On August 8, Sanofi-Aventis filed a complaint for patent infringement against Merck Sharp & Dohme in the U.S. District Court for the District of New Jersey regarding Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and Lantus® SoloSTAR® ([rDNA origin] insulin glargine) subcutaneous injection vial products.  The complaint alleges infringement of two patents: U.S. Patent Nos. 7,476,652 (“the ’652 patent”) and 7,713,930 (“the ’930 patent”).  The case has been docketed as Civil Action No. 2:17-cv-05914-SRC-CLW.

Whereas this new case involves Merck’s vial presentation of these insulin glargine products, Sanofi-Aventis separately sued Merck this past September in the District of Delaware for allegedly infringing 10 patents, including the ’652 and ’930 patents, based on Merck’s proposed prefilled cartridge presentation of these products.  According to Sanofi-Aventis’s new complaint filed last week, Merck has submitted a separate NDA seeking approval of the vial product prior to the expiration of the ’652 and ’930 patents. The cartridge case (Civil Action No. 16-812-RGA-MPT (D. Del.)) is currently in fact discovery and claim construction proceedings.

In June, Merck filed petitions for inter partes review of the ’652 patent (IPR2017-01526) and the ’930 patent (IPR2017-01528), which are pending decisions on the institution.

Stay tuned to the Big Molecule Watch for further updates.