Following an informal consultation in 2011 to investigate the impact of UK patent legislation on clinical and field trials, a formal consultation has now opened on UK Government proposals to amend section 60(5) of the Patents Act (PA) 1977 to provide an exception to patent infringement for activities involved in preparing or running clinical or field trials which use innovative drugs.
Under current UK law the experimental use exemption, also known as the research exception, set out in section 60(5)(b) of the PA 1977 exempts from patent infringement acts ‘done for experimental purposes relating to the subject matter of the invention’. However, the scope of this provision has been interpreted narrowly by the UK Courts such that it does not in general apply to acts done in order to obtain regulatory approval for a new drug.
Section 60(5)(i) was introduced into the PA 1977 in 2005 to exempt from infringement certain activities performed for the regulatory approval of generic drugs. Importantly, this exemption, commonly called the Bolar exception, does not extend to innovative drugs.
The current Government proposal is aimed at eliminating the present legal uncertainty for companies carrying out clinical trials in the UK. In addition, the Government wants to improve the ability of the UK to compete globally as a location for clinical trials. In many other EU Member States clinical and field trials using patented innovative drugs are specifically exempt from infringement when the trial is being used to collect data required by a regulatory authority.
Three options for changing the current legislation have been proposed:
- Change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs in all countries.
- Change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs in the EU and EEA only;
- Change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs and also all activities necessary for health technology assessment e.g. data to support assessment by the National Institute for Health and Clinical Excellence (NICE).
The Government is interested in assessing the benefits to industry if clinical or field trial activities with innovative drugs were exempt from patent infringement in the UK in terms of, for example, savings on freedom-to-operate searches, opposition and court costs, and licensing agreements. These will be balanced against the potential costs to patent holders including the loss of licensing fees and earlier reduction in market share for the patent holder after patent expiry. According to a recent presentation from the IPO1, the Regulatory Policy Committee (RPC) require that the cost savings and potential losses are monetised to provide justification for the proposed legislative changes.
The consultation on the proposal is set to run until 19 December 2012 and the proposal can be viewed at http://www.ipo.gov.uk/consult-2012-bolar.htm. It remains to be seen whether stakeholders are able to produce an indication of monetised costs and benefits to meet the requirements of the RPC. A government response is due Spring 2013 with possible implementation of the legislative changes by October 2013.
1 Presentation of Fiona Warner, Senior Policy Advisor – IPO at the CIPA Life Sciences Conference 2012