Eli Lilly and Co. won a court ruling that will keep generic versions of the chemotherapy drug Alimta off the U.S. market until a patent expires in 2022.
Proposed versions by Teva Pharmaceutical Industries Ltd. and Fresenius SE’s APP Pharmaceuticals unit would infringe the patent, a federal judge in Indianapolis said Tuesday. The decision was posted on the court’s electronic docket. She ordered that regulatory approval not be granted until the patent term ends.
The patent covers a way of administering Alimta’s active ingredient, pemetrexed disodium, with vitamins to reduce side effects in patients undergoing treatment for lung cancer and mesothelioma. Teva and APP want to sell their versions with similar prescribing information.
Even though it would be patients taking the vitamins, the doctor is directing the patients’ actions based on the patented method, U.S. District Judge Tanya Walton Pratt said.
She said she couldn’t rule in favor of the generic-drug makers “upon the mere possibility that some patients might not follow their physician’s instructions.” The judge had upheld the validity of the patent last year.
Alimta is designed to hamper cancer cells’ ability to use folic acid to grow after an initial treatment with other drugs. The drug generated $1.24 billion in sales in the first half of the year for Indianapolis-based Lilly.
The patent on the drug’s active ingredient remains in force through 2017. Lilly said it was pleased with the ruling regarding the vitamin regimen.
“The significant scientific research that Lilly performed in support of the vitamin regimen patent deserves intellectual property protection,” Lilly General Counsel Michael Harrington said in a written statement.
Teva spokeswoman Denise Bradley said the company was disappointed by the decision and was considering an appeal.
Lilly announced the decision after the close of U.S. stock markets. Company shares fell 3 percent Tuesday, to $78.26 each.