Mylan Announces IPR Proceedings Against Sanofi's Lantus Patents

Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus. The patents being challenged, US Patents number 7,476,652 and number 7,713,930, relate to formulation. Mylan filed the petitions for IPR of these patents in June 2017.

Mylan’s New Drug Application (NDA) for a follow-on insulin glargine product, in both vial and pen dosage presentations, is currently under review by the FDA. (In the United States, insulins are currently regulated as drugs and not as biologics; hence, drug makers must submit NDAs, rather than biologics license applications, for follow-on versions of originator insulin products.) Announcement of the IPR proceedings follows an October 2017 lawsuit, filed against Mylan by Sanofi, alleging that Mylan has infringed on 18 of the patents that cover Lantus. The October suit was triggered by Mylan’s submission of its NDA.

Heather Bresch, CEO of Mylan, said in a statement, "The PTAB's decision to institute IPR proceedings against the [2] Orange Book-listed patents for Lantus is another step forward in our ongoing efforts to bring an interchangeable insulin glargine to diabetes patients as soon as possible.” She added, “There are more than 29 million people in the [United States] living with diabetes who deserve access to more affordable treatment options. As a leading producer of oral diabetes medicines, we are deeply committed to this patient community and believe bringing lower-cost alternatives…will fulfill a critical medical need."

The instituted petition for IPR proceedings could help clear the way for Mylan to launch its yet-to-be-approved insulin product as a challenger to the high-earning Lantus. Mylan estimates that total sales for Lantus and Lantus SoloSTAR (a pen presentation of Lantus) for the 12 months ending on October 31, 2017, were approximately $2.74 billion and $4.98 billion, respectively.

Already competing for the US insulin glargine market is Boehringer Ingelheim’s (BI) Basaglar, the first FDA-approved insulin glargine follow-on product. Basaglar launched in the United States in 2016 after BI concluded a lengthy litigation with Sanofi over its Lantus patents. Since its launch, competition from Basaglar has produced declines in Sanofi’s share of the insulin market; in the second quarter of 2017; Sanofi’s US sales of Lantus and Toujeo (another Sanofi insulin glargine product) slipped by 23.9%. Sanofi attributed its reduced sales to the exclusion of Lantus from commercial formularies, such as those of CVS Health and UnitedHealthcare. In addition, European sales of insulin glargine sank by 2% after to competition from approved European biosimilar insulins.