The U.S. Patent and Trademark Office ruled in Eli Lilly and Co.'s favor relating to the patentability of the vitamin regimen for chemotherapy drug Alimta.
In the inter partes review proceedings initiated by Neptune Generics LLC and Sandoz Inc., the Patent Trial and Appeal Board found that the claims of the vitamin regimen patent were valid.
Alimta would maintain U.S. exclusivity until May 2022 if the the patent is ultimately upheld through all remaining challenges, preventing marketing of generic products for as long as the patent remains in force.
In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent, and in August 2015 ruled in Lilly's favor regarding infringement of the vitamin regimen patent.
In January, 2017 the U.S. Court of Appeals for the Federal Circuit confirmed these rulings in a unanimous decision declaring the patent valid and that it would be infringed by the generic challengers' proposed products.