09/02/2014

RGC Jenkins & Co

Jenkins reports on the expansion of the UK 'Bolar Exemption'

On 1 October 2014, a new legislative order is due to come into effect in the UK which will broaden the so-called 'Bolar' exemption provisions such that trials of innovative drugs will not infringe patent rights. This change is welcome news to laboratories and medical researchers in the UK and to certain pharmaceutical companies here and abroad.


The "Bolar exemption" as currently included in the UK Patents Act merely allows companies to carry out regulatory tests required for proving the equivalency between a generic drug and a patented drug. This means that generic drug companies are presently only allowed to obtain the necessary regulatory approval to launch their products prior to expiry of a patent protecting the original drug, so that when the patent expires, the marketing authorisation is in place. These provisions have so far precluded companies from carrying out wider clinical or field trials in the UK, where these trials are often required for the development of new, non-generic drugs, for example because the new drug falls within the scope of the patent or because the trials require comparison studies with a known drug which is patented. In some cases, companies have chosen to carry out their research and clinical trials in other countries where the exemption is of broader scope, representing a possible loss to the UK economy.


Section 60(5)(b) of the Patents Act 1977 provides an exemption from infringement in relation to acts done for experimental purposes relating to the subject-matter of the invention. The new order will add new subsection (6D) and will provide that anything done in or for the purposes of a medicinal product assessment is to be regarded as done for experimental purposes relating to the subject-matter of the invention. New subsection (6E) defines what is meant by “medicinal product assessment” as any testing, course of testing or other activity undertaken with a view to providing data for certain specified purposes such as:
· obtaining marketing authorisation and associated regulatory compliance in the UK or elsewhere; or
· permitting the National Institute for Clinical Excellence (NICE) or equivalent agencies in other countries to assess medicinal products.


The new order will therefore provide pharmaceutical companies around the world with more opportunities to conduct clinical or field trials in the UK, where these trials are required to obtain market authorisation for innovative drugs.


Insofar as other European countries such as Germany already have a broadened Bolar exemption, such provisions are typically limited to conducting trials for obtaining marketing authorisation in the EU. The new UK provision is not so limited in its geographical reach.