Dara Calleary (Mayo, Fianna Fail) | Oireachtas source

I congratulate the Minister of State on his appointment and wish him every success in his role.

Fianna Fáil is supporting this legislation as it enhances the ability of pharmaceutical companies based here to develop generic versions of medical and veterinary products while the derivative products continue to enjoy patent protection. It brings Ireland into line with other EU member states in providing a more liberal interpretation of restrictions on what constitutes patent infringement. It will create a level of legal certainty in Ireland similar to that enjoyed in other jurisdictions with a broader research exemption.

We also support the provision for the ratification of the Singapore Treaty on Trade Marks. This updates legislation taking account of developments since the Trade Mark Law Treaty was developed in the 1990s, an aeon ago in terms of trade mark protection. In particular, it reflects the use of trade marks in e-commerce and the development of non-traditional marks such as sounds, three-dimensional marks and holograms. By ratifying, Ireland will be acting in concert with some of the major players in the intellectual property world such as the USA and Australia who have already ratified the treaty.

The legislation is intended to enhance the research exemption in our patents legislation to benefit companies engaged in the pharmaceutical sector in Ireland. This will be done by providing legal certainty on the aspect of immunity from patent infringement where critical research and clinical trials are carried out to develop new or generic versions of medical and veterinary products, while the derivative products continue to enjoy patent protection. This country has a hard-won international reputation for excellence in research and development. We have an excellent base from which to make further progress. Science Foundation Ireland maintains 29 world-class research centres and works with more than 400 industry partners. Shortly before his appointment, the Minister of State, Deputy Tóibín and I had the pleasure of visiting Cork to see the work under way there. Seeing the work and its impact gives an indication of the importance of this investment.

Two thirds of our research and development is in the private sector, creating new product and service innovations that will drive exports, growth, and jobs. Productive, high-calibre research undertaken by highly skilled research teams working closely with industry partners must continue to be a priority. Ireland needs a research and development framework which is competitive in both encouraging research and development activity and providing robust protection for the output from such research.

Any patents system must strike a balance between rewarding innovation and ensuring a high level of competition. Patent holders are entitled to protection for a maximum of 20 years. A patent holder can also get an extension up to a further five years. This limits the ability of manufacturers to develop generic substitutes. A recent report on the importance of generic medicines across the EU indicates that more than half the volume of EU medicines currently are generics, but this represents just 18% in value terms. The report also mentions that, to date, generic medicines in the EU have generated savings worth €30 billion. This country has been slow to take on generic medicines and to realise their value, especially in the context of our health budget.

The Action Plan for Fobs highlighted a potential restraint on the innovation capacity of the pharmaceutical or life sciences sector. It called on the Department of Jobs, Enterprise and Innovation in February 2012 to "Review Section 42 of the Patents Act 1992 with the aim of clarifying research actions that do not constitute patent infringement under Irish law in order to maintain and attract high value added Bio-pharmaceutical investment". It has been suggested that the current wording of section 42(g) places certain pharmaceutical sector companies carrying out research in Ireland at a competitive disadvantage and may interfere with Ireland's ability to attract pharmaceutical or biopharmaceutical investment.

In all EU member states, before drugs for human use are put on the market, a pharmaceutical product must have a marketing authorisation. The manufacturer of a particular drug, including generics, must be the manufacturer of a medicinal product and must submit data to prove the safety of the product. In some cases a manufacturer of a generic product may rely on data submitted by the original manufacturer when applying for an authorisation for its products. If the original product is manufactured during the course of such trials, for example, to demonstrate similarity, the generic manufacturer is legally vulnerable to an infringement action.

Directive 2004/27/EC creates an exemption from patent infringement for acts carried out by generic or bio-similar manufacturers with a view to obtaining a market authorisation for a generic or bio-similar medicinal product. There has been disparity between member states, with differing interpretations of the exemption provision in force throughout the EU, especially in relation to clinical trials and research carried out by innovative pharmaceutical sector companies.

Some member states, such as Germany, opted for a broader interpretation when implementing the exemption provision in the directive. Ireland and the UK went for a more conservative interpretation leading to restrictions on the ability of pharmaceutical companies here to develop generic products. The UK broadened the exemption during 2013 by means of a legislative reform order, leaving Ireland with a more restrictive regime.

The main benefit of the proposed new legislation would be to create a level of legal certainty in Ireland similar to that currently enjoyed in other jurisdictions with a broader research exemption. This would help level the playing field when it comes to considering locations for future pharmaceutical investment. In encouraging innovation and research and development by the pharmaceutical sector, Ireland has greater flexibility to ensure it maintains its strong position and attracts high value added investment.

The objective of the Singapore Treaty is to create a modern and dynamic international framework for the harmonisation of administrative trade mark registration procedures. Its main provisions are in electronic communications and the expanded scope of trade marks and licences. The benefits of ratification include that the treaty will revise and update the Trade Mark Law Treaty, it will apply to the procedural aspects of trade mark applications, and its provisions reflect the worldwide growth in e-commerce over the past 20 years. Irish legislation and practice in recent years have encouraged the use of e-commerce in business, and ratification of this treaty would be a further step in that direction.

The strategy document, Building Ireland's Smart Economy: A Framework for Sustainable Economic Renewal, stresses the importance of intellectual property rights to Ireland's economic recovery. It is vital, therefore, that our legislation and practice are up to date and keep pace with international developments. In ratifying the treaty, Ireland will be acting in concert with some of the major players in the intellectual property world which have already ratified it. For Ireland not to ratify the treaty would put us at a commercial disadvantage.

The Minister of State referred to the necessity for a constitutional referendum on the unified patents court. This has been on the Department's agenda for some time but we do not seem to be any closer to a date. What are the difficulties in deciding on a date for setting out the referendum legislation, particularly as there are some referenda highlighted for next year? This would be a relatively uncontroversial referendum but it is important for our international standing.

I always get worried when I hear members of this Government slipping provisions relating to media mergers into legislation that has nothing to do with media. The Intellectual Property (Miscellaneous Provisions) Bill 2014 is being stretched to include matters linked to media mergers. I ask the Minister of State to give us advance sight of the proposed technical matters he intends to address on Committee Stage. I suggest they should be the subject of pre-legislative scrutiny at committee level before they are brought forward for decision during the Committee Stage debate. The Minister of State chaired the long debate that the committee had on the Competition and Consumer Protection Bill 2014. It strikes me as very odd and slightly suspicious that changes to that legislation would be stitched in under the Intellectual Property (Miscellaneous Provisions) Bill 2014.

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