In a ruling handed down by the UK Supreme Court, Lord Hodge has confirmed that discoveries made through well-established or routine research protocols can be inventive and rewarded with a patent.
“I do not construe the judgments of the Court of Appeal as supporting any general proposition that the product of well-established or routine enquiries cannot be inventive… efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they meet the statutory tests,” said Lord Hodge the lead judge in the decision.
This ruling has been welcomed by The UK BioIndustry Association (BIA) as the clarity provided by the decision on principles of patent law have a wider impact on the biotech sector beyond the parties in this particular case.
“The research and development of new medicines requires significant investment from companies so it is essential that they can protect the products of their investment through the patent system,” added Dr Martin Turner, head of policy and public affairs at BIA. “This in turn incentivises further investment in medical research in a virtuous cycle that delivers improved treatments for patients.”
The trade body intervened in the original case to ask that the Supreme Court not provide a decision that could have unintended adverse consequences for 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.
“The Supreme Court has today provided members of the BIA with a lot of the clarity they were seeking in their intervention, giving guidance on the application of some key principles of patent law,” concluded Nicole Jadeja, vice-chair of the BIA IP Advisory Committee and partner of Fieldfisher. “In a decision largely confined to the specific facts of the case, the Supreme Court has seemingly endeavored to determine the case in a way which will avoid unforeseen and far-reaching implications beyond the patentability of this particular dosage regimen patent.”
