The Legislative Reform (Patents) Order 2014 was placed before Parliament on 6 May 2014 to amend the UK Patents Act 1977 in order to extend the existing exemptions for certain clinical trials from patent infringement. Our earlier bulletin regarding the consultation carried out by the UK Intellectual Property Office on the exemptions can be found here.
Under current UK law the experimental use exemption, also known as the research exception, set out in section 60(5)(b) of the Patents Act 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 Patents Act 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 relatively narrow nature of the exemptions has been considered an impediment to 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.
The Legislative Order will amend section 60 of the Patents Act by creating new subsections 6D and 6E. New subsection 6D states that “anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject matter of the invention”.
In new subsection 6E “medical product assessment” is defined as including any testing, course of testing or other activity undertaken with a view to providing data for:
(i) obtaining or varying an authorisation to sell or supply a medicinal product in the UK or elsewhere;
(ii) complying with any regulatory requirements in the UK or elsewhere in relation to such an authorisation; and
(iii) enabling a government or public authority in the UK or elsewhere to carry out an assessment of the suitability of a medicinal product for human use for the purpose of determining whether to use it or to recommend its use in the provision of health care.
It is proposed that the Order to amend the Act will come into effect on 1 October 2014.
The aim of the legislation is to exempt from infringement activities involved in clinical trials and health technology assessments for innovative drugs or therapies or drug/therapy combinations. As such it should make the UK a more attractive place for drug companies conducting trials relating to innovative drugs. However, the legislation has implications for the value of patents for research tools. This is because use of a patented research tool appears to fall within the broader experimental use exemption. There are also issues to be faced regarding potential conflict between the new UK proposal and the Unitary Patent Court (UPC) agreement. Thus, patents with unitary effect could be subject to different exemptions from patents that have been opted out of the UPC.
For further information, please contact Matthew Spencer or your usual Boult Wade Tennant adviser.