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Firm Secures Federal Circuit Ruling for Mylan in Insulin Glargine Appeals
Client Highlights
December 29, 2021

On December 29, 2021, Wilson Sonsini secured another win for Mylan as the U.S. Court of Appeals for the Federal Circuit affirmed eight decisions from the Patent Trial and Appeal Board (PTAB) holding patent claims for five Sanofi device patents unpatentable. Sanofi had asserted the patents against Mylan in the U.S. District Court for the District of New Jersey. Both the district court and the PTAB held the claims unpatentable, leading to 11 appeals consolidated into four groups. The Federal Circuit heard argument in a marathon session on December 6, 2021, and issued short but strong opinions on December 29 categorically rejecting Sanofi's arguments in eight PTAB appeals and dismissing the remaining appeals as moot in view of the affirmances. 

This latest success follows previous wins against Sanofi's insulin glargine formulation patents. Insulin glargine is used to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. In November, Viatris launched branded and unbranded versions of insulin glargine, the first-ever interchangeable biosimilar.

Wilson Sonsini represents Mylan in patent matters, including those related to this litigation. The team representing Mylan in these appeals includes Rick Torczon, Ellie Steiner, Tasha Thomas, Wes Derryberry, and Steffen Johnson​.

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