Biocon Ltd. today announced that the U.S. Patent and Trademark Appeal Board (PTAB) has ruled in favour of Mylan, Biocon’s* partner in inter partes review (IPR) proceedings finding all challenged claims of Sanofi’s Lantus SoloSTAR device patents, 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.

Dr Christiane Hamacher, CEO & Managing Director, Biocon Biologics said, “We are extremely pleased with the U.S. PTAB’s ruling in favour 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 favourable ruling further clears the path for the anticipated launch of our Glargine in the U.S. in mid-CY20.. Biocon Biologics remains committed to use its science, scale and expertise to shift the access paradigm for patients in need of insulin across the globe.”

Last month, the PTAB held the sole challenged claim of another Lantus SoloSTAR device patent as unpatentable for U.S. Patent No. 8,679,069, and in March, Mylan and Biocon announced that the U.S. District Court of New Jersey found the asserted claims of the ‘844 patent not infringed by Mylan's Insulin Glargine product and invalid for lack of written description. Sanofi's formulation patents were previously affirmed to be invalid by the Federal Circuit by a non- appealable decision.

The positive IPR developments are greatly encouraging as we believe greater competition in the U.S. insulin market will help rationalize the cost of therapy and generate savings for the healthcare system. Once approved and commercialized our co-developed Semglee will expand access to insulin therapy.

Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar. Our partner, Mylan’s 505(b)(2) New Drug Application (NDA) is under active review by the U.S. Food and Drug Administration.

Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR®).

Sanofi’s total IQVIA sales for the 12 months ending March 31, 2020, were approximately USD 1.71 billion for Lantus 100 Units/mL and about USD 4.32 billion for Lantus SoloSTAR.