Biocon has won a US court ruling that invalidated a Sanofi patent on the Insulin Glargine device, removing a key legal hurdle to commercializing 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 (USFDA). The USFDA has set a Target Action Date for company’s Insulin Glargine application in June 2020. Biocon remains confident of being able to commercialize the product in calendar year 2020. The market opportunity for Insulin Glargine in the US is estimated at $2.2 billion.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
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