UK to become more attractive for conducting clinical and field trials
First appeared in Scrip Regulatory Affairs, 1 April 2013
Conducting clinical and field trials in the UK for innovative drugs can be a mine field due to the risk of infringing third party patents through the use of patented drugs in the trials or because the innovative drug infringes such patents. The UK Government announced at the end of February that it supports amending the Patents Act 1977 to remove this uncertainty and make the UK a more attractive place to conduct clinical and field trials.
The current UK legal position
The Patents Act 1977 contains a number of carve outs which exempt certain activities from patent infringement. Section 60(5)(b) provides an "experimental use" exemption but it has been defined narrowly by the English Courts and it is unclear how far it extends. Not all clinical trials are regarded as "experimental use", especially those which use a patented comparator. Section 60(5)(i) exempts certain activities performed to obtain regulatory approval for generic drugs (the so-called "Bolar Exception"). However, this exemption does not extend to innovative drugs, unlike in other EU countries such as Germany.
The narrow scope of these exceptions and their impact on clinical and field trials have been an issue for stakeholders for some time as they run the risk of being sued for patent infringement when conducting research and tests required for the regulatory approval of innovative drugs. In addition, Health Technology Assessments (HTAs) which, amongst other things, investigate how a new drug compares to alternatives currently on the market, are not exempt from patent infringement.
The Government response to the UK IPO consultation
To help address the situation, the UK IPO ran a formal consultation from 24 October to 19 December 2012 on proposals to amend the Patents Act 1977 to exempt activities relating to clinical or field trials for innovative drugs. The Government's response to the consultation was published on 26 February 2013. Twenty responses were received, of which all but one were in favour of change.
There was general acceptance from respondents that the current legislation puts the UK at a competitive disadvantage compared to other EU countries with broader exceptions to patent infringement. The proposed changes would bring certainty to the industry and align UK law with the majority of the EU countries.
There were, however, differing views as to the scope of the new exemption and which of the three options put forward by the UK IPO should be followed. One respondent expressed concern that the new exemption should not include marketing activities. Another that it should not be applicable once the product was marketed. Yet another that contributory infringement from, for example, CROs should be exempt.
Those respondents in favour of the inclusion of HTAs in the new exemption provided a number of supporting reasons including that HTAs are increasingly required in the UK and Europe, they are an onerous process requiring the use of third party products for comparative studies and it is desirable to generate HTA data from existing trial sites.
Very little quantified evidence was provided by respondents as to potential costs savings to them or the losses that might be incurred by patentees or licensees through the proposed changes. Several responses indicated that companies were being advised to do trial work in other jurisdictions and some did not consider running trials in the UK due to the risk of patent infringement. Other respondents referenced the significant costs of FTO searches, validity challenges and defending infringement actions. There was an acknowledgement by a number of respondents of the loss of licensing fees to patentees as a result of the proposed changes though the exact extent of the loss was unclear.
In light of the comments received, the Government concluded that "section 60(5) of the Patents Act 1977 should be changed to include an exemption from infringement, for activities involved in preparing or running clinical or field trials involving innovative drugs for the purpose of gaining regulatory approval in any country. The exemption should also cover activities involved in health technology assessment (HTA)".
Whilst the decision to include a new exemption in the Patents Act 1977 will, in principle, be welcomed in the industry, there is concern as to the exact scope of the exemption and the definition of terms such as: "HTAs", "innovative drugs" and "generic drugs". The exercise will have been futile if clarity and certainty as to the boundaries of the new exemption cannot be provided. The industry needs to know which acts will infringe and which will not. Assuming this is achieved, the proposals should attract more research and trials in the UK which would be a positive outcome for the UK economy.