New legislation drafted by the UK government should shield clinical trials in the United Kingdom from the risk of patent infringement in the near future.
In its current form, the UK Patents Act includes two provisions aimed at exempting certain experiments from infringement. These two statutory devices are as follows:
- The act exempts any act “done for experimental purposes relating to the subject-matter of the invention”.
- The Bolar exemption specifically exempts acts relating to clinical trials.
At present, a company wishing to carry out a clinical trial within the United Kingdom must rely on one of these two exemptions. However, the first provision (relief for acts for experimental purposes) has been interpreted too narrowly by the UK courts to provide relief for clinical trials. The second provision (the Bolar exemption) also provides limited relief because it is limited to clinical trials for authorisation of generic or biosimilar products, and only for trials aimed at obtaining authorisation within the European Economic Area (EEA).
As a result of these limitations, at present many clinical trials would not be sheltered from patent infringement by a statutory exemption in the United Kingdom. For example, companies wishing to carry out clinical trials on innovative drugs cannot currently operate under the safe harbour of an exemption (as opposed to trials for generic approvals.
Although the present Bolar exemption came as a result of the United Kingdom implementing an EU directive in 2005, the same directive was implemented differently in other EU member states. Notably, the Bolar exemption was implemented in Germany, Italy and France using text providing a far broader exemption, whereby clinical trials on innovative drugs and for ex-EEA authorisation are exempt.
The UK government is determined to make the United Kingdom an equally attractive destination for clinical trials by broadening the circumstances in which companies can rely on the exceptions to infringement (for further details please see "Extension of research exemptions in the United Kingdom").
The proposed legislation does not modify the Bolar exemption. Instead, the legislation lists specific acts that will be covered under the 'experimental purposes' exemption (the first exemption above), including “anything for the purposes of a medicinal product assessment”. A further definition of the term 'medicinal product assessment' clearly covers acts for obtaining a marketing authorisation for both generic and innovative products anywhere in the world.
The proposed change should have the desired effect and will therefore be welcomed by companies in the pharmaceutical industry wishing to carry out clinical trials in the United Kingdom without risk of patent infringement. The current proposal is for this draft legislation to come into force on October 1 2014.
Although the proposed change appears to achieve the UK government’s primary aim, the wording may have side effects and give rise to complications. Two examples are below.
Negative effect on research tool patents
One possible consequence of the proposed amendment is that some research tool patents would effectively become unenforceable because any would-be infringements would be exempted under the proposed amendment. Research tool patents may, for example, claim an assay or a kit for determining the effect of a drug on a target. Under the proposed legislation, these claims might arguably not be enforceable against use of the invention during the process of obtaining a marketing authorisation.
Consistency with UPC Agreement
The EU unitary patent is on the horizon and so is the Unified Patent Court (UPC) Agreement. In order to ratify the UPC Agreement, an EU member state must amend its national law to define infringement consistently with the UPC Agreement. There are two areas of possible inconsistency between the UPC Agreement and the new UK proposal.
First, the UPC Agreement mirrors the existing UK legislation (ie, it includes the two exemptions set out above). The term 'experimental purposes' is not defined in the UPC Agreement, so it does not necessarily exempt clinical trials from infringement in the same way as the new UK proposal does.
It has therefore been suggested that the United Kingdom would need to reverse the proposed change when ratifying the UPC Agreement.
Second, debate is ongoing over whether infringement of European patents that have been opted out of the UPC will still be governed by the UPC Agreement or alternatively national law. It is therefore possible that opting a European patent out of the UPC would result in a (different) national law being applicable, meaning that the exemptions for opted-out patents would potentially be more generous than that for patents governed by the UPC Agreement. If this situation develops, patentees would be well advised to consider the possibility of avoiding the broad new UK exemption when deciding whether to opt European patents out of the UPC.
The proposal is expected to be welcomed by the UK pharmaceutical industry and to encourage more companies to conduct clinical trials within the United Kingdom. Nevertheless, there are downsides for proprietors of research tool patents and potential complications, particularly concerning consistency with the UPC Agreement.
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