Experimental Use Exemption in the Pharmaceutical and Biotech Industries
Amendments to the UK Patents Act which came into force on 1 October 2014 have extended the scope of the so-called ‘Bolar’ exemption from patent infringement for experimental use in the context of trials of medicinal products. The exemption now covers 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).
The test to decide whether a study can benefit from the 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 any testing, course of testing or other activity undertaken with a view to providing data for one of the following purposes:
a) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product anywhere in the world;
b) complying with any regulatory requirement imposed in relation to such authorisation; or
c) 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 patent 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 the National Institute for Health and Care Excellence “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.
By extending the exemption to trials carried out for the purpose of gaining regulatory approval for innovative drugs, the legislative changes bring the UK into line with many other EU member states (notably Germany), and hopefully make the UK a more attractive place for companies to conduct clinical trials.
This information is simplified and must not be taken as a definitive statement of the law or practice.