FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi Loses Two Patents for Blockbuster Insulin Drug

Dec. 21, 2018
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The PTO’s Patent Trial and Appeal Board invalidated two patents for Sanofi’s cash cow Lantus (insulin glargine) siding with Mylan in its inter partes review proceedings.

Mylan challenged the formulation patents in June 2017, when it filed petitions arguing that they were obvious in light of prior art and that trained professionals would know to lower an insulin solution’s pH in order to stabilize it. The company contended the only difference between Sanofi’s brand name, patent-bearing drug and previous insulin glargine formulations was an additional, well-known compound that kept the insulin well-mixed.

In October 2017, Sanofi launched patent infringement litigation against Mylan’s NDA for generic versions of its Lantus vials and disposable injection pens.That litigation is still pending, with no trial date assigned.

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