Clinical Trials and Patent Infringement: The UK IPO Consultation. 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 remains uncertain.
The “Bolar-like” provision of Section 60(5)(i) Patents Act 1977 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 is whether the “experimental use” exemption provided by Section 60(5)(b) provides 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”. Despite some guidance from the Court of Appeal in Monsanto v Stauffer , relating to agrochemical field trials, there is presently no case law to confirm whether clinical trials will benefit from this exemption and, if so, whether all phases of the studies would be protected.
The UK Intellectual Property Office (UK IPO) has now issued a public consultation to investigate the impact of UK patent legislation on the conduct of clinical trials in the UK. See http://www.ipo.gov.uk/consult-2011-bolar.pdf. Responses are sought by 31 July 2011 and the results of the consultation will be reported in Autumn 2011.
If you are considering submitting a response, or if you wish to discuss these issues further, please do not hesitate to contact us.
Dr Penny Gilbert