US Court Rules In Favor Of Viatris For Interchangeable Semglee

Partners Biocon and Viatris To Continue To Market Insulin Glargine Biosimilar

Viatris and Biocon continue marketing their recently launched interchangeable biosimilar Semglee (insulin glargine-yfgn) as a US appeals court affirms that the challenged claims of five of Sanofi’s Lantus SoloSTAR device patents are unpatentable.

Court Ruling
Sanofi loses to Viatris as US Court finds challenged claims unpatentable • Source: Alamy

Partners Viatris and Biocon Biologics have announced winning the right to continue providing patients with access to interchangeable biosimilar Semglee (insulin glargine-yfgn) after the US Court of Appeals for the Federal Circuit upheld the US Patent and Trademark Appeal Board’s decisions for unpatentability of five device patents for Sanofi’s Lantus SoloSTAR brand, as well as a district court decision on one of these patents.

In 2020, Mylan – ahead of its merger with Pfizer’s Upjohn to become Viatris – received two favorable decisions on Lantus device patents, with a New Jersey district court finding US device patent 9,526,844 to be not infringed and invalid for lack of written description (Also see "Mylan Beats Sanofi On Lantus Patent" - Generics Bulletin, 16 March, 2020.) and the PTAB providing a further boost by finding multiple device patent claims to be unpatentable

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