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22 January 2015Europe

English High Court swats Warner patent case against Actavis

The English High Court has said it will not send a patent infringement case filed by Pfizer-owned Warner-Lambert Company against Actavis to trial, finding there was no “serious issue”.

The case centred on Warner’s epilepsy drug Lyrica (pregabalin), which can also be used to treat generalised anxiety disorder and neuropathic pain.

Warner markets Lyrica for three different indications. Its patent covering the active ingredient expired in 2013, though it holds a second medical use patent--EP—(UK)0 934 061, for one of the three indications—to treat pain.

Actavis sought to make and sell a version of Lyrica for the two non-patented indications, which it is lawfully entitled to do.

However, as many prescriptions do not state the indication for which a drug has been prescribed, to save money pharmacists may dispense the Lyrica generic  for the patented indication instead.

Warner had asked for an interim injunction requiring Actavis to take steps to ensure that the generic product, which will be marketed as Lecaent, is not dispensed for the treatment of pain, as it would infringe the ‘061 patent.

Actavis argued that this was anti-competitive and, accompanied by generic drug maker Mylan, moved to revoke the patent so that they could market the generic to treat the patented indication as well as the other two.

In  yesterday’s (January 21) ruling, Justice Richard Arnold concluded that there was “no serious issue” to be tried regarding Warner’s claim  that Actavis would infringe the ‘061 patent by marketing Lacaent.

Arnold added that even if there were a serious issue to be tried, “the balance of the risk of injustice would favour refusal of the relief sought by Warner”.

Paul England, senior associate at law firm Taylor Wessing in London, said that Arnold’s decision is an important one.

“Although such cases turn on their own facts, the pharmaceutical sector has been waiting for a decision on these issues for years. Generic companies will be relieved by the decision, but holders of patents for specific treatments will be frustrated that they cannot prevent generic drugs also being used for those treatments.”