Eli Lilly and Company (NYSE:LLY) today announced that the U.S. District Court for the Southern District of Indiana ruled in favor of Lilly that the Alimta® (pemetrexed for injection) vitamin regimen patent would be infringed by a competitor that had stated its intent to market alternative salt forms of pemetrexed prior to the patent's expiration in May 2022.
The ruling came in the case of Eli Lilly and Company v. Apotex Inc.
"We are pleased with today's District Court ruling finding the Alimta vitamin regimen patent would be infringed by the competitor's proposed products," said Michael J. Harrington, Lilly's senior vice president and general counsel. "Lilly's extensive research to discover the Alimta vitamin regimen patent deserves intellectual property protection. We depend on strong and effective intellectual property protection to support our investment in the next generation of breakthrough medicines."
On August 9, 2019, the U.S. Court of Appeals for the Federal Circuit Court ruled in favor of Lilly in appeals by Dr. Reddy's Laboratories, Ltd. and. Hospira, Inc., affirming the June 2018 district court's decisions finding infringement of Lilly's patent under the doctrine of equivalents.
Today's ruling means Apotex will be prevented from launching its alternative salt form of pemetrexed until the patent expires. Lilly expects Apotex to appeal.
In October 2017, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled in the company's favor regarding patentability of the vitamin regimen for Alimta.
In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent. In August 2015, the same court ruled in Lilly's favor regarding infringement of the vitamin regimen patent. The U.S. Court of Appeals for the Federal Circuit confirmed these rulings in a unanimous decision in January 2017, finding the patent is valid and would be infringed by the generic challengers' proposed products.