Dreyfuss Rochelle C, Nielsen Jane, Nicol Dianne
Engelberg Center on Innovation Law and Policy, New York University School of Law, New York, NY 10012, USA.
Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, TAS 7001, Australia.
J Law Biosci. 2018 Oct 1;5(3):550-589. doi: 10.1093/jlb/lsy021. eCollection 2018 Dec.
The landscape for patenting products and processes tied to the natural world has changed dramatically in recent times as a result of a series of decisions of the US Supreme Court, particularly 566 U.S. 66 (2012) and 569 U.S. 576 (2013) (). This article critically analyses these decisions and the multitude of lower court decisions that have followed them. This analysis provides support for the growing concern in the United States that it will be increasingly difficult to use the patent system to encourage the development of therapies and research intermediates useful in developing new therapeutic interventions. One option being posited in the industry to deal with this problem is to lobby Congress to reform the threshold patent eligibility standard in US patent law. It is argued in this paper that a more nuanced approach is preferable. Using the experience in Australia as a case study, this paper argues that such an approach is feasible. Australia has been chosen for analysis because the threshold patent eligibility standard is similar in both countries, much more so that with the European Union, and because the highest court in Australia has ruled on essentially the same patent as in , in [2015] HCA 35. In addition to the nuanced approach to eligibility currently exercised by the Australian courts and patent office, Australia also has a number of post-grant options for addressing the dynamics of patent monopolies. These include experimental use, compulsory licensing, and government use. It is concluded that, while it would be impractical to attempt to replicate the Australian environment in the United States, there is no reason why some lessons can't be learned from the Australian experience with patenting nature.
由于美国最高法院的一系列裁决,尤其是美国最高法院第566卷第66号(2012年)和第569卷第576号(2013年)的裁决,与自然界相关的产品和方法的专利申请情况在最近发生了巨大变化。本文对这些裁决以及随后众多下级法院的裁决进行了批判性分析。这一分析支持了美国日益增长的担忧,即利用专利制度鼓励开发对新治疗干预措施有用的疗法和研究中间体将变得越来越困难。该行业提出的应对这一问题的一个选择是游说国会改革美国专利法中的专利资格门槛标准。本文认为,一种更细致入微的方法更为可取。以澳大利亚的经验为例,本文认为这种方法是可行的。选择澳大利亚进行分析是因为两国的专利资格门槛标准相似,比与欧盟的标准更为相似,还因为澳大利亚最高法院对与美国最高法院第[2015]HCA 35号裁决中基本相同的专利做出了裁决。除了澳大利亚法院和专利局目前对资格采用的细致入微的方法外,澳大利亚还有一些授予专利后的选项来应对专利垄断的动态变化。这些选项包括实验性使用、强制许可和政府使用。结论是,虽然试图在美国复制澳大利亚的环境是不切实际的,但没有理由不能从澳大利亚在自然专利方面的经验中吸取一些教训。