Biotechnology and law: biotechnology patents. Special considerations on the inventions with human material.

The EC and the US differ considerably in their ruling on the patentability of biotechnological inventions apart from some exceptions. The most extreme positions in either direction with regard to the individual biotechnological inventions mark the margins of the scope which the WTO members may use for the ratification of Art. 27 TRIPS. Rulings which are not in accordance with Art. 27 TRIPS remain without consideration. In the most important point both WTO member agree: Human beings are not patentable. Other regulations could be considered, but one may assume that no member of the WTO intends to make use thereof. Thus the scope involving this option is only a theoretical one. The situation is different when it comes to the components of the human body. These may, provided they are produced artificially or are separated from the human body, be patented. According to the regulations in the US, this applies to all components with the exception of totipotent stem cells. They may be exempted from patenting entirely or their patenting is linked to far reaching conditions. As an example should be named here the regulation of the EPA for patenting gene sequences. The scope of this area is, thus, very great and allows for many options of applying the regulations of Art. 27 TRIPS. With regard to patenting procedures for cloning human beings, the scope is unlimited. These procedures may either be completely excluded from patenting as in the EC or may be considered patentable independent of their purpose as in the US. The same applies to procedures for gathering human stem cells in the US. Exempting procedures with regard to human genes or DNA sequences are, however, only possible in special cases, as for example in the EC with regard to procedures for altering the genetic identity of the germline of human beings. However, the interpretation of general patentability preconditions allows to influence the patenting of such procedures. This means, though, that the scope for interpretation is only a small one in this area.     

Technical Cooperation and the International Coordination of Patentability of Biotechnological Inventions

Within the formal international framework, the coordination and harmonization of substantive patentability is currently of a limited nature, confined to the level of general principles, in contrast to the greater degree of procedural coordination. This involves increased costs and a lack of legal certainty for those seeking patents in multiple jurisdictions, mainly transnational corporations in some research-based industries such as pharmaceuticals. The problems encountered in achieving even a basic level of international consensus have encouraged informal cooperation through what could be conceptualized as 'global patent networks'. Furthermore, the interrelationship between procedural and substantive patent law issues has led the Trilateral Patent Offices, an informal, transgovernmental regulatory network of technical specialists, to undertake projects relating to the harmonization of procedural and substantive patent law issues primarily in contentious areas of patentability such as biotechnology. This raises the possibility of developing convergent interpretations of the patentability rules, although with implications for accountability and legitimacy.     

The Effects of University Patenting and Licensing on Downstream R&D Investment and Social Welfare

A central argument behind the Bayh-Dole Act presumed that firms had no incentives to invest in downstream R&D aimed at developing university inventions committed to the public domain. The empirical evidence on university patenting and licensing is partly at odds with the premises of this argument. Non-exclusive licensing of university patents has been common and lucrative, and in the area of biomedical technologies university patents and licensing restrictions may be a hindrance to downstream R&D, rather than a stimulus. The paper presents a model of R&D competition based on a university invention where appropriability conditions are defined by the patentability of downstream innovations and imitation opportunities. A comparison of equilibria under “open access” to university inventions and under “university patenting” shows that only under restrictive conditions the latter regime results in increased R&D investment and social welfare. In general, university licensing royalties are therefore a poor gauge of social welfare gains from university patenting. This is an extensive revision of the paper “University Patents, R&D Competition, and Social Welfare” presented at the conference on University Spin-Offs at the Université du Québec à Montréal on February 27th, 2004. I would like to thank the conference participants and a referee from the journal for useful comments and suggestions.     

University opposition to unfettered research: a new bedfellow for biotech?

This Article examines university opposition to a proposed statutory exemption to infringement liability for basic genetic research and patient care. Gene patenting has allowed patentees to bar basic genetic research, slowing the progress of developing and administering diagnostics and gene-targeting therapeutics. Debates over the merits of gene patents have been heated, most recently leading to an unprecedented invalidation of several broad patents covering all variations and use of two genes linked to breast and ovarian cancers. More important, however (as this ruling was reversed in part), are proposed statutory exemptions to infringement liability. The Department of Health and Human Services' Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) has promulgated an exemption from liability for infringement that occurs in the course of research. This exemption would promote basic research by granting academic scientists unfettered access to genetic material. The proposal does not alter the patentability of gene sequences; it merely restricts patentees from using infringement threats to stop research. Surprisingly, the Association of University Technology Managers (AUTM), an organization responsible for promoting development of university research, opposes such an exemption. The AUTM alleges that the exemption would slow research by reducing the incentive for private firms to invest in upstream discoveries made in university laboratories. Yet the exemption would do the opposite: by opening the doors to research relating to any gene segment, a research exemption would accelerate basic research. Moreover, it would not affect collaboration with private industry: where there is potential to commercialize basic research, biomedical companies would continue to license the rights to university discoveries. Thus, the AUTM's motivations in opposing the proposed research exemption are suspect. They appear to reflect either a misunderstanding of the purpose behind granting property rights to publicly funded university research, or an improper alignment with industry goals.     

Wrongful life actions: the legal and ethical hurdles

This article discusses the various legal and ethical issues arising out of the cause of action for wrongful life. This action involves a claim by a child that but for the negligence of the doctor, hospital or other medical institution, his or her mother would have terminated the pregnancy and he or she would not have been born. The courts have generally rejected this cause of action on the basis of legal, ethical and policy considerations. The author proposes that the legal hurdles can be overcome and that the ethical and policy considerations do not outweigh the desirability of upholding wrongful life claims.     

Patenting and spin-off creation by Canadian researchers in engineering and life sciences

This paper examines the determinants of patenting and spin-off creation using survey data of 479 researchers in engineering and 449 researchers in life sciences funded by the Natural Sciences and Engineering Research Council of Canada (NSERC). The results show that research novelty and laboratory size are the only two variables significantly explaining patenting and spin-off formation in both engineering and life sciences. Network capital explains spin-off formation in engineering and in life sciences as well as patenting in life sciences, but not in engineering. Furthermore, the results suggest that many categories of resources explain patenting and spin-off formation in engineering and in life sciences, but that the combinations of resources required differ for patenting and spin-off formation and between engineering and life sciences. The results of this paper suggest that customized policies would be required to accommodate differences between spin-off formation and patenting as well as between engineering and life sciences.      

Patents impediment or expedient to technology transfer

This paper examines the role that patents play in transferring technology. The history of our patent system and the requirements for patentability are reviewed. The option of keeping an invention as a trade secret rather than applying for a patent is presented. The paper also discusses the rationale behind the government’s change in its policy which permits exclusive licensing of public-owned patents. The author concludes that patents are not a barrier but a significant help in promoting technology transfer.     

The Human Genome Diversity Project: The Politics of Patents at the Intersection of Race, Religion, and Research Ethics

The patenting of human genetic materials provokes wide-ranging misgivings about the appropriate place and scope of intellectual property protections. The issues implicated range from anti-competitive practices in the market, the imposition of limits on biomedical research, increasing costs for health care, research ethics, potentials for racial discrimination, and various violations of human rights. Exploring controversies around the Human Genome Diversity Project, patents on genetic sequences, and patents on higher life forms such as the so-called "Harvard mouse," the authors find that North American patent policy has developed in the absence of necessary political debate. They link this de-politicization to the hegemony of neo-liberal principles most fully demonstrated by the incorporation of intellectual property under international trade negotiations. They point, however, to the recent emergence and increasing audibility of new social movements that seek to reposition issues of intellectual property in larger debates about human rights, distributional equalities, and social justice.     

Theorizing waste in abortion and fetal ovarian tissue use.

This article explores the theoretical implications of the concept of waste as it specifically relates to arguments in favour of fetal ovarian tissue use as a source of donor eggs. The author begins by discussing medico-scientific constructions of women's reproductive bodies as wasteful. The article explores the works of Drucilla Cornell on bodily borders, Julia Kristeva on abjection, and Mary Douglas on pollution to develop a nuanced understanding of the relations between waste, women's reproductivity, and abortion in North American mainstream and medico-scientific cultures. This layered reading of waste and abortion deconstructs a significant assumption of arguments in favour of fetal ovarian tissue use as ethical--that such tissue is just "waste." The author suggests that theorizing waste this way may contribute to ethical analyses of uses of other reproductive materials (that is, embryos) that are supported, in part, by an assumption that those materials would otherwise be "wasted."     

Stem cell technologies: regulation, patents and problems

Human embryonic stem cell research promises to deliver in the future a whole range of therapeutic treatments, but currently governments in different jurisdictions must try to regulate this burgeoning area. Part of the problem has been, and continues to be, polarised community opinion on the use of human embryonic stem cells for research. This article compares the approaches of the Australian, United Kingdom and United States governments in regulating human embryonic stem cell research. To date, these governments have approached the issue through implementing legislation or policy to control research. Similarly, the three jurisdictions have viewed the patentability of human embryonic stem cell technologies in their own ways with different policies being adopted by the three patent offices. This article examines these different approaches and discusses the inevitable concerns that have been raised due to the lack of a universal approach in relation to the regulation of research; the patenting of stem cell technologies; and the effects patents granted are having on further human embryonic stem cell research.     

Academic patents and materials transfer agreements: substitutes or complements?

U.S. universities and academic medical centers long have been important performers of research in the life sciences, but their role as a source of patented intellectual property in this field has changed significantly in the late 20th and early 21st centuries. The expanded presence of formal intellectual property rights within the academic biomedical research enterprise has occasioned numerous expressions of concern from scholars, policymakers, and participants. One widely expressed fear involves the effects of patenting on the conduct of the scientific research enterprise. There is also considerable concern over the possible role of Materials Transfer Agreements (MTAs) in raising research “transaction costs”. On the other hand, others suggest that the contractual structure provided by MTAs may reduce transaction costs and facilitate exchange. This paper undertakes a preliminary analysis of the role of MTAs in the biomedical research enterprise at the University of Michigan, a significant patenter and licensor of biomedical intellectual property. We examine the relationship among invention disclosures, patenting, licensing, and the presence or absence of an MTA. Although data limitations make any conclusions tentative, our analysis suggests that the increased assertion of property rights by universities through MTAs does not appear to impede the commercialization of university research through patenting and licensing.

The Use of Nonhuman Animals in Biomedical Research: Necessity and Justification

Discourse about the use of animals in biomedical research usually focuses on two issues: its empirical and moral use. The empirical issue asks whether the use of nonhumans in experiments is required in order to get data. The moral issue asks whether the use of nonhumans can be defended as matter of ethical theory. Although the use of animals in research may involve a plausible necessity claim, no moral justification exists for using nonhumans in situations in which we would not use humans.     

The regulation of science and the Charter of Rights: would a ban on non-reproductive human cloning unjustifiably violate freedom of expression?

Non-Reproductive Human Cloning (NRHC) allows researchers to develop and clone cells, including non-reproductive cells, and to research the etiology and transmission of disease. The ability to clone specific stem cells may also allow researchers to clone cells with genetic defects and analyze those cells with more precisions. Despite those potential benefits, Parliament has banned such cloning due to a myriad of social and ethical concerns. In May 2002, the Canadian Government introduced Bill C-13 on assisted human reproductive technologies. Bill C-13 deals with both the scientific and the clinical use of human reproductive materials, and it prohibits a number of other activities, including NRHC. Although the Supreme Court of Canada has never ruled on whether scientific experiments area form of expression, academic support exists for this notion. The authors go through the legal analysis that would be required to find that scientific experiments are expression, focusing in part on whether NRHC could be considered violent and thus fall outside the protection of section 2(b). The latter question is complicated by the ongoing policy debate over whether an "embryonic cell" is property of human life. The authors then consider whether a ban on NRHC could be justified under section 1 of the Charter. They conclude that both the breadth of the legislative purpose and the proportionality of the measure are problematic. Proportionality is a specific concern because the ban could be viewed as an outright denial of scientific freedom of expression. Although consistent with current jurisprudence on freedom of expression, this paper runs against the flow of government policy in the areas of regulation and prohibition of non-reproductive human cloning. As there has been no Charter litigation to date on whether scientific research is a form of expression, the authors introduce a new way of looking at the legality of the regulation of new reproductive technologies.     

Public expectations of health professionals when patients telephone for medical advice

This article focuses on the ethical, social and liability implications of patients obtaining unsolicited medical advice over the phone. The ethical discussion centres on the demise of paternalism and the increase in patient autonomy and individualism and the growing public expectations of health professionals. The article then discusses the advantages and disadvantages of telephone consultations from a social and policy perspective. In light of these considerations it considers what the liability implications are for phone consultations. It argues that the ethic of individualism, coupled with recent Australian tort reforms, suggests that only in limited circumstances would a doctor be found liable for negligence in relation to telephone consultations. However, the increasing expectations being placed on medical personnel, as evidenced by the increase in unsolicited telephone consultations, if left untempered, may lead to a situation with which the health care system is ill equipped to deal.     

论刑法适用中道德评价因素的考量

道德评价能否在刑法适用中予以考虑,是刑事司法中的难题。一方面,道德评价在刑事司法中的体现是普遍存在的实然现象;而另一方面,法治原则一般又要求道德评价不应介入司法领域,否则,依法司法的理念将受到冲击。从理论上来看,道德评价可以在刑法适用解释中予以考虑,与其让道德评价潜在地、非理性地影响刑法的解释与适用,不如理性地承认和接受道德评价因素,并对其规范、限制和合理运用。道德评价因素在刑法解释和适用中的考量既是法理的要求,也是刑法原则所许可的,那种绝对排斥道德评价的观点,看似符合法治原则,但实际上并不能成立。从社会学的视角判断,刑法适用中考量道德评价因素是社会和谐的需求,也是社会学解释方法的题中应有之义。当然,对道德评价的考量与运用,应当在法律方法论的范围内,并在对其认真甄别、选择的基础上进行。     

Greenberg v. Miami Children 's Hospital: unjust enrichment and the patenting of human genetic material

Individuals and societal groups are questioning the practice of patenting human genetic material in the context of medical research and health care, where diverse ethical, social, and political objections are being raised by critics. A recent case provides a broad legal theory, the common law cause of action, unjust enrichment, and a precedent for challenging the commercialization and patenting of human genetic material.     

Selective justice,genetic discrimination,and insurance: should we single out genes in our laws?

This article discusses the desirability of legislation focusing on genetic discrimination, in particular in the context of insurance. Many American states and some European countries as well as the Council of Europe have introduced protective measures against discrimination on the basis of genetic susceptibility. The author questions their effectiveness and queries whether they may be inequitable, because they fail to address more fundamental underlying issues related to the nature of insurance, access to health care, and unequal distribution of wealth. There is also a problem of definition in these statutes. They fail to capture what constitutes genetic information. Nonetheless, the author argues it is important to consider the social consequences of genetic testing. Michael Walzer's theory of justice is used to examine the role of insurance and health care. Using this approach, the author finds the American system of distribution for health care to be problematic. This is then used to inform the author's discussion of the future of health care in Canada. Anti-discrimination provisions could be used in a way that is consistent with Walzer's theory of justice. They would encompass both genetic and non-genetic health factors. These can be modelled on current anti-discrimination statutes in Canada. The author then proposes administrative committee structures to regulate the use of genetic data in Canada.     

The patentability of human beings: the effect of a proposed exclusion in the Patents Act 1953

The author critically examines the debate over whether "human beings" ought to be patentable. The article outlines the choices between excluding just the patenting of whole organisms or parts of organisms. After considering New Zealand, Canadian, and European Union Patent law, the author concludes that at very least New Zealand must statutorily prevent the patenting of whole organisms.     

The birds,the bees,and the deep freeze: is there international consensus in the debate over assisted reproductive technologies?

This Comment traces assisted reproductive technologies from their historical beginnings in early artificial insemination techniques, through the revolutionary advent of in vitro fertilization two decades ago, and continues to current experimental procedures such as embryo twinning and cryopreservation of ova. It then examines the worldwide controversy surrounding clinical use of these technologies and international attempts to resolve these issues. The final focus is on whether or not a consensus exists within the international legal community on how to tackle the complex issues presented by recent advances in reproductive technology.     

An ethical analysis of the mandatory exclusion of immigrants who test HIV-positive

On 20 September 2000, Canadian newspapers reported that Health Canada recommended to Citizenship and Immigration Canada (CIC) that testing all prospective immigrants for HIV, and excluding those testing positive, constitutes "the lowest health risk course of action." Subsequently, the Minister of Citizenship and Immigration stated that CIC is indeed considering implementing mandatory HIV testing for all prospective immigrants to Canada, and excluding all those testing positive (with the exception of refugees and family-class sponsored immigrants) from immigrating to Canada on both public health and "excessive cost" grounds. This proposal was met with vehement opposition from a broad range of organizations and individuals. In particular, they pointed out that, as stated in the International Guidelines on HIV/AIDS and Human Rights (UNHCHR/UNAIDS, 1998: para 105), "[t]here is no public health rationale for restricting liberty of movement or choice of residence on the ground of HIV status." At the time of going to print, no final decision had been made about whether mandatory HIV testing for all immigrants would be implemented. There are sound ethical, legal, and public policy arguments against imposing mandatory testing and excluding those who test HIV-positive.