UK Supreme Court to hear Alimta patent dispute

The UK Supreme Court has said it will hear a patent dispute between Eli Lilly and Allergan centring on cancer drug Alimta (pemetrexed disodium).

The court granted permission yesterday, March 23, in a dispute which has made its way up from the English High Court.

Allergan, which was then known as Actavis, sought permission to market a generic version of the drug and asked for a declaration of non-infringement at the high court in 2012.

Eli Lilly’s 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, Mr Justice 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”.

It is this part of the ruling that the Supreme Court will assess.

However, in its June ruling, the appeals court left open the question of diluting the product with dextrose solution.

Allergan asked the appeals court to remit back to the high court the part of the trial 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 last month Arnold ruled in favour of Allergan.