The U.S. Court of Appeals for the Federal Circuit [USCAFC] has upheld the U.S. 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.
Viatris and Biocon Biologics had launched their interchangeable insulin biosimilar Semglee products [insulin glargine-yfgn] last month in the U.S. Semglee is the first, and currently the only interchangeable biosimilar to Lantus, 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’s total sales in the U.S. as per IQVIA for the 12 months ending September 30, 2021 were $1.4 billion for Lantus 100 Units/mL vial and $5.1 billion for Lantus SoloSTAR 100 Units/mL.
Sanofi sells the product in vials [Lantus] and as a disposable injection pen [Lantus SoloSTAR]. 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 said to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
The Patent Trial and Appellate Board (PTAB) at the U.S. Patent and Trademark Office [USPTO] had, in April and May 2020, found the challenged claims of U.S. Patent Nos. 8,679,069; 8,603,044; 8,992,486; 9,526,844; 9,604,008 unpatentable. Sanofi had appealed against PTAB’s decisions to the USCAFC.
“The decision of the U.S. 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. These developments are very encouraging and will greatly help in breaking down barriers to patient access. With Semglee, we will be able to offer people living with diabetes in the U.S. more treatment options, rationalise cost of therapy and generate savings for the overall healthcare system,” says Shreehas Tambe, CEO, Biocon Biologics.