Biocon Biologics partner Viatris wins US Court Decisions on Sanofi Appeals for Lantus Device Patents

Biocon Biologics Ltd., a subsidiary of Biocon Ltd. on Thursday announced that 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.

In a regulatory filing at the stock exchanges, Biocon said, "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."

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).

Biocon Biologics in a tweet said, "#BioconBiologics Partner Viatris Wins U.S. Court Decisions on all the five Sanofi Lantus® SoloSTAR® device patents. The court's decision is very encouraging & will significantly help break down barriers to people living with #diabetes."

Sanofi's total sales in the U.S. as per IQVIA for the 12 months ending September 30, 2021, were ~USD 1.4 billion for Lantus 100 Units/mL vial and ~USD 5.1 billion for Lantus® SoloSTAR 100 Units/mL.

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 all these PTAB decisions to USCAFC.

Of these five patents, the 9,526,844 ("the '844 Patent") was also held invalid and "not infringed" by the U.S. District Court for the District of New Jersey. The district court found non-infringement of the asserted claims for the '844 patent and held it invalid for lack of written description.

Sanofi had appealed the district court decision for the '844 patent. Since the USCAFC affirmed PTAB's decision for the '844 patent, Sanofi's appeal against the district court's decision is held as moot and thus dismissed.

The Federal Circuit judgments reinforce the continuing efforts of Biocon Biologics and Viatris to break down barriers to patient access to important medicines such as Semglee®. 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 Lantus, providing more affordable options for the millions of Americans living with diabetes.

The Semglee products are available in a 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.

Shreehas Tambe, CEO, Biocon Biologics, said: "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, rationalize the cost of therapy and generate savings for the overall healthcare system."

*Note: Biocon Biologics is a real party in interest pursuant to 37 C.F.R. §42.8 (b)(1) in these IPRs.