The Intellectual Property Office is undertaking a formal consultation on its proposal to amend the Patents Act to allow clinical and field trials for new drugs, which involve the use of already patented drugs, to be carried out without risk of patent infringement.

This would include the activities required to obtain regulatory approval to market new drugs or to assess their efficacy.

Under current UK patent law, there are very limited research and testing activities that can be conducted using patented products without infringing the rights of the patent owners, and these activities fall under what is known as the “Bolar” exception.

Unfortunately, clinical and field trials for new drugs are not exempt from patent infringement and use of a patented drug in any trial by a third party carries the risk of being sued by the patent holder.

The scope of the Bolar exception has been an issue for stakeholders for many years, and many experts have indicated that the narrow scope of the exception in the UK is hampering UK pharmaceutical innovation and R&D activities, compared to many other EU countries with much broader exceptions.

Given the rich history of pharmaceutical innovation in the UK, the government is keen to ensure that the UK remains a world-class player for many decades to come.

The new proposal by the UKIPO is to provide an exception to patent infringement for activities involved in preparing or running clinical or field trials which use innovative, or non-generic, drugs.

The consultation will take the views of industry, from patent holders to generics companies and the results will be published early this year.

For further information please contact Wilson Gunn.