Merck VS Mylan Pharma: US Court of Appeals for the Federal Circuit rules in favor of Merck in Sitagliptin Dihydrogen Phosphate patent lawsuit
The ruling from the U.S. Court of Appeals provides JANUVIA, JANUMET and JANUMET XR patent protection through May 2027, which includes six (6) months of pediatric exclusivity.
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Court of Appeals for the Federal Circuit ruled in favor of the company in a patent challenge brought by Mylan Pharmaceuticals, Inc. (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in JANUVIA (sitagliptin), JANUMET (sitagliptin and metformin hydrochloride) and JANUMET XR (sitagliptin and metformin hydrochloride extended-release).
Viatris had challenged validity of U.S. Patent No.7,326,708 in an inter partes review before the U.S. Patent Office. On May 7, 2021, the Patent Office issued a decision in Merck's favor, finding all challenged claims valid. Viatris appealed that decision to the Court of Appeals for the Federal Circuit, which today affirmed the decision.
Viatris had previously challenged validity of the patent in a case filed in the U.S. District Court for the Northern District of West Virginia. The District Court ruled in favor of Merck in a decision dated Sept. 21, 2022.
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The ruling from the U.S. Court of Appeals provides JANUVIA, JANUMET and JANUMET XR patent protection through May 2027, which includes six (6) months of pediatric exclusivity. The company has settled with multiple generic companies, providing that these generic companies can bring their sitagliptin dihydrogen phosphate or sitagliptin-metformin product to the market in May 2026 or earlier under certain circumstances, and their sitagliptin-metformin extended-release product to the market in July 2026 or earlier under certain circumstances.
