[This story has been updated from an earlier version to include comments from Eli Lilly, and to include the diabetes alliance with Boehringer Ingelheim, under which the biosimilar was developed].
In a case of dueling patents, Sanofi said yesterday it filed a federal lawsuit alleging that four of its patents for Lantus® were infringed by Eli Lilly in the biosimilar version of the blockbuster diabetes drug it developed with Boehringer Ingelheim. The action effectively scuttles Lilly’s plan to market the biosimilar next year, and delays its entry to market by more than two years.
The lawsuit, filed by Sanofi in U.S. District Court for the District of Delaware, triggered an automatic stay under the Hatch-Waxman Act of approval by the FDA for the Lilly-Boehringer NDA for their biosimilar version of the insulin glargine product, LY2963016 for types 1 and 2 diabetes.
That stay will run either 30 months—until the summer of 2016—or whenever the court decides on the suit; however, such decisions rarely occur within 30 months.
Lilly responded to the lawsuit late this morning with a statement denying it did anything wrong.
“Lilly respects the intellectual property of others and does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents,” Doug Norman, vp and general patent counsel for Eli Lilly, said in a company statement.
Lilly designed the development program for LY2963016 as part of its diabetes alliance with Boehringer Ingelheim, launched in January 2011. The European Medicines Agency last year accepted for review the companies’ marketing authorization application for the biosimilar.
Lilly had hoped to market the biosimilar to Lantus in the U.S. soon after the U.S. patent on its active ingredient expires on February 12, 2015. Lilly filed an NDA for its Lantus biosimilar last month. That filing that included a Paragraph IV certification challenging six of seven Sanofi patents listed in the FDA Orange Book for Lantus and Lantus SoloStar®—as well as an assurance from Lilly it would not market its biosimilar before February 2015.
Lantus generated €4.203 billion (about $5.7 billion) for Sanofi in the first nine months of 2013, up 20% from a year earlier—almost as much as the €4.96 billion (about $6.7 billion) in sales racked up during 2012, up 19.3% from 2011. The company will report full-year 2013 results along with results for the fourth-quarter of last year on February 6.