Source: Getty images
Biopharmaceutical firm Biocon Ltd and its partner Mylan have won a U.S. court ruling that invalidated a Sanofi patent on the Insulin Glargine device, removing a key legal hurdle to commercializing Semglee (Insulin Glargine) co-developed by Biocon and Mylan, in the U.S.
The U.S. District Court of New Jersey found the device patent claims asserted by Sanofi against Biocon and Mylan’s Insulin Glargine product ‘not infringed’ and ‘invalid’ for lack of written description.
Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are extremely pleased with the U.S. 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 U.S. Today, patients in parts of Europe, Australia, India and key emerging markets are already benefiting from our Insulin Glargine. Once approved and commercialized 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 use its science, scale and expertise to shift the access paradigm for patients in need of insulins across the globe.”
Biocon remains confident of being able to commercialize the product in calendar year 2020.
The market opportunity for Insulin Glargine in the U.S. is estimated at US$ 2.2 billion.
