Biocon, Mylan Win Patent Case Against Sanofi In U.S. For Insulin Glargine Device
The development removes the legal hurdle to commercialise Semglee that Biocon co-developed with Mylan NV for the U.S. market.
Biotech firm Biocon Ltd. on Wednesday said a U.S. court has invalidated Sanofi SA’s patent on a insulin glargine device, thus removing a legal hurdle to commercialise Semglee it co-developed with Mylan NV for the American market.
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, Biocon said in a filing to the BSE. As previously announced, Sanofi's formulation patents were earlier affirmed to be invalid by the Federal Circuit, it added.
The new drug application for Semglee is under active review by the U.S. Food and Drug Administration, Biocon said. The U.S. health regulator has set a target action date for the insulin glargine application in June 2020. The market opportunity for insulin glargine in the U.S. is estimated at $2.2 billion, it added.
"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.," Biocon Biologics' Chief Executive Officer Christiane Hamacher said.
Patients in parts of Europe, Australia, India and other key emerging markets are already benefiting from our insulin glargine, she said. "Once approved and commercialized our Semglee will expand access to this therapy.”
Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes for the control of high blood sugar.