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Consultation on patent infringement in pharmaceutical clinical and field trials opened by the IPO

5 November 2012

The Intellectual Property Office (IPO) is consulting on patent infringement in pharmaceutical clinical and field trials. A broader exception to patent infringement for activities related to obtaining regulatory approval of pharmaceuticals is being considered. The consultation is likely to lead to an amendment of the Patents Act 1977.

The Act currently allows generic drugs to be used in clinical and field trials and exempts clinicians from facing infringement actions, however these provisions do not apply to innovative drugs. This leaves clinicians using innovative drugs in clinical and field trials exposed to uncertainty as to which experimental acts fall within the scope of the current exemption and the risk of patent infringement. This risk may well curtail trials and prevent new pharmaceuticals being developed.

The current provisions do not provide enough protection to clinicians and pharmaceutical stakeholders using new drugs. The Government has accepted there is a need to change the UK patent law and hopefully this will lead to an infringement exemption for innovative drugs.

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