Eli Lilly defeat shows one size does not fit all in obviousness test: lawyers
The UK Supreme Court’s decision in Actavis v Eli Lilly confirms that a multi-factorial judgement should be used to determine whether an invention is obvious or not, lawyers have told WIPR.
Yesterday, March 27, the court ruled in favour of Actavis, upholding an earlier ruling from the English Court of Appeals and finding one of Eli Lilly’s patents was invalid for lacking an inventive step over the prior art.
The patent in dispute (UK number 1,173,181) relates to the use of the drug Cialis (tadalafil) in a dosage form for the treatment of erectile dysfunction.
Julie Carlisle, a partner at Mewburn Ellis in London, said there had been concerns in the pharmaceutical and life sciences industries that a ruling like this would have “unintentional wider effects on the patentability of medical innovations, which could harm investment and research”.
“However, rather than presenting the judgement as a ‘one-size-fits-all’ response, the Supreme Court has confirmed that a multi-factorial test should be used to determine whether an invention is obvious or not,” Carlisle said.
She added: “This particular patent has failed the test, but there should be greater clarity now about whether similar innovations will qualify for a patent.”
Peter Damerell, a partner at Powell Gilbert in London, said the ruling provides confirmation that “all relevant factors should be taken into account, with no one factor trumping any other”.
Damarell said that for patentees, the Supreme Court confirmed that even when discoveries are made through well-established research protocols, they can nevertheless be invented and rewarded with patent protection.
Trevor Cook, a partner at WilmerHale in New York, said it was a pity that the court did not try to engage with the question of why something that provides an “objectively unexpected benefit”, as Eli Lilly’s dosage form did, “should be deprived of patent protection simply because if someone was motivated to commercialise the prior art, they would be likely to stumble across it”.
Additionally, Carlisle said that by finding the ‘181 patent invalid, the court has opened the doors for competitors to market generic products, which will lead to greater choice and reduced prices for consumers.
“As a blockbuster drug (worldwide sales of £2.29bn in 2014), this will represent a major financial blow to Eli Lilly, even though the patent was due to expire in 2020,” she said.
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