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Lilly suffers damaging Alimta patent blow

Published on 15/02/16 at 09:49am

Eli Lilly says it plans to appeal a UK High Court’s verdict that could imminently open its blockbuster lung cancer drug Alimta up to generic competition.

The court ruled on Friday that Actavis would not infringe the Alimta (pemetrexed disodium) patent by marketing pemetrexed trometamol in the UK, France, Italy and Spain with instructions to dilute the product only with dextrose solution. 

The patent in question relates to a vitamin regimen given alongside the blockbuster lung cancer drug. In June 2015, Lilly won a case in the UK appeals court, which ruled its patent would be indirectly infringed by Actavis marketing certain alternative salt forms of pemetrexed with instructions to dilute the product with saline solution. The court did not make a judgement on dextrose solution alone at the time.

However, the high court overturned the decision, ruling against Lilly on Friday, and opening Alimta up to generic competition in the near future. The court said Actavis, (now Allergan), complied with its promises made in June over how it intended to market its generic version.

Alimta brought in worldwide sales of just under $2.5 billion last year, about $375 million of which came from the UK, France, Italy and Spain, and the company is naturally keen to hold onto such figures for as long as possible. The compound patents on the drug expired in the largest European markets in December 2015, however Lilly hoped it would be protected by the vitamin regimen patents, which are valid until June 2021.

Last year, a German court ruled in Actavis’ favour that the vitamin patents would not be overstepped by its generic, meaning a potentially rocky road ahead as Lilly tries to protect its interests.        

“We strongly disagree with the ruling by the UK High Court granting a declaration of non-infringement on the Alimta vitamin regimen patents under these circumstances,” says Michael Harrington, senior vice president and general counsel for Lilly. “We plan to seek permission to appeal this ruling."

Lilly also revealed it has applied for permission to appeal the direct infringement aspect of the June 2015 Court of Appeal decision to the UK Supreme Court. The company says that request is pending; however, it is by no means guaranteed it will be granted.

Joel Levy

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