Current Issues in Biotechnology, Bioethics and Intellectual Property Law

The Science of Biotechnology and Genetics

Agriculture Concerns

Biosafety and Environmental Concerns

Animal Rights

Ethics of Human Cloning, Reproduction and Stem Cell Research

Copyrights and Patents of Indigenous Cultures' Artifacts and Native Knowledge

Data Privacy of Citizens' Health and Genetic Medical Histories

Conflicts with Foreign Government Over Intellectual Property Rights

Patentability of Human Gene Sequences Under American Law

Bio-Terrorism

First, The Science - What is Biotechnology and Genetics?

Genetic Engineering is the heritable, directed alteration of an organism. A heritable alteration is a change that can be carried from one generation to the next. Genetic engineering is performed by modifying an organism's own DNA or introducing new DNA to perform desired functions.

Biotechnology is a broader term than genetic engineering and includes non-genetic techniques to modify organisms. Genetic engineering is the most powerful and least understood tool for biotechnology. Many of the same principles used in genetic engineering are involved in biotechnology.

Genetic Engineering involves DNA modifications.

DNA is the genetic material in all known forms of life. DNA contains genes (just as a recipe book contains recipes) that give us many of our physical characteristics. However, we are not simply gene-based machines - the environment we are in also determines our traits. One of the challenges of genetic engineering is to determine how genes influence our traits and how to modify DNA to alter these traits. Genes affecting disorders such as alcoholism provide only a predisposition. Having the gene for alcoholism may make one more prone to alcoholism but does not guarantee that one will become alcoholic, nor does not having the gene mean one is immune.

An important distinction in genetic engineering is between germline and non-germline cells. In most organisms, there are cells set aside just for reproduction. These are the eggs and sperm in humans. Non-germline cells are all the other cells in the body - muscle cells, skin cells, liver, etc. If a genetic modification does not alter germline cells, it should not have any effect on the genetic makeup of future generations (there are some possible exceptions to this). Thus, if one were to introduce the gene for purple hair into mouse hair cells, the offspring would not have purple hair, but the parent would. If the gene for purple hair were introduced into the parental germline cells, then the children could carry the purple hair gene.

This is complicated in plants because while many plants have germline cells, they can also be propagated asexually by taking cuttings. Additionally, it is possible to clone animals from single cells. Thus it is possible to clone a mouse from even non-germline cells. So even though introducing the purple hair gene into hair cells isn't a strictly heritable alteration, it is still possible to grow a whole mouse from a single hair cell (note: a hair cell, not a strand of hair).

Non-germline alterations are not carried to the next generation. Only half of our genes are given to our offspring, diluting any germline genetic modifications over time. DNA carries the instructions as genes, proteins perform the actions. Regulation is as important as gene function. Foreign DNA may be rejected.

While the human genome project may give us the entire sequence of our DNA, scientists must still determine how all the encoded proteins work.

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Agriculture Concerns

ISSUES: Is the modification of seeds, plants and animals making up the foods we eat causing these foods to be unsafe? Will the selling and use of genetically-engineered seeds, plants and animals cause food production costs to increase to the point where small farmers are forced out of the market? Will the use of genetically-engineered seeds turn farmers into economic dependencies on seed companies? Are the regulations of the United Stated Department of Agriculture and Food and Drug Administration sufficient to keep people from contamination? Why are Europeans, Asians and Canadians refusing to eat these foods? 

DISCUSSION: The production of transgenic animals and transgenic plants seem to have much to offer to the productivity and quality of farm products. However, small family farmers fear that allowing patents on transgenic animals will push them out of the market. Because generally altered animals, plants and seeds may be more expensive, small farmers fear that small number of large corporations will corner the market on genetically engineered animals, etc., and thereby deprive the small family farms of their livelihood. In addition, the small family farmers fear that the initial acquisition price of genetically altered plants, seeds and animals as well as subsequent royalties will increase rather than decrease the costs for farmers and consumers. On the other hand, transgenic farm capital assets could be stronger and more disease resistant and might balance the cost of the initial investment. 

Another concern of the American farming community is the intense resistance to "altered" (artificially-engineered) food and animal products by European and Asian consumers. This resistance has forced European and Canadian governments to ban foods having any transgenic components. Since transgenic seeds have been known to "jump" from a transgenically-planted field to a non-transgenic planted field, farmers can not ensure that the food they harvest will pass European food inspectors.   Recently, millions of dollars in lost harvests hurt farmers who had planted corn using the "StarLink" Monsanto seed. This transgenic seed jumped to other plantings of corn; thereby rendering them unacceptable for export or for use as the ingredients in other food products. In addition, some farmers did not realize the need to separate corn planted with the "StarLink" seed from non-altered corn. This resulted in all of their harvests being banned by food millers who could not afford to mix transgenic corn with unaltered corn.

A related issue concerns the level of review of transgenic food products by the federal Food and Drug Agency and the United States Department of Agriculture. Until recently, the USDA was under a mandate to assume that genetically-altered foods were safe unless proven to be otherwise. The Clinton Administration changed the operating assumption to be that these foods were not safe unless proven to be so.

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Biosafety and Environmental Concerns

ISSUES: What harm if any is caused to the rivers, lakes, land and forests by the release of genetically-engineered organisms?  Are sufficient regulatory controls in place to ensure that our environment is safe? What do you think the answers are?

DISCUSSION: Some environmental groups are concerned with what effect the release of transgenic organisms would have on the environment. The National Wildlife Foundation opposes patenting for transgenic animals because of the lack of legislation in the area concerning their release into the wild. The National Wildlife Foundation fears that allowing patents will cause a greater number of transgenic animals to be created, thus increasing the risk to the environment. 

There is little experience with environmental introductions of GMOs on which to base an assessment of their potential risks and benefits to biodiversity. For example, in Canada, there is growing information from small-scale field studies with genetically modified crop plants, but comparable information for microorganisms and animals is lacking. GMOs could pose risks to biodiversity if novel traits enabled the organisms to become more invasive of natural habitats. GMOs could also pose risks through gene transfer to other organisms, such that a novel gene could persist in the environment even after the GMO is no longer present. The introduction of GMOs could also provide benefits for biodiversity. Genetically modified microorganisms could be used to treat industrial wastewater and air emissions and to degrade toxic chemicals at contaminated waste sites, restoring habitat for other species. At this point, however, many of these risks and benefits to biodiversity remain uncertain, and yet a wide variety of GMOs is expected to enter the Canadian marketplace in the coming years.

Some environmentalists in the United States also speculate that such a release might be possibly harmful to human and environmental health. (See The Evaluation of Federal Programs in Agriculture Research, Education and Extension: Hearings Before the Subcomm. on Resource Conservation, Research, and Forestry of the House Comm. on Agric., 104th Cong. 250 (1996)). The uncertain nature of the environmental effects is certainly a plausible argument for regulating the release of transgenic animals into the wild. Should the Environmental Protection Agency have stricter regulatory review of release of GMOs into the environment?

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Animal Rights Concerns

ISSUES: Is it reasonable to inject genes of other species or genes containing human viruses into animals in order to more efficiently learn how diseases work and, ultimately, how to cure them?  Or, is this just another way that humans justify cruelty to other species? These are concerns about which some people think we should change.

DISCUSSION: It is customary in all Western societies to breed animals in order to study the effects of human illnesses on them in order to prevent or cure these illnesses. It is unpleasant to consider the experimental conditions that these animals must endure. Now, with the ability of science to place disease-carrying genes within an animal's genetic code, a sharp increase in the number of disease-carrying animals exists. The "engineered" animals are bred to suffer from diseases such as AIDS, sickle cell anemia, cystic fibrosis, and cancer. Some members of the public argue that it is inhumane and unethical to raise animals that will suffer as a result of genetic tampering.

On the other hand, it is quite possible that transgenic animals will actually limit the amount of animal suffering endured by research subjects and animals in general. For instance, using transgenic animals requires the use of fewer animals because the animals are created for the particular study purpose and are more responsive to the experimentation. However, there is no denying that some animals do suffer with transgenic research. Perhaps Congress should regulate the types of research performed. Legislation already exists that limits animal research and transgenic research is not among the varieties limited. 

In addition, the goal of producing transgenics in agriculture is to create healthier animals and food products. Therefore, transgenic animals that do not improve market value and provide healthy foods will not be produced.

Some opponents of transgenic engineering belief that the sanctity of life is not well served by allowing the creation of transgenic animals. The argument then suggests that patenting animal life exacerbates that problem because it increases the economic value of the patented animal. It is true that patent law reflects what activities a society believes should be encouraged. However, the responsibility for making this decision seems to rest with the American public and Congress, not with the Patent Office.

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Ethics of Human Cloning, Reproduction and Stem Cell Research

ISSUES: Should testing and research be done on fetal tissue in order to learn how to repair and heal human disease?  Is it moral/ethical to abort "extra" or "dying" fetuses and then use their tissue to study genetics?  Should the government fund research that may enable us to clone babies and solve infertility in a world where there are already too many people to feed? If the government doesn't fund the research and chooses not to prohibit it elsewhere, will cloning and artificial reproduction cause a de-valuing of people in general? These are some of the current issues in reproductive law involving genetics.

DISCUSSION: On October 3, 1995, President Clinton established the National Bioethics Advisory Commission (Exec. Order 12,975, 3 C.F.R. 409(1996)). (See http://bioethics.gov/general.html)  One requirement of the Commission is to review the appropriateness and implications of human gene patenting. On December 19, 2000, the Commission submitted a draft of its findings for public comment. The draft, entitled Ethical and Policy Issues In Research Involving Human Participants, contains the following conclusions and recommendations:

I. The Commission concludes that at this time it is morally unacceptable for anyone in the public or private sector, whether in a research or clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning. The Commission reached a consensus on this point because current scientific information indicates that this technique is not safe to use in humans at this point. Indeed, the Commission believes it would violate important ethical obligations were clinicians or researchers to attempt to create a child using these particular technologies, which are likely to involve unacceptable risks to the fetus and/or potential child. Moreover, in addition to safety concerns, many other serious ethical concerns have been identified, which require much more widespread and careful public deliberation before this technology may be used.

The Commission, therefore, recommends the following for immediate action:

• A continuation of the current moratorium on the use of federal funding in support of any attempt to create a child by somatic cell nuclear transfer.
• An immediate request to all firms, clinicians, investigators, and professional societies in the private and non-federally funded sectors to comply voluntarily with the intent of the federal moratorium. Professional and scientific societies should make clear that any attempt to create a child by somatic cell nuclear transfer and implantation into a woman's body would at this time be an irresponsible, unethical, and unprofessional act.

II. The Commission further recommends that:

• Federal legislation should be enacted to prohibit anyone from attempting, whether in a research or clinical setting, to create a child through somatic cell nuclear transfer cloning. It is critical, however, that such legislation include a sunset clause to ensure that Congress will review the issue after a specified time period (three to five years) in order to decide whether the prohibition continues to be needed. If state legislation is enacted, it should also contain such a sunset provision. Any such legislation or associated regulation also ought to require that at some point prior to the expiration of the sunset period, an appropriate oversight body will evaluate and report on the current status of somatic cell nuclear transfer technology and on the ethical and social issues that its potential use to create human beings would raise in light of public understandings at that time.

III. The Commission also concludes that:

• Any regulatory or legislative actions undertaken to effect the foregoing prohibition on creating a child by somatic cell nuclear transfer should be carefully written so as not to interfere with other important areas of scientific research. In particular, no new regulations are required regarding the cloning of human DNA sequences and cell lines, since neither activity raises the scientific and ethical issues that arise from the attempt to create children through somatic cell nuclear transfer, and these fields of research have already provided important scientific and biomedical advances. Likewise, research on cloning animals by somatic cell nuclear transfer does not raise the issues implicated in attempting to use this technique for human cloning, and its continuation should only be subject to existing regulations regarding the humane use of animals and review by institution-based animal protection committees.
• If a legislative ban is not enacted, or if a legislative ban is ever lifted, clinical use of somatic cell nuclear transfer techniques to create a child should be preceded by research trials that are governed by the twin protections of independent review and informed consent, consistent with existing norms of human subjects protection.
• The United States Government should cooperate with other nations and international organizations to enforce any common aspects of their respective policies on the cloning of human beings.

IV. The Commission also concludes that different ethical and religious perspectives and traditions are divided on many of the important moral issues that surround any attempt to create a child using somatic cell nuclear transfer techniques. Therefore, the Commission recommends that:

• The federal government, and all interested and concerned parties, encourage widespread and continuing deliberation on these issues in order to further our understanding of the ethical and social implications of this technology and to enable society to produce appropriate long-term policies regarding this technology should the time come when present concerns about safety have been addressed.

V. Finally, because scientific knowledge is essential for all citizens to participate in a full and informed fashion in the governance of our complex society, the Commission recommends that:

• Federal departments and agencies concerned with science should cooperate in seeking out and supporting opportunities to provide information and education to the public in the area of genetics, and on other developments in the biomedical sciences, especially where these affect important cultural practices, values, and beliefs.

Note:

The Commission also observes that the use of any other technique to create a child genetically identical to an existing (or previously existing) individual would raise many, if not all, of the same non-safety-related ethical concerns raised by the creation of a child by somatic cell nuclear transfer.

But efforts to clone human beings continue by private agencies and physicians. (See Richard Seed: People in Biotechnology News). For example, in October of 2000, leaders of a Canadian group said that for a six-figure fee they will help infertile or homosexual couples have cloned children. The group is led by a former race-car driver called Rael who claims knowledge of extraterrestrials. Surprisingly, the group has (acc. to the Washington Post) connected with a wealth American couple willing to finance the cloning of their l-month-old daughter who died in a medial accident.

In January 2001, another human cloning project was announced when two fertility experts said that they have lined up 10 infertile patients who want to be cloned. An international team of scientists will plan the project with the goal of producing a baby within two years, said the project's leaders, Italian doctor Severino Antinori and Panos Savos. (from Minneapolis Star Tribune, Feb. 18,2001).

NIH Proposes New Rules Governing Human Gene Transfer Studies

The NIH published a proposed notice changing the NIH guidelines for research involving recombinant DNA molecules in regards to the reporting and analysis of serious adverse events in human gene transfer studies in the Federal Register on December 12, 2000.

The proposed changes involve four main issues: 

• The scope and timing of serious adverse event reporting
• Public access to information about serious adverse events
• Protection of individually identifiable patient information as it relates to serious adverse event reporting
• A new mechanism for the review and assessment of data on serious adverse events and other relevant safety information.

(S.2015 Stem Cell Research Act of 2000 (Introduced in the Senate)) is one part of the federal government's efforts to amend a 1995 congressional ban on embryo research, which specifies that federal taxpayer money cannot be spent on biomedical research involving embryos outside the womb. Last December, the National Institutes of Health issued preliminary guidelines that would allow government-funded researchers to use stem cells from already destroyed embryos.If passed, S 2015 would allow researchers to use and destroy embryos under specific circumstances. 

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Copyrights and Patents of Indigenous Cultures' Artifacts and Native Knowledge

ISSUES: The United States Department of Agriculture and the National Institutes of Health list over 200 different plants found on American Objiway land that contain medicinal or food properties?  Should the Objiway Indians receive royalties for these plants or should the "inventor" (who discovered the genetic code, filed the applications and paid for the legal work)  receive royalties for the plants?   What about the fabric designer who developed textile fabrics based on Australian aboriginal designs found in a book?  The Western concept of "inventor" and "invented" is today being challenged by the United Nations and many tribal (non-governmental) groups who say that traditional information about their environment, their customs and their art are exploited by non-indigenous people while the tribes receive nothing in return.

DISCUSSION: Biotechnology has created the ability to realize create new wealth from the genetic code of plants, seeds, animals into the billions of dollars. However the search for these genes and the raw products they are contained in has caused a clash between peoples, countries and cultures on a scale never seen before. Instead of isolated contacts between tribes and Western biotech companies, today there are numerous forays into aboriginal and isolated tribal communities in search for the new genetic product. But many indigenous people have been poorly equipped to negotiate value for their knowledge and information.

For example, in Costa Rica, a nongovernmental organization named INBio, which maintains close links to the government, was given rights to commercialize biogenetic resources for Merck Pharmaceuticals. The agreement entitled them to collect samples on national lands, including those of eight indigenous peoples. No one ever consulted with any of the tribes about the collections, and none of the tribes was named as a beneficiary in the original agreement between Merck and INBio, which was signed in 1991.

Biodiversity prospectors assume that organisms and ecosystems are wild and therefore part of the public domain. Thus, even when indigenous peoples provide leads or processed materials, the company takes credit for the legally protectable "discovery." But the circumstances surrounding some of these discoveries raise doubts about the equity of this position.

The discoveries made from human blood samples provide a compelling example. The Human Genome Organization (HUGO), founded in 1988, and one of its subsidiary projects, the Human Genome Diversity Project, coordinates the collection of blood samples from isolated communities threatened with extinction. The goal of this ongoing blood collection project is to reveal evolutionary links and identify genetic sequences for gene therapies to improve human health. This effort, dubbed the "human vampire project" by indigenous peoples, has discredited much scientific research. Collections were made without the prior informed consent of the sampled groups, and the data and blood cells were made available for commercial exploitation after they were collected.

To date, at least three patent applications have been made for cell lines developed from this blood. The U.S. Department of Commerce holds the patent on one of these applications. The patent lists as inventors the government scientists involved in the project and the anthropologist who introduced the research team to the Papua New Guinea tribe from whom the blood was collected. To date, the government of Papua New Guinea has not lodged an official protest about this situation, and it is unlikely that it will ever do so. Is this a flaw in the intellectual property rights' laws?

While intellectual property rights laws are understood and accepted in most Western European nations, they remain an inappropriate mechanism for securing indigenous peoples' rights for a number of reasons.

First among these is the fact that the law is designed to protect information resulting from a specific individual act of discovery. However, indigenous knowledge is transgenerational and communally shared. It may come from ancestor spirits, vision quests, or lineage groups that transmit it orally but not necessarily from a specific individual act of discovery.

Once knowledge is in the public domain, it becomes impossible to establish the quality of uniqueness required for a patent application. Moreover, because of the difficulties involved in documenting inventions and identifying individual inventors, patents are ultimately of little use to most indigenous peoples. Even if they could satisfy the technical requirements, the costs of filing, maintaining, monitoring, legally implementing, and enforcing patents would be prohibitive. The same difficulties arise when indigenous peoples attempt to qualify for plant breeders' rights.

In 1961, the International Convention for the Protection of New Varieties of Plants created plant breeders' rights to protect the economic interests of plant breeders, people who breed, discover, or develop crop varieties. To be eligible for protection under the convention's 1991 revised guidelines, a plant variety must be "distinct, stable, uniform, and novel." A distinct variety is "distinguishable by one or more characteristics from any other variety whose existence is a matter of common knowledge." To qualify as stable, a variety must "remain true to its description after repeated reproduction or propagation."

A uniform variety remains "homogenous with regard to the particular feature of its sexual reproduction or vegetative propagation," while a novel variety must not have been offered for sale or marketed, with the agreement of the breeder or his successor in title, in the country of petition, or for longer than four years in any other country.

While indigenous farmers can in principle meet these requirements, they would have to invest in considerable laboratory research, necessitating both time and money. Even then, the protection afforded them by going through such a process is limited at best: The convention only has force in its 20 member countries.

The laws governing trade secrets and know-how (information that may give a person or a company a competitive advantage yet fail to fulfill the criteria of patentability) could potentially have greater applicability to indigenous peoples' situation. But they too entail specialized legal advice and corresponding expenses. To claim protection for a trade secret, for instance, an effort must be made to prevent its disclosure. Agreements to respect the confidential nature of the information (such as strictly enforced access restrictions) would have to be made between indigenous peoples and others.

Relatively speaking, appellation of origin and trademarks are the most accessible IPR mechanisms at indigenous peoples' disposal, and they can be effectively applied to products coming from indigenous lands or produced under indigenous auspices or licensing agreements. For instance, certifications of authentic indigenous art could be issued and medicinal plants and products could be affixed with a label indicating where they were produced. This would make it impossible for someone to claim to be using a genuine indigenous product if it were not affixed with the official (legally recognized) stamp.

Copyright is also easily obtained and can help protect written texts, works of art, and databases. But as with all the other IPR law mechanisms, enforcement and monitoring can be difficult, time-consuming, and costly. Nevertheless, some countries are attempting to put copyright-like mechanisms in place. Local communities that are compiling their own community inventories of indigenous knowledge are being offered a choice about whether to publish the information.

Publishing puts the inventory (referred to as a registry when it is compiled for the purposes of legal protection) into the public domain. Some people argue that information in the public domain should not be patentable. Thus they feel that publishing can help impede patent applications. This defensive publication strategy is risky, however. The problem is that biodiversity prospectors find leads to useful products or to sources of new products in publications. While the material (the inventory or the registry) that provides the lead to the original product or compound may not be patentable, the product or compound itself is, particularly since most patents are actually on processes of extraction, purification, or synthesis. In this way, publication may actually facilitate commercial exploitation of knowledge and resources.

Take, for example, the case of tiki uba, an anticoagulant used by the Amazonian Urueu-Wau-Wau tribe that was described in a well-known magazine. Based on the published information, Merck Pharmaceuticals "discovered" that the plant extract was indeed effective and might be useful in heart surgery.

Merck were ahead and began trying in 1988 to develop a new pharmaceutical product based on this compound without any consideration for the Urueu-Wau-Wau, who were by then threatened with extinction. To date, Merck has not announced what progress (if any) it has made. The pitfalls of expense and expertise aside, the ultimate flaw in IPR law is that it grants exclusive rights to "natural" and "juridical" persons or "creative individuals," not to collective entities such as indigenous peoples. In other words, contemporary intellectual property law is constructed around the notion of the author as an individual solitary and original creator, and it is for this figure that its protections are reserved. Those who do not fit this model - custodians of tribal culture and medical knowledge, collectives practicing traditional artistic and musical forms, or peasant cultivators of valuable seed varieties, for example - are denied intellectual property protection.

But for Indigenous peoples, knowledge and determination of the use of resources are collective and inter-generational. No Indigenous population, whether of individuals or communities, nor the government, can sell or transfer ownership of resources which are the property of the people and which each generation has an obligation to safeguard for the next. Given the divergence between indigenous peoples' views of intellectual property rights and the law itself, how can the inequities of situations like INBio's collection on indigenous lands be resolved? As the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) sees it, indigenous peoples need "a system of protection and recognition of our resources and knowledge which is in conformity with our world view and contains formulas that will prevent appropriation of our resources and knowledge." This alternative system, based on rights and not economics, is known as traditional resource rights.

Traditional Resource Rights: Traditional resource rights (TRR) reflect the awareness that maintaining control over knowledge and traditional resources (including tangible and intangible cultural, scientific, and intellectual resources) is a central part of indigenous peoples' struggle for self-determination. A statement on intellectual property rights and biodiversity issued by COICA and the United Nations Development Programme (UNDP) in 1994 embodies this stance. It states that all aspects of the issue of intellectual property (determination of access to natural resources, control of the knowledge or cultural heritage of peoples, control of the use of their resources and regulation of the terms of exploitation) are aspects of self-determination. For Indigenous peoples, accordingly, the ultimate decisionon this issue is dependent on self-determination.

TRR amasses bundles of rights that are already widely recognized. These include basic human rights to development, environmental integrity, religious freedom, land and territory, privacy, prior informed consent, and full disclosure as well as farmers' rights, intellectual property rights, neighboring rights (which are similar to performance rights wherein the performance of something is protected and not the thing itself), cultural property rights, cultural heritage recognition, and the rights of customary law and practice.

These rights are found in a variety of legally binding and non-legally binding agreements Because they exist on such different political footings, however, these rights are still inadequate and need to be unified.

Contracts are legal agreements consisting of negotiated promises. Drawing them up requires only limited legal assistance, and indigenous peoples can find them useful for ensuring that any transfer of knowledge and resources is fairly compensated. Contracts typically provide the following benefits: up-front payments, training, technology transfer, royalties, and other financial and nonmonetary forms of benefit sharing.

Covenants establish principles that can lead to legally binding agreements, but they also contain ethical and moral commitments that go beyond mere commercial agreements. The Global Coalition for Bio-Cultural Diversity developed a model Covenant on Intellectual Cultural and Scientific Property that has been used to ensure equitable relationships between the Body Shop, International (a cosmetics corporation) and various indigenous groups. This covenant includes provisions for immediate benefits, including a trust fund for legal assistance, consultation, negotiation, and possible litigation, and an independent monitor to effect a yearly socioenvironmental audit of the agreement. Provisions for compensation and profit sharing in the case of commercialized products are also included.

Benefits may be in the form of up-front benefits, a trust fund, or future royalties. In exchange, MTAs usually grant the recipient of the material the right to apply for patents if the material turns out to have commercial potential. The patent holder is then free to commercialize a product based on the material.

Information transfer agreements (ITAs) are adaptations of material transfer agreements. They are negotiated between indigenous groups and outside organizations interested in using traditional ecological knowledge in a commercial way. Because biogenetic resources are often modified by human action, these agreements recognize the traditional processes, medicinal formulas and other mixtures, and conservation practices that afford the germplasm improvements. Copatenting agreements be-between researchers and indigenous communities would be extensions of ITAs.

In India, local communities have developed community registers documenting all the known plant and animal species in an area and the details of their use as a means of securing control over their traditional ecological knowledge. Members of the community can exercise practical control by unilaterally refusing access to the register or by setting conditions under which access is allowed. (Patent No. 5401504, USPTO, August 13, 1997) (withdrawal of patent for the use of turmeric powder as a wound healing agent on the grounds that the use of turmeric was known in India for centuries)

From a legal standpoint, community registers serve as evidence of local people's intimate knowledge of their environment and thus support their claims to legal title of the land and territory. Ultimately, these community registers could become part of regional and national registers provided the local communities agree.

Other indigenous peoples have taken a slightly different approach to documentation. For instance, the Canadian Inuit of Nunavik and another Canadian people, the Dene, have established electronic databases. Other communities, including the Kuna of Panama and the Inuit Tapirisat of Canada, are instead trying to control the research conducted with their information.

The Kuna and Inuit Tapirisat insist that only community-controlled research be carried out within their territories. This strategy allows them to decide what the research objectives and methodologies will be. The Proyecto de Estudio para el Manejo de Areas Silvestres de Kuna Yala and the Asociacion de Empleados Kunas of Panama put together an information manual outlining the principles of scientific monitoring and cooperation they wish researchers to uphold. The guidelines summarize the Kuna's objectives with regard to forest management, the conservation of biological and cultural wealth, scientific collaboration, and research priorities. The tribe encourages collaboration with Western scientists for basic ecological research, botanical and faunal inventories, and the study and recording of Kuna traditions and culture. All such research is, of course, designed to provide the Kuna with information useful to them that remains under their control.

The CBD  (See The Convention on Biological Diversity) and related UNCED agreements call for access to, protection of, and benefit sharing from the use and wider application of traditional technologies. However, neither a general consensus about what to enforce nor any enforcement mechanisms are close to appearing on the international scene. The fundamental question of what should be legally required versus what should be moral and ethical responsibilities portends many difficulties for all stakeholders. There are, however, efforts underway to grapple with this and other pressing questions. At a workshop held at the Green College Centre for Environmental Policy and Understanding at Oxford University in June 1995, participants from around the world drafted several findings and formulated a number of recommendations. Those recommendations included (among others) a call for NGOs and governmental organizations to follow the principles already established in legal documents dealing with indigenous rights and to disseminate and integrate these principles into their guidelines for policy and operations.

The participants recommended that a consortium of institutions be formed to establish codes of conduct, identify gaps between policies and practices and correct the deficiencies, and make sure that scientists, government officials, and NGOs are properly informed of indigenous peoples' rights and views. To address concerns about biosafety, they suggested that local communities be included in monitoring and evaluating genetically modified organisms; that institutions exercise the precautionary principle; and that the creation of life patent-free zones be investigated. In addition to fostering the development of traditional resource rights, stakeholders were encouraged to explore other legal systems and other ways of protecting intellectual and cultural resources, including customary practice. Until adequate and effective mechanisms for protection and compensation have been established, participants suggested that a moratorium on biodiversity prospecting be observed.

Some governments have recognized these new kinds of rights based on the concept of traditional resource rights. In 1997, the government of Brazil established the Brazilian Programme of Molecular Ecology for Sustainable Use of Biodiversity (PROBEM). It is aimed at making the Amazon region a source of high value-added products and advanced scientific know-how, especially through the use of biotechnology.

The need to conserve natural wealth and develop eco-tourism was late in gaining recognition in Brazil. Its Amazon region is home to as many as half of all the world's insect species and over one- fifth of plant species. This programme is aimed at changing the current model of economic growth in the region, which is based on the extraction of wood and minerals, ranching and one-crop farming - activities that destroy the forests.

In addition, indigenous people and other long-time residents of the region will also benefit through remuneration for their contributions to the development of new products, such as their traditional knowledge of the medicinal properties, food value and cosmetic and aromatic uses of native plant or animal species. The knowledge held by forest-dwellers helps local and foreign investigators reach their discoveries much earlier.  

PROBEM: Was endowed with a financial mechanism enabling its implementation: a fund for financing biotechnology projects and for paying royalties to local residents. The organization was inspired in the Permanent Alaska Fund created by the United States in 1977 for the payment of royalties from oil in exchange for environmental conservation and the payment of indemnification and dividends to Eskimos/Innuit. That successful experiment had already accumulated 27 billion dollars by 1998.

Any companies or institutions interested in developing products based on substances found in the Amazon will have to associate themselves with Bioamazonia, a mixed organization set up by the Brazilian government in conjunction with the scientific community and representatives of civil society to administer PROBEM. Bioamazonia has been equipped with the Amazonian Biotechnology Centre, as well as a financial instrument, the Permanent Fund for the Conservation and Sustainable Use of the Biodiversity in Amazonia (FPBA).

To set up the FPBA fund, Bioamazonia turned to the Axial bank, a unique financial institution specializing in investments in the environment, especially biodiversity. The Axial bank obtained one million dollars in aid from the United Nations conference on Trade and Development and the Inter-American Development Bank to get the FPBA off the ground.

Companies interested in biological material and data obtained by Bioamazonia will pay a fee that will go into the fund. As in prospecting for oil, companies doing research on biological substances found in the region will be subject to bidding and paying for concessions and to paying royalties from the products developed  and marketed, he added.

PROBEM: Still requires the passage of a law regulating access to Brazil's genetic resources in order for it to control genetic and biological material from the Amazon. Given that legal vacuum, the UN Convention on Biological Diversity, which makes authorization by the State in question necessary for the removal of any genetic material, applies. Without government authorization, the removal of any biological substances by foreigners is illegal,  the Environment Minister pointed out. The key to a successful program is removing activities damaging to the environment, conserving biological diversity, all the while converting the natural wealth of the Amazon into business profits. 

(For more specific information regarding India, see "Bio-Piracy, Environment and Culture" by Dr. Jayapaul Azairah)

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Data Privacy of Citizens' Health and Genetic Medical Histories 

ISSUES: Insurance Companies closely measure risk factors in order to earn profits from employers' health insurance programs. Therefore, it is not fair for employers and their health insurers to demand access to predictive genetic tests for employees from their doctor? Scientists and medical researchers predict that such genetic tests will be available no later than one decade from now. Use of such tests could result in certain people being refused jobs based on their tendency to inherit disease or refusal of health insurance coverage. The Americans With Disabilities Act prohibit employers from asking or seeing such information before hiring. However, no legislation currently prohibits such information subsequent to the hire.

What about the state and federal government?  Do they have a right to inspect your health and genetic records as part of a review for state-paid health insurance, welfare benefits, imprisonment, etc?  If so, is it likely that non-government parties can receive the same information under a Freedom of Information Act?

DISCUSSION: Each time a patient sees a doctor, is admitted to a hospital, goes to a pharmacist or sends a claim to a health plan, a record is made of their confidential health information. For many years, the confidentiality of those records was maintained by our family doctors, who kept our records sealed away in file cabinets and refused to reveal them to anyone else. Today, the use and disclosure of this information is protected by a patchwork of state laws, leaving large gaps in the protection of patients' privacy and confidentiality. There is a pressing need for national standards to control the flow of sensitive patient information and to establish real penalties for the misuse or disclosure of this information.

President Clinton and Congress recognized the need for national patient record privacy standards in 1996 when they enacted the Health Insurance Portability and Accountability Act of 1996 (HIPAA). That law gave Congress until August 21, 1999, to pass comprehensive health privacy legislation. After three years of discussion in Congress without passage of such a law, HIPAA provided HHS with the authority to craft such privacy protections by regulation. Thee President drafted regulations to guarantee patients new rights and protections against the misuse or disclosure of their health records and the President and Secretary Donna E. Shalala released them in October of last year. 

This final rule provides the first comprehensive federal protection for the privacy of health information. However, because of the limitations of the HIPAA statute, these protections do not fully achieve the Clinton Administration's goal of a seamless system of privacy protection for all health information. Members of both parties in Congress will need to pass meaningful, comprehensive privacy protection for American patients that would extend the reach of the standards being finalized today to all entities that hold personal health information.

Covered Entities

As required by HIPAA, the final regulation covers health plans, health care clearinghouses, and those health care providers who conduct certain financial and administrative transactions (e.g., electronic billing and funds transfers) electronically.

Information Protected

All medical records and other individually identifiable health information held or disclosed by a covered entity in any form, whether communicated electronically, on paper, or orally, is covered by the final regulation.

New Requirements

The new standards would require that health-care providers obtain written consent form patients for the use or disclosure of information in their medical records. The new regulations will also:

• Allow all Americans to review and copy their medical records, and change them if they find errors.
• Require health-care providers to state their privacy policies in writing. Patients will also have to consent to any disclosure of information related to treatment, payment and health-care operations.
• Allow patients to request that their health-care information not be disclosed. Doctors may choose to override the request if they have compelling reasons.
• Prevent employers from receiving medical information that could be used in employment decisions.

New Legislation

Congress is also readying more legislation to help protect Americans' privacy with regard to medical genetic information. In February 2001, Congressmen Louise Slaughter (D-NY) and Senator Tom Daschle (D-So.Dak.) introduced a bill that would bar health insurers from using predictive genetic information to deny, cancel or change the rates and conditions of insurance coverage. Employers would be prohibited from using the information in hiring, firing, promoting, and other employment-related decisions. The bill had 171 cosponsors. 

On Feb. 17, 2001, Slaughter addressed scientists at the conference of the American Association for the Advancement of Science. She said, "The science is not fully understood," and conclusions that insurers or employers could draw at this point would be "so inaccurate as to be almost useless."  For example, when a genetic mutation underlying breast cancer was discovered, scientists initially claimed that women who carried the mutation faced a 80 percent risk of getting the cancer. but within two years, the risk was lowered to 50 percent.

Slaughter also stressed that genetic discrimination shouldn't be allowed to happen because everyone has genetic defects of one kind or another and people with genes increasing the risk for a certain disease don't always get the disease.

Within 10 years, doctors will be equipped with genetic tests that can predict a patient's risk for at least a dozen major diseases, including heart disorders, diabetes and some cancers, said Dr. Francis Collins, director of the National Center for Human Genome Research.

J. Craig Venter, president of Maryland-based Celera Genomics, called genetic discrimination one of the "key issues" raised by the genome project. but efforts to pass a genetic privacy bill have failed five times, he said. "We hope we will have a much better outcome this time."

The bill is opposed by groups representing several different industries. The Health Insurance Association of America argues taht insurers are not using genetic test results in coverage decisions and therefore the legislation isn't needed. "There is no discrimination by health insurers and no plans for it." said the association's spokesman.

The pharmaceutical industry also has weighed in against the bill, said Slaughter, because of provisions that would keep genetic information about individuals private and therefore off limits to companies that want it for research or marketing reasons.

Lawsuit Files to Protect workers' Genetic Information 

In late February 2001, a lawsuit was filed by a group of employees of the Burlington Railroad objecting to their privacy and worker's compensation rights that they say were violated by the company's demand for genetic screening tests. Several employees had filed health insurance and worker's compensation benefit requests based on disability caused by carpal tunnel syndrome. As part of the worker compensation benefit process, theinsurance company doctor requested extra vials of blood be drawn from each worker. The purpose of the blood was to run a test for "genetic screening" to see if the workers had a genetic propensity for carpal tunnel syndrome. The employees objected to this procedure and filed a lawsuit. The railroad agreed in court not to run the test. Outcome of the lawsuit is still pending.

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Conflicts with Foreign governments over Intellectual Property Rights

ISSUES: Should the United States change its patent and copyright laws in accordance with other countries?  Should the United States' government require pharmaceutical companies receiving government research money or government inventions to lower the cost of drugs in areas of the world suffering from health epidemics?  Must United States' citizens bear the cost for drug companies providing needed drugs at a lower price for other people?  Should the United States quit trying to impose its economic priorities on other countries? Are patents issued in the country so broad as to hamper future medical research?  These are the current issues in intellectual property law.

DISCUSSION: Many countries realize that their intellectual property rights' laws can be used to reflect their particular cultural values and maximize the economic value of the products of that country. The United States, in the last 15 years, has pushed other regimes to harmonize their IPR (intellectual property rights) with those of the United States - or at least, with the Berne and Paris Conventions. In the context of rapidly changing technologies, international markets, and inadequate international regimes (WIPO, WTO, TRIPS, GATT), national policymakers try to decide how to adjust domestic and international policies in a manner that appropriately accommodates the new technologies at home and encourages similar accommodation abroad, preferably without undermining the otherwise useful international IPR regimes.

A coercive approach to international IPR reform can undermine foreign support for the particular policy goals and perhaps damage the prospects for international cooperation in other areas. The international patent and copyright regimes may move slowly, but they do provide a sure and predictable method of coordinating domestic and foreign IPR rules, which facilitates investment in information-intensive technologies (such as biotechnology). In addition, the international agreements help to disseminate new technology globally by reducing the transaction costs of obtaining and enforcing exclusive rights in different countries. Bilateral understandings, on the other hand, may introduce policy inconsistencies, interpretive difficulties for domestic businesses, increase administrative complexity, and raise the transaction costs of obtaining IPR abroad. If the United States circumvents the IPR regimes of other countries, it could lose it ability to influence how other nations and the international regimes accommodate the new technologies and protect U.S. intellectual property products in general.

The serious economic consequences of IPR reform have increased major cleavages in the world economy, cleavages that set rich countries against poor as well as rich countries against each other. Many countries do not even share the basic definitional underpinnings of western IPR concepts. For example, copying in traditional Korean society is an expression of honor, to an infringement of an inherent ownership right. Other countries object to U.S.-style IPR protection on economic grounds. Brazil has long denied IPR protection for U.S. pharmaceutical products on the dual grounds that doing so would lock Brazil into technological dependency and would create an enormous public health problem by  making much needed pharmaceutical products prohibitively expensive.

The most cooperative strategy is to facilitate other country's harmonization process through international conferences, cross-national policy reform discussions, and so forth--as has primarily been the case with regard to biotechnology patent rules. Coercive tactics are somewhat broader in range--the United States can encourage foreign adherence to regime rules through "carrot and stick" tactics such as the reciprocity provocation of the Semi Conductor Protection Act, or it can use even more forceful tactics such as the threat of trade retaliation (as has been the case in software).

Although most of the advanced industrial states have PR regimes with similar normative underpinnings, there are nonetheless substantial conflicts between them over the proper scope and terms of IPR protection. For example, members of the European Patent Office (EPO) only recently (9/99) agreed to allow the patenting of human cells as well as transgenic plants and animals. Compare this with the decision by the USPTO to allow the patenting of transgenic animals and life forms since Diamond v. Chakrabarty in 1980. 

Biotechnology is an industry that commands higher and higher R&D outlays at the same time that relatively inexpensive copying technologies are available. Because biotechnology is so complex and unusual, and because the industry that deploys them is largely international in scope, the politics of adjusting domestic IPR rules invariably coexists with political pressure for foreign IPR reform. This duality suggests that external IPR negotiations are influenced by international competitive pressures as well as by domestic political bargaining concerning the creation and regulation of biotechnology products and processes. 

In terms of market structure, the biotechnology industry is relatively new and based on rapidly changing, information-intensive technology. In addition, the market for biotechnology is global in the sense that products are developed, produced and sold on an international scale. However, neither condition is uniform. Technology varies in terms of its level of development and markets vary in terms of the product cycle. Because of this variability, IPR reform should vary across different technological and market circumstances. In a new market involving developing technologies (like biotechnology) IPR reform has more long-term implications for economic competitiveness. IPR reforms primarily affect the potential for developing new products and markets. Consequently, IPR reform does not provoke immediate trade conflicts.

IPR policy in Biotechnology reflects the industry's relatively low level of commercialization and generally cooperative intra-industry relations. although biotechnology is highly international in terms of R&D and marketing requirements, it is still a developing technology and consequently confers a relatively low degree of trade leverage. Because international markets are underdeveloped and expanding, IPR disputes have not provoked trade tensions except in the secondary markets of pharmaceutical sales. In drug sales, countries having lower economic standards of living are pressured to either allow for sales of "generic" copies that replace the more expensive foreign (mostly U.S.) patented drugs or negotiate (either singly or through an international organization) for markedly lower prices from the drug companies for these much needed drugs.

Biotechnology is characterized by a symbiotic and generally cooperative relationship between small, highly innovative R&D firms and large multinational enterprises, both of which stand of gain from stronger patent protection for biotechnology products. Their ability to pursue IPR reform has been aided by the lack of a contrary industry coalition, either from the biotechnology field or form unrelated holders of industrial patent rights. The primary resistance to increased IPR protection for biotechnology products has come from consumer advocates and some public sector agencies who are wary of both the ethical implications of patenting life and the uncertain health and safety ;implications of new biotechnology. In addition, although the Human Genome Project (to identify all the genetic composition of  the human body) has been funded and undertaken as an international research project by various governments, several well-financed private commercial companies have competed to identify and patent gene sequences. Public concern with potential restriction to these gene forms and their potential for medicines has caused several well-known biotechnology researchers to speak out against patenting of these markers. (See Varmus, Collins) 

Another concern of public policy is whether patents granted to biotechnology companies cover too broad a subject area and ultimately stifle further research instead of providing motivation in pursuing research. Broad patents may also reinforce social protests against the patenting of life forms. For example, In 1992 a patent was granted to the North American biotechnology company Agracetus on all genetically engineered cotton plants. Two years later, the same company obtained a similar patent on all transgenic soya bean plants in Europe. At least five other companies have obtained similar broad patents on plant species, among them Coffea arabica, the most important commercial coffee species, and the entire Brassica family. In January 1995, Mycogen Corporation, California, obtained a patent on a method to design synthetic genes probably covering all plants containing these genes. And in March 1995, also in the USA, a patent was issued to the National Institutes of Health on all ex vivo gene therapies.

There is an advantage of some broad patents. One example is Bell laboratories' patent on the transistor. The holders of such patents have a good prospect of royalty income and a strategic position in negotiations with other firms. However, for most firms, such an early position in a technology cannot be realized. Instead, they rely on alternative methods. One such method is to claim an invention in an early phase, too early to indicate the precise function of what has been invented. This process was followed by he US national Institutes of Health when the organization filed for r a patent on several thousands of partial human DNA sequences it had identified. This patent would ensure NIH a strategic position at the time a commercial product would come out of their work.

A second option for pursuing a strategic position in he biotechnology research is broadening the scope of the patent. This can be achieved by claiming an area in which the invention can be applied on the basis of limited exemplification. In this case the inventor extrapolates the effect of his invention in the "model system" to a number of other organisms without providing proof for that. For example, in 1988, Harvard University claimed that their invention on transgenic mice would work with every other non-human mammal, even though the working examples included only mice.

In the case of Agracetus and its modification of the genome of cotton and soya bean with Agrobacterium tumefaciens, it claimed patent coverage for all possible transgenic plants of these species, regardless of the techniques and genes used for the transformation. In contrast, patents in the chemical and pharmaceutical industry cover both the process and the product obtained by that process as described in a chemical formula (my emphasis). Agracetus's claims covered possible transformations of cotton and soya beans that had no connection with its techniques.

Research that is conducted with a non-commercial objective is usually not hampered by a patent even though formal authorization is required from the patent holder. But, every commercially-oriented type of research in a wide technological field will be effected. Researchers can be sued because they are using the same or similar process or transgenic. As an alternative, when researchers find out that a patent covers their research, they have to negotiate for a license with the patent holder in order to continue their work. The patent holder may grant non-exclusive licenses against conditions which are considered to be reasonably or the patentee may ask for payments that are too high for smaller companies. Agracetus reportedly asked $1 million dollars for a license. In addition, the patentee may restrict the exploitation by the licensee. 

These patent rights can extend far beyond the United and Europe. Argacetus filed for patents on transgenic cotton in the main other cotton producing countries, such as India, Brazil and China. In India, a broad cotton patent was initially granted in 1991, but subsequently revoked in October 1994 because the government decided that the objective of the patent was to deny opportunity to biotechnologists in India to develop pest-resistant cotton plants by recombinant DNA techniques. Most government retain the right to prevent patents from frustrating innovation if they determine that the patent grant would impair public safety, health, or "morals". However, governments are pressured not to invoke these sanctions unless absolutely necessary. (However, compulsory licensing and parallel imports are both being considered by the governments of poor nations in the grip of medical crisis' now.)

The attempt by the NIH to patent thousands of DNA fragments was eventually rejected by the United States Patent and Trademark Office. NIH did not appeal the decision and decided to abandon its policy to seek patent protection for DNA sequences. In early 2001, the USPTO adopted new guidelines for its patent claim examiners, requiring that specific use for transgenic materials be adequately shown in the patent application to satisfy the utility requirement of the Patent Act. (See United States Patent and Trademark Office Final Computer-Related Patent Examination Guidelines). Under the new guidelines expected to take effect in the next few months, gene fragments (ESTs) will probably not qualify for patents. However, fully characterized genes whose functions are known will continue to be patentable. This action will alleviate some of the concerns the American public as to the reach of genetic patents by forcing companies to narrow their scope of claims and to justify the public good of the patent grant.

(Thanks to Universiteit Van Amsterdam, Department of Political Science for some of this information)

For Information on Other Concerns Among Nations Due to Claims of Intellectual Property Rights, See Copyrights and Patents of Indigenous Cultures' Artifacts and Native Knowledge.

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Patentability of Human Gene Sequences Under American Law

Human gene sequences occur naturally. The current policy of the U.S. Patent Office is to treat human gene sequences like naturally occurring substances and chemicals. Naturally occurring substances and chemicals may be patented if they are extracted, isolated, and purified. However, the substances must have some greater value than previously existed in the naturally form. (Merck & Co. v. Olin Mathieson Chem. Corp., upholding a patent for a vitamin B concentrate which had been extracted from its natural form and purified and  Parke-Davis & Co. v. H.K. Mulford & Co., upholding a patent for adrenaline isolated from animal suprarenal glands).

Gene sequences contain a great deal of extraneous information because they are composed of sections which code for proteins as well as sections that do not. When scientists clone sequences hey isolate only the protein-coding portions, thus isolating and purifying the gene sequences. Is it appropriate that isolated and purified gene sequences be awarded patent protection in accordance with the novelty standard?

Patents have sometimes failed for lack of utility. It is generally known that gene sequences produce human protein but not what the actual function of the protein is . In these cases, the patent applicants try to show that the gene sequences function as different types of markers, probes and primers for various genetic research. If the applicants are capable of showing that their sequence can be used for one of these purposes, they will have satisfied the utility requirement under 35 U.S.C. Sec. 101.

However, the guidelines for refusing a patent for human gene sequences require the examiner to clearly assert why an innovation is rejected for lack of utility. (50 Pat. Trademark & Copyright J. (BNA) 195, 304-05 (July 20,1995) (holding that human testing of pharmaceuticals not necessary to satisfy the utility requirement). In January of 2001, the PTO published Final Guidelines for Determining Utility of Gene-Related Inventions.

The utility Guidelines are applicable to all areas of technology. However, they are particularly relevant in areas of emerging technologies, such as gene-related technologies, where uses for new materials that have not been fully characterized are not readily apparent. The guidelines were issued because of concerns by the scientific community that gene sequences were being patented without any express or specific use for them. Ultimately, that situation would result in patents on many gene sequences for which a medical or scientific use would be found later. This meant that companies could "stockpile" gene sequences and prevent important research from being undertaken by reason of their patent. This Guideline is expected to require more specifics on the projected use; i.e., a justification why the patent should be given to the applicant (what useful public policy reason does it fulfill).

In re Deuel,  the court relaxed the obvious standard by stating that general motivation to search for some gene that exists does not necessarily make obvious a specifically-defined gene that is subsequently obtained as a reuslt of that search. This case seems to allow  patents to be granted for DNA molecules even if the method for finding the DNA was obvious. But note that the  1995 amendment to 35 U.S. C. Sec. 103 seems to require that both the process and the molecule be nonobvious to satisfy the nonobviousness requirement.)

On October 3, 1995, President Clinton established the National Bioethics Advisory Commission (Exec. Order 12,975, 3 C.F.R. 409(1996)). One requirement of the Commission is to review the appropriateness and implications of human gene patenting. Some experts have suggested that the NBAC identify and separate categories of biotechnology research that are appropriate (from a social standpoint) for patents from those that are not. such categories could include transgenic research animals, transgenic farm animals, and human gene sequences with unknown utility. Isolating separate categories of biotechnology will allow more narrow categories than limiting the discussion to the issue of biotechnology patenting as a whole. The NBAC should present these categories to Congress for adoption under Title 35. Creating categories and offering suggestions as to the appropriateness of patent protection for each category would give the PTO some guidance so that the PTO may continue to decide "novelty" rather than "morality". There is some guidance existing in the Constitution, current precedent, and formerly proposed legislation to aid in the creation of such guidelines.

In August of 1999, the U.S. Patent and Trademark Office rejected an application for a broad patent on the creation of human-animal chimeras. The patent was rejected because a chimera "includes within its scope a human being" and "people are not patentable', according to the patent agency. Stuart Newman and Jeremy Rifkin plan to appeal the ruling to the U.S. Supreme Court if necessary.

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Bio-Terrorism

Definition: Biological and Chemical Warfare is a warfare that employs biological or chemical agents to intentionally inflict harm. Biological agents usually are dispersed by an aerosol spray that must be either inhaled or ingested. Biological agents usually have an incubation period of several days before any symptoms appear. Chemical agents are absorbed through the skin or by inhalation. Chemical agents typically cause immediate symptoms.

What type of biological agents are out there?

The Center for Disease Control has a section on infectious diseases with detailed information, including maps, images and fact sheets. Here's a basic rundown:

Anthrax: Anthrax is a bacteria. It has a spore form that makes it extremely resistant to the environment. It is highly infectious and lethal when inhaled. It is a one-time agent--it does not spread from person to person. An anthrax vaccine does exist, but is not readily available.

(Also: Read the Dept. of Defense's information on anthrax). Or, read a scientific presentation on anthrax (with pictures) from the U. of Wisconsin's Dept. of Bacteriology lecture.

Smallpox: Smallpox is a virus. It is highly contagious, transmits through the atmosphere very easily and has a high mortality rate. A worldwide vaccination program eliminated smallpox in the 1970s. Both the United States and the former Soviet Union officially maintained small quantities of the virus at two labs. However, there is the suspicion that it may have been or is still researched and developed at other labs either within Russia or in other countries, thus increasing the concern of smallpox being used as a biological weapon.

Plague: Plague is a bacteria that is highly contagious. It causes a type of pneumonia in a number of patients and can be fatal if not caught early. (see the CDC site above for more.)

Ebola: Ebola is a viral hemorrhagic fever caused by a virus. It is extremely lethal and its symptoms are profuse bleeding from the orifices. There is no cure or treatment.

Marburg: Marburg is another hemorrhagic fever caused by a virus. It is extremely lethal and its symptoms are profuse bleeding from the orifices. There is no cure or treatment.

Botulism: One of the deadliest toxins caused by a bacteria. It can be inhaled or ingested. Severe botulism causes respiratory failure and paralysis.

Tularemia: Tularemia is a bacteria. It causes non-lethal diseases that are extremely incapacitating such as weight loss, fever, headaches and often pneumonia.

What type of chemical agents are out there?

Chemical agents include nerve agents, toxins, mustard agents and others. Two well-known nerve agents are VX and sarin. Nerve agents affect the transmission of nerve impulses in the nervous system. Symptoms depend on the concentration of dosage and can range from mild poisoning to death. There are both preventive antidotes as well as antidotes that can work if given to the victim in time.

The Organization for the Prohibition of Chemical Weapons offers more information on nerve agents.

What countries have biological warfare programs?

According to the U.S. Department of Defense, more than ten countries have, or are developing biological warfare programs. According to the Office of Technology Assessment and U.S. Senate committee hearings, the number is about 17 and includes: Russia, Israel, Egypt, China, Iran, Iraq, Libya, Syria and North Korea.

What is the Biological Weapons Convention?

It is the 1972 multi-lateral treaty that bans offensive biological weapons. The goal of the treaty was total elimination of weapon systems; however, defensive work is allowed. By mid-1996, 137 countries had signed the treaty.

(In 1973, the Chemical Weapons Convention was drafted. As of early 1996, 160 countries had signed this treaty.)

What is the history of the United States' biological warfare program?

The United States' program began during World War II and the government developed and produced a number of biological weapons. The program culminated in a large series of successful aerosol tests in the Pacific Ocean in 1969. This all came to a halt at the end of 1969, when President Richard Nixon reviewed the program (which had not been reviewed in 15 years) and concluded the program was wrong for the United States. He not only terminated the program, but ordered the destruction of all weapons. Part of the reasoning was that the United States already had a nuclear deterrent; therefore, it wasn't necessary to develop biological weapons that would make it possible for other countries, including non-state entities, to develop them.

What does it take to make a bio-weapon?

If it is a bacteria, once there is access to the agent itself (seed stock), growing it is not that difficult. However, if it's a virus, growing it is harder and requires training. The hardest part is obtaining the seed stock and then once there is a large quantity of the agent, figuring out how to disseminate it as a stable aerosol that a human being will breathe in. The technological challenges of creating an aerosol of this kind are significant, but they're not so high that an individual or a small group of people couldn't do it.

What is the most scary incident to date of biological or chemical terrorism?

On March 20, 1995 the religious cult, Aum Shinrikyo (Supreme Truth) released sarin gas into the Tokyo subway system. Aum members had placed small containers in the trains filled with sarin gas that they then punctured during morning rush hour. Twelve people died and over 5,000 were injured. Due to the poor quality of the sarin gas and the inadequate delivery system, the casualty rate was low for a subway system that handles five million riders each day. Aum Shinrikyo was founded in 1987 by Shoko Asahara. The group had actively developed both biological and chemical weapons and are suspected of running smaller tests on the population before the subway attack.

How easy is it to transport biological weapons across the borders of countries?

Very easy. For example, a small amount of biological agent can be hidden in a pen and carried in a coat pocket.

What is the United States doing about this threat?

Although there is a tremendous amount of activity that is going on around the issue of bio-terrorism in the United States, some members of the medical and public health community are concerned about the lack of vaccines, antibiotics and local planning. Of particular concern is local planning, because it will be the local emergency rooms and doctor offices that will first deal with a biological attack and it could take days before any determination is made on what is actually happening. Many officials feel local emergency and health care workers are not prepared to handle such a disaster.

The U.S. has added funding to the Dept. of Defense's budget to deal with biological and chemical weapon threats--money for research and development of protective clothing for military personnel; providing instruction and training for local communities (about 120 cities are involved with training of their first responders to a biological or chemical attack); and developing biological identification detection units.

What does the United States need to do?

The U.S. needs to improve its ability to detect suspicious disease outbreaks and to identify those disease outbreaks as biological weapons attack. The emergency response personnel must have the training and equipment in order to mount a prompt and effective medical response.

The U.S. also needs to improve its ability to track down the perpetrators. This means increasing intelligence capabilities and doing a better job looking for the signatures of improvised weapons programs, and looking for people who are buying respirators, aerosolization equipment, low-scale fermenters or pathogenic agents.

The U.S. also needs to develop and produce medicines and vaccines to treat victims and/or potential victims.

Is there a danger in the fact that the number of biotechnology scientists in the world is increasing?

Some experts feel this is a factor in the growing concern about a bio-terrorist attack. Most of the materials and technologies used to make such weapons are readily available for commercial purposes around the world. It doesn't take a lot of money. However, it does take someone with knowledge to put these things together to make a potent weapon.

Are there any vaccines or antidotes that can be given to the American population?

No. For example, in the United States today, there is somewhere between seven and ten million doses of the smallpox vaccine. Some of it may be in a condition that is not effective. There is no capability in this country today to manufacture smallpox vaccine, because after the World Health Organization declared the disease eradicated in 1980, it was determined that it was no longer necessary to produce and administer the vaccine. Today, it would require an incredible effort to even hope that the U.S. could have enough vaccine in the next two to three years.

Terrorists would have little trouble getting their hands on the technology. Hearings in South Africa in June 2000 revealed that the apartheid government produced terrorist weapons containing anthrax, Salmonella and cholera. Soviet scientists who have prepared weapons-grade anthrax and smallpox are known to have emigrated, possibly to well-funded terrorist groups like the one run by Osama bin Laden in Afghanistan. Even small groups such as the Aum Shinrikyo sect in Japan have been able to cook up vats of Salmonella or botulin, the toxin that causes botulism.

With bioweapons so readily available, how can governments protect us from a terrorist armed with anthrax, smallpox or plague? In May, scientists, policy makers and security experts gathered in Stockholm to discuss how to limit the devastation of a biological attack on civilians. Until now, most biological defence strategies have been geared to protecting soldiers on the battlefield rather than ordinary people in cities. The situations are quite different, and novel technologies are needed for civilian defence.

Suppose a commuter stumbled across a time bomb filled with anthrax on an underground railway platform. Until this year, no police force in the world had any way to disarm such a device safely. One novel solution that attracted attention at Stockholm was a tent full of antiseptic foam. Researchers at Irvin Aerospace in Fort Erie, Ontario, have developed a dome-shaped tent made of ultratough Mylar that can be filled with a stiff foam--the exact composition of which is a closely guarded secret--that kills germs and also neutralises chemical weapons. Once covered by the foam-filled tent, the bomb can be safely detonated.

But what if germs are already in the air? The protective suits and masks used by most emergency services don't have seals tight enough to exclude microorganisms, making them useless against biological attacks, says Jack Sawicki, a former fireman who now works for Geomet Technologies near Washington DC. And the lack of standards for gas masks sold to civilians in most countries makes it as likely that a mask will suffocate you as save you, he says. The suits developed for the military do work--their tight joints and zippers keep bugs out--but they are too pricey for the average fire department.

Both Geomet and Irvin Aerospace are about to market civilian bio-suits. In the meantime, other companies are designing protective gear that actually kills pathogens. Molecular Geodesics in Cambridge, Massachusetts, for example, is developing a suit made of a tough, sponge-like polymer that traps bacteria and viruses, which are then destroyed by disinfectants incorporated into the fabric.

Emergency Services: None of this gear will do any good, however, if the emergency services do not know there has been an attack. And an assault may not be obvious. A terrorist might not use a weapon that goes off with a dramatic bang, or even produces an obvious cloud of germs. The first hint of a biological attack may be a sudden cluster of sick people.

Who's Tracking: In the US, financial cutbacks have crippled programmes to track disease outbreaks, natural or deliberate. Some could be either, such as food poisoning caused by Escherichia coli O157 or Salmonella. Medical agencies fear that the extra money requested by President Bill Clinton this spring as part of an anti-terrorist initiative will not be enough to create an adequate surveillance network.

In Europe, disease surveillance is only beginning to be organised on the continent-wide scale needed to track a biological emergency. But in addition to monitoring infected people, Nicholas Staritsyn of the State Research Centre for Applied Microbiology near Moscow says that more effort should be made to find out which bugs live where. For example, a particular variety of anthrax may occur naturally in South Africa, but not in Canada. Having access to such information could help authorities to distinguish between natural outbreaks and deliberate attacks.

Even when infected people start turning up at local hospitals, early diagnosis of their illness might not be easy, says Steve Morse, who heads the US programme on new diagnostic technologies run by the Defense Advanced Research Projects Agency (DARPA). The first symptoms of anthrax, plague and many other potential agents of bioterrorism resemble those of flu: headaches, fevers, aching muscles, coughing. What's more, some of these symptoms might be brought on by panic attacks, which are likely to be widespread among people who have just been told that they are the victims of a biological attack.

One answer discussed in Stockholm would be for hospitals to have the type of high-tech detectors being developed to identify airborne pathogens on the battlefield. With a detector at each bedside, doctors could pick out the volatile molecules released by damaged lung membranes at a very early stage of infection and instantly tell whether a patient was a victim of a biological attack, says Mildred Donlon, head of environmental detection research at DARPA.

Eventually, DARPA would like to develop a detector that weighs no more than 2 kilograms, can identify as few as two particles of 20 different biological agents in a sample of air, costs less than $5000 and does not give false negatives. Such detectors could be deployed around cities to give early warning of airborne disease.

In the meantime, researchers led by Wayne Bryden at Johns Hopkins University in Baltimore are working on revamping the traditional laboratory workhorse, the mass spectrometer, for use in the field or in hospitals. They've reduced this unwieldy piece of equipment to a suitcase-sized machine that can distinguish between, say, Shigella, which causes dysentery, and Salmonella. A shoebox-sized version, says Bryden, could be ready in five years.

Other researchers are experimenting with devices that would not seem out of place in an episode of Star Trek: Voyager. Tiny electronic chips that contain living nerve cells may someday warn of the presence of bacterial toxins, many of which are nerve poisons. Like a canary in a coal mine, the neurons on the chip will chatter until something kills them. "Anything that stops it singing is immediate cause for alarm," says Donlon.

While the "canary on a chip" could detect a broad range of toxins, other devices are designed to identify specific pathogens. One prototype consists of a fibre-optic tube lined with antibodies coupled to light-emitting molecules. In the presence of plague or anthrax bacteria, or the toxins botulin or ricin, the molecules light up.

Devices based on antibodies are far from foolproof. First, you need to have the correct antibodies--not easy when you consider the vast number of pathogens you'd need to include, and their ever-changing repertoire of surface proteins. "And even the right antibodies can identify only what is on the outside of a particle," Donlon points out. Bugs can be encapsulated in gels or biological polymers to foil antibodies, or normally harmless bacteria engineered to carry nasty genes. "I want to know what is on the inside," she says.

To do this, DARPA-funded researchers are developing identification techniques based on RNA analysis. Unlike DNA, which is now used to identify unknown organisms, RNA is plentiful inside cells and need not be amplified before identification begins. And messenger RNA molecules reveal not only what a microorganism is, but what toxins it is making.

Once the biological agent has been identified, how do you combat it? Vaccinating people before they are exposed is one answer. This is the strategy the military is betting on. Last year, the US military launched a programme to develop vaccines against potential biological weapons. It will create jabs for diseases for which none exist, such as Ebola, and improve existing vaccines--including the 30-year-old anthrax vaccine being given to 2·4 million American soldiers.

But vaccines are no cure-all. An attacker need only generate a germ that sports different antigens to those used in a vaccine to render that vaccine ineffective. Plus, as bioterrorists get more sophisticated, they will develop novel, possibly artificial, pathogens against which conventional vaccines will be useless, predicts Morse.

To get around these problems, DARPA is looking at ways of developing vaccines quickly enough for them to be created, mass-produced and distributed after an attack. The first step, which many researchers including those in the fast-paced field of genomics are now working on, involves speeding up DNA sequencing so that an unknown pathogen's genes could be detailed in a day. The resulting sequences could then be the basis for developing an instant DNA vaccine.

Making the vaccine is only half the problem, however. Soldiers can be ordered to take shots, but immunising the rest of the population is another matter. Civilians are unlikely to volunteer for the dozens of vaccinations that would be necessary to protect them against every conceivable biological threat. An attack would make many change their minds, but in such circumstances there might not be enough to go around. Although Clinton has called for the stockpiling of vaccines, the US has only 5 million doses of smallpox vaccine--not enough to contain a hypothetical attack, says Ken Berry, president of the American Academy of Emergency Physicians.

Ken Alibek, the former second-in-command of the Soviet germ warfare programme who revealed earlier this year that the Soviets had weaponised tonnes of smallpox, argues that it is short-sighted to put too much effort into developing vaccines. Instead, says Alibek, who is now at the Batelle Institute in Virginia, researchers should concentrate on ways to treat victims of biological weapons. Today's antibiotics may be useless because germs could be equipped with genes for resistance to all of them. Russian scientists have already created such a strain of anthrax (This Week, 28 February, p 4).

For any treatment to be effective amid the potential chaos of a bioterrorist attack, speed will be of the essence. At the Stockholm meeting, researchers reported their efforts to develop drugs that work against a wide variety of infections and so can be used even before definitive diagnosis. Some are trying to take advantage of recently identified similarities in the way many pathogens produce disease to develop broad-spectrum drugs.

For example, Ebola, anthrax and plague all kill their victims by inducing a widespread inflammatory reaction similar to toxic shock syndrome. A team in Cincinnati is testing an anti-inflammatory drug that could stop all of them. Another gang of bacteria--including plague, Salmonella, Shigella and Pseudomonas aeruginosa (one of the bacteria that can cause pneumonia and meningitis)--relies on very similar proteins to latch onto human cells and inject toxins. Drugs that block this system might save people from all these germs, Åke Forsberg of the Swedish Defence Research Establishment in Umeå told the meeting.

The trouble with all these new anti-bioweapon gizmos, gadgets and medicines is that it's far from certain that they would be available in time to shield the first major city targeted for a bioterrorist attack. At the moment, the US is one of the few countries taking the bioterrorist threat seriously. Sweden, France and Israel have trained emergency teams and stockpiled gas masks. Other countries do not seem concerned. "The threat of bioterrorism has not seized our European friends," says Mike Moodie of the Chemical and Biological Arms Control Institute, a think-tank near Washington DC. "They feel it's too improbable."

Perhaps they should reconsider. Berry, who helped run the doomsday simulations that ravaged San Francisco, says: "Security experts are not asking if a biological attack on a civilian population is going to happen, but when."

(From the United States Center for Disease Control)

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