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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 theethical arguments related to patenting in biotechnology research. The paper
reviews the criteria used for intellectual property protection, and how this hasbeen applied to inventions and discoveries made in biology and biotechnology.
The ethical arguments for and against patenting are reviewed, emphasizingwhether 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 apatent is against public order. European patent law has treated living organismsdifferently to inorganic matter, and despite recent directives that allowedpatenting 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 itshould continue so that deeper ethical goals of beneficence, justice and rights
should be served beyond economic development itself.
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BIOTECHNOLOGY, PATENTS, AND BIOETHICS
1. Introduction ...............................................................................................................................................2
2. Intellectual Property Protection ..............................................................................................................23. Ethical and Moral Issues...........................................................................................................................54. Moral Arguments Supporting Patenting...............................................................................................7
5. Ethical Arguments against Patenting.....................................................................................................9
6. Rewarding Historical Innovation ......................................................................................................... 117. Morality Exclusion of Patents............................................................................................................... 13
8. Conclusions and Predictions................................................................................................................. 16Bibliography ................................................................................................................................................. 19
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BIOTECHNOLOGY, PATENTS, AND BIOETHICS
Darryl R. J. Macer and Makina KatoInstitute of Biological Sciences, University of Tsukuba
1. IntroductionThe scientific field and in particular biotechnology is dominated by commercialresearch 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 byprivate 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 whichdecided that publicly funded science should be commercialized, and during the
1980s intellectual property rights were decentralized from government toresearch institutions to create commercial incentives. This trend has becomeworld-wide.
Ethically we can start by asking rather simple questions, is the principle ofbeneficence, 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 havingpatents? 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, aproduct 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 ofethics, 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 notbe 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 thepublication of research results and the deposit of the product in a central
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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 ofhuman intellectual activity, such as technological methods and literaryexpressions, 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, anddesigns) rights, 2) copyright and 3) other rights, such as rights concerning tradesecrets (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 theProtection of Literary and Artistic Works was signed. The Paris Conventionadopted 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 thenation where it is issued, and is independent like currency) and the principle ofpriority (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 WorldIntellectual 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 theproblems and one of the expert committees has examined the TreatySupplementing 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.
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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 developedcountries. By April 1998, 132 countries had signed the Trade Related Aspects of
Intellectual Property Rights (TRIPs) agreement, discussed under the GeneralAgreement 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 regardingbiotechnology have been discussed at various international forums includingWIPO, WTO and UPOV, as well as at each national patent office.
The question of patenting of genetic material continues to be a contentiousissue, despite the global agreement with article 4 of the Universal Declaration
on the Human Genome and Human Rights, passed by UNESCO GeneralConference 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 interpretationsof what natural state means, given that in regard to biotechnology what isbeing 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 shouldchange 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 inventionprinciple, and has broad socio-economic impacts because a few companies are
dominating genomic sequencing. One company, Celera (and former TIGR, bothbased 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 asimilar way to how US genomics companies have applied for patents on manygenes.
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
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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 ofwhose germ cells and somatic cells contain a recombinant activated oncogenesequence 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 itcan be useful for carcinogenicity testing. During 1987 the US Patent andTrademark Office made the following announcement: "The Patent and
Trademark Office now considers non-naturally occurring non-human multi-
cellular 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 anoyster in 1987 in the U.S. Genetic information can also be used to cure adisease, 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 inmodern 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 amoral society.
The principle benefit claimed for patents is that rewarding an inventor creates apositive environment for progress of research that leads to the betterment ofsociety. If this is true then this is consistent with the ethical principle of
beneficence. History suggests that the financial interest in a free market createsmore funding for research, and faster overall progress in research in importantareas has been the result of the intense research efforts. This point has been
used by industry to oppose moves to block patents on biotechnologicalinventions that arise from other ethical concerns.
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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 losersin trade. We have to consider the ethical principles of justice, and non-
maleficence. Even more complex is deciding just who are the actors involved inthe 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 beyondbeneficence. The debate over patenting has been intense and it remains
unsettled. The debate will most likely continue even though public policy hasdemanded that legal measures be adopted to guide the application of patentlaw to biotechnology.
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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 weneed to encourage an inventive society so that we can progress knowledge into
the future. Rewarding inventions means some members of society can devotetheir time and energy to creativity. The commercial use of inventions is notdependent upon the patent itself this is, instead, the product of social demand.
The encouragement of inventiveness, through patenting, means that it promisesuseful consequences (e.g. new products/research). To develop new tools is agood 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. Thisconcept 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 aglobal 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 amodern free market system. It is almost impossible for any country to stand onits 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 ifpatenting 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. Ifa company believes it can keep an invention secret for more than twenty yearsthen 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
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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 thegovernment 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 privatecompanies do the research, which would create more total biomedical researchknowledge, 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 sequenceseveral 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 aconsortium 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 mapswould be public domain. The motive is commercial, because having the SNPmap 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 theSNPs 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 isconsistent with the working philosophy of individualistic modern society wherepeople 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.
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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 isclosely related to the commercialization of biotechnology, but some sort of
information protection is accepted as an incentive to invest in research ofbenefit to society. The arguments against patenting include a variety ofarguments 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 tradedanimals and medicine has traded medicines, for millennia.
Until the Convention on Biological Diversity (CBD) made local living organismsthe intellectual property of states, there was the concept that living organismsare 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 includeincreased costs to consumers, and payment of royalties for succeedinggenerations. 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 thecommercial monopoly held by the company that was able to patent AZT, theinitial 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 keyroles that government funded research played in developing AZT and
demonstrating that it was active against AIDS. There are other examples wherethe commercial monopolies obtained can not be said to be in the best publicgood, 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 toconsider the broad social consequences.
In fact a number of these above issues may not be directly affected bypermitting patents, as the issues like the distribution of wealth and international
competitiveness exist independent of the patent debate. A general criticism of
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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 humansociety. The assumption that wealthier societies protect the environment more
than poorer ones is flawed, especially when we see the rising consumptionpatterns 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 mostefficient 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 indeveloped countries spend on luxury products, such as cosmetics, that may be
considered a waste of research investment in terms of distributive justice, whencompared to life threatening diseases.
Is the sequencing of DNA really an invention? The DNA could be viewed as arandom sequence of bases, and the author is the sequencer, but this is not whatwe 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 tothe property no matter how it was developed by the colonizers. The sequencersof 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 far as to call those who seek to profit andto control the decisions concerning the human genome project without general
consultation, a type of "genomic imperialist". The DNA is not random, it ismerely 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 ofinformation 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 inmedicine. We can think of the research supported in North America, Japan and
Europe, when compared to other regions of the world. However, beforeaccepting the results in terms of a measure of Nobel Prizes, or patentapplications, we should consider how products of traditional agriculture andmedicine 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 plantswhich are freely accessible is much greater than the contributions of patentedmedicines and technologies.
Using a more positive argument, the knowledge gained should be considered asthe common property of humanity. There is an existing legal concept that things
that are of international interest of such a scale, should become the culturalproperty of all humanity. It can be argued that the genome, being common toall 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 fromthe shared ownership are that the utilization must be peaceful, access should beequally 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 knowledgethey had with each other to develop the common understanding of the truth
and workings of life, has shifted to a commercialized paradigm. The CBD thatresulted from the Earth Summit held in Rio de Janeiro in 1992 gave eachcountry the right to commercial exploitation of the indigenous genetic materialof their country. It is applied to material collected after that date, so that
materials previously collected and distributed, for example in botanic gardens inother countries, or seed banks, are exempt. Before this time, the ethicalargument was that all species were the common heritage of humankind,
however, this had led to exploitation of indigenous knowledge by researchers inrich 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 medicinalcompounds in Costa Rican rain forest in exchange for financial assistance toprotect 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 torecognize plant breeders rights, and control access to genetic resources. Thisrecognizes 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 individualfrom a community wants to share the knowledge with outside parties, whereas
other members do not. Individuals also differ on how much benefit sharing theydemand, 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? Thereare several active NGOs that publicize these cases, including the GeneticResources Action International (GRAIN) and the Rural Advancement Foundation
International (RAFI).
There have been procedures adopted for benefit sharing to providers of plantand 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 theCBD. 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 ofit, 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. Thegeneral benefits of new research and medicines should be available to all, butthe 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 patentsystem really benefits the world. Product substitution has led to nationaleconomies 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 theneed 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 diverseoverall impacts on ecosystem and farmer health. The environmental ethicsmovement, 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 biotechnologyinventions. 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 patentlaw of 1970 excluded biological products and processes, for example. Thisexclusion is based on ethical arguments, and also the implementation of the
idea that no application against common morality should be supported. Thebasic three criteria are:
Novelty: An invention must have some novel or new characteristic that is notknown 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 mustnot be obvious to others with good knowledge and experience of the subject ofthe 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 usemust 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 onmoral 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 providedthat the exploitation shall not be deemed to be so contrary merely because it isprohibited by law or regulation in some or all of the contracting states.
The patent examiner can use a variety of arguments to determine opposition topatents, and appeal courts have used other ones. They may include cost benefit
analysis, balancing of interests and if something is considered abhorrent itmay 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 ingeneral 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 notabsolutely protected in any society because of the principle of justice, for thesake 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 ofanimals, 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 tobuy 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 buytheir seed every year rather than mixing seeds themselves on the farm. Ingeneral 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 terminatortechnology, 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 publicopposition on the prospects of this technique being used to prevent farmersgrowing 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 producingpharmaceuticals 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 genealteration making the organism sterile could spread to other varieties, whichcould 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 useof transgenic organisms with these genetic alterations.
8. Conclusions and Predictions
Ethically, we can apply the principle of love or beneficence. Does allowingpatenting 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. Atthe same time, love says that no one should be stripped of the respect thatothers 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 environmentalproblem. In fact, the application of biotechnology to clean polluted environmentssuch as bioremediation is one emerging area. This is beyond the development of
cleaner procedures and products. Since biotechnology companies use technologywith 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 technologythat may alter peoples view of life. Biotechnology companies must face the
issues concerned with human rights immediately in their operations and bioethicalprocedure 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 indirectinfluences on regional and international economy, which may differ dependingon 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 facingnew 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 cannotoverlook 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 discusswhether the Council of Europe should develop a further Bioethics Convention to
meet the challenges that ethical patenting faces from biotechnology. Despitethe 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 alsodepend 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 humancuriosity 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 andeconomic paradigms gathered. We can expect further questioning of theeconomic 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 Nationsagencies. This is ethically justified, as every society should seek deeper ethicalgoals of beneficence, justice and rights beyond economic development itself.
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Bibliography
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