T 0385/14 - Activated oocytes

Key points

• This is an opposition case. The OD had issued the decision 19.12.2013 finding the method of claim 1 unallowable as it involved stem cells derived from human embryonic stem cells.
• The CJEU decided on 18.12.2014 that "unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a 'human embryo'" (ECLI:EU:C:2014:2451).
• The Board: "In view of this ruling and the fact that a protocol to derive human parthenogenetic embryonic stem cells from parthenotes (activated oocytes) was made available by [WO 2003/046141] on 5 June 2003, the European Patent Office now considers that an objection under Article 53(a) EPC and Rule 28(1)(c) EPC [] cannot be raised in respect of an application pertaining to human pluripotent stem cells, [] if (i) the application has an effective date[] on or after 5 June 2003, and (ii) its technical teaching can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes."
• "The board sees no reason, in the context of the present case, to question [this] revised interpretation [by the  EPO].
• "Consequently, the method of claim 1 cannot be regarded as excluded from patentability under Article 53(a) EPC."
• As a comment: the "revised interpretation" appears to never have been published by the EPO. See e.g. T2365/13. I add that in T2365/13 actually had remitted the examination appeal without any substantive findings. 
• As a comment, the present Board appears to adopt the substantive position that activated oocytes are not "human embryos" in the sense of Rule 28 EPC without any examination of the technical merits of that position (I note that the opponent made no submissions on Rule 28). A question is whether the Board has a duty to consider the technical merits of the CJEU's position that oocytes are not "human embryos" in view of the reference to the EU Biotech directive in Rule 26(1) EPC, laid down by the Administrative Council, and the Board's task and independent responsibility under the EPC. 

EPO T 0385/14  link

Reasons for the Decision

Main request (claims as granted) - Articles 100(a) and 53(a) EPC and Rule 28(1)(c) EPC

1. In the decision under appeal, the opposition division, referring to decision G 2/06 of the Enlarged Board of Appeal (OJ EPO 2009, 306) and the Guidelines for Examination in the EPO, Part G, Chapter II-32.5.3(iii), found that the method of claim 1, as far as it involved the use of in vitro differentiated cardiomyocytes that were derived from a human embryonic stem cells, was excluded from patentability under Article 53(a) and Rule 28(c) EPC, because at the effective date such cells could be prepared exclusively by a method which necessarily involved the destruction of human embryos.

2. After the date on which the decision under appeal in the present case was taken, the European Patent Office revised the interpretation of Rule 28(c) EPC in the light of judgments C-34/10 and C-364/13 of the Court of Justice of the European Union on the interpretation of Article 6(2)(c) of the EU Directive 98/44/EC. In judgement C-364/13 [ECLI:EU:C:2014:2451], the Court of Justice had ruled:

"Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a 'human embryo', within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine."

3. In view of this ruling and the fact that a protocol to derive human parthenogenetic embryonic stem cells from parthenotes (activated oocytes) was made available by the publication of a patent application under the PCT (WO 2003/046141) on 5 June 2003, the European Patent Office now considers that an objection under Article 53(a) EPC and Rule 28(1)(c) EPC as entered into force on 1 July 2017 (formerly Rule 28(c) EPC) cannot be raised in respect of an application pertaining to human pluripotent stem cells, including human embryonic stem cells, uses thereof or products derived therefrom if (i) the application has an effective date (i.e. a valid priority date or, if no priority is claimed or the priority is not valid, a filing date) on or after 5 June 2003, and (ii) its technical teaching can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes.

4. The board sees no reason, in the context of the present case, to question the revised interpretation of Rule 28(1)(c) EPC (formerly Rule 28(c) EPC) by the European Patent Office. The revised interpretation applies to the patent at issue. The patent was granted on a European application filed on 11 May 2005, claiming the priority of a previous application filed on 11 May 2004. There is no evidence on file showing that the cardiomyocytes required for carrying out the method of claim 1 cannot be obtained by in vitro differentiation of human embryonic stem cells derived from parthenogenetically activated human oocytes. Hence, contrary to the finding in the decision under appeal, it cannot be asserted that, at the effective date, putting into practice the invention to which the patent relates necessarily involved the destruction of human embryos.

5. Consequently, the method of claim 1 cannot be regarded as excluded from patentability under Article 53(a) EPC.

Remittal for further prosecution (Article 111(1) EPC)

6. In the decision under appeal, the grounds for opposition of Article 100(a) in connection with Articles 54 and 56, and 100(b) EPC were not examined in connection with the claims as granted. The board exercises the discretion conferred by Article 111(1) EPC to remit the case to the opposition division for further prosecution.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the opposition division for further prosecution on the basis of claims 1 to 31 as granted.