsuits like Amarin’s could disincentivize generic drugmakers and lead to increased drug prices.”
Anna Bratulic penned an article for FirstWorld Pharma similarly reporting how the Supreme Court’s decision “is expected to strengthen legal protections for generic manufacturers that launch products using the Hatch-Waxman Act’s ‘carve-out’ process.” The author explains that this process allows generic manufacturers “to market their products for unpatented uses of a reference drug, while excluding still-patented indications from their FDA-approved labels.”
Eileen McDermott published a blog post for IPWatchdog suggesting the Supreme Court’s decision “scolded” the Federal Circuit “for its recent approach” and “has potentially far-reaching implications for the induced infringement standard across sectors.” McDermott recounts how the Federal Circuit “said that Amarin’s allegations . . . ‘at least plausibly state a claim for induced infringement.’” McDermott observes how “the Justices seemed concerned about the potential impact” of the Federal Circuit’s decision “for the generic pharmaceutical industry.”
Steve Mollman authored an article for Newsweek emphasizing that “all nine justices” joined Justice Jackson’s opinion in this “closely watched pharmaceutical patent dispute.” Mollman highlights how Justice Jackson “has been one of the court’s most frequent dissenters, making her authorship of a unanimous opinion all the more notable.” Mollman suggests the “decision highlights a reality frequently overlooked in public discourse: the Supreme Court still decides a significant share of its cases unanimously.”