Lilly suffers set back in Alimta vitamin regimen patent lawsuit in UK

The UK High Court decided that the Alimta vitamin regimen patent would not currently be infringed by Actavis marketing pemetrexed trometamol in the UK, France, Italy and Spain with instructions to dilute the product only with dextrose solution.

The decision follows a ruling by the UK Court of Appeal in June last year that said Lilly’s patent would be indirectly infringed by several alternative salt forms of pemetrexed with instructions to dilute them with saline solution.

However, there was no clarity on whether those diluted in dextrose would infringe.

In major European countries, the basic compound patents for Alimta expired in December 2015, but its vitamin regimen patents remain in force until June 2021.

Lilly senior vice president and general counsel Michael Harrington said: "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.

"We plan to seek permission to appeal this ruling."

Lilly has also applied for permission to appeal the direct infringement aspect of the June 2015 Court of Appeal decision to the UK Supreme Court.

Alimta is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer.

It is not indicated to treat patients with squamous cell non-small cell lung cancer.