Sanofi announced that it filed a patent infringement suit against Merck Sharp & Dohme Corp. (“Merck”) on September 16, 2016 in the United States District Court for the District of Delaware. In its suit Sanofi alleges infringement of ten patents.
The suit was triggered by a notification received from Merck in early August, in which Merck stated that it had filed an NDA (505(b) New Drug Application) with FDA for an insulin glargine drug product. Merck also stated that its NDA included a paragraph IV certification challenging all of the ten Sanofi patents listed in the FDA Orange Book for Sanofi’s Lantus® and Lantus® SoloStar® products.
