The Legislative Reform (Patents) Order 2014 (here) will introduce a ‘clinical trial’ exemption in the United Kingdom. It is expected to come into force on 1 October 2014.
The Order proposes amendments to the UK Patents Act 1977 to introduce an exemption from patent infringement for early work on potential new pharmaceutical products. The exemption will permit activities such as clinical trials to be undertaken to obtain data to satisfy regulatory approval requirements or to enable an assessment to be made as to a product’s suitability for human use. Specifically, the exemption will extend to:
- activities involving innovative drugs, as well as generic drugs already provided for; and
- activities undertaken to obtain regulatory approval in any country, not just the United Kingdom.
The Order, when it comes into force, is expected to have broad benefits for the United Kingdom, by facilitating the conduct of more clinical trials in the United Kingdom, with the associated economic benefits and potential early access to new medicines.
At an EU level, the Order in the United Kingdom will also bring it into line with Germany, whose Bolar exemption is widely regarded to be industry friendly (2005, Section 11 Nr. 2 b GPA, which reads: “The effects of the patent shall not extend to studies and trials and the resulting practical requirements necessary for obtaining a marketing authorization to place a medicinal product on the market in the European Union or marketing approval for a medicinal product in the Member States of the European Union or in third countries”). However, there is still some way to go before the Bolar exemption is applied equally across all European Union countries.