Clinical Trials and Patent Infringement: Proposed Amendments to the UK Patents Act

Following the UK IPO’s consultation on the scope of the “Bolar-like” and experimental use exemptions, the UK Government has accepted that the UK Patents Act should be amended.

Issue

The question of whether conducting clinical trials in the UK can amount to patent infringement is one that frequently concerns our clients in the Life Sciences sector. Although the UK Patents Act 1977 offers potential exemptions from patent infringement the scope of these exemptions has been uncertain.

The current “Bolar-like” provision of Section 60(5)(i) of the UK Patents Act expressly provides a defence to patent infringement when testing for the purpose of an abridged (or hybrid abridged) procedure for obtaining marketing approval for generic or biosimilar medicinal products. Thus clinical trials for new active substances, for example, will not fall within the scope of this exemption. The issue then has been whether the “experimental use” exemption provided by Section 60(5)(b) would provide a defence for innovator clinical trials. This section provides a defence for acts “done for experimental purposes relating to the subject-matter of the invention”, but there is presently no case law to confirm whether clinical trials would benefit from this exemption and, if so, whether all phases of the studies would be protected.

Proposals

Following a public consultation in 2011 on the scope of the “Bolar-like” provision and the experimental use exemption, the UK Intellectual Property Office (UK IPO) issued a further consultation paper in October 2012 which set out in detail the UK Government’s proposals to amend the UK Patents Act to include an additional exemption from patent infringement for innovator clinical trials.

Three proposed options were put forward to expressly exempt from infringement all activities required to secure regulatory approval to market innovative drugs:

(i) in all countries;

(ii) in the EU and EEA only; and/or

(iii) all further activities necessary for health technology assessment (e.g. data to support pricing and reimbursement by the National Institute for Health and Clinical Excellence (NICE)).

Responses

94% of stakeholders who responded indicated that activities carried out to gain regulatory approval of innovative drugs should be exempt from infringement. 63% indicated that activities conducted for health technology assessment should also be exempted.

Conclusion

The UK Government has now accepted that Section 60(5) of the UK Patents Act should be amended such that activities involved in preparing or conducting clinical (or field) trials of innovative products in the UK for the purpose of gaining regulatory approval in any country should be exempt from infringement. Further, this exemption should also cover activities involved in health technology assessment.

A copy of the response document is available at:

http://www.ipo.gov.uk/pro-policy/consult/consult-closed/consult-closed-2012/consult-2012-bolar.htm

If you wish to discuss these issues and their impact on your business further, please do not hesitate to contact us.

Dr Penny Gilbert

T: 020 3040 8020 | email: penny.gilbert@powellgilbert.com