High-stakes dispute between Lilly, competitor over migraine drugs winding down

Two months after a federal judge overturned a $176 million jury verdict against Eli Lilly and Co in a patent infringement lawsuit, the dispute seems to be winding down. 

Indianapolis-based Lilly and Israel-based Teva Pharmaceuticals told a federal judge last week they would dismiss a related patent case with prejudice, meaning it cannot be refiled. 

The two companies have been battling for years over patents for migraine headache drugs—Emgality for Lilly and Anjovy for Teva. Both drugs are once-monthly injections and were approved 13 days apart in September 2018 and have a similar mechanism of action. 

The competition in the multi-billion-dollar migraine market has been intense ever since. Teva’s drug was approved first, which gave the company a head start on Lilly. About two weeks later, the Food and Drug Administration approved Lilly’s drug.  

The stakes are high for both companies. Lilly rang up worldwide sales of $650 million last year for Emgality, while Teva sold $377 million worth of Anjovy. Pain medications are the “next chapter of growth” for Lilly, CEO David Ricks told investors in early 2018. 

The legal tussle between the two companies has been going on for years, with Lilly and Teva filing claims and counterclaims over various patents. 

Teva had argued that its corporate affiliate, Labrys Biologics Inc., had made a major breakthrough in research for migraine treatment, and its biologic product with an active ingredient, fremanezumab, was covered by numerous patents. 

Lilly contended that the antibody in its Emgality drug differed from Anjovy’s antibody. It added that Teva’s patent claims were too broad, attempting to cover all antibodies in a class that could be discovered for treating headaches. 

In November 2022, a federal jury in Massachusetts found for Teva and awarded it $36.7 million in royalty damages, $90 million in lost profits and $49.8 million in future lost profits. 

Ten months later, in September 2023, Judge Allison D. Burroughs of U.S. District Court in Massachusetts covered that decision in a 55-page ruling. She said that even viewing the evidence “in the light most favorable to the verdict,” the evidence was insufficient for Teva to claim the entire class of drugs for the treatment of headaches. 

“The court does not reach this decision nor overturn a jury verdict lightly,” she said. 

Teva has since appealed the judge’s ruling that the patents in that case were invalid, according to Reuters. 

In 2021, Teva filed a separate lawsuit accusing Lilly of infringing two patents related to Teva’s migraine drug. Earlier this year, the U.S. Patent Trial and Appeal Board issued a ruling holding that invalidated the Teva patents at issue.  

The Patent office found that Teva’s two patents were invalid based on earlier publications that disclosed the same methods for treating migraines with antibodies, Reuters reported last week. 

“Teva agrees not to sue, assert any claim, or otherwise participate in any action or proceeding against Lilly or any affiliates for infringement of the Teva patents” concerning the migraine drugs, according to the court filing. 

Lilly told IBJ on Monday that the company had no comment.