Full Title Name:  Detailed Discussion of Genetic Engineering and Animal Rights: The Legal Terrain and Ethical Underpinnings

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Andrew B. Perzigian Place of Publication:  Michigan State University College of Law Publish Year:  2003 Primary Citation:  Animal Legal and Historical Center 1 Country of Origin:  United States

This paper discusses the legal, environmental, and ethical dilemmas involved with genetic engineering technology and its creation of transgenic animal species. Currently, transgenic animal species are patentable subject matter in both the United States and in Europe and the use of such technology is largely left unregulated. This paper discusses the pros and cons that genetic engineering technology bring to the modern world in light of the relative absence of legal barriers facing genetic engineers.


I. Part I: Introduction and Overview

With the advent and rapid development of genetic engineering technology, the animal rights movement is currently facing one of its greatest challenges and dilemmas.   This technology is capable of efficiently creating multi-cellular, transgenic animals.   Like any technological breakthrough, genetic engineering brings with it as much promise as it does uncertainty, and so, the value judgments we make regarding the direction and scope of this technology are sure to have far reaching implications.   Such value judgments, though routed in science, involve legal dilemmas as well.   Importantly, the use of patents as a means of protecting and owning genetically engineered animals and species figures to be one of the more prominent battlegrounds in the emerging debate on genetic engineering.  

Part II of this paper provides an overview of the current limits and future possibilities of genetic engineering.   It also distinguishes genetic engineering from traditional cross-breeding methods.   Part III provides a critical response to the heralded solutions that genetic modification of animals promises.   Part IV introduces the legal terrain surrounding genetic engineering.   It discusses relevant legislation, in particular patent law in both the United States and the European Union (EU).    Part V briefly concludes with some final remarks on the moral and ethical dilemmas that genetic engineering poses to both the environmental and animal rights movements.  

II. Part II: Genetic Engineering:   The Capabilities and Potential 

Transgenic animals are animals that have specific traits from another plant or animal genetically engineered into them.   Unlike controlled breeding, which is confined to the genetic material contained in a single species, genetic engineering permits an almost limitless scope of modification and introduction of otherwise foreign genetic material. 1   Traditional methods, which could only breed with two closely related species, produced offspring that carried a diverse amalgamation of each of its parent's traits.   In contrast, modern genetic engineers are able to introduce completely foreign genetic material, from both plants and animals, into another plant or animal.   This permits only the desired traits, and not the host of other traits common from crossbreeding, to be effectively introduced into new, transgenic animal species. 2    Eventually genetic engineers will be able to manufacture genes that nature has never produced. 3   Regardless, genetic engineering is currently able to create whole organisms that are not natural to the planet, and whose specific genetic make-up is as much a result of human manipulation as it is natural selection. 4   Thus, the ethical, cultural, and environmental implications involve issues of the greatest magnitude and importance. 5

A. Transgenic Agricultural Animals

Transgenic farm animals can be created, as some observers argue, that "are better able to resist disease, have increased growth performance, and have better reproductive traits." 6   For instance, transgenic salmon, that grow larger and at a faster rate than natural varieties, have already been created and farmed. 7   Another common use of genetic engineering technology is the use of bovine growth hormone in dairy cows to increase their milk production. 8   In the future, transgenic sheep can be created to produce better wool and cows can be engineered to more efficiently convert grain into higher quality milk and meat. 9

Biotechnology is equally poised to transform factory farming with the creation of transgenic farm animals that are created to be non-sentient, without the ability to experience pleasure or feel pain.   By removing the "stress" gene from livestock, genetic engineers may render animals non-sentient and thus outside the concern of much animal rights ideology. 10   Making animals unaware of their suffering could provide a powerful argument against allegations of mistreatment, inhumane practices, and result in a great "diminution" of the animal rights movement's "moral imperative to feel for animals." 11   Jon Owens, a legal analyst with the Environmental Protection Agency, asserts that this technology would leave the modified animals with the "same status as a rock, which earns no protection under the movement's philosophy." 12   Peter Singer, one of the great animal rights theorists in modern times, agrees, believing that such technology would actually be the "triumph" of his moral philosophy, that it would realize a great reduction in the human causes of animal suffering. 13   Of course, this process would not be generally applicable for the biomedical community since animal-based research often relies to a large extent on measuring the sentient reactions of animals to drugs, household products, psychological stimuli and physical harm.

This potential may be quickly outdated with the advent of animaless meat.   Genetic engineers will likely be able to do this, to create the meat, or flesh of animals without creating the whole being. 14   This could potentially eradicate the suffering of agricultural animals, the huge environmental damage caused by factory farming, and it could provide leaner, more nutritious meat than what is naturally produced as a result of traditional and close confinement agricultural methods. 15

B. Transgenic Animal Research Models

Genetic engineering is fast altering the biomedical research world.   By creating animal models that express only desired traits, biomedical research is made faster, more accurate, less expensive, 16 and at the expense of fewer animal lives. 17   For instance, when specific genes are removed from animals, researchers are then able to determine the exact function of that gene by observing the various biological changes the transgenic animal model exhibits. 18   Researchers are also able to study a hereditary human disease, like breast cancer, by injecting cancer-causing genes (oncogenes) into non-human mammals.   This was the case for the first transgenic animal patent, the "oncomouse," secured by Harvard researchers in 1988. 19   Because the oncomouse had a propensity for developing breast cancer, researchers have been able to better understand carcinogens and their replication into cancerous cells. 20  

Various other diseases, from hypertension, 21 to AIDS, Down's syndrome, Alzheimer's' disease, high cholesterol, anemia, and hepatitis B, are likewise being studied through the use of genetically engineered animal models. 22   Transgenic animals have made research of such diseases more accurate, less expensive and faster, 23 while at the same time permitting such results with the use of fewer individual animals in any given study. 24

C. Transgenic Animals and the Production of Medicine

Animals are also engineered to produce therapeutic drugs that are otherwise impossible to replicate in the laboratory setting.   Transgenic animals, like goats, sheep, and cattle, have been engineered to produce large amounts of complex human proteins in their milk. 25   Such proteins can be especially beneficial for hemophiliacs (clotting factors in proteins), AIDS and cancer patients with depleted bone marrow, and those suffering from emphysema and various other lung problems. 26

Prior to such technology, animals (mostly pigs and sheep) have been used "as factories for producing such proteins as human growth hormone and insulin." 27   Typically, such animals had to be slaughtered before such proteins could be derived.   By engineering these animals to release these and other proteins in their milk, the mass production of high quality therapeutic drugs is made less costly, easier to manufacture, and at the expense of fewer animal lives than what was formerly the case. 28     

Researchers are also genetically modifying animals so that they produce genes able to be used in human gene therapy. 29   For instance, transgenic, albino mice have been cured of albinism with the use of such therapy, and the hope of a human cure is thus much greater. 30   Finally, much research has been forwarded with the goal of creating "near human" organs inside transgenic animals. 31   Such organs, researchers hope, will provide a more viable source of livers, kidneys, and hearts for humans in need of transplants.

D. Cloning Endangered Species

The World Wildlife Fund estimates that within 30 years, 20% of the earth's biodiversity will be lost to extinction, almost entirely as a result of human causes. 32   A different species becomes extinct every fifteen minutes, amounting to 35,000 species per year. 33   As Chief Justice Burger remarked in TVA v. Hill, the importance of individual endangered species and their supporting populations is "incalculable." 34   This potentially irreversible result of human exploitation and depletion of the earth's resources has found an incremental solution in genetic engineering technology. 35   Since the 1997 birth of Dolly, the first fully cloned mammal derived from adult cells, cloning technology has been used for the renewal of endangered species populations and the resurrection of species already extinct.   In Iowa, an adult cow gave birth to a guar, an endangered species of ox from South America, whose embryo had been cloned and implanted in the mother cow. 36   And, efforts in Australia are currently underway to clone a Tasmanian tiger that has been extinct for nearly 100 years. 37   Around the world, scientists are searching for intact woolly mammoth DNA in hopes of resurrecting this species, a hotly debated use of genetic engineering technology since the earth has been without the woolly mammoth for nearly 10,000 years. 38  

Regardless of this sort of controversial use of bioengineering technology, cloning endangered, or recently extinct species may provide many benefits. 39   Significantly, cloning would help support endangered species populations, at least in zoos and laboratories, with a greater genetic diversity and thus a more sustainable population for reintroduction into the wild. 40   Also, scientists could clone endangered species from frozen DNA, which is stored throughout America's zoos, thereby permitting otherwise "lost" genes to be reintroduced to the endangered species gene pool. 41   Finally, species like tigers and pandas, who are notoriously difficult to breed in captivity, could also be cloned and their populations thereby preserved more efficiently than is otherwise possible in controlled breeding circumstances. 42

III. Part III:   Negative Implications of Genetic Engineering Animals

While genetic engineering is quickly making an indelible mark on society, and its promise is great, there are a number of concerns about the ramifications that genetic engineering has for society and the environment.   Environmental advocates and animal rights groups are often the loudest voices in opposition.   For each solution that genetic engineering claims to solve, there are inherent risks.   In general, opponents of genetic engineering assert that such technology creates a huge diminution in the standing of animals, leaving them as nothing more than "test tubes with tails," only of benefit for the exploitive practices of factory farming, and drug and organ manufacturing. 43   There are both real and potential risks associated with biotechnology and its manipulation of animal genetics.

A. Transgenic Agricultural Animals:  

a. Ecological Implications

Transgenic agricultural animals pose a number of threats.   Many argue that creating more efficient farm animals will cause a cessation of selective breeding, thereby lessening the genetic diversity of such animals.   This could make whole herds susceptible to new strains of infectious diseases. 44   Others argue that transgenic farm animals are far more likely to endure greater suffering than what is already experienced on factory farms.   For instance, when the USDA implanted a human growth hormone into a pig, the unfortunate result were pigs who ended up "bowlegged, cross-eyed, arthritic, and had dysfunctional immune systems that made them susceptible to pneumonia." 45   Likewise, dairy cows, who are commonly injected with recumbent bovine growth hormone (rBgh) to increase their rate of mild production, are much more likely to suffer from udder disease.  

Transgenic animals, if released or escape into natural, wild environments, pose an enormous threat to native animal populations and the overall balance of the ecosystem. 46   Some argue that any leak of genetically engineered organism into the wild is "tantamount to playing ecological roulette." 47 This is so because of the complexity of biochemical functions, about which very little is known regarding the precise function that each species serves within the greater ecosystem.   Artificially created species, the argument goes, are unsustainable because they are not a part of the "web of highly synchronized relationships" that have evolved over millions of years. 48   For instance, in a study done at Purdue University, scientists calculated that if 60 genetically engineered salmon escaped into a native, natural population of 60,000, it would take only 40 generations for the wild salmon to be completely wiped out. 49   There is no way of predicting the exact effects of transgenic animals on the environment, and because studies indicate that unnatural genetic manipulation poses a devastating threat to wild environments, opponents of genetic engineering believe that overconfidence must be tempered and that genetically engineered solutions are no answer for the world's current agricultural challenges. 50   After all, "even in the cases where no adverse impacts on the ecological functioning of natural ecosystems occur, the mere presence of introduced genes and genetically-altered organisms degrades these ecosystems by diminishing the naturalness or wildness of these ecosystems." 51

b. Moral Implications

Creating transgenic farm animals is considered not only threatening to natural ecosystems, but also devastating as a form of mistreatment.   This concept centers upon the notion of species integrity, the idea that every animal, whether owned by humans or not, has a natural right to have its genetic code left intact and untouched. 52   This notion of integrity, though calling for a complete ban on transgenic animals, centers mostly on the use of biotechnology on agricultural animals because of the widespread threat such animals pose to natural ecosystems. 53  

Apart from a complete ban on transgenic animals, the species integrity argument serves as an important consideration with regard to agricultural animals that are engineered insentient.   Because this use of biotechnology is so new, few scholarly reactions have been published in regard to it.   At minimum, such technology helps to substantiate the belief that animals are sentient, that they are conscious beings deserving not only of protection, but deep respect and thoughtful consideration.   Likewise, if such technology is eventually practiced and utilized, the culpable act of killing, or mistreatment and cruelty of animals will still exist.   Nothing will have been done to address this underlying dilemma.  

This is true because sentience is not the only aspect that separates animals from, say, plants or rocks.   Insentient animals, presumably, would still experience the world in a number ways beyond their judgments of pain or pleasure - by thinking, communicating, moving, seeing, touching, tasting, nurturing their young, among others.   Such animals would still demand greater consideration than plants or rocks.  Potentially, genetic engineering animals to be senseless to mistreatment might only exacerbate what is really the focus of the call for animal rights - the belief that mistreating animals is cruel, abusive and wrong and that no amount of technology or distance from the slaughterhouses can erase complicity.  

Ned Hettinger, one of the few scholars to comment briefly on this use of bioengineering, remarks,

A future where descendents of chickens are wired to the floor, connected to input tubes, and do not mind because their sentience has been biotechnologically removed is not a pleasing picture of what biotechnology may bring.   There exists a significant burden of justification against the production of such monstrous transformations of living beings into mechanical, artificial modes of existence.   Prima facie, biotechnology should not be used to impoverish creatures, to strip away their capacities, or to diminish the richness of their lives. 54

On the other hand, the potential for biotechnology to create flesh without the animal seems to be a far less heinous proposition.   Although there is also very little scholarship involving this topic, it seems that such technology might actually solve many of the problems that animal rights advocates and environmentalists see with the use of sentient animals for food, medicine, and clothing.   Of course, there might still be debate regarding what exactly constitutes an animal and too what extent the presence of animal DNA or animal cellular structure demands protection under the animal rights movement.

B. Transgenic Animal Models May Increase Suffering for Research Animals

Creating more efficient research animals, though potentially a means of reducing the absolute number of individual animals used for experiment, threatens to actually increase the suffering experienced by research animals.   One of the more common uses of bioengineering is for the purposeful creation of animals who are either diseased or afflicted with a predisposition to develop a fatal, genetic disease. 55   Such research animals are purposefully created to suffer.   The entire population of genetically engineered research animals exist in bodies whose inevitable fate is constant pain and unnaturally rapid deterioration.   These animals are specifically "tailored to be hypersensitive to a variety of carcinogens, mutagens, taratogens, or other poisons." 56   There lives, many would argue, are a nightmare, worse than even their human counterparts, purposefully tailored to experience our greatest maladies behind wire cages, underneath microscopes, and inside laboratories.   If anything, engineering animals to be more efficient research tools, to accentuate their sentience for the benefit of the human predicament alone, only perpetuates the same concerns that animal rights organizations have always held-that research animals are abused, badly mistreated, and without even the most basic of rights.

C. Cloning Endangered Species May Promote Complacency in Habitat Protection

While cloning endangered species may provide a short-term, partial solution to the modern extinction crisis, it by no means addresses all the issues of conservation biology and the need to protect both the endangered species and the habitats that support them. 57   All animals, including endangered species, serve hugely important functions within their ecosystems. 58   While only few animals act as lynchpins in the overall sustainability of human dominated ecosystems, 59 there is much to be understood about all the subtle bio-chemical purposes that each species serves within the whole.  

Cloning endangered species does little to address the underlying causes pushing such species so near to extinction.   The World Wildlife Fund reports that the greatest threats to endangered species are a result of human settlement, deforestation, water, soil and air pollution, climate changes due to overuse of fossil fuels, and poaching to supply international markets with rare animal parts. 60   These threats still loom large even with the possibility of cloning.   Most opponents agree that cloning endangered species should only be implemented "as a last, desperate attempt to try and preserve a given species," not as strategy for their protection. 61

Since cloning animals is a hugely expensive procedure, opponents also argue that cloning endangered species should not be a means of cutting into the already stretched funds needed to maintain critical habitats and overall biodiversity. 62   The primary goals of biodiversity are not solely for the protection of the most threatened species, but for the maintenance of a thriving pool of genetically diverse, naturally selected organisms that are specifically adapted to their given environments. 63   Cloning technology can exist within these goals, but it is neither a complete solution nor a feasible alternative to habitat preservation and the real threats causing a contraction of Earth's biodiversity.

IV. Part IV: Governing Laws in the United States and the EU

Animal cloning and genetic engineering research in both the United States and the European Union (EU) are largely outside the rubric of even the most current legislation meant to regulate this technology.   The marked difference between United States and EU legislation is the United States' comparative lack of concern for humane research and agricultural practices. 64   While the United States does provide for humane treatment of animals, under the existing laws, most animals used in research and agriculture are excluded from such protection (see MMPA and AWA ). 65    This leaves the vast majority of animals facing genetic manipulation without any governmental regulation or protection. 66   This is especially true since much of the most genetic research and engineering occurs in the private sector, which is notoriously more difficult to regulate than are publicly funded projects. 67

Most modern legislation regarding genetic engineering and cloning technology ensued following the birth of Dolly the sheep, the first multi-cellular organism cloned from adult cells. 68   The primary objectives of United States and EU legislation was twofold: (1) to prohibit the cloning of humans or transgenic hominids, and; (2) to ensure that genetic engineering research would not be hampered. 69   France, Denmark, the Netherlands, Germany, and Spain, immediately following the birth of Dolly, created legislation that banned all research on human embryos, while Germany and Spain specifically banned any human cloning. 70   Likewise, the United Nations responded with the passage of the Universal Declaration of Human Rights, which includes a complete prohibition on human cloning. 71   Animal cloning, on the other hand, has been markedly absent from recent legislation regarding biotechnology. 72

A. U.S. Legislation: Animal Welfare Act and the Patent Act

The Animal Welfare Act (AWA) is the primary federal legislation that regulates animal property in the United States.   The AWA is generally considered to have failed in its goals of creating and maintaining federal standards and regulations for the humane treatment of non-human animals. 73   The AWA seeks to provide protection for "[a]ny live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet." 74

Unfortunately, "[b]irds, rats...mice...bred for use in research, and horses not used for research purposes and other farm animals, such as, but not limited to livestock or poultry," are excluded from the Act's protection. 75 Amendments made in 1985 were meant to ensure that primates used for research experience a "minimized" level of suffering, 76 by providing for a "physical environment adequate to promote [their] psychological well-being." 77   Despite such efforts, the AWA remains a relatively weak and convoluted law that is as difficult to interpret as it is selective in its protection.   The act has been criticized for its lack of breadth, 78 meager congressional allocation of resources, 79 and its implementation by the USDA is generally considered scant at best. 80   Numerous lawsuits have complained that the USDA has neglected to lawfully enforce, through regulation and implementation, the AWA . 81 Furthermore, Mendleson explains, "[a] primary factor in undermining the AWA's objectives, however, is the inability of third parties, specifically animal welfare and animal rights organizations, to litigate claims successfully against the federal government and individual violators under the statute." 82   In fact, neither private litigants nor animals have been given a cause of action against those in violation of the AWA . 83   Since the AWA extends no consideration for most of the species involved in genetic engineering research, legislation in the United States fails to regulate nearly all forms of genetic manipulation currently practiced. 84  

Patent law in the United States is similarly disposed.   Patent law essentially provides a monopoly on new technology.   As a result, the biotechnology industry has an enormous incentive to experiment and create various new species and "quasi-lifeforms." 85   Patent law in the U.S. is codified under the Patent Act of 1952 , which requires that patentable things must be novel, have utility, and be non-obvious. 86   Section 101 of the act explains that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement hereof, may obtain a patent..." 87   Biotechnology patents generally fall under the "composition of matter" group, and until the advent of transgenic organisms, animal species and other "products of nature" had been exempt from patent protection. 88  

The doctrine exempting products of nature from patent protection was essentially overruled by the Supreme Court in the landmark case, Diamond v. Chakrabarty . 89   This case involved genetically engineered bacteria that were designed with a unique capacity to break down crude oil.   Mr. Chakrabarty's patent application had been denied by the Patent and Trademark Office (PTO) and later by the Board of Patent Appeals and Interferences (BTAI), only to have his application approved by the United States Supreme Court. 90   The Supreme Court remarked, that in passing the Patent Act , while Congress may not have foreseen the use of patents for biotechnology, they did intend for patentable subject matter "to include anything under the sun that is made by man." 91   Shortly thereafter, the United States Commissioner of Patents (who heads the PTO) declared that "the Patent and Trademark Office now considers nonnaturally occurring nonhuman multicellular living organisms, including animals, to be patentable subject matter." 92   Within two years, Harvard researchers secured the first animal patent for their oncomouse (discussed above). 93

Once a patent is awarded, judicial review is rare, and third parties are unable to challenge the veracity of existing patents and the PTO policy supporting them.   In Animal Legal Defense Fund v. Quigg , 94 a federal circuit court ruled against the Animal Legal Defense Fund in their challenge of the procedural and substantive fairness of the amended PTO policy that permitted animal patents following the Chakrabarty ruling.   The federal court in Quigg dismissed ALDF's claims for lack of standing, which thereby settled the substantive issue of transgenic animal patents without ever addressing the environmental or ethical concerns posed by the use of patent protection for transgenic animal creations. 95   Thus, only patentees may challenge the validity of a patent. 96   Third parties may request that a patent be re-considered, but not for reasons outside the novelty and non-obviousness requirements set out under the statute. 97   Thus, the availability of patents for transgenic animals remains essentially unchallengeable.  

As a result, in the United States, private research faces few, if any limitations on genetic engineering research or development.  Without judicial review or legislative consideration of the ethical and environmental implications of genetic engineering, patent protection provides bioengineers great incentive and support in their creation of transgenic animals. 98   Human cloning and human genetic engineering remain the only censured uses of biotechnology.   Although patent protection does not extend to cloned or transgenic humans, it is available for non-human, transgenic animals that have human gene sequences engineered in them. 99   To what extent human material may be engineered into transgenic animal remains to be seen. 100  

B. EU Standards and Practices

The EU is similar to the US with regard to its lack of regulation of animal cloning and biotechnology research. 101   The EU, through Article 100 of the Treaty of Rome, may issue directives to its member states regarding a limitation on animal cloning and biotechnology research, ask member states to impose civil penalties for those defying its directives, and it may reject patent applications linked to biotechnology or the products of the biotechnology industry, like food and drugs. 102   The EU does not have any direct power over its member states to regulate cloning or biotechnology research, but its directives serve as a decisive factor in shaping European policy and procedure. 103   Animal cloning and biotechnology research in the EU is permissible "only for objectives which are justified on ethical grounds and to the extent that the operations involved are effected on an ethical basis." 104   Member states must comport their laws along such guidelines.   Thus, "non-technological concerns, such as those related to the well-being of animals, the overall ethical consequences of a certain invention, the environmental protection," are given consideration within the EU. 105   

European patent law follows a similar developments with the United States'.   The same Harvard mouse patented in the United States was the first transgenic animal patent awarded by the European Patent Office (EPO) in 1990.   Although the EPO's requirements differ slightly in term, transgenic animals are equally patentable in Europe as they are in the United States.   The Convention on the Grant of European Patents (EPC) article 52(1) asserts that "European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step." 106   Unlike in the United States, the EPO awards patents for transgenic animals and the individual gene sequences that have been bioengineered into these animals. 107   Both the animal and its genetically engineered genes can be separately patented in Europe. 108

Another contrast between the EU and the United States is in regard to the ability of third parties to challenge the validity of patent awards.   EPO patent awards, under EPC Article 99, are open for third party review within 90 days of the patent's issuance. 109   Compared with the United States, this ensures greater citizen involvement and oversight of bioengineering patent awards. This, coupled with the EU's inclusion of a moral dimension to their patent application procedure, makes the European system of patents more attuned to public concerns about bioengineering than is PTO in the United States.   Many scholarly examinations of the two systems have concluded that the United States may learn important lessons from its European counterparts with regard to patent procedures and its insistenc on ethical uses of animals by the biotechnology industry. 110

V. Part V: Conclusion

Bioengineering technology, used as a means of cloning whole animals and for creating new breeds of transgenic animal species, promises as many triumphs as it clouded with great uncertainty and backlash.   Proponents of the technology assert that transgenic animals (and plants) may one day help solve many of our modern day challenges in life; from starvation and ill health, to environmental degradation and the modern extinction crisis.   Critics believe that bioengineering brings with it greater risks than it does alleviate current problems.   They argue that genetic engineering threatens to increase animal suffering and decrease species integrity, while at the same time creating a potentially devastating impact on the balance and sustainability of Earth's ecosystem.  

While each side's assertions may be equally valid, there is no doubt that genetic engineering will continue to expand the frontiers of cloning and the creation of transgenic animals well into the future.   Both the United States' and the EU's legal systems have been slow to respond with legislation specifically regulating biotechnology, and each have permitted their patent law to provide a supportive ground for genetic engineering research and development to continue with great incentive.   Although human cloning is proscribed, little is in the way of genetic engineers from creating vast arrays of transgenic agricultural and research animals in both the United States and the EU.   How this technology will effect human populations and how it will be perceived by the general public and animal rights groups alike, largely remains to be seen.   One thing is for sure, we must not sit complacently by as this technology rapidly changes the fabric of our existence from the inside out.   We must not wait and see what the effects are.   We must form educated opinions, inspire legislative regulation, and hope that whatever direction that bioengineering takes, is a positive step towards decreased animal suffering, increased environmental sustainability, and an overall compassionate regard for the earth and its precious life.  


(Animal Legal and Historical Web Center, Student Researcher, Summer 2003.

1        Paul Blunt. Selective Breeding and the Patenting of Living Organisms, 48 Syracuse L. Rev. 1365, 1381 (1998); Net Hettinger, Patenting Life: Biotechnology, Intellectual Property, and Environmental Ethics, 22 B.C. Envtl. Aff. L. Rev. 267, 274 (1995).  


        J. Leslie Glick, The Industrial Impact of the Biological Revolution, in Technology and the Future, 363 (Albert H. Teich ed., 5th ed. 1990).

        Robert K. Colwell, Natural and Unnatural History: Biological Diversity and Genetic Engineering, in Scientists and Their Responsibilities 1, 27 (William R. Shea & Beat Sitter eds. 1989).

        Hettinger, supra nt. 1,at 274.

        Carrie F. Walter, Beyond the Harvard Mouse:   Current Patent Practice and the Necessity of Clear Guidelines in Biotechnology Patent Law, 73 Ind. L.J. 1025, 1033 (1998).

        See generally, Genetically Engineered Organisms:   Assessing Environmental and Human Health Effects (Deborah K. Detourneau & Beth Elpern Burrows eds. 2002).  

        Michael Fox, Superpigs and Wondercorn, 123-24 (1992).  

        Stacy J. Ratner, Baa, Baa, Cloned Sheep, Have You Any Law?   Legislative Responses to Animal Cloning in the European Union and United States, 22 B.C. Int'l and Comp. L. Rev. 141, 144 (1999).

10         Jon Owens, The Future of the Animal Rights Movement:   Environmental Conflict, Artificial Intelligence, and Beyond, 33 ELR 10265, 10270-72 (2003).

11        Id. at 10270.  

12         Id.

13        Id. at 10270.  

14        Ray Kurzweil. Human Cloning is the Least of It (Originally published as a message in WIRED Magazine's Future List on January 9, 2001), available at http://www.kurzweilai.net/articles/art0097.html? (last visited May 12, 2003).

15        Id.

16        Walter, supra   nt. 6, at 1031.

17        Blunt, supra nt. 1, at 1368.

18        Jerzy Koopman, Article: The Patentability of Transgenic Animals in the United States Of America and the European Union: A Proposal For Harmonization, 13 Fordham Intell. Prop. Media & Ent. L.J. 103, 114 (2002).  

19         U.S. Pat. No. 4,736,866 (April 12, 1988).

20        Malcolm Gladwell, Building a Better Mouse To Minimize Lab Guesswork, Wash. Post, Oct. 30, 1989, at A3.

21         James R. Chiapetta. Of Mice and Machine: A Paradigmatic Challenge to Interpretation of the Patent Statute, 20 Wm. Mitchell L. Rev. 155 at 175 (1994).

22         Walter, supra. nt. 6, at 1031.

23         Id.  

24         Blunt, supra nt. 1, at 1368.

25         Anne Simon Moffat. Transgenic Animals May Be Down on the Pharm, 254 Sci. 35, 35 (1991); Transgenic Animal-Based Protein Products Move Toward Clinical Trials, in Genetic Engineering News, May 1, 1996, at 37, available in 1996 WL 9121156.

26         Chiapetta, supra nt. 21.  

27         Walter, supra nt. 6, at 1032.

28         Id.  

29         Koopman, supra nt. 17.  

30         Id.

31         Thomas Traian Moga. Transgenic Animals as Intellectual Property (or the Patented Mouse that Roared), 76 J. Pat. [& Trademark] Off. Soc'y 511 (1994).  

32        W orld Wildlife Fund, Endangered Species; A few of the Many;   A Partial Listing of Endangered Species, at
http://worldwildlife.org/species/ (last visited Jul. 15, 2003).   

33         C.C. Mann, Extinction:   Are Ecologists Crying Wolf?, 253 Sci. 736 (1991).

34         TVA v. Hill, 437 U.S. 153, 194 (1978).  

35         See generally, Caroline P. Rogers, Solution or Stumbling Block?:   Biological Engineering and the Modern Extinction Crisis, 30 Ga. J. Int'l & Comp. L. 141 (2001); Robert F. Bloomquist, Legal Perspectives on Cloning:   Cloning Endangered Animal Species?, 32 Val. U.L. Rev. 383 (1998); Owens, supra nt. 11.     

36         Ellen Goodman, Can Animal Cloning Stop the 'Flood of Extinction'?, Athens Daily News, Oct. 13, 2000 at 8A.

37         Rogers, supra nt. 6, at 153.

38         Corey A. Salsberg, Resurrecting the Wholly Mammoth, 2000 Stan. Tech. L. Rev. 1 (2000).  

39         Rogers, supra nt. 35, at 154; Owens, supra nt. 11, at 10270.

40         Id.

41         Id.

42         Jon Cohen, Can Cloning Help Save Beleaguered Species?, 276 Sci. 1329, 1329 (1997).  

43         Rod Fee, Well...hello Dolly! Assessing the Impact of Cloning, in Successful Farming, May 15, 1997, at 49 (quoting People For the Ethical Treatment of Animals (PETA)); Ratner, supra nt. 9, at 145.

44         Ratner, supra nt. 9, 145 (1999).  

45        G ary Comstock, Should We Genetically Engineer Hogs, 8 Between the Species 196 (1992).  

46         Jeremy Rifkin, Creating the Efficient Gene, in Philosophy of Biology 222, 224 (Michael Ruse ed., 1989).

47         Id.

48         Id.

49         Jill Rubin, Risky Salmon, in Boston Globe, March 5, 2001, at A12.  

50         Hettinger, supra nt. 1, at 300.

51         Id.

52         See generally, J. Rifkin, Algeny (1984).   

53         Merges, supra nt. , at 1060.

54         Hettinger, supra nt. 1, at 298-99.  

55         Id.   Hettinger explains that 75% of the first waves of animal bio-patents have been awarded for such animals.  

56         Henry J. Miller. Patenting Animals, ISSUES SCI. & TECH., Winter 1988-89, at 24, 24. :

57         Rogers, supra nt. 35, at 145-46.

58         Id.

59         John Copeland Nagle, Playing Noah, 82 Minn. L. Rev. 1171, 1214 (1998).

60         See World Wildlife Fund, supra   nt. 32.

61         Bloomquist, supra nt. 35, at 414

62         Jon Cohen, supra nt. 42, at 1329.  

63         Rogers, supra nt. 35, at 158-59.  

64         Id. at 156.  

65         Ratner, supra nt. 9, at 14.    

66         Id.

67         Ratner, supra nt. 9, at 150.

68         Id. at 146; Rogers, supra nt. 35, at 154.  

69         Ratner, supra nt. 9, at 150.

70         Rogers, supra nt. 35, at 154.

71         Id.  

72         Id.

73         Nicole Fox, Note and Comment: The Inadequate Protection of Animals Against Cruel Animal Husbandry Practices Under United States Law, 17 Whittier L. Rev. 145, 146-7 (1995).

74         9 C.F.R. §1.1 (definition of "animal") (implementing 7 U.S.C. §2132(g)).

75         Id.

76        S ee, Pub. L. No. 99-198, 99 Stat. 1645 (1985).  

77         7 U.S.C. §2143(a)(2)(B), implemented by, 9 C.F.R. §§3.80-3.92.  

78         Fox, supra n. 74, at 168.

79         Gary Francione, Animals Property and the Law, Temple University Press, 185-250 (1995).

80         Joseph Mendelson, Should Animals Have Standing? A Review of Standing Under the Animal Welfare Act, 24 B.C. Envtl. Aff. L. Review. 795, 796 (1995).

81         See e.g., Animal Legal Defense Fund, Inc.   v. Glickman , 154 F.3d 426, 430-31 (D.C. Cir. 1998); Animal Legal Defense Fund, Inc., v. Espy, 23 F.3d 496, 501 (D.C. Cir. 1994).   

82         Mendelson, supra n. 81, at 796.  

83         See, International Primate Protection League v. Behavioral Research, Inc., 799 F.2d 934, 939-40 (4th Cir. 1986).  

84         Rogers, supra nt. 35, at 157.

85         Owens, supra nt. , at 10271.  

86         35 U.S.C. 101-03 (1994) .   Of these, the novelty requirement seems to be the most daunting.   So long as an living organism is in some ways "man-altered," through genetic engineering, not cross-breeding, then the novel requirement is easily fulfilled.   Transgenic animals and genetic engineering technology, generally, are considered to have utility and the means with which genetic manipulation occurs is typically non-obvious.   See generally, Walter, supra nt. , at 1037-40.    

87         35 U.S.C. 101 (italics added).

88         Walter, supra nt. 11, at 1035.  

89        Diamond v. Chakrabarty , 447 U.S. 303 (1980).  

90         Id. at 309.

91         Id.


93         U.S. Pat. No. 4,736,866 (Apr. 12, 1988); see also, Sheldon Krimsky, Biotechnics and Society: The Rise of Industrial Genetics 44-45 (1991).

94         932 F.2d 920 (Fed Cir. 1991).  

95         See, Elizabeth J. Hecht, Note:   Beyond Animal Legal Defense Fund v. Quigg:   The Controversy Over Transgenic Animal Patents Continues, 41 Am. U. L. Rev. 1023, 1060 (1992).  

96         Id. at 1059-60.

97        35 U.S.C. 102 (2000)

98         J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124 (2001).   In this case, the Supreme Court upheld the PTO's issuance of a patent on technology created to manufacture genetically engineered plants without even considering the environmental or moral problems that biotechnology poses.

99        W alter, supra nt. 6, at 1047.

100      Id.  

101      Ratner, supra nt. 9, at 149.

102      Robin Herman, European BioEthics Panel Denounces Human Cloning, in Wash. Post, June 10, 1997, at z19.  

103      Ratner, supra nt. 9, at 149.  

104        Commission Proposal for a European Parliament and Council Decision Concerning the 5th Framework Programme of the European Community for Research, Technological Development and Demonstration Activities, 19978 O.J. (C173) 26.  

105        Koopman, supra nt. 17, at 181.

106        Convention on the Grant of European Patents, October 5, 1973, art. 52(1), 1065 U.N.T.S. 199, 271.  

107      Council Directive 98/44/EC, 1998 O.J. (L213) art. 9.  

108      Jerzy Koopman, supra nt. 17, at 178.

109      Id. at 186.   Such third party appeals are said to carry great respect and consideration.   

110      See, id; Ratner, supra nt. 9.  

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