Generally, the European Patent Office does not allow claims to methods involving the use of human embryos for industrial or commercial purposes. It was therefore perhaps not surprising that the Examiner objected to the claims of EP 05028411.6, which related to a method for obtaining pluripotent embryonic stem cells from an embryo. In defence of the claims, the applicant argued that, since the embryo was not destroyed in the method, the claims were allowable following the decision of the Enlarged Board of Appeal G2/06 (the "WARF" Decision).
However, this argument was not accepted. The Examining Division maintained that the overriding consideration as to whether a method involving the use of a human embryo is patentable or not is whether the claimed method is of diagnostic or therapeutic benefit to the embryo. Since the embryo did not benefit from the claimed method, the application was refused.
On appeal it was accepted by the Board of Appeal that, where the claimed method was of diagnostic or therapeutic benefit to the embryo, there would be an exemption from the general exclusion from patentability of methods involving the use of embryos. The applicant tried to rely on this by arguing that the cells obtained by the claimed method could later be used to treat the human that had developed from the embryo from which the cells had been obtained. However, as this future use was not specified in the claim, the Board rejected the argument.
The applicant then attempted to amend the claims to disclaim "industrial and commercial uses" of the stem cells obtained by the method of the invention. Since the application as filed did not have specific basis for the disclaimer it was necessary for the Board to consider whether the proposed disclaimer fell within the conditions laid down in the Decision G1/03 of the Enlarged Board of Appeal as to whether the disclaimer was allowable. The Board held that the proposed disclaimer did not fall within the specific circumstances laid down in G1/03. It reasoned that the claims without the disclaimer were directed to a method of obtaining embryonic stem cells as a direct product of the method. The proposed disclaimer merely excluded the future use of the obtained stem cells and, as such, the subject matter that the applicant was attempting to exclude was not covered by the original claims and as such could not now be disclaimed without adding subject matter. The appeal was therefore rejected.
It is apparent that, in order to be patentable, a method involving human embryos must be of diagnostic or therapeutic benefit to the embryo itself and that the step giving the benefit must be specified in the claim. Applicants should therefore take care when drafting patent applications to inventions involving the use of human embryos to specify diagnostic and therapeutic benefits in the application. In addition, it may be advisable to state in the description that, for example, stem cells recovered may not be for commercial or industrial usage in order to provide basis for any disclaimer which may subsequently be required.