The UK BioIndustry Association (BIA) has been granted permission by the UK Supreme Court to intervene in a case that could have far-reaching impacts on the life sciences sector. The BIA is arguing that medical innovations should be patentable irrespective of how the invention is made.
The Supreme Court is reviewing Actavis vs ICOS, a case that addresses the patentability of a discovery made during the dosage regime testing stage of a clinical trial.
Generics pharmaceutical company Actavis, which is seeking 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 claimed in the Court of Appeal that it would have been obvious starting from a prior publication to reach the patented discovery – a low effective dose of tadalafil that shows reduced side-effects – during routine pre-clinical and clinical trials, rendering it unpatentable. ICOS argued that it would not have been 'obvious to try' the 5mg daily dose because at the start of the development process the skilled team would have no idea whether or not such a dose would be safe and effective.
The Judge at first instance agreed with ICOS but the Court of Appeal overturned that decision. ICOS is now challenging the Court of Appeal’s decision in favor of Actavis.
The BIA highlights in its application to the Supreme Court that the design and conduct of clinical trials and other forms of biomedical research frequently involves the application of significant skill and complex decision making, despite often following a step-wise well-established path to ensure regulatory compliance. It submits that 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 also urges the Supreme Court not to make a decision in this case that could have unintended consequences for other patents for inventions made during the pre-clinical 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. 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,” BIA CEO Steve Bates said. “We are delighted that the Supreme Court will give consideration to the arguments we are making on behalf of the UK bioscience sector.”
The BIA’s application was prepared by Fieldfisher together with other members of the BIA’s Intellectual Property Advisory Committee.