Rimmer Matthew
Faculty of Law, Australian National University.
J Law Med. 2003 May;10(4):488-505.
This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called "Edinburgh patent", and the inquiry of the European Group on Ethics in Science and New Technologies into "The Ethical Aspects of Patenting Involving Human Stem Cells".
本文探讨了专利法在干细胞研究方面所起的整体作用。它强调了对商业化、基本药物获取和生物伦理的担忧。文章认为,1990年《专利法》(澳大利亚联邦)在干细胞研究是否属于可专利主题方面存在根本性的模糊之处。鉴于国家干细胞中心的设立以及2002年《涉及胚胎的研究法》(澳大利亚联邦)的通过,有必要修订相关立法。文章对威斯康星校友研究基金会和杰龙公司在美国干细胞研究方面获得的强有力专利保护表示担忧。它认为一些法律改革可以保障干细胞系以及由此产生的药物和疗法的获取。最后,本文探讨了在《欧洲生物技术指令》框架内如何处理伦理问题。它审视了欧洲专利局关于所谓“爱丁堡专利”的决定,以及欧洲科学与新技术伦理小组对“涉及人类干细胞专利的伦理问题”的调查。