Oireachtas Joint and Select Committees

Tuesday, 4 November 2014

Select Committee on Jobs, Enterprise and Innovation

Intellectual Property (Miscellaneous Provisions) Bill 2014: Committee Stage

10:35 am

Photo of Damien EnglishDamien English (Meath West, Fine Gael)
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I move amendment No. 3:


In page 3, line 14, to delete "2006))" and substitute "2006)) of subsection (1)".
Section 2 inserts a new paragraph (h) into the existing section 42 of the Patents Act 1992. This new paragraph provides for an expanded research exemption in contrast to the exemption currently obtaining under paragraph (g) of section 42. The change that the Bill provides for is to ensure that acts such as clinical trials, tests, experiments etc. done for the purpose of obtaining a marketing authorisation not only for generic drugs but also for new and innovative drugs in any State will not be regarded as an infringement of a patent. The current exemption that applies under section 42(g) of the Act provides for a narrower research exemption in respect of acts done to obtain a marketing authorisation for a generic drug in the EU and EEA.
Amendment No. 3 is a technical drafting amendment resulting from the new formatting and numbering of section 42 of this Bill. The amended section 42 will have two subsections instead of the original single section proposed which will, therefore, become subsection (1).
Amendment No. 4 is also a technical drafting amendment that facilitates the later amendment No. 9. It provides for the insertion of a new paragraph (c) into section 2 of the Bill. Amendment No. 5 is a technical drafting amendment reflecting the renumbering of section 42 of the Act of 1992 into subsections (1) and (2).
Amendments 8 and 9 are related with the latter inserting a new paragraph (c) into section 2 of the Bill, which will have the effect of inserting a new subsection (2) into section 42 of the 1992 Patents Act. This new provision contains stand-alone definitions for "medicinal product for human use", "substance" and "veterinary medicinal product". For reasons of legal certainty, the linking of the references to medicinal product for human use and veterinary medicinal product to the EU directives on the Community codes relating to medicinal products for human use and for veterinary medicinal products are being discontinued and replicated as stand-alone definitions in Irish law. In that way, any future question arising as to the interpretation of these definitions in the context of Irish law will rest solely with the Irish courts. As the EU definition can change, it is important we have in place our own clear definition.
Amendment No. 8 proposes the deletion of the references to medicinal product for human use and veterinary medicinal product which were those as defined in the EU directives on the Community codes relating to medicinal products for human use and for veterinary medicinal products. Amendment No. 9 inserts a stand-alone definition for these terms, as well as a definition for "substance", rather than defining these terms by reference to the directives. In the event of a legal action, the Irish courts will be the appropriate body to interpret these terms. The scope of material covered by the definitions reliably reflects the scope under the directives.