Conducting a clinical trial of a medicine to generate data for regulatory submissions is likely to involve acts which could amount to patent infringement. EU medicines legislation1 provides for an exemption from patent infringement for tests and trials carried out with a view to obtaining an EU marketing authorisation for a generic pharmaceutical. However, individual Member States are free to provide broader protection from patent infringement for other trials, such as comparative trials required for new innovative products.
In 2005, when the exemption was first introduced, the UK adopted the minimum required by EU legislation and the exemption covered only those trials carried out to obtain EU marketing authorisations for generic medicinal products. Other EU Member States apply broader exemptions. For example, clinical trials can be conducted in Germany in order to obtain regulatory approval for new originator or generic pharmaceutical products anywhere in the world.
The UK Intellectual Property Office recognised that the narrow scope of the UK exemption was putting the UK’s pharmaceutical industry at greater risk of patent infringement when running clinical trials and health technology assessments in the UK than elsewhere in the EU. Following consultations with pharmaceutical industry stakeholders in 2011 and 2012, the UK Government decided to broaden its exemption in order to bring the UK in line with other EU countries with a more liberal regime, and to make the UK a more attractive location for the conduct of clinical trials.
The New Exemption
The new legislation,2 which was approved by the UK government on 14 July and will come into force on 1 October 2014, substantially widens the scope of the UK exemption in a number of ways:
- the territorial reach is extended, so that the exemption now covers acts carried out to provide data to regulatory bodies both within and outside the EU;
- the exemption applies to tests relating to any type of medicinal product, including all new drugs and new combination products, not just generics;
- post-authorisation testing is covered if it is a regulatory requirement of the product’s authorisation; and
- the exemption extends to acts carried out for the purpose of health technology assessments, such as the technology appraisals carried out by the public body NICE in the UK to determine whether to recommend a treatment for use by doctors under the UK’s National Health Service.
The hope is that broadening the scope of the UK's clinical trials exemption will make the UK a more attractive location in which to run clinical trials. As with any statutory exemption, there remains scope for debate as to its interpretation – for example, is a test conducted "with a view" to one of the permitted purposes if that purpose is one of several aims of the test? In addition, the decision as to where to run a clinical trial involves a number of factors of which the patent infringement position is only one. However, the broadening of the clinical trial exemption will remove one potential barrier for a large number of clinical trials in the UK.