UK Patent law has finally been revised to exempt from infringement certain acts relating to clinical trials of patented innovative drugs. The law change, which came into effect on 1 October 2014, was enacted in response to calls (reported here) to extend the scope of the so-called “Bolar” exemption, which in the UK only exempts trials relating to patented generic drugs from infringement. It is hoped that as a result of the new legislation, the UK will become a more attractive location for carrying out clinical trials.
On 1 October 2014 the Legislative Reform (Patents) Order 2014 came into effect (not to be confused with the Intellectual Property Act 2014, which brought about a number of changes to UK Patent and Design law).
The UK previously implemented an EU Directive(1) regarding clinical trials by introducing a so-called Bolar exemption, under which trials done for the purposes of obtaining marketing approval for generic drugs are exempt from infringement(2). The UK Bolar exemption is very narrow, in contrast to corresponding exemptions that are in force in other EU states such as Germany, which also exempt trials relating to new, non-generic, drugs from infringement.
UK law also includes a provision that exempts acts done for “experimental use” from infringement, but this provision was to date also considered to be very narrow.
The Legislative Reform (Patents) Order 2014 has broadened the experimental use exemption, setting out that “anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject-matter of the invention”(3). A “medicinal product” is defined in this context as “a medicinal product for human use or a veterinary medicinal product”. Thus, whilst there is no explicit reference to innovative products, there seems to be no restriction placed on the types of medicinal products covered, so it is widely accepted that this provision exempts from infringement trials relating to innovative drugs.
A “medicinal product assessment” is defined as “any testing, course of testing or other activity” undertaken with a view to providing data for obtaining marketing authorisation. It remains to be seen precisely which acts are exempt under this provision. For example, with regard to the Bolar exemption, it is currently unclear whether the supply of patent-protected products to a company which intends to use the product in tests necessary to obtain marketing authorisation is exempt from patent infringement in Europe. The Court of Justice of the EU is currently considering this issue in pending case C-661/13 (reported here). Similar questions are likely to arise with regard to the new exemption.
It must also be remembered that the Agreement on the Unified Patent Court contains a somewhat different and arguably narrower exemption, raising the question as to what the scope of the exemptions will be if and when the Agreement on the Unified Patent Court comes into force.