The government is today (26 February 2013) 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.
Notes to editors
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Clinical trials are tests carried out while developing a drug to demonstrate that it is safe and effective. There are various stages of clinical trials which must be done before a drug is approved for use and given a marketing authorisation.
Field trials are clinical trials for a veterinary product.
Health technology is a range of methods used to promote health, prevent and treat disease and improve rehabilitation and long term care including drugs, devices, procedures, settings of care and screening.
Health Technology Assessment asked important questions about health technologies such as when is counselling better than drug treatment for a condition, what is the best operation for a condition. These questions are answered by investigating (i) whether the technology works, (ii) for whom, (iii) at what cost and (iv) how it compares to the alternatives.
The consultation ran for eight weeks from 24 October to 19 December 2012.
The full response to the consultation has been publised.
The Bolar exception allows the research needed to gain regulatory approval to sell generic medicines to be undertaken without infringing any patented medicines.
The problem of patent infringement in clinical trial and research is that there is no equivalent exception to Bolar in the UK patent law for work needed to approve new, innovative medicines where this work involves using medicines covered by patents belonging to someone else.
Most other European Union countries exempt all clinical or field trial work with medicines from patent infringement. Individual companies and the Association of the British Pharmaceutical Industry have stated that this position has caused them to move some clinical trial work from the UK to other EU countries with more favourable patent laws.
Gordon Wright is a UK and European Patent Attorney. He has a PhD in Molecular Pharmacology from the University of Oxford and is a former chairman of the European Federation of Pharmaceutical Industries and Associations (EFPIA)’s Trade Mark Group.
The Intellectual Property Office (IPO) is within the Department for Business, Innovation, and Skills (BIS) and is responsible for the national framework of Intellectual Property rights, comprising patents, designs, trade marks and copyright.
The government’s economic policy objective is to achieve ‘strong, sustainable and balanced growth that is more evenly shared across the country and between industries’. It set four ambitions in the ‘Plan for Growth’ (PDF 1.7MB), published at Budget 2011:
- to create the most competitive tax system in the G20
- to make the UK the best place in Europe to start, finance and grow a business
- to encourage investment and exports as a route to a more balanced economy
- to create a more educated workforce that is the most flexible in Europe.
Work is underway across government to achieve these ambitions, including progress on more than 250 measures as part of the Growth Review. Developing an Industrial Strategy gives new impetus to this work by providing businesses, investors and the public with more clarity about the long-term direction in which the government wants the economy to travel.