Following the UK IPO’s informal consultation in 2011 on the scope of the “Bolar-like” and experimental use exemptions in the UK, the UK IPO has now issued a formal consultation paper with proposed amendments to the UK Patents Act.

The UK Intellectual Property Office (UK IPO) issued an informal public consultation in June 2011 to investigate the impact of the current UK law on patent infringement on the conduct of clinical (and field) trials by the life sciences industry. In the light of the responses it received, the UK IPO has now issued a formal consultation paper which sets out in detail the UK Government’s proposals to amend the UK Patents Act to include an additional exemption from patent infringement.

As foreshadowed in the earlier consultation documents, this paper now includes three proposed options for amending section 60(5) of the UK Patents Act 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)).

Should you wish to participate in the consultation process, a link to the formal consultation document is provided below. All responses should be received by the UK IPO by 19 December 2012. http://www.ipo.gov.uk/consult-2012-bolar.htm

If you wish to discuss these issues further, please do not hesitate to contact us.