Damien English (Meath West, Fine Gael) | Oireachtas source

I am grateful to the Senators for having me here again. The House has been like a second home lately.

I am pleased to bring the Intellectual Property (Miscellaneous Provisions) Bill 2014 before the House. Although quite short, it is a significant Bill, amending intellectual property legislation as well as addressing some minor technical issues arising from the implementation of the recently enacted Competition and Consumer Protection Act. The Bill will change patents legislation, giving additional legal protection for medical research carried out prior to obtaining regulatory approval for new or generic drugs for human and veterinary use.

The Bill will also introduce a small number of changes in the area of trademarks to allow Ireland to ratify the Singapore Treaty on the Law of Trademarks. This international treaty aims to reduce the administrative burden on trade mark applicants worldwide. Taken together, the legislative proposals will enhance Ireland's innovative environment making it more conducive for entrepreneurs to exploit their intellectual property. The changes to the media merger provisions in the Competition Act 2002 that were recently amended by the Competition and Consumer Protection Act will ensure there is a robust and coherent media merger assessment process.
I will set out for Members the context in which I bring the Bill before the House. Intellectual property is key to supporting innovation and business. Patents add enormous economic value to new inventions by granting them a 20-year monopoly and enabling the commercial exploitation of novel ideas in the marketplace. Trade marks ensure that businesses can promote brand identity and safeguard hard-won reputations for quality products and services by protecting brands from illegal imitation. The pace of legislative change has accelerated in the area of intellectual property in recent years. It is no longer sufficient simply to update IP legislation once every decade or so. It is now incumbent on Government to ensure that we stay at least level with, if not ahead of, best practice internationally to maintain our competitive advantage. Our strong IP regime and the substantial research and development support Ireland offers greatly contribute to our continued success in attracting and retaining foreign direct investment, or FDI. IP protection is a key factor in attracting FDI and Ireland continues to score strongly in this area. A Grant Thornton report published earlier this year highlighted that key decision-makers involved in making investment decisions stressed the importance of an effective and responsive intellectual property regime, combined with research and development benefits, rating this even more highly than tax incentives.
The current body of intellectual property law in Ireland was drafted in the 1990s and early 2000s. With some significant amendments since that time, it continues to serve our national needs and to meet our international obligations. A 2013 international study carried out jointly by the European offices overseeing patents and trade marks pointed to the fact that in Ireland, intellectual property intensive industries accounted for almost 49% of Irish GDP and some 22% of employment. Future economic growth in Ireland will depend on deepening levels of creativity and innovation at all levels of enterprise. Both indigenous and multinational innovators are key to creating greater asset value and maintaining and creating sustainable jobs and employment.
The section of the Bill amending current patents legislation owes its origin to two EU directives from 2004 which introduced provisions into Irish law protecting medical researchers from patent infringement for acts done while seeking regulatory approval in the course of developing a generic drug. This regime was introduced into Irish law in 2006 by amending section 42 of the Patents Act 1992. Section 42 of the 1992 Act originally protected certain acts such as those done privately for non-commercial purposes or acts done for experimental purposes from prosecution as patent infringements. Section 42(g), inserted in 2006, broadened the provision's scope with the effect that since then any acts done in conducting studies and tests necessary for regulatory approval for medicinal products are also not regarded as patent infringements. The provision allows generic drug manufacturers to carry out the various studies and tests necessary for regulatory approval or marketing authorisation to place generic drugs on the market.
I stress that the proposed changes will not affect the pricing of generic drugs in Ireland or the extent to which they are currently used. Instead, the focus of proposals is on enabling the pharma sector to develop new and generic drugs while protecting them from unnecessary patent litigation. It is also important to emphasise that the transposition of the 2004 directives into Irish law was correctly done in line with EU law and was faithful to their wording. However, several EU member states, including Germany, took a more expansionist approach and adopted a broader research exemption. This enhanced legal certainty for the pharma sector has been cited by the industry as an incentive to undertaking medical research and testing in those jurisdictions which introduced it. The broader research exemption has grown in popularity among member states and is now valued by the pharma sector when investment options in Europe are considered.
Following consultations with our stakeholders, my Department reviewed the existing provisions and drafted legislation aimed at expanding the existing research exemption. I am also conscious that our nearest neighbour, the United Kingdom, recently implemented similar changes to its research exemption. The expanded research provision in the Bill will assist the pharma sector with its substantial employment and export footprint in Ireland to continue to invest and undertake important research and development activities in Ireland within a legal framework that provides greater clarify as to what is possible without fear of infringing existing patents.
Senators may be interested to know that Ireland exported more than €21 billion of medicinal and pharmaceutical products last year.

It is in this context that the Government will continue to prioritise the enhancement of our regulatory environment to sustain this crucial economic sector.
The part of the Bill amending the existing trade mark legislation allows Ireland to take a step towards acceding to the Singapore Treaty on the Law of Trademarks. The Singapore treaty was adopted under the auspices of the World Intellectual Property Organisation at a diplomatic conference in 2006. It revises and updates the previous 1994 trademark law treaty, of which Ireland is already a member. The key objective of the Singapore treaty is to create a modern and dynamic international framework to harmonise administrative trademark registration procedures. Trademarks are important business assets and trademark rights are secured through registration. By agreeing to the common standards in the Singapore treaty, we aim to establish greater certainty and reduce costs for all those seeking to protect their trade marks in Ireland.
Accession to the Singapore treaty compliments Ireland's current participation in the trademark law treaty and reinforces Ireland's ongoing efforts to encourage e-commerce. It is important that Irish legislation and business practices keep pace with international developments in this area. Many of our key trading partners have ratified the Singapore treaty and accession would also enable Ireland to participate in the future direction of the administration of trademark law at an international level.
To date, there are 38 contracting parties to the Singapore treaty, including 17 EU member states. Much of the legislative requirements to accede to the treaty are already in place in Irish law. The only amendment required to current trademarks legislation relates to licences. Currently, the trademarks Act imposes an excessively high penalty on licensees who fail to register their details with the Irish Patents Office within the prescribed time period. The Bill before the House today seeks to correct this imbalance and ensure that an unregistered trademark licensee can join with a registered proprietor in infringement proceedings against a third party and receive part of the proceeds of any damages following a successful infringement action. This will be in line with the provisions of the Singapore treaty.
I now wish to turn to the specific provisions of the Bill and explain what each is designed to achieve. Sections 1 and 5, which deal with the definitions, the Short Title and collective citations, are standard legislative provisions, while sections 2 and 3 are at the core of the Bill. As I have mentioned, section 4 addresses minor technical issues arising from the implementation of the recently enacted Competition and Consumer Protection Act 2014.
Section 2 amends section 42 of the Patents Act 1992. That section provides for limitations on the effect of patent rights. Section 2(1) provides for an additional paragraph in section 42 after paragraph (g), namely, section 42(h) which inserts the key provisions of the expanded research exemption into the Patents Act 1992. It provides that acts done in conducting studies, tests, experiments and trials - we deliberately took a broad, non-prescriptive approach here so as not to inadvertently narrow our new broader exemption - in legitimate pursuit of regulatory approval, will not be considered in violation of a patent. Section 2 extends the limitation of patents to "any act done which is required as a consequence" of the acts required to pursue marketing authorisation, ensuring again that the broader research exemption does indeed fulfil its role and allows for legal certainty and broad protection for such key medical research.
The definitions of a "medicinal product for human use" and "veterinary medicinal product" are derived from the relevant 2004 EU directives but are stated in full in the amendment. This is to guard against any possible future revisions of these definitions in EU law affecting this expanded research exemption in Irish law, as well as ensuring the definitions in the amendment are subject to interpretation by Irish, rather than EU, courts.
I am conscious that the effects of proposed amending legislation, even for a relatively small Bill such as this, can often be unclear. To clarify, the provisions of section 2 will affect the Patents Act 1992 in two principal ways. First, it will broaden the research exemption and bring legal certainty where there was ambiguity, by ensuring that all research on patented medical and veterinary products done for regulatory approval or "marketing authorisation" as it is known in Ireland, will be protected from patent litigation. This change will extend the current protection of research on generic medicines to include new and innovative medicines.
Second, it expands the exemption to cover acts done here in order to obtain regulatory approval outside of the European Economic Area, namely, beyond the EU and Iceland, Norway and Liechtenstein, as currently provided for in EU legislation. We do not intend to limit the opportunities of the Irish-based pharma sector to undertake vital research and development here in order to obtain a marketing authorisation in non-EU or EEA states due to an absence of legal certainty in this area.

Section 3(1)(a) amends section 29(3)(b) of the Trade Marks Act 1996. This amendment will enhance legal certainty by ensuring that the rights of the unregistered licensee in cases of infringement, as set out in sections 34 and 35 of the Trade Mark Act, are not conditional upon the registration or recordal of the trade mark licence on the trade mark register. Section 3(1)(b) amends section 29(4) of the Trade Marks Act 1996. The existing provision
imposes too heavy a penalty on the unregistered licensees and does not comply with the Singapore treaty. Up until now, the unregistered licensee was not entitled to damages or a share of profits in respect of any infringement of the registered trade mark that occurred after the date of the transaction of the licence and before the date of the application of the recordal of that license on the register. It is proposed, therefore, to drop the requirement that recordal of a licence is necessary in order for a licensee to obtain damagesin an infringement action. Instead, it is proposed that recordal will be required in order for a licensee to obtain legal costsin any such action. A less onerous penalty will meet the requirements of the treaty and promote the public policy objective of providing transparency.
Section 3(2)(a) sets the commencement date for the new provisions under section 3 to come into effect. Section 3(2)(b) provides for the definitions of "infringement of a registered trade mark" and "registered trade mark" in accordance with the relevant sections of the Trade Marks Act 1996.
Section 4includes three amendments to the Competition Act 2002. I am happy to facilitate these amendments in the Bill on the basis that they deal with a number of minor technical issues that emerged during the implementation of the media merger provisions contained in the Competition and Consumer Protection Act 2014 Act which, inter alia, amended the 2002 Competition Act. In effect, there are two separate sets of amendments. The first set relate to section 28B(2)(b) and the process around the notification of a media merger to the Minister for Communications, Energy and Natural Resources. As it stands, the Act allows parties to notify that Minister immediately after they have notified the Competition and Consumer Protection Commission. However, while the Act gives that Minister 30 days from the end of the CCPC or European Commission process, whichever applies, to complete his or her initial examination, the Act also currently allows, under section 28D(9), for the Minister to effectively stop the clock on the process while he or she awaits further information requested from parties. However, this ability of the Minister is contingent, at present, on the date of notification rather than the end of the CCPC or European Commission process, meaning that a situation could theoretically arise in which the Minister could lose the ability to request further information while suspending the time limits, given that he or she cannot actually commence examination of the merger until after the end of the previous part of the process. This amendment, to section 28B(2)(b), clarifies that notification can now only occur after the end of the CCPC or European Commission process, thus removing the possibility that the Minister might be deprived of the ability to require further information from the merging parties with the appropriate protections.
There is also an amendment to subsection 4B, as inserted by section 59 of the 2014 Act, which ensures that in circumstances in which parties submit proposals to the CCPC, the timelines and the process are unaffected. Importantly, this amendment has no effect on the length of the process that parties must go through and does not represent an additional time burden for businesses; it merely ensures that the process remains robust and coherent
throughout.
The second set relates to a single amendment to section 28E(13)(b) and corrects an incorrect cross-reference to a subsection. This is a drafting error in the text, and this change ensures that the phase 1 and phase 2 assessment can operate in the same manner. Section 4 also provides clarification on the treatment of media mergers notified during the interim period between 31 October 2014 - when the media merger part of the 2014 Act came into effect - and the coming into effect of these amendments.
Notwithstanding the proposed minor changes to the Competition Act, the focus of the Bill remains on updating the intellectual property regime in Ireland. Other changes to the IP regime are also taking place, particularly at EU level. The EU has long played a central role in the area of trade marks ever since the establishment of a European trade mark back in 1994. Trade mark policy continues to evolve, with the greatest reforms of the EU trade mark system in 20 years close to agreement at EU level. However, progress on agreeing an EU patent has been far more gradual. A patents package has been agreed and is in the process of implementation. This package consists of a unitary patent in Europe to be administered by the European Patent Office, and an international Unified Patent Court to be established between a majority of member states. This means that when the system is in place, innovators will be able to secure a single patent covering up to 25 member states and then enforce their IP rights in a single legal action, saving time and money.

Ireland has long been committed to a unitary patent system within the European Union to provide a streamlined and cost-effective system. Only last month, the Minister for Jobs, Enterprise and Innovation, Deputy Richard Bruton, announced Ireland's intention to establish a local division of the court in Ireland. This will facilitate SME access to the court, saving time and money and lowering the barriers that in the past prevented them from defending their intellectual property rights. All of this, however, is subject to the Unified Patent Court being approved by the people in a constitutional referendum on a date to be agreed by the Government.

These reforms in key areas of intellectual property will require further national legislation in the coming years to embed them in Irish law. They will form a vital part of Ireland's overall IP strategy that will enable researchers, inventors and designers in Ireland to protect and extract value from their ingenuity and creativity. They will also ensure these intangible assets can be leveraged to drive jobs and growth. I re-emphasise that the Bill is a modest but significant enhancement of Ireland's intellectual property regime. The amendments to the Competition Act 2002 will remove any potential ambiguity as to how one should interpret the provisions related to the full media mergers process and particularly the role of the Broadcasting Authority of Ireland when examining such a merger. I look forward to engaging with Senators on all Stages in this House and will be happy to respond to any issue that arises. In the meantime, I commend the Bill to the House.