A U.S. administrative court has rejected arguments by Indianapolis-based Eli Lilly and Co. challenging the validity of another manufacturer’s patents for a migraine treatment drug.
On Tuesday, the Patent Trial and Appeal Board upheld the validity of three Teva Pharmaceutical Industries Ltd. patents on its migraine treatment Ajovy. The ruling helps protect Israel-based Teva’s patents for Ajovy, which was approved by the Food and Drug Administration in 2018.
A few months later, the FDA approved Lilly’s competing migraine treatment, Emgality. Teva then sued Lilly for infringing its patents, a case that’s still pending.
In return, Lilly asked the Patent Trial and Appeal Board, a court ruled by the U.S. Patent and Trade Office, to reconsider whether the Teva patents were even valid.
California-based Amgen Inc., Teva and Lilly all were developing migraine treatments simultaneously, each receiving approval from the FDA within months of each other in 2018.
Each of the drugs is part of a class called CGRP inhibitors, which are antibodies that bind to a chemical involved in pain transmission. In its petition to the Patent Trial and Appeal Board, Lilly had argued CGRP was a clinically validated target for treating migraines before TEVA filed its patents.
Teva hopes to use sales from Ajovy to help repay its debt and turn around the company. Analysts estimates compiled by Bloomberg when Ajovy received regulatory approval in 2018 showed the medication could generate around $500 million in sales by 2022.
For Lilly, Emgality is expected to break $700 million in sales by that year, according to data compiled by Bloomberg. Lilly has been pushing hard over the years to break into the headache and pain drug sector.
A Lilly spokesman did not immediately respond to IBJ’s request for comment.
A Teva spokeswoman told Reuters that the company was pleased with the outcome and called the ruling a “testament to the strength of Teva’s intellectual property.”