Clinical Research “Likely to Return to the UK” Following Change in Patent Law

Comment from Intellectual Property specialists Marks & Clerk on the Government decision to exempt clinical and field trials from patent infringement -

The UK Government has today announced plans to exempt clinical and field trials from patent infringement, following a period of consultation by the UK Intellectual Property Office (IPO). This experimental use exemption from patent law will mean that parties are free to use innovative drugs for clinical and field trials to obtain regulatory approval for them in any country, even if the innovative drugs, or aspects of them, are covered by other parties' patents.

Currently, organisations undertaking the necessary activities required to secure regulatory approval to market innovative drugs, such as clinical trials for human drugs and field trials for veterinary drugs, can run the risk of infringing other parties' patents. Responses to the UK IPO's consultation suggested that existing UK law causes legal uncertainty and significant expense for affected organisations. According to participants in the consultation, because of the current legal situation, clinical and field trials are being "off-shored" to more innovator-friendly countries such as Germany, manufacturing of innovative new drugs is taking place outside the UK and, consequently, there are delays in innovative new drugs going to market and reaching patients in the UK.

Under the Government’s plans, which are scheduled to come into effect on Tuesday 1 October 2013, the Patents Act will be amended by a Legislative Reform Order. The exact changes to the law to be made have not yet been proposed.

James Robertson, Life Sciences Patent Attorney and Partner at Marks & Clerk, comments:

“This is excellent news for many in the UK life sciences industry, including originator drugs companies, clinical researchorganisations, publicly funded research bodies and charities. The Government’s plans to exempt clinical and field trials involving innovative drugs from patent infringement will reduce the current legal uncertainty and costs associated with possible infringement. This will help remove the need to off-shore clinical and field trials, encourage UK manufacturing, and give UK patients earlier access to innovative new drugs.

"Since the new exemption to patent infringement will apply to the use of innovative drugs for clinical and field trials to obtain regulatory approval for them in any country, this may help the UK become a more attractive centre for international clinical trials."

James Robertson continues:

“By adopting this research exemption, the UK Government is bringing UK patent law in line with patent laws in other European countries. In the UK, although an exception already exists in the Patents Act, it has been subject to many court cases, which have narrowed its interpretation and shorn it of its power. The Government is now seeking to redress this imbalance, and ensure that the UK's intellectual property system supports the life sciences sector.”

Have Your Say Rate this feature and give us your feedback in the comments section below