Indigenous self-determination in an age of genetic patenting: recognizing an emerging human rights norm

This Note explores how the law can help indigenous people obtain meaningful control of their genetic material. Part I will briefly discuss the background of genetics, life patents, and indigenous groups. Part II sets out the domestic common law and international human rights law and demonstrates that neither currently provide adequate protection for indigenous peoples. Part III considers the human right of self-determination in the context of indigenous research and patenting, and illustrates that an emerging international norm recognizes an indigenous people's right to control their genetic material. Part IV argues that Congress should pass legislation to adequately meet the human rights needs of indigenous peoples generated by the rapid advancement of biotechnology. This Note concludes that congressional action to protect indigenous peoples is consistent with domestic and international law, and is a natural advancement of human rights and responsible state action.     

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.     

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.     

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.     

Human Genome and Patent

The first phase of the Human Genome Project came to an end by the summer of 2000. We have a fairly complete and accurate listing of all the genes in a typical human being. Apart from the tremendous impact that this knowledge will have on health care, it also represents a patent rush where both private and public institutions are trying to gain temporary control, through patents, over the use and reproduction of genetic information. This paper introduces the reader to issues involving the patent ability of genes, the tests used by patent offices to award patents. The ownership of the human genome--and the access to the tools and databases necessary to make sense out of the millions of bits of information that make up the estimated 100,000 human genes--constitutes one of the hottest debates in the public policy arena not just in the field of science but sociology, politics, law and ethics.     

The governance of human genetic research databases in mental health research

The field of mental health offers a valuable context in which to examine new challenges presented by human genetic research databases to the legal, ethical and regulatory frameworks for human genetic research. Longitudinal prospective genetic research of psychiatric disorders often involves access to human genetic research databases and to stored tissue for future uses that cannot be specified at the time the patient consents to their collection. The potential of such research to contribute to an improved understanding and treatment of complex genetic diseases such as schizophrenia presupposes sound ethical, legal and regulatory frameworks to ensure public trust and preparedness to participate in such research. This article provides a brief overview of some of the ethical and legal challenges posed by human genetic research databases and their implications for how genetic research should be conducted in the field of mental health.     

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.     

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.     

Diagnostic testing of genetic disorders: limiting the scope of patent claims through disclosure requirements

The breadth of claims in patents relating to genetic inventions has been controversial for some time. Possible adverse effects of broad claims include inhibiting research and higher costs, restricting patient access to genetic testing. The Australian Law Reform Commission's Report on Genes and Ingenuity--Gene Patenting and Human Health examined this issue, and concluded that the existing disclosure requirements contained in s 40 of the Patents Act 1990 (Cth) provide adequate mechanisms to control the breadth of claims. However, application of these requirements may be problematical in practice due to lack of relevant case law to provide guidance to patent examiners. It has been suggested that this deficit in direct judicial guidance can be obviated by developing appropriate analogies with other chemical systems in decided cases. This article focuses on gene-based diagnostic patents for human diseases, such as those held by Myriad Genetics for testing predisposition towards breast and ovarian cancer using the gene BRCA1. By examining the application of disclosure requirement by courts in genetic and non-genetic chemical inventions, it is possible to provide insight into how this might be applied by courts considering the validity of patent claims for diagnostic testing methods based on mutations in a gene such as BRCA1.     

The Use of USPTO “Continuation” Applications in the Patenting of Software: Implications for Free and Open Source*

This paper examines the role played by “continuations” (procedural revisions of patent applications) within software patenting and the implications that the use by patentees of continuations has for free and open‐source software design. Our research analyzes data on continuations in software patenting 1987–99, providing information on the effects of changes made to the U.S. patent laws in 1995 intended to curb “submarine patenting.” Our analysis of all U.S. patents issued 1987–99 shows that the use of continuations grew steadily in overall U.S. patenting through 1995, with particularly rapid growth in continuations in software patenting. Sharp reversals in these growth rates after 1995 suggest that changes in the U.S. patent law were effective. We analyze the role of continuation patents in creating opportunities for patentees to engage in strategic “hold‐up” of software adopters and follow‐on software innovators, and extend the analysis to open‐source software.     

Chinese university patents: quantity,quality, and the role of subsidy programs

Chinese university patenting has gained importance in recent years. Using a comprehensive dataset of university patents by 155 leading Chinese universities from 1991 to 2009, our study pursues two objectives: First, we analyze the quantity and quality of patents filed by leading Chinese universities. Second, we analyze the role of subsidy programs with regard to university patenting in China. With regard to the first objective, our results show that university patents witnessed rapid growth in terms of quantity while patent quality did not increase to a similar degree. Regarding the second objective, we find that a subsidy program to promote research excellence at selected universities is a significant driver of patent quantity and quality. In contrast, a subsidy program that decreases the costs of patent applications seems to enhance patent quantity but not patent quality. We conclude that innovation policies which aim to stimulate patents of higher quality should focus primarily on increasing university R&D, and to a lesser extent on decreasing the costs of university patenting.     

The conflict of understanding the genetic make-up of man and his knowledge of it

The rapid development within the research of the human genome offers a great potential with regard to the diagnosis of genetic diseases but it also bears dangers of misuse. The starting point for avoiding these dangers is the autonomy of the individual, i.e. that the information about his genetic constitution should only be ascertained with his explicit consent. It is the duty of law to protect the individual and his relatives - who might also be concerned - without undermining the right to self-determination. Furthermore, it is discussed whether genetic tests should be limited to "health purposes" only. The problem of this limitation, however, is to define the term "health purposes" particularly when the criterion of "quality of life" is also taken into consideration. In order to assure a responsible handling of the genetic data, genetic analysis and especially the counselling of the subject should be reserved to the medical profession, since only a real understanding of the individual's genetic constitution with all risks and chances will enable him to make an informed and self-determined decision.     

美国2011年专利法第一案Myriad案评——人类基因可专利性的再思考

Myriad公司从人体DNA中分离的两种基因片断(BRCA1,BRCA2)获得了专利。美国分子病理协会等提起诉讼,宣称人类基因不是可专利性客体,该专利无效。上诉法院判定该基因片断是合法的专利客体,但该判决与最高法院的先例并不完全吻合。在成文法及司法先例对基因类专利都没有明确规定的情况下,公共政策的分析是更适当的切入角度。从政策性角度分析,否认人类基因的可专利性是对社会最有利的政策。专利制度是工具,不是目的。加拿大的有益实践启示我国也应坚持否认人类基因类专利的政策。     

The impact of international human rights norms—a “law undergoing evolution”

Abstract

In this paper, the author outlines the history of, and reasons for, the growing impact of international human rights jurisprudence upon the work of judges in New Zealand, Australia, England and elsewhere in the Commonwealth of Nations. Formerly, international and domestic law were virtually entirely separate. But now, there is increasing legal authority to support the use of international human rights jurisprudence in domestic judicial decision‐making. It can be done in the application of constitutional or statutory provisions reflecting universal principles stated in international treaties. But, according to the Bangalore Principles, it can also be done where there is a gap in the common law or where a local statute is ambiguous. The judge may then fill the gap or resolve the ambiguity by reference to international human rights jurisprudence which will ensure that domestic law conforms, as far as possible, to such principles.

In its decision in Tavita, the New Zealand Court of Appeal declared this to be “a law … undergoing evolution”. The author outlines some of the impediments and problems for the evolution. But he also collects the reasons why it is a natural and inevitable phase of the common law in the current age. He suggests that judges should be aware of the developments. In appropriate cases, they should inform their decisions with relevant international human rights jurisprudence. That will at least ensure that they develop domestic human rights law in a principled way, consistently with international law, and not in an idiosyncratic fashion “discovering” new fundamental rights which may otherwise be criticised as mere judicial invention.     

Developments in medical law in the United Kingdom in 2005 and 2006

This article highlights and summarises the key developments in medical law in the jurisdictions of the United Kingdom in 2005 and to April 2006. Topics are mental health and mental capacity, data protection, freedom of information and the impact on health data, the Human Tissue Act, genetic research databanks, Human Fertilisation and Embryology Act--Review of the legislation, consultations and related case law, developments in embryo and embryonic stem cell research, clinical trials and human subject research, medical futility, and physician assisted dying.     

Biomedical patents and ethics: a Canadian solution

World Trade Organization member states are preparing for the upcoming renegotiation of the Agreement on Trade-Related Aspects of Intellectual Property Rights. One of the important elements of that renegotiation is the ethical considerations regarding the patenting of higher life forms and their component parts (e.g. DNA and cell-lines). The interface between the genetic revolution, patentability, and ethical considerations is the subject of this article. The author identifies, explores, and critiques four possible positions Canada may adopt in respect of patentability of biomedical material. First, Canada could do nothing. This approach would mean keeping biomedical materials outside the patent system and outside the stream of commerce. Canada would simply wait for an international consensus to develop before adopting a position of its own. Second, Canada could go it alone. It could implement a policy that balances the incentive effects of patents with the need to incorporate ethical and social values into the decision-making process regarding the use of biomedical materials. In respect of this option, the author proposes a model whereby non-profit bodies would hold the exclusive rights to research, use, and exploit biomedical materials. Third, Canada could follow the United States, Europe, and Japan by providing for almost unrestricted patenting of biomedical materials. This would be the most industry-friendly alternative. The fourth and final option is to use the medicare system to promote discussion of ethical considerations involved in the use of biomedical materials. The power of provincial health agencies may be used as a lever to ensure the discussion of ethical considerations concerning the use of biomedical materials. The author concludes that the fourth and final option is the best alternative for Canada while waiting for an international consensus to emerge.     

What motivates the engineers to patent? A study at the Chinese R&D laboratories of a European MNC

Corporate R&D engineers, being usually the initiators of a patent, are important contributors to the patenting performance of their employers. Hence, patenting motives of R&D engineers encompass an interesting and promising research field. However, the literature on patenting motivation of the engineers in the corporate context is scarce. We apply self-determination theory on human motivation to investigate patenting motives of a sample of local R&D engineers in China employed by a European-based multi-national corporation. Factor analysis reveals four groups of motives: “reward and recognition”, “reputation and promotion”, “making a contribution” and “interest and sense of achievement”. The results of multiple hierarchical regression show the influence of working climate on “making a contribution” and “interest and sense of achievement” motivation factors. Implications for patent management are discussed.

     

Rationing human life: health care reform and people with disabilities

Peter Singer has proposed health care rationing that includes an invidious discrimination against people with disabilities. Unfortunately, Congress has codified the potential for such discrimination in the 2010 Patient Protection and Affordable Care Act. But why should any public official have the discretion to treat the lives of people with disabilities as of "lower value" than the lives of anyone else. There must be a comprehensive limitation in the law against the misuse of comparative clinical effectiveness research to support the rationing of human life.     

Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule

The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes.