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.