Production & Manufacturing

Lilly wins Alimta vitamin regimen patent case in UK

PBR Staff Writer Published 10 July 2017

Eli Lilly and Company has been given a favourable ruling in the UK Supreme Court in the vitamin regimen patent litigation case relating to its cancer drug Alimta (pemetrexed disodium) against Actavis.

The pharma company had filed a lawsuit alleging that Teva Pharmaceutical subsidiary Actavis’ alternative salt forms had directly infringed the Alimta vitamin regimen patent in the UK, Spain, France and Italy.

While also affirming the indirect infringement finding by the UK Court of Appeal, the UK apex court stated that the full judgment will be released on 12 July.

Two years back, the UK Court of Appeal gave a ruling that when the generic product from Actavis is reconstituted or diluted in saline, the Alimta vitamin regimen patent would be indirectly infringed. However, the court ruled that the vitamin regimen would not be directly infringed as per the doctrine of equivalents.

Lilly senior vice president and general counsel Michael J. Harrington said: “We continue to emphasize 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.”

Following the June 2015 ruling from the UK Court of Appeal, Actavis had introduced pemetrexed Armisarte, previously known as Pemetrexed Actavis, at risk. The latest ruling from the UK Supreme Court finds the product to be infringing irrespective of the diluent used in dilution or reconstitution.

In February 2016 as well, Lilly suffered a setback when the UK High Court ruled that the Alimta vitamin regimen patent would not be infringed as long as Actavis marketed its generic form of the cancer drug in the UK, France, Spain and Italy with instructions to dilute the product only with dextrose solution.