Home >Companies >News >Biocon partner Mylan gets favourable ruling in insulin device patent row
The US Food and Drug Administration is currently reviewing Biocon and Mylan’s application for Semglee
The US Food and Drug Administration is currently reviewing Biocon and Mylan’s application for Semglee

Biocon partner Mylan gets favourable ruling in insulin device patent row

  • Sanofi had challenged that Mylan’s device for insulin glargine product Semglee infringed the company’s patents for Lantus SoloSTAR
  • Sanofi’s Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes

NEW DELHI: Biocon Ltd’s biologics partner Mylan received a favourable ruling from the US Patent and Trademark Appeal Board (PTAB) in its dispute with Sanofi over four patents of their insulin injection pen.

Sanofi had challenged that Mylan’s device for insulin glargine product Semglee infringed the company’s patents for Lantus SoloSTAR. The PTAB, however, found Sanofi’s claims unpatentable.

Sanofi’s 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, and the company sells the product in vials under the brand Lantus and disposable injection pens under the brand Lantus SoloSTAR.

The US Food and Drug Administration is currently reviewing Biocon and Mylan’s application for Semglee.

“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. Our partner’s new drug application (NDA) for Semglee is under active review by the US FDA and this favourable ruling further clears the path for the anticipated launch of our Glargine in the U.S. in mid-CY20 (2020)," Christiane Hamacher, chief executive officer and managing director of Biocon Biologics India, was quoted as saying in a release.

The company said the positive patent review developments will aid greater competition in the US insulin market and rationalise the cost of therapy.

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