Last week, Sanofi-Aventis U.S. LLC filed a complaint against Merck Sharp & Dohme Corp. over its proposed follow-on biologic to Lantus (insulin glargine injection). The complaint asserts that Merck will infringe 10 different U.S. patents with its follow-on biologic product. According to the complaint, Merck has submitted an NDA seeking FDA’s approval to market an insulin glargine [rDNA origin] in a pre-filled delivery device for subcutaneous injection. We previously posted about Merck’s NDA here.
The case is Civil Action No. 16-00812 (D. Del.) and has been assigned to Judge Andrews.
Stay tuned to Big Molecule Watch for more updates as this litigation progresses.