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Patenting Lives Conference
Ethical, Legal and Social Issues of Human Gene Patents Panel
The Varieties of Open Source and the Implications for Medical Genetics
David Castle
Intellectual property in biotechnology raises concerns about the potential for harmful distributional effects resulting from the ownership and control of genes. The unease is felt both with respect to the potential impact on freedom to research, but also on the downstream, post-commercialization effects on consumers. The other concern is that, apart from harmful distributional effects, intellectual property in biotechnology encourages a culture of proprietarianism with respect to knowledge that could benefit all of humanity. For these reasons, various forms of open source intellectual property regimes have been explored. Recently, especially in the case of intellectual property in agricultural biotechnology, some open source strategies have been implemented. At first glance, it appears that the initial models for open source access to gene patents may arise in the context of agricultural biotechnology. Open access to human gene patents may eventually borrow these models, and so it is worth considering now what implications open access in agricultural biotechnology might have on human gene patents.
Patent Scope in Genes: A Comparative Analysis of Scope
Richard Gold
The field of patentable inventions is ever widening into new areas of science and now even extends to elements of humans, such as genes. However, just because genes are patentable this is not necessarily prima facie evidence that all aspects of a gene are protected by patent rights. In fact, the scope of patent rights is tied to the claims of the patent. There are two instances when the scope of claims may be decreased, during patent prosecution and as a result of claims construction. It is rare that claims are drafted in clear language and as such the act of construing patent claims may result in a radically different interpretation of the breadth of the claims being arrived upon than that which was previously accepted as representing the scope of the claims in question. Gene patents have been construed with surprising results in recent judgements. These examples of the result of construing claims over elements of humans may instruct us as to the potential viability of patenting humans in the future.
Stem Cell Patents: Converging Social Concerns?
Tim Caulfield
Debates about the patentability of human biological material have been with us for decades. For example, the rapid advances that have occurred in the area of human genetic research, spurred on by the Human Genome Project, introduced a variety of new patenting controversies. But despite intense academic and policy scrutiny, outside of a very few jurisdiction, the technical patentability of human genetic material has never been in doubt. With stem cell research, however, jurisdictions have taken very different paths, thus creating a high degree of legal uncertainty. For example, the US allows the patenting of embryonic stem cell lines, while the law is less clear in Europe . Indeed, there are reasons to believe that in some jurisdictions, such as Canada , stem cell patents could become a focal point of public concern. This presentation will examine and critique the legal and social issues associated with stem cell patents, including: public opinion data regarding biological patents; the relevant variation in international patent regimes and stem cell research policy; and the growing concern regarding the impact of patents the "commodification" and "commercialization" human biological material.
Cross Jurisdictional Gene Patenting: The Evolution and Effect of Myriad Genetics' BRCA1 and BRCA2 Patent
Stuart Smyth
This paper is an analysis of the economic, legal and social (ELS) impacts of the Myriad Genetics patent on the Breast Cancer 1 ("BRCA1") and Breast Cancer 2 ("BRCA2") genes in Canada , Europe and the United States . Some research has shown that roughly ten percent of all diagnosed cases of breast and ovarian cancer are hereditary. Resulting from this discovery is the premise for the patenting of the BRCA1 and BRCA2 genes used in diagnostic testing for the pre-disposition of breast and ovarian cancer. More specific to the ELS analysis contained in this paper, this paper discusses the question of business strategy of the private corporation versus testing availability within the scope of the provision of healthcare services as well as the evolution of the rights granted under the original patent to what rights are afforded under the same patent today in Canada, Europe and the United States.
