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

Forgotten your password?

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

Business and Property Courts: remote hearings to remain, for now…

For business disputes, it looks likely that remote hearings will be an option into the future.

View blog

Insolvency applicants: getting the basics right

A number of interesting developments have emerged from what was quite a run-of-the-mill insolvency application brought by a litigation funder assignee.

View blog

Moratoriums

The new Part A1 moratorium was introduced partly in response to the Covid-19 pandemic and its impact on businesses. The moratorium is not intended to be used to simply delay the inevitable insolvency of a company, but rather to allow breathing space for that company to restructure and/or achieve an effective rescue.

View blog

Covid-19 insolvency measures extension

From 26 March 2021 the Corporate Insolvency and Governance Act 2020 (Coronavirus) (Extension of the Relevant Period) Regulations 2021 will come into force with the effect of extending several of the temporary measures brought in by the Corporate Insolvency and Governance Act 2020 (CIGA).

View blog

Mailing list sign up

Select which mailings you would like to receive from us.

Sign up