UK Extends Scope of Clinical Research Exemption

From 1 October 2014 the experimental use exemption to patent infringement (also known as the research exemption) of section 60(5)(b) of the UK Patents Act is changing. The changes are intended to make it easier to use a patented product to carry out drug testing or other activity to provide information to regulatory or public bodies.

The changes cover activity carried out to provide information required by regulatory bodies e.g. in clinical trials. Also covered will be activity carried out to provide information to a public body to assess if a medicine should be used in the provision of healthcare e.g. health technology assessments.

Examples of regulatory bodies include the Medicines and Healthcare Products Regulatory Authority (http://www.mhra.gov.uk) and European Medicines Agency (http://www.ema.europa.eu). An example of a body which assesses if a new drug should be used in the provision of healthcare is the National Institute for Health and Care Excellence (http://www.nice.org.uk).

The new provisions are intended to cover both use of a patented medicine as a comparator and assessments on a drug combination (where a patented drug is part of the combination).

Obviously, the exemption will not extend to commercial activities, such as sale, commercial supply, or manufacture.

The changes are enacted by the Legislative Reform (Patents) Order 2014 (http://www.legislation.gov.uk/uksi/2014/1997/contents/made).

These changes will not apply retrospectively and will only apply to activities carried out after 1 October 2014.

If you would like more information on this change to UK patent law, please contact us.

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