Oireachtas Joint and Select Committees
Tuesday, 4 November 2014
Select Committee on Jobs, Enterprise and Innovation
Intellectual Property (Miscellaneous Provisions) Bill 2014: Committee Stage
This meeting has been convened for the purpose of consideration by this committee of the Intellectual Property (Miscellaneous Provisions) Bill 2014 which was referred to the select committee by order of Dáil Éireann on 23 October 2014.
I welcome the Minister of State with responsibility for skills, enterprise and innovation at the Department of Jobs, Enterprise and Innovation, Deputy Damien English, and his officials here this morning.
I ask members and officials to switch their mobile telephones to flight mode. It is not enough to put them on silent as they will continue to interfere with the broadcast.
It is intended to consider the Bill until we conclude Committee Stage today. Is that agreed? Agreed.
I move amendment No. 1:
Amendment No. 1 is of a drafting nature and replaces section 1 "Definitions" with an expanded version that includes a definition of both the Patents Act 1992 and the Trade Marks Act 1996. Consequential on amendment No. 1, amendment No. 2 defines the Act of 1992 as meaning the Patents Act 1992 and it is therefore more appropriate to refer to the Act of 1992 throughout the Bill.
In page 3, between lines 8 and 9, to insert the following:
1.In this Act—“Act of 1992” means the Patents Act 1992;
“Act of 1996” means the Trade Marks Act 1996.”.
I move amendment No. 3:
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.
In page 3, line 14, to delete "2006))" and substitute "2006)) of subsection (1)".
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.
I move amendment No. 6:
This is a drafting amendment which clarifies the reference to a marketing authorisation as being a reference to a marketing authorisation that is required by the law of any State.
In page 3, line 22, to delete "(howsoever described)" and substitute "(howsoever described) that is".
I move amendment No. 7:
In response to concerns expressed by stakeholders that the Bill does not provide legal certainty that the act of offering to sell or supply the drug for which marketing authorisation is being sought benefits also from the research exemption, the amendment is intended to provide the necessary clarity.
In page 3, line 24, to delete "sell or supply" and substitute "sell or supply or offer to sell or supply".
I move amendment No. 8:
In page 3, to delete lines 25 to 30 and in page 4, to delete lines 1 to 6 and substitute the following:"(I) a medicinal product for human use, within the meaning of subsection (2), or
(II) a veterinary medicinal product, within the meaning of subsection (2),".
I move amendment No. 9:
In page 4, line 10, to delete “as appropriate.”.” and substitute the following:
(c) by the insertion of the following subsection:“(2) In this section (other than paragraph (g) of subsection (1))—(2) Section 42 of the Act of 1992 as it stood immediately before the passing of this section shall be referred to as subsection (1) of the said section 42 and, accordingly, references in any enactment passed before the passing of this Act to section 42 of the Act of 1992 shall be construed as references to subsection (1) of section 42 of that Act.".
'medicinal product for human use' means—(a) any substance or combination of substances having or purporting to have properties for treating or preventing disease in human beings,'substance' means any matter of—
(b) any substance or combination of substances which may be used on or be administered to human beings with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;(a) human origin (including human blood and human blood products),'veterinary medicinal product' means—
(b) animal origin (including micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products),
(c) vegetable origin (including micro-organisms, plants, parts of plants, vegetable secretions and extracts), or
(d) chemical origin (including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis);(a) any substance or combination of substances having or purporting to have properties for treating or preventing disease in animals, or
(b) any substance or combination of substances which may be used on or be administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.".
I move amendment No. 10:
Intellectual property is a hot topic around the world, especially when it is linked to cigarette packaging and the transatlantic trade and investment partnership, TTIP. The TTIP negotiations are creating many worries among people in the context of intellectual property. Recently, the US Chamber of Commerce lodged an objection with the European Commission regarding the Government's plan to introduce plain packaging of tobacco products. The Commission was also warned that this would have an impact on the economy as it would be seen to damage significantly the concept of intellectual property rights. The US Chamber of Commerce said it would damage intra-EU trade if Ireland set a dangerous precedent and damaged intellectual property rights by adopting plain packaging.
In page 4, between lines 10 and 11, to insert the following:
3.The Patents Act 1992 is amended by the insertion of the following new section after section 61:"Common good
61A.The achievement of the common good may require permanent or temporary interference with the rights, including intellectual property rights, of persons or corporate entities.".".
British American Tobacco, Imperial Tobacco, Philip Morris and a number of other large tobacco firms, which make their money selling a product that kills one in two users, took the Australian Government to court in Australia on the issue of intellectual property rights and plain packaging. They did not win in Australia but they are now taking the government to court in Hong Kong, which has a trade agreement with Australia. Property rights are important but they cannot be the only right that is important. It is critical that governments have the right to legislate and create policy that affects people's health and welfare.
The text of the amendment is copied from the Irish Bank Resolution Corporation legislation, which reads "And whereas in the achievement of the winding up of IBRC the common good may require permanent or temporary interference with the rights, including the property rights, of persons". This sets a precedent for the use of a provision to ensure certain rights are more important than these property rights. That is why I ask the Minister of State to include the amendment.
I thank the Deputy for his amendment. I understand its intent and I know what he is trying to achieve. We believe it is provided for but I will go through that. His proposal is to include a new so-called common good provision in the Patents Act 1992 to allow for the possibility of interference with intellectual property rights enjoyed by individuals or corporate entities in pursuance of the common good.
Patents are but one form of intellectual property rights, which term includes also copyright, trademarks, industrial designs, etc. The Constitution specifically recognises the importance of property, with Article 43 acknowledging the natural right to private ownership of external goods and "the State guarantees to pass no law attempting to abolish" this right of private ownership. As the Deputy said, however, in recognition of the principles of social justice, the Constitution provides that the State may, as occasion requires, delimit by law the exercise of such rights in the exercise of the common good.
At national, European and international level, intellectual property rights enjoy protection set down under well-established and respected principles. We have legislative acts at domestic level on trade marks, copyright, patents, industrial designs and so on. Equally, there is harmonisation at EU level in the area of trade mark and industrial design law and we have signed up to commitments to respect intellectual property rights.
At international level, the State is party to a number of international treaties and conventions that sign us up to a certain level of IP protection. These include the Paris Convention for the Protection of Industrial Property, dating from 1883, and the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPs agreement. The TRIPs agreement introduced intellectual property into the international trading system and remains the most comprehensive international agreement on intellectual property to date.
Whether at national, European or international level, IP protections are not, of themselves, absolute rights and states are permitted to apply derogations that allow for the suspension of part of the legal obligation which can operate to restrict some rights under certain circumstances, such as in the pursuit of broader compelling public policy reasons or for greater public interest considerations. Section 42 of the Patents Act 1992, which is itself being amended by the Bill, already limits the rights of patent holders in certain restrictive circumstances. Circumstances permitted include acts done privately for non-commercial purposes and acts done for experimental purposes on or into a patented invention.
I recognise Deputy Tóibín's amendment reflects the good faith intention to allow for the limitation by the State of intellectual property rights to achieve objectives for the common good. It is the case that there exists under the Constitution, and specifically in intellectual property legislation, the provisions to allow the State, if necessary and in particular circumstances, to delimit intellectual property rights. It would be wholly inappropriate and undesirable, however, to provide for the limitation of intellectual property rights on a blanket basis in a provision of the Patents Act. Existing provisions are set out that allow for the delimitation of rights in certain expressed circumstances in a manner the State can support without conflict with domestic, European or international obligations. As drafted, Deputy Tóibín's amendment goes beyond what is permitted and for this reason I cannot support his amendment. Given the rationale I have outlined, I hope Deputy Tóibín can agree to withdraw his amendment.
If the Deputy wishes I will provide him with a full briefing document prior to Report Stage. We feel it is quite well covered and that we can achieve the Deputy wants. We understand what he is trying to do but we believe it is already permitted under law and in the Constitution. The Department is very clear about what can be done and what the TRIPs agreement allows.