New Delhi: Biotechnology major Biocon on Monday said the US patent authority has ruled in favour of its partner Mylan for four device patents of Sanofi’s Lantus SoloSTAR. The favourable ruling in inter-parts review proceedings by the Patent and Trademark Appeal Board (PTAB) would pave the way for launch of insulin product Glargine in the US, Biocon said in a filing to BSE.
“We are extremely pleased with the US PTAB’s ruling in favour of our partner Mylan for four device patents of Sanofi’s Lantus SoloSTAR. This strengthens our resolve to provide a high quality affordable Insulin Glargine to diabetic patients in the US and generate savings for their healthcare system,” Biocon Biologics CEO and MD Christiane Hamacher said.
A new drug application (NDA) of Biocon’s partner for Semglee is under active review by the USFDA and this favourable ruling further clears the path for the anticipated launch of our Glargine in the US in mid-CY2020, she added.
The Patent and Trademark Appeal Board found all challenged claims of Sanofi’s Lantus SoloSTAR device patents — US Patent Nos. 8,603,044, 8,992,486, and 9,526,844 unpatentable in inter-partes review (IPR) proceedings, Biocon said.
“The PTAB found three claims of the 9,604,008 patent unpatentable, and two claims to be patentable. However, Mylan and Biocon have previously obtained a covenant not to sue from Sanofi on the ‘008 patent and therefore this ruling does not impact Biocon and Mylan’s ability to commercialize Semglee (insulin glargine) upon final approval from the US Food and Drug Administration,” it added.
“Once approved and commercialized our co-developed Semglee will expand access to insulin therapy,” it added.
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, the filing said.
Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR), it added.
“Sanofi’s total IQVIA sales for the 12 months ending March 31, 2020, were approximately USD 1.71 billion for Lantus 100 Units/mL and about USD 4.32 billion for Lantus SoloSTAR,” the filing said.
Shares of Biocon Ltd were trading at Rs 370.35 per scrip on BSE, up 4.41 per cent from the previous close.
