Otsuka America Pharmaceutical v. Hetero Labs Limited (Fed. Cir., July 1, 2026) 2025-2016
This episode concerns a ruling from the United States Court of Appeals for the Federal Circuit regarding a patent dispute over the neurological drug Nuedexta. The court affirmed a preliminary injunction preventing Hetero Labs from launching a generic version, centering its decision on the interpretation of weight-to-weight ratios for the active ingredients dextromethorphan and quinidine. While the judges agreed that the patent terms include the compounds in their salt forms, they split on whether the weight calculation should reflect the total salt weight or only the active moiety. Despite…
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