In Europe, the Research Exemption or Safe Harbour is referred to as the “Bolar” Exemption and is a statutory defence to patent infringement to permit companies to perform research and other tests, needed, for example, to obtain regulatory approval for medicinal products for human use.
Existing Irish patent law (Section 42 Irish Patents Act) provides for an exemption to patent infringement.
These exemptions include (a) exemptions for private and non-commercial acts and (b) exemptions for acts for experimental purposes relating to the subject-matter of the invention. As with all exemptions, they must be narrowly construed. Accordingly, the application of part (a) is likely to be limited due to the dual requirement that the acts are done for both private and non-commercial purpose. Hence, if there is a commercial purpose to this acts then this exemption won’t be applicable. Part (b) exempts acts ‘done for experimental purposes relating to the subject matter of the invention’. However, the statute contains no definition of ‘experimental purposes’ and case law provides guidance on its interpretation in specific circumstances. To date it has been concluded that experiments carried out in order to discover something unknown or to test a hypothesis or even in order to find out whether something which is known to work in specific conditions will work in different conditions can be regarded as experiments in accordance with part (b) and will be exempt from infringement.
However, at present the research exemption is not as broad as that which applies in a number of European States. Accordingly, these provisions have been the subject of recent review by the Irish Government as reported here.
In 2006, these provisions were amended to exempt studies, tests, and trials necessary to apply for a marketing authorisation in respect of a medicinal product for human or veterinary use and comply with EU Directive 2004/27/EC. This section is now being amended again to bring the Irish exemption provisions in line with other EU Member States. The IP (Misc Provisions) Bill 2014 was published on 4 August 2014. As anticipated, this new bill amends the definition of studies, tests, and trials by expanding the current provision for research exemption to include all studies, tests, experiments, clinical trials, field trials, and any consequential acts necessary for the purpose of obtaining marketing authorisation for new and generic products. In addition, the expanded research exemption will cover acts done in this country relating to the acquisition of a marketing authorisation in a non-EU country.
In order for these new provisions to be signed into Irish law by the President, they need to go through Second Stage, Committee Stage and Report and Final Stage in both Houses of the Irish Government (the Dail and the Seanad). We have been advised that this Bill is expected to come into operation in early December 2014.
This is a positive step and these measure aims to ensure that Ireland continues to be an attractive base for the location of future investment by pharmaceutical companies that rely on a safe environment for the research and development of new products.