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Patentability of stem cells in Europe - Decision G 2/06

Patentability of stem cells in Europe - Decision G 2/06

09/12/08

Background

As discussed in our earlier news article (http://www.wpt.co.uk/news/view.jsp?ref=49), a European patent application of Wisconsin Alumni Research Foundation (WARF) was refused as being in contravention of the following article and implementing regulation of the European Patent Convention (EPC):-

 Article 53(a) EPC: European patents shall not be granted in respect of [...] inventions the commercial exploitation of which would be contrary to ‘ordre public’ or morality”

 Rule 28 EPC: Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following [...]

  (c) uses of human embryos for industrial or commercial purposes”

An appeal against this refusal has now resulted in the Enlarged Board of Appeal of the European Patent Office (EPO) clarifying the meaning of the law in this area. The Enlarged Board issued its ruling on 25 November 2008 as Decision G 2/06.

The Ruling 

Four questions were referred to the Enlarged Board:

1) Does Rule 23d(c) [now 28(c)] EPC apply to an application filed before the entry into force of the rule?

2) If the answer to question 1 is yes, does Rule 23d(c) [now 28(c)] EPC forbid the patenting of claims directed to products (here: human embryonic stem cell cultures) which – as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, if the said method is not part of the claims?

3) If the answer to question 1 or 2 is no, does Article 53 (a) EPC forbid patenting of such claims?

4) In the context of questions 2 and 3, is it of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos (here: e.g. derivation from available human embryonic cell lines)?

These were answered as follows:

1) Rule 28 (c) EPC (formerly Rule 23d(c) EPC) applies to all pending applications, including those filed before the entry into force of the rule.

2) Rule 28 (c) EPC (formerly Rule 23d(c) EPC) forbids the patenting of claims directed to products which - as described in the application — at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said, products are derived, even if the said method is not part of the claims.

3) No answer is required since questions 1 and 2 have been answered with yes.

4) In the context of the answer to question 2 it is not of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos

The Enlarged Board also rejected a request for a preliminary ruling by the European Court of Justice (ECJ) as inadmissible.

The Key Issues

 WARF's patent claims sought to cover embryonic stem cells (including human embryonic stem cells) whereas Rule 28(c) concerns uses of human embryos for industrial or commercial processes. One of WARF's arguments was that its case should not be prohibited under Rule 28(c) because the claims did not cover the use of human embryos.

The Enlarged Board disagreed. It stated: “What needs to be looked at is not just the explicit wording of the claims but the technical teaching as a whole as to how the invention is to be performed. [...] Since [in this case] the only teaching of how to perform the invention to make human embryonic stem cell cultures is the use (involving their destruction) of human embryos, this invention falls under the prohibition of Rule 28(c) EPC” (Reasons for the Decision, Paragraph 22, emphasis added).

The Enlarged Board reached this conclusion despite considering the legislators’ intentions behind the prohibition which led to Rule 28(c) and noting that a draft wording was: “the following shall be considered unpatentable: [...] methods in which human embryos are used” (Reasons for the Decision, paragraph 17, emphasis added). The Enlarged Board has not followed the general principle that exclusions to patentability should be construed narrowly.

The Enlarged Board emphasized that the fact that the invention (as described in the application) necessarily involved the use (and destruction) of human embryos was decisive.

The Enlarged Board stated that it was not relevant that after the filing date the stem cell cultures could be obtained by a method which did not necessarily require the destruction of human embryos, because otherwise there would be legal uncertainty, and third parties who later provided an innocuous way to carry out the invention could be disadvantaged.

As to the Enlarged Board’s refusal to seek guidance from the European Court of Justice (ECJ), several reasons were given: there is no provision in the EPC enabling a referral to the ECJ; EPO Boards of Appeal are courts of tribunals of an international organization whose contracting states are not all members of the EU; the Implementing Regulations of the EPC state that the relevant EU law is only to be used as a supplementary means of interpretation; the EPC states that the members of the Boards shall comply only with the provisions of the EPC; and the EPO Boards do not count as the highest national courts of EU states.