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3 December 2008
Stem Cells Patent Case Decided by EBA
On 25 November 2008, the European Patent Office (EPO) issued the long-awaited stem cells decision G 2/06 of the Enlarged Board of Appeal (EBA). The EBA has decided that under the European Patent Convention (EPC), patent protection is not available for inventions concerning products (here: human embryonic stem cell cultures) which necessarily involve the destruction of human embryos.
Background to the Decision:
During prosecution before the EPO, the Examining Division refused a patent application filed by Wisconsin Alumni Research Foundation (WARF), because the EPC prohibits patents to be granted for inventions concerning "uses of human embryos for industrial or commercial purposes". The WARF application claimed a cell culture comprising primate embryonic stem cells and, at the time of filing, it was necessary to destroy a human embryo in order to obtain the stem cells. This refusal of the Examining Division was appealed to the Technical Board of Appeal (TBA) under the number T 1374/04, and the TBA referred specific questions to the EBA under the number G 2/06.
As noted above, the EBA has now upheld the refusal, deciding the following:
(1) The EPC forbids the patenting of claims directed to products which at the filing date could be prepared exclusively by a method which necessarily involves the destruction of the human embryos from which said products are derived, even if said method is not part of the claim.
(2) It is irrelevant that after the filing date the same products could be obtained without having to use a method necessarily involving the destruction of human embryos, as technical developments after the filing date cannot be taken into consideration.
(3) The Appellant's request to have the case referred to the European Court of Justice (ECJ) was refused because there are no provisions in the EPC or the Implementing Regulations for a referral by any instance of the EPO of questions of law to the ECJ.
Impact on Patenting:
It is important to note that this decision was based on the specific questions referred to the EBA. The EBA has stressed that "this decision is not concerned with the patentability in general of inventions relating to human stem cells or human stem cell cultures". Thus, this decision does not rule out grant of European patents relating to human embryonic stem cells, provided destruction of human embryos is not involved.
Questions Referred to the EBA:
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 the question 1 or 2 is no, does
Article 53(a) EPC forbid patenting 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: eg derivation from available
human embryonic cell lines)?
