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Mylan Receives favourable ruling from US PTAB on Sanofi’s four device patents

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Last month, the PTAB held the sole challenged claim of another Lantus SoloSTAR device patent as unpatentable for US Patent No. 8,679,069, and in March, Mylan and Biocon announced that the US 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

Biocon announced that the US 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, US 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 commercialise Semglee® (Insulin Glargine) upon final approval from the US Food and Drug Administration. The PTAB also found Sanofi’s proposed amended claims for the ‘486 and ‘844 patents unpatentable.

Dr Christiane Hamacher, CEO and 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 US FDA and this favourable ruling further clears the path for the anticipated launch of our Glargine in the US 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.”

Last month, the PTAB held the sole challenged claim of another Lantus SoloSTAR device patent as unpatentable for US Patent No. 8,679,069, and in March, Mylan and Biocon announced that the US 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 (U.S. Patent Nos 27,476,652 and 7,713,930) 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. insulins market will help rationalise the cost of therapy and generate savings for the healthcare system. Once approved and commercialised 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
US 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 $ 1.71 billion for Lantus 100 Units/mL and about $ 4.32 billion for Lantus SoloSTAR.

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