Eli Lilly defeated as Cialis patent found obvious on appeal
The English Court of Appeal has ruled that patent claims protecting blockbuster drug Cialis (tadalafil) are invalid as obvious, handing victory to Actavis, Teva and Mylan.
Three judges said today, November 1, that a patent directed to Eli Lilly’s erectile dysfunction drug should have been found invalid for obviousness by Mr Justice Birss in the English High Court.
The generic companies had sought to revoke the patent on several grounds, and while Birss’s decision was largely backed by the appeals court, it overturned his finding of non-obviousness.
The disputed patent—EP (UK) 1,173,181—is owned by Icos Corporation and is exclusively licensed to Eli Lilly.
It covers the use of tadalafil in a dosage form, and can be found in Cialis, which also treats benign prostatic hyperplasia, and Adcirca, a treatment for pulmonary arterial hypertension.
In 2014, worldwide sales of Cialis totalled nearly $2.3 billion, while UK sales were just under $100 million. UK sales of Adcirca were $1 million in the same year.
The generic companies said the patent, which was filed in 2000, lacked novelty and was obvious, and added three other grounds of complaint.
In August last year, Birss ruled largely in favour of Eli Lilly, saying that just two claims lacked novelty and that the patent was not obvious. He added that there would be infringement if the generic companies launched their own versions of the drugs.
The generics appealed on five grounds, with the appeals court swatting aside four of them, apart from the finding of non-obviousness.
Writing for the court, Lord Justice Kitchin said Birss had “lost sight” of the fact that the claimed invention “lies at the end of the familiar path through the routine pre-clinical and clinical trials process”.
He added that a skilled but non-inventive team would embark on that process with a reasonable expectation of success and, “in the course of it, they would carry out Phase IIb dose ranging studies with the aim of finding out, among other things, the dose response relationship”.
Therefore, said Kitchin, it would be very likely they would test a dose of 5mg tadalafil per day and, if they did so, “they would find that it is safe and efficacious”.
At that point, he concluded, they would have arrived at the claimed invention.
Kitchin said that claims 1, 7 and 10 of the ‘181 patent are invalid for lack of inventive step, while the other two judges in the case, Floyd and Lewis, both agreed.
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