New UK 'Bolar' Exemption to Patent Infringement

18 May 2014

On 6 May 2014 a draft Legislative Reform (Patents) Order 2014 (the "Order") was placed before Parliament to amend the UK Patents Act 1977 (the “Patents Act") by exempting certain clinical and field trials for drugs from patent infringement.  The Order will amend section 60 of the Patents Act by broadening the so-called 'Bolar' exemption so as to cover  the carrying out of necessary trials and health technology assessments for all drugs (novel as well as generic) and all applications for marketing approval (European as well as non- European).  This amendment to UK legislation is intended to bring the UK into line with the majority of other EU member states which implemented a broader version of the Bolar exemption from the outset. 

The new legislative test to apply in deciding whether a study can benefit from the new Bolar exemption is whether it is carried out for the purposes of a 'medicinal product assessment'  (for 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:

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 have been made specifically to permit two types of study in the UK (both of which were previously not permitted).  The specific studies now permitted are:

i) Clinical trial studies required to obtain regulatory approval or market authorisation for a new drug from a Competent Authority (such as the MHRA or the EMA).  Often these require comparative work to be carried out using a currently available drug which is patented.  New combination therapies making use of a drug that is under patent protection also require testing to obtain market authorisation.

ii) 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 can also require the use of a currently available patented drug for comparative studies.

Until now in the UK only studies carried out for the purpose of generating data used to support an abridged application for regulatory approval in Europe have been exempt from patent infringement.  The fact that the exemption is now being broadened so as to apply to trials carried out for the purpose of generating data to support full dossier applications as well is potentially of considerable importance to the pharmaceutical industry as it makes the UK a more attractive place for innovator drug companies to conduct the trials required to obtain marketing authorisations for their novel drugs.

It is expected that the Order to amend the Act shall come into force on 1 October 2014.