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Federal Circuit Affirms Preliminary Injunction Against Generic Nuedexta
07/07/2026
In Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited, No. 2025-2016 (Fed. Cir. July 1, 2026), the U.S. Court of Appeals for the Federal Circuit affirmed a preliminary injunction barring Hetero Labs Limited (“Defendants-Appellants”) from launching a generic version of Nuedexta, a drug used to treat neurological disorders.
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Non-Speculative Evidence Of Irreparable Harm Is Required For Preliminary Injunction
05/20/2025
Incyte Corporation and Incyte Holdings Corporation’s (collectively, “Incyte”) owns U.S. Patent No. 9,662,335, which claims deuterated versions of ruxolitinib used to treat diseases associated with autoimmune disorders. The ’335 patent is set to expire in December 2026.
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Federal Circuit Affirms Finding Of Personal Jurisdiction And Preliminary Injunction Against Biosimilar Applicants
02/11/2025
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction by the Northern District of West Virginia in favor of Regeneron Pharmaceuticals, Inc. against Samsung Bioepis Co., Ltd. (“SB”) and other biosimilar applicants. Regeneron had sued defendants for infringing its U.S. Patent No. 11,084,865, which covers formulations of aflibercept, a fusion protein that binds to vascular endothelial growth factor (VEGF) and is used to treat angiogenic eye diseases. Regeneron markets aflibercept under the brand name EYLEA®.
