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UKIPO Consultation on Clinical Trial Exemption

The UKIPO has launched a consultation concerning the introduction of a new exemption to infringement into the UK Patents Act 1977. The proposed exemption would cover clinical and field trials which are carried out using innovative drugs.

In order to market a drug in the UK and EU, regulatory approval is needed. Where the clinical trials necessary to obtain regulatory approval involve the use of a patented product, then the ability of a company to carry out those trials without infringing the patent is currently unclear.

As the law stands, is not an infringement of a patented product to carry out clinical trials for generic products, for the production of data solely used to obtain EU approval (the so-called “Bolar” exemption). This exemption, relating to generic products only, does not provide any protection for the development of innovative drugs.

In addition, an act is not an infringement of a patented product if it is carried out for experimental purposes relating to the subject-matter of the invention. The scope of this exclusion, while potentially covering clinical and field trials carried out using innovative drugs, is not clear and there is a dearth of relevant case law in the UK. German courts have interpreted an equivalent exclusion broadly, covering even Phase III clinical trials, and there has been some speculation that the UK courts would follow this precedent. However, in the absence of relevant decisions of the UK courts on this point, the position for pharmaceutical companies remains uncertain.

The UKIPO is now proposing to introduce a new exemption which would allow clinical and field trials using innovative drugs to be carried out without infringing existing patent rights. This would enable a company to, for example, compare a new drug to a patented product, or to develop therapies combining a new drug with a patented product.

It is hoped that this change to the law will make the UK a more favourable place for the development of new drugs, promoting jobs and supporting growth in the UK pharmaceutical industry. Of the proposals, the Chief Executive of the UKIPO said “Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials. This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector.”

The consultation can be found here and is open until 19 December 2012.


14 November 2012

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