INTELLECTUAL PROPERTY AND BIOETHICS A DRAFT ISSUES PAPER

INTELLECTUAL PROPERTY AND BIOETHICS A DRAFT ISSUES PAPER Informal draft only, for consideration within the UNIACB, not for further dissemination in this form Comments on this draft are welcomed. Draft as at 22.x.06 PART I: IP AND BIOETHICS OVERVIEW 4 1. Characteristics of the IP system 4 (i) International and national dimensions 5 (ii) What is IP protection? 5 (iii) Patents 6 (iv) Other forms of intellectual property: 8 (v) The ethical basis of IP policy 9 2. Aspects of ethics and morality (i) International law 10 11 (ii) Distinguishing law and ethics 12 PART II: THE INTERACTION BETWEEN IP AND BIOETHICS 14 1. Life sciences and public policy 14 2. Four key aspects of IP and bioethics 14 (i) Ethical aspects of technology as such 15 (ii) Ethical aspects of granting exclusive IP rights over a technology 16 (iii) Ethical aspects of seeking exclusive IP rights over a technology (iv) Ethical aspects of exercising exclusive rights over a technology 16 17 Working with these distinctions 17 Scope of the paper 17 3. IP and bioethics: some general themes 18 (i) Transparency 18 (ii) Consent 18 (iii) Equitable sharing of benefits 19 (iv) Accommodating different value systems 20 PART III: BIOETHICS AND THE INNOVATION PROCESS 21 1. Research policy and planning 21 2. Research phase 22 3. Acquisition of IP rights Patentability issues 23 25 (i) Patentable subject matter 25 (ii) Novelty, inventiveness and utility 27 (iii) Scope of rights claimed 28 1

(iv) The entitlement to apply for a patent 29 4. The use of new technology and exercise of IP rights 30 Test data 30 Benefit-sharing Exercise of IP rights 30 31 Licensing in the life sciences 33 Guiding licensing policies 33 Alternative forms of innovation 34 PART IV. CONCLUSION: ISSUES FOR CONSIDERATION 36 Some issues for further consideration 36 2

THE CONTEXT OF THIS PAPER The UN Inter-Agency Committee on Bioethics was formed in 2003 in order to promote co-ordination and co-operation among a number of UN organizations and specialized agencies and international inter-governmental groups that deal with the field of bioethics, including its human rights aspects and other related issues. Members are the FAO, ILO, UNHCHR, UNESCO, WIPO and WHO as well as several associate member organizations (including AU, ALESCO, CoE, ICGEB, EC, OECD and WTO). Since its formation, the Committee has identified the need for close attention to the interplay between intellectual property (IP) and bioethics issues. In view of the complexity and significance of these issues, the Committee felt that an issues paper would be the best approach to address the subject. The paper would survey issues that arise in the interplay between IP and bioethics; it would serve as one point of reference for current debates and policy processes, rather than take a position in any debate. As the committee itself was formed to play an advisory role, rather than to take the policy lead, the aim of preparing such a paper is essentially to raise awareness of the Executive Heads of Member and Associate Members of the Committee and of their Member States, and through them to promote informed consideration of these issues. It is intended as a background resource for some selected issues only, and does not aim to address all issues in a comprehensive manner. It does not represent the views of any of the Committee Members. Above all, this draft is open for comment, criticism and stakeholder review, depending on decisions taken within the Committee. Next steps This draft was prepared by the Secretariat of WIPO, as agreed within the Committee, as a follow up to the discussion on IP and bioethics at the fifth session of the Committee. It draws on the presentations made to the Committee and general discussion in the Committee. An initial draft was circulated to Committee participants. The present draft has been revised on the basis of comments received from participants, including concrete proposals and a number of editorial changes. In this revised form, it is circulated to committee participants only, for review prior to the sixth session of the committee. The Committee will need to make decisions at its sixth session concerning any further revision and dissemination of this document. 3

PART I: IP AND BIOETHICS OVERVIEW This document addresses current issues that concern the relationship between intellectual property (IP) and bioethics. It considers the following four sets of issues, and clarifies the important distinctions between them: (i) the ethical aspects of a technology as such (e.g. the ethics of stem cell research); (ii) the ethical aspects of national authorities granting exclusive IP rights over a technology (e.g. the ethics of a patent office granting patents on life forms); (iii) the ethical aspects of an individual seeking exclusive IP rights over a technology (e.g. the ethics of a public funded agency patenting its research); and (iv) the ethical aspects of the forms of exercising exclusive rights over a technology by an IP right holder (e.g. the ethics of licensing patent rights over key medical technologies). These sets of issues are broader than bioethics as such, and entail a range of actors: some bioethical aspects are a matter for governments and official agencies, such as the choice whether or not to grant a patent for a certain technology that may be contrary to morality; other bioethical aspects are a matter for firms or individuals, such as ethical aspects of licensing technologies. This document is intended only to address bioethics issues, not the law, legal issues or regulation as such. Of course bioethics clearly has a dynamic and complex relationship with various areas of law and regulation, including international law (such as the law of human rights), national laws (including laws within and beyond the domain of IP), and other forms of regulation (such as laws governing research on stem cells). Even taken separately, IP and bioethics are two complex fields dealing with diverse, pressing policy issues. Therefore, before considering their relationship and their interaction, it may be helpful to review the basic elements of each of the two fields. 1. Characteristics of the IP system The IP system is a multifaceted discipline, created as a set of public policy mechanisms to contribute to various policy goals including: the promotion of innovation and creativity, the acknowledgement of the moral and economic rights of creators in their creations, 4

the promotion of public access to the fruits of innovation and creation, and the dissemination of technology, fair competition and transparency, the transfer of technology with the aim of fostering economic and social development. This paper does not describe the IP system as a whole, nor characterize all of its features, but simply highlights some of its principal characteristics. (i) International and national dimensions The law, policy and practice of IP have national and international aspects. IP rights are created, administered and exercised under the national jurisdiction of each state. Their legal effect is restricted to the territory of the states in or for which they are granted. Hence, the impact of IP law and policy is ultimately felt through the national laws that are drafted and implemented by national authorities. Several international treaties lay down general legal and administrative standards, and provide for administrative coordination. But these international standards may be implemented in diverse ways in national laws. Some states have agreed on regional systems for the protection of IP, creating various forms of regional IP rights but even these are exercised and enforced under national laws. Some fundamental legal questions, of potential interest to the bioethics community, are barely dealt with at an international level. Rather, they are left to national or regional authorities to determine: these include the definition of the core concept of invention and the notions of morality and ordre public 1 that should apply in the interpretation and administration of patent laws. (ii) What is IP protection? IP, very broadly, means the legal rights which result from intellectual activity in the industrial, scientific, literary and artistic fields. Those rights do not apply to the physical object in which the creation may be embodied but instead to the intellectual creation as such. So, you may own a book, a physical object, but the author may continue to own copyright in the literary work reproduced in the book. IP is traditionally divided into copyright and industrial property. Copyright includes literary and artistic works, including original aspects of databases. Industrial property 1 The term ordre public, derived from French law expresses concerns about matters threatening the social structures which tie a society together, i.e., matters that threaten the structure of civil society as such. Resource Book on TRIPS and Development: An Authoritative and Practical Guide to the TRIPS Agreement, ICTSD & UNCTAD, Geneva, 2005. Public order is not an accurate English translation, so the term is generally left in its original language. 5

includes inventions, trademarks, industrial designs, and geographical indications. IP systems protect certain well-defined subject matter by giving limited entitlements to eligible right holders to exclude others from certain uses of the protected material. This right to exclude is normally considered a form of intangible property, which may be transferred, bought, sold, and otherwise dealt with similarly to tangible property. However, some forms of IP-related protection fall short of property rights as such. For example, laws suppressing unfair competition fall within the general field of IP, but they often simply give an aggrieved party the right to take legal action, without conferring specific property rights. As another example, geographical indications are protected as a form of IP but are not necessarily owned by any particular private owner. IP rights generally do not give a positive right to use the protected subject matter. Any product or creation may be subject to other laws regulating its use. For instance, the law may restrict the use of a genetically modified organism (GMO) whether patented or not, or restrict the advertising of tobacco products, even if these products are sold under registered trademarks. (iii) Patents Patents are the form of IP most relevant to biotechnology and medical research, and are most often discussed in the context of bioethics. The history of patent law and policy is the continuing endeavor to reconcile the inventor s private interests with the broader interests of society by harnessing private interests to serve the public and by creating new technology as a public good. Patent holders are entitled to control the commercial exploitation of a protected invention for a limited number of years. In exchange, they must fully disclose their invention. It is impossible to both keep a new technology secret and to benefit from patent protection. In many countries, patent applications are published, often on the Internet, before the patent is granted. Consequently, the new knowledge is available to the public soon after its conception. Key concepts: the patentable invention The fundamental concept of a patent law is the invention: an invention is both the subject of protection under the patent, and the technological knowledge which is newly introduced to the public through the publication of the patent document. There is no legal definition of the term invention on the international level, but it can be understood as a solution to a specific technical problem, potentially consisting of a product, a process, or both. An invention must meet certain criteria to be eligible for a patent, or to be patentable. These patentability criteria are interpreted and applied differently in different national laws, but in general they require an invention to be (i) appropriate 6

subject matter; (ii) new, inventive and industrially applicable or useful; and (iii) fully disclosed in the patent document. These criteria, discussed at more length below, have been developed and refined in national patent laws over many years as a distillation of the public interest, in particular to ensure that exclusive rights are only granted for genuine, substantive contributions to technological knowledge. Key concepts: patent rights A patent is issued by a government office on the basis of an application by the inventor or by someone deriving the entitlement to apply from the inventor (e.g. the inventor s employer). In many countries, but not all, the patent application is subjected to an examination as to whether the claimed invention complies with the patentability criteria (as well as with other legal requirements). If granted, a patent gives the owner the exclusive right, for a fixed term, to control how the claimed invention is exploited within the territory covered by the relevant national law. The patent term is generally twenty years from the date of filing the patent application, but many patents lapse well before their full term. While the patent remains in force, its owner is entitled to prohibit others from manufacturing, using, selling or importing the patented invention within the jurisdiction where the patent has legal effect. The rights conferred by a patent are territorially restricted in other words, they deploy effects only within the territory for which the patent office is competent. In the case of some regional patent organizations, patents have effect in the member states of those organizations. A patent does not confer any rights in other jurisdictions. To be protected in another country, the invention would need to be separately patented under the law of that jurisdiction; otherwise the invention would be in the public domain in that country, where it would be both fully disclosed and free to use. Key concepts: technological disclosure The complete disclosure of an invention in a patent publication ensures the entry of the patented technology into the public domain. The knowledge as such is freely accessible as soon as it is published, as there are no constraints on accessing and sharing the knowledge even during the term of the patent. The publication normally takes place 18 months after the patent application has been filed. The disseminated knowledge contained in the patent may be used by anyone to form the basis for further development of the technology. Patent information is widely available internationally on free databases. After a patent expires or lapses, the patented subject matter becomes part of the public domain, free for all to use (provided no other law restricts its use, such as regulations on GMOs or on pharmaceuticals). 7

Key concepts: exceptions and limitations For public policy reasons, IP systems normally provide for certain exceptions and limitations. For instance, many national patent laws provide for a so-called research exemption to allow third parties to undertake research on a patented invention. Such exceptions may facilitate public and private research to further develop a patented technology even during the course of the patent term and the search for alternative or improved technologies. Other exceptions can permit competing companies to go through necessary regulatory steps, especially in preparing to produce generic versions of patented pharmaceuticals, while a patent is still in force. But such exceptions do not allow for full commercial use of the technology. It should be recalled that, due to the geographical restriction of patent rights, published patent information can be used without any restriction in countries where no patents have been granted on a specific technology. Under some national laws, patent holders may be obliged to meet reasonable expectations that the invention be worked or in some way be exploited for the benefit of the public. For instance, in France, the invention must be used within three years after the patent has been issued. The patent holder may be subjected to a compulsory license that permits someone else to exploit the invention if he or she fails to do so adequately. There has been considerable focus in contemporary debate on compulsory licensing and government use provisions: these provide, in certain circumstances, for governments or judicial authorities to override the patent owners rights and to grant specific use rights to third parties so as to remedy specific problems, or for governments directly to use patented technology. In such cases, however, compensation is payable to the patent holder for the permitted use. Recent policy debate in the World Trade Organization (WTO) and other fora has underscored that governments retain the right to determine the grounds for compulsory licensing and government use authorizations, although international rules (especially the WTO Agreement on Trade Related Aspects of Intellectual Property Rights, TRIPS) do provide important conditions on the grant of such licenses or authorizations. The WTO Doha Declaration on TRIPS and Public Health and a consequent revision of TRIPS deal with this question in the specific context of ensuring access to patented pharmaceuticals. (iv) Other forms of intellectual property: Several other forms of intellectual property may also be relevant in considering the relationship between the IP system and bioethics, for instance: Plant breeders rights or plant variety rights systems give IP rights over new plant varieties, generally with an exception for further breeding. 8

Copyright, sui generis database rights and ethical aspects of access to information may have bearing on the bioethics aspects of bioinformatics and genetic information. Law of confidentiality and the protection of undisclosed information may have ethical implications, for instance concerning obligations to protect individual genetic information. Bioethics issues concerning clinical trials and prior informed consent questions may be relevant to the protection of test data concerning the safety and efficacy of chemical entities, because of the public interest role of this information. Within the domain of unfair competition, international IP law includes a general requirement to suppress behavior contrary to honest commercial practices. (v) The ethical basis of IP policy Contemporary IP systems are largely developed and applied through specific statutes, as a conscious policy construct by legislators. IP principles do, however, have deep roots in the common law, and to some extent reflect broader themes in international public law. In principle, IP protection aims to promote policy objectives consistent with widely accepted ethical principles. There are different approaches regarding the ethical basis of IP laws. Some IP laws and principles are argued to have a natural rights basis, namely an inherent entitlement to just reward and recognition for one s intellectual and creative contributions. This is reflected in international legal instruments in the field of human rights law. Examples include: the Universal Declaration of Human Rights (UDHR), which states that everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author (Art 27.2 UDHR), the International Covenant on Economic, Social and Cultural Rights (ICESCR) affirms the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author (Article 15.1(c)). On the other hand, the commentary on Article 15.1(c) ICESCR notes that it is important not to equate intellectual property rights with [this] human right. For example, human rights cannot be waived or assigned, whereas IP rights can. The technology transfer and access to knowledge functions of patent law also have a human rights dimension: for example, the ICESCR affirms the right to enjoy the benefits of scientific progress and its applications (ICESCR, Article 15.1(b)). These human rights principles, while expressed in legal instruments and therefore forming part of international public law, are viewed as having an ethical dimension as well. 9

One approach to ethical theory is utilitarianism: the idea that the ethical value of an act should be assessed according to the overall benefits it provides the general population. There is a strong utilitarian flavor to IP law and policy, as a conscious tool to promote social welfare. This utilitarian ethic is increasingly emphasized in current debate on IP as a tool of public policy, and finds echoes in Article 7 of the WTO TRIPS Agreement, which provides that the protection and enforcement of IP rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. However, this question touches upon a far deeper debate about the relationship between law and ethics, and the ethical aspect of laws that are created as an expression of public policy. This is discussed further below. From one perspective, IP laws may be viewed as ethically neutral, because it is a relatively technical form of legislation and the patent examination process may not be able to address all ethical issues related to a technology. Or patent laws may be considered as establishing a policy space for ethical considerations to apply. The contrast between law and morality arises in the question of whether morally questionable technologies should be legally patentable, and how patent laws should give space for ethical assessments. Patent law in many countries excludes the patentability of technology when the prevention of the exploitation of this technology is necessary to protect ordre public or morality, and thus creates a legal context in which moral judgments are exercised to determine whether or not an IP right should be granted. 2. Aspects of ethics and morality Ethics is a diverse discipline. Broadly, it endeavors to establish norms or standards of conduct (normative ethics), and to analyze the basis of how judgments are made about what is right and wrong (descriptive ethics). Applied ethics is the application of theoretical ethical tools and ethical norms to address practical moral problems. Bioethics is a specific branch of ethics, concerned with the ethical implications of life sciences research and its applications: the Oxford English Dictionary defines it as the discipline dealing with ethical questions that arise as a result of advances in medicine and biology. Bioethics may have a normative, descriptive and applied character. The UDBHR addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions. Specific bioethics issues arise in debates over consent to medical treatment, freedom of research, consent of the donor of human genetic material, access to health care and distribution of health resources, equitable access to the outcomes of biological research, the dignity of the human body, and 10

beginning-of-life and end-of-life issues, as well as animal protection and environmental ethics. A very general distinction can be drawn between ethics and morality, although the two terms frequently overlap in discussion. Practical ethics seeks to provide guidance for right behavior; morality can refer to a broader moral system or outlook, and the underlying set of moral values that are used to assess what is right and wrong. In the field of IP, many patent laws refer to inventions the exploitation of which would be contrary to ordre public or morality, and some trademark laws refer to trademarks that are contrary to morality. In this sense, morality may be seen as referring to the shared values of a community. These values may, in turn, inform or guide more precise ethical judgments. (i) International law Discussion of bioethics issues often touches upon laws and legal instruments. This includes national laws and international treaties that help shape public international law. The international law of human rights may be considered highly relevant to the discussion of bioethics. International instruments, including treaties that arise in discussion of bioethics issues: The International Covenant on Economic, Social and Cultural Rights (ICESCR); the Convention on Biological Diversity (CBD); the FAO International Treaty on Plant Genetic Resources for Food and Agriculture; the TRIPS Agreement; the Doha Declaration on TRIPS and Public Health Non-binding international instruments may also have persuasive effect, and may help shape the international framework on bioethics. The keystone international instrument on human rights, the Universal Declaration on Human Rights (UDHR), is itself a non-binding declaration, although it has strong persuasive effect. Many legal experts consider it to have legal effect, having the status of customary international law. Other non-binding legal international instruments include: The UNESCO Universal Declaration on Bioethics and Human Rights (UDBHR), the UNESCO Universal Declaration on the Human Genome and Human Rights (UDHGHR), and the UN General Assembly Declaration on Human Cloning. Apart from legal texts, contributions to the debate can be found in supplementary reports and commentaries. These include the work of the Special Rapporteur on the 11

right of everyone to the enjoyment of the highest attainable standard of physical and mental health, and the General Comment No. 17 on art 15.1(c) of the ICESCR. (ii) Distinguishing law and ethics The distinction between law and ethics should be kept in mind, even if these concepts have important areas of overlap and close interaction. Complete consistency between legal systems and ethical expectations cannot be assumed. For instance, some acts that are considered legal may be considered unethical. Medical practitioners may refuse to assist with lawful executions because of ethical prohibitions on the taking of human life. Research on certain aspects of the human genome may not break any law, but may still be viewed as unethical. A clear understanding of the distinction between law and ethics is essential. For instance, while there may be strong commonality between human rights law and ethical norms and expectations, it would actually misrepresent the legal effect and reduce the status of human rights law to regard it as giving ethical guidance only. And not all ethical judgments are necessarily carried across to binding law: in fact, it can be an important policy option not to legislate in certain areas, as a conscious choice to allow ethical considerations and not legal rules to govern some aspects of behavior. This distinction between law and ethics is helpful in navigating through the many issues that arise in considering the interplay between IP and bioethics. The law may provide specific rules that indicate when ethical or moral considerations should be weighed by decision-makers. In other words, ethical questions may need to be considered for the proper implementation of some laws. Specific ethical questions are most often addressed at the level of national law, within the legal framework established by the law. For example: At the level of international law, States have agreed that they may choose, within their national patent laws, to exclude from protection inventions when the prevention of the commercial exploitation of those inventions within their territory is necessary to protect ordre public or morality (Article 27.2, WTO TRIPS Agreement). At the level of national law, a country may choose to exercise this entitlement by passing a law that actually gives effect to such a morality exclusion. Thus, a national law may be passed that explicitly creates a framework in which ethical considerations may apply. At the level of implementation of such a national law, when fulfilling their statutory responsibilities, decision-makers may be required to make an ethical or moral assessment about technology. In particular, in exercising their legal obligations under national patent law, a patent office or a court may need to form 12

an opinion as to whether the commercial exploitation of a certain technology would be contrary to ordre public or morality. The decision-maker would therefore need to make a specific ethical or moral judgment about the technology, when giving effect to this legal requirement. In this example, States agree among themselves to leave open the space for morality considerations to apply at the level of their domestic laws. They then have the option to create a specific morality exception within their own national patent laws. Finally, in exercising such an exception, a decision maker working within the national system may be required to undertake a specific ethical judgment about a particular technology. 13

PART II: THE INTERACTION BETWEEN IP AND BIOETHICS 1. Life sciences and public policy The distinctive characteristics of life sciences research open it up to particular scrutiny from an ethical and broader public policy perspective: Life sciences research touches on fundamental human needs such as human health, food and a safe environment, and on fundamental human values such as human dignity and integrity; it is a sector which has a strong component of public and publicly-funded or philanthropically funded research, and many important inputs to applied research and development can be traced to public sources; the products of life sciences research are typically subject to intensive and lengthy regulatory processes, which (i) creates the need to establish appropriate mechanisms and incentives to generate necessary data on the impact of new technologies (such as clinical trials for the safety and efficacy of new pharmaceuticals), and in turn leads to (ii) concerns about access to and use of such data; because of the lengthy product development process, there may be distinct needs to garner resources for initial research and for subsequent development, with complex interactions between public and private sector entities; there can be significant ethical questions regarding genetic inputs to research, whether these are human genetic resources or genetic resources obtained through bioprospecting or research collaboration. These distinct aspects have an impact on the law and practice of IP in the life sciences. 2. Four key aspects of IP and bioethics A wide range of ethical questions arises in the debate over biotechnology and IP rights. At times these questions can relate more to the acceptability of a technology or of an IP right in relation to the technology. It may concern choices by the State or by government authorities or the behavior of individuals, firms or institutions. Such issues are not totally isolated or independent. Even so, it can be important to bear in mind some key conceptual, legal and ethical distinctions. The issues most actively debated may be grouped into these four distinct clusters: (i) The ethical aspects of a technology as such; 14

(ii) the ethical aspects of national authorities granting exclusive IP rights over a technology; (iii) the ethical aspects of an individual, a firm or an institution seeking exclusive IP rights over a technology; (iv) the ethical aspects of how an IP right holder should exercise exclusive rights over a technology. The following examples may help to illustrate and distinguish between these four aspects: (i) Ethical aspects of technology as such This aspect concerns ethical judgements over such matters as forms of research, including research involving human subjects and genetic materials, and over technologies such as genetically modified organisms. Bioethical issues may arise over such technologies whether or not they are patented. Important bioethical issues, such as prior informed consent, apply to the very practice of research, long before there is any research outcome that may or may not be patented. Research on stem cells, particularly embryonic stem cells, has raised considerable ethical debate. The question of whether to permit stem-cell research at all is distinct, and may have distinct ethical aspects, from the question of whether the outcomes of such research should be eligible for patent protection. Some commentators have argued that genetic use restriction technologies (GURTs), which prevent farm-saved seeds from being replanted, may be unethical, or should be legally prohibited. But such ethical questions are strictly distinct from whether a patent should be granted over such technologies; a patent on a GURT does not entitle its owner actually to practice the technology. Certain practices may be considered unethical and contrary to morality and consequently simply prohibited. However, such prohibition alone does not automatically prevent the grant of patents related to this knowledge. Not all countries have the same ethical or legal restrictions. Many patent laws exclude explicitly the grant of patents where the exploitation of inventions is considered to be contrary to ordre public or morality (such laws are therefore relevant to aspect (ii)). On the other hand, biotechnological research in most cases is not merely allowed, but actively encouraged, such as the development of new pharmaceuticals. Many technologies have a positive ethical aspect; and some technologies may have ethical and unethical uses. Even pharmaceutical research that is ultimately unsuccessful may be encouraged and welcomed by society. Nonetheless, it is generally illegal to market 15

a new pharmaceutical prior to regulatory approval following the successful conclusion of extensive clinical trials. (ii) Ethical aspects of granting exclusive IP rights over a technology This aspect especially concerns the choices made in national patent systems by legislators, by courts, by patent authorities whether or not in principle to make patents available over certain categories of subject matter. For instance, for various public policy reasons, including ethical considerations, some countries have chosen to exclude from patentability methods of medical treatment: this is based, of course, on a choice not to cover such methods under the patent system, not because of any negative ethical judgment about novel medical treatments as such. In parallel with the debate about the ethics of genetically modified organisms, there has been extensive debate about the ethics of patenting life forms, particularly higher life forms such as genetically modified mammals. National policymakers have chosen to resolve these issues in different ways, these differences perhaps in part corresponding to different ethical perspectives and other social values. Patenting of genes or nucleotide sequences, especially without any disclosed utility, has also been controversial. The question has been also raised whether it is morally sound for society to grant exclusive property rights over nucleotide sequences that are derived from the human genome, when no specific use has been found and disclosed for the patented sequence. Commentators have argued, on various policy, legal and ethical grounds, that the bare information provided in human gene sequences should not be patented. But that is not to take issue with the ethical aspects of the sequencing as such of the human genome, which has been widely welcomed. (iii) Ethical aspects of seeking exclusive IP rights over a technology This aspect concerns more the ethical aspects of the choices of an individual actor a firm, a research institution, a university over whether or not to pursue a patent for a particular invention, even if the invention as such would be legally eligible for a patent under national patent law. Some commentators argue that there should be legal or ethical constraints on seeking patents for an invention based on genetic resources or traditional knowledge obtained without prior informed consent and without equitable benefit-sharing, and legal measures have been introduced in national laws and proposed for international law to address these concerns. This argument can arise when the claimed invention is otherwise valid. This issue has generally been considered as a legal matter, in terms both of international and national law, but it may also have an ethical aspect for instance if the input to an invention has been obtained strictly legally but unethically. Some laws have constraints on obtaining or exercising patent rights when they have 16

been secured through inequitable behavior; while this is technically a legal question it may also be considered to have an ethical dimension. (iv) Ethical aspects of exercising exclusive rights over a technology This aspect concerns not the ethics of a technology, or of patenting that technology, but the ethical questions that arise when a patent holder chooses to exercise a valid patent the kind of ethical constraints that could be argued to apply when a patent holder operates within his or her legal entitlements, but still attracts ethical scrutiny. The ethics of how a patent right is licensed may arise when there is strong public interest in the patented technology, even when the licensing complies with the law. There has been recent debate over the ethics of licensing diagnostic tools that have been patented. In particular, if a patent holder has exclusive rights over a diagnostic tool, and chooses to license those rights in a highly restrictive way, could it be argued that are ethical obligations on that patent holder to grant wider access, even if the licensing is strictly legal? Working with these distinctions From the point of view of a policymaker or regulator addressing a particular issue, it is necessary to clarify which of these four aspects is actually concerned and whether the issue is or should be considered a strictly legal, or an ethical question, or both. For instance, if the concern relates directly to the ethical character of research (such as the requirement for prior informed consent) or the ethical characteristics of the technology (such as a genetically modified mammal), then it may be necessary directly to address the ethical problems of that research and that technology (aspect (i) above), before considering IP aspects. Scope of the paper Given its focus on IP and bioethics, this paper will not deal directly with issues concerning the ethical implications of technologies (aspect (i) above) or issues relating to research procedures, regulation of technology as such or commercial ethics as such (e.g. corporate social responsibility). Instead, this paper will limit its consideration to IP matters only, within the overall context of bioethics. Because of this same focus on bioethics, this paper will also not directly address the strictly economic aspects of IP law and policy, which are widely debated in international fora. Just as ethical assessments of innovations, as such, depend on the value-system of a society, an ethical assessment of exclusive IP rights needs to take into account the social and economic development of the country granting such rights or being affected by them. The effect of IP systems for the economy of a specific country will depend on how they are embedded in an appropriate innovation system. Universities and public 17

research institutions play a key role, but factors such as a supportive regulatory environment are also important. 3. IP and bioethics: some general themes Before addressing specific bioethics issues within the scope of IP law and policy, some general cross-cutting themes may need to be considered: (i) Transparency The UDBHR (Article 2f) calls for the greatest possible flow and the rapid sharing of knowledge concerning medical, scientific and technological developments. In the course of product authorization procedures, information regarding new biotechnological products will often have to be disclosed. The patent system also has a fundamental role to play in promoting this flow of timely information. As noted, it is often through the patent system that a new biotechnology is first, and most fully, disclosed to the public. Patent information systems provide the complete details of new inventions. Additionally they reveal the identity of inventors, commercial enterprises, as well as governmental and educational institutes that are involved in the creation and development of those technologies. Patent information systems shed light at an early stage on the development of technologies that may have important bioethical implications. They may be used to monitor: overall trends and patterns in the development of key technologies, the state of the art, research and patenting activities of specific firms, institutes and individuals. The transparency of the patent system therefore supports ethical scrutiny of biotechnology and can help inform the bioethics debate. However, the sheer volume of information disclosed through the patent system can make it difficult for policymakers and other participants in the debate to make improved use of and access to patent information. Further distillation and analysis of this raw patent data may be needed by policymakers and others concerned with bioethics issues so that the broader implications can be assessed. (ii) Consent Consent to use certain inputs to biotechnological research has been a recurrent issue with bioethical implications. There have been cases where genetic materials taken from the human body have been used as inputs for research, leading to inventions, which were subsequently patented. This has raised questions about the need to 18

obtain the prior consent of the human subjects concerned, and whether consent extends to the patenting of outputs from research. Consent is a key issue in bioethics, and it can be helpful to explore the relationship and the boundaries between legal and ethical aspects of consent to use genetic inputs to research. The issue of recognition of the interests of the donor of human genetic resources may overlap with questions of research involving human subjects in general. It may be necessary to clarify whether consent to take part in medical research or to undergo medical treatment extends to consent to the obtaining of IP based on that research. Various texts state the importance of the consent of the persons involved either in research in humans or owners of plant resources. The UDBHR (Article 6 (II)) provides that scientific research should only be carried out with the prior, free, express and informed consent of the Consent, bioethics and Mr. Moore s spleen The Moore case (in the USA) highlights some of the issues regarding consent that can arise when research on genetic materials leads to a patented invention. In 1976, Dr. Golde recommended that Mr. Moore s spleen be removed to slow the progress of hairy-cell leukemia. Moore signed a written consent form authorizing a splenectomy. Surgeons at UCLA Medical Center removed Moore s spleen a few days later. Dr. Golde and his assistants at a research lab established a cell line from Moore s T-lymphocytes by 1979. Moore was not told, at that stage, of the research work or potential of this cell line. In 1981, Dr. Golde applied for a patent, which was issued in 1984. Moore sued him and sought the ownership interest in the patent as well as redress from the doctor for breach of his professional obligations. The Supreme Court of California concluded that Moore had no ownership interest in the patent (as he was not an inventor), but that Dr. Golde was liable for breach of his professional obligation. In this decision, at least, a distinction was drawn between the legal context of access to the genetic resource, and the legal context of patenting a subsequent invention making use of the resources. person concerned. More specifically, the UDHGHR calls for prior informed consent to any research affecting an individual s genome. On the regional level, the Council of Europe Additional Protocol To The Convention On Human Rights And Biomedicine Concerning Biomedical Research, 2005 states that a fundamental principle for research involving human beings is the free, informed, express, specific and documented consent of the person participating. A similar debate applies to other genetic resources, such as genetic resources obtained through bioprospecting, which are subsequently used in research to create new technologies for which patent protection may be sought. For instance, the CBD, at the level of international law, provides that the use of genetic resources is subject to the principle of prior informed consent. (iii) Equitable sharing of benefits A further cross-cutting theme is how the benefits of research should be shared, and what it means for the sharing to be equitable. This theme potentially has both legal and ethical aspects. For example, the CBD establishes as an international legal principle that the benefits of research on genetic resources should be equitably shared. Similarly, articulating a bioethics principle, the UDBHR calls for equitable 19

access to medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge concerning those developments and the sharing of benefits, with particular attention to the needs of developing countries. As one means of generating benefits from biotechnological research, the IP system and in particular the patent system could have a potential ancillary role in helping to identify and equitably apportion such benefits. Under the FAO International Treaty on Plant Genetic Resources for Food and Agriculture, a multilateral system of benefit-sharing for the use of plant genetic resources has been established. (iv) Accommodating different value systems As noted above, ethics may be guided by the community s sense of morality and the values of the community. Naturally, these values differ between societies, and the moral basis of ethical judgments will also differ. This creates a cross-cutting issue for IP law, and in particular patent law. A technology that is considered immoral in one country may be considered morally acceptable, indeed positively desirable, in another. Some aspects of stem cell research fall into this category. This raises the question of how the IP system should deal with these different value systems, for instance in the interpretation and application of exceptions in patent law for technology that is contrary to morality. As noted above, another factor that may lead to different assessments of moral and ethical issues is the state of economic and social development of a country. 20

PART III: BIOETHICS AND THE INNOVATION PROCESS The relationship between bioethics and IP law and policy is complex, and discussion of this linkage is potentially diffuse. One way of structuring this discussion is to consider the bioethical issues that arise at each stage of the innovation process and in the development of a technology. These are: 1. research policy and planning 2. the research phase 3. the acquisition of IP rights 4. the use of new technology 1. Research policy and planning The interplay of IP and ethics arises well before research actually commences, as issues need to be addressed at the point of setting directions for research, reviewing the ethical and legal framework for research, and establishing institutional policies. Ethical issues may arise as a consequence of the policies of funding agencies and public sector research programs. IP and bioethics questions may therefore need to be built into institutional arrangements, research planning, and the policies and laws that guide research activities. For instance, before commencing any research activities, it may be necessary to consider some or all of the following: Ethical aspects of the genetic and biological inputs to research and ethical aspects of traditional knowledge used in research. According to some perspectives, this may entail recognizing ownership or custodianship of resources and knowledge, or recognizing other equitable interests in research inputs. Prior informed consent and appropriate consultative processes. Ethical and IP aspects of the appropriate dissemination of and access to research outcomes. Obligations whether legal or ethical for equitable benefit-sharing. Ethical aspects of ownership, access and control over research outcomes. Ethical questions regarding ownership of publicly funded research; and how to set IP management and ownership policies accordingly. The research planning and policy development phase may also be assisted by surveys of existing technology, including identifying useful research inputs, patterns of research activity and ownership, freedom to operate for upstream research and downstream technological development, and the assessment of technology partnering 21

and pooling options; this information does not strictly concern bioethics as such, but would provide a valuable empirical backdrop against which to review the ethical implications of planned research. 2. Research phase IP and bioethics issues that may need to be considered during the research phase include: ethical and legal aspects of access to necessary research tools; scope of legal rights and related ethical issues; clarification of the distinction between ethical aspects of research as such and the ethical implications of seeking patent and other protection for research outcomes; a linkage of IP mechanisms with consent and benefit-sharing obligations, including ethical and legal linkages; monitoring and implementing publication and IP management policies for researchers in accordance with ethical guidelines and legal requirements. Legal and ethical questions may arise when biological material or genetic resources are used as inputs for research. Depending on how the resources are accessed, there may be limitations on how they should be used, as well as questions of prior consent, ownership and benefit sharing. Legal regimes governing contracts and real property ownership as well as government systems regulating access to resources have been relied on to regulate access by researchers to biological materials useful in their research. Ethical guidelines for researchers have been articulated for accessing plant and microbial resources as well as human tissues. Three general forms of genetic resources may need to be distinguished, as there are distinct laws and obligations that concern them: genetic resources and biodiversity-related traditional knowledge, governed by the CBD; the plant genetic resources for food and agriculture specifically governed by the FAO International Treaty; human genetic resources and traditional medical knowledge, which are not directly regulated by a distinct international legal regime but are central to bioethical considerations. As explained above, regulation of research, as such, should be distinguished from the law governing the grant and exercise of patents. Questions such as the legitimacy of research on embryonic stem cells are a matter of law governing research as such, and some governments have chosen to regulate such research in various ways. But in particular when such legislation is missing, there is increased pressure on patent law to offer guidance, as the granting of a patent on a particular technology may be 22