Biocon, Mylan wins patent case for insulin device against Sanofi in the US; Will commercialize Semglee in US

Biopharmaceutical major Biocon with its partner Mylan has won litigation in a US District Court of New Jersey, which invalidates Sanofi's patent on insulin Glargine device. This verdict removes a key legal hurdle for the biotech major to commercialize Semglee (Insulin Glargine) co-developed with Mylan, in the US.

Biocon in a press statement said, "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 US court ruling in favour of our Insulin Glargine device 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," said Christiane Hamacher, CEO, Biocon Biologics.

Biocon's Insulin Glargine has received regulatory approval in 70 countries and has been commercialised in markets such as Japan, Australia, Brazil, Mexico, and UAE.

In October 2017, Sanofi had initiated patent infringement litigation against Biocon and Mylan's NDA in the US District Court 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.

Biocon said it should be able to commercialize the product in the calendar year 2020. The market opportunity for Insulin Glargine in the US is estimated at $ 2.2 billion. It treats adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes for the control of high blood sugar.