Following publication of the results of the Intellectual Property Office's consultation on the subject, the Government has announced that the Patents Act (section 60(5)) shall be amended to include an exemption from infringement for activities involved in preparing or running clinical or field trials of innovative drugs for the purpose of gaining regulatory approval in any country.
This change will exempt from infringement the activities required to secure regulatory approval to market innovative drugs, and also activities necessary for health technology assessment – for example, data to support assessment by the National Institute for Health and Clinical Excellence.
It is hoped that the change in law will improve the clinical trials environment in the UK, making it a more desirable location for clinical trials and, in turn, benefitting patients, the industry and the economy.
It is proposed that the amendments to the Patents Act will come into effect on 1 October 2013.
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