Biocon Biologics said that the US Court of Appeals for the Federal Circuit upheld the US Patent and Trademark Appeal Board's decisions for unpatentability of five device patents for Sanofi's Lantus SoloSTAR and a district court decision on a patent.
Biocon Biologics, a subsidiary of Biocon, said that the Patent Trial and Appellate Board (PTAB) at the U.S. Patent and Trademark Office (USPTO) in April and May 2020 had 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 U.S. Court of Appeals for the Federal Circuit (USCAFC).
Of these five patents, the 9,526,844 patent was 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 9,526,844 patent and held it invalid for lack of written description. Sanofi had appealed the district court decision for the 9,526,844 patent. Since the USCAFC affirmed PTAB's decision for the 9,526,844 patent, Sanofi's appeal against the district court's decision is held as moot and thus dismissed.
Viatris and Biocon Biologics launched their interchangeable Semglee products (insulin glargine-yfgn) last month, which are the first, and currently the only, interchangeable biosimilars to Lantus, to combat diabetes.
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). As per IQVIA for the 12 months ending 30 September 2021, Sanofi's total sales in the U.S. were $1.4 billion for Lantus 100 units/ mL vial and $5.1 billion for Lantus SoloSTAR 100 units/ mL.
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's consolidated net profit fell 18.3% to Rs 159.70 crore on a 5.2% increase in net sales to Rs 1,840.40 crore in Q2 September 2021 over Q2 September 2020.
Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune.
Shares of Biocon gained 0.84% to Rs 364.20 while Sanofi India fell 0.27% to Rs 7,735.40 on BSE.
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