Dáil Éireann debate -
Thursday, 16 Nov 2000

Vol. 526 No. 2

Patents (Amendment) Bill, 1999: Second Stage (Resumed).

Question again proposed: "That the Bill be now read a Second Time."

Mr. Creed:

This Bill has been described as non-contentious and technical. I could think of a few other adjectives to describe it, such as turgid and boring. It is not the type of legislation on which one is likely to be accosted on a regular basis in the local public house or to have representations from constituents. However, it is necessary. It highlights the importance of intellectual property rights and their capacity to act as the economic engine which drives industrial development and creates job opportunities. It also gives us an opportunity to raise a number of issues.

The plethora of legislation which has been enacted in this House in the 1990s alone begs the question of whether the Patents Office, which I understand is now in Kilkenny, has the necessary staff to carry out the additional duties and responsibilities which are being foisted on it. I ask the Minister of State when replying to assure the House that that office has the financial and human resources to implement and administer the legislation and to deal with public inquiries on patents. There is an increasing awareness of the patent issue. This is a relatively innovative society and it would be regrettable if we could not capitalise on that as a result of inadequate staff or financial resources in the Patents Office.

Innovation is not a guarantee of economic prosperity. We have often met people with great ideas who cannot see them through to fruition. This raises another question about the potential of each invention. Are we adequately facilitating business angels and providing technical supports to bring on stream those innovations? We could look at the curriculum in our education system to see if we support innovation and if we are capable of matching it with the necessary entrepreneurial skills and financial resources. If we can do that, we will have a recipe for economic success.

Much legislation was passed in this area during the 1990s. The Patents Act was passed in 1992, the Trade Marks Act was passed in 1996 and the Intellectual Property (Miscellaneous Provisions) Act was passed in 1998. This section of the Department has been extremely busy and have come under pressure from events outside its control.

The raison d'être for this Bill is twofold, namely, the World Trade Organisation talks, the TRIPs agreement and the European patent convention. It highlights the growing importance of intellectual property. My understanding of the necessary trade off in terms of the World Trade Organisation is that the European Union placed considerable importance on intellectual property rights. However, in doing so it may have traded off certain areas of interest about which I have reservations.

It is clear from the raison d'être at European and world trade talks level that there is an attempt to harmonise the legal framework for patents. That is desirable because we are increasingly operating in a global village where an idea in Bangkok, if it is placed in an appropriate legal framework, can be exploited in Ballyvourney in my constituency to the benefit of the originator of the patent and the person capable of bringing it to economic reality. There is, therefore, a need to put in place a world-wide framework.

The history of this originated in the Industrial Revolution. The first attempt was the Paris Convention, 1883, which has been revised on several occasions. Approximately 157 countries have signed up to it. I am not sure if it has a legal framework but it is indicative of the growing importance of putting in place the kind of framework proposed in this legislation. The Patent Co-Operation Treaty, signed in Washington in 1970, was followed by the European Patent Convention in 1973, which established the office in Munich. A number of directives have arisen from that and I understand more are envisaged in the near future. The relevant section in the Minister of State's Department will be very busy dealing with these provisions. When replying to this debate I ask him to assure the House that the necessary resources will be provided, not only within his Department but in the Patents Office.

We have received a number of submissions by innovative people who have approached the Pat ents Office. It has been suggested that the modus operandi of the office is not user friendly and that considerable financial costs are incurred by those pursuing to a successful conclusion the issue of a patent through the office. This week the Joint Committee on Enterprise and Small Business received a presentation from the Inventors Association of Ireland. Given the shortcomings they perceive at the Patents Office they are seeking Exchequer funding to make up the shortfall. They also want to establish the title of Global Inventions Management Limited, a company that will be more user friendly and approachable than the Patents Office.

The association raises serious allegations because the inference is that people with very worthwhile ideas are being short changed by the Patents Office, that they find the technical and administrative side unhelpful and that excessive cost barriers are being put in their way. In view of this they say people are not pursuing the issue of a patent. While the Minster of State may not wish to comment on the proposal to establish Global Inventions Management Limited, of which I am sure he has received a proposal, it would be appropriate for him to comment on the issue of resources and on the need to make the Patents Office user friendly and approachable and on the need to ensure that it is not excessively expensive to have the issue of a patent successfully concluded.

The Minister of State at the Department of Enterprise, Trade and Employment, Deputy Treacy, raised the issue of exemptions to the rule of patentability. He outlined three permissible exemptions. First, where the commercial exploitation of same would be contrary to the public order or morality. That is understandable. Second, inventions concerning diagnostic, therapeutic and surgical methods for treatment of humans or animals may be exempted. I am not sure what is involved here. Perhaps the Minister of State will elaborate. Third, member countries may exclude from patentability plants and animals other than micro-organisms and what are essentially biological processes for the production of plants and animals other than non-biological and micro-biological processes. This is a potential minefield.

Legislators, both here and elsewhere, have been exposed as being inadequate in terms of keeping up with advances in genetic engineering and micro-biology. The Government has established a working committee to look at this. Recently there was much fanfare about the mapping of the human genome. I do not understand all of its potential uses, but would it be desirable for somebody to patent that and thereby secure exclusive rights to the commercial exploitation of the human genome? I am not sure if there is a vocabulary and lexicon associated with this area, or if these two issue are entirely related. Nevertheless, there is considerable public concern about the lack of an adequate legal framework within which this industry operates. Do the patent exemptions outlined by the Minister of State, Deputy Treacy, apply to the human genome? Perhaps the Minister of State will clarify this.

This is by and large a technical Bill. There is unlikely to be any strong objection to it in principle. We will study it in greater detail before Committee Stage with a view to assisting the Minister of State in passing optimum legislation in this area.

Dr. Upton:

The EU Commission has proposed the introduction of a common Community patent system, saying that it will save small businesses thousands of pounds in patenting costs while at the same time giving EU wide protection to the inventions of many who have been unable to afford it in the past. At present, businesses may apply to a European patent office for a European patent, but in reality what is available is a collection of national patents, each subject to a set of different national rules.

The purpose of any patent regime is to strike a balance between the interest of the inventor, the investor and the public, so that there is an incentive to produce knowledge and to use it as widely as possible. Lawsuits on the basis of patent infringement, particularly patents issued for the business method of using technologies in a particular way, are currently the subject of debate in the US. The criticism of such patents is that the patents throttle new markets by giving a formidable first mover the advantage to file first for a patent on a general process – an idea of how something might be done rather than a concrete invention like a machine. Supporters of such patenting in the digital age say that ideas and knowledge, not inventions, should be capable of being patented property.

The cost of applying for a patent for a small company is prohibitive in Europe because of an expensive document translation service. In effect this means that applying for a European patent is three to five times more expensive than, for example, applying for an American or Japanese one.

The criterion for granting a patent to an inventor is that the invention must be novel – no other person can have made it public. It must also be innovative and useful and cannot simply be a discovery. Software development is a particularly confusing and complex area, one which is developing with enormous speed. Without an adequate licensing agreement, developers could lose control of their intellectual property while companies which hire a firm to develop software for them do not have ownership of the programme unless an agreement assigns the rights to them.

The patenting of the human genome is a new area in which patenting is already big business. To date, some 9,364 patents relating to the human genome have been filed. The applications cover 126,672 genes or partial sequences. For example, nine patents have been applied for on the genes which determine a person's eyeball and 40 for a person's heart. Two genes where mutations give women a predisposition to develop breast cancer have been identified and a dispute is ongoing about the ownership of that gene. A Japanese firm has been granted a worldwide patent on an unnamed human gene, the natural chemical which produces it and the use of that chemical for the treatment of bone diseases such as osteoporosis.

There is an extraordinary escalation in the rush to patent the blueprint for life in all its forms from the tiniest microbe to the mouse. The reason for this rush is not difficult to understand. The fast developing genetic sciences and patent law are two areas of interest and enormous complexity. Chromosome 22 is the smallest of the 23 pairs of chromosomes and is significant in that it contains genes related to, among other things, schizophrenia, mental retardation and congenital heart disease. Once the other 22 chromosomes have been decoded, it is believed that we will be on the brink of a revolution in medicine. Drugs will be customised to patients' needs based on their genetic make-up and earlier and more specific diagnoses will be possible. A study completed earlier this year suggested that by 2009, sales of DNA based treatments will exceed £45 billion.

A patent is no more than a temporary protection which prevents others from making money from one's discovery. Once businesses have filed a patent claim, they can publish and other researchers throughout the world can use what could be valuable information in a variety of ways. If people can afford a patent, they can risk the ten years and £100 million required to take a drug from idea to pharmacy counter.

The first gene based patents were made 20 years ago but these were few in number and many were never exploited. In the past few years, the biotech companies have been sprinting from the laboratory to the patent office with armfuls of applications. There has been intermittent anger and anxiety but very little debate on this issue. The level of awareness and concern about this issue is dangerously low. Genes have become intellectual property to be kept on a shelf, licensed to the highest bidder or simply lost in the tangle of takeovers and bankruptcy which is inevitable in the new high risk industries. Even modest sized biotech companies have been filing patents at the rate of 100 per week.

The opponents of gene patenting argue that genes are pure discovery. However, the modern automated gene analysis technology makes gene innovation doubtful. Naturally occurring life forms cannot be patented but genetically engineered plants and animals, such as genetically modified maize and laboratory mice designed to be prone to cancer, can. So, too, can the naturally occurring chemical codes and substances which allow all plants and animals, including humans, to function on a cellular level, like genes or hormones, as long as the inventor can specify a use for them.

Holding a patent on human, animal or plant genes gives the holder control over the commercial exploitation of that gene. If it is a human gene, that may involve diagnosis or therapy for a disease. If it is a plant or animal gene, it may also involve disease, the promotion of desirable characteristics such as a sweet taste or the transfer of a gene from one organism to another. Many biotechnology companies hold that genes must be patentable to allow firms to recoup their investment in identifying them. Other firms fear that allowing genes to be patented before any specific proven use has been established will hold back medical science.

Doctors and scientists in search of causes and cures for diseases started the systematic search for this information 20 years ago on diseases such as Huntingtons, muscular dystrophy or cystic fibrosis. At that time, charities and families who were hoping for a cure or mitigation often raised the money for this research. The search has since widened and accelerated. It has gone from muscular dystrophy to maize and has covered many other areas in between. It will be wonderful if the new products and new cures which may emerge are widely available. Their wide availability is a key point in this debate. There is a concern that natural resources, intended to help the hungry, sick and desperate will be hijacked and cornered by the rich and powerful who will use them to get richer. The gain is likely to be at the cost of those who are most vulnerable.

The two main reasons for worrying about the patenting of genes is that patents could increase the cost of medical research or even inhibit it. While patents clearly have a role in protecting investment and research, researchers could be deterred by the pile of patents they will have to negotiate before a drug will get on to the market. Given how little we know about how our genes work, slapping a patent on them will only slow down the advance of publicly available scientific knowledge. Developing countries argue that the knowledge economy is being stitched up for decades to come to their gross detriment, thus reinforcing a pattern of technological inequality.

Now and in the future, the control of gene patenting must be carefully monitored and managed. The greed of large multinationals which have the muscle to control and manipulate must not be allowed to dominate. It is because of Third World countries, the deprived and the uninformed, that gene technology must be free and widely available. The part-sequencing of the human genome earlier this year was a huge development, one which went largely unnoticed. I believe its import will be manifested not this year or next year but in the next couple of decades. Thereafter, the financial, moral and ethical implications of this development will be very significant but it may be too late for anyone to cry "stop". There is still time to ensure the enormous ethical implications of this discovery can be managed in a positive and constructive fashion with its benefits being made universally available. The first step would be to ensure the patenting of the genome is prohibited.

Recently in Ireland, we have been confronted with the prospect of genetic testing being used by insurance companies to determine premia for life insurance purposes. The possible outcome of this is that life insurance will be denied to many people because of a potential predisposition to certain diseases. In the UK, the Government has permitted gene testing for certain diseases. The most unfortunate consequence of this decision is that people who really need to have gene testing carried out are likely not to in order to avoid the risk of being refused insurance cover. This is just one aspect of the implications of a developing technology which should be addressed urgently. The implications of this development for everyone in the community have not been appreciated. We are merely witnessing the tip of the iceberg in terms of the potential opportunities and risks associated with gene detection.

The human genome project is on a scale parallel to the invention of the printing press, digital technology and any other invention which has had a profound influence on the way we live. Unless it is used positively, this information could be badly mishandled. On the positive side, properly managed and used, it could provide a cure for haemophilia, cystic fibrosis or other genetic disorders. There is a danger, however, that gene therapy could well be placed beyond the reach of the ordinary citizen as well as allowing employers to discriminate against people on the basis of their genetic predisposition. What will be the likely decision of an insurance company when a gene which predicts a predisposition to Alzheimers, cancer or heart disease can be detected?

In the agri-bio industry, there is a danger of a growing concentration of ownership in the hands of a small number of major companies. Large companies continue to merge with the result that the ownership of information falls to a smaller number of companies and a monopoly develops. The expanding global food market is at stake in this regard. Population growth and economic expansion is driving up demand. The International Food Policy Research Institute expects a 40% rise in grain demand within 20 years. Arable land is becoming less available and the use of biotechnology for increasing yields is becoming attractive. However, ownership of the relevant genes, controlled by a small number of powerful brokers makes the weak and underprivileged very vulnerable. Once again it is back to the patenting of the genetic information and allowing a small powerful group, because they can afford the risk involved, to be in a position to completely control future markets.

Given the scale of the issues in terms of human well-being and development, it is a scandal that the subject of gene patenting has been so neglected. Debate is urgently needed, and as the knowledge economy gathers pace, it is vital that concerns of public interest are built into its regulation through patent law. The knowledge econ omy should be for all and not for the most powerful, who can, if they choose, be ruthless in its application and implementation.

As it stands in the patents rush, there are thousands of absurd applications which are so speculative or vague that they are very unlikely to be granted. Companies and public laboratories have been applying for patents on genes of which they do not even understand the function. There are anomalies such as different patents being granted on the same gene sequence for different purposes. Only one thing is certain and that is in the years ahead patent lawyers will become very rich because it can cost hundreds of thousands of pounds to defend or challenge a patent. Probably what is most worrying is the speed and scale at which patent applications are being made. It is not possible that this is prompted by a sudden outbreak of creativity and inventiveness. Unless people look at the issue seriously, unless the rules are changed, in a few years we will find the very basis of knowledge and information has been privatised.

In June this year the French President, Jacques Chirac, wrote to the head of the European Commission saying gene patenting should not be permitted. Yet delegates to the conference to revise the treaty governing European patent law, opening in Munich next Monday, are not even planning to discuss gene patenting. Fears that investors will pull out of a country if patenting is prohibited has forced many countries to retain patenting of the genome.

In this Bill the proposal to offer a European wide patenting system has much merit, in that it gives EU protection to inventions for those to whom it was prohibitive in the past for cost reasons. It should also offer a greater degree of legal certainty and consistency as disputes are referred to national courts which adjudicate on the basis of national law.

Movement to the American market could, however, continue to present problems and without careful preparation Irish technology companies moving in to the US risk losing ownership of intellectual property such as software designs. Without an adequate licensing agreement, developers could lose control of their intellectual property, while companies which hire a firm to develop software for them will not have ownership of the programme unless an agreement assigned the rights to them. Ownership to the rights of a programme must be clear because no one will buy a property where a clear ownership trail is not established.

The co-ordination of patent law is welcome at European level and in particular the making available as a right licences under this patent, thereby reducing by half the renewable fees payable to keep that patent in force, but wider implications of patenting of the human genome must also be addressed.

Mr. Naughten:

I welcome the Bill and the opportunity it gives to debate very important issues in relation to patenting. I welcome Deputy Upton's contribution as she was fundamental to me taking an interest in this area a long time ago in Belfied.

This is an important Bill as the use of patents, particularly in relation to biotechnology and genetic engineering, has not been debated in Ireland. We have tried to brush it under the carpet. The debate has taken place over a number of years in the scientific community and to a certain extent is now over. The public, the Parliament and many other parliaments in the EU have failed to recognise the important impact it will have in the years ahead and the tough decisions which need to be made regarding the future of this technology and patenting legislation.

While the vast majority of countries in the EU now realise this will have a major impact on the future development of their economies, and have set about introducing legislation, establishing parliamentary committees to debate it and have had debates on the floor of their Parliaments, we have failed to grasp the issue. It is a huge disappointment that we have ignored and continue to ignore the issue. We see from legislation which is pending and debates on the Order Paper that there is little relating to this area. Indeed the motion for a debate on biotechnology and genetic engineering, which commenced in the House about 12 to 18 months ago, is still on the Order Paper and the debate has not yet resumed. We need to discuss the area more thoroughly and I ask the Minister to seriously consider the report of the Oireachtas sub-committee on science and technology, which recommends that under the auspices of his Department an Oireachtas committee should be established specifically for the area of science and technology, with outside representatives from the scientific community so that some of these issues can be debated. This would perhaps allow us to come up with some of the answers which are urgently required, rather than brushing the issue under the carpet and waiting for the EU to make decisions in which the Irish Government does not seem to take an active role.

Patenting concerns getting a balance between the protection of the rights of and encouraging innovation and ensuring it is not used to stall future innovation or block new developments for the benefit of the community. The points I will raise highlight some of the inadequacies which exist and show where we need to improve legislation and reform the current situation.

My colleague, Deputy Creed, spoke about Ireland in general being a very innovative country, which is true. Statistical tables in this regard show Ireland mid-way in terms of EU countries when it comes to lodging patents, particularly in manufacturing. However, throughout the EU we have been slow in patenting services. The US has gone to the opposite extreme in patenting services.

An important point raised by Deputy Creed was the criticism being laid at the door of Enterprise Ireland in relation to facilitating small, individual inventors who want to patent particular inventions which would hopefully be of benefit to them and the country. One issue is the cost of doing a patent search, which can range from £300 to £1,000. This may not seem much money to some people or to big industries, but it can be a prohibitive cost for individuals who may not have the financial backing or resources and may mean an innovative idea or project will not get off the ground. I ask the Minister, with his European colleagues, to examine the feasibility of establishing a proper search engine and database, such as exists in relation to DNA which allows us to check particular patents on a database over the Internet. I see no reason the same cannot be done in regard to patents. It has been an extremely useful tool in the whole area of biotechnology in the past in relation to finding out the background to a particular sequence of DNA, the genes it may form and the uses for it. Yet in the whole area of patenting the position is archaic. I am not up to speed on the procedures involved in searches but it is important to structure a proper database and use a proper search engine that could be funded through the European Union. That would dramatically reduce the cost of these searches for individuals.

The second criticism which small individual inventors have is the cost of lodging their initial application, which can cost approximately £700. Those resources are not available to these inventors. I wonder whether Enterprise Ireland can be flexible in relation to these individuals and encourage innovative new ideas of net benefit to the whole community that can be patented in the future. I ask the Minister to look at the proceedings on Tuesday last of the Joint Committee on Public Enterprise and Transport in which some of these criticisms were outlined.

It is much easier in the US to get a patent than in Ireland or the EU where there are additional costs for those lodging a patent. There are pros and cons. There is no question but that we need to improve and streamline the position within the EU and in Ireland. It is important not to go to the extreme as in the US. Perhaps the Minister will outline how the Reach project will impact on patenting in Ireland? It is one of the key objectives of the Government and the Taoiseach to introduce the Reach project over the next two years.

The position in the US, where there is too much flexibility, is stifling innovation particularly in areas of e-commerce by granting patents too liberally. This means people are facing barriers when they want to develop a new product or implement a new service because of all the patenting bureaucracy they have to go through. The decision by the EU in relation to this matter will be of fundamental importance to the development of ecommerce within the EU and Ireland. One of our key strategic goals is to develop Ireland as the e-commerce hub of the European Union. It is important to ensure that case is made within the EU to ensure we do not go the route of the United States, especially in the area of software, where there is already a protection under the copyright Act. Given that it is already protected under the copyright Act why the need for this additional tier of bureaucracy, which will stifle innovation, as happened in the United States? A number of reports have been published which highlight the fact that research and development in the whole area of software has fallen since the new patenting regime came into force in the US. We should seriously consider going down that route before taking a decision. Perhaps the Minister will outline the Government's views on this matter and the position it will take within the European Union in relation to software patenting to protect the future viability of e-commerce here.

To give an example of how far the US has gone, a new method of booking an hotel bedroom over the Internet has been patented. The US has gone to extremes. If we were to go down this avenue in the EU not only would it make the whole situation farcical and hinder the development of e-commerce, it would be a bureaucratic nightmare for the Patents Office to have to deal with all these Mickey Mouse patent applications and would seriously damage the efficiency of that office.

I understand that additional patenting legislation will come before the House in the next couple of months. In a parliamentary reply on 3 October the Minister pointed out that there needs to be a revision of the European Patents Convention. Is it his intention to amend this legislation on Committee Stage or to introduce an additional Bill? It is important that we have a thorough look at any new additional amendments he may introduce rather than introduce large new sections of legislation on Committee Stage, which is unfair on members of the committee and those who debate these issues on Second Stage.

Section 4 enables the wording of paragraph (f2>a) of section 10 of the Principal Act concerning exclusion from patentability of inventions whose exploitation would be contrary to public order or morality to be brought into line with Article 27.2 of the TRIPs Agreement.

Public order or morality is one of the fundamental issues that need to be resolved in the whole issue of patenting. The headline of an article in the Sunday Business Post on 9 July 2000, read: “Iceland's £100 million DNA sale has Irish implications”. The article mentions that Ireland has decided to sell its rights to their citizens' DNA to a commercial firm for approximately £100 million. Most Members or the majority of the general public would not be aware of this but some people in the scientific community would be conscious of the fact that a huge proportion of Icelandic genes are the same as Irish genes. Basically, the Icelandic Government has sold the vast majority of the genes of the Irish population to a commercial company for £100 million. This is a fundamental issue relating to the whole issue of why and how genes should be patented. It is a fundamental issue as to why Iceland or any other country can sell its DNA pool to major multinational companies. A huge debate needs to be opened up in this area. As we map human genes additional genes will continually be patented. As Deputy Upton said, the large biotechnology companies are running to patents offices to register genes. It will stifle development in this whole area, including the use of gene therapy and the treatment of genetic disorders. Yet we seem unwilling to debate the issue and are willing to turn our backs on it. Genes should not be patented. A gene is not an invention as it has existed for thousands of years. However, because multinational companies decide this is the way to go everyone will have to go to such companies. We have failed to address the issue and this legislation does not do so either. There is a need for a thorough debate in this area.

There is also a need for legislation because, as the human genome project is completed over the next two to three years, many more genes will be registered and patented. This will cause significant problems over the next ten to 20 years while these patents last. To the best of my knowledge most patents last up to 20 years. This will mean that, over the next 20 years, medical research and developments will be in the hands of a few large multinational companies and other research facilities will not have access to or permission to use these genes.

It is unbelievable that any country can sell its DNA and gene pools to a multinational company. This development has major implications for Ireland because of the gene pool involved, our historic connection with Iceland and the impact this will have on the treatment of disorders which are specific to or more prevalent in countries such as Ireland and Iceland. The Minister of State needs to examine this issue and it is fundamentally important that we introduce legislation in this area.

Legislation is important, not only for future medial developments, but also because of the ethical problems which will arise. There was much discussion this summer concerning the Adam Nash case which opened up the debate in the area of patenting human life and the use of human genome technology and research. Senator Henry unsuccessfully attempted to introduce legislation in the Seanad in this area. An interdepartmental committee is examining biotechnology and these issues need to be addressed. Legislation must be brought forward and Ireland must be to the fore in leading ethical opinion rather than the current situation where we are dragging our heels and waiting for the EU and the US to make decisions. The US, in particular, is dictating the way forward to the EU and other countries.

We are also failing to even consider the impact of these issues on the future development of the Third World's biotechnological capabilities. Fundamental questions need to be addressed and we must have a thorough and frank debate. I ask the Minister of State to examine the science and technology recommendations of the Oireachtas Joint Committee on Education and Science. The way to proceed in this area is by way of an Oireachtas committee. I commend the Bill to the House.

Minister of State at the Department of Enterprise, Trade and Employment (Mr. T. Kitt):

I thank Deputies for their contributions to this debate which goes back over seven months. I am conscious of the fact that this is a technical Bill. I agree with Opposition Deputies who stated that this should not be a contentious Bill as it is necessary legislation. However, valid points were raised, some of which are not specific to this Bill but are connected to it.

Much work has been done in the area of intellectual property in the past few years. There was a reference to the Copyright Act which was a long drawn out process. I wish Deputies Naughten and Upton well in their new portfolios. My ministry covers trade, labour and consumer affairs and the Government has done much work in the area of intellectual property. The unit in the Department has been expanded and the Patents Office has moved to Kilkenny.

There have been many positive recent developments. However, there have also been delays which have been acknowledged on this side of the House. We are dealing with important legislation, some of which will go over many people's heads, but it is important to pursue this issue and debate is important to that process.

Deputy Rabbitte stated that he will table amendments on Committee Stage but the overall response to the Bill has been positive. The Minister of State, Deputy Treacy, opened the debate on the Bill because I was out of the country. Deputy Rabbitte quoted a passage from the speech of the Minister of State regarding proposed amendments to the existing provisions on compulsory licences. That passage tried to show that some of the existing grounds in Irish patent law on which a compulsory licence could be sought, which include, in particular, that the demand for a patented product in this country was being met by imports, are contrary to the Agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPs.

TRIPs provides that patent rights shall be enjoyed without discrimination as to, inter alia, whether patented products are imported or locally produced. We then indicated that, under the amendment proposed, if a patented product is produced in any WTO country and is subsequently imported to another country in amounts sufficient to satisfy local demand, it would not be possible to obtain a compulsory licence in that country.

Deputy Rabbitte also inquired about the delay in bringing this measure forward when it was supposed to be enacted over three years ago. The delay arose because work on the measure began at a time when matters relating to patent policy and legislation were in the process of transferring from the Patents Office to the intellectual property unit of the Department of Enterprise, Trade and Employment. Staff resources for dealing with patent matters within the intellectual property unit were constrained at the time, which I have already acknowledged.

Furthermore, it initially appeared that it would be possible to transpose the patent provisions of TRIPs into Irish law by way of a statutory instrument and the measure was first prepared in that format. The Attorney General's office subsequently took the view that the measure would have to be in the form of primary legislation and work proceeded on that format immediately. These are the reasons for the delay in introducing this legislation.

Deputies Rabbitte and Creed asked for the justification for the exemption from patent protection of inventions concerning diagnostic, therapeutic and surgical methods for the treatment of humans. Irish legislation exactly reflects the requirements of the European patent convention. The policy behind the exclusion of such methods from patent protection is to ensure that those who use such methods as part of the medical treatment of humans or the veterinary treatment of animals should not be inhibited or restricted in their work by patents.

I welcome the fact that a number of Deputies referred to the issue of gene technology and the patenting of biotechnological inventions. On the comments of Deputies Creed, Naughten and Upton, the human genome project is not capable of being patented. Patenting of bio-technological inventions is based on a Community directive which Ireland has recently implemented. Deputies Naughten and Upton have referred extensively to this area and I agree with them that it is an area which needs very detailed discussion. During my period as Minister of State, I have been conscious that I am coming to this at the end of a lengthy process of debate not just at European ministerial council level but at European Parliament level, as the Deputies would be aware. I am referring here to the directive on the patenting of bio-technological inventions. It has been contentious and has warranted very careful debate. I have represented at EU level, the kind of concerns which have been expressed here. Rightly there were references to the fact that new cures would be widely available. Everybody recognises the huge potential for cures, particularly for AIDS and other diseases, which result from the patenting of these bio-technological inventions but it is important that they be widely available. The debate has been going on for several years. It began under the last Government with extensive debate at political level and at official level, but I agree with the Deputy that there is a need for a wider debate on this subject. The bottom line, as far as I am concerned, is that we have endeavoured to get the right balance at EU level. I have endeavoured to reflect the views to which the Deputies referred here. It is equally important that the public and the NGOs, which are quite active in this area and with which I have tried to liaise, would be involved as much as possible in this debate. It is important to point out that we have always worked very closely with our EU colleagues and any developments in this area are conducted firmly under the umbrella of EU legislation.

Deputy Upton also referred to other issues regarding initiatives at EU level. There have been several initiatives at EU level to reduce the cost of patenting, focusing especially on the cost of translation of patent specification.

On the question of patenting software-related inventions, to which Deputy Naughten also referred, the EU Commission has launched a consultation process with interested parties in Europe. This process will be completed before Christmas and the Commission will propose measures based on the outcome of that process. At present it is possible to patent software-related inventions provided they comply with the general criteria for patenting.

Deputy Rabbitte sought information on the submissions made to the Department of Enterprise, Trade and Employment by the Association of Patent and Trademark Agents. The association has made submissions covering the matters it wished to have dealt with in the Bill. I have included some, but not all, of these matters in the Bill. The association has, in effect, asked the Government to reconsider its position on those matters which have not been included and we have replied to it. While none of the extra amendments proposed by the association are controversial or complex, I concluded that it would not be timely to provide for them now.

Apart from Deputy Rabbitte's comments on the substantive part of the Bill, other Deputies made points of a more general nature. Deputies Stanton, Rabbitte and Creed raised the matter of resources – this has come up on a number of occasions – for both the intellectual property unit and the Patents Office, especially in the context of the extra work requirements flowing from the Copyright and Related Rights Bill, 1999, which has now been enacted. The Government is satisfied that the Patents Office is sufficiently well staffed for the demand being made of it now and we will ensure that any further net new demands will be met by a well-staffed technologically up-to-date office.

I am especially pleased at the way the Patents Office has bedded down in Kilkenny in such a short space of time and I acknowledge the effort made by all the staff, most of whom had not worked in the patents area before taking up office in Kilkenny. While this is an especially busy time on all fronts for the intellectual property unit of the Department, the Government is satisfied that the unit is sufficiently well staffed to meet the demands being made. However, I stress that this areas is being continually reviewed. I am conscious, as the Deputies have said, that this is a vibrant area and the agenda continues to move on.

Deputies Stanton, Perry and Naughten mentioned the importance of the small inventor, whether in the form of an SME or an individual person. In that connection, the Deputies also raised the importance of widespread dissemination of information on the patenting process. It is a valid point, to which thought is being given at EU level. The EU Commission has indicated its intention, as part of its programme to advance innovation, to act in this front and it will in due course issue a communication on the subject of better dissemination of information among inventors, researchers and SMEs. On Deputy Naughten's suggestion that we examine carefully what was said at the recent committee meeting on Tuesday, I will ask my officials to look at the reports of that debate. I watched some of that debate on the television in my office and I feel it is important that we listen to what was said.

On patents search, which was raised by Deputy Naughten, it is possible at present to carry out a search of patent documents in the Patents Office. Many of these documents are available on CD-ROM.

Deputy Naughten also raised the revision of the European Patents Convention. A diplomatic conference to reverse the European Patents Convention will be held in Munich from 20-29 November. Our legislation will need further amendment as a consequence of changes which will be effected in the European Patents Convention following this diplomatic conference. The question of amending this Bill to incorporate the necessary change is under consideration.

I hope I have addressed most, if not all, the points made by the Deputies in the course of the Second Stage debate. I will obviously be able to deal on Committee Stage with any areas I did not cover. I again thank the Deputies for their contributions. I commend the Bill to the House.

Question put and agreed to.