UK Patents Act and the Bolar Exemption
Draft UK legislation has been published that effectively extends the so called “Bolar” provisions in the UK to exempt from patent infringement certain
activities related to gaining regulatory approval in any country for innovative as well as generic drugs, particularly activities relating to the carrying out
of clinical trials. The exemption will also cover activities involved in health technology assessment (HTA).
In order to market a medicinal product regulatory approval must first be obtained by conducting clinical trials to prove that the product is safe and effective. However, under the current UK Patents Act, a party carrying out the clinical trials might run the risk of patent infringement if they conduct clinical trials in the UK on a patented product before the patent has expired.
The so-called “Bolar provision” is already included in the UK Patents Act. The Bolar provision provides an exemption for infringement, but this exception is limited to trials carried out in respect of generic drugs only.
The current limited scope of the Bolar exemption in the UK has been an issue for stakeholders for some time; with concerns that the current regulatory framework may put stakeholders at risk of patent infringement when carrying out clinical and field trials for innovative or non-generic drugs. In some cases stakeholders have decided to run some trials in more favourable jurisdictions resulting in a potential loss to the UK economy.
Earlier this year the UKIPO carried out a consultation on whether the UK Patents Act should be amended to broaden the scope of the UK Bolar exemption. Most respondents stated they would like the exemption to cover activities carried out to gain regulatory approval of new drugs, and a significant majority wanted the exemption to extend to the studies required for their health technology assessment.
Given the responses, the UKIPO sought to amend Section 60(5) of the UK Patents Act to include a new exemption. This would exempt from patent infringement the activities required to secure regulatory approval to market innovative drugs, and also activities necessary for health technology assessment e.g. data to support assessment by the National Institute for Health and Clinical Excellence (NICE).
Draft amendments to the Patent Act have now been published and, if approved, would come into force from 1st October 2014. It is proposed to add a new subsection to the Act stating that “anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject-matter of the invention.” As such, these acts would therefore no longer constitute an infringing act. “Medicinal product assessment” is itself defined as any testing, course of testing or other activity undertaken with a view to providing data for a set of specific purposes. The definition of “medicinal product” embraces both products for human and animal use.
Improved clarity on the applicability and broadening of the Bolar exemption to innovative drugs in the UK will no doubt be welcomed.