The Supreme Court has given its consent to the UK’s BioIndustry Association (BIA) to intervene in a case that the latter says “could have far-reaching impacts on the life sciences sector”.
The Supreme Court is currently reviewing litigation between Actavis and ICOS regarding the patentability of a discovery made during the dosage regime testing stage of a clinical trial.
Actavis, which wants to market its own version of the drug tadalafil, has challenged the patent owned by ICOS on the grounds that the discovery was obvious.
Actavis claims it would have been obvious starting from prior research to reach the patented discovery - a low effective dose of tadalafil that shows reduced side-effects - during routine preclinical and clinical trials, rendering it unpatentable.
ICOS insists that it would not have been 'obvious to try' the patented 5mg daily dose because at the start of the development process the team would not have known whether or not such a dose would be safe and effective.
At the first hearing the Judge agreed with ICOS, but subsequently the Court of Appeal overturned that decision, which the firm is now challenging in the Court of Appeal.
The BIA is arguing that medical innovations should be patentable “irrespective of how the invention is made”.
In its application to the Supreme Court, the BIA says the design and conduct of clinical trials frequently involves significant skill and complex decision making, despite often following a well-established path to ensure regulatory compliance.
According to the Association, the assessment of obviousness “should be based around the knowledge at the relevant time and not simply on the nature and type of research which led to the claimed invention”.
The BIA is also urging the Supreme Court “not to make a decision in this case that could have unintended consequences for other patents for inventions made during the preclinical or clinical trial process, which would significantly raise the hurdle for companies to attract the investment needed to identify and develop new medical innovations”.
“Clinical trials are an important part of medical innovation and it is vital that companies can protect their discoveries regardless of what stage in the research process they are made,” commented its BIA chief executive Steve Bates.
“Without a strong and consistent patents regime that rewards innovation, UK bioscience companies will not be able to attract the investment they need to develop the life-saving drugs of tomorrow.
“We are delighted that the Supreme Court will give consideration to the arguments we are making on behalf of the UK bioscience sector."