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 upholding the injunction, the appellate court vacated a lower court's decision to waive a security bond, requiring the plaintiffs to provide financial protection for the defendants during the appeal. A partial dissent argues that the majority’s construction ignores the therapeutic purpose of the invention and potentially excludes the branded product itself from patent coverage.

This podcast is for entertainment purposes only and does not create an attorney-client relationship. The AI-generated hosts are not attorneys and are not providing legal advice. The choice of a lawyer is an important decision and should not be based solely upon advertisements.