Biocon gains as partner receives favourable ruling from PTAB

Biocon rose 1.89% to Rs 361.40 after the company's partner Mylan received favourable ruling from the United States Patent and Trademark Appeal Board (US PTAB) on Sanofi's four device patents for Lantus SoloSTAR.

Biocon today announced that the U.S. Patent and Trademark Appeal Board (PTAB) has ruled in favour of Mylan, Biocon's partner in inter partes review (IPR) proceedings finding all challenged claims of Sanofi's Lantus SoloSTAR device patents unpatentable.

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 U.S. Food and Drug Administration.

The PTAB also found Sanofi's proposed amended claims for the '486 and '844 patents unpatentable.

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).

Sanofi's total IQVIA sales for the 12 months ending 31 March 2020, were approximately $1.71 billion for Lantus 100 Units/mL and about $4.32 billion for Lantus SoloSTAR.

Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Insulin Glargine is one of the 11 biologic products being codeveloped by Mylan and Biocon Biologics for the global marketplace. Biocon Biologics is a subsidiary of Biocon.

Dr Christiane Hamacher, CEO & Managing Director, Biocon Biologics said our partner's New Drug Application (NDA) for Semglee is under active review by the U.S. FDA and thisfavourable ruling further clears the path for the anticipated launch of our Glargine in the U.S. in mid-CY20.

Biocon is a global biopharmaceuticals company. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.

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