More on amendments to Bolar provisions - this time in Ireland

Merpel's investigations are
unaffected by the legislation

This moggy has been thinking a lot about Bolar provisions in the United Kingdom, where they have recently been amended by the Intellectual Property Act 2014, in a thought-provoking manner that he discussed back in May (coincidentally on the same day that the IP Bill received Royal Assent). Well, it turns out that across the Irish Sea, changes are also afoot to Bolar provisions in the Republic of Ireland.  Resident Irish Kat David Brophy has solicited this explanation from his colleague Donal Kelly.

David Brophy is on a brief catnap, and has asked me to put paw to paper (well, to keyboard), to give you a brief overview of some legislative proposals that would primarily effect Bolar type exemptions in Ireland.

 The Irish Government has presented a new intellectual property bill in Dáil Éireann (the lower house of the Irish legislature). The Intellectual Property (Miscellaneous Provisions) Bill 2014 has a dual proposition to amend the Irish Patents Act to provide legal certainty in relation to Bolar type exemptions; and to amend the Irish Trade Marks Act in order to accede to the Singapore Treaty on the Law of Trademarks.

 Section 42 of the Irish Patents Act limits the rights conferred by a patent - so-called exemptions to infringement. This section was amended in 2006 to implement a provision in EU Directive 2004/27/EC to exempt studies, tests, and trials necessary to apply for a marketing authorisation in respect of a medicinal product for human or veterinary use.

 The new bill proposes to clarify 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 an attempt to strike a balance between rewarding innovation and ensuring a high level of competition, the expanded research exemption will also cover acts done in Ireland, even if those acts are done for the purpose of obtaining marketing authorisation in another country.

 There have been no Irish judicial challenges of the interpretation of the provision set down in EU Directive 2004/27/EC to date - the bill has been presented in response to the fact that some 13 of the world’s top 15 pharmaceutical companies have established manufacturing operations in Ireland and over 50% of all enterprises in Ireland engage in considerable research and development activities - and the primary purpose of the bill is to clarify what research can be legitimately undertaken in Ireland by bringing Irish exemption provisions in line with the United States and other EU Member States, most notably Germany. The proposed changes appear to also be in line with the broadening of the exemption suggested by the UK Government by means of a new Legislative Reform Order.

 The amendments proposed to the Irish Trade Marks Act 1996 are to ratify the Singapore Treaty on the Law of Trade Marks by allowing unregistered trade mark licensees to join the registered proprietor in infringement proceedings and by requiring the registration of the licence for the sole purpose of claiming costs arising in the course of those proceedings; and will not be seen as a substantial change given that Ireland’s legislation is already broadly consistent with the requirements of the Treaty.

 The presented bill must pass four further stages in Dáil Éireann, and be passed to Seanad Éireann (the upper house of the Irish legislature), before signature by the Irish President and enactment.

This moggy is most interested in this development, and, as with the UK provision, is interested in how this may be affected (if at all) by legislation in respect of the Unified Patents Court Agreement, that has its own version of the Bolar exception.  He is still not clear the extent to which, as he mewsed in an earlier post, UPCA-enacting legislation may trump existing national provisions.  The new proposed Irish provision appears to be a separate exception to infringement, unlike the UK provision which puts a gloss on the existing "experimental use" exemption.  He therefore wonders how both the UK and Irish Bolar provisions will mesh with the UPC ones.  Presumably both national provisions are intended not to conflict with the UPCA, otherwise it would be a bit of a waste of legislative time.  Doubtless more will become clear as UPCA ratifications proceed.  Thoughts are in the meantime, of course, welcomed from our readers.