• Sep 24 2018
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  • Category: CAFC Updates

Actavis filed an ANDA for a generic counter-part of Zubsolv (approved by the FDA for treatment of opioid dependence), accompanied by a Paragraph IV certification, leading to this Hatch-Waxman litigation. Of the two Orexo patents challenged by Actavis, U.S. Patent No. 8,454,996 (entitled “Pharmaceutical Composition for the Treatment of Acute Disorders”) was held valid in the district court. Orexo appeals the decision of the District Court, holding certain claims of U.S. Patent No. 8,940,330 (entitled “Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence”) invalid on the ground of obviousness. The CAFC concludes that obviousness was not proved by clear and convincing evidence, finding that there is no suggestion in the art that the specified elements should be selected and combined, and that the designated sublingual formulation would be less subject to abuse than prior formulations for substitution therapy, and reverses.

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