Eli Lilly and Co. has won another patent-infringement lawsuit against a competitor who was preparing to launch an alternative form of the chemotherapy drug Alimta prior to its patent expiration in May 2022.
A federal judge in Indianapolis issued summary judgment Monday in favor of Indianapolis-based Lilly and against Canadian drugmaker Apotex Inc.
Alimta is used to treat cancer of the lung, chest and abdomen. It is Lilly’s third-best-selling drug, with global sales of $2.1 billion last year — behind only diabetes drugs Trulicity ($3.2 billion) and Humalog ($2.9 billion).
Apotex had won tentative approval from the Food and Drug Administration to sell a salt form of the drug, also known by its generic name, pemetrexed, for non-squamous non-small cell lung cancer in combination with chemotherapy drug cisplatin, and several other types of cancer.
Lilly filed a civil court action against Apotex in August 2017, claiming patent infringement and seeking to prevent the Canadian company from selling pemetrexed before Lilly’s patent expired in 2022. Apotex claimed that its version of the drug did not violate the patent.
Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana ruled that Apotex’s filing of a new drug application infringed at least 10 parts of Lilly’s patent. The ruling means Apotex will be prevented from launching its alternative salt form of pemetrexed until the patent expires.
In a statement, Lilly said it expects Apotex to appeal. Apotex did not immediately respond to IBJ for comment.
It’s the latest court decision in favor of Lilly on its Alimta patent. On Aug. 9, the U.S. Court of Appeals for the Federal Circuit Court ruled in favor of Lilly in appeals by Dr. Reddy’s Laboratories Ltd. and Hospital Inc., affirming the June 2018 district court’s decisions finding infringement of Lilly’s patent.
In October 2017, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled in Lilly’s favor regarding patentability of a vitamin regimen for Alimta — or using the drug in combination with vitamin B-12 injections.
In March 2014, the U.S. District 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 U.S. Court of Appeals affirmed the rulings in a unanimous decision in January 2017.
“Lilly’s extensive research to discover the Alimta vitamin regimen patent deserves intellectual property protection,” Michael Harrington, Lilly’s general counsel said in a written statement. “We depend on strong and effective intellectual property protection to support our investment in the next generation of breakthrough medicine.”