-Biocon Biologics Ltd, said its partner Viatris has won favourable decisions from a US federal court in Sanofi’s challenge over unpatentability of device patents for disposable insulin injection pen
-The Semglee® products are available in vial and prefilled pen presentations and are interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
Biocon Biologics Ltd, an arm of biotechnology major Biocon Ltd, on Thursday said its partner Viatris has won favourable decisions from a US federal court in Sanofi’s challenge over unpatentability of five device patents for disposable insulin injection pen.
The US Court of Appeals for the Federal Circuit (USCAFC) has upheld the US Patent and Trademark Appeal Board’s decisions for unpatentability of five device patents for Sanofi’s Lantus SoloSTAR, as well as a district court decision on one of these patents, the company said in a statement.
Lantus 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. Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR).
The Patent Trial and Appellate Board (PTAB) at the US Patent and Trademark Office (USPTO) had in April and May 2020 found the challenged claims of the five patents unpatentable. Sanofi had appealed against all these PTAB decisions to USCAFC.
“The decision of the US federal court in favour of our partner Viatris, on all the five Sanofi Lantus SoloSTAR device patents is a vindication of our long-held position on intellectual property,” Biocon Biologics dCEO Shreehas Tambe said.
These developments are very encouraging and will greatly help in breaking down barriers to patient access, Tambe said.
Viatris and Biocon Biologics Ltd launched their interchangeable Semglee products (insulin glargine-yfgn) last month, “which are the first, and currently the only, interchangeable biosimilars” to Sanofi’s Lantus.
The Semglee products are available in vial and prefilled pen presentations and are interchangeable for the reference brand, Lantus, allowing for substitution at the pharmacy counter.
Semglee is indicated to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes, the company said.
“With Semglee, we will be able to offer people living with diabetes in the US more treatment options, rationalise cost of therapy and generate savings for the overall healthcare system,” Tambe said.
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a growing portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 38,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.