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U.S. Supreme Court Holds Generic Manufacturer’s “Skinny Label” and Marketing Did Not Induce Patent Infringement
06/09/2026On June 4, 2026, Justice Ketanji Brown Jackson, writing for a unanimous Supreme Court of the United States, reversed a decision by the United States Court of Appeals for the Federal Circuit and held that Amarin Pharma, Inc. failed to plausibly allege that Hikma Pharmaceuticals USA Inc. actively induced patent infringement through its generic version of Vascepa under 35 U.S.C. § 271(b). Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 (U.S. June 4, 2026). Plaintiff alleged that the totality of defendant’s statements across its “skinny label,” website, patient leaflet, and press releases induced physicians to prescribe defendant’s generic drug for plaintiff’s patented cardiovascular use.Categories: Generic Drugs, Induced Infringement, Infringement, IP in the Supreme Court, Patent, Supreme Court
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Federal Circuit Affirms Findings Of Non-Obviousness And Infringement Of Method Of Treatment Patent Claiming Dosing Regimen For Long-Acting Antipsychotic Injectable
04/22/2025
On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced healthcare providers to infringe the asserted claims of U.S. Patent No. 10,143,693 (“the ’693 patent”), and that Mylan did not demonstrate by clear and convincing evidence that the ’693 patent is invalid. Janssen Pharms., Inc. v. Mylan Lab’ys Ltd., No. 2023-2042, slip op. (Fed. Cir. Mar. 28, 2025).
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Federal Circuit Reverses Dismissal Of Induced Infringement Claim Based On Skinny Label And Marketing Materials
07/17/2024On June 25, 2024, the United States Court of Appeals for the Federal Circuit (“CAFC”) reversed a decision by the United States District Court for the District of Delaware dismissing Amarin Pharma, Inc.’s induced infringement claims against Hikma Pharmaceuticals USA Inc. Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 2023-1169 (Fed. Cir. June 25, 2024). The CAFC held that the totality of Amarin’s allegations plausibly stated a claim for induced infringement of patents allegedly covering Hikma’s generic version of Amarin’s Vascepa® product.