The “Bolar exemption” is an exception to the exclusive right granted by a patent, permitting use of patented products in experiments for the purpose of obtaining regulatory approval for medicines. Following extensive industry lobbying of the UK government to facilitate trials for existing drugs and for the development of new, non-generic drugs, the UK Patent Act has been amended, as of 1 October 2014, to include trials of new drugs falling within the scope of a patent or requiring comparative studies with a known patented drug.
As included in the UK Patents Act prior to 1 October 2014, it merely allowed companies to carry out regulatory tests required for proving the equivalency between a generic drug and a patented drug. This meant that generic drug companies were allowed to do no more than obtain the necessary regulatory approval to launch their products prior to expiry of a patent protecting the original drug, so that when the patent expires, the marketing authorisation would be in place. However, the “experimental use” exception has now been extended by the addition of Section 60(6D) to the Patent Act:For the purposes of subsection (5)(b), 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.
New subsection 6E defines what is meant by “medicinal product assessment”. Notably, it includes:
• testing with a view to providing data for obtaining marketing authorisation and associated regulatory compliance anywhere in the world (by contrast, some corresponding provisions in other EU countries only permit testing for purpose of obtaining marketing authorisation and regulatory compliance in the EU); and
• enabling anyone (government, public authority or any person real or legal, anywhere) who has the function of providing public health care (anywhere) or of providing advice about the provision of health care to such public authority to carry out an assessment of suitability (typically referred to as a “Health Technology Assessment”, e.g. by the National Institute for Clinical Excellence) of a drug for purposes of determining whether to use it or recommend its use.
This new limitation on the scope of patent protection (or, if you like, extension of the “experimental use” exception) will encourage companies to carry out their research and clinical trials in the UK where those trials are required to obtain market authorisation for innovative drugs. This is expected to have a positive effect on the UK economy. Ireland has recently implemented a similar exemption.
There is debate as to whether this intention of the legislature may be circumvented by applying for a European patent registered in the name of a company located in a member state (e.g. Belgium, Cyprus, Netherlands or Sweden) that has a narrower exemption, and declaring such a patent as having unitary effect. This is a debate that is likely to run and run. Please visit our webpage
http://www.jenkins.eu/unitary-patent/ for updates.