Biocon, Mylan Win Patent Litigation against Sanofi for Insulin Glargine Device

Bengaluru: Biocon Ltd. 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 with
Mylan, in the U.S.

Dr Christiane Hamacher, CEO, Biocon Biologics said, “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.”

Insulin Glargine is a long-acting insulin used to treat adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes for the control of high blood sugar.
Biocon’s Insulin Glargine has received regulatory approval in ~70 countries around the world and has also been commercialized in many emerging markets such as Brazil, Mexico, Malaysia, South Korea, UAE, as well as, developed markets like Japan, Australia and parts of Europe.

“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,” Dr Hamacher said.

In October 2017, Sanofi had initiated patent infringement litigation against Biocon’s NDA in the U.S District Court for the District of New Jersey that included the formulation patents covering Insulin Glargine as well as patent covering the Insulin Glargine injection pen, triggering a 30-month stay on the product’s approval.

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