English High Court refuses to stay Pharmacia patent revocation case

The England and Wales High Court has refused Pfizer subsidiary Pharmacia’s request to stay Actavis’s patent revocation action against it.

Wishing to make and sell a generic sustained release formulation of pramipexole, Actavis filed suit against Pharmacia in April, arguing that its European Patent 1 536 792 covering the drug lacks novelty.

It added that Pharmacia is not entitled to any of the patent priority dates it claimed.

The patent covers the sustained release dosage form of pramipexole for the treatment of Parkinson’s disease and restless leg syndrome, and is exclusively licensed to Boehringer Ingleheim.

In June, Pharmacia applied to stay proceedings until the European Patent Office (EPO) determined the validity of the patent.

Actavis argued that the stay should be refused because English proceedings will be resolved much earlier than the EPO proceedings, and will give it a degree of reasonable commercial certainty.

Pharmacia offered to seek expedition of EPO proceedings and not to seek an injunction against Actavis until determination of EPO proceedings to support its stay application.

Last Friday (June 11), Justice Arnold found that the “competing considerations are finely balanced”, but favoured the refusal of a stay.

“The EPO proceedings have only just begun,” he said. “Even with expedition, it is likely that the EPO proceedings will take at least three years to resolve, and there is a risk that this will take significantly higher. By contrast, the English proceedings will be resolved in two years.”

According to the decision, the UK market for sustained release pramipexole is worth about £14 million ($24 million) a year.