1 Oliver Brüstle v Greenpeace e.V., Case C-34/10, decision of 18 October 2011.

2 For a brief technical overview of HESCs and the associated ethical concerns see Cheney, Kenneth C., “Patentability of Stem Cell Research under TRIPS: Can Morality-Based Exclusions be Better Defined by Emerging Customary International Law?”, 29 Loyola of Los Angeles International and Comparative Law Review (2007), pp. 505 et sqq Google Scholar.

3 The directive was adopted on 6 July 1998. The Netherlands brought Case C-377/98 before the CJEU against the adoption of the directive with six different pleas and requested the annulment of the directive. In its ruling of 9 October 2001 the Court dismissed the application brought by the Netherlands and confirmed the validity of the directive.

4 The list also includes the following non-patentable inventions: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

5 Analogous provisions are contained in Article 27(2) of the TRIPS Agreement (“Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality”) and Article 53(a) of the European Patent Convention (EPC) (“European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to “ordre public” or morality […]”. Rule 28 EPC reflects the contents of Article 6(2) of the Biotech Directive. The EPC Guidelines, Part C, C-IV and paragraph 4.1 confirm that the purpose of the patentability exclusion under Article 53(a) EPC is “to deny protection to inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behavior”. The Guidelines mention antipersonnel mines as an obvious example and note that this exception is likely to be relied on in extreme cases only, e.g. when the invention applied for is so abhorrent that the grant of the patent would be inconceivable.

6 See paragraphs 35-36 of the decision.

7 See paragraphs 42-43 of the decision.

8 The European Parliament's “Resolution on Patents for Biotechnological Inventions” of 26 October 2005 (P6_TA (2005) 0407) had already endorsed this position: “The European Parliament insists that the creation of human embryonic stem cells implies the destruction of human embryos and that therefore the patenting of procedures involving human embryonic stem cells or cells that are grown from human embryonic stem cells is a violation of Article 6(2) of the Directive” (paragraph 14).

9 It is clear from the way the third question was formulated that the said prior use of human embryos is a destructive one.

10 See paragraph 108 AG's opinion.

11 It should, however, be noted that the Brüstle ruling does not affect future HESCs inventions which do not involve the destruction of human embryos. This is an interesting point as new approaches have recently been proposed for deriving HESCs lines without injuring embryos.

12 Yet, the patenting of HESCs inventions has also been blamed for paving the way towards anticompetitive behaviors. In particular, it has been argued that many HESCs patents rely on very broad claims, which might stifle follow-on innovation in the nascent stem cells industry. See Bakardjieva, Antonina, “Stem Cells Patenting and Competition Law”, in Plomer, Aurora and Torremans, Paul (eds.), Embryonic Stem Cell Patents (Oxford: Oxford University Press, 2009), p. 372 Google Scholar.

13 The TRIPS Agreement was signed by all WTO member countries in 1994 and covers all types of intellectual property including patents, copyright and trademarks. It requires intellectual property rights to be protected in all WTO member countries.

14 See Van Den Bossche, Peter, The Law and Policy of the World Trade Organization: Text, Cases and Materials, (Cambridge: Cambridge University Press, 2008), p. 785 CrossRefGoogle Scholar.

15 See Dan Leskien and Michael Flitner, “Intellectual Property Rights and Plant Genetic Resources: Options for a Sui Generis System”, IPGRI, Issues in Genetic Resources No. 6, 1997, p. 15, available on the Internet at <ftp://ftp.cgiar.org/ipgri/Publications/pdf/497.pdf> (last accessed on 4 January 2012).

16 See Gerard Porter, “Human Embryos, Patents and Global Trade: Assessing the Scope and Contents of the TRIPS Morality Exception”, in Plomer and Torremans (eds.), Embryonic Stem Cell Patents, supra note 12, pp. 359–360.

17 See Plomer, Aurora, “Towards Systemic Legal Conflict: Article 6(2) (c) of the EU Directive on Biotechnological Inventions”, in Plomer, and Torremans, (eds.), Embryonic Stem Cell Patents, supra note 12, p. 178 Google Scholar.

18 Committee on Legal Affairs and Citizens’ Rights, 25 June 1997, A4-0222/97. Report on the Proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions/COM/95/0661.

19 See Plomer, “Towards Systemic Legal Conflict”, supra note 17, p. 180.

20 Ibid., p. 186.

21 See paragraph 79 of the decision (Case C-377/98).

22 See paragraphs 106–108 AG's opinion.

23 The cases are many and have been widely reported. See for example the “enola”, “neem” and “ayahuasca” cases. See also the position of Peru in the context of the WTO talks (WTO document IP/C/W/447, p. 6).

24 The Biodiversity Convention was signed in 1992 and entered into force in December 1993. It establishes, (i) that states enjoy sovereignty rights on the genetic resources found on their territories, (ii) a system which allows respect for “prior informed consent” of the country providing the resource. and (iii) the fair and equitable sharing of the benefits arising out of the utilization of the resources with the above entity.

25 In the context of WTO talks some states have adopted similar views. See the position of Peru which has proposed to add an additional letter to Article 27(2) TRIPS, by specifying that WTO Member States may also exclude from patentability “(c) products or processes which directly or indirectly include genetic resources or traditional knowledge obtained in the absence of compliance with international and national legislation on the subject, including failure to obtain the prior informed consent of the country of origin or the community concerned and failure to reach agreement on conditions for the fair and equitable sharing of benefits arising from their use. Nothing in TRIPS shall prevent Members from adopting enforcement measures in their domestic legislation, in accordance with the principles and obligations enshrined in the Convention on Biological Diversity” (see WTO document IP/C/W/447, p. 13).