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Full-text available at SSRN. See link in this record. ; The patent systems of most countries have gradually extended patent protection to inventions involving, and even consisting of, living organisms. In fact, the World Trade Organization ("WTO") Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS") mandates that, in all of its member countries, "patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application." By allowing member countries to deny patentability to "plants and animals other than micro-organisms," TRIPS implies that the default rule is that the full range of organisms, from microbes to macrobes, are indeed potentially patentable subject matter. Canada represents a marked exception. The Supreme Court of Canada ("Supreme Court") negated the patentability of animals and plants, in general, and a genetically engineered mouse, in particular, despite the fact that Canadian statutory patent law is silent on the issue. Although the Canadian government had never availed itself of the escape clause of TRIPS Article 27(3)(b), which allows member states to exclude from patentability "plants and animals other than micro-organisms," a bare majority of the Supreme Court divined that the intent of Parliament was to exclude "higher life forms" from patentability. The Supreme Court variously justified its decision on the basis of "commonly understood" distinctions of "higher" and "lower" life forms, and the striking hypothesis that "higher," though not "lower," life forms "transcend" their genomes. The Supreme Court offered no scientific evidence whatsoever to justify its demarcation of the border between patentable and unpatentable organisms, nor could they because no scientific evidence exists. Failing to cite supporting evidence in this way might be acceptable if the science purported to underlie the decision were self-evident, either through ...

Full-text available at SSRN. See link in this record. ; Since the existence of a discrete unit of heredity was first proposed by Gregor Mendel, scientific concepts of the "gene" have undergone rapid evolution. Beyond obvious epistemic and operational importance to the scientific community, changing gene concepts have exerted strong effects on institutions such as medicine, the biotechnology industry, politics, and the law. A particularly rich example of this is the interplay between gene concepts and patent law. Over the last century, biology has elaborated gene concepts that variously emphasized genes as discretely material, genes as information, and genes as extremely complex. By contrast, patent law has steadily adhered to a simpler, more stable concept of the gene since the advent of gene patents in the late 1970s. In fact, while the biology community has increasingly engaged in vigorous internal debate regarding the gene's complexity and uncertainty, it has tended simultaneously to emphasize the simplicity and certainty of the gene to constituencies outside the biology community, most notably the United States Patent and Trademark Office (USPTO) and the Federal courts. Rather than allow gene concepts to become contested by constituencies outside biology, the biology community appears to have used its authority to maintain a portrayal of the gene that facilitates the appropriation of rents from genes through the patent system. This use of "gene talk" has undergirded the growth of biotechnology into a powerful industry that has economically rewarded investors, academic institutions, and biologists. Not only may gene talk have facilitated the patenting of genes, but the prominence of gene patents describing a relatively simpler gene concept may have fed back into biological science to promote a simpler, and more patentable, concept of the gene even among members of the biology community.

Full-text available at SSRN. See link in this record. ; Planet earth is host to a dazzling variety of living organisms. This diversity of life, or – biodiversity, is vital to the survival and prosperity of humanity, supplying such vital amenities as food, clothing, shelter, natural biochemicals useful in medicine, industry, and agriculture, and even irreplaceable ecosystem services, such as clean air and water. Despite the prodigious amount of biodiversity on earth, human activities have been depleting it at an accelerating rate that has now reached the level of a mass extinction event. The five greatest threats to biodiversity can be summarized by the – HIPPO acronym: (1) Habitat loss, (2) Invasives, (3) Pollution, (4) Population, and (5) Overexploitation. Together, these five factors describe the phenomena largely responsible for the current mass extinction event, and patent law offers valuable assistance in combating each one. Though it cannot offer a complete solution to the biodiversity crisis, the patent system can offer powerful tools to help save biodiversity. On first inspection, patent law might appear an unlikely ally for conserving biodiversity for at least two reasons. First, beyond bioprospecting, patents would seem only tangentially relevant to biodiversity loss. Second, as a tool for promoting economic growth, the patent system might be viewed as contributing to biodiversity loss by those who assume that economic growth and environmental protection are mutually antithetical. However, patents can indeed benefit biodiversity. This article illustrates how patents can combat each of the major threats to biodiversity that constitute the HIPPO acronym. By creating an extinction bar to patentability, patents create incentives for bioprospectors, biopharmaceutical firms, and countries that host abundant biodiversity to prevent habitat destruction. Sovereign immunity provides the federal and state governments with the right to make use of patented inventions useful for countering invasives. Existing ...

Full-text available at SSRN. See link in this record. ; In his Nobel Prize acceptance speech more than half a century ago, Edward L. Tatum suggested an ambitious new goal for biology: "not only to avoid structural and metabolic errors in the developing organism, but also to produce better organisms." Synthetic biology aims to effect such a paradigm shift in the biological sciences by marrying approaches from engineering and computer science to an expanding array of standardized biological parts and sophisticated biological methods. By importing engineering principles, such as standardization, decoupling, and abstraction, into the biological sciences, synthetic biology may transform biology into a field in which it is routine to design and construct genes, gene combinations, genomes, proteins, metabolic pathways, cells, viruses, and whole organisms rapidly, inexpensively, and easily. Already, a number of institutions have helped synthetic biology achieve considerable success, both in terms of science and public awareness. The BioBricks Foundation (BBF) and the Registry of Standard Biological Parts have successfully built a collection of thousands of standard DNA parts (BioBricks), which can be combined in a manner analogous to Lego® bricks, or even modified into new BioBricks, and the International Genetically Modified Machine (iGEM) competition has attracted participation from thousands of contestants and hundreds of teams from dozens of countries. While the ethos of openness that pervades synthetic biology promises a democratization of biology, significant challenges to its openness still exist. The proprietary restrictions imposed by "closed" intellectual property - chiefly patents - create legal risk and uncertainty. Ironically, synthetic DNA sequences are likely more easily patentable and copyrightable than are DNA sequences derived from natural sources, thus creating the possibility that synthetic biology may increase, rather than decrease, the potential for intellectual property restrictions. Furthermore, ...

Full-text available at SSRN. See link in this record. ; In the past, opposition to GMOs and GM crops has tended to focus on alleged dangers to human health and environmental safety. The United States, Canada, and Europe have all established regulatory frameworks whose stated aims are to ensure that GMOs and GM crops do not harm the health of their citizens or threaten the well-being of their environments. However, these jurisdictions have set up regulatory hurdles of significantly different heights. North American neighbors, the United States and Canada, have tended to regulate GMOs and GM crops with a relatively light touch that tends to ease approval for field-testing and commercial marketing. By contrast, Europe has applied much stricter regulatory standards, with the result that few GM crops have been field-tested or GM foods allowed onto the market there. A large and growing body of scientific studies into the human health and environmental safety of GMOs and GM crops has failed to find significant justification for the extreme precautionary approach adopted by Europe. Furthermore, a WTO panel decision forcefully critical of the European regulatory regime for GMOs and GM crops was recently accepted by Europe, and may herald the adoption of a new regulatory regime more accepting of GMOs and GM crops. As prospects have faded that scientific evidence will demonstrate that GMOs and GM crops pose unique threats to human health and environmental safety, a third locus of anxieties has been growing in significance: patent monopolies over new and useful GM crops. Concerns about monopoly control of GM crops are the obverse of concerns about human health and environmental safety. Where the latter rationales counsel against the easy and widespread adoption of GM crops, the former rationale would operate to ensure such easy and widespread adoption. Both the United States and Europe offer patent protection for GM plants and animals, making regulation against patent monopolies in GM crops difficult. However, Canada does ...

Planet earth is host to a dazzling variety of living organisms. This diversity of life, or "biodiversity," is vital to the survival and prosperity of humanity, supplying such vital amenities as food, clothing, shelter, natural biochemicals useful in medicine, industry, and agriculture, and even irreplaceable ecosystem services, such as clean air and water. Despite the prodigious amount of biodiversity on earth, human activities have been depleting it at an accelerating rate that has now reached the level of a mass extinction event. The five greatest threats to biodiversity can be summarized by the "HIPPO" acronym: (1) Habitat loss, (2) Invasives, (3) Pollution, (4) Population, and (5) Overexploitation. Together, these five factors describe the phenomena largely responsible for the current mass extinction event, and patent law offers valuable assistance in combating each one. Though it cannot offer a complete solution to the biodiversity crisis, the patent system can offer powerful tools to help save biodiversity. On first inspection, patent law might appear an unlikely ally for conserving biodiversity for at least two reasons. First, beyond bioprospecting, patents would seem only tangentially relevant to biodiversity loss. Second, as a tool for promoting economic growth, the patent system might be viewed as contributing to biodiversity loss by those who assume that economic growth and environmental protection are mutually antithetical. However, patents can indeed benefit biodiversity. This article illustrates how patents can combat each of the major threats to biodiversity that constitute the HIPPO acronym. By creating an extinction bar to patentability, patents create incentives for bioprospectors, biopharmaceutical firms, and countries that host abundant biodiversity to prevent habitat destruction. Sovereign immunity provides the federal and state governments with the right to make use of patented inventions useful for countering invasives. Existing compulsory licensing schemes provide models for how patented pollution abatement technologies could be widely disseminated to combat pollution. The incentives created by the patent system can help to create more efficient new technologies capable of counteracting the damage inflicted on biodiversity by human population growth. Finally, the patent system has already proved itself adept at spurring the creation of ingenious inventions capable of alleviating overexploitation of biodiversity. Though far from a panacea, the patent system does have important roles to play in ameliorating the biodiversity crisis.

Planet earth is host to a dazzling variety of living organisms. This diversity of life, or "biodiversity," is vital to the survival and prosperity of humanity, supplying such vital amenities as food, clothing, shelter, natural biochemicals useful in medicine, industry, and agriculture, and even irreplaceable ecosystem services, such as clean air and water. Despite the prodigious amount of biodiversity on earth, human activities have been depleting it at an accelerating rate that has now reached the level of a mass extinction event. The five greatest threats to biodiversity can be summarized by the "HIPPO" acronym: (1) Habitat loss, (2) Invasives, (3) Pollution, (4) Population, and (5) Overexploitation. Together, these five factors describe the phenomena largely responsible for the current mass extinction event, and patent law offers valuable assistance in combating each one. Though it cannot offer a complete solution to the biodiversity crisis, the patent system can offer powerful tools to help save biodiversity. On first inspection, patent law might appear an unlikely ally for conserving biodiversity for at least two reasons. First, beyond bioprospecting, patents would seem only tangentially relevant to biodiversity loss. Second, as a tool for promoting economic growth, the patent system might be viewed as contributing to biodiversity loss by those who assume that economic growth and environmental protection are mutually antithetical. However, patents can indeed benefit biodiversity. This article illustrates how patents can combat each of the major threats to biodiversity that constitute the HIPPO acronym. By creating an extinction bar to patentability, patents create incentives for bioprospectors, biopharmaceutical firms, and countries that host abundant biodiversity to prevent habitat destruction. Sovereign immunity provides the federal and state governments with the right to make use of patented inventions useful for countering invasives. Existing compulsory licensing schemes provide models for how patented pollution abatement technologies could be widely disseminated to combat pollution. The incentives created by the patent system can help to create more efficient new technologies capable of counteracting the damage inflicted on biodiversity by human population growth. Finally, the patent system has already proved itself adept at spurring the creation of ingenious inventions capable of alleviating overexploitation of biodiversity. Though far from a panacea, the patent system does have important roles to play in ameliorating the biodiversity crisis.