Biotecnologia, Patentes y Bioetica

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

Lesser W. (1991). Equitable Patent Protection in the Developing World: Issuesand Approaches, 148 pp. Christchurch, New Zealand: Eubios EthicsInstitute. [Examines the possibilities for intellectual property rightsprotection 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 aroundthe world through the 20 th century and that human rights make it theproperty of all].

Macer D.R.J. (1994) Bioethics for the People by the People, 454 pp.Christchurch, New Zealand: Eubios Ethics Institute. [Results of theInternational Bioethics Survey conducted in 1993 in ten countries in Asia-Pacific 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 StatesControversy, 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 ofbody 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].

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Thambisetty S.R. (2000). Morality as a ground for patent exclusion. Eubios

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U.S. Congress Office of Technology Assessment (1989). New Developments inBiotechnology, 4: Patenting Life, 200 pp. Washington, USA: U.S.G.P.O.[Review of the ethical, legal, and social issues of intellectual propertyprotection on living organisms, especially in USA].

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