Merck prevails in sitagliptin patent dispute

There was positive news from US pharma giant Merck & Co (NYSE: MRK) this morning, with respect to patent litigation relating to its blockbuster diabetes drug franchise.

Merck disclosed that the US District Court for the Northern District of West Virginia ruled in favor of the company in a patent infringement suit against generic drug major Viatris (Nasdaq: VTRS) related to sitagliptin, an active ingredient in Januvia, Janumet and Janumet XR, which together pulled in sales of $1.23 billion in the second quarter of this year. The Court found that both Merck patents at issue were valid and infringed. The decision is subject to appeal.

Two Merck patents were involved in the suit. The first, US Patent No 7,326,708, covers the dihydrogen phosphate salt of sitagliptin and is set to expire on November 24, 2026, with pediatric exclusivity extending to May 24, 2027. The second, US Patent No 8,414,921, covers the co-formulation of sitagliptin and metformin found in Janumet and is set to expire January 21, 2029, with pediatric exclusivity extending to July 21, 2029. Merck had filed infringement actions against Viatris under both patents, for which Viatris alleged non-infringement and/or invalidity.