A consultation by the UK Government and the UK Intellectual Property Office has found widespread support for an extension to what is known as the “bolar” exemption. This exempts certain drug testing/research activities from liability for patent infringement in the UK. For many years the current UK exemption was seen as narrower and less liberal than most other European countries with the fear that this meant that more and more clinical research trials were taking place outside the UK due to the fear that those instructing and/or carrying out the research faced liability for patent infringement in the UK in relation to tests related to new or non generic drugs. This was claimed to have resulted in a depleted skill base and increasing delays in getting new drugs to the market in the UK.
Although no concrete assessment has been carried out there is a legitimate concern that the current position is placing the UK at a competitive disadvantage in the field of clinical research trials resulting in significant financial loss. Clearly a key issue in the assessment of where and who to instruct to carry out such trials will be the potential risk of liability for patent infringement. It is not surprising then that 94% of responses supported a wider exemption.
The consultation results conclude that Section 60(5) of The Patents Act 1977 should be widened and amended to include an exemption from infringement for activities involved in preparing or running clinical or field trials involving innovative drugs for the purpose of gaining regulatory approval in any country (i.e. not just for obtaining drug or regulatory approval in the UK or EU). It is likely that this will also extend to health technology assessment activities for example in compiling data to support assessment by organisations such as The National Institute for Health and Clinical Excellence (NICE).
The next step is legislative reform and given the clear support from both government and the related pharmaceutical and clinical research industries it is anticipated that the revisal could be in place in 12 months time. At a time when there are wider initiatives such as the Patent Box (offering a very attractive rate of tax in the UK as from April 2013 for revenue generated from qualifying patents) aiming to encourage more innovation and investment in research and development in the UK, this proposal is to be welcomed. Hopefully this will result in more home based trials which should benefit pharmaceutical and life sciences organisations as well as clinical research organisations – all of whom are key players in the Scottish economy.
On February 28, 2013