Biotechnology firm Biocon on Wednesday said a US court has invalidated a Sanofi patent on the insulin glargine device.
It will now remove a key legal hurdle to commercialising Semglee co-developed with Mylan in the US market.
In a filing to the Bombay Stock Exchange Biocon said, “The US 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.”
As previously announced, Sanofi’s formulation patents were earlier affirmed to be invalid by the Federal Circuit, it added.
The new drug application (NDA) for Semglee is under active review by the US Food and Drug Administration (USFDA), Biocon said.
The US health regulator has set a target action date for the insulin glargine application in June 2020.
The market opportunity for insulin glargine in the US is estimated at USD 2.2 billion, it added.
“We are extremely pleased with the US 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 US,” Biocon Biologics CEO Christiane Hamacher said.
Today, patients in parts of Europe, Australia, India and key emerging markets are already benefiting from our insulin glargine, she added.
“Once approved and commercialized our Semglee will expand access to this therapy,” Hamacher said.
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 said.
“In October 2017, Sanofi had initiated patent infringement litigation against our NDA in the US 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,” it added.