Amendments to the UK Patents Act will come into force on 1 October 2014 which broaden the scope of the so-called ‘Bolar’ exemption from patent infringement for ‘experimental use’ in the context of trials of medicinal products.
The Legislative Reform (Patents) Order 2014, which comes into force on 1 October 2014, amends the UK Patents Act by inserting new definitions of uses which are expressly deemed to be exempt from patent infringement. The effect of the change is to broaden the so-called 'Bolar' exemption to cover all necessary trials and health technology assessments for all drugs (not just generics and biosimilars) and all applications for marketing approval (anywhere in the world).
This amendment to UK legislation is intended to bring the UK into line with other EU member states, which implemented a broader version of the Bolar exemption (which was derived from an EU directive) from the outset.
The new test to decide whether a study can benefit from the new exemption is whether it is carried out for the purposes of a 'medicinal product assessment' (for either human or veterinary use). A medicinal product assessment is defined as meaning any testing, course of testing or other activity undertaken with a view to providing data for one of the following purposes:
- obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product anywhere in the world;
- complying with any regulatory requirement imposed in relation to such authorisation; or
- enabling any government or public authority to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care.
The changes are specifically intended to allow clinical trial studies required to obtain regulatory approval or market authorisation for a new drug to be carried out without risk of infringement. Often, these studies require comparative work to be carried out using a currently available drug, which may be patented. New combination therapies making use of a patented drug, which also require testing to obtain market authorisation, should also be protected by the new exemption.
The changes are also directed towards Health Technology Assessments (carried out by organisations such as NICE) which are required for a new treatment to be recommended for use by the NHS. These may also require the use of a currently available, patented, drug for comparative studies.
Both of these activities would not have been exempt from infringement under the previous UK law. Until now, only studies carried out for the purpose of generating data used to support an abridged application for regulatory approval in Europe (e.g. for a generic version of an existing drug) have been exempt.
It is hoped that the broadening of the exemption in this way will make the UK a more attractive place for innovator drug companies to conduct clinical trials for their novel drugs.