Panis Sarah
University of Antwerp, Belgium.
Med Law. 2013 Sep;32(3):347-72.
This paper analyses the meaning of Article 6, para. 2, sub c of the Biotechnology Directive prohibiting patents on inventions using human embryos for industrial or commercial purposes. It first examines the evolution ofthe Court of Justice ofthe EU's interpretation of this provision (which is part of the morality clause) and focuses on its most recent decision, Brüstle v. Greenpeace. This is considered a landmark case for three reasons: firstly, because it defines for the first time the term "embryo" in patent law; secondly, because it is the Court of Justice (and not EPO) that ruled on patent law; the third reason is its very broad interpretation of the morality exclusion. The exclusion is no longer limited to embryos but is extended to (even banked) embryonic stem cells and all downstream products made with them. It then looks into the consequences for the patentability of inventions using cells derived from human embryonic stem cells, such as Brüstle's invention. The recent decision by Germany's Federal Court of Justice on the validity of Brüstle's patent emphasises the limited influence on the patentability of those inventions. After that, the paper addresses possible cuts in funding stem cell research and even legislative bans of this type of research. This is followed by an evaluation of the existence and content of the morality exclusion. After a comparative analysis with the US, which is lacking in such morality exclusion, the paper concludes that the morality clause as a whole paid its dues but the provision on the use of human embryos is questionable as there is no European consensus against the use of human embryos for industrial or commercial purposes.
本文分析了《生物技术指令》第6条第2款c项的含义，该项禁止对利用人类胚胎用于工业或商业目的的发明授予专利。文章首先考察了欧盟法院对这一规定（该规定是道德条款的一部分）解释的演变，并重点关注其最新判决——“布吕斯特勒诉绿色和平组织案”。该判决被视为具有里程碑意义的案件，原因有三：其一，它首次在专利法中界定了“胚胎”一词；其二，对专利法作出裁决的是欧盟法院而非欧洲专利局；其三，它对道德排除条款作出了非常宽泛的解释。这种排除不再局限于胚胎，而是扩展到（甚至包括储存的）胚胎干细胞以及用它们制造的所有下游产品。接着文章探讨了对于使用源自人类胚胎干细胞的细胞所做发明（如布吕斯特勒的发明）的可专利性的影响。德国联邦法院最近就布吕斯特勒专利有效性作出的判决强调了这些发明对可专利性的影响有限。此后，文章探讨了干细胞研究资金可能削减甚至对此类研究的立法禁令。接下来是对道德排除条款的存在及内容的评估。在与缺乏此类道德排除条款的美国进行比较分析后，文章得出结论，道德条款总体上发挥了作用，但关于使用人类胚胎的规定存在疑问，因为在欧洲对于将人类胚胎用于工业或商业目的并无一致反对意见。
