Mylan Beats Sanofi On Lantus Patent

Company Ready To Launch Insulin Glargine Upon FDA Approval

A US district court has ruled in favor of Mylan in a dispute with Sanofi over a Lantus SoloStar device patent, with the patent protecting the insulin glargine injector pen found to be invalid and not infringed. Mylan, along with partner Biocon, expects to launch its Semglee version mid-year, following FDA approval.

Lantus
A Lantus SoloStar device patent has been found not infringed and invalid for lack of written description • Source: Shutterstock

A US district court in New Jersey has ruled in Mylan’s favor as part of a dispute with Sanofi over its Lantus SoloSTAR (insulin glargine) device. The court found that claims of US device patent 9,526,844, asserted by Sanofi against Mylan’s Semglee insulin glargine product and Vystra device, were not infringed and were invalid for lack of written description. However, the court found that Mylan had failed to demonstrate that the patent was invalid for obviousness.

Specifically, the district court was not persuaded by Sanofi’s argument that Mylan’s Vystra device infringed a limitation contained in claim...

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