The new exceptions enable companies to trial a new drug or a generic version against an established brand without violating its patent.
The changes to the Patents Act could both strengthen the UK as a base for pharmaceutical R&D and improve the medical value of clinical trial findings.
Life science industry trade associations have welcomed the new regulations for the boost they offer to innovative drug development, despite potential losses to established brands.
An Intellectual Property Office consultation showed overwhelming industry support for both changes to the patent law: the ‘research exception’ for trials of new drugs and the ‘Bolar exception’ for trials of generic drugs.
Not only does the rule that head-to-head clinical trials infringe patent make it harder to establish new drugs, it has also led to widespread criticism of clinical trials that compare a new drug with placebo – which no doctor prescribes.
Most EU countries exempt clinical trials from patent infringement, and the UK law has been a barrier to clinical trial work in the UK.
“The Government is keen to create a supportive environment for pharmaceutical research and development in the UK,” said Lord Younger (pictured), Minister for Intellectual Property.
“Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.”
Stephen Whitehead, CEO of the ABPI, commented: “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.”