On 26 February 2013, the UK government announced a proposed change to the Patents Act to exempt clinical and field trials, as well as "health technology assessments," e.g., tests to obtain data to support assessment by the National Institute for Health and Clinical Excellence (NICE), for any new drugs from any claim of patent infringement.
Currently, the so-called Bolar defence provides that conducting tests for obtaining data to support applications for the approval of generic pharmaceutical products is not a patent infringement. The defence extends to consequential practical requirements such as importing or manufacturing the pharmaceutical product to be used in those tests.
The Bolar defence does not apply if the tests are being conducted to provide data to support an application for approval of a new drug. Whilst the Patents Act provides a defence to those conducting research for experimental purposes, this has been construed narrowly by the UK Court and has been found not to apply to clinical trials and tests involving new drugs. This limited exemption has been viewed as a barrier to innovation within the pharmaceutical industry as companies are unable to undertake proper and necessary clinical trials within the UK without running the risk of an action for patent infringement.
The UK Intellectual Property Office conducted an open consultation on the Bolar defence and received an overwhelmingly positive response supporting a broadening of it. The broadening of the defence to include new drugs will no doubt help the UK life sciences industry remain at the cutting edge of innovation.
The UK Intellectual Property Office will seek to implement the changes into the UK Patents Act by the end of 2013. We will report further, once the revised wording of the Act has been finalised.
For additional information regarding this topic, please see:
• "UK Government Considers Broadening Bolar Exemption," November 19, 2012
This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK. Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.