Eli Lilly and Company has won a victory in litigation initiated by Novartis’ generic arm, Sandoz, and Neptune Generics, a specialty and generics pharmaceutical company, regarding patentability of Lilly’s vitamin regimen for Alimta (pemetrexed for injection), a lung cancer drug, with 2016 sales of $2.3 billion.

In an inter partes review proceedings initiated by Neptune Generics and Sandoz, the US Patent and Trademark Office 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, according to Lilly.

Lilly has faced multiple patent-infringement cases in reference to Alimta. 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.

In another case, in June 2015, a UK Court of Appeal ruled that the Alimta vitamin-regimen patent would be indirectly infringed when the generic product is reconstituted or diluted in saline, but not directly infringed under the doctrine of equivalents. Following this decision, Actavis launched pemetrexed Armisarte, previously pemetrexed Actavis, at risk. The UK Supreme Court found the Actavis product infringing, regardless of the diluent used in reconstitution or dilution in the case of Actavis v. Eli Lilly and Company.

Source: Eli Lilly and Company