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Abstract This paper discusses the issues of inventions and morality with a specific focus on biotechnology.

It reviews intellectual property protection, and discusses the ethical arguments related to patenting in biotechnology research. The paper 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 are discussed in a global framework. The history of patenting is presenting, 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 be served beyond economic development itself.

BIOTECHNOLOGY, PATENTS, AND BIOETHICS

1. Introduction ...............................................................................................................................................2 2. Intellectual Property Protection ..............................................................................................................2 3. Ethical and Moral Issues...........................................................................................................................5 4. Moral Arguments Supporting Patenting...............................................................................................7 5. Ethical Arguments against Patenting.....................................................................................................9 6. Rewarding Historical Innovation ......................................................................................................... 11 7. Morality Exclusion of Patents............................................................................................................... 13 8. Conclusions and Predictions................................................................................................................. 16 Bibliography................................................................................................................................................. 19

BIOTECHNOLOGY, PATENTS, AND BIOETHICS Darryl R. J. Macer and Makina Kato Institute of Biological Sciences, University of Tsukuba 1. Introduction The scientific field and in particular biotechnology is dominated by commercial research and industry. Most multinational pharmaceutical companies have more research scientists than the whole continent of Africa, and in the genomics age we have seen an announcement of completion of genomic sequencing by private companies. 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 can start by asking rather simple questions, is 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 by the incentive system of patents than we would by not having patents? We will also consider whether 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 to share the same goals as that of ethics, namely can we expect ideal ethical laws or some compromise? 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 research results may not be published at all if a company does not think it can keep the benefits from the research costs invested to itself. A patent, on the other hand, guaranties the publication of research results and the deposit of the product in a central

repository, for use in the future development of research to create better inventions. Intellectual property rights (IPRs) are the rights given to persons over the creations of their minds (WTO homepage). They legally protect the results of human intellectual activity, such as technological methods and literary expressions, mainly by giving some form of exclusive control over the use of an idea. Although there are various ways to categorize intellectual property rights, roughly they consist of 1) industrial property (inventions, trademarks, and designs) rights, 2) copyright and 3) other rights, such as rights concerning trade secrets (protected by laws concerned with fair competition), semiconductor circuits, and new plant or animal varieties. Intellectual property moves across boundaries and its international protection is said to be necessary for technological and cultural exchanges, and for promotion of trade. There have been international attempts to harmonize the system. In 1883, the Paris Convention for Protection of Industrial Property (Paris Convention) was established, and in 1886, the Berne Convention for the Protection of Literary and Artistic Works was signed. The Paris Convention adopted assimilation with nationals, enabling the people of member nations to apply for patents in other member nations as well. This convention stipulated the principle of the mutual independence of patents (patent is valid only in the nation where it is issued, and is independent like currency) and the principle of priority (if one applies in another country, based on the first application, in a certain term, one can avoid inconveniences occurring in the term between two applications). Currently, one of the specialized agencies of the United Nations, the World Intellectual Property Organization (WIPO), which came into force in 1970, administers these conventions and promotes the worldwide protection of intellectual property rights. It has various kinds of committees to discuss the problems and one of the expert committees has examined the Treaty Supplementing the Paris Convention for the Protection of Industrial Property as far as Patents Are Concerned, the so-called Patent Harmonization Treaty, although this new treaty has not been implemented.

Taking into account the importance of intellectual property rights in trade, the World Trade Organization (WTO) has been dealing with the various related problems, such as harmonization of rules between developing and developed countries. By April 1998, 132 countries had signed the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement, discussed under the General Agreement on Tariffs and Trade (GATT) and the WTO. As far as biotechnology is concerned, intellectual property rights are covered by laws of patent, plant variety, trade secrets, and fair competition. IPRs regarding biotechnology have been discussed at various international forums including WIPO, WTO and UPOV, as well as at each national patent office. The question of patenting of genetic material continues to be a contentious issue, despite the global agreement with article 4 of the Universal Declaration on the Human Genome and Human Rights, passed by UNESCO General Conference in 1997, and adopted by the UN General Assembly in 1998, which states "The human genome in its natural state shall not give rise to financial gain." The continuing contention is because there are numerous interpretations of what natural state means, given that in regard to biotechnology what is being patented is not a chemical substance but the information included in the sequence of the substance. Nelkin and Andrews (1998) asked, like many, what are the limits to commercialization of the human body, and wonder if we should change the species name to Homo economicus? 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 impacts because a few companies are dominating genomic sequencing. One company, Celera (and former TIGR, both based in Maryland, USA) sequenced half of the first two dozen complete genomes to be sequenced. This is not restricted to 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 "Oncomouse" was patented in 1988 in the USA. It was U.S. Patent number 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, "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." The activated oncogene means that it is more easy to be mutated so that the animal is more susceptible to cancer-causing chemicals, so it can be useful for carcinogenicity testing. During 1987 the US Patent and Trademark Office made the following announcement: "The Patent and Trademark Office now considers non-naturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter ...". 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 U.S. 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 then this is 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 the ethical principles of justice, and nonmaleficence. Even more complex is deciding just who are the actors involved in the equation. Some key ethical issues in patenting in scientific research include: Is the principle of beneficence, or loving good, served more by having research than by not having research? Do we encourage more research into more beneficial areas of science by the incentive system of patents than we would by not having patents? Is justice served by systems of intellectual property protection? How can we justly reward all the inventors in the often long process of developing a useful product? Should we only reward the final step, and how to value farmers innovations in the development of plant and animal varieties? How to value indigenous knowledge, and to share the benefits with the communities whose ideas gave raise to pursuit of a new product, for example with medicinal plants? What are the tolerable limits of doing harm by research subject, e.g. animals including humans? What are the tolerable limits of doing harm by rigid enforcement of patents if price becomes a barrier to use of a product by persons in need? 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 to share the same goals as that of ethics, namely can we expect ideal ethical laws or some compromise? 4. Moral Arguments Supporting Patenting In this section we will explore some of the arguments that go beyond beneficence. The debate over patenting has been intense and it remains unsettled. The debate will most likely 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 need to encourage an inventive society so that we can progress knowledge 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 this is, instead, the product of social demand. The encouragement of inventiveness, through patenting, means that it promises useful consequences (e.g. new products/research). To develop new tools is a good for society, although not all new products are necessarily good. However, if people and society are really given a choice on which products to use this means that what is good for society is determined by commercial factors. This concept is questionable because the ideal of free market choice is too simple to explain the real world. Support for patents is often put in the context of protecting the national economy. The perception is that if one countries support patents, then another country needs to also if its biotechnology industry is to be able to compete in a global market. The morality of exclusion in patent laws will be discussed below. There is a balance between an ideal of sharing all knowledge, versus the harsh reality of countries engaging in tough international competition created by a modern free market system. 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. 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 the knowledge would also be available with a small delay. The 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 of the 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 so that the SNP maps would be 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 they can before the SNPs 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 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 is the common morality of Western society where individual work is rewarded.

5. Ethical Arguments against Patenting Despite the above arguments for patenting, this issue remains contentious and the fact that different countries have conflicting policies 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 three of this paper. 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 (CBD) made local living organisms the intellectual property of states, there was the concept that living organisms are the common heritage of humankind, so they should not be exploited. Opponents of patenting claim it promotes inappropriate human control over information that is common heritage. 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 avoiding the consequences of the system. There have been some controversies regarding the commercial monopoly held by the company 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 demonstrating that it was active against AIDS. There are other examples where the commercial monopolies obtained can 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. In fact a number of these above issues may not be directly affected by permitting patents, as the issues like the distribution of wealth and international competitiveness exist independent 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 chemical pesticide industry or expensive pharmaceutical alternatives to existing medicines. We can also consider the amount of money 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. 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 of 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 uncharacterized land, the name of mappers is rather suitable for this analogy. Some critics of ownership could go as 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 "genomic imperialist". The DNA is not random, it is merely unknown. This is an important difference, in addition to 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 have more claims to that title than the sequencers, in addition they can be called the owners (only in this general way the human sequencers are shared owners because they also possess DNA).

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6. 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 the research supported in North America, Japan and Europe, when compared to other regions of the world. However, before accepting the results in terms of a measure of Nobel Prizes, or patent applications, we should consider how products of traditional agriculture and medicine have been applied to provide the introductions 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 much greater than the contributions of patented medicines and technologies. 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 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 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 common understanding of the truth and workings of life, has shifted to a commercialized paradigm. The 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

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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 breeders rights, and control access to genetic resources. This recognizes that indigenous knowledge may not be restricted to modern national boundaries, and 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). 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 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, however the Human Genome Organization (HUGO) Ethics Committee released guidelines in April 2000. They suggested that a 1% charitable donation be made by all companies that use genetic material extracted from humans. The general benefits of new research and medicines should be available to all, but 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

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good public relations, and tax incentives, in the absence of enforceable rights by those who donate material or knowledge. The negative impact of product substitution is another issue that relates to 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 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 upon, as production systems vary in their use of artificial chemical and organic pesticides. 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 a 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 inventions. Denmark has an exclusion in its national law to the 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 the implementation of the idea that no application against common morality should be supported. The basic three criteria are: Novelty: An invention must have some novel or new characteristic that is not known as so-called prior art. So an invention cannot be patented if it is already

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available to the public before the date on which the application for a patent is filed. As to the standard of novelty, there is a difference over the term concerned with publicity and application, the so-called "grace period", especially between U.S. and other countries. Non-obviousness: An invention must involve an inventive step. This step must not be obvious to others with good knowledge and experience of the subject of the invention, namely, to ordinarily skilled researchers in the relevant technical field. Utility: An invention must be of practical use and capable of industrial/useful application, though patent holder may merely hold it or exercise it. A specific use must be identified for chemical compositions. Drugs should be demonstrably effective. The 1623 Statute of Monopolies (UK), expressly limits the scope of patentable subject matter. Patents may be granted if they are not contrary to the law nor mischievious to the state or generally inconvenient. This is considered the first statutory immorality clause. In the UK Patent Office manual (1907) there was a refusal to grant patents for contraceptives and sexual aids. The exclusion on moral grounds clause in the European Patent Convention is article 53: Art 53(a) Patents shall not be granted for 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. 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 abhorrent 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. 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 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

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conducted in 1993 in ten countries in 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 "public interest", "social need", and "public utility", societies can confiscate property. An issue which is important for agriculture is the concept of farmers 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 1998 European Commission Directive on Patenting of Biotechnology Inventions. In the late 1990s there was much debate over the use of so-called terminator 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 on the prospects of this technique being used to prevent farmers growing their own seeds. In late 1999 the company Monsanto announced it would not use the technology, after much debate. There is 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

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autonomy of the occupation of farming, and justice to be able to grow your own food. However, we can think of 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. 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. Biotechnology companies must consider the novel aspects of any new technology or process they use, beyond simply human health concerns. The first is the impact on the environment. Now every industrial sector tackles with the environmental problem. In fact, the application of biotechnology to clean polluted environments such as bioremediation is one emerging area. This is beyond the development of cleaner procedures and products. Since biotechnology companies use technology with living organisms, they need to especially take account of biosafety, biodiversity and the complexities of intricately tuned ecosystems. The second is the impact on society. Biotechnology is often said to be a technology that may alter peoples view of life. Biotechnology companies must face the issues concerned with human rights immediately in their operations and bioethical procedure are inevitable, such as keeping customers privacy and informed consent. It is necessary for them to consider the values and concerns of users and community, and to convey the right information through labeling, education etc.

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The third one is economic impact. New alternative products can substitute for old, and newer methods to produce refined products can reduce the need to import the raw materials. As artificial sweeteners caused damage to the sugar industry in tropical countries, this is collapsing some industry in developing countries. Thus, epoch-making technology may cause direct and indirect influences on regional and international economy, which may differ depending on the country. One big multinational company can change the structure of agricultural trading. Sharing benefit from biotechnology is another issue, if we think its resources as common property. The progress of modern biotechnology has raised a variety of bioethical issues. As seen in medical ethics, where doctors and patients need to be on similar levels and let patients express the results of their decision making while facing new medical care, companies ,as producers, and consumers, need to both participate in making decisions. We should not merely criticize companies profit making, since we use their products or services and the ethical principle of beneficence supports our community including companies if they do no do harm. However, we cannot overlook the influence of commercial biotechnology upon global economics and trade, and we must not sit complacently ignoring our part in choosing the goals of global society with growing economic disparity. In conclusion we should 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 Parliaments 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 CBD, 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

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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 brig 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.

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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, 43pp. Copenhagen, Denmark. The Danish Council Of Ethics. [Example of arguments against patenting of human genes from a European country]. Lesser W. (1991). Equitable Patent Protection in the Developing World: Issues and Approaches, 148 pp. Christchurch, New Zealand: Eubios Ethics Institute. [Examines the possibilities for intellectual property rights protection in the developing countries]. Macer D.R.J. (1991) Whose Genome Project? Bioethics 5(2), 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 AsiaPacific region, http://www.biol.tsukuba.ac.jp/~macer/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 u n i v e r s a l b i o e t h i c s t h e o r y , http://www.biol.tsukuba.ac.jp/~macer/bll.html]. Macer, D.R.J. Inventions, patents and morality. Encyclopedia of Life Sciences (UNESCO 2001). Marques M.B. (1993). Patenting life: Foundations of Brazil-United States Controversy, 104 pp. Rio de Janeiro, Brazil: Oswaldo Cruz Foundation. [Discusses the differences in views of patents between North and South]. Nelkin D. and Andrews L. (1998). Homo economicus: The commercialization of body tissue in the age of biotechnology. Hastings Center Report 28(5), 30-39. [Discusses how far human beings should commercialize their bodies]. Rawls J. (1971). A Theory of Justice, 607 pp. 8th Impression, Oxford, U.K.: Oxford University Press. [Basic universal theory of justice]. Sieghart P. (1985). The Lawful Rights of Mankind, 252 pp. Oxford, UK: Oxford University Press. [Reference work on the Universal Declaration on Human Rights and subsequent Conventions]. Thambisetty S.R. (2000). Morality as a ground for patent exclusion. Eubios Journal of Asian and International Bioethics 10, In Press. [Reviews history and grounds used as moral exclusions in patent law].

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U.S. Congress Office of Technology Assessment (1989). New Developments in Biotechnology, 4: Patenting Life, 200 pp. Washington, USA: U.S.G.P.O. [Review of the ethical, legal, and social issues of intellectual property protection on living organisms, especially in USA]. Wartburg W.P. von & Liew J. (1999) Gene technology and social acceptance, 338 pp. Washington D.C., USA: University Press of America. [Looks at social acceptance of biotechnology, especially in Europe, with discussion of arguments over patenting].

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