Eli Lilly and Company has announced that the US court of appeals for the federal circuit has upheld the district court's decision and ruled in the company's favour regarding validity and infringement of the vitamin regimen patent for Alimta (pemetrexed for injection).
In the case of Eli Lilly and Company versus Teva Parenteral Medicines, 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 US 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 US 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."ith discovery to make life.