UK Supreme Court invalidates Eli Lilly patent relating to Cialis
The UK Supreme Court has ruled in favour of Actavis (which has been acquired by Teva) and Mylan in a patent dispute against Eli Lilly, after an earlier court found that one of Eli Lilly’s patents was invalid for lacking an inventive step.
The court issued its judgment today, March 27, dismissing an appeal from Eli Lilly after the English Court of Appeals found the patent to be invalid. The disputed patent (UK number 1,173,181) relates to the use of the drug Cialis (tadalafil) in a dosage form for the treatment of erectile dysfunction.
Tadalafil is a competitor to sildenafil, which is sold under the brand name Viagra.
In its arguments Eli Lilly asserted that the essence of its invention was the discovery that tadalafil is effective in treating erectile dysfunction at a low dose and with minimal side effects.
It said its discovery allowed the drug to be taken daily for chronic use, rather than on demand, avoiding the need to anticipate when sexual activity might occur.
This is, Lilly claimed, a significant technical advantage as sildenafil is approved for on-demand use only.
In its decision, the UK Supreme Court said that considering the prior art, it was “very likely” that a skilled team would carry out research by testing small doses of 5mg and 10mg of the drug.
This is because the prior art, known as the “Daugan” patent (EP number 0,839,040) posed a problem, “because it does not set out an appropriate dosage regime” for an oral treatment of erectile dysfunction.
The court determined that a “motive was clearly present” for a team of skilled people to carry out a search for a dose-response relationship.
The court also cited a clinical pharmacologist, Dr Saoud, who said the decision to test doses was a “no brainer”.
In a statement to WIPR, Eli Lilly said it strongly disagrees with the decision.
“Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve,” Eli Lilly said.
“Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs,” it added.
In November 2017, the appeals court found the ‘181 patent was invalid on grounds of obviousness, after Actavis and Mylan sought to revoke the patent.
In its ruling, the appeals court said the claimed invention “lies at the end of the familiar path through the routine pre-clinical and clinical trials process”.
Up until now, Eli Lilly has been rigorous in its protection of the ‘181 patent.
In April 2018, it attempted to stop chinese company HEC Pharm from manufacturing a generic version of Cialis.
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