Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited

Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited The Federal Circuit affirmed the preliminary injunction, holding that the claim terms “dextromethorphan” and “quinidine” in the asserted weight-to-weight ratio refer to the form administered, including salt forms, supporting Otsuka’s likelihood of proving infringement. The court vacated the district court’s waiver of the Rule 65(c) bond requirement and remanded for reconsideration of an appropriate bond. The decision is a practical reminder that pharmaceutical claim construction may turn heavily on how the patent uses salt-form shorthand, and that courts in commercial patent injunction cases may have limited room to waive Rule 65(c) security. Affirmed in part, vacated in part, and remanded. Claim 1 of the ’282 patent recites administering dextromethorphan with quinidine, including a weight-to-weight ratio limitation of 1:0.5 or less. Hetero argued the ratio should be calculated using only active-moiety weights, which would place its generic product outside the claim; Otsuka argued the ratio uses the weights of the administered compounds, including salts. The majority relied on dependent claims, the specification’s repeated use of dextromethorphan/quinidine to include salt forms, prosecution history, and the improbability of excluding Nuedexta to adopt Otsuka’s construction. The court rejected Hetero’s indefiniteness concern, reasoning that the ratio is calculated from the measurable form actually administered. Applying Third Circuit law, the court held the district court erred in waiving Rule 65(c) security because Hetero’s enjoined generic launch was a commercial, money-making activity. claim construction infringement § 112(b) injunction / stay remand Hatch-Waxman / ANDA precedential waiver / forfeiture claim construction infringement § 112(b) injunction / stay remand Hatch-Waxman / ANDA precedential waiver / forfeiture claim construction infringement injunction / stay remand waiver / forfeiture