An amendment to the UK’s patent legislation could help encourage clinical research in the country, according to law firm Mewburn Ellis LLP.
The Legislative Reform (Patents) Order 2014, which came into force yesterday, amends the UK Patents Act by inserting new definitions of uses which are expressly deemed to be exempt from patent infringement.
Effectively, it removes the risk of patent infringement claims arising when carrying out clinical trials and other experimental testing as part of the development of innovative medicinal products, extending earlier protection that only applied to generics.
The amendment marks the first time that the UK has fully implemented the so-called Bolar exemption – named after a lawsuit between Roche and Bolar Pharmaceutical – which removed intellectual property (IP) barriers preventing trial sponsors from using a product patented by another rights holder.
While the original Bolar case focused on whether a generics company could use a branded product in trials, the interpretation of Bolar has since been extended to include “all necessary trials and health technology assessments for all drugs (not just generics and biosimilars) and all applications for marketing approval anywhere in the world,” according to Mewburn Ellis.
“This amendment to UK legislation is intended to bring the UK into line with other EU member states, which implemented a broader version of the Bolar exemption … from the outset,” it said.
The changes allow comparative trials to be carried out with a patented drug – including combinations with a proprietary product for example – and also apply to studies intended to support HTAs, according to the lawfirm.
“Broadening of the exemption in this way [should] make the UK a more attractive place for innovator drug companies to conduct clinical trials for their novel drugs,” it concluded.
That view is echoed by Nicholas Jones, partner and patent attorney at Withers & Rogers, who said: “This legal change is good news for UK research and it is likely to lead to more research projects taking place here.”
“This is important because we need to retain research skills and expertise and it should also help to avoid delays when bringing new drugs and treatments to market,” he added.
The UK has come into line with the rest of the EU just as the regions member states are facing major change in IP law with the introduction of the unitary patent and a single court to handle validity and enforcement actions.