Inventions, patents and morality


entry E6-58-09-03 in Encyclopedia of Life Support Systems (UNESCO 2001).
Author: Darryl R. J. Macer

Institute of Biological Sciences, University of Tsukuba, Japan

Contents

1. Introduction

2. Intellectual Property Protection

3. Ethical and Moral Issues

4. Moral Arguments Supporting Patenting

5. Ethical Arguments Against Patenting

5. Rewarding Historical Innovation

7. Morality Exclusion of Patents

8. Conclusions and Predictions

Glossary

Bioethics: Study of the ethical issues relating to the use of life sciences, medicine, and environment. The love of life.

Copyright: Copyright protection applies to eight categories of works: literary; musical; dramatic; pantomime and choreographic; pictorial, graphic and sculptural; motion pictures and audio-\visual work; sound recording; and computer programs. Copyright protects the expression of an idea, not the idea itself.

Cultivar: An international term denoting certain cultivated plants that are clearly distinguishable from others by one or more characteristics and which when reproduced retain those characteristics. In the USA g"variety" h is considered to be synonymous with cultivar (derived from cultivated variety).

Deontology: A theory according to which actions are judged right or wrong based upon inherent right-\making characteristics or principles rather than on their consequences.

Egalitarian: A social philosophy that advocates human equality.

Human Genome Project: Collective name for several projects begun in the mid 1980's in several countries, following the USA Department of Energy decision to (a)1) create an ordered set of DNA segments from known chromosomal locations, (b)2) develop new computational methods for analyzing genetic map and DNA sequence data, and (c)3) develop new techniques and instruments for detecting and analyzing DNA.

Intellectual property: That area of the law involving patents, copyrights, trademarks, trade secrets, and plant variety protection.

Invention: An original device, contraption, or process developed after study and experiment. Genetically engineered animals, plants, and micro-organisms have been recognized as patentable forms of biological invention in the United States, but this is not always the case in other countries, especially where animals are concerned.

Justice: Giving everybody an equal opportunity, equal share, or what they deserve.

Marker: An identifiable physical location on a chromosome (for examplee.g., restriction enzyme cutting site, gene, RFLP marker) whose inheritance can be monitored. Markers can be expressed regions of DNA (genes) or some segment of DNA with no known coding function but whose pattern of inheritance can be determined.

Novelty: One of the criteria used in the evaluation of patent applications. The invention or discovery being evaluated must be new and must not have previously existed through the work of others in order to be accepted on the grounds of novelty.

Obviousness: Obviousness is one of the criteria used in the evaluation of patent applications. Obviousness addresses the degree of difference between the invention being evaluated and that which is already known and available.

Patent: A patent is a grant issued by different governments through a Patent and Trademark Office that gives the patent owner the right to exclude all others from making, using, or selling a patented invention within the country for the term of the patent (for example,e.g. in the USA this is for 17 years).

Plant variety: Cultivated plants that are clearly distinguishable from others by one or more characteristics, and that when reproduced retain those distinguishing characteristics.

Plant variety protection: Patent-\like protection for certain sexually produced plants. Plant variety protection is granted by many countries, and applies within those countries. It only applies if the holder ensures a reasonable commercial supply of that variety to all who want it.

Prior art: That which is already known or available, part of the criteria of obviousness used in evaluating patent applications.

Technology transfer: Movement of inventions and technical know-\how across national borders. The process of converting scientific knowledge into useful products.

Teleology: A teleological explanation is explaining phenomena by their design, purpose, or final causes.

Utility: The state of being useful or producing good.

Utility patents: Usefulness or utility is one of the criteria used to evaluate patent applications. Utility patents are patents issued to inventors of any new and useful process, machine, manufacture, or composition or any new and useful improvement thereof.

Summary

This article reviews the criteria used for intellectual property protection, and how this has been applied to inventions and discoveries made in biology and biotechnology. The ethical arguments for and against patenting are reviewed, emphasizing whether beneficence is served by encouraging patents, and whether justice is served by the protection period for exclusive marketing given by patenting. Access to knowledge and discoveries is discussed in a global framework. The history of patenting is presented, with the use of exclusion clauses when a patent is against public order. European patent law has treated living organisms differently to inorganic matter, and despite recent directives that allowed patenting of transgenic organisms and genetic material, the matter does not appear to have been resolved. It is predicted that the global debate on the morality of patents will continue in the future, and it is argued that ethically it should continue so that deeper ethical goals of beneficence, justice and rights should can be served beyond those of economic development itself.

1. Introduction

This theme of the morality of patents has been one of the more controversial aspects of biotechnology, often becoming political and heated. Despite the fact that many of the early patents on medical products of biotechnology, such as insulin and human growth hormone, and genetic engineering techniques, will soon be terminated because the period of patent coverage is terminatedexpired, there is an expanding rate of new patent applications for novel gene discoveries and for inventions of new processes. The coverage of these patents and their enforcement has social implications of a global nature, between the private and public sector, and between many different countries.

Although the granting of patents has been demonized by many groups opposed to the idea that, by genetic engineering, we can modify any living organism to provide better goods or services to human society, it is a practice that has become a standard way of thinking for most academics to think. We have seen the growth of patent applications by academic and public sector researchers to a point where they may out-\ number those of industry applicants, especially in the case of biotechnology. The trend towards commercialized science is symbolized by the U.S. Congress which decided that publicly funded science should be commercialized, and during the 1980s intellectual property rights were decentralized from government to research institutions to create commercial incentives. This trend has become world-wide.

Ethically we one can start by asking rather simple questions., Iis the principle of beneficence, or loving good, served more by having research than by not having research, and do we encourage more research into more beneficial areas of science encouraged by the incentive system of patents than we would by not having patents? We will also consider whetherAre other ethical principles such as justice and doing no harm are served by systems of intellectual property protection. Ethically, can anyone own a product of their mind, a product of nature, a product of a designed process, a discovery, or even an invention? Does it make any difference whether the product or process involves living organisms or rocks? Should we expect the practical law be expected to share the same goals as that of ethics, namely can we expect ideal ethical laws be expected, or some compromise?

This article will discuss the issues of inventions and morality with a specific focus on biotechnology. It will review intellectual property protection, and discuss the ethical arguments related to patenting in biotechnology research.

2. Intellectual Property Protection

There are several systems of intellectual property protection designed to reward inventors. To qualify for a patent. an invention must be novel, non-\obvious, and useful. Industrial competitiveness leads to secrecy, and results may not be published at all if a company does not think they can keep to themselves the benefits to themselves from of the research costs invested, or the money used to purchase the rights to the use of results of research from a university research team. A patent guaranteies the publication of the results and the deposit of the product in a central repository, for use in the future development of research to create better inventions.

An alternative system to for protecting an invention against being used by a competitor is keeping it as a trade secret. The closing of results from other workers is against the principle of scientific openness, but is a common feature of certain forms of industrial research, especially when the process used to create a product may be expected to be kept a secret for some years. However, with biotechnology inventions, once the product is sold, the DNA can be sequenced and reproduced by another team of researchers. Specific techniques, such as nuclear transfer or cell manipulation techniques may be kept secret a little longer, but still tend to be made open through the patent system.

Patents can generally be sought either on products or processes used to manufacture the product. It is easier to obtain a process patent, but it has been harder to prove that a competitor is using your process, as access to their production facilities may be restricted. There were have been general patents awarded on the process for transfer of DNA into other organisms, and in the methods used to transfer, for example using Agrobacterium or projectiles (biolistics) in plants.

If the claimed invention is the next, most logical step which is clear to workers in that field, than it cannot be inventive in the patent sense. If a protein sequence is known, than the DNA sequences that code for it will not in general be patentable, unless there is a sequence which is particularly advantageous, and there is no obvious reason to have selected this sequence from the other sequences that code for the protein. In the case of natural products there are often difficulties because many groups may have published progressive details of a molecule or sequence, so it may have lost its novelty and non-\obviousness. These are essentially short pieces of the human genome. However, recently, genomics companies have applied for patents on previously published sequences from databases, and in the United States, the a policy seems to be emerging in the United States that will favour reward of research investment and interpret novelty in such a way so as to encourage industry.

There are also patents on protein molecules which have medical uses. In this case the protein structure is patentable if it, or the useful activity, was novel when the patent was applied for. The invention must also be commercially useful. A new use may be allowed a new patent, although an Australian judge in 1998 rejected such an application. There are patents on short oligonucleotide probes used in genetic screening. If someone can demonstrate a use for a larger piece of DNA, thean they can theoretically obtain a patent on it. An example of a larger patentable section of genetic material would be a series of genetic markers spread at convenient locations along a chromosome. Another set of genetic markers on the same chromosome can be separately patented if they also meet those criteria.

The question of patenting of genetic material continues to be a contentious issue, despite the global agreement within Aarticle 4 of the Universal Declaration on the Human Genome and Human Rights, passed by UNESCO General Assembly in 1997, and adopted by the UN General Assembly in 1998, which states g"The human genome in its natural state shall not give rise to financial gain.h". This is because there are numerous interpretations of what natural state means, given that what is being patented is not a chemical substance but the information included in the sequence. In 1998, Nelkin and Andrews , like many, asked, , like many, what are the limits to commercialization of the human body, and wonder if we should change the species name be changed to g"Homo economicush"?h

The trend to apply for patent protection on a large number of genes simultaneously could be considered to be a new use of the reward of invention principle, and has broad socio-\economic impact because a few companies are dominating genomic sequencing. One The companiesy, Celera (and the former TIGR, (both based in Maryland, USA), sequenced half of the first two dozen complete genomes to be sequencedcompleted. This is not restricted to the USA;, in 1999 the Helix Research Institute in Japan applied for a patent on 6000 human genes, in a similar way to how US genomics companies have applied for patents on many genes.

The direct use of products, such as therapeutic proteins, is well established. The information may also be used in the study of a particular disease, for example, by the introduction of a gene into an animal to make a model of a particular human disease, and it was for this reason g"Oncomouseh" was patented in 1988 in the US,A. It was as U.S. Patent Nnumber 4 ,736 ,866. The patent awarded was broad, applying to any non-\human mammal containing an activated oncogene, although the animal itself was a mouse with one particular activated form of the myc oncogene. Precisely it read, g"A transgenic non-\human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at the embryonic stage.h". The activated oncogene means that it is more easy to be mutated so that the animal is more susceptible to cancer-\causing chemicals, so itand thus can be useful for carcinogenicity testing. During 1987 the US Patent and Trademark Office made the following announcement: g"The Patent and Trademark Office now considers non-\naturally occurring non-\human multi-\cellular living organisms, including animals, to be patentable subject matter ..."..h The conflict between economic advantage and moral objection is further highlighted in the granting of animal patents, as will be discussed below.

The first patent obtained for a living organism was obtained after the court case Diamond v. Chakrabarty in 1980, and the first patent on an animal was on an oyster in 1987 in the USA. The genetic information can also be used to cure a disease, for example using the technique of gene therapy with a specific gene vector, and this can also be patented. The ethical issues relevant to the debate on patenting life are discussed below.

3. Ethical and Moral Issues

Intellectual property protection is one of the social systems that has evolved in modern society. Like the technology that it is applied to protect, it is a system that needs to be subject to ethical analysis to examine whether it is suitable for a moral society.

The principle benefit claimed for patents is that rewarding an inventor creates a positive environment for progress of research that leads to the betterment of society. If this is true, thean theyis areis consistent with the ethical principle of beneficence. History suggests that the financial interest in a free market creates more funding for research, and faster overall progress in research in important areas has been the result of the intense research efforts. This point has been used by industry to oppose moves to block patents on biotechnological inventions that arise from other ethical concerns.

The issue is, however, more complex than a simple examination of the benefits of intellectual property to one society, because there are always winners and losers in trade. We have to consider tThe ethical principles of justice, and non-\maleficence need to be considered. Even more complex is deciding just who are the actors involved in the equation. Some key ethical issues in patenting in scientific research include:

4. Moral Arguments Supporting Patenting

In this section we will explore some of the arguments that go beyond beneficence will be explored. The debate over the patenting has been intense, but it remains unsettled despite the positions taken. T I expect the debate is likely to continue even though public policy has demanded that legal measures be adopted to guide the application of patent law to biotechnology.

One of the ethical arguments expressed when supporting patenting of biotechnology inventions is that patent law regulates inventiveness, not commercial uses of inventions. Those arguing this position would claim that we the need to encourage an inventive society so that we can progress knowledge can be progressed into the future. Rewarding inventions means some members of society can devote their time and energy to creativity. The commercial use of inventions, is not dependent upon the patent itself;, that is subject to social demands.

The encouragement of inventiveness, through patenting, means that it promises useful consequences (for example,e.g. new products and/or /research). To developDevelopment of new tools is good for society, although not all new products are necessarily good. However, if the concept that people and society are really given a choicemake decisions on which products to use is decided byon the basis of commercial factors, and could can be questioned. The ideal of free market choice is too simple to explain the real world.

Support for patents is often seen when a national economy is being defended;. iIf other countries support patents, then our country needs to. This applies also, if the a biotechnology industry is to compete in a global market. (In a following section we will discuss tThe morality exclusion in patent laws is discussed in Section 7.) There is a balance between an ideal of sharing all knowledge with each other, and a giving society, versus the harsh reality that countries are engaged in tough international competition that a modern free market has created. It is almost impossible for any country to stand on its own in a global system, and the institution of the World Trade Organization (WTO) and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) have made this legally binding.

Biomedical research is performed and funded in many countries. For many years science has not only been the individual pursuit of people with unusual ideas, but rather it involves the funding of research by public or private money, consisting of taxes, charities, and business investments. We should not be surprised therefore to hear the justifications for the funding of the a project in terms of the business opportunities. All politicians are convinced of the usefulness of funding biotechnology by as a means of giving the opportunity to boost their national biotechnologystrengths in the field, the same applies to of almost all of science.

Conversely, however, there is an ethical duty to fund science placed on all countries. There are several reasons why research funding should be shared. The basic ethical reason is the principle of justice:, that we should all contribute to shared knowledge that we can benefit from. People from every country will be able to benefit from the information, though to different degrees. Many people also believe that the pursuit of knowledge itself is a good, but although this is not an ethical reason but a philosophical one, notably the currently popular philosophy of science. There is also the connection between basic research and the standard of university teaching, and if we consider education to be a basic moral good we can claim that to perform research has a positive effect on the teaching standards; this which may be a more significant benefit in small countries than the direct results of research. Another argument people give ftor promotinge research is that of national pride;, that people want those of other countries to have a high opinion of their own country.

One argument that is often neglected by opponents of patenting is that, if patenting is not permitted, useful information will become trade secrets. Patenting actually forces an invention to become public knowledge, so that other researchers can begin to investigate knowledge from the new invention. If a company believes it can keep an invention secret for more than twenty years then it may be better economic strategy to keep that knowledge a trade secret. The indirect results will be affected by factors such as whether during the period of patent exclusion certain companies have been well established and are able to provide beneficial services or monopolies, and the relative advantages of the open knowledge after patenting compared to industrial secrecy that could occur if patenting was difficult to obtain.

More significantly, there may be a greater amount of total knowledge and a more rapid completion date using the approach involving private companies. The means by which these approaches are pursued differs. In one approach, the government laboratories spend their resources on particular focused projects like the genome project at the expense of other projects, but with the cumulative results being openly available to all. In the other approach, the private companies do the research, which would create more total biomedical research knowledge, but certain parts of this would be tied up in patents, though although the knowledge would also be available with a small delay.

We have seen theThe competition between genomics companies like Celera and the international government genome project led to the completion of the genome sequence several years ahead of schedule, in the year 2000, instead 2005 of theas planned 2005 completion date. While there were gaps in the initial genome sequence that resulted from the race, it still allowed completion several years in advance. Another example is competition between genomics companies and a consortium of major pharmaceutical companies in the development of maps of single nucleotide polymorphisms (SNPs). It was novel to see competitors in pharmaceuticals funding together the SNP consortium together so that the SNP maps would be in the public domain. The motive is commercial, because having the SNP map public then allows companies to explore individual SNPs for medical treatment, without having a complex web of royalties to pay to genomics companies that are attempting to patent as many SNPs that as they can before the SNPsthose that they claim are listed in the public domain.

Another argument follows the ethical principle of autonomy, and is that patenting rewards innovation. It says that if I invest something I have some right to use that knowledge first. It is an ethically\ethically weak in philosophy, however, it is consistent with the working philosophy of individualistic modern society, where people are rewarded for their hard work. The harder we work the more money we are said to be able to claim,_ the spirit of entrepreneurship. It This is the common morality of wWestern society where individual work is rewarded.

5. Ethical Arguments Against Patenting

Despite the arguments for patenting given above, theis issue remains contentious and the fact that different countries have conflicting policiesy reflects this. The issue is closely related to the commercialization of biotechnology, but some sort of information protection is accepted as an incentive to invest in research of benefit to society. The arguments against patenting include a variety of arguments in response to the questions raised in section threeSection 3 of this article.

Important to many are metaphysical concerns about promoting a materialistic conception of life through economic valuation. However, farming has traded animals and medicine has traded medicines, for millennia.

Until the Convention on Biological Diversity made local living organisms the intellectual property of national the states, there was the concept that living organisms are the common heritage of humankind, so they should not be exploited. Opponents of patenting claim that it promotes inappropriate human control over information that is common heritage.

The morality exclusions of the European Patent Convention 53(b), as will be discussed later, had been interpreted in the 1990s to mean there should not be patents awarded to plants and animals. Some countries, like Denmark, specifically do not permit patents specifically, like Denmark. This has led to opponents citing this diversity as a justification to ban patents in general.

There are particular ethical concerns over the use of animals in research. Increased use of animals may be promoted by the development of a greater variety of transgenic animal models. If this led to more animals being used in research it would be against the efforts of the animal welfare movement. However, trends suggest that less fewer animals can be usedrequired, by the use of cloned animals, because less fewer need to be used for control studies if they are genetically identical. The patenting question is separate from the development of new animal varieties and animal testing. Laboratories market animal clones and varieties at market prices, so that a patent may make the price of animals even higher, thus encouraging alternative methods rather than promoting animal use.

Patenting is said to produce excessive burdens on medicine. These include increased costs to consumers, and payment of royalties for succeeding generations. The claim that the function of patents is to regulate inventiveness, rather than to regulate commercial uses of inventions, is perhaps avoids addressinging the consequences of the system. There have been some controversies regarding the commercial monopoly held by the company which that was able to patent AZT, the initial HIV/AIDS treatment, which gained large profits in view of its monopoly. It is all the more questionable whether this should be allowed because of the key roles that government\ funded research played in developing AZT and showing it was active against AIDS. There are other examples where the commercial monopolies obtained couldan not be said to be in the best public good, and the existence of patent laws is certainly relevant to the later commercial uses of inventions. The economic system is tied to patent recognition, and as in the title of this section in the encyclopedia, we need to consider the broad social consequences need to be considered..

In fact a number of these above issues may not be directly affected by permitting patents, as the issues like such as the distribution of wealth and international competitiveness exist independently of the patent debate. A general criticism of modern biotechnology is that it may encourage technology to be done for its own sake, and for the creation of new markets and employment, rather than seeking the best solution to a problem in terms of the environment or human society. The assumption that wealthier societies protect the environment more than poorer ones is flawed, especially when we see the rising consumption patterns of richer societies.

It is not really clear whether the type of research supported by patenting and the research investment it protects, is the research of most benefit to society. Medical and agricultural products are clearly needed, but not always the most efficient and sustainable processes and products are used, as seen for example in the chemical pesticide industry or expensive pharmaceutical alternatives to existing medicines. Also, t We can also consider the amount of money that people in developed countries spend on luxury products, such as cosmetics, that may be considered a waste of research investment in terms of distributive justice, when compared to life\ threatening diseases.

Do the ends justify the means? The end is a product or genome sequence, which is open to all. However, by pursing certain means of achieving this end we may not obtain the same specific end. If we allow more privately funded research there may be more restrictions on the end information, in order to encourage private funding. If restrictions are applied to the general access to information, thean it is clear that we will havethere will be a different short\-term end when a we use a shared ownership approach is used, compared to that from a free private market approach allowing private ownership. After the period of patent exclusion , than the direct result is the same, i.e.that is, full knowledge and open use.

Is the sequencing of DNA really an invention? The DNA could be viewed as a random sequence of bases, and the author is the sequencer, but this is not what we would normally talk ofis normally implied as an author or inventor, rather the sequencers are discoverers. In the days of colonial rule a discoverer could claim a land as their property, but later it was recognized that the pre-\existing people had claims to the property, no matter how it was developed by the colonizers. The sequencers of DNA are not sequencing un-\owned land but rather they are sequencing un-\characterized land, the name of mappers is rather suitable for this analogy. Some critics of ownership could go as so far as to call those who seek to profit and to control the decisions concerning the human genome project without general consultation, a type of g"genomic imperialist.h".. The DNA is not random, but it is merely unknown. This is an important difference, in addition to which is the common possession of the DNA sequence by every member of humanity_, the sequencers are not authors. While it may also be unconventional to call the possessor of information the author, they do have more claims to that title than the sequencers, in addition they can be called the owners (only in this general way sense, the human sequencers are shared owners because they also possess DNA).

5. Rewarding Historical Innovation

The countries most supportive of patenting also appear to have been the most successful at generating research funding and making new products for use in medicine. We can think of, for example, the research supported in North America, Japan, and Europe, when compared to other regions of the world. However, before accepting the resultsthis in terms of a measures of Nobel Prizes, or patent applications, iwe should t needs to be considered how products of traditional agriculture and medicine have been applied to provide the introductions starting points for current agricultural and pharmaceutical applications of biotechnology. Overall, the contributions of free knowledge and living organisms, like local farm varieties and medical plants which are freely accessible, is are much greater than the contributions of patented medicines and technologies.

There is a specific ethical problem with patents following whole genomic sequencing. This is that the knowledge from the private\ sector large genomics laboratories will be obtained in only a one or two year period, and in advance of publicly funded efforts. Should that year in advance be translated to a twenty year period of exclusive patent use? Ethically we may question the length of patents in such tight races by companies with the greatest money, when they have the potential to monopolize numerous genomes. The technology and knowledge being exploited to map genomes is the result of a century of scientific work in genetics, and the choices of which organisms to sequence is often based on a much longer history of knowledge of unique organisms. On the other hand, the patent system stimulated these companiesm to invest and to speed up the process of genomic sequencing by several years, which must deserve some reward.

Using a more positive argument, the knowledge gained should be considered as the common property of humanity. There is an existing legal concept that things which that are of international interest of such a scale should become the cultural property of all humanity. It can be argued that the genome, being common to all people, has shared ownership, is a shared asset, and therefore the maps and sequence should be open to all. Some of the common factors that derive from the shared ownership are that the utilization must be peaceful, access should be equally open to all while respecting the rights of others, and the that common welfare should be promoted.

There has been much concern over the growing dominance of ever\ larger biotechnology and pharmaceutical companies in a globalized and open trading market. The traditional image that scientists would freely share the knowledge they had with each other to develop the a common understanding of the truth and workings of life, has shifted to a commercialized paradigm. At the end of the 1990s the mergers between companies led to the world seed market being controlled by a fraction of the number of companies who controlled it in the 1980s. The Convention on Biological Diversity (CBD) that resulted from the Earth Summit held in Rio de Janeiro in 1992, gave each country the right to commercial exploitation of the indigenous genetic material of their country. It is applied to material collected after that date, so that materials previously collected and distributed, for example in botanic gardens in other countries, or seed banks, are exempt. Before this time, the ethical argument was that all species were the common heritage of humankind, however, this had led to exploitation of indigenous knowledge by researchers in rich countries. Local knowledge of medicinal plants or disease resistance varieties was shared with researchers, who would then extract active ingredients and attempt to improve upon them.

One publicized example of an agreement for bioprospecting is the agreement between Costa Rica and Merck and Co., enabling Merck to look for medicinal compounds in Costa Rican rain forest in exchange for financial assistance to protect the rain forest, and a share of any patent that results from the prospecting. The Andean Community (including Bolivia, Columbia, Peru, Ecuador, and Venezuela) legislated together under the Cartagena Agreement to recognize plant breederf's rights, and control access to genetic resources. This recognizes that indigenous knowledge may not be restricted to modern national boundaries, and that cooperation would help each other. Knowledge is tied to cultural systems, and it becomes even more problematic when one individual from a community wants to share the knowledge with outside parties, whereas other members do not. Individuals also differ on how much benefit sharing they demand, with many persons being willing to give knowledge openly with no idea of reward for it. Can a community demand a share of the benefits later on, after a member of that community has given the knowledge away freely? There are several active NGOs that publicize these cases, including the Genetic Resources Action International (GRAIN) and the Rural Advancement Foundation International (RAFI), which have homepageInternet sitess.

There have been procedures adopted for benefit sharing to providers of plant and animal genetic resources at an intergovernmental level, under the auspices of the Commission on Genetic Resources in Food and Agriculture (CGRFA) at the United Nations Food and Agricultural Organization (FAO), and under the CBD. The documentation relating to these are available on the Internet through the FAO homepage. The CGRFA is a permanent inter-governmental forum to discuss and negotiate matters relevant to genetic resources for food and agriculture. The main objectives of the Commission are the conservation and sustainable use of genetic resources for food and agriculture, as well as to ensure fair and equitable sharing of benefits derived from their utilization, for present and future generations. The Commission aims to reach an international consensus on these areas of global interest through negotiations. It was established by FAO in 1983 (Conference Resolution 9/83) as the Commission on Plant Genetic Resources (CPGR). In 1995, the mandate of the Commission was broadened to cover all genetic resources of relevance to food and agriculture (Conference Resolution 3/95) and it was renamed as the Commission on Genetic Resources for Food and Agriculture (CGRFA). At present 160 countries and the European Union are members of the CGRFA. Membership is open to all FAO Member Nations and Associate Members on official request.

The Commission reviews, monitors, and advises the FAO on policy, programmes, and activities related to conservation, sustainable use, and equitable sharing of benefits derived from the utilization of genetic resources of relevance to food and agriculture. The Commission is developing a comprehensive system for genetic resources of relevance to food and agriculture. In 1997, it established two subsidiary Intergovernmental Technical Working Groups (ITWGs): the Intergovernmental Technical Working Group on Plant Genetic Resources for Food and Agriculture, which advises on the Global System for the conservation and sustainable utilization of plant genetic resources; and the Intergovernmental Technical Working Group on Animal Genetic Resources for Food and Agriculture, which advises on the Global Strategy for the management of farm animal genetic resources. Some practical discussion of benefit sharing mechanisms between countries has been developed, including possible formulas for the sharing of benefits based on different benefit-\indicators.

The question of benefit sharing for human genetic material is not covered by the CBD, following a decision on the meeting on the agreed interpretation of it. In April 2000 the Human Genome Organization (HUGO) Ethics Committee released a statement on benefit sharing. The HUGO recommendations were:

1) that all humanity share in, and have access to, the benefits of genetic research.

2 ) that benefits not be limited to those individuals who participated in such research.

3) that there be prior discussion with groups or communities on the issue of benefit-sharing.

4) that even in the absence of profits, immediate health benefits as determined by community needs could be provided.

5) that at a minimum, all research participants should receive information about general research outcomes and an indication of appreciation.

6) that profit-making entities dedicate a percentage (e.g., 1-3%) of their annual net profit to healthcare infrastructure and/or to humanitarian efforts.

Although the traditional view is that if any financial benefits arise, the benefit sharing will be a sharing of royalties from patent fees or profits from sales of compounds, HUGO suggested more general benefits of new research and medicines should be available to all. This was because it is impossible to define who is the community that should have the benefits shared with them. The general recommendations to give a percentage of profits leaves the creative ideas to the companies, rather than creating a new bureaucracy that would take away resources from the communities who deserve to receive some benefits. The companies marketing them may offer the products freely, or at low cost, to the groups who contributed to the knowledge. This could mean giving free medicine to the patients who gave blood samples to enable gene discovery, for example. Moral responsibility by companies is also helped by the prospect of good public relations, and tax incentives, in the absence of enforceable rights by those who donate material or knowledge.

A final point that could be made is the question of whether biotechnology research that is encouraged by the patent system really benefits the world. Product substitution has led to national economies collapsing, as seen with development of artificial sweeteners and the collapse in the sugar industry in tropical countries, and vanilla and various oils. As alternative methods for production of substances are found using biotechnology, industrialized countries can produce the compounds themselves, reducing the need for imports from producer countries, often developing countries. Thus the economic benefits of patents to rich countries that can afford the research and product testing to bring products to market, may be economic losses for other countries, which creates huge social impact. The environmental impact is quite difficult to generalize uponabout, as production systems vary in their use of artificial chemical and organic pesticides, and the quantities used and manner in which they are used, can have widely diverse overall impacts on ecosystem and farmer health. The environmental ethics movement, and long\ term economic assessment, demand total environmental impact assessment. This should include looking at biocentric and ecocentric concerns, not just anthropocentric goals.

7. Morality Exclusion of Patents

There are two basic approaches to applying patent law to biotechnology inventions. One is that the normal patentability criteria shall apply to everything, that is, the invention has the attributes of novelty, non-\obviousness, and utility, and the invention should be deposited in a recognized depository. The second is to have a specific exclusion on certain types of invention. Denmark has an exclusion in its national law to patenting of animals, and the Nigerian patent law of 1970 excluded biological products and processes, for example. This exclusion is based on ethical arguments, and also application of the idea that no application against common morality should be supported.

The 1623 Statute of Monopolies (UK), expressly limits the scope of patentable subject matter. Patents may be granted if they are not g"contrary to the law nor mischievious to the state or generally inconvenient.h". This is considered the first statutory immorality clause. In the UK Patent Office manual of 1907, there was a refusal to grant patents for contraceptives and sexual aids. The g'exclusion on moral groundsh' clause in the European Patent Convention is Aarticle 53:

Art 53(a) Patents shall not be granted for g"inventions the publication or exploitation of which would be contrary to ordre 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.h".

The patent examiner can use a variety of arguments to determine opposition to patents, and appeal courts have used other ones. They may include cost benefit analysis, balancing of interests and if something is considered g"abhorrenth" it may be excluded. There have been cases of exclusion seen in the Oncomouse case when it was first considered by the European Patent Office, and in other cases. The US Ppatent Ooffice decision, as discussed in section 2 above, led to the US House of Representatives passing a bill in 1989 which barred the granting of patents to humans and provides for a farmerf's exemption from patent infringement with respect to transgenic farm animals. The only standard exception to the US Patent Officef's g"anything goesh" interpretation of the law on the patentibility of animals lies in the reluctance of the US Patent Office to allow a claim to an animal broad enough to encompass human beings. The Commissioner has asserted that the g"grant of a limited, but exclusive property right in a human being is prohibited by the Constitution.h". A legal point that has not been defined is what is the definition of a human being, in the case that animal\-human hybrids are made, although attempts by test cases have been made to define the boundaries.

According to European Patent Convention Article 53(b), microorganisms are patentable, but g"plant or animal varieties or essentially biological processes for the production of plants and animalsh" are expressly barred. Since the animals need to be reproduced by a natural biological process, reproduction, then they can be regarded as nonpatentable. However, property rights have long been recognized for breeding animals such as prize bulls and racehorses. Although the European patent office in Munich has turned down the application for a European patent for Oncomouse initially, it is possible to interpret clause 53(b) in a different way, and the OECD has recommended that this be done. In this case a new plant or animal would be considered a new variety only if it was explicitly described as such. Then in 1999 a new patent directive by the European Commission effectively allowed the patenting of transgenic organisms, and the European Patent Office altered its official policy to be consistent with that.

If common morality is being used as a standard then the weight of public opinion should be a factor. Protests are only one measure, because small extreme groups will lobby or protest about almost anything. There is more public rejection of the idea of patenting genes, plants, and animals than inventions in general in many countries, as seen in the International Bioethics Survey conducted in 1993 in ten countries in the Asia-\Pacific region. While there is support for patenting a cure for AIDS, there is less support for patenting genes or living organisms. When we think about this in more detail, which is the least ethical, to patent a medical cure or to patent a seed for a new crop? The answer is not so clear.

While patenting rewards innovation, as discussed above, there is an existing difference in the protection of property rights compared with other rights in international law and declarations of human rights. Property rights are not absolutely protected in any society because of the principle of justice, for the sake of g"public interest,h", g"social need,h", and g"public utility,h", societies can confiscate property. In the United Nations Declaration of Human Rights, Article 27 there are two basic commitments that many countries in the world have agreed to observe (in their regional versions of this declaration). These are (1) Eeveryone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits. (2) eEveryone 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. This second part could be applied to the shared authorship of the common heritage of the genome, and Aarticle 4 of the Declaration on the Human Genome and Human Rights.

Therefore there is an existing precedent for exemption from property ownership, which is the point of the exclusiveness of patents, when some property is of great benefit to the public. As for the argument that we should support patents because other countries do, there are certainly many countries that have exemptions for patent protection. The exemption because of social need would apply if there would be more benefit from patent exclusion, which is not necessarily so. It depends on the way information is used. Therefore some argue that no one person or company should own the results of a genome sequence.

The patenting of new varieties of plants and animals is subject to some restrictions in different countries, and internationally the concept of farmerf's rights has been accepted under the CGRFA, and the CBD. The useful attributes of varieties are the result of long periods of breeding, so the additional insertion of a new gene onto this background is only a further increment to the good characters of the variety. So while a new flower pattern could be patented, and a new property patented, a whole flower could not. The UPOV Convention governs an alternative system of intellectual property called plant variety rights, which allows the breeder to market the crop variety as long as they can provide seed at reasonable price to all. Developing countries are mixed in their reception to intellectual property, for example some countries in Africa support the UPOV Convention, and others want to restrict overall patenting of plant varieties.

In the USA the commercialization of human cells and tissues is generally permissible unless it represents a strong offence to public sensitivity. The idea that the human genome sequence should be public trust and therefore not subjected to copyright was also the conclusion of the U.S. National Research Council, and the American Society of Human Genetics. The European Parliament g"Human Genome Analysish" program limited contracting partiesf' commercial gains with the phrase g"there shall be no right to exploit on an exclusive basis any property rights in respect of human DNA.h".

While respect for autonomy suggests some self\-interests must be considered for the sake of researchersf' autonomy and their future work, most rapid progress will be obtained if data is shared between all researchers. It is unethical by for any researcher to withhold information that could provide medical therapy if released. Until now there have been very few medical procedures that have been patented, despite their suitability. Only instruments and products used in diagnosis or treatment have been patented, actual procedures have been left open for all to use free of patent liability in accord with the principle of beneficence. The principle of justice, would argue that new foods, or medical therapy should be available to all at an affordable price, and without discrimination. This issue is highlighted by the barriers to use of many products and processes imposed by those who cannot afford to pay royalties, or buy products, not only the majority of the world's population who live in developing countries.

An issue whichthat is important for agriculture is the concept of farmerf's privilege. Do farmers have a right to keep seed from their farm, or keep the offspring of animals, and to use them to stock the farm in the future. This saves the farmer having to buy more seed for the next generation from the seed company, or animal breeders. Modern intensive agriculture has tended to use hybrid seeds, so that after one or two generations it is better economically for the farmer to buy fresh hybrid seed, rather than mixing in the seed stock of the seeds that the farmer has. The yields of hybrid seed in the next generation vary, but a seed company may prefer the yield to be low so that the farmer is better off to buy their seed every year rather than mixing seeds themselves on the farm. In general it is accepted that farmers can keep enough seed from patented plants for their own use, but not to sell to others, and this was included in the 1999 European Commission Directive on Patenting of Biotechnology Inventions.

In the late 1990s there was much debate over the use of so-\called g"terminatorh" technology, which would make a seed sterile. This would make it necessary for the farmer to buy the seed every year with no option. The company with this patent was absorbed by the large company Monsanto, which led to more public opposition overn the prospects of this technique being used to prevent farmer's from growing their own seeds. In late 1999 the company Monsanto announced it would not use the technology, after much debate. There is are likely to be other technologies developed to accomplish the same goals, so the issue has only been delayed. From an ethical perspective, the tradition of farmers to grow their own seed is generally supported by public opinion, and is supported by both the autonomy of the occupation of farming, and justice to be able to grow your own food. However, we can think ofthere are several ethical uses of technology to stop reproduction of transgenic organisms, for example, seeds producing pharmaceuticals or fish growing in fish farms that have potential risk to escape and breed with native fish stocks. There is also the remote risk that the gene alteration making the organism sterile could spread to other varieties, which could have serious consequences for farmers who have mixed varieties growing in one area, as well as for native species. It would be important to gather the field trial data from gene interventions such as these before allowing open use of transgenic organisms with these genetic alterations.

8. Conclusions and Predictions

Ethically, we can apply the principle of love or beneficence can be applied. Does allowing patenting of biotechnology give more benefits than a ban to the most people? Does it work for love of life and the environment, compared to alternatives? The benefits should be in terms of general medical or agricultural development, rather than economic prosperity of one company or country over another. At the same time, love says that no one should be stripped of the respect that others owe to them, and we should work for the benefit of all without ignoring the weak.

In conclusion we shouldis the need to reflect reflect further on how to reward intellectual property, and be more open to diverse approaches that are appropriate in different societies. In Europe a conference was held in Oviedo in May 1999 to discuss whether the Council of Europe should develop a further Bioethics Convention to meet the challenges that ethical patenting faces from biotechnology. Despite the acceptance by the European Patent Office of the European Parliamentf's 1998 directive on patenting inventions produced through biotechnology, there are ethical issues that require further resolution. The patent situation will also depend upon the relationship between TRIPS, UPOV Convention and the Convention on Biological Diversity, which oversee the international situation.

Globalization has many implications, however it is not clear that patenting will be the best solution to the questions of sharing the benefits gained by human curiosity with all of society. In existing law there is room for interpretation of the public morality clause in different ways, but whatever decision is made at least the law should be predictable within a given society otherwise industry cannot make long-\term policy to pursue research and bring new products to market. Public opinion is heated as seen in the December 1999 World Trade Organization meeting in Seattle, where protestors against global free trade and economic paradigms gathered. We can expect further questioning of the economic imperative as the prime motivator for social systems, and a debate between the United Nations and the WTO could be expected, despite the recent avoidance of discussion of the morality of patents in the United Nations agencies. This is ethically justified, as every society should seek deeper ethical goals of beneficence, justice and rights beyond economic development itself.

Bibliography

Bruce D. M. and Bruce A. (1998). Engineering Genesis, 337 pp., London, UK: Earthscan Publications. [Comprehensive review of the ethical and social issues of genetic engineering including discussion of patenting.].

Danish Council Of Ethics. (1994). Patenting Human Genes, 43 pp. Copenhagen, Denmark:. The Danish Council Of Ethics. [Example of arguments against patenting of human genes from a European country.].

Bartha Maria Knoppers, Ruth F. Chadwick, Hikaru Takebe, Kare Berg, Jose Maria Cantu, Abdallah S. Daar, Eve-Marie Engels, Michael Kirby, Darryl R.J. Macer, Thomas H. Murray, Renzong Qiu, Ishwar C. Verma, Dorothy C. Wertz (2000) "HUGO urges genetic benefit sharing", Community Genetics 3: 88-92.

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Macer D. R. J. (1991). Whose Genome Project? Bioethics 5(2), pp. 183-\211. [Concludes that the genome project is the joint work of scientists around the world through the 20th century and that human rights make it the property of all.].

Macer D. R. J. (1994). Bioethics for the People by the People, 454 pp. Christchurch, New Zealand: Eubios Ethics Institute. [Results of the International Bioethics Survey conducted in 1993 in ten countries in Asia-\Pacific region, http://eubios.info/BFP.html.].

Macer, D. R. J. Bioethics is Love of Life, 162 pp. Christchurch, New Zealand: Eubios Ethics Institute. [Outlines theories of bioethics and proposes universal bioethics theory, http://www.biol. tsukuba.ac.jp/~macer/bll.html].

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UNESCO International Symposium (2001): Ethics, Intellectual Property and Genomics; Intellectual property in the field of the human genome: preliminary analysis of available documents concerning intellectual property in the field of the human genome [http://nesdoc.unesco.org/images/0012/001219/121903e.pdf]

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Biographical Sketch

Darryl Macer was Foreign Professor (1990-\1995), and Associate Professor (1995-\Current) in the Institute of Biological Sciences, University of Tsukuba, Ibaraki 305-\5872, Japan. He was born 1962 in New Zealand, graduated from Lincoln College, University of Canterbury in biochemistry in 1983, and completed a Ph.D. in molecular biology at the University of Cambridge in 1987. Since then he teaches and researches bioethics. He is director of the Eubios Ethics Institute, based in New Zealand and Japan, which includes an international network on bioethics and genetics <http://eubios.info/index.html>. He was a founding member of the UNESCO International Committee on Bioethics (1993-\1998), and is a member of the HUGO Committee on Ethics, and a Board member of the International Association of Bioethics, and the International Association of Law, Ethics and Science. He has published more than 10 books and 100 papers on bioethics.


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