Insulin Device Patent Row: Biocon, Mylan Get Favourable Ruling from US Patent Board

Bengaluru: Biocon Ltd. has announced that the U.S. Patent and Trademark Appeal Board (PTAB) has ruled in favor of Mylan, Biocon's partner in inter partes review (IPR) proceedings finding all challenged claims of Sanofi's Lantus SoloSTAR device patents, U.S. Patent Nos. 8,603,044, 8,992,486, and 9,526,844 unpatentable.

The PTAB found three claims of the 9,604,008 patent unpatentable, and two claims to be patentable. However, Mylan and Biocon have previously obtained a covenant not to sue from Sanofi on the '008 patent and therefore this ruling does not impact Biocon and Mylan's ability to commercialize Semglee (Insulin Glargine) upon final approval from the U.S. Food and Drug Administration. The PTAB also found Sanofi's proposed amended claims for the '486 and '844 patents unpatentable, Biocon said in its recent release.

Dr. Christiane Hamacher, CEO & Managing Director, Biocon Biologics said, "We are extremely pleased with the U.S. PTAB's ruling in favor of our partner Mylan for four device patents of Sanofi's Lantus SoloSTAR. This strengthens our resolve to provide a high-quality affordable Insulin Glargine to diabetic patients in the U.S. and generate savings for their healthcare system. Our partner's New Drug Application (NDA) for Semglee is under active review by the U.S. FDA and this favorable ruling further clears the path for the anticipated launch of our Glargine in the U.S. in mid-CY20. Biocon Biologics remains committed to using its science, scale, and expertise to shift the access paradigm for patients in need of insulins across the globe."