Background
Otsuka America Pharmaceutical, Inc. and Avanir Pharmaceuticals, LLC sued Hetero Labs Limited to prevent the launch of a generic version of the drug Nuedexta. The district court granted a preliminary injunction, finding likely infringement of U.S. Patent Number seven, six, five, nine, two, eight, two, and waived the bond requirement under Federal Rule of Civil Procedure sixty-five, subsection C. Hetero appealed both the claim construction and the bond waiver.
The court’s reasoning
The majority held that the terms dextromethorphan and quinidine in the patent claims include the compounds in both free base and salt forms. The court found that intrinsic evidence, including the specification and prosecution history, supported Otsuka’s construction that the weight-to-weight ratio should be calculated based on the administered salt forms. Regarding the bond, the court applied Third Circuit law, noting that waiver is rare and generally not permitted when an injunction prevents commercial, money-making activities.
The dissent
What it means going forward
Generic manufacturers must post a bond to appeal preliminary injunctions in commercial patent disputes, and patent claim terms may be interpreted to cover salt forms of active ingredients based on specification usage.