US Patent Office Rules Sanofi's Formulation Patents on Multibillion-Dollar Lantus Invalid

Mylan announced the U.S. Patent and Trademark Appeal Board (PTAB) has ruled in favor of Mylan in its inter partes review (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 (NDA) for generic versions of Lantus and Lantus SoloSTAR, co-developed with Biocon, is under active review by the U.S. Food and Drug Administration.

"For years, Mylan has been investing in the development of a more affordable generic to insulin glargine for diabetes patients," Mylan CEO Heather Bresch said. The PTAB's favorable ruling that invalidates two Sanofi Lantus® formulation patents is an important step forward in our journey to help address the needs of nearly 30 million Americans living with diabetes. We take seriously the responsibility to improve insulin access and are honored to be a part of the solution that will bring much-needed competition to this critical market."

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.

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