German court rules against Eli Lilly in Alimta patent case

The German Court of Appeal has ruled that Indianapolis-based Eli Lilly’s European “vitamin regimen” patent for lung cancer injection Alimta (pemetrexed disodium) would not be infringed by Actavis’s generic version.

The court overturned an April 2014 ruling from the Regional Court of Düsseldorf.

Eli Lilly’s patent covers the administration of Alimta with vitamin B12 and folic acid.

Actavis sought to make a generic version of Alimta for administration with vitamin B12 and folic acid when Eli Lilly’s European patent covering the compound expires, in December 2015.

After Actavis filed for a declaration of non-infringement in the UK, France, Germany, Italy and Spain, Eli Lilly filed a counter-claim concerning the “threatened” infringement of the patent.

The Düsseldorf court then issued an injunction against Actavis to stop it from infringing the patent.

Michael Harrington, Eli Lilly’s senior vice president and general counsel, said of the latest decision: “We strongly disagree with the ruling by the German Court of Appeal regarding Alimta’s vitamin regimen patent.

“Although Alimta's compound patent remains in force and is expected to provide exclusivity in Germany through [to] December 2015, we continue to believe that Alimta’s vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms, in Europe prior to June 2021.”

He added that Eli Lilly will seek permission to appeal against the ruling to the German Supreme Court (Bundesgerichtshof).

In May last year, the English High Court made a similar ruling to the German Court of Appeal, finding that Eli Lilly’s European patent covering the Alimta vitamin dosage regimen would not be infringed by generic competitors.

Eli Lilly’s appeal against this decision is still pending and is scheduled for hearing today (March 9) at the UK Court of Appeal.

A spokesperson for Actavis told LSIPR that the company was happy with the court's decision but that it could not comment further.