Sanofi loses patent for insulin device

Biocon & its partner, Mylan, have won a patent case in the US District Court of New Jersey against Sanofi’s patent on the insulin Glargine device. The court found the device patent claims (US Patent No. 9526844) asserted by Sanofi against Biocon and Mylan’s insulin Glargine product ‘not infringed’ and ‘invalid’ for lack of written description. The verdict has opened gates for the biotech major to commercialize Semglee. This is a major win for the company considering that the market opportunity for Insulin Glargine in the US is forecasted to be valued at US$ 2.2 billion.

“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,” Christiane Hamacher, CEO, Biocon Biologics, told reporters.

In October 2017, Sanofi had opened a patent infringement litigation against Biocon and Mylan’s NDA that included the formulation patents covering insulin Glargine as well as patent covering the Insulin Glargine injection pen. This caused a 30-month stay on the product’s approval.