The UKIPO have announced a consultation on whether to amend section 60(5) of the Patents Act 1977 to provide an exception to patent infringement for activities connected to clinical trials or field trials involving innovative drugs.
Currently section 60(5)(b) of the Patents Act 1977 sets out the experimental use exemption which excludes trials carried out to discover something unknown, to test a hypothesis or to find out whether something will work under particular conditions from being infringing acts. However, any acts carried out to demonstrate to a third party that a product works or to collect information to satisfy a third party, are not considered to be acts done for an experimental use and therefore are not exempt from infringement.
Section 60(5)(i) of the Patents Act 1977, known as the Bolar Exemption, exempts certain activities performed for the regulatory approval of a generic drug from infringement. This exemption does not currently apply to innovative drugs.
Thus, there is currently no specific exemption from infringement under UK law for clinical or field trials relating to innovative drugs.
The Government therefore proposes to amend section 60(5) of the Patents Act 1977 to provide such an exemption. Three proposed options have been put forward for changing the current legislation which are:
- to exempt from infringement all activities needed for regulatory approval for innovative drugs in all countries,
- to exempt from infringement all activities needed for regulatory approval for innovative drugs in the EU and EEA and
- to exempt from infringement all activities needed for regulatory approval for innovative drugs and additionally for health technology assessment.
The consultation can be found at http://www.ipo.gov.uk/pro-policy/consult/consult-live/consult-2012-bolar.htm and all responses are to be received by 19 December 2012.