Bolar provisions – proposals for a new Irish patent infringement exemption for trials involving innovative drugs

May 2013

Ireland transposed the so-called “Bolar” exemption provision contained in Article 10.6 Directive 2001/83/EC (as amended by Directive 2004/27/EC) by way of S.I. No. 50 of 2006 “European Communities (Limitation of effect of Patents) Regulations 2006.

Similar to the position adopted in the UK, Ireland took a literal interpretation of the provision as set down in the Directive. Other member states (including France and Italy) opted for a broader interpretation of the exemption and implemented the exemption provision beyond the Directive. The provision creates an exemption from patent infringement for certain acts carried out by a generic manufacturer with a view to obtaining a marketing authorisation for a generic medicinal product.

On 14 April 2012, the Intellectual Property Unit in the Department of Jobs, Enterprise and Innovation, launched a formal consultation on proposed changes to the legislation to broaden the scope of the “Bolar” type research exemption provisions set down in Section 42 (g) of the Patents Act, 1992.   The aim of the new proposal is to broaden the scope of the exemption provision for both medical products for human use and veterinary medical products, as set down in Section 42 (g) (i) and (ii) of the Patents Act, 1992.   Specifically, it is proposed to extend the exemption to:

1.  “include all studies/tests/experiments/clinical/field trials and the consequential practical requirements which are necessary for the purpose of obtain a market authorisation for a new as well as a generic product (i.e. carrying out tests on a combination product where one of the components is patented by a third party),
2. Cover acts done in this country relating to the acquisition of a marketing authorisation in a non-EU country”.

Responses to the consultation had to be submitted to the Intellectual Property Unit in the Department of Jobs, Enterprise and Innovation by 20 April 2012.  We understand that the responses received suggested that it would be useful to clarify the existing exemption and were also supportive of a change in the primary legislation to broaden the scope of the current exemption to include other elements.

Whitney Moore understands that the Department of Jobs, Enterprise and Innovation has studied the responses and that they are currently finalising a Regulatory Impact Assessment which will give an overview of the issues raised and set out the appropriate action to take.   Once finalised, the Regulatory Impact Assessment will then be submitted for ministerial consideration.

While new legislation is likely to be implemented in the UK by 1 October 2013, it is unlikely that any proposed new legislation in Ireland will be implemented until 2014.