The German Federal Supreme Court has granted the appeal by Eli Lilly and Company in the case of Eli Lilly and Company v. Actavis, vacating the prior decision denying infringement. The German Supreme Court returned the case to the Court of Appeal (Dusseldorf) for further proceedings. The case concerns whether Lilly’s vitamin regimen patent for Alimta (pemetrexed disodium) would be infringed by a generic competitor that had stated an intention to market a dipotassium salt form of pemetrexed in Germany.

“We are pleased with the ruling by the German Federal Supreme Court granting our appeal regarding infringement of Alimta’s vitamin regimen patent in Germany,” said Michael J. Harrington, senior vice president and general counsel for Lilly, in a company statement. “This ruling supports our continuing belief 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.”

The separate infringement proceeding and validity challenge with Hexal AG will continue unaffected by this ruling. The preliminary injunction against Hexal was confirmed by the German Court in late May 2016 and will stay in force pending any further appeal by Hexal and the outcome of the cases on the merits. The separate infringement proceedings with ratiopharm GmbH should continue, taking this ruling into account, according to Lilly.

In major European countries, the compound protection for Alimta expired in December 2015. The patent protection for the Alimta vitamin regimen will expire in June 2021.

Alimta was Lilly’s second highest selling drug in 2015 with sales of $2.49 billion.

Source: Eli Lilly and Company