On March 10, Wilson Sonsini secured a major win for Mylan in its efforts to provide a lower cost alternative to Sanofi’s Lantus SoloSTAR insulin glargine product.  Following a week-long trial in December, Judge Chesler of the U.S. District Court of New Jersey ruled that the sole remaining device patent of the 16 initially asserted by Sanofi against Mylan’s proposed insulin glargine pen product was not infringed and invalid for lack of written description.

The Federal Circuit previously affirmed the invalidity of two Sanofi patents relating to Sanofi’s Lantus vial product, upholding decisions from the Patent Trial and Appeal Board (PTAB).  This decision brings Mylan closer to marketing its proposed insulin glargine products to meet unmet patient needs, pending final approval from the FDA.

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, with Sanofi’s vial and pen products having sales of approximately $1.73B and $4.24B, respectively, for the 12 months ending January 31, 2020.

The Wilson Sonsini team representing Mylan in this matter included associate Tasha Thomas.