Eli Lilly said the Patent Trial and Appeal Board of the US Patent and Trademark Office (PTO) ruled in the company’s favor regarding patentability of the vitamin regimen for Alimta, which used to treat some lung cancers and mesothelioma.
“In the inter partes review (IPR) proceedings initiated by Neptune Generics, LLC and Sandoz Inc., the U.S. PTO found that the claims of the vitamin regimen patent are valid,” said Lilly.
“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.”
Alimta is Lilly’s third biggest-selling drug, accounting for $2.28 billion of its $21.22 billion of revenue last year, according to Reuters.
Lilly general counsel Michael Harrington said: “We are pleased with today’s ruling by the U.S. PTO finding the claims of the Alimta vitamin regimen patent are valid.
“This ruling largely confirms the earlier decision of the district court which was affirmed on appeal by a unanimous court …
“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.”
Lilly said that in March 2014, the US Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent.
It said that in August 2015, the same court ruled in Lilly’s favor regarding infringement of the vitamin regimen patent.
Lilly said 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.”