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Photo: Eli Lilly and Company
16 May 2014Big Pharma

Lilly’s Alimta dosage patent invalidated at English High Court

The English High Court has ruled that a patent covering vitamin dosage regimens for Eli Lilly’s lung cancer drug Alimta (pemetrexed disodium) would not be infringed by generic competitors.

The ruling allows Actavis to launch a generic version of Alimta for administration with vitamin B12 and folic acid after Lilly’s basic compound patent covering the drug expires in December 2015.

Seeking to make a generic version of Alimta, Actavis originally filed the case for a declaration of non-infringement in the UK, France, Germany, Italy and Spain.

Lilly later filed a counterclaim for threatened infringement of its European 1 313 508 patent, which covers the use of pemetrexed disodium in combination with vitamin B12 and folic acid, in the UK.

In the May 15 decision, Justice Richard Arnold also granted declarations of non-infringement regarding the dosage regimen patent in France, Italy and Spain.

In a statement, Actavis said it was the first time that the English High Court has exercised jurisdiction regarding foreign designations of a European patent.

It added that it was pleased with the ruling and that it expects to launch its product after Alimta’s basic patent expires in December 2015.

Lilly said that it plans to seek permission to appeal against the ruling at the Court of Appeal.

Michael Harrington, senior vice president and general counsel for Lilly, said: “We strongly disagree with the ruling.”

He added: “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.”

According to figures quoted by Actavis, sales of Alimta in the UK, France, Italy and Spain totalled approximately €325 million ($443 million) in 2013.