Court Upholds Patent for Lilly’s Blockbuster Vitamin Regimen

Eli Lilly and Company has received a favorable ruling from the US Court of Appeals for the Federal Circuit, which upheld a federal district court’s decision regarding validity and infringement of the vitamin regimen patent for Alimta (pemetrexed for injection), an anti-cancer drug.

In the case of Eli Lilly and Company versus Teva Parenteral Medicines, Inc., et al., the court affirmed an 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.

Alimta was approved by the US Food and Drug Administration in 2004 and is indicated for treating mesothelioma in combination with cisplatin and for treating non-small cell lung cancer as a single agent. The drug is one of Lilly’s top-selling products with approximately $2.5 billion in 2015 sales.

Source: Eli Lilly and Company 

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