Alimta to face generics after UK court ruling
Lilly’s cancer drug Alimta is to face early generic competition in several European countries after a UK court ruling.
The English High Court has ruled that the vitamin dosage regimen patents for Alimta (pemetrexed) would not be infringed by proposed generic competitors, which use an alternative salt forms of pemetrexed.
The case has been brought by Actavis and other generic firms, which hope to seize a share of the $1.49 billion revenues Alimta earned outside the US in 2013.
Lilly says it plans to appeal against the ruling, but if it stands, generic versions will be launched in a number of European Union countries when Alimta’s compound patents expire in 2015.
The court ruled that Alimta’s vitamin dosage regimen patent would not be infringed by a generic competitor based on 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 of the same patents in France, Italy and Spain, which means generics could also be launched in these markets.
In a similar case regarding alternative salt forms of the drug earlier this year, the Regional Court of Dusseldorf in Germany ruled in Lilly’s favour regarding infringement of Alimta’s vitamin dosage regimen patent under German law. However this ruling has been challenged by generics firms, and 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. “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.”
The decision is bad news for the US company, which is currently suffering from other major patent expiries, those of Cymbalta and Evista.
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