Viatris wins US court decision on Sanofi’s appeals for Lantus patents invalidation, Health News, ET HealthWorld

Bengaluru: Biocon Biologics Ltd, Thursday introduced that the U.S. Court of Appeals for the Federal Circuit (USCAFC) has upheld the U.S. Patent and Trademark Appeal Board’s choices for unpatentability of Sanofi’s 5 system patents. Additionally, USCAFC additionally upheld the district court’s decision on the ’844 Patent that had discovered non-infringement of the asserted claims.

The Patent Trial and Appellate Board (PTAB) within the U.S. Patent and Trademark Office (USPTO) had in April and May 2020 discovered 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 in opposition to all these PTAB choices to USCAFC.

Of these 5 patents, the 9,526,844 (“the ’844 Patent”) was additionally held invalid and “not infringed” by the U.S. District Court for the District of New Jersey. The district court discovered 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. USCAFC affirmed PTAB’s decision for the ‘844 patent, thus dismissing Sanofi’s enchantment in opposition to the district court’s decision.

Commenting on US federal court’s decision, Shreehas Tambe, Deputy CEO, Biocon Biologics, mentioned: “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. 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 cost of therapy and generate savings for the overall healthcare system.”

Viatris and Biocon Biologics Ltd. launched the Semglee merchandise (insulin glargine-yfgn) that are the primary and at present the one interchangeable biosimilars to Lantus. The Semglee merchandise are a extra inexpensive possibility for thousands and thousands of Americans residing with diabetes.

The Semglee merchandise can be found in vial and prefilled pen shows. They are interchangeable for the reference model Lantus, permitting for substitution on the pharmacy counter.

Semglee merchandise may help in controlling excessive blood sugar ranges in adults; pediatric sufferers with kind 1 diabetes and adults with kind 2 diabetes. This property of the product is much like Lantus, a long-acting insulin used to manage excessive blood sugar ranges which Sanofi sells in vials (as Lantus) and as a disposable injection pen (Lantus SoloSTAR).

According to IQVIA, Sanofi’s complete gross sales within the U.S. for 12 months ending September 30, 2021 was USD 1.4 billion for Lantus 100 Units/mL vial and ~USD 5.1 billion for Lantus SoloSTAR 100 Units/mL.