Biocon and Mylan win patent litigation over Insulin Glargine in US

Biocon and its partner Mylan have won a patent lawsuit in the United States initiated by Sanofi in relation to formulation patents covering insulin Glargine as well as patent covering the Insulin Glargine injection pen. In 2017, Sanofi had initiated patent infringement litigation against Biocon and Mylan that triggered a 30-month stay on the product’s approval.

The New Drug Application (NDA) for Semglee is under active review by the US Food and Drug Administration (USFDA). The FDA has set a target action date for our Insulin Glargine application in June 2020. Semglee is co-developed by Biocon with Mylan in the US.

The US District Court of New Jersey found that the device patent claims asserted by Sanofi India against Biocon & Mylan’s Insulin Glargine was ‘not infringed’ and ‘invalid’ for lack of written description.

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.

According to Christiane Hamacher, CEO, Biocon Biologics, “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.”