It is uncertain whether clinical trials of innovative drugs are exempt from patent infringement. Clinical trials on generic drugs already are, because of the "Bolar" exemption, set out in Section 60(5)(i) of the Patents Act 1977. The United Kingdom Intellectual Property Office (UK IPO) has now published the results of its consultation on extending the scope of the research and Bolar exemption to cover clinical trials using innovative drugs. For an outline of the consultation, please visit our earlier alert on the proposed amendments.
Most respondents think that trials of new drugs should be exempt from patent infringement. They also want to see the exemption extended to include clinical studies required for health technology assessments (HTAs). HTAs include those assessments required by the National Institute for Health and Clinical Excellence (NICE) to demonstrate the effectiveness of a medicine. The NHS is legally obliged to fund medicines that are recommended by NICE.
The UK IPO will propose drafting for the new exemption, but there is bound to be argument over its extent. The responses to the consultation have already identified issues such as:
- the exemption should also apply to the comparator drug in a comparative trial;
- the exemption should extend to contributory infringement, so as to cover the activities of contract research organisations and active pharmaceutical ingredients manufacturers;
- whether biosimilars will fall within the proposed definitions;
- what "activities" are covered; and
- whether patents covering biomarkers, assays and electrical equipment are also to be included.
Some other EU countries, notably Germany, already have wider exemptions than the UK, so any final amendments may take us nearer to (and may exceed) the German position.
However, the recently signed Unified Patent Court Agreement (UPCA) seems to limit the exemptions narrowly to those required by EU Directives (at Article 27). This may lead to wider exemptions for national patents in some countries compared with those for the Unitary Patent (and for European Patents which are not opted out of the Unified Patents Court when it comes into effect). That will include the UK if these amendments go ahead, which is likely.
Finally, it is somewhat ironic that the new proposed amendment to the UK Patents Act does not cover plant protection products at all. This is because the leading UK case on the application of the experimental use exception to trials, Monsanto v Stauffer  RPC 515, which was the cause of the uncertainty in this area that the consultation seeks to address, dealt with field trials for a herbicide.