Mylan Obtains Favorable PTAB Ruling for Insulin Drug

On December 12, 2018, Wilson Sonsini Goodrich & Rosati secured wins for Mylan against Sanofi in inter partes reviews at the Patent Trial and Appeal Board (PTAB), clearing a significant hurdle towards marketing of Mylan’s proposed long-acting insulin glargine vial product. The PTAB ruled in favor of Mylan, finding all claims of the two Sanofi Orange Book patents relating to Sanofi's Lantus vial product invalid for obviousness. In finding the claims obvious over the prior art, the PTAB noted that "the record supports that an ordinarily skilled artisan would not have suspected insulin glargine to behave differently than other insulins, due to the differences in amino acids between them, when exposed to hydrophobic surfaces."

Lantus is a prescription medicine indicated for improving glycemic control in adult patients with diabetes mellitus, with the vial product having sales of approximately $2.14 billion for the 12 months ending October 31, 2018. The two formulation patents had been set to expire in 2023.

The WSGR team representing Mylan in these matters includes partners Doug Carsten, Jeff Guise, and Nicole Stafford; Of Counsels Rick Torczon, Ellie Steiner, and Lori Westin; and associates Clark Lin, Art Dykhuis, Annie Tung, and Alina Litoshyk.