FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

PTAB Begins IPR Review of Two Sanofi Patents

Dec. 26, 2017
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The PTO’s Patent Trials and Appeals Board launched an inter partes review of two patents for Sanofi’s Lantus insulin glargine injection following a challenge from Mylan.

Lantus was Sanofi’s leading product in 2016, with net global sales of $6.4 billion.

Mylan filed petitions against the patents in June, arguing they were obvious in light of prior art. The two patents cover acidic preparations of the insulin.

Mylan argued the Sanofi claims are unpatentable, and that any trained professional would know to lower an insulin solution’s pH to make it more stable.

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