Eli Lilly And Company Responds To Sanofi Lawsuit

By Ed Miseta, Chief Editor, Clinical Leader

This morning brought news that Eli Lilly and Co is being sued by Sanofi, a drug manufacturer based in France. The lawsuit alleges patent infringement on four of its patents relating to Lantus, the company’s popular treatment for diabetes. The lawsuit is expected to delay the launch of Lilly’s version of the treatment. Lilly applied to the FDA for permission to sell a biosimilar version of Lantus about a month ago.

With annual worldwide sales of over $6 billion, Lantus is the most prescribed insulin product in the world, but is set to come off patent in the U.S. in 2015. Analysts from Citigroup note the delay may provide increased pricing power for Sanofi.

In a statement issued by Eli Lilly regarding the lawsuit, the company states it respects the intellectual property of others and does not believe the application filed for its glargine product infringes any of the alleged patents.

According to the statement, “Under the Hatch-Waxman act, the initiation of the lawsuit automatically invokes a stay on FDA approval of the product for a period of 30 months, or until a court finds in favor of Lilly, whichever is sooner.  It is too early to speculate whether a resolution would occur before the end of the 30-month litigation stay in mid-2016.”