New Zealand Yearbook of New Zealand Jurisprudence
Last Updated: 11 April 2015
PATENTING "LIFE": HUMAN GENETICS, ETHICS AND PATENT LAW
BY ANNA KINGSBURY.
This article provides a background and context for the New Zealand debate about the patenting of human genetic and other life form inventions. It reviews the application of patent law to human genetic research internationally, examines the arguments against the patenting of genetic materials, and considers alternatives to the patent regime for human genetic research. The author concludes that the patent system is the most appropriate and effective regime for the protection of human genetic inventions, but that it is not the most appropriate forum for the resolution of moral and ethical problems in human genetic research, or for the regulation of such research. It is argued that moral and ethical considerations in human genetic research should be removed from the patent system, and regulated by more representative social institutions.
Since the identification and elucidation of the structure of DNA in the 1950s, research in genetics and biotechnology has developed very rapidly; far more rapidly than the regulatory frameworks which supposedly govern its activities.' In the area of human genetics, the Human Genome Project was established in 1988 to gain "complete knowledge of the organization, structure and function of the human genome."2 Co-operating internationally, scientists aimed to sequence the entire human genome and then to identify specific functions within the genome. A related project, the Human Genome Diversity Project, aimed to record genetic biodiversity. The very scope of knowledge involved in these projects, and the potential implications of that knowledge, have led to concern about the
BA (Auck), LLB MLIS (Well), LLM (Melb), Lecturer in Law, University of Waikato. For a useful summary of advances in genetic research, see J Kinderlerer and D Longley "Human Genetics: the New Panacea?"  61:5 Modern Law Review 603. For an introduction to biotechnology issues and terminology generally, see New Zealand Independent Biotechnology Advisory Council, The Biotechnology Question (1999), http://www.ibac.org.nz/booklet/ibac/pdf.
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appropriateness and adequacy of existing ethical, legal and regulatory frameworks for genetic research. It is a widely expressed view that science, rather than ethics or law, is setting the agenda for research, and driving the regulators. To many, science is seen as "out of control".3
Of all the legal and regulatory issues arising from genetic research and the "new genetics", one of the most hotly contested has been the patentability of genetic material and genetically modified organisms. This is understandable as patenting genetics raises very awkward questions about whether life can or should be "owned", and then consequently whether life should be susceptible to commercial exploitation. These issues have been extremely contentious as they apply to plants and animals.4 But once questions of patentability are applied to the products of human genetic research, the issues become even more stark. To patent human DNA sequences seems to involve patenting the very fundamentals of human life. According to McLean:
Whilst it is generally accepted that people and companies will not innovate without profit in view, the possibility of 'owning' something so central to what it is to be human poses, for some, the ultimate nightmare scenario. This is because there is something both intimate and special about what it is that is to be the subject of property rights. 5
In New Zealand, debate continues about the patenting of human genetics and other life form inventions. In February 1999 the New Zealand Ministry of Commerce issued discussion documents for consultation with Maori on the patenting of life forms.' The Ministry sought advice as to whether inventions involving human beings should be patentable, whether the "contrary to morality" exception to patentability should be retained, and whether a new exception for human beings should be enacted. The Maori Patenting of Life Forms Focus Group has recommended a number of exceptions to patentability, including exceptions for humans, parts of humans, and highly significant species. It also recommends a ground for objection or revocation where a patent is "contrary to Maori values and interests.'
5 McLean, "Science's 'Holy Grail"', op cit n 2, 247.
In a related development, in response to concerns about the ethics and safety of biotechnology research, an Independent Biotechnology Advisory Council was established in May 1999, reporting to the Minister of Research, Science and Technology. This Council has no legislative or regulatory responsibility. Rather, it:
will help New Zealand explore and consider issues arising from advances in biotechnology. Its main role will be to stimulate dialogue and enhance public understanding about biotechnology. IBAC will also provide independent advice to Government on the environmental, economic, ethical, social and health aspects of biotechnology.'
The purpose of this article is to provide a background and context for the New Zealand debate about patenting of human genetics. The article reviews the application of patent law to human genetic research internationally, examines the arguments against the patenting of genetic materials, and considers alternatives to the patent regime for human genetic research. The author concludes that the patent system is the most appropriate and effective regime for the protection of human genetic inventions, but that it is not the most appropriate forum for the resolution of moral and ethical problems in genetic research, or for the regulation of such research. It is argued that the patent system is a non-representative, technically oriented institution designed to promote innovation and research by providing monopoly rights in inventions for a limited term. At best, it is poorly equipped to deal with moral and ethical concerns, as recent cases illustrate.' It is therefore submitted that moral and ethical considerations in human genetic research should be removed from the patent system, and regulated by more representative social institutions, for example on the model provided by the Group on Ethics in Science and New Technologies established by the European Biotechnology Directive.10
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2. PATENT LAW: THE AVAILABILITY OF PATENT LAW PROTECTION
BIOTECHNOLOGY AND GENETIC RESEARCH IN AUSTRALIA, NEW
ZEALAND, EUROPE AND THE UNITED STATES
The purpose of patent law is to provide an incentive for innovation and promote investment in research. It has been suggested that the biotechnology industry is particularly concerned to receive legal protection for its work, and that biotechnology industries devote proportionately more time and money to patent protection than any other industry." Significant biotechnology and genetics research activity is motivated by the availability of patent protection, and there is therefore considerable interest in the availability of patent protection for the results of human genetic research. 12
Requirements of Patentability
The requirements for a valid patent are broadly similar across patent systems internationally!' Generally, an invention is patentable if it:
iv)involves an inventive step (is not obvious to a person skilled in the art)
v) is useful/ industrially applicable
vi)is not covered by one of the exceptions to patentability (which exceptions
vary across jurisdictions).
A number of problems arise when these criteria are applied to the results of human genetic research. Some of these problems are technical or practical problems in applying patent law to a new area, and some have an ethical or moral dimension.
(i) Full Description
It is a requirement of patent law that the patent specification must describe the invention fully, including the best method known to the applicant of performing the invention." The purpose of this provision is that the reader of the specification should have sufficient information to reproduce the invention.
" C Roberts, "The Prospects of Success of the National Institute of Health's Human Genome Application" (1994) 1 European Intellectual Property Review 30.
12 Graeme T Laurie, "Biotechnology and Intellectual Property: A
Marriage of Inconvenience?" in Sheila McLean (ed), Contemporary Issues in
Law, Medicine and Ethics (1996) 240.
13 See Patents Act 1953 (NZ).
For biotechnology inventions this requirement initially caused difficulties. Merely describing a living organism was not sufficient for it to be reproduced. For microorganisms, this difficulty was overcome by the creation of depositories under the terms of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure 1977.
However, there may still be problems in sufficiently describing human genetic material in order for a reader of the description to reproduce it. This is unlikely to be a problem for synthetic material, but it may be a problem in patenting human genetic material in its naturally occurring form.
(ii) Patentable Subject Matter: Is Living Material Invention or Discovery?
In patent law, there is a long-standing distinction between discoveries and inventions. Patents cannot be obtained for discoveries of things occurring in nature. Patents are for inventions, that is, for things falling within the definition of "manner of new manufacture" within s 6 of the Statute of Monopolies.' Inventions are distinguished from discoveries as they involve some human technical activity or ingenuity. This distinction between discoveries and inventions reflects the essential principle of patent law; that the law grants a monopoly to an inventor as an incentive and a reward for skill, effort and endeavour. Such a reward should not therefore be available to someone who merely finds something which may turn out to be useful.'
However, the distinction between discoveries and inventions has created considerable difficulties in its application to biotechnology research. Much of the work done in biotechnology research, and especially in human genetics research, may not go sufficiently beyond discovery to qualify for patent protection. For example, much of the work involved in sequencing the human genome involves identifying molecular entities that occur in a natural state in the human body. Arguably these are no more than discoveries, and do not qualify as inventions for the purposes of patent law. However, there is also a distinction drawn in Patent Offices internationally between things found naturally occurring in nature, which are regarded as discoveries, and things which occur in nature but have been isolated from nature by technical means, where the process for isolation is regarded as being a patentable invention. Further, the substance itself will be patentable so long as it can be shown to be new and inventive in the sense of not having
15 See Patents Act 1953 (NZ), s2; Patents Act 1990 (Cth), s
16 Laurie, op cit n 12, 242.
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been previously recognised to exist.' On this basis, patents have been regularly granted since the 1980s for products of genetic engineering, in the same way as they are granted for other chemical substances!'
The distinction between discovery and invention is inevitably linked in the area of biotechnology to moral and ethical questions about the appropriateness of patenting 'life', and biotechnology patents have been opposed on this ground. Opponents have argued that life forms are not or should not be patentable per se, and that all life forms should be regarded as discoveries.
In the area of biotechnology, the distinction between discoveries and inventions has been considered in a number of cases in recent years. In the United States, it was the basis of the 1980 decision in the case of Diamond v Chakrabarty.I9 This was a case which involved genetically engineered bacteria which were said to break down multiple components of crude oil, and therefore to be useful in cleaning up oil slicks. The patent application was refused by the patent examiner on the grounds that the bacteria were products of nature and living things. The patent examiner's decision was rejected by the majority of the United States Supreme Court. The Court held that "anything under the sun that is made by man"' is patentable, and that:
The distinction is not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.'
Chakrabarty opened the way to large-scale patenting of biotechnology in the United States. It was inevitable that in time the scope of the decision would be tested in relation to higher forms of life. In 1988 the issues were raised in relation to the Oncomouse. The Oncomouse was a transgenic animal: a mouse specially bred to develop cancer. Harvard University obtained a US Patent for it in 1988 with little difficulty.' The claim was very broad, covering any transgenic non-human animal bearing an activated oncogene sequence introduced by genetic engineering. Although a living thing, it was regarded as an invention within the scope of Chakrabarty.
17 Guidelines for Examination in the European Patent Office. See also G Dworkin, "Should There be Property Rights in Genes?" (1997) 352 Phil Trans R Soc Lond B 1077, 1080, and Laurie, op cit n 12, 243.
19 Diamond v Chakrabarty  USSC 119; 447 US 303, 100 S Ct 2204, 65 L
Ed 2d 144, (1980),USSC.
20 Ibid, 150.
21 Ibid, 152.
22 US Patent No. 4,736,866.
However, when Harvard University lodged a similar patent application with the European Patent Office (EPO), it faced considerable opposition. Initially the patent was granted by the EPO, but proceedings were brought to have the patent revoked, and these proceedings have still not been concluded. The European opposition to the Oncomouse patent was based on moral and ethical arguments, with critics suggesting that Oncomouse should come within the exceptions to patentability 23
The distinction between discoveries and inventions in relation to biotechnology arose again in the Howard Florey/Relaxin decision.' In that case a patent had been granted for the expressed nucleotide sequence for the protein Relaxin which is produced by women during pregnancy, and which relaxes the uterus during childbirth. The Green Party opposed the application on a number of grounds, including a concern that "the patenting of human genes means that human life is being patented"?' Another major argument was that the application related to a discovery rather than an invention. The gene encoding Relaxin was always present in the female body. Finding it was therefore merely a discovery, not an invention. The EPO rejected this argument on the basis that the technical effort involved in extracting and isolating the gene constituted an invention within the EPO Guidelines. The isolated Relaxin gene was therefore the product of an invention 26
Thus, the definition of invention has been widely drawn, so that the biotechnology industry now experiences little difficulty in satisfying the invention criterion.
Related to the patentable subject matter requirement and the distinction between discovery and invention is the requirement that the invention be novel. Novelty concerns may arise when patents are sought for the results of genetic research where these are similar or related to existing research, or where the results are the product of known techniques to identify something naturally occurring.'
24  EPOR 541.
27 J McKeough and A Stewart, Intellectual
Property in Australia (2"d ed, 1997), 338-9.
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(iv) Inventive Step
To be patentable, an invention must involve an inventive step, that is, it must not be obvious to a notional non-inventive person skilled in the art. Obviousness is a question of fact for a court in any particular case, and depends on expert evidence.
Questions of obviousness commonly arise in the area of biotechnology where known techniques are used to produce a known and commercially desirable product, for example in the use of recombinant DNA to produce a known protein.28 Similarly issues of obviousness are also likely to arise in human genetic research, where known techniques are used to identify genetic material.
(v) Utility and Industrial Application
Another technical difficulty that arises in patents for biotechnology, and particularly for patents for human DNA, is the problem of utility. To be patentable, an invention must have some utility; it must be useful.
Much genetic research to date has concentrated on isolating and identifying gene sequences and DNA fragments. The Human Genome Project is a clear example of this activity. The Human Genome Project was established in 1988 with the purpose of mapping and sequencing the entire human genome. The project was coordinated by the Human Genome Organisation (HUGO), and is now approaching completion.29
In 1991, the United States National Institutes of Health (NIH), as a result of work on the Human Genome Project, filed applications to patent 2412 human DNA sequences. These DNA fragments had never previously been identified, but the complete gene sequences and their function in the human body were not then known. Further, at the time of applying for the patent they had no known utility.
These patent applications were made in the midst of considerable controversy about the appropriateness of patent protection for human genetic sequences. Concerns were expressed about the ethical and moral issues in patenting human life, and it was argued that the information in the human genome forms part of the common heritage of humanity and should not be
28 Ibid, 340.
29 See http://www.nligri.nih.gov/HGP/ and Intp://www.ornl.gov/.
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made the subject of a monopoly.' There was also concern expressed about the effects patenting the human genome might have on genetic research and product development. It was argued by some scientists that early protection of gene sequences might operate as a disincentive to others to engage in more complex product development. Such an effect would be contrary to the very purpose of patent law, which is to encourage innovation and research.' It should be noted here that these objections were not to the patenting of gene sequences with a known function which can be isolated and used to produce therapeutic products of commercial value. The objections were rather to the patenting of gene sequences whose function is unknown and which have no known utility or industrial application." Where the sequence has no known use, then it may simply be a discovery without the utility required for patentability.
In 1992, the United States Patent and Trademark Office rejected the applications for several reasons including obviousness and lack of novelty, but the primary reason was that the identified sequences had no known utility.33 The NIH had attempted to address the concerns about utility and industrial applicability by specifying possible uses. For example, the NIH suggested that they could be used as identification markers and as markers within genome research.' However these suggested uses were unacceptable to the United States Patent Office. Some were held to lack utility, some to be too vague, some to provide insufficient information and some to be obvious." Subsequently, European Patent Offices made similar decisions on the patenting of human gene sequences.
In 1994 the NIH decided against appealing the USPO decision, and a number of similar applications by other organisations have since been withdrawn. The Human Genome Organisation has now stated that:
Raw human genomic DNA sequences, in the absence of additional biological information and demonstrated utility, is inappropriate material for patent filing...[Access] to the initial genomic sequence as it is generated will provide the maximum opportunity for research and the development of new products37
31 Laurie, op cit n 12,
32 Dworkin, op cit n 17, 1082.
33 Laurie, op cit n 12, 247, McKeough and Stewart, op cit n 27, 337.
34 C Anderson, "US Patent Application Stirs Up Gene Hunters" Nature 353 (1991) 485-6.
35 Dworkin, op cit n 17, 1082.
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HUGO now asserts that all human genomic information should be in the public domain to encourage research and development, and because it is the common heritage of humanity. In 1996 all HUGO participants met and agreed on two key principles:
(i) Primary genomic sequences should be in the public domain; and
(i) Primary genomic sequences should be rapidly released.
HUGO reaffirms, however, the role of patents for new processes and products which use genes. Such processes and products avoid problems of patentable subject matter, novelty and obviousness, and they are likely also to meet the requirement of utility and industrial applicability.38
(vi) Exceptions to Patentability
A product or process arising from human genetic research may meet all the requirements of patentability discussed above, but there still remains the additional hurdle presented by the exceptions to patentability.
In recent times, exceptions to patentability have become the principal focus for the moral and ethical arguments surrounding patentability of genetically modified plants and animals, such as Oncomouse, and also some human genetic research products such as Relaxin. It is therefore likely that future opposition to patenting genetic techniques, such as cloning, will be focussed on the exceptions to patentability. However, the attempt to use the exceptions as a means to regulate research ethics has produced rather unsatisfactory results to date.
Exceptions to patentability vary considerably across jurisdictions, despite international attempts to achieve a more uniform approach. A serious attempt to achieve such a uniform approach was made in the context of the General Agreement on Tariffs and Trade Uruguay Round negotiations, which culminated in the Trade Related Intellectual Property Rights (TRIPS) Agreement adopted in 1994 as part of the GATT Final Agreement.
All members of the World Trade Organisation (WTO) are signatories to TRIPS, which sets minimum standards for the protection of intellectual property rights, and is enforceable through the WTO dispute resolution processes.
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Article 27 of the TRIPS Agreement relates to patentable subject matter. Article 27(1) provides that, subject to 27(2) and (3):
Patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.
Articles 27(2) and (3) provide for exclusions from patentability:
(2) Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
(2) Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(a) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this sub-paragraph shall be reviewed four years after the date of entry into force of the WTO Agreement."
The question of exclusions from patentability was a controversial one both during the TRIPS negotiations, and subsequently. International debate about patentable subject matter focussed particularly on four concerns.
First, there was concern that patent protection for developmentally important products such as agricultural chemicals and pharmaceuticals would protect the interests of large international companies at the expense of local research and development.' Indeed, India's continuing concerns about patents for pharmaceuticals and agricultural chemicals led to the first TRIPS dispute under the World Trade Organisation dispute resolution process. The United States complained to the WTO that India had not complied with the TRIPS patent protection provisions, and the complaint was upheld both by the WTO panel and on appeal!'
" Note the final sentence in Art 27(3)(b) requires that 27(3)(b) be reviewed in 1999.
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Second, there was concern that "biopiracy" by pharmaceutical companies would lead to those companies acquiring patents for indigenous knowledge, plant and animal materials. Indigenous and local peoples might then be excluded from using those traditional sources of information, except at a prohibitive price.' A similar concern arose in relation to human genetic research, when a patent was granted in the United States for a human T-cell line from the Hagahai people of Papua New Guinea.' The ensuing storm of controversy led to the patent being withdrawn in late 1996."
Third, there was concern about the impact of new agricultural and pharmaceutical technologies on biodiversity and the environment. This concern was reflected in the Rio Convention on Biological Diversity 1992, particularly the Preamble and Articles 8, 15 and 16.
Fourth, there were ethical concerns about the morality of granting patent monopoly rights for living things and genetic material. Concerns were raised about whether there should be property rights in life forms, and particularly for human beings and human genetic material.' This concern was fuelled by publicised developments in genetic research, such as the Human Genome Project, and by the growth of biotechnology industries.
The original United States draft text for TRIPS allowed for no exceptions to patentable subject-matter." This reflects the approach to patentability of the US Supreme Court in Diamond v Chakrabarty; that:
Anything under the sun should be patentable if it meets the required conditions of novelty and inventiveness and is capable of industrial application."
" US Patent Application No 05397696, assigned to the National Institutes of Health,
granted 14 March 1995.
See discussion in Pottage, op cit n 25.
17 Diamond v Chakrabarty  USSC 119; 447 US
303, 100 S Ct 2204, 65 L Ed 2d 144, (1980), USSC.
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The EC draft text excluded patents for (i) inventions that would be contrary to public policy or health; and (ii) plant or animal varieties, and the biological processes for their production. The European proposal was based on Article 53 of the European Patent Convention 1973.
A draft submitted by a group of twelve less developed nations agreed with the EC proposed exceptions, and also proposed excluding "discoveries, materials or substances already existing in nature, methods for the medical treatment of humans or animals, and nuclear material".'
The final text of Article 27 was thus a compromise between the various positions in this debate, and it in part echoes the EC draft and the provisions of the European Patent Convention.
Article 27(2) allows, but does not require, Member States to exclude certain things from patentability. It is therefore useful to consider State practice, and the effect of existing exclusionary provisions.
Exceptions to patentability in the United States, Australia, New Zealand and
The United States
In the United States there is no express legislative exclusion from patentability on grounds of morality or public order. The USPO has generally followed the approach to patentability of the US Supreme Court in Diamond v Chakrabarty."
Patents for biotechnology and life forms are granted regularly in the United States. However, prompted by publicity surrounding a biotechnology patent application, the USPO issued a statement in April 1998 indicating that the test for utility might in some cases require consideration of ethical arguments.
In Australia, the principal relevant exception to patentability is that excluding "human beings and the biological processes for their production"?' There is also a discretion for the Commissioner to refuse an
43 McGrath, op cit n 40, 401.
49 Diamond v Chakrabarty  USSC 119; 447 US 303, 100 S Ct 2204, 65 L Ed 2d 144, (1980), USSC.
30 Patents Act 1990 (Cth), s 18(2).
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application for an invention "the use of which would be contrary to law".5I A wider discretion is incorporated in the definition of invention by reference to section 6 of the Statute of Monopolies, providing that patents should not be granted for inventions that are "contrary to the law [or] mischievous to the State...or hurt of trade, or generallie inconvenient". Australia has no legislative exclusion for public order or morality, as exists in other jurisdictions, notably in Europe.
In practice, the Australian Patent Office has a liberal policy of accepting most applications, taking a similar approach to the United States Patent Office after Chakrabarty. However, it may be that ethical considerations will arise in relation to utility, as they have begun to in the United States.
Like Australia, New Zealand has preserved the discretions in the Statute of Monopolies definition. In addition, it excludes from patentability inventions which are "contrary to morality".' However, the practice of the Patent Office is similar to the liberal approach taken by the Australian Patent Office.
The New Zealand Ministry of Commerce has been considering reforms to the Patents Act 1953, including the exceptions to patentability, for some years." Most recently, in February 1999, the New Zealand Ministry of Commerce issued a discussion paper for consultation with Maori on the patenting of life forms.54 The Ministry particularly sought advice as to whether inventions involving human beings should be patentable, whether the "contrary to morality" exception to patentability should be retained, and whether a new exception for human beings, possibly similar to the Australian provision, should be enacted.'
51 Patents Act 1990 (Cth), s 51(a).
52 Patents Act 1953 (NZ), s 17.
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Article 53 of the European Patent Convention provides that:
European patents shall not be granted in respect of:
(a) inventions the publication or exploitation of which would be contrary to "order public" or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States...
The European Patent Office Guidelines initially indicated that the Article 53 exception would only be applicable in extreme cases, such as an application for a letter bomb.' However, in recent years Article 53(a) has been used as a basis for opposition to the patenting of life forms and genetic material on ethical grounds.
The first major debate was over the patent application for the Harvard Oncomouse, the mouse specially bred to develop cancer. The European Patent Office agreed to consider ethical issues in light of Article 53(2). The Examining Division took an approach which assessed whether the invention was morally acceptable to the public by weighing the benefits of the invention against the detriments. The benefit was the utility to humanity in possibly curing cancer, and this was weighed against the detriments in the form of environmental hazards and negative effects on the welfare of the transgenic animals. Broad concerns of principle were excluded from this balancing exercise which focussed on specific objections only. For example, the objection that transgenic animals pose an unethical interference with evolution was not considered, because the possibility of escape into the environment was regarded as minimal. As a result of the balancing approach it was decided that the benefits of a possible cure for cancer outweighed the detriments. The invention was therefore held to be publicly acceptable morally, and the application was granted. But the decision is now subject to opposition procedures, and a final decision is still pending.
The EPO was widely criticised for its balancing approach to the Oncomouse application, from all sides of the debate. There was criticism of the EPO for involving itself in ethical considerations in which it has no expertise. It was argued that the Patent Office is not the appropriate forum for ethical debates, and that there are more appropriate fora for the assessment of morality. Opponents of the application argued that the range of moral concerns taken
56 Dworkin, op cit n 17, 1081.
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into account was too narrow. Proponents argued that morality should be considered elsewhere than the patent system, and that patents should be granted unless they are for inventions which are unlawful. Further, it was argued that morality debates in the EPO can only lead to delays and inefficiencies in processing applications, to the detriment of the patent system and consequently to industry and innovation 58
In two subsequent decisions, Plant Genetic Systems N1159 and Howard Florey/Relaxie the EPO took a different approach.' It took the view that the Patent Office was not the appropriate forum for balancing the ethical benefits and detriments of an application. Rather, it chose to avoid ethical debate by applying a different test for patentability. Under this approach, the EPO would not decline patent applications on morality grounds except in cases where the general public would consider the invention to be so abhorrent that patenting it would be inconceivable.'
However, the "abhorrence" test has also been criticised, particularly by opponents of patents for life forms, as setting too high a standard. Debate has continued in Europe, much of it focussed on proposals for a European biotechnology directive.
European Directive on the Legal Protection of
Inventions July 1998w
In response to concerns about the uncertainty of legal protection of biotechnology industries in Europe, especially as compared with the United States and Japan, in 1988 the European Commission proposed a new Directive to harmonise protection.' The proposal provoked considerable debate about the ethical issues involved, and was only finally agreed by the European Parliament in July 1998.
The Directive preserves in Article 6(1) the EPC exception to patentability where commercial exploitation would be contrary to ordre public or morality. In Article 6(2) it goes further and specifies certain things that will be considered unpatentable:
58 Dworkin, op cit n 17, 1081. See also Warren, op cit n 57,
" (1993) 24 IIC 618.
60 (1995) OJEPO 388;  EPOR 541.
61 Characterised as a "light-touch" approach. Dworkin op cit n 17, 1081-2.
63 Directive 98/44/EC,  O.J. L213.
64 Recitals 1-3 and 8. Dworkin, op cit n 17, 1083.
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On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:
(a) processes for cloning human beings
(a) processes for modifying the germ line genetic identity of human beings"
(a) uses of human embryos for industrial or commercial purposes
(a) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes".
Article 5(1) also excludes from patentability "the human body at the various stages of its formation and development and the simple discovery of one of its elements", although Article 5(2) permits patents for elements isolated by means of a technical process.
Recital 38 states that Article 6(2) is an inclusive rather than an exhaustive list, and does not preclude other examples.' However 6(2) is arguably inconsistent with Article 53(a) EPC, as interpreted by the EPO light-touch approach in recent decisions such as Relaxin. The balancing exercise required by 6(2)(d) appears similar to that employed by the EPO in Oncomouse and since rejected.'
Article 7 is a response to the perceived need for ethical expertise, and provides that ethical problems will be the responsibility of the Commission's European Group on Ethics in Science and New Technologies. The Group is to report annually to the European Parliament under Article 16.
Recitals 12 and 36 of the Directive refer to the TRIPS agreement and indicate that the exclusions from patentability in the Directive are within TRIPS 27(2). Article 2 provides that the Directive shall be without prejudice to the obligations under TRIPS and also under the Rio Convention on Biological Diversity. However, the mandatory exclusion of items listed in Article 6 may actually be beyond the scope of 27(2). Arguably, Member States may rely on 27(2) TRIPS and not implement the Article 6 exclusions. Alternatively, if they do implement Article 6, they may be subject to criticism for non-compliance with 27(2) TRIPS'
The Cloning Patent: The Next Debate?
66 Ford op cit n 46,
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It is likely that the question of the test to be used in applying the morality criterion will arise again in Europe in relation to the patent applications based on Dolly the cloned sheep.' The Roslin Institute in Edinburgh has filed two patent applications internationally covering the cloning techniques used to produce Dolly. The applications are framed broadly to cover the cloning by somatic cell nuclear transfer of "all animals", including a process for the cloning of humans.' Unsurprisingly, there has been considerable opposition to these "cloning patents". For example, the Rural Advancement Foundation International is taking steps to ensure that it will be rejected by WIPO."
Of course, prima facie it appears that granting of a human cloning patent would be prevented by Article 6(2) of the Directive which prevents patenting of "processes for modifying the germ-line genetic identity of human beings" and "processes for cloning human beings". However, Article 5(2) allows patents for human biological material once isolated from the human body. It may be possible to patent the product of a nuclear transfer technique applied to human cells, because it is the technique applied to humans that is not patentable, not the product of the technique. This will depend upon the interpretation of the Article 5 prohibition on patenting the "human body, at the various stages of its formation and development"."
It therefore seems that human cloning may be patentable in Europe, unless it is found to be contrary to public order or morality. Thus, the European Patent Office may once again have to address the morality criterion. Many commentators argue that the "public abhorrence" test used by the European Patent Office in Relaxin is a preferable approach to the intricate balancing exercise of Oncomouse.' There may be more chance of achieving agreement as to what is "abhorrent" than there is as to what is "unacceptable".
The higher abhorrence test is preferred because, it is argued, the patent system is not the appropriate forum for the regulation of morality.' Other regulatory bodies are better equipped than the Patent Office to conduct rigorous moral assessments; even the Oncomouse balancing approach did
70 See information at http://www2si.bbsrc.ac.uk/library/research/cloningllarchive/nt-ip.html
[30 April 1999]. The patents have a priority date of 31 August 1995. See also
Warren, op cit n 53.
71 See RAFT website http://www.rafi.ca and Warren, op cit n 57, 445.
72 Ibid, 450.
73 Ibid, 445.
24 Ibid, 448.
1999 Patenting "Life": Human Genetics, Ethics and Patent Law 107
not consider the objections in principle that should be included in a moral assessment. Further, as patenting is not necessarily contemporaneous with exploitation, morality applied at the time of patenting could therefore be outmoded by the date of exploitation. Combining moral assessments of exploitation with legal questions of patent protection can produce public misunderstandings about what it is that is the subject of the patent.'
A human cloning patent application might well succeed under the abhorrence test. While there is presently widespread support for a ban on human cloning, so that a cloning patent might well be regarded as abhorrent, there is nevertheless considerable support for allowing nuclear transfer technology in limited circumstances, for example in correcting human genetic "defects".76 This suggests that the process and products are unlikely to be regarded as abhorrent for all purposes.
In contrast, under an Oncomouse-type balancing test the patent would be less likely to succeed. While there are arguments for human cloning, for example in therapeutic applications and in offering reproductive choice for infertile people, it is unlikely that on balance these applications would outweigh concerns about human cloning.
However, under either test it is possible that a patent for human cloning would be excluded in the present climate, and that the Roslin Institute will be limited to some category of "non-human" animals.
3. OPPOSITION TO GENETICS PATENTS: THE ARGUMENTS
Opponents of creating property rights in human genetic material through the mechanisms in the patent system raise a number of arguments in opposition.
Property Rights in Human Beings
Fundamental to the concerns raised about patenting of "life", and particularly the patenting of human genetic material, is a moral and philosophical objection to the creation of property rights in human beings. There are a number of formulations of this objection.' The first formulation is that if a person is not a slave and nobody else owns their body, then they
108 Yearbook of New Zealand Jurisprudence Vol 3
must own their own body. Thus, every individual owns his or her own body, to the exclusion of others. This naturalistic approach is immediately attractive to contemporary conceptions, and it is widely held. However, it is based on flawed reasoning.
From the fact that nobody owns me if I am not a slave, it simply does not follow that I must own myself. Nobody at all owns me, not even me.78
Nevertheless, the objection is useful as a device for emphasising a principle of bodily-use freedom.' And it is an argument widely used in opposition to the creation of property rights in the human body and human DNA. For example, Magnusson makes this kind of argument when he suggests, in the interests of preserving human dignity, that:
Human tissue may usefully be regarded as personal property in order to enforce possession and to prevent damage and destruction, for the purposes of criminal offences such as theft, and for the purposes of bailment."
A second formulation of the objection to the creation of property rights in human beings is the argument that the human body is something which is fundamentally outside or beyond the reach of property analysis.' Thus, critics of patenting human genetic material commonly draw a distinction between "nature" and "culture"; between "things", which can be owned, and "persons", which cannot. According to Pottage:
Most critiques of biotechnology patents seek to restore the proper bounds of property; the common basic practical response consists in the "juridification" of human life, granting it a form of legal immunity from commodification. 82
On its face, this distinction is compatible with the patent law distinction between discovery and invention, a distinction which also reappears in Article 5 of the European Biotechnology Directive. Thus, human life as "nature" or "discovery" is beyond the scope of patent rights. Indeed, this distinction is heavily relied upon to justify patenting of genetic material, and it is not uncommon to hear patent experts complain that much opposition to biotechnology patents is based on a fundamental misunderstanding of the distinction. For example, the EPO Opposition Board replied to Green Party concerns about the Relaxin patent by saying that opponents had fundamentally misunderstood the nature of a granted patent: a patent does
8' John Stuart Mill, for example, argued that human
beings are beyond the scope of property. Harris also makes a version of this
see Harris, op cit n 77, 72.
82 Pottage, op cit n 25, 745-6.
1999 Patenting "Life": Human Genetics, Ethics and Patent Law 109
not give the proprietor any right over a human being but merely the right to prevent another from practising the same invention outside the human body." In the Board's words:
It cannot be overemphasised that patents covering DNA encoding human H2-Relaxin, or any other human gene do not confer on their proprietors any rights whatever to individual human beings...No woman is affected in any way by the present patent... 84
However, the discovery/invention distinction appears simplistic when applied to biotechnology. In a sense biotechnology reduces a person to his or her component elements, and thereby by its very nature renders the discovery/invention distinction "transparent or implausible"." As the EPO Opposition Board said in relation to opposition to the Relaxin patent, DNA is not life but rather a chemical substance which carries genetic information to produce medically useful proteins.' It is therefore arguable that political opposition to biotechnology patents is not fully answered by the patent law distinction between discovery and invention:
Rather, although their force is blunted by legal proceduralisation, political arguments show how legal doctrine mistakes its own interested definition of `nature' for nature 'as such'. From this perspective the doctrinal distinction between inventions and discoveries is itself a form of violence against nature!'
Human Dignity and Human Rights
Opponents of genetic patents also argue that patent rights in living things, especially in human beings, are contrary to the ideas of individual freedom, self-determination and human dignity that are essential to contemporary thought. Creating property rights in people is likened to slavery, and is described as fundamentally degrading to human beings.' In the human dignity conception, the human body is seen as the means of existence of the human person, and as inalienable from the person as is freedom or citizenship.'
Human dignity arguments form a basis for the protections which are increasingly appearing in human rights instruments. An example is the
83 Dworkin, op cit n 17, 1081.
85 Pottage, op cit n 25, 745-6.
86 Dworkin, op cit n 17, 1081.
87 Pottage, op cit n 25, 753.
89 Pottage, op cit n 25,
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January 1998 Council of Europe Additional Protocol To The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings.' Similarly, the Preamble to UNESCO's Universal Declaration on the Human Genome and Human Rights emphasises that human genome research "should fully respect human dignity, freedom and human rights"."
However, human dignity in this context is a fragile concept, and it is difficult to see how it might most usefully be applied to the question of biotechnology patents. In practical terms the human dignity approach tends to be proceduralised through liberal requirements for informed consent.' For example, in the Relaxin case, it is not clear that human dignity arguments could have prevailed over property rights, given that the pregnant women who had supplied the tissue had consented freely to do so."
Thus, human dignity may be an insufficient basis for opposition to property rights. Rather, human dignity concerns may co-exist within a framework of regulated property rights. But the reliance on informed consent is not a guaranteed safeguard for human dignity in the commercialising of property in genes. As with any market in which trade is based on free choice, there will be imbalances in bargaining strength, asymmetries of information and anti-competitive behaviour.' Additional regulation may be required to correct such imbalances.
The now famous case of Moore highlights another interesting issue in relation to human dignity and informed consent arguments. Moore had his diseased spleen removed in a necessary and successful operation conducted by the medical centre at the University of California, on the advice of his doctor, Dr Golde. Moore was then required to attend regularly at the centre for the next seven years, and samples of his blood and other bodily substances were taken. Eventually, Moore learned that his diseased spleen
90 (Not yet in force). Relevant provisions are:
1 Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.
2 For the purpose of this article, the term human being "genetically
identical" to another human being means a human being sharing
with another the
same nuclear gene set.
91 Adopted 11 November 1997.
92 Pottage, op cit n 25, 765.
93 D Beyleveld and R Brownsword, "Human Dignity, Human Rights and Human
Genetics" (1998) 61:5 Modern Law Review 661, 675.
94 Ibid, 676.
1999 Patenting "Life": Human Genetics, Ethics and Patent Law 111
had unique characteristics that gave it great therapeutic potential, and that Dr Golde and an associate had developed a cell-line from his spleen and the other extracted substances. The Regents of the University of California obtained a patent for the cell-line, and the patent became the basis for a three billion dollar pharmaceutical industry. Moore sued the doctors, the University Regents and the pharmaceutical company, arguing conversion, breach of fiduciary duty and lack of informed consent. He was successful on fiduciary duty and informed consent, but unsuccessful in conversion. The Court of Appeals held that Moore was unable to claim a property right in either his excised cells or in the genetic information coded into the cells which became the subject of the patent.96 The court relied on a number of reasons for this conclusion, among them the discovery/invention distinction. It stated that:
The patented cell line is both factually and legally distinct from the cells taken from Moore's body. Federal law permits the patenting of organisms that represent the product of human ingenuity but not naturally occurring organisms... Human cell lines are patentable because "[I]ong-term adaptation and growth of human tissues in culture is difficult - often considered an art..." and the probability of success is low...it is this inventive effort that patent law rewards, not the discovery of naturally occurring raw materials. 97
Thus, the court overrode the naturalistic argument that Moore owned his own body and/or the genetic code in his cells, in favour of the patent law construct that distinguishes "naturally occurring raw materials" in which he has no property, and "the product of human ingenuity" in which there can be property rights in the interests of encouraging research.
Thus, the court created an anomalous situation. Moore was not able to profit from his contribution to a three billion dollar industry, but his doctors were. Moore had no property claim, and was not entitled to a return. But the researchers involved were granted a patent monopoly on their 'invention' which was based on that tissue. The only obligations the researchers had to Moore were fiduciary obligations requiring informed consent. Thus, the regulatory environment based on principles of informed consent provides no return for the individual in Moore's situation, and "unjustifiably licenses entrepreneurs to take the whole profit from their exploitation of the human genome"."
96 Boyle, op cit n 45, 23-4.
" Moore v Regents of the University of California  249m Cal Rptr
494 (Court of Appeals);  271 Cal Rptr 146 (California Supreme Court),
98 Beyleveld and Brownsword, op cit n 93, 676.
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It is arguable, given that the court left open the possibility of property rights in human tissue for some purposes," that Moore could have legally sold his diseased spleen to Dr Golde and thereby secured a return." However it is by no means clear that this would have been the view of the majority, and it is equally possible that Moore would not have been entitled to sell his tissue, because he did not have property rights in it." In New Zealand, legislation provides for consent to use of donated tissue for scientific or medical purposes, implying some kind of property rights in the tissue, but this does not extend to donors selling their own tissue.'
Thus, the arguments against property rights in the form of patents in human genetic material have not to date been particularly successful. While some patent applications have been withdrawn in the face of controversy, the opposition to patenting has not succeeded in prohibiting patents for human genetic material under the morality exceptions in Europe, the United States, Australia or New Zealand. Patents are likely to be increasingly granted for the results of human genetic research, and it is likely that patents for human cloning technology will also eventually be granted in some form.
However, it is also likely that genetics patent applications will continue to attract controversy, and probably increasing controversy, about morality of patenting and commercialising genetic research. It is already clear that the patent system is not well-adapted to deal with controversy surrounding considerations of morality, and there is growing concern about the possible effects of such controversy on the patent system. The patent system is designed to promote innovation by providing incentives in the form of a monopoly grant on commercialisation for a limited period. Its effectiveness in so doing will be seriously undermined if substantial delays and inefficiencies are created by political debates.
It is therefore desirable to find a solution to the more controversial aspects of commercialisation of genetic research outside of the patent system. To be effective, any alternative to patents must not only avoid the potential controversy involved in creating property rights in human beings, but it must also be commercially effective. Therefore, to be acceptable to the biotechnology industry, alternatives to patents must provide adequate
For example, to prevent theft or damage to severed tissue. Moore v Regents
of the University of California  249m Cal Rptr 494 (Court of Appeals);
 271 Cal Rptr 146 (California Supreme Court),
100 Magnusson, op cit n 80, 53.
Ioi Beyleveld and Brownsword, op cit n 93, 676.
1999 Patenting "Life": Human Genetics, Ethics and Patent Law 113
rewards as an incentive to innovation. However, biotechnology is a very profitable industry, and it is possible that research would disclose that a lesser reward than that provided by the patent system might still constitute sufficient incentive.
4. ALTERNATIVES TO PATENT PROTECTION
There is an at least theoretical possibility that copyright law might provide an alternative to patent protection for the results of genetic research. Where results are recorded they will attract copyright protection. If unauthorised copying then occurs, and can be established, an action for infringement will be available. Because there is no requirement of registration, the problems associated with applications and oppositions are avoided. However, since copyright is similar to patent law in that it creates property rights, the objections to creation of property rights in human beings would presumably still stand.
In reality, there has been little reliance on copyright by the biotechnology industry, and the use of copyright is little more than theoretical. This is for two main reasons. First, copyright does not provide protection from independent creation as patents do. In a highly competitive and lucrative industry, this is a crucial difference that reduces the value of copyright protection. Second, proof of copying is likely to be difficult. Therefore, copyright is not a complete alternative to patent law for the biotechnology industry.
It is arguable that trade secrets law provides a viable alternative to patent protection. Genetic research could be kept secret as confidential information, protected from disclosure through the action for breach of confidence. This approach both avoids the controversy surrounding the creation of new property rights, and also avoids the technical requirements of patentability. This may well be an option in some circumstances, for example for genetic research which does not satisfy the criteria for patentability.'
However, this option is anathema to scientists, especially academic scientists who wish to publish their work and disseminate their results. For this reason
103 For example, research might not be generally known, but might not meet the test for
inventive step. McKeough and Stewart, op cit n 27, 341.
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alone, trade secret protection is unlikely to be a popular option. Further, trade secret protection depends upon a very high level of secrecy being maintained, and this is another practical limitation vis a vis the patent system. 104
Another alternative means of protecting genetic research is to rely on the action of unjust enrichment. Unjust enrichment has the advantage that it depends on the appropriation of value rather than on property rights, and it provides a remedy in restitution. Unjust enrichment may therefore be of use to researchers wishing to share the results of their research with others, but wanting to prevent those others from using those results to unjustly benefit. For example, if a defendant took a database of genetic research data, to which limited access had been granted for particular purposes, and began to make that database available to others at a profit, then the original database producer might have an action in unjust enrichment.' However, as with copyright, the drawback to unjust enrichment from the point of view of the biotechnology industry is that it does not provide protection against independent creation, and therefore does not provide the level of economic incentive for research that is available through the patent system. It does not assure an inventor of monopoly profits, as patents do.
Interestingly, there is another possible application of unjust enrichment law in human genetics research. Unjust enrichment may provide a remedy for the donor in Moore's situation, where tissue is taken and used without consent, to the economic advantage of the taker. Unlike conversion, unjust enrichment does not require proof of property rights, and is available where the property interfered with in an unjustly enriching manner is an intangible, such as information in genetic code."
Unjust enrichment is to the information age what the tort of conversion is to the mechanical/industrial age. In essence they are the same obligation dealing with different degrees of tangibility.m
However, Magnusson identifies a curious anomaly in the application of restitution law to the tissue donor. Under Australian (and New Zealand) law, donors cannot sell their own tissue for direct financial advantage. As a result:
1°5 B. Fitzgerald and L. Gamertsfelder
"Protecting Informational Products (including Databases) through Unjust
Enrichment Law: An Australian
Perspective" (1998) European Intellectual
Property Review, 244, 245.
106 Ibid, 244-5.
107 Ibid, 255.
1999 Patenting "Life": Human Genetics, Ethics and Patent Law 115
It would be very generous indeed to consent to the use of tissue samples for biotechnological research, since this would vitiate the potentially enormous financial gains which a donor could obtain indirectly by way of damages or restitution for the donee's unauthorised use of tissue in the process of biotechnological manufacture.m
Thus, unjust enrichment may provide an at least partial solution to regulating the interface between genetics researchers and source donors of tissue, without creating the problems associated with property rights as encountered in patent law. But it will not provide a complete alternative to patent law in providing incentives and protections for the biotechnology industry.
Patent law has attracted considerable controversy in its application to biotechnology research, and this controversy is likely to increase as more patents are sought for human genetic materials. The problems are sourced not in patent law itself, but in trying to integrate moral and ethical considerations into a patent system which is not inherently adapted to cope with them. The patent system is a technical system with a narrow ambit. It is not the appropriate forum for community debates about the regulation of genetic research.
It is therefore desirable to remove moral and ethical debates about regulation of genetic research from the patent system. One means of achieving this might be to employ an alternative system of incentives and protection for genetic research. Such a system would need to provide similar economic incentives to that provided by the patent system, but without creating the problems associated with property rights. As has been seen, none of the alternative regimes is adequate for this purpose. Existing alternative legal frameworks provide a partial solution at best. Patent law remains by far the best system for protecting and promoting innovation in biotechnology.
It is therefore submitted that patents should be available for all inventions that are lawful, and that ethical concerns in genetic research should be removed altogether from the patent system into a more representative forum. In New Zealand, the new Independent Biotechnology Advisory Council is a step toward this approach. But it has broad terms of reference encompassing biotechnology generally, it has no regulatory role, and its independence is limited by the requirement that it report to the Executive rather than to
1°8 Magnusson, op cit n 80, 54.
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Parliament.' A better, if still imperfect model is The Group on Ethics in Science and New Technologies established by the European Biotechnology Directive."° The Group is an expert committeee that reports to an elected and representative body: the European Parliament. Although there are still unresolved questions as to exactly the role this group will play, it is submitted that such a group is better suited to governance of genetic research than are the Patent Offices. It is a more representative and accountable body, reporting to a constitutionally established and elected institution. It has better mechanisms by which to consult citizens, take account of community and social concerns, and give consideration to broader concerns of human rights and human dignity. It can interface with the patent system by providing guidance in applying and interpreting morality criteria. The patent system will benefit from being removed from the centre of political debate, and enabled to get on as efficiently as possible with its role of administering the patent system and facilitating research and innovation. And the debates about the future applications of biotechnology research can be held where they should be held: in a democratic and representative forum.
109 Note that the New Zealand Environmental Risk Management Authority regulates the development of genetically modified organisms. However, the definition of "organism" does not include a human being or a genetic structure derived from a human being. See Hazardous Substances and New Organisms Act 1996, s 2. There is no equivalent authority dealing with human genetic research and development.
110 European Group on Ethics in Science and New Technologies, established by Article 7 of the European Biotechnology Directive 1998. This Group reports annually to the European Parliament under Article 16 of the Directive.