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UK Court weighs in on Lilly-Actavis Alimta case

Published on 26/06/15 at 10:06am
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Actavis will be infringing Lilly’s patent if it were to produce generic versions of Alimta, the UK Court of Appeal has ruled.

Judges blocked a move by Actavis to market certain alternative salt forms of Alimta (pemetrexed disodium) in the UK before the patent's expires in June 2021.

Specifically, the Court of Appeal decided that if Actavis were to market a generic copy of the lung cancer drug, this “would constitute indirect infringement by supplying an essential means for putting the patented invention into effect”.

Lilly is facing challenges to its Alimta patent in different European countries. Earlier this year the German Court of Appeal in Dusseldorf ruled in favour of Actavis, and ruled that Lilly’s patent for its lung cancer drug Alimta would not be infringed by generic competition when it expires later this year.

However, the Court of Appeal decision in London also held there is no difference between the law in the UK and that in France, Italy and Spain as it relates to indirect infringement. It reversed the High Court's decision granting declarations of non-infringement over the Alimta vitamin regimen patents in those countries.  

In Europe, the compound patents for Alimta remain in force and are expected to provide exclusivity through December 2015. But the UK decision increases the likelihood that the vitamin regimen patents for Alimta will provide exclusivity in the UK, France, Italy and Spain through June 2021.

Actavis may seek permission to appeal the decision at the UK Supreme Court. Actavis may also ask the High Court to decide whether a different proposed product – a different salt form of Alimta – would infringe the patent, which Lilly says it will defend ‘vigorously’.

"We are pleased with the UK Court of Appeal's ruling that confirms the Alimta vitamin regimen patent would be infringed by the entry of these generic pemetrexed products in the United Kingdom prior to June 2021. We are also pleased the ruling has cancelled the declarations of non-infringement with respect to France, Italy and Spain," says Michael Harrington, senior vice president and general counsel for Lilly.

He adds: "We continue to emphasise that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs."

Lilian Anekwe

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