Sanofi has filed a patent-infringement lawsuit for two patents against Merck & Co. in a federal district court regarding Sanofi’s top-selling product, Lantus (insulin glargine), which had 2016 sales of EUR 5.7 billion ($6.7 billion).

The suit was triggered by a notification received by Sanofi in late June 2017 in which Merck stated that it had filed a new drug application ([505(b)(2) NDA]) with the US Food and Drug Administration (FDA) for an insulin glargine vial drug product. A 505 (b)(2) NDA is a pathway created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. It applies to various uses, including changes in dosage form, strength, route of administration, formulation, dosing regimen, or indication.

Merck also stated that its NDA included a Paragraph IV certification challenging all of the Sanofi patents listed in the FDA Orange Book, which publishes all FDA-approved drug products with therapeutic equivalence, for Sanofi’s Lantus and Lantus SoloStar products. A Paragraph IV certification refers to the certification required of an applicant that patents in question are invalid or are not infringed by the applicant’s product.

Source: Sanofi