Big Molecule Watch
May 31, 2018

Trial Begins in Insulin Glargine Follow-On Biologics Litigation

On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware.  As we reported here, Sanofi had sued Merck for patent infringement based on Merck’s proposed follow-on versions of Sanofi’s Lantus® and Lantus® SoloSTAR® ([rDNA origin] insulin glargine) prefilled cartridge products.  As we reported here, Merck’s motion for summary judgment of non-infringement on the grounds of patent exhaustion and implied license was denied.

On the same day that trial began, Judge Andrews issued an order directing entry of a Judgment of Non-infringement as to U.S. Patent No. 9,604,008 and U.S. Patent No. 9,526,844 and dismissal of Merck’s Counterclaims 12 and 22 challenging the validity of these patents.  The parties had jointly stipulated to a judgment of non-infringement of these patents and dismissal of the counterclaims.

Closing arguments are scheduled to be heard on June 4.


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