UNESCO INTELLECTUAL PROPERTY AND THE HUMAN GENOME* Justice Michael Kirby**

 

SUMMARY

 

            At the beginning of 2001, just before the publication in February 2001 of the first preliminary draft of the entire sequence of the human genome, UNESCO convened an international symposium in Paris on the subject of Ethics, Intellectual Property and Genomics.  The author attended that symposium as a member of UNESCO's International Bioethics Committee.  He chaired the concluding working session.  This article represents an informal account of the debates and controversies that emerged during the symposium.  A deep gulf quickly opened up between experts from developed countries, who supported intellectual property law as applied to use of human genomic materials and participants from developing countries and non-governmental organisations who expressed alarm at how the law was being applied.  Possible future legal responses to this division, in UNESCO, WIPO, the WTO and other international and regional bodies is reviewed.  The report concludes with a list of the main emerging problems and some ideas for solutions.  UNESCO has established a working group to follow up the symposium.  The author is a member of that working group. 

 

CONTEXT

 

          The United Nations Educational, Scientific and Cultural Organisation (UNESCO) is sometimes described as the "think-tank" of the United Nations.  It is a body whose mission is to promote international peace through the exchange of ideas, knowledge and experience.  It facilitates dialogue between different disciplines, different regions of the world and governmental, private and non-governmental organisations.

 

          When in 1990 the Human Genome Project (HGP) was started, its scientific importance made it a natural subject for attention within UNESCO.  In June 2000 of the completion of the provisional first draft of the sequence of the entire human genome was announced.  Coinciding with this development a number of important ethical, economic and legal questions were raised.

 

          Within UNESCO, some of these concerns were considered by the International Bioethics Committee (IBC).  Growing out of the work of UNESCO since the 1970s on issues of bioethics, that committee had earlier drawn up the first international instrument specifically addressed to some of the key questions presented by the HGP.  In due course, the IBC adopted and recommended a draft Universal Declaration on the Human Genome and Human Rights (UDHGHR).  This draft was modified in certain respects by representatives of the governments of member states of UNESCO.  On 11November 1997, as so modified, the UDHGHR was adopted unanimously by the governing body of UNESCO, the General Conference.  On 9 December 1998, it was endorsed by the United Nations General Assembly, symbolically enough during the celebrations of the fiftieth anniversary of the Universal Declaration on Human Rights.

 

          Article 1 of the UDHGHR states that the human genome is the "heritage of humanity".  Article 4 states that "the human genome in its natural state shall not give rise to financial gains".  Other provisions of UDHGHR, such as articles 18 and 19, urge dissemination of scientific knowledge and cooperation of states in the sharing of such knowledge, specifically with developing countries, so that all will receive the full benefit of the achievement of scientific and technological research. 

 

          In May 2000, the newly elected Director-General of UNESCO, Mr Koïchiro Matsuura , requested the leaders of the G8 nations to adopt a declaration upholding the free access of the global scientific community to data derived from human genome sequencing¹.  In consequence of this appeal, the Okinawa communiqué of 23 July 2000, issued at the close of the G8 summit, called "for the further rapid release of all raw fundamental data on human DNA sequences as such" and also for multilateral collaboration.

 

          In August 2000², the Subcommission on the Promotion and Protection of Human Rights of the United Nations adopted a resolution expressing concern that the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) of 1994³ did not "adequately reflect the fundamental nature and indivisibility of all human rights".  This resolution mentioned the "apparent conflicts between the intellectual property rights regime embodied in the TRIPs Agreement, on the one hand, and international human rights law on the other"⁴.  It called for the World Trade Organisation (WTO), the body responsible for the TRIPs Agreement, to take fully into account the existing state obligations under international human rights law.  It requested the United Nations High Commissioner for Human Rights, as well as all other relevant international organisations, to continue "in-depth analysis of the human rights impact of the TRIPs Agreement".

 

          Various initiatives by the World Intellectual Property Organisation (WIPO), WTO, the European Union⁵, the Council of Europe⁶, the Organisation of African Unity⁷, other regional bodies, patent bodies and national initiatives provided the background against which the UNESCO international symposium on ethics, intellectual property and genomics of January and February 2001 must be understood.  Many of the main players in the global debate about intellectual property of the HGP were present at the symposium.  A notable absentee was Celera Genomics Inc, the United States private sector body which, for a time in 1999-2000, challenged the publicly funded HGP in a race to complete the first draft of the sequence of the human genome⁸.  That company, and others in the private sector, had been invited by UNESCO but did not take part.

 

          Despite such absences, a broad cross-section of views was expressed at the UNESCO symposium.  The Secretariat of the UNESCO Division of Human Science, Philosophy and the Ethics of Science and Technology provided a preliminary analysis, "Intellectual Property in the Field of the Human Genome"⁹.  This report gave focus to some of the main points made by the participants in the symposium.  The object of the exercise was to promote the sharing of experience and opinion and to stimulate further activity within UNESCO and the other participating bodies.  It was not to obtain agreement on an action plan.  Nor, as such, was it to pass resolutions or reach agreed conclusions.  Present throughout the symposium was the President of the IBC (Professor Ryuichi Ida of Japan) and many members of the IBC, including this reporter.

 

INTRODUCTION

 

          The symposium was opened by Director-General Matsuura.  He suggested that, if the twentieth century had been the century of material things, the twenty-first century would probably be that of living things.  It behoved humanity to ensure that progress towards the understanding of living things (including of the human species itself) afforded the basis of a better life for all.  Specifically, the progress achieved since Watson and Crick first described DNA in 1953 gave rise to unprecedented hopes for the ultimate elimination of disease.  However, new concerns had arisen about the way in which biological data would be used.  It was those concerns that had led UNESCO to create the IBC, an interdisciplinary body of 36 members drawn from all regions of the world. 

 

          The UNESCO Director-General described the special difficulty of obtaining informed public policy responses to the challenging problems of bioethics presented by the HGP.  Public opinion, upon which such responses were commonly dependent, was often extremely poorly informed.  The symposium was an initiative by UNESCO to promote an exchange of ideas.  In its future programme UNESCO will place priority upon the ethical concerns presented by rapid advances in science and technology, including genomics.

 

          Professor Ida (President of the IBC) in his opening remarks touched upon the commonly expressed concern about the future of genomic data where this was confined to private sector organisations unwilling to ensure that the results of genomic sequencing were open to free access by the general scientific community throughout the world.  He referred to the then recent report of the sequencing of the genome of rice, the staple diet of about half of the world's population.  The implications of intellectual property rights in respect of this data and its utilisation were enormous.  They presented the basic question of what is presently, and what should be, the subject of patent law.  The IBC, and later UNESCO, had adopted the principle in article 4 of the UDHGHR.  Professor Ida said that translating the principle of "common heritage" into effective content in intellectual property law was the challenge which the symposium should address.  It should recognise that, in a sense, humanity was at a cross-roads.  Decisions made now would profoundly affect the future.

 

          Mr Marcelo Palacios, President of the International Society of Bioethics, traced the history of genomics from Mendel to the discovery of DNA and up to the present time.  He outlined some of the controversies which contemporary society had to face.  They extended beyond the subject matter of the symposium.  Such controversies included the development and consumption of transgenic food; advances in gene therapy; mamalin cloning; developments involving stem cells; the controversy over reproductive cloning of the human species; and the implications of the completion of the first provisional sequence of the human genome.  He said that it was critical to ensure that this last development should contribute to the improvement in world health, to universal social justice and to the alleviation of poverty and disease. 

 

          Mr Palacios suggested that sound bioethics, including the specific area of intellectual property law choices, had to be based upon good science.  It had to fight disinformation, prejudice and ignorance.  Surveys of European citizens revealed very high levels of ignorance about genomics.  This was a matter of great concern because such ignorance impeded rational dialogue and effective, democratic decisions.  Mr Palacios encouraged the sharing of views and information so that a culture of bioethics would become as much a part of the global reality as the HGP would itself become.

 

          The Minister of Research of the French Republic and the Minister of Science and Innovation of the United Kingdom, who were scheduled to take part in the meeting, did not appear.  The opening ceremony closed, as such occasions generally do, with recognition of the importance of the topic of the symposium but without specifics as to the subject of intellectual property developments that had brought it about.

 

ETHICS AND THE PROTECTION OF INTELLECTUAL PROPERTY

 

          The first substantive session came directly to the relationship between intellectual property law, which includes patents, and ethical debates.  This session was chaired by Ms Michelle Jean of Canada, a member of the IBC.

 

          The first speaker was Professor Mireille Buydens of the Catholic University of Louvain (Belgium).  Approaching the problem from the context of the philosophical writings of Descartes she suggested that the role of ethics was to ensure that, in a new scientific development, such as genomics, evil and harm should be avoided and what was best for all maximised.  Intellectual property rights represented a legal means of appropriating new knowledge to the benefit of identified persons who, in turn, shared it with society but upon condition that, for a specified time, they would enjoy particular privileged rights.  Before and during the twentieth century, intellectual property rights had expanded to include patents, copyright, trade mark entitlements and the moral rights of performing artists.  The limits of intellectual property protections were ultimately to be decided by the law and imposed by reference to conceptions of the general good of society.  To some extent, such rights were exceptions to the general principle of the free flow of information and free competition, unimpeded by monopoly or like privileges.  Because intellectual property rights were exceptions to the general hypothesis of the uninhibited access to data, principle suggested that such rights should have a restrictive interpretation.  However, in recent times, disturbingly, patent law had been pressed into new and different uses.  This was especially so in the United States of America but also true in Europe, Japan and elsewhere.  In the United States, for example, patents had been granted over business methods and over a state of the art data base.  And now, it was suggested, patents could be granted in respect of genetic sequences.

 

          Professor Buydens called attention to the practical problem which was faced by patent offices generally and specifically the United States Patent and Trademark Office (USPTO) and the EPO (EPO) in Munich, the two busiest patent offices in the world.  An official at such a patent office might spend about eight hours on average considering a single request.  Much more could not be allowed because of the sheer pressure of waiting applications.  Such officials were sometimes even rewarded by the payment of a bonus for each request processed.  The starting salary of such officials was extremely modest in comparison with the salaries typically paid to patent attorneys.  Institutionally, therefore, there were pressures which tended to favour the grant, and not the refusal, of patents.  They also tended to minimise consideration of bioethical or other public policy concerns, unless these were specifically required by law.  Patent officials could hardly be criticised for failing to consider matters which were not clearly identified in the law as requiring consideration.

 

          Professor Buydens drew attention to the differentiation in European patent law between invention (in respect of which patent protection was available) and discovery (in respect of which it was not).  A basic difficulty was that this differentiation did not exactly parallel that between elements appearing in nature and in products that could be called inventions.  If a naturally appearing element was identified as one which could be used to solve a particular problem, it could be patented.  It was this fact that, for many years, had led to the grant of patents in respect of living non-plant materials adapted for new and particular uses.  Prior to 1980, some experts in intellectual property law considered that living organisms, being part of nature, were not patentable.  However, in Diamond v Chakrabarti¹⁰, the United States Supreme Court, by majority, changed this understanding.  It held that micro-organisms which used genetic engineering were not excluded from the scope of patentability as defined by United States patent law.  In the result, a patent for a transgenic organism was granted in the United States .  It was quickly followed by others. 

 

          According to Professor Buydens, the scene changed still further in the early 1990s in the United States with a large number of applications made for patents on gene sequences as such, initially by Mr Craig Venter.  The scientific and legal developments in that country had, in turn, led to an active debate in Europe.  Eventually, this resulted in the Biotechnology Directive ("the Directive") issued by the EPO pursuant to the European Patent Convention 1973.  Although the Directive provides that the human body and its elements in a natural state are unpatentable¹¹ and that a mere DNA sequence without indication of function is not patentable¹², closer examination showed that these controls were largely devoid of meaning if the gene in question was produced by technical means.  Inventive activity, novelty and usefulness in the product were required.  But so long as they could be shown, a patent could be secured from the EPO conformably with the Directive.

 

          Professor Buydens asked whether intellectual property rights should now give way to higher rights that the law would establish.  Such higher rights might, for example, include the need to protect access to knowledge for teaching and research.  Another might be for use of scientific information for wholly non-commercial purposes.  Yet another might be for legitimate scientific experimentation.  Still further exceptions might be specified for reasons of public policy or public morality.  Such possibilities are already recognised in Article 53(a) of the European Patent Convention, prohibiting the patenting of inventions whose commercial use would be contrary to public policy. 

 

          According to Professor Buydens an urgent task was to establish legal exceptions which would permit a more appropriate balance to be struck between the legitimate requirements of intellectual property protection and the demands of competing considerations upon which society (and preferably global society) was entitled to, and should, speak with a clear voice.  Professor Buydens was confident that intellectual property law could yield principles which would set proper limits to the patentability of living material.  But she emphasised the need to search for mechanisms that would ensure that uniform decisions were made and that the practical constraints within which such decisions were made every day in patent offices would be kept in mind.

 

          Mr Axel Kahn is chairperson of the high-level group of experts for the life sciences within the European Commission.  He also holds an appointment as director of the Department of Genetics of Institut Coshin in Paris.  He traced the history of intellectual property law from its early origins in England, France and the United States.  The original idea had been that of a contract between an inventor and society.  Each benefited from the exchange inherent in the contract.  Initially, only invented things were patentable.  Human tissue, and other matter naturally appearing were not themselves viewed as objects susceptible to intellectual property regulation.  It was biotechnology which had changed this scene and presented new puzzles. 

 

          Mr Kahn pointed out that, at the end of the nineteenth century, Louis Pasteur had taken out a patent in France over a biological process involving the use of yeast.  Similar patents had been granted in the United States.  In 1930, legislation in that country had drawn a distinction between plant varieties cultivated by human beings and others appearing in nature.  But the real breakthrough in patent law on this subject had come with the decision of the United States Supreme Court in Diamondv Chakrabarti. 

 

          Following that decision, the United States Appeals Court had interpreted the Supreme Court ruling as providing a green light for providing patents by reference to living matter.  Thus, in 1987 it was held that certain polypoid oysters were a patentable subject matter in the United States¹³.  This led, in turn, to a flurry of activity to create transgenic animals, such as the Harvard oncomouse¹⁴.  This is a mouse into which an active oncogene was introduced in order to give it a genetic disposition to develop cancerous tumours and hence to be specially suitable for laboratory testing of anti-cancer drugs. 

 

          According to Mr Kahn, all of these developments in the United States had been spurred on by the new patent application policy of the National Institutes of Health (NIH) under Mr Craig Venter (a policy later reversed).  That policy originally put pressure on the EPO to provide a regime offering equivalent protections to European scientists and corporations.  The result was the new draft European Directive which, after much debate, came into force in 1998 and required member states to amend their patent law to ensure compliance¹⁵.  As an outcome, the EPO almost immediately received thousands of relevant applications.  Hundreds of patents have already been granted¹⁶.

 

          Mr Kahn pointed out that these legal and industrial developments had presented ethical dilemmas.  Even if plants and animals could be viewed as things or objects, the provision of patents in respect of living cells was now affording to the "inventor" a species of property in respect of life itself with specific relevance to human life.  In Mr Kahn's opinion, this could not be defended either in terms of bioethical principles or in terms of traditional intellectual property law.  He acknowledged that those who supported this development asserted that there was an "inventive step" in putting living materials to use, either in the form of new genetic tests or therapies or for industrial or like purposes.  But according to Mr Kahn, to a biologist, what was involved was a function of a naturally appearing phenomenon.  The result was a significant shift in economic power in favour of those who secured intellectual property protection.  This, in Mr Kahn's view, was against the public interest in developed countries.  But it could be even more devastating for developing countries.  It was therefore appropriate for the international community, under the auspices of UNESCO, to address itself to the phenomenon without delay.

 

          The next speaker in this session was Mrs Elizabeth Longworth, a consultant from New Zealand.  She placed the developments of intellectual property law in the context of the globalisation and regionalisation of national economies.  Pointing out that law never exists in a vacuum, but reflects the moral values of the society which makes it, she concluded that what was necessary was a clarification of the contemporary ethical basis for intellectual property law.  A dilemma was posed by developments in patent laws as they affected living matter.

 

          According to Mrs Longworth, it was the feature of patent rights, giving the holder exclusive entitlements for a time, that caused community anxiety about patents in relation to, or dependent upon, living materials.  It was the very number of such patent applications, and their potential to affect adversely the maximisation of scientific knowledge, that gave rise to strenuous debates.  She referred to recent announcements by the USPTO of refinements in respect of its policies for the granting of patents in this connection¹⁷.  These required careful attention from other countries, given the practical significance of what happened in the United States for intellectual property law elsewhere, the practice of other patent offices and law and the rights of humankind.

 

          Mrs Longworth pointed out that such legal developments also had to be seen in the context of the mandatory provisions of the TRIPs Agreement.  Article 7 of that Agreement states, amongst its objects:  "The protection and enforcement of intellectual property rights" which "should contribute to the promotion of technological innovation and the transfer and dissemination of technology".  Intellectual property protection was often justified by the large reported costs (sometimes said to be $US500m) to develop a significant biotech product to the point of commercial viability.  If no intellectual property protection were assured, it was commonly assumed that the huge investments needed to develop such products would not be forthcoming.  But an obvious ethical question, presented by the TRIPs Agreement, was the extent to which the laudatory aim of technology transfer to developing countries would be achieved under current arrangements.  Or whether this Agreement, and the activities of the WTO and other international economic organisations, would really help advance the interests, and meet the needs, of people in developing countries. 

 

          Mrs Longworth pointed out that the UDHGHR only addressed the debates about intellectual property and the genome obliquely.  It did so in Article 4, previously mentioned, and in Article 12.  The latter states that "benefits from advances in biology, genetics and medicine, concerning the human genome, shall be made available to all, with due regard for the dignity and human rights of each individual".  The UDHGHR also propounds the principle that "freedom of research, which is necessary for the progress of knowledge, is part of freedom of thought" and that applications of research in connection with the human genome should "offer relief from suffering and improve the health of individuals and humankind as a whole".  Picking up these themes, Mrs Longworth emphasised that it was important for human society to face up to, and make, the moral decisions which the advances in genomics demanded.  She said that the World Bank itself had questioned whether intellectual property law was indeed, as its proponents commonly asserted, an efficient way of encouraging inventiveness.  Such assumptions needed to be proved.  In particular, they needed to be demonstrated in the context of modern biotechnology.

 

          Mrs Longworth acknowledged that it was difficult to turn back the clock on developments in the field of intellectual property law which had already occurred.  By reason of patent decisions already made, significant economic interests had been accrued.  Any suggestion of a new regime would obviously affect established economic and legal rights.  People affected could be expected to resist change.

 

          Mrs Longworth urged that countries should ensure that the trade-off represented by patent law was fully achieved.  She stated that a problem sometimes arising from current legal provisions in municipal patent law and practice was that knowledge effectively became locked up and nothing effective was done to translate that knowledge into products useful to society.  She raised the particular issues of the rights of indigenous peoples, reported cases of bio-piracy and the need to ensure that patent holders take their own responsibility for technology transfer to developing countries.  She urged the need for a global approach in responding to the dilemmas that were presented at the symposium.  But she did not under-estimate the difficulty of securing such an approach given the differing national interests that would be involved and the competing economic interests at stake.

 

          At the end of this session a number of interventions from the floor highlighted the differing viewpoints held by participants in the symposium.  Professor Michel Revel (Israel), a member of the IBC, explained the ultimate purpose of patents as being to ensure that knowledge obtained by an inventor was made available to society upon conditions affording the inventor monopoly rights for a limited time.  Specifically, Professor Revel defended the balance which the European Directive set out to strike.  On the other hand, spokesmen for a number of non-governmental organisations were not convinced.  They saw current intellectual property law in this context, and the TRIPs Agreement and European Directive specifically, as nothing more than a contract between government and industry.  According to their viewpoint, it was a contract which had effectively excluded the public and, especially, the public in developing countries.  The consequence of the monopoly afforded by patent law was more likely to be protection of the share prices of firms enjoying intellectual property rights than the advancement of the general public benefit.  Particular concern was expressed in respect of patenting of a genetic sequence for an identified industrial application where, subsequently, it was discovered that the same gene, or a connected protein, had different applications of different and possibly greater utility.  In such a case, the later applications "downstream" were hostage to the earlier patents granted "upstream" and the necessity to secure licences to comply with the granted patent.

 

          Mr Kahn, in reply, emphasised that everybody should be in favour of the availability of patents.  The real question was the extent to which this developed body of law, with quite extensive periods during which monopoly rights were afforded, was suitable for application, unamended, to genetic materials.  Professor Buydens, in her reply, emphasised the growing coalescence of European and United States patent law, even though the concepts of each were, in material respects, different.  Mrs Longworth returned to her theme.  According to her, the essential question before the symposium was not what present patent law provided in relation to genomics but whether the law, as presently framed, was satisfactory.  She appealed to the symposium to face up to the ethical choices that were presented and not to surrender these to established legal norms or even apparently insurmountable impediments to change.

 

CURRENT LEGISLATION

 

          The second session on contemporary legislative texts and regulations on intellectual property law in force or under consideration was chaired by Madame Nicole Questiaux, President of the Conference of National Bioethics Committees of the Council of Europe.

 

          Mme Questiaux emphasised that most of the participants in the symposium, like most who debated these topics in society, were not themselves scientists.  It was therefore difficult for them fully to comprehend the complex and technical problems which genomic science had presented for national, regional and international regimes for intellectual property protection.  She acknowledged that the "explosion of patents", which had seen more patent applications lodged than at any other time in the existence of intellectual property protection, had presented acute policy questions.  Upon the answers to those questions, civil society, and not just industry, had legitimate interests to be taken into account.  She emphasised that generalities in the ensuing debates were not sufficient.  It was impossible to tackle the emerging ethical questions without exploring the detail both of the science and of the relevant law. 

 

          The opening address in the second session was given by Professor Héctor Gros Espiell, former Ambassador of Uruguay to UNESCO and a member of the IBC.  From the viewpoint of his expertise in the field of public international law, he outlined the background against which the UDHGHR was to be understood.  This included the 1883 Paris Convention for the Protection of Intellectual Property (last amended in 1979) and the Patent Cooperation Treaty of 1970 (Washington) (last amended in 1984).  He also explained the operation of the TRIPs Agreement and of the Convention on Biological Diversity, adopted in 1972 in Rio de Janiero.  The lastmentioned convention does not explicitly apply to the human genome, being concerned with "plant, animal, microbial or [genetic material of] other origins"¹⁸.  After reviewing European and other regional developments relevant to the debates, Professor Gros Espiell classified national laws as including those most favourable to the provision of intellectual property protection in respect of genomic material; those partially favourable; and those least favourable.  He drew attention to provisions in a number of national constitutions, such as Article 124 of the Constitution of Venezuela.  This article forbids any registration of patents in respect of defined genetic data which is to be used for the common interests of all. 

 

          Professor Gros Espiell stressed that intellectual property rights had to be viewed in the context of the developing jurisprudence of human rights generally.  It was also important that the principle of technology transfer and the protection of the rights of peoples in developing countries should be given more than lip service.

 

          Professor Tim Holbrook of the Chicago-Kent College of Law in the United States outlined the origin, history and current provisions of United States patent law.  He pointed out that there were four basic requirements for the provision of intellectual property protection by way of patents under United States law.  These were that the subject matter of the application was eligible, that is, that it did not include a mere law of nature, an abstract idea or naturally appearing phenomenon; that the product was "novel"; that the process involved was not "obvious"; and that the applicant would conform to disclosure requirements once the patent was issued.  In exchange for such compliance, the patent holder secured specified rights for twenty years. 

 

          Professor Holbrook stated that his reading of the newly published requirements of the USPTMO of 5 January 2001 specified that the "utility" of the propounded product must be "substantial, specific and credible".  He said that this appeared to "ratchet up" the preconditions for patentability in a way that was relevant to the products of biotechnology.  He said that this should make it more difficult to secure a patent in respect of such biological innovations.

 

          Professor Holbrook explained how the USPTMO had rejected the general proposition that, because genetic sequences appear in nature, they were ipso facto insusceptible of patent protection.  The view had been taken that genes are chemicals and that, when isolated and put to use in specified ways, they could attract the application of the legislation.  In this regard, the USPTMO was simply conforming to the law as elucidated by the courts of the United States.  In a society governed by the rule of law, administrators had no option but to do this. 

 

          Professor Holbrook explained the important function of the United States Court of Appeals for the Federal Circuit in deciding particular cases in that country and in thereby establishing the principles to be observed by the USPTMO and by patent lawyers and their clients generally.  He pointed out that the United States Supreme Court had not addressed the issue of patentability of genomic sequences.  The closest that the Court had come to such a consideration was when it refused to consider an appeal against an analogous decision in which a patent had been granted in respect of a business methods system.  One Justice appended a concurring opinion to the decision refusing the application to appeal in that case.  This made it clear that, in his opinion, the refusal did not necessarily mean that the decision was correct on its merits.  Professor Holbrook predicted that the new guidelines issued by the USPTMO in 2001 would not meet all of the concerns that had been expressed in the United States and elsewhere about this topic.  He suggested, however, that the new guidelines might prompt either the Congress or the Supreme Court to interest themselves further in this area. 

 

          Professor Koichi Sumikura holds the Chair of Science, Technology and Intellectual Property in the University of Tokyo.  He outlined the large expenditures of the government of Japan over the past five years to support areas of research relevant to genomics.  He explained the provisions of Japanese patent law under which products appearing in nature, without human intervention, are not treated as an "invention", susceptible to patent protection.  On the other hand, products that are isolated from those appearing in their natural state and which are rendered useful for an identified purpose may secure patent protection.  According to Professor Sumikura, many patents have been issued in Japan in connection with DNA sequences, including in respect of express sequence tags present in a living cell.  The DNA fragment itself would not be regarded as an "invention", susceptible to patent protection.  But if it were demonstrated that it could be put to use, for example, for the diagnosis of a genetic condition, that use might attract a patent so long as the other conditions (novelty, non-obviousness and inventive step) were fulfilled. 

 

          According to Professor Sumikura, it was more difficult in Japan than in the United States to patent genetic sequences.  Japanese law included exceptions on the grounds of public order, public morality and public health.  He considered that there was a need for an ethics body to provide ethical guidelines on how these exceptions should operate in practice.

 

          The third speaker in the second session was Mr Jacques Warcoin, a French patent lawyer.  He explained the overlap between information technology and biotechnology.  He also explained the applicable inter-relationship of patent and copyright law.  He outlined the somewhat turbulent history of the development of the European Directive.  Once adopted, this obliged the member states to bring their laws into line with the Directive.  However, because of public disquiet about patenting with respect to genomic sequences, the French draft law has not yet been enacted.  Indeed, most member states in Europe were in the same position.  Mr Warcoin expressed regret about the uncertainty which the failure to adopt laws consistent with the Directive had produced for the countries affected.  He suggested that there were other ways to meet the concerns of the opponents than preventing the passage of the new laws. 

 

          Bringing a practical dimension into the debate, Mr Warcoin explained how the scene of patenting and genomics had been changed forever as a result of the activities in the United States of Mr Craig Venter.  When he was working for the National Institute of Health (NIH) patent applications were lodged in respect of over 2,200 genetic applications about whose operation nothing was at that time known.  This action enlivened an urgent national and international debate.  In the end, NIH decided not to proceed with the applications.  But an idea was planted and there would be no escaping its consequences. 

 

          Mr Warcoin listed a number of practical issues which, he said, were controversial amongst intellectual property law experts in France.  They included:  identification of the time from which a patent can be secured in this area; the consequences of subsequent discovery of a second and different utility of a genetic sequence "downstream" and how this could secure a protection compatible with a patent already granted; and the provision of patent protection in respect of proteins and how this could be reconciled with the needs of public health.

 

          At the end of formal presentations, Mme Questiaux returned to the fundamental question.  Given the complexity of the science, how could the problems explored at the symposium be explained in terms that would permit elected representatives of the people, and officials advising them, to make informed democratic choices on such important issues?  Are choices truly available in the modern world or will they be overtaken either by scientific developments or by the sheer force of economic pressures exerted by the practice and laws of powerful countries or by international bodies such as the WTO?

 

          Speakers from the floor drew attention to the existence of a European Group on Ethics which works in conjunction with the EPO.  However, it was pointed out that this body is substantially limited to dealing with general issues of principle.  There is no actual ethical input into the decisions of the EPO on particular patent applications.

 

          One participant condemned what he described as the manipulation of those who ultimately adopted in 1998 the European Directive.  He described what he called "people with white collars pushing persons in wheelchairs with rare diseases in order to put pressure on the members of the European Parliament".  He suggested that the development of tests and therapies for rare genetic diseases was not truly a priority of the pharmaceutical industry.  In this and like interventions from the floor, demands were made for public health exceptions from intellectual property law protection, so as to ensure that research and development, connected with patented genetic sequences, did not distort the priority of essential therapies; blow out the costs to the public health budgets of developed countries; or put most such therapies beyond the pockets of developing countries.

 

          Professor Michel Revel suggested that, in the real world, many patented drugs would be supplied free of charge or at lower cost, to developing countries.  He urged that the debates of the symposium should retain a sense of realism about the reach of patent law beyond those developed countries in which, as a matter of practice, such law was commonly obeyed.  Mr Wakoin supported this observation, pointing out that, as a matter of practicalities, most people engaged in pure research were not unduly impeded by the existence of patents.  He said that it was in industrial applications, derived from such research, that problems of an existing patent could present themselves.  He stated that in thirty years of experience as a patent lawyer he had never heard of legal provisions being used effectively to impede pure scientific research.

 

          A speaker from Tunisia likened the developing international patent law, reinforced by the TRIPs Agreement, to a new form of colonisation.  He drew an analogy to the costs extracted for therapies for HIV.  Whilst these therapies were not at the moment genomic in character, he suggested that they presented a warning, by analogy, about the implications of patent law for drugs and public health throughout the world when the therapeutic benefits of genomic research came to be felt. 

 

          A legal expert from Algeria protested at what was seen as the use of human beings, and living material derived from them, as "objects" which he regarded as offensive to principle.  A speaker from Finland proposed that patent law should return to a basic distinction between the elements of nature which were "discovered" and products which were "invented".  Thus, if a genetic sequence appeared in nature, and was discovered by the high powered machines used by the HGP or Celera, it was not properly susceptible to patent protection.  This participant urged that lawyers, specifically patent lawyers, were not necessarily the best experts to judge the considerations that had to be taken into account to make bioethical decisions.  There was therefore a need, she said, to support the work of patent offices in respect of particular applications, by the establishment of informed multidisciplinary ethics committees.

 

          A speaker from the floor from India stressed that the human genome had developed over millions of years of evolution.  No one had "invented" it.  It should not "belong" to anyone.  He stated that, for example, the drug used for treating breast cancer could not be afforded by the very people in India who had contributed genetic samples used in its development.

 

          Professor Holbrook stated in his reply that he had been unfamiliar with the suggested dichotomy between "discovery" and "invention".  This was not the formula used in United States law.  Nor could it be, because the United States Constitution expressly refers to "discovery" and not "invention" when referring to the applicable head of legislative power given to the Congress.  Professor Holbrook expressed his personal agreement with the need for an international and multidisciplinary approach to the problems discussed in the symposium.  He said that he could understand the concerns expressed that, in effect, decisions made in the USPTO would have profound ethical and economic consequences for people in all parts of the world.

 

          Professor Gros Espiell, in reply, acknowledged the limited scope of Article 4 of the UDHGHR.  He said that the IBC had not been unaware of the importance of the patents issue.  Article 4 had represented a first step on the path to a more comprehensive treatment of the subject.  He called attention to the context of international law in which the UDHGHR was to be read.  This included the International Covenant on Economic, Social and Cultural Rights which recognises the human right to health.  He acknowledged that patents were a reality, recognised by international as well as regional and national laws.  He accepted that major economic groupings could put pressure upon most countries of the world.  He agreed that the symposium had to be realistic about the subject of its debates.  But these considerations did not release the participants from the duty to view contemporary intellectual property law from an ethical perspective.

 

          Professor Sumikura, in conclusion, accepted that patents may sometimes inhibit scientific research.  However, he said that there were practical checks in that, if the costs or inhibitions were too high, a real risk would be presented that the law would be ignored or that ways would be found to circumvent it.  Mr Warcoin pointed out that in France, as in many countries, the government reserved to itself a power to produce or facilitate particular drugs if they were deemed critical for public health and were either available in insufficient quantity or at too high a price.  He agreed to the suggestion that the symposium should approach the issue before it, so far as possible, dispassionately rather than emotionally.  It was a subject for expert reflection and high particularity, not generalities and catch-cries.

 

APPROACHES OF INSTITUTIONS

 

          The second session was followed by a Round Table moderated by Mr Najib Zerouali Quariti, Minister of Higher Education of Morocco.  He praised the initiative of UNESCO both in adopting the UDHGHR and in convening the symposium.

 

          The first to speak in the Round Table was Mr Bruno Hansen, Director for Life Science Coordination of the European Union.  He returned the debate to the provisions of the European Patent Convention and the European Directive.  He pointed out that there were cultural differences in the member states of the European Union which, in accordance with the Amsterdam Treaty, had to be respected.  Such differences were sometimes grounded in perspectives of the ethics of controversial policy choices.  He said that in current circumstances patenting presented such choices and that it was essential for officials, scientists and corporations with genomic investment, to take the ethical controversy seriously.  The result of ignoring it would be a serious backlash and possibly even worse. 

 

          Professor Ida (President of the IBC) explained the way in which the IBC had approached the issues of intellectual property connected with the human genome.  He pointed out that it was the distinction between the DNA molecule itself and the information derived from that molecule which presented the possibility of intellectual property protection.  A recognition of this fact, and of the proper place of intellectual property law in a modern economic and legal system, had produced the endeavour within the IBC to establish links with relevant international and regional bodies such as WIPO, the WTO and the European Union.  Although a proposed workshop involving all of these bodies, and the IBC, some eight years ago had not taken place, the present symposium was a belated endeavour to open the lines of communication in a context of a genuine international ethical reflection. 

 

          Professor Ida posed the question of what the UDHGHR had meant in Article 1 in declaring that "[i]n a symbolic sense" the human genome is "the heritage of humanity".  Was it no more than a metaphor?  Or did it have implications for the endeavour to secure property, and thus intellectual property rights, in aspects of the genome?  A partial answer to that question was found in Article 4 of UDHGHR stating that "the human genome in its natural state shall not give rise to financial gains".  Initially, as drafted by the IBC, the words "in its natural state" did not appear.  Those words were added to the draft prepared by the IBC by the Committee of Government Experts who scrutinised the draft convention before it was presented to the General Conference of UNESCO.

 

          Dr Maria Freire is Director of the Office of Technology Transfer, within NIH in the United States.  She began by calling attention to the huge investment in research in areas of concern to public health in the United States.  The NIH did not believe that all products of research which it funded should be patented.  For example, it commonly decides that products or surgical procedures, developed under its auspices, should be available to all who can use them in the furtherance of better healthcare.  Dr Freire  pointed out that, in the United States, most of the funding for the HGP came from NIH.  NIH had also established a programme to scrutinise the ethical, legal and social implications of the HGP.  NIH abided by the Bermuda Principles.  It published sequences of the HGP within 24 hours of the sequence becoming known to it.  There has sometimes been a creative tension with the USPTMO.  NIH has taken concrete steps to galvanise scientists in the United States to resist undesirable expansion of intellectual property protections.  This was done, for instance, in 1988 when the USPTMO initially indicated that ESTs would be patentable.  Eventually that Office changed its position.

 

          Dr Freire pointed out that she had succeeded Mr Craig Venter in the position she now held in NIH.  She mentioned the then impending publication mid-February 2001 both by Celera (in Science[19]) and by the HGP (in Nature²⁰) of the preliminary draft sequences of the human genome which together would present a composite picture of the entire human genome.  She reminded the symposium that the last object to come out of Pandora's Box was "hope".  She said that it was hoped that a proper balance would be secured between the free circulation of scientific knowledge (a core value of the United States as elsewhere) and appropriate protection of intellectual property rights.  She stated that NIH made many practical contributions to the achievement of this objective.

 

          Mr S Bhatti of WIPO next described the mandate of that organisation as a specialised agency of the United Nations.  It has 173 member states.  Its main activities include the development of international treaties and the modernisation of municipal legislation on intellectual property; the application of present treaties; the provision of advice and technical assistance to developing countries; and the pursuit of protection through the Patent Cooperation Treaty.

 

          Mr Bhatti outlined the development of the global regimes of intellectual property law.  He stated that in 1999 WIPO had decided to convene a working group on biotechnology which would review the application of present legal standards.  Specific attention would be given to "downstream inventions" and to the identification of sound public policy principles that should govern the granting of patents in this connection.  He also outlined consultations that were proceeding between WIPO and the Food and Agriculture Organisation of the United Nations (FAO).  He stated that in September 2000, the WIPO General Assembly had established a new forum for future consideration of issues of biotechnology.  The intergovernmental committee so established, although comprising member states, would be open to attendance by non-governmental organisations that attained ad hoc observer status.  WIPO believed that an efficient patent system should include an effective way of addressing ethical concerns.  A study of the relationship between ethics and patent law was timely.  WIPO therefore welcomed the contribution which the UNESCO symposium would make to this end.

 

          Madame T-L Tran of the WTO then explained the operation of the TRIPs Agreement and the current work of the TRIPs Council within the WTO.  She pointed out that the WTO comprised three pillars, namely GATT, GATS and TRIPs.  She explained the role of the dispute settlement body and stressed that the WTO, itself, had no power to interpret conclusively the provisions of the TRIPs Agreement.

 

          Mme Tran drew attention to Article 27.2 of the TRIPs Agreement which acknowledges that parties may refuse recognition to patents if doing so is necessary to protect public order or public morality in connection with human life and health, animal life and health or serious harm to the environment.  She also drew attention to the exception in Article 27.3(a) referring to diagnostic and other uses and to other exclusions envisaged by the TRIPs Agreement.  She said that these provisions were designed to provide a regime permitting just exceptions whilst at the same time upholding the legitimate rights of patent owners to the protection of a form of property of great importance to the modern global economic system.

 

          Mme Tran stated that WTO was fully aware of the highly sensitive and political questions which were represented by human, animal and plant genetics and intellectual property rights in connection thereto.  She raised a fundamental question as to what the "ethics" of the title of the symposium meant.  How could global consensus be secured with respect to such a topic?  The existence of a patent was an objective fact.  It was either granted or it was not.  But some means had to be developed to provide mechanisms that would allow for settlement of different points of view about the content of ethics in this connection.  Such mechanisms would need to respect the diversity of the opinion of humanity on such questions whilst at the same time upholding the operation of intellectual property law and providing incentives for new inventions that would translate scientific "discoveries" into developments of practical utility for use by human beings.

 

          Dr E Ronchi of the Organisation for Economic Cooperation and Development (OECD) outlined the work of that organisation.  She pointed out that the OECD was not a regulatory agency.  But it conducted surveys and questionnaires in many areas, including some related to genomics.  Since 1982 it has reviewed the legislation of member countries and provided reports comparing patent law in such countries.  These reports are publicly available.

 

          In 2000, the OECD published a report indicating that existing systems of genetic testing were causing concern in many member countries.²¹  Whilst the OECD recognised fully the need for patent laws, this report raised questions about the restrictive licensing of some genetic tests and the consequences that this would have on the availability of genetic services both as between countries and within a particular country.

 

          During the general discussion of the subjects raised by the Round Table, various members of the IBC attending the symposium expressed concern at the emerging picture.  One (Dr M Hamdan of Jordan) urged that the scientific community make a contribution by  helping to identify a appropriate line distinguishing between "discoveries" and "inventions", in respect only of the latter of which patents should be available.  Many participants from the floor expressed anxiety about the ultimate outcome of the global enforcement of intellectual property laws.  One participant from Tunisia apologised for going against the trend of the symposium to the effect that patents were beneficial.  This participant disagreed and stated that genetic samples would be secured from developing countries but the benefits that would be provided in return would be minimal.  To secure useful samples, it was commonly important for scientists to procure samples from, and conduct research on, large family groups typically found in developing, but not developed, countries.  This participant urged the importance of converting the generalities of the UDHGHR about technology transfer into practical reality.

 

          Professor Michel Revel criticised the vagueness of some of the interventions.  He stressed the important difference between the genome and genes.  When defined and adapted, an isolated  gene could well be of great practical utility and benefit, for example in the making of a diagnostic tool or the development of a therapy.  If this was demonstrated it would be patentable.  On the other hand, the genome, in its natural state, did not have such utility.  It would therefore not attract intellectual property protection within the law.  Other commentators suggested that this distinction, reflected in the European Directive and in many national laws, simply underlined the empty character of declarations such as Article 4 of the UDHGHR.

 

          A representative of the European Ethics Committee pointed out that contemporary scientists were working in an environment completely different from that of their predecessors.  It was a highly competitive world in which great pressure was placed upon them to secure intellectual property protection for their work.  A spokesman for a large European chemical company stressed that it was practically impossible to train scientists in intellectual property law.  This was why industries and institutions had to provide intellectual property experts.  The discipline was highly technical.  It could not be expected that scientists would master it, in addition to their own vocation.

 

          A governmental science adviser from Sri Lanka stated that the talk of the symposium would be of little practical value unless it was followed up.  He stated that UNESCO should establish a high level committee to ensure that the concerns expressed at the symposium, particularly by participants from developing countries, were addressed effectively.  He considered that the alleged cost of converting a scientific research to a viable pharmaceutical product, namely $US500-600m, was grossly inflated.  He urged that action be taken to ensure that the concerns of the developed world about the availabilities of affordable therapies should have attention.  Otherwise, as it was later put, the HGP would be distorted by undue attention to wrinkles rather than malaria.

 

          Dr Guessous-Idrissi, a member of the IBC, shared her anxiety about technology transfer to developing countries.  She referred to the point inherent in Article 19 of the UDHGHR, and in recommendations of the Ethics Committee of HUGO, to the effect that a proportion of the nett profits made by corporations protected by intellectual property law, should be ploughed back to the benefit of developing countries.  Several floor participants raised the issue of how the debate about science and society could be fostered in civil societies.  Professor Ida argued that the issue of the relationship between developed and developing countries in the instant case could not be seen in isolation.  It was but one aspect of a major question presented to the twenty-first century.  It transcended the specific topic of bioethics.  It related to the broad challenge of cooperation between the north and the south in the world.

 

          Dr Freire pointed out, in her reply, that there was an inherent cost in undertaking scientific research.  She suggested that those who secured the benefit of that research should not always be surprised by the demand that they should contribute to its cost.  She stated that NIH in the United States was one of the top funding agencies contributing to research on tropical diseases of great concern to developing countries.  She argued for the inclusion of the study of ethics in scientific courses so that the scientists of the future would at least know that there were issues to be addressed and would have reference points by which to make their choices. 

 

          Mr Bhatti, in concluding, agreed that the symposium had demonstrated the urgency of initiating dialogue within, and beyond, WIPO concerning the particular impact of intellectual property laws and practice on genomic research.  He said that the issue of benefit sharing might need to be addressed both in respect of human genomics and plant varieties.

 

          Madame Tran of the WTO emphasised that patents afford rights to their holders for a limited period, currently twenty years.  She stated that this was not a very long period, especially by contrast to trademark protection which could be indefinite.  She addressed herself to the question of why all medical use of scientific knowledge should not be exempted from the TRIPs Agreement.  She stated that such exclusions were matters for the member countries.

 

          Dr Ronchi urged the participants to look ahead.  She stated that until now, genomic research had been substantially concerned with single gene disorders.  Genomic research would ultimately become concerned about multiple gene disorders or genetic disorders in interaction with the environment.  This carried the risk that patents, provided now, would later return to impede both scientific research and its availability to the benefit of humanity.  In this context, a twenty year patent could have a very significant impact for millions of people.  The problem needed to be addressed.

 

SPECIFICITY OF PATENTING GENOMIC SEQUENCES

 

          The third session of the symposium was chaired by Dr Emmanuel Roucounas, Professor of International Law at the Academy of Athens and a member of the IBC.  He took the participants back to the distinction drawn by Aristotle between the natural world and man's inventions.  He pointed out that Alexander Fleming had not sought to secure patent protection in respect of his development of penicillin.  Similarly, Watson and Crick had not sought to secure any personal advantage.  But something had happened to change the culture of scientific endeavour.  The symposium was therefore most timely and UNESCO was to be congratulated for convening it.

 

          Dr S K Brahmachari is Director of the Centre for Biochemical Technology in New Delhi, India.  He returned to a point made during the floor discussion in the Round Table.  He pointed out that many complex disorders are best tracked in large extended families which, in large numbers, exist today only in developing countries.  Such persons and groups represent a valuable genetic resource.  Thus, schizophrenia had been studied in large family groups in India to elicit genetic patterns.  Similarly China, with its huge population was endowed with great genetic diversity.  With the advent of the one child policy, this was now somewhat diminished.  But India and China together presented a precious laboratory from which a huge amount of genetic data could be secured.  It was essential that those countries, and others of the developing world, should receive benefits from this contribution to humanity.  They should not simply be raided for precious resources by rich countries as had happened in earlier centuries.  There had to be, for the developing countries, a genomic dividend. 

 

          Dr Brahmachari pointed out that India would join the WTO in January 2005.  It would therefore be subject to the enforcement of the TRIPs Agreement.  This fact had called attention to the text and to the need for exceptions for the legitimate requirements of research and public health care of the people of India. 

 

          Dr Brahmachari drew attention to the Statement of the Ethics Committee of HUGO that one to 3 per cent of the annual net profits of pharmaceutical corporations engaged in genomic developments should be passed on to developing countries.  He considered that this was a first step in the right direction.  He pointed out that isolated population groups and families in India were perfect sources of genetic discoveries concerning predisposition to particular genetic conditions.  The large populations, the ease of conduct of clinical trials, the inexpensive character of such trials and the availability of a skilled medical and scientific community made India, and like countries, highly suitable for such research.  However, it was essential that there should be a return.  Dr Brahmachari proposed that all applicants for patent protection should be required to reveal the source material used in the subject research.  They should be obliged to comply with the laws of the nations from whose people such materials were taken.  They should be required to enter into a benefit-sharing arrangement in the event that the commercialisation of their product proved profitable.  They should be obliged to afford healthcare, derived from the sample, at a cost which the donor community could afford and to provide other benefits at least in accordance with the HUGO Ethics Committee's recommendations.

 

          Dr Friederike Stolzenburg, a patent attorney from Germany, described the basic European law of patents.  She explained once again the controversies which had surrounded the entry into force in July 1998 of the European Directive.  She took the symposium through the provisions of Articles 51 to 57 of the EPO.  She described the policy of the EPO and the way in which, even before the European Directive was binding, it was implemented, as a practical matter, by the EPO.

 

          Ms E S M Iwamura of the University of Sao Paulo, Brazil, presenting the paper of Professor Marco Segre, urged an attitude of optimism.  She pointed out that the earlier advent of nuclear weapons, which had presented many large challenges to humanity had led to the adoption of a treaty regime which, so far, had been observed by the nation states.  She considered that similar initiatives could produce results in connection with intellectual property protection and the genome.  However, current patent law was commonly regarded as inflexible.  In many developing countries it was seen as contributing to a depreciation of the values of human life which had evolved over millions of years.  Specifically, proposals for use of embryonic materials were seen in many developing, and other, countries as offensive to the powerful symbol of the embryo as a potential human person.  She described the legislation of Brazil requiring the involvement of supervisory ethics committees in the use of genetic screening and research.

 

          Professor Huanming Yang is Director of the Human Genome Center, Chinese Academy of Medical Sciences.  He is also Secretary-General of the Chinese Human Genome Project and a member of the IBC.

 

          He expressed his deep concern within countries such as his own about the implications of patent law as it was developing in the context of the human genome.  Whilst the advantages of intellectual property rights were understood, it was urgent to consider what was happening in a global context.  That he took to be the purpose of the UNESCO symposium.

 

          Dr Yang referred to the coming publication, in mid-February 2001, of the initial sequencing and analysis of the entire human genome.²²  He pointed out that computers were now engaged not only in mapping the genome but also in preparing and filing genomic patents.  The result was that a relatively small number of corporations in the developed world were filing a very large number of patent applications which had very significant potential ramifications for the future.  He expressed a specific concern about the terms of the publication of the USPTMO of 5 January 2001.  He pointed out that it did not differentiate between "discovery" and "inventions".  It did not adequately recognise the common heritage of humanity in the genome.  It reflected the culture of the race to patent genes which had been taking place globally in the past decade.  Dr Yang stated that published figures showed that, as of November 2000, more than 160,000 patents had been granted or applied for in connection with genetic sequences.  The result was that a very significant proportion of the discovered genetic sequences were the subject of patents enjoyed by a very small number of companies existing in an even smaller number of countries.  The result of this would be that developing countries would run the risk of becoming laboratories for researchers in developed countries but without commensurate benefits for their contribution to the research.  According to Dr Yang, developing countries are themselves "vulnerable groups" in terms of the UDHGHR.  He said that it would be intolerable if those countries were forever to be condemned to remain "developing".  He called for urgent international action to limit and control the extension of intellectual property rights in respect of genetic sequences and to do so before it was too late.

 

          The foregoing contributions sparked a number of lively comments and questions. 

 

          Professor Michel Revel stated that it would be open for any company which enjoyed patent protection to provide its product free of charge to users in developing countries.  There was nothing in patent law that would forbid this.  Only if a gene was found which could be put to practical use would it qualify for patent protection.  In the long term it was in the interests of humanity to encourage investment in genomic research, development and application.  This would best be done through an efficient and just patent system.

 

          Some participants suggested that more non-governmental organisations should have been present at the symposium to express their concerns about the emerging picture of global intellectual property protection.  Professor Ida pointed out that it was impossible, and undesirable, to roll back the global regime of intellectual property law.  What was needed were concrete proposals for any improvements in the system. 

 

          Professor Alex Capron, a member of the United States National Ethics Advisory Commission, called the participants back to the title of the meeting.  He laid emphasis on the primacy of ethics in the subject of the symposium.  This was a powerful idea.  It was important that those reflecting on intellectual property law should be motivated by ethical concerns.  They should not, from this perspective, be controlled exclusively by the existing legal regimes or, to an undue extent, by practical, economic or political considerations.  Such matters could be left to others.  The purpose of the symposium was to address the ethical considerations suggested by the language of the UDHGHR itself.  This took the participants back to the concepts of "human heritage", "dignity" and the "heritage of humanity".

 

          One participant called attention to the suggestion of Professor Jeremy Rifkin that the HGP was to be compared with the space project.  In the end there was substantial global consensus about space exploration.  In a sense it could be seen as an extension of human evolution.  Likewise, it was essential to obtain a global consensus about the HGP and the use of the emerging knowledge for the benefit of all humanity.

 

          Father Almeida of the Vatican raised questions concerning municipal constitutional and legal controls over genomic research and developments.  He emphasised the importance of upholding the legal supremacy of constitutional and human rights, where necessary, even over the decisions of international bodies such as the WTO, quite naturally focussed on economic considerations.

 

          In their concluding comments, Dr Brahmachari urged that a benefit-sharing model should be developed.  He endorsed moves by UNESCO, HUGO, WIPO and other relevant agencies in this regard.  Dr Stolzenburg emphasised the importance of continuing to follow closely developments in patent law in the United States.  As a matter of practicality, those developments were likely to influence patent law and practice elsewhere.  The appeal concerning the Harvard oncomouse was still pending before the United States courts.  The ethical concerns would need to be addressed in a world greatly influenced by economic agendas.  The pace was often set by the main players.

 

          Dr Yang concluded as he had started.  In his opinion "something is going really wrong".  He drew attention to the consequences of this including, he suggested, potential international tension.  He stated that creative ideas were needed to reconsider the global intellectual property regime in the context of genomic discoveries.  He expressed the hope that, with collective wisdom, it will be possible for humanity to develop a legal regime that was more effective and ethical than the present.

 

FUTURE LEGAL FRAMEWORK

 

          Session 4 was chaired by the author.  It was opened by an address by Mr André Rémond (France), Principal Director of the EPO in Munich.

 

          Mr Rémond recounted the suggestions for reform of intellectual property law in the wake of identification of genes, new proteins, therapies and the development of useful genetic tests.  He reviewed the various possible solutions that were available to the law.  He described the dichotomy of attitudes between influential commentators in developed and developing countries.  He foreshadowed the likely growth of international agencies as depositories of patent applications.

 

          Mr Rémond reviewed the source of resistance to the provision of patents in the present context.  He recognised that the resistance focussed (1) on the dichotomy between "discoveries" and "inventions", given that under most  patent law outside the United States "discoveries", as such, were not patentable; (2) the contention that genomic sequences exist in nature and should therefore not be patented; and (3) the invocation of suggested exceptions to the grant of patents based upon moral considerations.  He stressed that if current patent law was not internationally, nationally and publicly acceptable it would  need to be reformed.  But he pointed to convergence in international practice being observed by patent offices in different parts of the world which would make major changes in current approaches extremely difficult to obtain.  He thought it more likely that present rules would be applied more strictly.  He instanced the recent change of practice in the USTMPO as an illustration of this trend.

 

          Dr Sandra Thomas, Director of the Nuffield Council on Bioethics (United Kingdom) emphasised that patents can stimulate research and development.  Investment would be essential to maximise the great achievement which the HGP represented for humanity.  However, she expressed concern at the proliferation of patent applications and accepted that some of these might not be socially defensible.  Others were likely to benefit principally lawyers.  Whilst it might be hoped that the patent system would be self-correcting, it tended to embrace change slowly.  There was relatively little evidence on how it actually operated to encourage innovation and investment.  Often this was just assumed or asserted by patent holders and other players in the patents system.

 

          Dr Thomas attached great importance for the development of an appropriate international policy forum to permit the effective presentation of the kinds of views that had been expressed at the symposium.  She said that such a forum should be set up without delay, if necessary by UNESCO.  But she doubted that the present patent system needed a complete overhaul.  She did not think that human inventiveness and scientific inquisitiveness should be under-estimated or would be unduly inhibited, in practice, by current patent law.

 

          Professor Bernard Edelman of the University of Paris I (France) placed the debates about patent law, its history and future directions, in a philosophical context.  He suggested that contemporary developments concerning intellectual property rights over the human genome raised fundamental questions as to whether the human species and human life were no more than a source or product or object to be used and exploited.  He pointed to the significant change in the nature of contemporary scientific research from the time when patent law was originally conceived.  Nowadays, he said, researchers do not typically have their hands on products which they invent.  Instead, they are "assemblers of know-how".

 

          According to Professor Edelman the European Directive upset fundamentally the previous landscape in European law which reserved patents for novel inventions.  In practice, the Directive took a distinct step in favour of affording legal protection to discoveries.  This raised specially acute dilemmas because of the universality of the subject of the discoveries (the human genome) and the limited number of countries in which the economic advantages of patents were presently being procured.

 

          Professor Bartha Maria Knoppers, chair of the HUGO Ethics Committee (Canada) described the long process, in which she had herself been engaged, towards the drafting of the UDHGHR by the UNESCO IBC.  Similarly, the European Directive had taken ten years to be completed.  These delays were a consequence of the sensitivity of the issues, the disparity of laws and the diversity of national attitudes and interests. 

 

          Professor Knoppers described the responses that were emerging in developing countries to the subjects discussed in the symposium.  Whereas India, Brazil and China had created centralised regulatory agencies to supervise, and authorise the removal of genetic samples, other countries, such as Costa Rica had embraced a contractual model.  They had reached agreement with pharmaceutical corporations to provide highly valuable genomic data in exchange for technology transfer, training of scientists and provision of pharmaceutical benefits.

 

          Professor Knoppers emphasised the importance of establishing ethical and legal bodies to consider all of the issues presented by genomics, including those special to intellectual property law.  She urged consideration of utility to human health as an exception for patent protection.  She suggested the possible need for greater public funding to ensure that critical research was performed at arm's length, freed from the power of commercial investment.  She stressed the need for improved facilities of informed donor and patient consent, in accordance with national law, for the procurement and use of biological materials.  She proposed more attention to the concept of the common heritage of humanity.  This was a legal concept which could be traced back, in international law, specifically to the writings of Grotius on the law of the sea.  But she stressed that it was impossible for philosophers and ethicists to abolish the market just as it was impossible to trust the market with respect for all of humanity's objectives. 

 

          Ms G Pinet (WHO) outlined the initiatives which that organisation had taken.  One of these was the collection and publication of applicable national legislation.  With Dr Thomas, she stressed the importance of education of the public in the issues presented by the HGP.  Otherwise, talk of public opinion was empty because the lay public (and politicians) would simply not understand the complexity of the issues presented for decision.

 

          There followed an extended debate in which participants from the floor of the conference expressed their opinions.  A representative of a non-governmental organisation for disabled persons expressed total opposition to any patents over genetic materials.  This viewpoint was repeated by many individuals.  A representative of an international students' organisation urged the desirability of involving the young in the ethical debates about this topic.  Professor Knoppers supported this idea, suggesting that it might help reduce the polarisation which was emerging in the debate.  Particular aspects were raised by speakers concerned with issues affecting mentally ill patients, data protection bodies, scientific research workers, religious schoolteachers and patent holders.

 

          Professor Taljudin (Indonesia; member of the IBC) expressed support for a further study of this subject by the IBC.  He also endorsed the call of Professor Yang for international bodies to ensure that the data of the HGP was, in practice, available for the benefit of all.  Professor D C Nombella (Spain; member of the IBC) expressed the hope that patenting laws would define more clearly the circumstances of their application.  He suggested that, as a result of the symposium, the IBC might conduct workshops of its own to follow and explore further several of the subjects discussed.

 

            Professor Revel (Israel; member of the IBC) cautioned against getting carried away by emotion about patents.  He said that intellectual property law could operate for the benefit of science and of society.  Madame Jean (Canada; member of the IBC) suggested that recent events of popular concern, including mass demonstrations in Seattle, indicated the political significance of the topic discussed.  Accurate definition of the content of patent protection, in accordance with informed democratic choices, was a high priority.  Professor Ida (President of the IBC) acknowledged the anxiety that had been voiced during the symposium.  He attributed much of this to the lack of effective accountability that had accompanied recent developments in intellectual property law and practice.  He suggested that it was now up to lawyers to include appropriate ethical safeguards and exceptions into patent law and practice.  How this should be done was a matter for further expert reflection.  It was clear that there would be a need for the IBC to follow up the results of the symposium and to treat its subject matter as one of the IBC's priority subjects of discussion.

 

          Mr Rémond pointed to the great difficulty of securing public opinion on subjects as complicated and technical as patenting of genetic sequences.  This was one area where opinion polls would not be very useful.  Referring to the suggested need for sui generis intellectual property protection for genomic advances (perhaps of a shorter duration than twenty years) he questioned this idea.  The experience with the separate legal protection for plant varieties suggested a need to rationalise, not proliferate, forms of legal protection.

 

          Dr Thomas, in her reply, stressed the need for better leadership amongst policy makers.  She singled out as very important the improvement in the system of licensing by patent holders.  Because the patent system was not going to be dismantled, attention should be focussed on how it could be made to operate better.  There was a need to monitor the data on its operation so that future strategies were based on information not emotion.  Professor Knoppers emphasised that patent law was as complex as tax law.  But because it had a high potential component of ethical choices and involved, in some aspects, the common heritage of humanity, it was indisputable that patent law should establish an effective legal basis for collaboration between informed interests in the consideration of ethical choices.

 

          The fourth session concluded with numerous interventions from the floor, many voicing the concerns of particular non-governmental organisations.  The need to involve such bodies in the future work of UNESCO and WIPO on this topic were emphasised by several speakers.  Reference was made to the participation of patients' associations at the last meeting of the IBC in Quito, Ecuador.  However, several participants suggested that much more was needed.  Otherwise the economic power of the corporate sector would dominate not only intellectual property law but also the use made of the scientific knowledge derived from the HGP.

 

          The fourth session eventually closed with repeated expressions of concern that, although the genome was indeed common to humanity, technology, abetted by intellectual property law, would in practice address only, or substantially, the concerns of the developed world.  They would ignore or postpone attention to the diseases of the developing world.

 

          The symposium ended with a summary of conclusions presented by Mr Maurice Cassia (France) and some concluding observations by Professor Francois Dagognet and Professor Ida, President of the IBC.  The commitment of the IBC to continue its exploration of the issues addressed in the symposium was repeated.

 

EMERGING PROBLEMS

 

          A reflection on the UNESCO symposium on ethics, intellectual property and genomics identifies a number of problems in respect of intellectual property law and the genome which need to be studied further by international agencies, the international community and relevant experts.  The sources of these problems include:

 

§ A change in the culture of science, with a significant shift towards individuals and institutions securing intellectual property protection for their work, such as did not occur in past generations.

 

§ A recognition that part of the pressure for this intellectual property protection comes not only from the corporate sector but also from universities and research institutions.  Initially, some of this pressure followed legislative initiatives, such as those introduced by the United States Congress designed to require institutions in receipt of federal funds to procure intellectual property law protection for the outcomes of their research.

 

§ A special difficulty of securing common approaches in the future of intellectual property law is the disparity in the constitutional and other legal provisions governing patents.  Thus whilst European and most world systems reflect a differentiation between "discovery" and "invention", the United States Constitution refers explicitly to "discovery".  Disparities of this kind are difficult to harmonise, even when the legislative regimes, on the whole, tend to produce generally common solutions.

 

§ Of particular concern is the likely future utilisation of intellectual property law over genetic sequences to the economic disadvantage of developing countries, already burdened with economic debt to the developed world.  But of equal concern for developed countries is the likely increase in the costs to national health systems and health delivery generally of the provision of essential tests and therapies the subject of intellectual property protection.

 

§ A special concern is the possible way in which patents granted over genetic sequences may impede research and development "downstream".  The subsequent elucidation of the particular and different use of proteins and of the interaction of genetic sequences with the environment might create problems for the application of current patent law in the future.  One possible solution might be an enlargement of the powers of modification or revocation of patents where this is shown to be justified.

 

§ A need for global benefit sharing was clearly demonstrated.  There is a particular utility to developed countries in the use of samples, and the conduct of research, in developing countries.  In part this is because of the ready availability of isolated communities, with large families, manifesting genetic conditions that can be included in trials at low cost and small risks of litigation.  The suggestion of the HUGO Ethics Committee for a dividend in the form of a percentage of nett profits deserves further consideration.²³

 

§ The sheer complexity of patent law is also an impediment to reform.  But, ultimately, the law serves humanity, not vice versa.  Various possible reforms were mentioned ranging from the introduction of a new system of protection with shorter duration to improved licensing and the greater availability of modification and revocation of patents.

 

§ Although patent offices have certain leeways for choice, ultimately they are staffed by people who must obey the law as expressed by the municipal legislature and interpreted by the courts.  By the same token, patent offices need the infusion of ethical opinions not only at the level of general policy but also, to the extent that the law allows, in deciding particular patent applications.

 

§ The global character of the intellectual property regimes and their reinforcement by the policies of the WTO place great burdens on bodies such as UNESCO and WIPO.  Resolving the demarcation of responsibilities and ensuring effective and prompt initiatives to influence future directions of intellectual property law is by no means easy.  The effective refusal, or failure, of large players in the corporate sector to participate in the symposium was an indication of the extent to which those with present economic power will not readily surrender or endanger it.  Means are needed to ensure that private global economic power is brought under the discipline of effective, and just, international law.

 

§ Above all, there is a need for political leadership on this subject.  The lack of such leadership is not surprising given that the problem extends beyond borders; that most nations are relatively powerless to change the international legal regime; and that the science and law involved are so technical.  These difficulties conceded, there is an acute problem which it is to be hoped national and international bodies will rally to solve.

 

RESULTING SOLUTIONS

 

          So far as solutions are concerned, various ideas were voiced during the symposium.  These included:

 

§ The desirability of continuing the dialogue between lawyers, ethicists, patent experts and non-governmental organisations begun at the symposium.

 

§ The need for expertise to disclose the exact nature of the technical, scientific and legal problems involved.  It is one whose broad contours can be understood by the amateur.  But to secure practical reforms, experts with precise knowledge of the law and of the relevant science must be engaged and they must work together with people knowledgeable about ethics to produce viable responses.

 

§ The utility, necessity and essential reasonableness of the provision of measures of intellectual property protection for those who invent new products and techniques and make investments for such purposes may be conceded.  Inventiveness is commonly for the benefit of humanity.  Monopoly rights for a given time in exchange for the provision of information to the public can be a sensible contract which commonly works well and which, in any case, is deeply entrenched in national and transnational laws.

 

§ A recognition of this fact and of the practical unlikelihood of fundamental changes in the fundamentals of intellectual property law presents a useful starting point for those who are calling for reform to meet the special problems perceived in the application of patent law to genomic developments. 

 

§ It is possible to think positively because the international community, and national lawmakers, have, in the past, frequently responded effectively to very complicated scientific advances.  The global regulation for atomic or nuclear materials and the global regulation of space were mentioned.  Perhaps a close analogy was the OECD Guidelines on Privacy.²⁴  These were developed to meet the challenge of transborder data flows.  Those Guidelines have been adopted in the national laws of many countries occasioned by changes in information technology and telecommunications.  Where there is a perceived new transnational problem, international cooperation can sometimes promote effective responses.  The difficulty illustrated by the symposium lies chiefly in the delay in the provision of responses to the issues examined and the accumulation, in the meantime, of large and powerful economic interests that favour supporting the present legal regime unchanged.

 

§ The reported initiatives of WIPO to engage in dialogue about the subjects of the symposium are to be welcomed.  The establishment of an inter-governmental forum to study these subjects and to propose answers to the emerging problems, is a welcome starting point.  So is the report that this group will involve participation, as observers, of interested non-governmental organisations. 

 

§ UNESCO and the IBC should also continue their involvement in these themes.  UNESCO should cooperate with the WIPO forum and itself stimulate ethical reflections about the issues of the symposium in WIPO, the WTO, the World Bank and other global organisations.

 

§ High priority should be attached by the IBC to the topic of intellectual property protection and genomics.  Encouraged by the symposium, the IBC should place this topic on the top of its list of subjects for priority attention.

 

§ It may be hoped that the Director-General of UNESCO, whose personal interest in the subject is welcome, will continue to bring to the notice of the leaders of the world's main industrialised countries the types of concerns that were expressed at the symposium.  In particular, the need to ensure, in the terms of Article 19 of the UDHGHR that "developing countries ... benefit from the achievements of scientific and technological research so that their use in favour of economic and social progress can be to the benefit of all".  It is essential that these words should be translated into action.  Effective technology transfer and appropriate benefit-sharing are, or should be, high priorities for the advance of the HGP.  Words are not enough.  Action is required.  National action will not alone be effective.  International initiatives are essential.  UNESCO has a vital role to play to ensure that action comes about and does not get swallowed up in words alone.

 

                 Acting with commendable speed, the Director-General of UNESCO entrusted the IBC with developing proposals to follow up the symposium.  The IBC has established a working group for this purpose with a mandate to draft proposals for discussion with the IBC in September 2001.  The author is a member of this Working Group which has its first meeting in June 2001. 

---