lunes, 8 de junio de 2026

Long Live the Skinny Label June 7, 2026 By Sara W. Koblitz —

https://www.thefdalawblog.com/2026/06/long-live-the-skinny-label/?utm_source=rss&utm_medium=rss&utm_campaign=long-live-the-skinny-label The skinny label is back from the dead. While back in 2021, it seemed like the skinny label was effectively dead after the Federal Circuit twice held Teva liable for induced infringement of GSK’s labeling in GSK v. Teva, the Supreme Court breathed new life into it last week—and just as the House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet was starting a hearing on “Medicines and IP: Balancing Innovation and Access,”, with a focus on skinny labeling—with its unanimous decision in Hikma v. Amarin. In Hikma v. Amarin, the Supreme Court made clear that an innovator must plausibly allege that a generic actively encouraged infringing uses; allegations that a physician could read a statement to induce

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