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Abstract:
Patent systems are often justified by an assumption that innovation will be spurred by the prospect of patent protection, leading to the accrual of greater societal benefits than would be possible under non-patent systems. However, little empirical evidence exists to support this assumption. One way to test the hypothesis that a patent system promotes innovation is experimentally to simulate the behavior of inventors and competitors under conditions approximating patent and non-patent systems. Employing a multi-user interactive simulation of patent and non-patent (commons and open source) systems ("The Patent Game"), this study compares rates of innovation, productivity, and societal utility. The Patent Game uses an abstracted and cumulative model of potential innovations, a database of potential innovations, an interactive interface that allows users to invent, make, and sell these innovations, and a network over which users may interact with one another to license, assign, infringe, and enforce patents. Initial data generated using The Patent Game suggest that a system combining patent and open source protection for inventions (that is, similar to modern patent systems) generates significantly lower rates of innovation (p<0.05), productivity (p<0.001), and societal utility (p<0.002) than does a commons system. These data also indicate that there is no statistical difference in innovation, productivity, or societal utility between a pure patent system and a system combining patent and open source protection.

Patent, patent law, patent system, patent clause, intellectual property, innovation, open innovation, commons, technological innovation, invention, game, simulation, empirical, productivity, social utility, license, infringement, enforcement, economic experiment

Abstract:
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 not allow the patenting of GM plants and animals, thus avoiding patent monopolies in GM crops per se. Ironically, just as Europe might look to Canada for a new method of regulating GMOs and GM crops, Canada may be undergoing a transition toward allowing such inventions to be patented.

Of the three loci of regulation of GMOs and GM crops, the patent system maintains the most integrity. The scientific justifications for strictly limiting GMOs and GM crops due to concerns over human health and environmental safety have yet to materialize to any significant degree. In fact, there is so little scientific evidence of unique risks of GMOs and GM crops that even invocation of a conservative precautionary principle may be unjustified. Regardless of how regulation of GMOs and GM crops changes in Canada and Europe in the future, it is likely that concerns over monopoly control will grow in significance as a rationale for regulation, while the rationales of human health and environmental safety will continue to fade in the absence of a reversal of the current trend of scientific evidence.

patents, genetic engineering, GMO, environment, health

Abstract:
Biodiversity possesses significant economic value, not least as a source of natural biochemicals discovered through bioprospecting. However, human activities are currently destroying biodiversity at a rapid rate, along with a rich source of natural biochemicals. Stemming this destruction requires novel conservation instruments, and the enablement requirement of patent law can be harnessed to provide one. The enablement requirement presents a significant hurdle to the patentability of biotechnological inventions, including those involving natural biochemicals. However, applying the logic of Ex parte Rinehart (Bd. Pat. App. Int. 1985), a case involving the patentability of natural biochemicals derived from a marine organism called a tunicate, a patent applicant should be able to satisfy the enablement requirement for patenting natural biochemical inventions by disclosing in a patent application specific kinds of useful information about an invention. Notably, source organisms of natural biochemicals could themselves be considered in situ deposits in satisfaction of the enablement requirement in exchange for provision by patent applicants of detailed information regarding the specific location, habitat, geographic range, and phylogenetic relationships of the source organisms. The information thus generated would enhance the public storehouse of knowledge, providing detailed information useful to biologists, conservationists, and future inventors. In addition, the in situ deposit could create an 'extinction bar' to patentability and enforceability because disappearance of the source organism would lead to loss of patent rights. This extinction bar would provide a new incentive for conservation of biodiversity because the economic interests of both patent applicant and source country would be aligned to ensure the survival of any source species upon whose survival monopoly profits rested. No modification of current patent law would be required, only proper application of existing, though as yet unrealized, patent law.

patents, biodiversity, biotechnology, pharmaceuticals, medicine, bioprospecting, biological deposits, enablement, extinction, conservation

Abstract:
The patent system can play a vital role in preparing for, mitigating, reacting to, and preventing disasters. In the far term, it ensures that society continually improves its technological capacity to deal with disasters. In the near term, the patent system includes a diversity of legal options for ensuring access to patented inventions needed in disasters. Foreseeable and surprise disasters require different legal approaches to ensure timely access to patented inventions while ensuring that society is able to continue enhancing both its general and specific technological capacities. Accomplishing optimal results requires careful balancing of far term and near term interests, respect for both international and U.S. patent law, a clear understanding of the interrelation of different aspects of patent law, insight into the incentives that drive technological innovation, and appreciation of the disparate challenges posed by different kinds of disasters. When employed wisely, the patent system can offer society powerful assistance to prevent, prepare for, and mitigate disasters.

patents, disasters, innovation

Abstract:
Patent protection for genetic enhancements would tend to spur genetic innovation, but would tend to limit access to those genetic enhancements through discriminatory mechanisms such as price and favoritism. The patent system would likely ensure high rates of genetic enhancement innovation, research, and development, efficiently mediate access to genetic enhancements, but would also likely allow access to genetic enhancements to fewer members of society. Most importantly, the patent system has the potential to promote the kinds of genetic enhancements that might lead to human evolutionary change. Public policy and the law must grapple with the implications of genetic enhancement before current technological possibilities become societal realities. The patent system is an odd candidate to become a substantial arbiter of parental decisions regarding genetic enhancement of their offspring. It is certain that the implications the patent system has for future human genetic enhancement should be subjected to thorough analysis and debate prior to the imminent arrival of human genetic enhancement technologies. Otherwise, patent law may drive human evolution in directions either unplanned - or worse - undesired.

patent, gene, genetic, genetic engineering, genetic modification, evolution, human evolution, genetic enhancement, human genetic enhancement, human evolution

Abstract:
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 overwhelming abundance or general acceptance among the scientific community. However, far from abundantly available or generally accepted, the scientific evidence needed to justify the Supreme Court's decision does not exist. Rather, through its rhetoric the Supreme Court majority reveals its prescientific Weltanschauung in which evolution progresses ever onwards and upwards toward an identifiable endpoint (notably the apex of evolution, Homo sapiens). From the Supreme Court's biologically unsupportable perspective, "complex" organisms are accorded privileged status over "simpler" life forms, and "higher" life forms somehow "transcend" their genomes while "lower" organisms apparently remain earthbound by their mundane genomes. In essence, the reasoning of the Supreme Court majority, in denying patentability to animals and plants, owes more to the ancient "Chain of Being" than it does to the accepted scientific view of evolution first published a full century and a half ago in Charles Darwin's The Origin Of Species. In effect, the subsequent Monsanto Canada Inc., v. Schmeiser decision went some distance towards reversing the rule of Harvard College, allowing the de facto patenting of at least one category of "higher" life forms: crop plants. However, even that decision failed decisively to disavow the dichotomy of "higher" and "lower" organisms. The strong influence that prescientific reasoning appears to hold on Canada's Supreme Court has worrying implications for the rational administration of a patent system whose existence is premised on the societal value of scientific advances, not to mention for other legal questions significantly influenced by modern science.

patent, patentable subject matter, evolution, religion

Abstract:
In vivo conversion is a process, often metabolic in nature, wherein one substance, usually a chemical compound, is altered significantly by physiological pathways in the body into one or more different substances. For example, when a patient ingests a therapeutic drug, that drug is often converted by the natural physiology of the digestive system into one or more chemically different metabolites. The end products of in vivo conversion sometimes possess therapeutic efficacy. Many patent applications have claimed such therapeutic metabolites, either as compositions per se or as parts of methods of treatment. Although the USPTO has granted patent claims to such products generated by in vivo conversion of ingested drugs, and courts have noted the eligibility of such products as patentable subject matter, never has a United States court of final appeal upheld such a patent claim as valid, enforceable, and infringed. The unanimity of results in cases involving patent infringement triggered by in vivo conversion is striking. In fact, its very improbability suggests a common underlying explanation for why in vivo conversion does not ever seem to trigger patent infringement. Explanations based on inherency or a lack of evidence provide a satisfactory explanation for only a minority of in vivo cases. The Physiological Steps Doctrine, which suggests that products and processes of in vivo conversion are unpatentable subject matter under U.S. patent law, offers an explanation that spans all in vivo conversion cases. Though the rationales offered to explain the results in a number of in vivo conversion cases are suggestive, there are several advantages for a more explicit recognition of the Physiological Steps Doctrine. Consistent with much international, European, and U.S. patent law, the Physiological Steps Doctrine provides a theoretical underpinning to explain the results in cases involving products and processes of in vivo conversion. This theoretical underpinning not only has explanatory power for interpreting previous case law but is also useful in predicting the outcome of future in vivo conversion cases. In addition, the Physiological Steps Doctrine increases the understanding of where inventions involving human beings, and the biological products and processes thereof, fit within the spectrum of patentable subject matter.

Patent, pharmaceutical, drug, biotechnology, in vivo conversion, prodrug, statutory subject matter, patentability, patentable subject matter, mental steps doctrine, physiological steps doctrine, abbreviated new drug application, ANDA, generic drug, inherency, evidence

Abstract:
During the middle of the 20th Century the courts and the United States Patent and Trademark Office developed a legal doctrine governing the patentability of claims involving “mental steps.” This “Mental Steps Doctrine” rendered unpatentable any patent claim to a process made up of human thought. In a famous statement of this rule, the court in In re Abrams, 188 F.2d 165 (C.C.P.A. 1951), declared that “[i]t is self-evident that thought is not patentable.” Though the Mental Steps Doctrine lost much of its vitality over subsequent years, it now appears to be reemerging in the jurisprudence of both the Court of Appeals for the Federal Circuit (“CAFC”) and the United States Supreme Court. Though the appeal in LabCorp v. Metabolite (U.S. 2006) was ultimately dismissed as improvidently granted, the vigorous dissent to this dismissal argued that the claims at issue (that is, methods of correlating the concentration of a chemical to a human patient’s health) should have been found invalid as unstatutory subject matter for involving human thought. In the wake of LabCorp v. Metabolite, the CAFC’s decisions in In re Cominsky (CAFC 2009) and In re Bilski have revived the Mental Steps Doctrine by reaffirming the unpatentability of claims involving human thought. Many rationales have been offered to justify why thoughts should be unpatentable subject matter, some focusing on possible abstract violations of the First Amendment and others suggesting that “higher” forms of thought, such as mathematical reasoning, should be less patentable than more reflexive forms of thought. Neurobiology offers a powerful lens through which to view such rationales, and may suggest a different approach to the patentability of thought. Recent insights from neurobiology suggest that there exist at least two rather different categories of “thought”. Cerebral cortex-like thoughts may tend to possess a significant volitional character, and may therefore be avoided with conscious effort, whereas cerebellum-like thoughts may tend to be significantly non-volitional in nature. Although some might privilege cerebral cortex-like thoughts over cerebellum-like thoughts because the former often involve “higher” intellectual content than do the former, neurobiology might suggest the opposite result. Since cerebellum-like thoughts are less likely to be under volitional control, infringement of patent claims involving such thoughts may tend to be involuntary; even specific knowledge of a patent claim would tend to be insufficient to discourage infringement, because infringement would tend to be non-volitional. Involuntary patent infringement would seem tantamount to a sort of “patent servitude”. By contrast, it is much more likely that cerebral cortex-like thoughts could be avoided with care and effort, thus allowing the possibility that specific knowledge of a patent claim could discourage, and allow avoidance of, infringement, because infringement would tend to be volitional. Neurobiology can provide useful insight into how patent law might inform a modern, and more rational, Mental Steps Doctrine.