Extension of research exemptions in the United Kingdom

Exemptions from infringement under the UK Patents Act in relation to the research and development (R&D) of innovative drugs are set to be extended from October 2013. The government has indicated, in response to a consultation of stakeholders carried out in the latter part of 2012, that the act should be amended to include an exemption from infringement for activities involved in trials of such drugs in order to gain regulatory approval in any country and, in addition, for activities involved in health technology assessment. The prospective changes should make the United Kingdom a more attractive place to conduct these activities.

Objectives
This recent announcement can be seen as part of a wider series of UK government incentives, including the R&D tax relief and Patent Box systems, designed to encourage innovative companies to operate in the United Kingdom, as indicated by Minister for Universities and Science David Willetts:

“We are committed to creating the right environment in the UK for life sciences companies to thrive... This will make the UK a more attractive location for research and development, supporting growth and innovation.”

It is intended that this amendment will bring economic benefits to the United Kingdom and benefit the consumer by reducing delays in the progress of products to market. It should also reduce the financial burden for companies wishing to carry out trials in the United Kingdom, reducing or eliminating the costs incurred in, for example:

• Obtaining licences.
• Carrying out freedom-to-operate analyses and validity opinions.
• Defending infringement actions.
• Bringing opposition and revocation proceedings.

Crucially, the amendment should also remove the legal uncertainty surrounding the current safe harbours provided by the Bolar and research exemptions.

Current situation
The Bolar exemption in the UK Patents Act is the implementation of the minimum requirements of EU Directives 2004/27/EC and 2004/28/EC. It is limited to trials carried out for authorisation of generic or biosimilar products within the European Economic Area only.

By contrast, most other EU countries, such as Germany, Italy and France, implemented the Bolar exemption more broadly, extending it to trials carried out for authorisation of any medicinal product in any country.

Companies wishing to carry out trials in the United Kingdom for authorisation of other products and/or for authorisation in other countries need to rely on the narrow research exemption in the UK Patents Act, which relates to any act done for “experimental purposes relating to the subject-matter of the invention”. The UK courts have interpreted this exemption to be far more narrow than equivalent exemptions in other national patent laws. It does not extend to trials carried out “in order to amass information to satisfy a third party [eg, a regulatory body] that the product works as the maker claims”, so is not considered to exempt clinical trials from infringement.

Proposed amendments
The UK government now proposes to extend the exemption from infringement to cover activities involved in preparing or running clinical and field trials of innovative drugs in order to gain regulatory approval in any country and, in addition, to cover activities involved in health technology assessment of such drugs, such as those carried out to support assessment of drugs by the UK National Institute for Health and Clinical Excellence.

These amendments are likely to bring UK legislation into line with that in much of the rest of Europe, and closer to the safe harbour provided by the equivalent provisions in the United States. However, the precise shape of the amendments to this section remains to be seen. Although the government appears to be broadly receptive to the consensuses within the stakeholder responses to the consultation, it has made no indication of which specific aspects of the recommendations are likely to be put forward in the proposed legislation.

However, regardless of the eventual form of the amendments, it is clear that the UK government is following through on its commitment to create a supportive environment for R&D, particularly in pharmaceuticals and life sciences. This will be welcomed in many corners, from innovator companies and clinical research organisations to charities and public research bodies.

The authors would like to thank Mark Abthorpe for his contribution to this article.