The UK Government has made fresh changes to the Patents Act that aims to help the UK pharma companies with the development of their new medicines.
The change will allow clinical and field trials – and also health technology assessment – for new drugs to be carried out without running the risk of being sued for patent infringement, according to the government.
The law change, announced this week, is set to remove the risk of drug development companies infringing patents in this way, and also aims to make the UK a more attractive place to run clinical and field trials.
Minister for universities and science David Willetts said: “We are committed to creating the right environment in the UK for life sciences companies to thrive.
“Today marks an important step forward by removing the risks of patent infringement when testing new drugs and treatments. This will make the UK a more attractive location for research and development, supporting growth and innovation.”
Lord Younger, minister for intellectual property said: “The government is keen to create a supportive environment for pharmaceutical research and development in the UK. Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.”
Currently drug development companies have to conduct clinical and field trials before obtaining the necessary approval to market their brand new drug. This often requires comparing the new drug to the market-leading drug for a particular disease.
Once marketing approval is agreed, a health technology assessment such as NICE further investigates how the new drug compares to alternatives, usually the market-leader. Under the current law, carrying out these trials and assessments with the patented market-leader is infringement.
Steve Bates, chief executive, of the BioIndustry Association, said: “The BIA welcomes the government’s activity in the area and their recognition that an amendment to the Patent Act, to remove the risk of drug development companies infringing patents while conducting research, could improve the UK as a location for clinical trials. We are pleased to see this now being taken forward.”
Stephen Whitehead, chief executive of the ABPI, said: “I am pleased to welcome the changes which the Government has announced to the Patents Act. 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.”
