U.S. Court of Appeals Rules In Lilly’s Favor on Alimta Vitamin Regimen Patent

Indianapolis, Indiana – The U.S. Court of Appeals for the Federal Circuit has upheld the district court’s decision and ruled in favor of Eli Lilly regarding validity and infringement of the vitamin regimen patent U.S. Patent No. 7,772,209 for Alimta® (pemetrexed for injection).

In the case of Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et al., the court affirmed the earlier district court’s rulings that the vitamin regimen patent is valid and would be infringed by the generic challengers’ proposed products. If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force. The Alimta compound patent remains in force through January 24, 2017.

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.

“We are pleased with today’s ruling by the Court of Appeals, affirming the earlier district court’s decisions, finding the Alimta vitamin regimen patent is valid and would be infringed,” said Michael J. Harrington, senior vice president and general counsel for Lilly. “The significant scientific research that Lilly performed in support of the vitamin regimen patent deserves intellectual property protection, which has been confirmed in every validity challenge to date. We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. These rights help support the development of the next generation of innovative medicines to treat unmet medical needs.”

The case was before Chief Judge Sharon Prost, Judge Pauline Newman and Judge Timothy B. Dyk in Appellate Court Case No. 2015-2067. Chief Judge Prost wrote the opinion.

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