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New Experimental Use Exemption for Pharma and Biotech Industries
The Legislative Reform (Patents) Order 2014 came into force in the UK on 1 October 2014. It serves as an amendment to the UK Patents Act 1977, and extends the existing exemptions for certain clinical trials from patent infringement.
Under the old law, the experimental use exemption (often known as the research exception), as set out in section 60(5)(b) of the Patents Act exempted those acts ‘done for experimental purposes relating to the subject matter of the invention’ from patent infringement. The scope of the old law was interpreted relatively narrowly by the UK Courts, and it was rarely applied to acts done in order to obtain regulatory approval for a new drug.
In 2005 section 60(5)(b) was retained but section 60(5)(i) was introduced into the Patents Act. This section introduced the so-called ‘Bolar’ exemption, exempting from infringement a particular subset activities carried out to enable regulatory approval of generic drugs. However, this exemption did not extend to phase I-III clinical trials for innovative drugs containing a new active substance that had not yet received any marketing authorisation.
The narrow nature of the ‘Bolar’ exemption was considered by many to have impeded the UK’s ability to develop as a global player for clinical trials. This view was compounded by many other EU Member States already having provisions which specifically exempt clinical and field trials using patented innovative drugs from patent infringement if the trial includes the collection of data required by a regulatory authority.
The Legislative Reform (Patents) Order 2014 further amends section 60 of the Patents Act, creating new sub-sections 6D and 6E.
New sub-section 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, ‘medicinal product assessment’ is defined as any testing, course of testing or other activity undertaken in the United Kingdom or elsewhere with a view to providing data for:
(a) obtaining or varying an authorisation to sell or supply a medicinal product;
(b) complying with any regulatory requirements in relation to such an authorisation; and/or
(c) enabling a government or public authority 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.
In summary, this most recent amendment to the legislation aims to exempt activities carried out in clinical trials and assessments for innovative drugs or therapies and the like from infringement, in the hope that it will make the UK a more attractive place for pharmaceutical companies to conduct trials relating to innovative drugs. It also aims to bring the UK into line with the majority of EU member states, which implemented a broader ‘Bolar’ exemption from the outset.
However, there may be issues regarding a potential conflict between the UK legislation and the Unitary Patent Court (UPC) agreement. Whilst Article 27 of the UPC agreement includes an exemption that mirrors the of the UK Act ‘acts done for done for experimental purposes relating to the subject matter of the invention’, it does not include wording equivalent to new subsections 6D and 6E. Thus, European patents with unitary effect could be subject to different exemptions from patents that are ‘opted out’ out of the UPC (see http://mskpatents.com/patents/unitary-patent-2/). However, the situation here will become clearer when more is known about the UPC agreement.