A German Court of Appeal has ruled that Eli Lilly and Company’s vitamin regimen patent for its cancer drug, Alimta (pemetrexed disodium), would not be infringed by a generic competitor that intends to market a dipotassium salt form of pemetrexed in Germany once the compound patent expires in December 2015. The German Court ruled in favor of the generic competitor in the case of Eli Lilly and Company v. Actavis. This decision vacated the prior decision of the Regional Court of Dusseldorf in April 2014. The compound patent for Alimta in Germany remains in force and is expected to provide exclusivity through December 2015. Alimta is approved to treat locally advanced or metastatic monsquamous non-small cell lung cancer, a specific type of lung cancer, and malignant pleural pmesothelioma, a cancer that affects the inside of the chest cavity.

We strongly disagree with the ruling by the German Court of Appeal regarding Alimta’s vitamin regimen patent,” said Michael J. Harrington, senior vice president and general counsel for Lilly, in a company statement. “Although Alimta’s compound patent remains in force and is expected to provide exclusivity in Germany through 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. We will seek permission to appeal this ruling to the German Supreme Court.”

In April 2014, the English High Court ruled that the vitamin regimen patents for Alimta would not be infringed by a generic competitor that has stated intent to market certain alternative salt forms of pemetrexed in United Kingdom, Italy, France, and Spain. The appeal of this decision remains pending and is scheduled for hearing starting March 9, 2015.

Lilly’s vitamin regimen patent was upheld in a prior ruling by the Opposition Division of the European Patent Office. An appeal is pending before the Technical Board of Appeal of the European Patent Office.

Source: Eli Lilly and Company