Activities undertaken in clinical drugs testing will be exempt from patent infringement, Government announces

The Intellectual Property Office (IPO) said the changes to the Patents Act (24-page / 262KB PDF) which it has outlined had been backed by an "overwhelming" number of respondents to a consultation it had previously held on the issue.

In its response to its consultation the Government outlined its intention to amend Section 60 (5) of the Patents Act. The amendment will mean that "activities which are carried out when preparing, or running, clinical or field trials using innovative drugs" will be exempt from being considered as patent infringement. The exemption will also cover activities involved in 'health technology assessment' - a term which broadly describes the process of establishing whether methods used to prevent and treat diseases are effective and which patients those methods can most benefit and at what cost.

The Government said it will use a "legislative reform order" to affect the changes to the law.

Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said that change would broaden the scope of the existing research and 'Bolar' exceptions. The research exemption had been "narrowed" in recent years as a result of UK court rulings, she said.

In 2005 changes were made to the Patents Act to make the use of patented material during some clinical testing of human and animal medicines exempt from being an infringement of patent owners' rights. This is called the 'Bolar exemption' and stems from EU law. Under the Patents Act any act "done for experimental purposes" relating to the subject-matter of an invention are also exempt from being classed as acts of infringement.

Cline said that legal uncertainty around the existing research and Bolar exemptions had caused drugs firms to look elsewhere in the EU to undertake clinical testing.

"The proposed changes to patent law should mean that the boundaries of the exemption will be more clearly drawn and it should be clearer whether or not certain activities in drug development fall within the exemption," Cline said. "The changes will bring the UK legislation into line with other European Union countries such as Germany which exempt all clinical or field trial work with medicines from patent infringement."

"In the response to the consultation companies stated that the current UK position has led them to move some clinical trial work from the UK to other EU countries with a broader interpretation of the exemptions in their patent laws," she said.

The IPO said that the UK economy would stand to benefit from the amendments to the Patents Act because the changes could encourage stakeholders to run drugs trials in the UK where skills and knowledge could be retained. It also said the decision could encourage those firms to elect to manufacture drugs in the UK to the benefit of the UK's economy. It said that there is an "unquantifiable loss to patient groups" in the UK if companies elect not to include them in drugs trials run abroad.

"We are committed to creating the right environment in the UK for life sciences companies to thrive," Minister for Universities and Science David Willetts said in a statement. "Today marks an important step forward by removing the risks of patent infringement when testing new drugs and treatments. This will make the UK a more attractive location for research and development, supporting growth and innovation."

"The Government is keen to create a supportive environment for pharmaceutical research and development in the UK," Lord Younger, Minister for Intellectual Property added. "Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy."