A new consultation launched sets out proposals to make the UK a more favourable place for pharmaceutical companies to carry out research and development of new drugs.
The UK Intellectual Property Office (IPO) is proposing to make changes to the Patents Act to make the system fairer by allowing clinical and field trials for new drugs to be carried out without risking being sued for patent infringement.
Marketing a drug in the UK, needs regulatory approval which requires conducting human clinical trials or animal field trials to show the product is safe and effective.
Under current UK patent law, limited research and tests can be conducted using patented products required for the regulatory approval of generic drug products without infringing the rights of the patent owners. However, clinical and field trials for new drugs are not exempt from patent infringement.
There are many instances where a company may legitimately need to use a patented drug in a clinical trial, for example to compare their new drug to a patented product, or to develop therapies which combine the use of their new drug and a patented product. Currently, if a pharmaceutical company uses a patented product as part of their trial they risk being sued by the patent holder. Today’s proposals would remove this risk and create a more supportive environment for pharmaceutical research and development in the UK.
Minister for Intellectual Property, Lord Marland said:
“The UK needs an intellectual property system which supports our world class UK pharmaceutical industry that invests over £12 million in Research and Development every day.
“Our proposals look to remove the uncertainty around patent infringement in clinical and field trials, so that our life sciences sector continues to create jobs and growth in the UK economy “
The Intellectual Property Office’s Chief Executive, Sean Dennehey said:
“Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials. This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector.
“I look forward to receiving a wide response providing views and evidence enabling us to move in the direction which industry needs to succeed."
The consultation will run for eight weeks from 24 October to 19 December 2012.
Source: UK Department for Business, Innovation and Skills
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