Mylan : Sanofi' Formulation Patents On Lantus Invalidated By U.S. Patent Office

(RTTNews) - Mylan N.V. (MYL) announced that the U.S. Patent and Trademark Appeal Board or PTAB has ruled in favor of Mylan in its inter partes review or IPR proceedings and found all claims of Sanofi's Lantus (insulin glargine 100 Units/mL) formulation patents (U.S. Patent Nos. 7,476,652 and 7,713,930) 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). Mylan's 505(b)(2) New Drug Application for generic versions of Lantus and Lantus SoloSTAR, co-developed with Biocon, is under active review by the U.S. Food and Drug Administration.

In October 2017, Sanofi initiated patent infringement litigation against Mylan's NDA in the United States District Court for the District of New Jersey that includes these two formulation patents listed as covering Lantus as well as other patents listed as covering the Lantus SoloSTAR injection pen. That litigation is pending, and no trial date has been set.

Sanofi's total IQVIA sales for the 12 months ending Oct. 31, 2018, were approximately $2.14 billion for Lantus 100 Units/mL and about $4.39 billion for Lantus SoloSTAR.