Mayne Pharma International Pty. Ltd. v. Merck Sharp & Dohme Corp.

Mayne’s 745 patent discloses and claims pharmaceutical compositions of azole antifungal drugs that are practically insoluble in aqueous media. The patent explains that insoluble drugs are difficult to formulate into dosage forms because of their low absorption and poor bioavailability and purports to provide a pharmaceutical composition addressing these shortcomings. On MSD’s petition, the Patent Trial and Appeal Board initiated inter partes review and found several claims unpatentable as anticipated or obvious, 35 U.S.C. 103 The Federal Circuit affirmed, upholding the Board’s decision to permit MSD’s amendment, finding no indication of intentional concealment, no bad faith on MSD’s part, no attempt to circumvent the estoppel rules, or any other material benefit to it in its delay in naming MCI as a real party in interest. The Board did not err in its constructions of either “pharmaceutical composition” or the “wherein” clauses; under the Board’s constructions, the claims are obvious or anticipated View "Mayne Pharma International Pty. Ltd. v. Merck Sharp & Dohme Corp." on Justia Law