Eli Lilly and Company reports that the English High Court has determined that the vitamin dosage regimen patents for the anticancer drug Alimta (pemetrexed) would not be infringed by a generic competitor that has stated an intent to market certain alternative salt forms of pemetrexed in several European countries upon expiry of the Alimta compound patents in 2015. The decision came in the case of Actavis UK Limited and others v. Eli Lilly and Company.

The English court ruled that Alimta’s vitamin dosage regimen patent would not be infringed by a generic competitor that had stated its intent to market certain alternative salt forms of pemetrexed in the United Kingdom prior to the UK patent’s expiration in mid-2021. In addition, the English court granted corresponding declarations of non-infringement regarding Alimta’s vitamin dosage regimen patents in France, Italy, and Spain. Eli Lilly said it plans to seek permission to appeal the ruling to the Court of Appeal.

The compound patents for Alimta in major European countries remain in force and are expected to provide exclusivity through 2015. In a parallel infringement case on one of the alternative salt forms of pemetrexed earlier this year, the Regional Court of Dusseldorf in Germany ruled in Lilly’s favor regarding infringement of Alimta’s vitamin dosage regimen patent under German law. Lilly agrees with the decision in Germany, which is currently under appeal.

“We strongly disagree with the ruling by the English High Court regarding infringement of Alimta’s vitamin dosage regimen patents,” said Michael J. Harrington, senior vice-president and general counsel for Lilly, in a press statement. “Lilly takes the view that the court did not correctly apply the legal standards in the UK and failed to make the assessments for France, Italy, and Spain using the correct approach as required by national laws in those countries.”

Harrington continued, “Although Alimta’s compound patents remain in force and are expected to provide exclusivity in major European countries through 2015, we continue to believe that Alimta’s vitamin dosage regimen patents would be infringed by the entry of generic pemetrexed in Europe prior to June, 2021. The significant scientific research that Lilly performed in support of those vitamin dosage regimen patents deserves intellectual property protection. We plan to seek permission to appeal this ruling.”

Source: Eli Lilly