The U.K. Supreme Court has handed Eli Lilly a huge patent victory for its cancer drug Alimta in a battle with Actavis, protecting some European sales of the blockbuster for another four years. It also represents a stunning loss for Actavis, now owned by Teva, which launched its generic several years ago at risk.
The Indianapolis, Indiana-based company today said that the U.K. Supreme Court found the Actavis “alternative salt forms of Alimta” directly violated Lilly's patent for Alimta in combination with vitamins in the U.K., France, Italy and Spain. It also upheld a lower court ruling in its favor of an indirect infringement of its vitamin regimen patent.
Lilly pointed out the court ruled Alimta was protected regardless of whether a generic used a different diluent than the Lilly regimen.
The reasoning behind its findings won’t be known until the court posts them next week, but Lilly was ready today to declare its victory.
"While we do not yet know the court's reasoning, we are pleased with the UK Supreme Court's key conclusions that confirm the Alimta vitamin regimen patent would be infringed by these generic pemetrexed products in the U.K., France, Italy and Spain prior to June 2021," said Michael J. Harrington, Lilly general counsel, in a statement.
"We are disappointed with the U.K. Supreme Court's decision," Teva spokeswoman Denise Bradley said in an email. "We have not fully reviewed the decision, therefore we are unable to comment further."
While the drug generates about $1.2 billion in sales outside of the U.S., the ruling affects about $300 million in sales in the countries where it applies, according to Evercore ISI analyst Umer Raffat.
A Lilly spokeswoman said that Lilly "generally will seek damages for infringing product launches," but that it was too early to say what that amount might be.
Actavis launched its pemetrexed Armisarte in June 2015 after the U.K. Court of Appeal ruled that the Actavis product did not directly step on Lilly’s patent under the doctrine of equivalents. But it also ruled that the patent would be indirectly violated when Actavis product is reconstituted or diluted in saline.
Used to treat advanced non-small cell lung cancer and mesothelioma, Alimta is a top seller for the drugmaker, pulling in about $2.3 billion in 2016 pretty evenly split between the U.S. and the rest of the world.
Lilly has been fighting off Alimta generics on battlefronts around the world with mixed results. In 2015, it lost a similar patent fight with Actavis in Germany. Earlier this year, in a patent tussle with Teva, a U.S. appeals court rescued Alimta from generics until 2022. However, Lilly still faces an inter partes review of the drug’s patents in the U.S., which should be decided this month.