Patent research exception

Note of public discussion sessions held at Harmsworth House on 24 September and 1 October 2008

As part of the process of gathering evidence for the consultation on the patent research exception two public discussion sessions were held at Harmsworth House. A broad cross-section of the public attended the sessions including representatives from academia, industry (pharma, IT, manufacturing, etc), plant breeders, the legal professions and several industry representative bodies. From these representatives, a number of guest speakers were invited to present an outline of their experiences of the research exception and how it affected their daily business. We also asked all of those attending to let us know: whether there was a problem; what evidence there was; and what, if anything, they wanted the Intellectual Property Office to do about it.

There was agreement amongst most participants of the need for clarification of the research exception either through new legislation or guidance and discussions also considered several possible options for change. The current research exception was largely seen as an issue of concern only to certain sectors, in particular the life sciences and plant breeders. There was no evidence of it being an issue in non-biotechnological research, though several participants questioned whether the exception was therefore not adequately performing its original intention in other sectors. Several IP professionals reported that they were often called upon to explain to clients what the research exception meant. Others believed that the lack of clarity meant that organisations were afraid to use patented inventions in research. That said, there were several advocates for status quo, who did not consider there to be a major problem and that any changes could have unforeseen consequences, for example a revised definition of 'research' could introduce different boundaries which might lead to a new legal rigidity and/or uncertainty in other areas.

Some academic institutions felt that the lack of clarity meant they erred on the side of caution and would not begin a research project if they thought that there was a risk of an infringement action being brought against them. Furthermore, a university would be unlikely to defend such an action and would bring the alleged infringing research to a halt. It was generally agreed that "private" use (as provided for by Section 60(5)(a)) did not extend to universities, since its original intention was to cover the man-in-a-shed scenario. However it was thought that most university researchers would say that their work is private and that no company would sue them. Indeed, some believed that no ethical company would take action against a university engaged in research since they would need to consider the PR implications of doing so. In addition, many academic institutes were customers of industry who would be disinclined to sue.

The development of comprehensive guidance or awareness raising relating to the research exception was another option considered. It was felt that this would be welcomed by universities amongst others. Questions were raised as to what would be the purpose of any guidance; would it seek to inform or to interpret the law? Consideration would also need to be given to who would participate in drawing up guidance, since it would have no legal weight and it was suggested that should this option be pursued, the judiciary should be asked to help draw up said guidance.

Views on research tools ranged from amendment of the law to extend the scope of the research exception as done in Belgium to maintenance of the status quo. Some participants argued that even a small amendment to the law could kill the research tool industry, which is a thriving sector in the UK. A similar argument applied to the issue of compulsory licences for research tools as applied in the recently implemented amendment to Swiss patent law.

Some time was given to the issue of plant breeders which was seen as a standalone subject. It was accepted that any new plant variety would constitute a potential infringement where the end product contained a patented gene. The area of concern was for where research involved the use of a patented gene even if it was ultimately bred out of the final version. It was unclear whether UK law permitted such cross-breeding without infringing research, and the risk was that the research base would move to countries where it is clearly allowed through legislation, such as France or Germany. However, the small number of patents in Europe for genetic sequences has not been a hindrance so far and concerns were being raised on the potential for future difficulties, particularly if the EU ban on genetically modified plants was lifted. The case made by the plant breeders was recognised by others as one which had some merit, though some suggested that further legal counsel on this issue may be the most appropriate way forward.

The discussions proved useful and constructive although there was very little actual clear cut evidence of the effects of the research exception or of potential difficulties which needed to be addressed through legislative change. In a straw poll of participants 15% favoured legislative changes, 20% thought that we need do nothing and 10% wanted harmonisation at European level. However, over 50% were in favour of more guidance as their preferred option.