Sanofi Sues Mylan Over Infringement of Lantus Patents

This week, drug maker Sanofi filed a patent infringement suit against Mylan in a New Jersey district court. Sanofi’s suit alleges that Mylan has infringed on 18 patents for its originator insulin glargine, Lantus.

The suit was triggered by Mylan’s filing of a New Drug Application (NDA) with the FDA for a pre-filled pen and a drug vial presentation of a follow-on insulin glargine (in the United States, insulins are regulated as drugs and not as biologics; hence, drug makers must submit NDAs rather than biologics license applications for follow-ons of originator products). According to Sanofi, the Mylan NDA included a challenge to all of Sanofi’s patents listed for Lantus in the FDA’s orange book.

Mylan’s filing of an NDA for its proposed insulin glargine follows the recent release of data demonstrating comparable efficacy, safety, and immunogenicity with Lantus, as well as the follow-on’s pharmacokinetic and pharmacodynamic equivalence with the reference drug. Mylan, working together with India-based partner Biocon, is also seeking European approval for its product; in September, Biocon received a certificate of compliance from the European Union for its manufacturing facility in Malaysia where it plans to produce the insulin. Approval of the facility was welcome news for Biocon; high operational costs related to the Malaysian facility had been partially responsible for a 51% drop in Biocon’s second-quarter net profits, despite the company’s strong sales of insulins.

Sanofi faces challenges from other drug developers who seek a share of the Lantus market; in July, the FDA granted Merck’s follow-on insulin glargine a tentative approval, but will not provide the drug with a final approval until patent litigation, brought by Sanofi, has concluded. Sanofi’s suit triggered an automatic stay of 30 months.

Already on the US market is Boehringer Ingelheim’s (BI) Basaglar, the first FDA-approved insulin glargine follow-on, which launched in 2016 after a lengthy patent litigation with Sanofi. Competition from Basaglar led to steep declines in insulin market share for Sanofi in the second quarter of 2017; Sanofi’s US sales of Lantus and Toujeo (a second insulin glargine) dropped by 23.9%. CEO Oliver Brandicourt has alerted investors that the company’s fortunes were unlikely to change in the remainder of 2017, and warned that the company could see accelerated declines in sales of its insulins as it faced further competition.