Biocon, Mylan win patent litigation for Insulin Glargine device patent in the US

Biocon has won a US court ruling that invalidated a Sanofi patent on the Insulin Glargine device, removing a key legal hurdle to commercialising Semglee (Insulin Glargine) co-developed with Mylan, in the US.

The US District Court of New Jersey found the device patent claims (US Patent No. 9,526,844) asserted by Sanofi against Biocon and Mylan’s Insulin Glargine product ‘not infringed’ and ‘invalid’ for lack of written description. Separately, as previously announced, Sanofi’s formulation patents (US Patent No 7,476,652 and US Patent No 7,713,930) were previously affirmed to be invalid by the Federal Circuit.

The 505(b)(2) New Drug Application (NDA) for Semglee is under active review by the US Food and Drug Administration (FDA). The FDA has set a Target Action Date for our Insulin Glargine application in June 2020. Biocon remains confident of being able to commercialise the product in the calendar year 2020. The market opportunity for Insulin Glargine in the US is estimated at $ 2.2 billion.

Dr Christiane Hamacher, CEO, Biocon Biologics said, "We are pleased with the US court ruling in favour of our Insulin Glargine device as this takes us closer towards bringing a more affordable Insulin Glargine for patients with diabetes in the US. Today, patients in parts of Europe, Australia, India and key emerging markets are already benefiting from our Insulin Glargine. Once approved and commercialised our Semglee will expand access to this therapy. This patent win endorses our commitment to innovation and value creation through incisive IP strategy. 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."

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