Eli Lilly and Company reports that a federal district court has ruled in its favor in patent litigation over Alimta (pemetrexed for injection), used to treat certain types of lung cancer. The drug is one of the company’s top-selling products with 2018 global sales of $2.13 billion. 

The US District Court for the Southern District of Indiana ruled in favor of Lilly that the patent for the Alimta vitamin regime would be infringed by a competitor that had stated its intent to market alternative salt forms of pemetrexed prior to the patent’s expiration in May 2022. The ruling came in the case of Eli Lilly and Company v. Apotex Inc.

On August 9, 2019, the US Court of Appeals for the Federal Circuit Court ruled in favor of Lilly in appeals by Dr. Reddy’s Laboratories, Ltd. and. Hospira, Inc., affirming a June 2018 district court’s decisions finding infringement of Lilly’s patent under the doctrine of equivalents. 

The most recent ruling means Apotex will be prevented from launching its alternative salt form of pemetrexed until the patent expires. Lilly says it expects Apotex to appeal. 

In October 2017, the Patent Trial and Appeal Board of the US Patent and Trademark Office ruled in the company’s favor regarding patentability of the vitamin regimen for 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 was valid and would be infringed by the generic challengers’ proposed products, according to information from Lilly.

Source:  Eli Lilly and Company