Eli Lilly and Company has announced that the Patent Trial and Appeal Board of the US Patent and Trademark Office (PTO) has ruled in the company's favour regarding patentability of the vitamin regimen for Alimta (pemetrexed for injection).

In the inter partes review (IPR) proceedings initiated by Neptune Generics, LLC and Sandoz Inc., the US PTO found that the claims of the vitamin regimen patent are valid. 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.

"We are pleased with today's ruling by the US PTO finding the claims of the Alimta vitamin regimen patent are valid," said Michael J. Harrington, senior vice president and general counsel for Lilly. "This ruling largely confirms the earlier decision of the district court which was affirmed on appeal by a unanimous court."

Harrington continued, "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."

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. The US 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.