Sanofi Files Patent Suit Against Mylan Over Sanofi’s Top-Selling Drug LantusBy
Sanofi has filed a patent-infringement suit in a federal district court against Mylan for Sanofi’s top-selling drug, Lantus (insulin glargine). Lantus had 2016 sales of EUR 5.7 billion ($6.7 billion).
Sanofi alleges infringement of 18 patents in its suit. Sanofi said that the suit was triggered by notifications received from Mylan beginning in mid-September 2017 under which Mylan stated that it had filed a new drug application (NDA) ([505(b)(2) NDA]) with the US Food and Drug Administration (FDA) for insulin glargine prefilled pen and vial drug products. 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.
Sanofi said that the notification from Mylan also stated that its NDA included a Paragraph IV certification challenging all of the Sanofi patents then listed in the FDA Orange Book, which publishes all FDA-approved drug products with therapeutic equivalence, for Sanofi’s Lantus (insulin glargine injection, 100 units/mL) 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.
In August 2017, Sanofi filed a patent-infringement lawsuit in a federal district court for two patents regarding Lantus against Merck & Co. The suit was triggered by a notification received by Sanofi in late June 2017 in which Merck stated that it had filed a 505(b)(2) NDA with the FDA for an insulin glargine vial drug product.