The UK is preparing to enact legislation that would alter the definition of what constitutes 'experimental use' and, as a result, would broaden the range of acts that are exempt from patent infringement during the development of medicines.
These changes are intended to make the UK a more attractive venue for those conducting the trials necessary for regulatory approval, and are to be implemented in a manner that is intended to endure when the Unitary Patent Regulation and Unified Patent Court (UPC) Agreement come into force.
In order to obtain approval from national and regional regulatory bodies, those seeking to market a generic version of a previously-approved medicine must typically conduct their own trials, which will require them to produce or purchase and then use the relevant active ingredient. If regulatory approval is to be obtained in sufficient time to allow for marketing immediately after the expiry of the innovator's patent protection, as is desirable, the relevant trials will need to be commenced well before.
UK patent law provides two exemptions to infringement that are potentially relevant to such acts: the 'experimental use' exemption; and the so-called 'Bolar' provision (named after similar US legislation).
However, the UK courts have interpreted 'experimental use' as relating only to tests designed to obtain new information, and not for the confirmation of previously-obtained results, as is often required in clinical trials. Moreover, the Bolar provision is derived from a European directive and, in its narrowest interpretation (as enacted in UK law), provides an exemption only for trials required to gain approval for a generic version of a previously-approved medicine (using the so-called abbreviated procedure) in the European Economic Area (EEA).
The current legislation, therefore, leaves significant gaps and areas of uncertainty in respect of the possibility of infringement when conducting trials in the UK. In particular, those conducting clinical trials to gain regulatory approval outside of the EEA, or using the relevant agent for comparative purposes during the development of a new medicine, are unlikely to be exempted from infringement.
The current situation in the UK contrasts with that in many other European countries, where a considerably broader set of exemptions exist. For example, in Germany there is an exemption for acts required to gain regulatory approval for any medicine (not just a generic versions) in any country. This makes the UK less attractive as a venue for companies seeking to develop generic and/or innovative medicines.
The UK parliament is currently considering legislation that, in its current form, would significantly broaden the range of acts exempted from infringement, for example, in relation to clinical trials. This would be achieved through a re-defining of what constitutes ‘experimental use', with the existing Bolar provision remaining unchanged (and, perhaps, becoming redundant).
Full details of the currently-proposed legislation can be found at www.legislation.gov.uk Of course, the proposed legislation may be amended prior to its passing. The proposed legislation would broaden the definition of experimental use to cover all acts performed for the purpose of a "medical product assessment", which is broadly defined and potentially covers the full range of acts required for gaining or varying approval from a regulatory body, and from health authorities assessing whether to permit its use. This would exempt acts done in order to gain regulatory approval in any country, and for drugs with or without prior approval (i.e. both generic and innovative medicines).
It is hoped that this change will at least place the UK on a par with other European countries, such as Germany, as being an attractive venue for performing clinical trials and, in turn, will attract a broader range of companies operating in the pharmaceutical area to the UK.
Long term view
With the existence of the European Unitary Patent and UPC seemingly drawing closer, the participating countries may soon begin enacting legislation intended to make national laws consistent with the agreed common provisions. The UK Government's consultation on the implementation of these provisions can be found at www.gov.uk
The provisions of the UPC could have implications for the Bolar and experimental use exemptions in force in European countries. For example, if the harmonised provisions relating to the UPC are interpreted as defining the extent of the Bolar provision, this may dictate a narrow scope. In contrast, it appears that interpretation of the experimental use exemptions may be less affected and, if so, could differ between territories (i.e. in line with local law).
If so, a country having previously adopted a broad exemption by modification of the Bolar provision could have the scope of that exemption limited, whereas a country having implemented such an exemption by reference to an experimental use provision (as is proposed in the UK) would be unaffected. Thus, the UK government's decision to enact a broad exemption through amendment of the experimental use provision may allow for greater long term certainty than can be expected in other territories.