By Daniel Hunter
The government is today (Tuesday) announcing a change to the Patents Act which will help the UK's world class life sciences industry remain at the forefront of innovation.
The change will allow clinical and field trials and health technology assessment for new drugs to be carried out without running the risk of being sued for patent infringement.
The response to the Intellectual Property Office consultation on the research and Bolar exceptions showed an overwhelming majority of responses supporting a change to the law. The law change announced today removes the risk of drug development companies infringing patents in this way and makes 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.“
At the moment 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 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.
The consultation asked for comments from the life science sector on various options to change patent law. These included:
- exempting trials of new drugs to get marketing approval only
- exempting trials done to gain approval for NHS (activities necessary for health technology assessment such as data to support assessment by the National Institute for Health and Clinical Excellence) and
- geographical scope of the proposed exceptions for example across the European Union, the European Economic Area only or all countries.
Gordon Wright, member of the Chartered Institute of Patent Attorney’s (CIPA) Life Sciences Committee said: “CIPA broadly welcomes these proposals. They will facilitate access of innovative products and treatments to all markets and will clarify what has been a tricky area of patent law for users and advisors alike. It is to be hoped that if the proposals are implemented that the boundaries of the exemption will be clearly drawn, so that the users, particularly academics, will know whether or not their activities fall within the exemptions.”
Steve Bates Chief Executive Officer of the BioIndustry Association (BIA), 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.”
The vast majority of responses wanted to see activities required for regulatory approval exempt from infringement and also wanted the exemption to include health technology assessment.
Join us on