Eli Lilly refused injunction against Teva, Actavis and Mylan

The English High Court has refused to grant Eli Lilly an injunction which would have stopped Teva, Actavis and Mylan marketing a generic version of its drug Cialis (tadalafil).

Cialis, a drug used to treat erectile dysfunction, had worldwide sales of nearly $2.3 billion in 2014.

Eli Lilly and its subsidiary Icos Corporation applied for an interim injunction to stop the launch of 2.5 mg and 5 mg generic tadalafil by the three generic companies.

The launch was scheduled for Monday, November 13, the same day that a supplementary protection certificate, which protected 10 mg and 20 mg tadalafil, was set to expire.

On November 1, the English Court of Appeal overturned a finding by Mr Justice Birss that the patent in suit, which protected the 5 mg or less daily dosage regimen, was inventive.

The generic companies had sought to revoke the patent, EP (UK) 1,173,181, on several grounds, and while Birss’s decision was largely backed by the appeals court, it overturned his finding of non-obviousness.

The Court of Appeal also gave Eli Lilly permission to apply to the High Court for interim injunctive relief, pending a decision on its application for permission to appeal to the Supreme Court.

Although Eli Lilly is petitioning the Supreme Court, the application is unlikely to be determined for several months, according to the English High Court.

“It may seem counterintuitive to consider injunctive relief in respect of a patent which has been held to be invalid. However, where an appeal is pending which has a real prospect of success, the inquiry is more complex than might appear at first sight,” said Mr Justice Henry Carr, in the decision handed down on November 10.

Carr said that he believes there is no realistic prospect that this appeal will succeed.

“The judgment is an application by the Court of Appeal of the facts as found by the judge to existing and settled principles of law. Therefore, I do not consider that this application for an interim injunction crosses the first hurdle of a realistic prospect of success,” he said.

However, he didn’t rest his decision on that basis alone, and considered unquantifiable harm to the parties.

Carr found that Eli Lilly had not established that it will suffer unquantifiable damage.

“If I am wrong about that, and Eli Lilly is able to establish some unquantifiable loss, it appears to me that the unquantifiable loss to the claimants, if an injunction were granted, considerably outweighs any unquantifiable loss to Eli Lilly,”he concluded.

He explained that this was because the three generic companies were “first movers” in the market.

“That does not mean that one company will be first to the market, but rather that all three will be early to the market,” said Carr.

“Later entrants to the market are much less likely to make serious inroads. Therefore, it is very important to these claimants (although they may be in competition with others as well) to be able to launch as soon as possible.”

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