Official Consultation on the Legal Barriers to Conducting Clinical or Field Trials in the UK
19 November 2012
If your business is affected by the UKIPO’s proposals, which are discussed below, you may wish to respond to the consultation in order to make your views known. The UKIPO is seeking submissions from interested parties on, among other things, whether a change to UK legislation is required; and if so, the form that the change should take.
Details of the consultation can be found at http://www.ipo.gov.uk/consult-2012-bolar.pdf Submissions should be filed directly at the UKIPO.
In Europe, companies conducting clinical or field trials cannot always be certain that their activities will be exempted from patent infringement on the basis of being merely "experimental" uses of patented inventions.
An additional exemption from patent infringement that was introduced in 2004 greatly reduced the uncertainty for companies conducting trials that generate data to support the authorisation of generic or "biosimilar" medicinal products in Europe. The intention of this exemption is to permit, prior to patent expiry, the preparatory acts necessary for generic or biosimilar medicinal products to be launched immediately after patent expiry.
However, the Community legislation that created this so-called "Bolar" exemption has not clarified the situation for trials (particularly late stage trials, such as Phase III clinical trials) that are conducted:
- on innovative (as opposed to generic) medicinal products; and/or
- in order to gather data to support regulatory submissions outside of Europe.
Unlike the UK, certain European territories (such as France and Germany) have implemented national legislation that attempts to remove these areas of uncertainty. Consequently, the UK may now be less attractive than Germany and France for business relating to clinical or field trials.
With the aim of ensuring that the UK remains an attractive venue for conducting clinical and field trials, the UKIPO has decided to request an amendment to UK patent law. It is now seeking comments on the form that these amendments should take.
The UKIPO has proposed three options for amending the current legislation. These involve explicitly exempting from infringement all acts required to secure regulatory approval for innovative medical and veterinary drugs:
- in any country;
- in the EU and/or European Economic Area (EEA); or
- either (1) or (2), plus an exemption for all acts required for health technology assessment (e.g. assessment by the National Institute of Clinical Excellence (NICE)).
All of the proposals put forward by the UKIPO could potentially take rights away from patent holders. Further, none of them appears to have any explicit support in the Community legislation upon which the UK is mandated to base its patent law.
On the other hand, all of the proposals could be viewed as merely clarifying the scope of the pre-existing exemption for "experimental" use of an invention. Moreover, some action appears warranted to "level the playing field" for the UK in terms of its attractiveness as a location within Europe for conducting clinical or field trials.
It appears to us that only options (2) or (3) would provide an explicit exemption that is as broad as that under German patent law. We also note that none of the UKIPO's proposals explicitly addresses field trials of agrochemicals (or other plant protection products); the consultation defines 'field trials' as relating to veterinary drugs, not agrochemicals.
If you would like to discuss how the proposed changes may affect your commercial activities, please contact either Mike Snodin or your usual contact at Potter Clarkson.