Eli Lilly loses latest round of Alimta patent battle

Eli Lilly has lost the latest round of its patent battle with Allergan centring on the lung cancer drug Alimta (pemetrexed disodium).

In a judgment handed down on Friday, February 12, the English High Court said Eli Lilly’s patent would not be infringed by Allergan marketing a generic version of the drug as long as it included instructions to dilute the product only with dextrose solution.

The dispute can be traced back to 2012 when Allergan, seeking to market a generic version of the drug, sought a declaration of non-infringement at the high court.

The patent in question, EP 1,313,508, covers the use of Alimta’s active ingredient “in the manufacture of a medicament for use in combination therapy with vitamin B12 and, optionally, folic acid”. It is due to expire in June 2021.

In a judgment handed down on May 15 2014, Judge Richard Arnold ruled that Allergan’s generic would not amount to either direct or indirect infringement of the patent.

But in June 2014, the English Court of Appeal reversed the decision on indirect infringement.

The appeals court said the patent would be indirectly infringed by Allergan’s proposal to sell “certain alternative salt forms of pemetrexed with instructions to dilute them with saline solution”.

However, the court left open the question of diluting the product with dextrose solution.

Allergan then asked the appeal court to allow it to remit part of the trial to the high court centring on whether it would infringe the patent if its product had instructions to “reconstitute and/or dilute the products with 5% dextrose solution instead of saline.”

The appeals court accepted and in Friday’s ruling Arnold ruled in favour of Allergan.

Michael Harrington, senior vice president of Eli Lilly, said: “We strongly disagree with the ruling by the high court granting a declaration of non-infringement on the Alimta vitamin regimen patents under these circumstances.”

Harrington added that it planned to appeal against the ruling.

Allergan was formerly known as Actavis. It began using the name Allergan after acquiring a company of the same name earlier that year.

The decision also takes effect in France, Italy and Spain.