On 31 July 2014, the Irish legislature published the Intellectual Property (Miscellaneous Provisions) Bill 2014. This Bill will, among other things, provide research companies in Ireland with greater legal protection against infringing existing patents when they take steps necessary to obtain regulatory approval for the marketing of human and veterinary medicinal products. The Bill, when enacted, will amend Section 42 of the Patents Act 1992, by expanding the scope of the Bolar-type research exemption currently provided for under Irish law. It will bring Ireland into line with other EU countries with more expansive protections such as Germany.
The current Bolar-type exemption in Section 42 creates a defence to patent infringement claims for studies, tests and trials conducted by pharmaceutical companies with a view to obtaining market authorisation for a medicinal product for human or veterinary use. The exemption was implemented into Irish law in 2006 by the European Communities (Limitation of Effect of Patent) Regulations 2006 on foot of an EU Directive (2004/27/EC). At the time, each Member State was left to interpret and implement the Directive as it saw fit. The Irish legislature, like its counterpart in the UK, provided for literal interpretation of the Directive's exemption provision, which seems to be narrow in its effect. It is thought that the current wording places certain pharmaceutical companies carrying out R&D in Ireland at a competitive disadvantage and this may impact on Ireland's ability to attract foreign direct investment from companies involved in such R&D.
As highlighted by the Department of Jobs, Enterprise and Innovation in its Regulatory Impact Analysis (April 2013) concerning the proposed expansion of the defence under Irish law, the exemption only extends to studies and trials needed for filing applications for a marketing authorisation in the EU only. The proposed amendment under the Bill will effectively expand the current patent infringement defence for "studies, tests and trials" to include all "studies, tests, experiments and trials (including clinical trials and field trials)" and will cover acts done in Ireland relating to the acquisition of a marketing authorisation outside the EU.
The Department's Regulatory Impact Analysis considered the costs, benefits and impacts of the proposed amendment. It concluded that there were limited costs to its implementation, it would not negatively impact consumers or competition, and would most likely add to national competitiveness by enhancing the attractiveness of Ireland as a location to undertake research and development activities in the generic pharmaceutical sector. At the same time, it recognised the balancing of the rights of innovative companies to recoup their original R&D investment in obtaining the existing patent rights involved.
This amendment will provide greater certainty for pharmaceutical companies engaged in R&D in relation to the type of research activities which do and do not constitute patent infringement under Irish law. It will also move Ireland towards a more harmonised approach in the law between Ireland, the US and other EU Member States. The proposed legislative change will ensure that existing patent rights do not hamper research and innovation in Ireland and encourage companies engaged in such activity to carry out activities here without the fear of patent litigation.
The Bill is only in draft form at present and must pass further stages in both the Dáil and the Seanad before enactment into law. But in light of the conclusions of the Department summarised above, and the importance of R&D activities to the Irish economy, it is likely that this more liberal amendment will be make its way into law shortly.
Originally published in Research & Innovation, Vol. 1, Issue 2.
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