Biocon Biologics partner Viatris wins US court decision on 5 Sanofi Lantus SoloSTAR device patents

Bengaluru: Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has announced that the U.S. Court of Appeals for the Federal Circuit (USCAFC) has upheld the U.S. Patent and Trademark Appeal Board's decisions for unpatentability of five device patents for Sanofi's Lantus SoloSTAR, as well as a district court decision on one of these patents.

 The Patent Trial and Appellate Board (PTAB) at the U.S. Patent and Trademark Office (USPTO) had in April and May 2020 found the challenged claims of U.S. Patent Nos. 8,679,069; 8,603,044; 8,992,486; 9,526,844; 9,604,008 unpatentable. Sanofi had appealed against all these PTAB decisions to USCAFC.

Of these five patents, the 9,526,844 ("the '844 Patent") was also held invalid and "not infringed" by the U.S. District Court for the District of New Jersey. The district court found non-infringement of the asserted claims for the '844 patent and held it invalid for lack of written description. Sanofi had appealed the district court decision for the '844 patent. Since the USCAFC affirmed PTAB's decision for the '844 patent, Sanofi's appeal against the district court's decision is held as moot and thus dismissed. The Federal Circuit judgments reinforce the continuing efforts of Biocon Biologics and Viatris to break down barriers to patient access for important medicines such as Semglee. Viatris and Biocon Biologics Ltd. launched their interchangeable Semglee products (insulin glargine-yfgn) last month, which are the first, and currently the only, interchangeable biosimilars to Lantus, providing more affordable options for the millions of Americans living with diabetes.