0370 270 6000

already registered?

Please sign in with your existing account details.

need to register?

Register to access exclusive content, sign up to receive our updates and personalise your experience on brownejacobson.com.

Privacy statement - Terms and conditions

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.

related opinions

Legal fees for advising on settlement agreements

When entering into a settlement agreement, it is a requirement for the employee to get independent legal advice on the terms and effect of the agreement.

View blog

High Court finds against WASPI women

The High Court has rejected the judicial review claim brought by the campaign group BackTo60 against the Department of Work and Pensions (DWP).

View blog

The importance of three magic words: subject to contract

A recent case illustrates the importance of ensuring that all emails discussing the terms of a proposed acquisition are headed ‘subject to contract’.

View blog

Vegetarianism is not a philosophical belief under the Equality Act 2010

In its Judgment earlier this month, the Tribunal considered whether vegetarianism is capable of being a philosophical belief capable of protection under the Equality Act 2010.

View blog

mailing list sign up



Select which mailings you would like to receive from us.

Sign up