Biocon has won a US court ruling that invalidated a Sanofi patent on the insulin glargine device removing a key legal hurdle to commercializing Semglee (insulin glargine) co-developed with Mylan in the US.
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 505(b)(2) New Drug Application (NDA) for Semglee is under active review by the US Food and Drug Administration (FDA). The FDA has set a Target Action Date for insulin glargine application in June 2020.
Biocon remains confident of being able to commercialize the product in calendar year 2020. The market opportunity for Insulin Glargine in the US is estimated at US$ 2.2 billion. In October 2017, Sanofi had initiated patent infringement litigation against this 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.
“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.
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. Biocon Biologics remains committed to use its science, scale and expertise to shift the access paradigm for patients in need of insulins across the globe, said Dr Christiane Hamacher, CEO, Biocon Biologics.
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.