- U.S.-based Eli Lilly has been trying to defend its patents associated with the vitamin regimen that accompanies use of Alimta (pemetrexed), which is used to treat lung cancer.
- Lilly has alleged that Allergan (formerly Actavis) will be infringing its patent if it markets its generic version of pemetrexed, along with instructions to dilute its vitamin regimen with dextrose solution instead of saline solution.
- The UK High Court has determined that the patent would not be infringed due to these instructions. This decision affects how the drug can be marketed in the U.K., France, Italy and Spain.
Alimta's basic patents expired in December 2015 in most of the E.U. However, in June 2015, an appeals court in the U.K. determined that Lilly's patent would be indirectly infringed if certain alternate salt forms of pemetrexed were used with instructions to dilute the accompanying vitamin regimen with saline solution. Therefore, a separate trial was needed to address the issue of using a different dilutant.
Lilly, of course, disagrees with the decision and will attempt to have the decision appealed. "We strongly disagree with the ruling by the U.K. High Court," said the company's general counsel Michael Harrington in a statement.
Even though the patent on Alimta has expired, the patents on the vitamin regimen are in force until June 2021. And Lilly's incentives here are clear: Alimta brought in sales of $375 million in the four markets affected in the court ruling.
The company has also had better luck in the U.S., where a federal court last year ruled that a similar Alimta-plus-vitamins regimen being hawked by Teva infringed on Lilly's patent.