The Irish Government has proposed new legislation to widen the scope of the “bolar” exemption available under patent law, the effect of which will be to bring Ireland into line with the position prevailing in other EU member states. This followed a Regulatory Impact Analysis on the review of the Research Exemption Provision in respect of section 42(g) of the Patents Act 1992 (the Act) in April 2013.
On 2 July 2013, the Government approved proposals to amend the Act in order to expand the research exemption provision originally provided for in EU Directive 2004/27/EC relating to medicinal products for human use (the Directive). The proposed Intellectual Property (Miscellaneous Provisions) Bill will amend section 42(g) of the Act, known as the “Bolar Exemption”, which previously came into force to protect the generic industry from possible infringement of a patent when carrying out trials required to obtain a marketing authorisation. The current section 42(g) extends to the “necessary studies, tests and trials” conducted in order to demonstrate bioequivalence of a product. This wording was seen by many as a narrow interpretation of the Directive, compared to other EU countries and as a result, placed certain companies carrying out research in Ireland at a competitive disadvantage.
The aim of the new proposal is to broaden the scope of the research exemption in the Act to include all studies, tests, experiments, clinical and field trials and the consequential practical requirements required to obtain marketing authorisation for new and generic products (i.e. carrying out tests on a combination product where one of the components is patented by a third party). Furthermore, a revised, expanded research exemption will cover acts done in Ireland relating to the acquisition of a marketing authorisation in a non-EU country.
Hopefully this expansion will bring the Act more in line with those countries who have a more liberal exemption system in place and in turn will strike a balance between rewarding innovation and ensuring a high level of competition.