The UK Intellectual Property Office (UKIPO) has launched a consultation to amend the UK Patents Act 1977 (PA) to provide an exemption to patent infringement for activities involved in preparing or running clinical or field trials which use innovative drugs.
This proposed amendment can be seen as one aspect of a push by the EU, and by the UK on its own, to promote the EU and UK as attractive locations for clinical trials of innovative medicines because such trials attract investment and jobs and also help to provide patients with early access to new treatments.
Back in 2004, the EU introduced the Clinical Trials Directive to harmonise the regulations across Europe with the aim of reducing the barriers for innovators, but depressingly it has had the opposite effect. For example, since the introduction of the Clinical Trials Directive (2001/20/EC), the number of global clinical trials with UK involvement has fallen from 6% in 2004 to 2% in 2008. Consequently, the EU Commission proposes to replace the Clinical Trials Directive with a new Regulation to streamline conduct of multinational clinical trials in Europe.
Current UK exemptions to patent infringement for clinical trials
From an intellectual property point of view, clinical trials in the UK are covered by a patchwork of the research exemption and the "Bolar" exemption. The problem with the current position concerning the UK Bolar exemption is that it only covers trials for generic products (rather than innovative products) and then only for the creation of data that is solely used for EU approvals. This causes a problem since most clinical data is required for data packages for marketing approval applications around the world. On the other hand, the research exemption is plagued by the lack of relevant case law in the UK. The leading case is Monsanto v Stauffer dating back to 1985 which was a decision on an application for an interim injunction and therefore was not fully argued at trial. The case involved an unusual set of circumstances in that the product was already being marketed following extensive field trials but that subsequent field trials were being carried out to obtain certain post-marketing approvals.
There are however a number of cases in other EU jurisdictions, particularly in Germany, which have given a wide interpretation of the research exemption covering, for example, any planned procedure for obtaining information or clearing up uncertainties with regard to the object of the patented invention which cover even Phase III clinical trials. It is thought by many commentators that the UK courts would follow the German case law. Though the English Court has referred to it in one case, the position remains uncertain. It is thought by some (although that opinion is by no means universal throughout the pharma industry) that such uncertainty over the patent infringement position (and the costs and time of analysing the patent landscape) may be one of the factors contributing to the decline in the number of clinical trials carried out in the UK.
Despite this uncertainty, there have been few court proceedings dealing with infringement by clinical trials. The reasons for this are probably many but include the following: patentees wishing to avoid negative PR by stopping clinical trials of a competitor's drug that may help patients (particularly when patient groups are becoming even more important in supporting the adoption of innovative medicines); patentees having the opportunity to bring proceedings later to prevent the commercial launch of a product if it infringes (and the product may well fail in clinical trials in any event); the view (mentioned above) that the wide interpretation under the German case law will be adopted by the UK courts; and where there are potential infringement issues, the sponsor of a trial may well conduct it in countries such as Germany with a wider exemption for clinical trials or otherwise outside the EU.
The UKIPO consultation
As a result of this perceived uncertainty, the UKIPO carried out an informal consultation in the summer of 2011 to understand whether there was an appetite for changing the law in respect of clinical trials. Following this consultation, the UKIPO decided that legislation to amend the PA was required.
At the heart of the UKIPO's current proposal are three options for changing the current legislation to add a new exemption to section 60(5) PA 1977 to remove the risk of infringement when carrying out clinical and field trials using innovative drugs. The UKIPO is asking for views on which of the three options should be adopted and these options are:
- Change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs in all countries
- Change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs in the EU and EEA only
- Change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs and also all activities necessary for health technology assessment for example, data to support assessment by the National Institute for Health and Clinical Excellence (NICE)
Arguably, the second option of limiting the exemption to those activities required to secure regulatory approval to market drugs in the EU and EEA only would not resolve the problem, for the reasons mentioned above in relation to the current UK Bolar provision. Therefore, one of options 1 and 3 appear to be more attractive. As health technology assessments are becoming more important in the current climate of the attempts by the NHS to reduce the drugs budget and the introduction of "value based pricing" (and the issue here is of comparative trials with patented drugs), then it may be as well to deal with this issue and therefore include a wide exemption. If this option is adopted, the drafting will need to be sufficiently clear so as not to exempt the primarily commercial exploitation of infringing products.
The UKIPO is very clear that this new exemption will only relate to clinical and field trials so will not deal with certain other anomalies in the research exemption (outside the clinical trials arena). For example, a purchaser of an infringing product which is used for experimental purposes does not infringe but the supplier of such a product does infringe because the supply is not done for experimental purposes .
In conclusion, although there have not been many UK court proceedings dealing with infringement by the carrying out of clinical trials in the UK, the consequent absence of legal authority means that there is uncertainty in this area. Therefore the UKIPO's proposal to reduce this uncertainty is to be welcomed. Anyone who wishes to comment on the proposals may do so directly to the UKIPO by the deadline of 19 December 2012.