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Clinical trials: the unitary patent and bolar exemptions

1st Mar 2013

The Government has announced a change to the UK Patents Act which – when in force – should mean that clinical trials for innovative (rather than generic) drugs can be carried out in the UK without running the risk of patent infringement.

UK patent law does exempt some activities from patent infringement. The so-called “experimental use exemption” has the effect that acts (relating to the subject matter of the invention) done for experimental purposes1 do not constitute infringement. However, UK courts have interpreted this narrowly; acts, such as clinical trials, having the purpose of obtaining regulatory approval for a new drug would not generally be considered to fall within this exemption.

Acts required to obtain marketing authorisation for a generic medicine in accordance with the EU Bolar Directive are specifically exempt from infringement under UK law2. However, the UK has implemented the Bolar Directive narrowly; the permitted acts relate to obtaining marketing authorisation for a generic medicine (not any drug). A clinical trial with the purpose of obtaining marketing authorisation for an innovative drug would not be exempt from infringement (in the UK) by this provision.

Other EU member states have, however, implemented the Bolar Directive in a different way, which appears to extend permitted acts to marketing authorisations for any drug. This means that a clinical trial for an innovative drug which is not an infringement in some EU member states, would represent an infringement in the UK. This, of course, has an effect on those interested in performing such trials in the UK.

The UKIPO performed a formal consultation on whether acts relating to the running of clinical trials for innovative drugs should be exempt from patent infringement in the UK. The overwhelming majority of responses were in favour of a change in the law, and the Government is to act accordingly. The law change is expected to become effective in October 2013 or later, and according to the UKIPO, “the change will allow clinical and field trials and health technology assessment for new drugs to be carried out without running the risk of being sued for patent infringement”.

In the meantime, the relentless march of change extends beyond the UKIPO. The proposed (and possibly imminent) unitary patent package has been devised with the intention of providing a truly European wide patent right which will be enforced by the Unified Patent Court (UPC).

It appears that acts relating to obtaining marketing authorisation for a generic medicine in accordance with the Bolar Directive are to be specifically exempt from infringement of a unitary patent3. However, the differences in the way that the Bolar Directive has been applied in different member states means that, effectively, the scope of European patents varies between member states, and this will need to be resolved by the UPC. The announcement means the UK is falling into step with member states that have interpreted the Bolar provisions broadly, but other member states may not. The current draft wording of the UPC suggests a narrow interpretation of Bolar, but where will the UPC decide to draw the line?

It seems inconceivable that the momentum behind the unitary patent (and UPC) will falter in the face of the Bolar directive. However, the uncertainty on how the Bolar Directive will be applied by the UPC is another factor for patentees in the pharmaceutical field to consider, when deciding whether to use the unitary patent. If the UPC interprets the Bolar Directive narrowly, this means broader patent scope; the unitary patent may be favourable. If the UPC interprets the Bolar Directive broadly, this means narrower scope of protection, and patentees in the pharmacutical field may then elect to opt out of the unitary patent – while they can still do so – to maximise patent protection in those member states where the Bolar exemption is interpreted narrowly.

  1. Section 60(5)(b) UK Patent Act 1977.
  2. Section 60(5)(i) UK Patents Act 1977; Directive 2004/27/EC3 Article 27(d) Draft Agreement on a Unified Patent Court

This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.

Phil Bates
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Would you like to know more? You can talk to Phil Bates who will be able to help. Call +44 (0)20 7242 0901


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