MAYNE PHARMA INTERNATIONAL PTY v. MERCK SHARP & DOHME CORP.
- Jun 21 2019 |
- Category: CAFC Updates
Mayne Pharma appeals from the final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (“the Board”) in an inter partes review, concluding that certain claims of U.S. Patent 6,881,745 relating to pharmaceutical compositions of azole antifungal drugs are unpatentable as anticipated or obvious. In response to Mayne’s argument that the Board should not have instituted review because the petition was time-barred under 35 U.S.C. § 315(b), the CAFC finds that the Board did not err in allowing Merck to amend its disclosures to add another Merck entity as a real party in interest without altering the petition’s filing date. With respect to claim construction, Mayne argues that the Board construed the term “pharmaceutical composition” too broadly to encompass toxic compositions that do not have any demonstrated beneficial therapeutic properties. However, the CAFC finds that because the specification is silent as to whether the claimed pharmaceutical composition is limited to being nontoxic, there is no basis to import such a limitation into the claim. Mayne next argues that the Board erred in failing to limit the claimed pharmacokinetic parameters to humans, but the CAFC finds that that the broadest reasonable interpretation of the claims is not limited to humans. Accordingly, the CAFC affirms the decision of the Board.