Patents on inventions related to human embryonic stem cells: the morality clause after Brüstle v. Greenpeace.Med Law. 2013 Sep;32(3):347-72
Authors: Panis S
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.