Dr Matthew Rimmer, Australian Centre for Intellectual Property in Agriculture, ANU.
This presentation considers the legal and public policy debate over patent law and stem cell research. It examines the relationship between commercialisation, access to medicines, bioethics, and consumer rights.
The field of stem cell research has raised difficult issues about the limits and the boundaries of patentable subject matter. This presentation highlights the lack of harmonisation in the treatment over patent law and stem cell research. First, this presentation considers the debate over patent law and stem cell research in Australia. It examines the legislative history behind section 18 (2) of the Patents Act 1990 (Cth), which provides that ‘Human beings, and the biological processes for their generation are not patentable inventions.’ It considers the interpretation of s 18 (2) of the Patents Act 1990 (Cth) in two key decisions by the Deputy Commissioner of Patents - Fertilitescentrum AB and Luminis Pty Ltd and Woo-Suk Hwang. Second, this presentation examines the significance of the ruling of the 2012 Supreme Court of the United States in the Association for Molecular Pathology v. Myriad Genetics on gene patents for stem cell research. In particular, it considers the challenge by the Consumer Watchdog and the Public Patent Foundation to the United States Court of Appeals for the Federal Circuit to a patent on human embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF). The public interest groups have argued that a rejection of the patent would be “especially appropriate in light of the recent Supreme Court ruling” in the case of Myriad Genetics, which held that genes cannot be patented. Third, this presentation examines the significance of the decision of the Court of Justice of the European Union in the Oliver Brustle v. Greenpeace case. In this matter, the Court interpreted the European Union Biotechnology Directive 1998 as meaning that 'any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’.' The Court of Justice noted that 'it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.' Moreover, 'The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.' Finally, this presentation considers the ongoing public policy debates over intellectual property and biotechnology.
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