Last week, Sanofi-Aventis U.S. LLC filed a complaint against Merck Sharp & Dohme Corp. over its proposed biosimilar to Lantus (insulin glargine injection). The complaint asserts that Merck will infringe 10 different U.S. patents with its biosimilar 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.