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 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 US patent numbers 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, Biocon Biologics, of which Viatris is a partner, notified via a statement.
Of these five patents, the 9,526,844 (“the ’844 Patent”) was also held invalid and “not infringed” by the US 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, added the statement.
According to the statement, Lantus is a long-acting insulin used to treat adults with type-II diabetes and adults and paediatric patients with type-I diabetes for the control of high blood sugar. Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR). Its total sales in the US as per IQVIA for the 12 months ending 30th September, 2021 were approximately $1.4 billion for Lantus 100 units/mL vial and approximately $5.1 billion for Lantus SoloSTAR 100 units/mL, concluded the statement.