Tag: Hatch-Waxman
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Exelixis v. MSN Labs: Federal Circuit Upholds Crystalline Salt Genus Under § 112 Written Description
The Federal Circuit’s precedential decision in Exelixis, Inc. v. MSN Laboratories Private Ltd., Case No. 25-1236 (Fed. Cir. Aug. 31, 2026), affirmed a bench-trial finding that patents claiming crystalline cabozantinib (L)-malate satisfied the written-description requirement even though the specification expressly characterized only two crystalline polymorphs. The court concluded that the chemical name and formula of…
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Otsuka v. Hetero Labs: Federal Circuit Upholds Patent Injunction but Requires Rule 65(c) Bond
The Federal Circuit’s decision in Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited, Case No. 2025-2016 (Fed. Cir. July 1, 2026), upheld a preliminary injunction delaying the launch of a generic version of Nuedexta but vacated the district court’s decision allowing the patent owner to obtain that injunction without posting security under Federal Rule of…
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Hikma v. Amarin: Supreme Court Narrows Induced Infringement Claims Against Skinny-Label Generics
A Significant Win for Generic Drug Manufacturers The Supreme Court’s unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., Case No. 24-889 (Jun. 4, 2026), is one of the most important patent law decisions of the 2025-2026 Term. While the case arises from the pharmaceutical industry’s unique Hatch-Waxman framework, its significance extends well…
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Merck v. Aurobindo: Patent Term Extensions and Reissued Patents
Introduction The Federal Circuit recently issued a significant ruling in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., clarifying how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act. The court upheld the U.S. Patent and Trademark Office’s (PTO) decision to calculate the PTE for a reissued patent based on…