The UK government has announced plans to change patent law to remove the risk that many clinical trials could infringe existing patents.
The Intellectual Property Office said that those running trials aimed at obtaining regulatory approval for new drugs will not be liable for infringing patents, such as those on medicines already on the market. In a recent government consultation on the issue, researchers and industry bodies warned that the current UK rules meant those comparing their drugs to existing treatments — as is often required — could fall foul of patent claims, making running such trials in the United Kingdom more costly and difficult than elsewhere.
“Today marks an important step forward by removing the risks of patent infringement when testing new drugs and treatments,” science minister David Willetts said.
Other countries — such as the United States, Canada and many European nations — already have such ‘research exemptions’, sometimes also called Bolar exemptions. In total, 94% of those responding to the government’s consultation called for the United Kingdom to also protect trials carried out for regulatory approvals.
In a statement, Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, said, “This is a welcome development that will make the UK a more attractive place in which to conduct clinical trials, which in turn will encourage pharmaceutical companies to continue operating here.”