Updated - Enlarged Board of Appeal Decision on the Patentability of Stem Cells

Article from our Winter 2008-2009 edition of InsideIP.

The long-awaited decision from the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) regarding the patentability of stem cells (G2/06) has now been published.

The decision confirms that European patent law forbids the patenting of claims directed to products which, at the filing date of the application, could be prepared exclusively by a method which necessarily involved the destruction of the human embryo from which the products are derived, even if the method is not part of the claims. In this context, it is not relevant 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.

In More Detail

Four questions relating to the interpretation of what constitutes industrial or commercial use of a human embryo were referred to the EBA by the EPO Technical Board of Appeal in their decision T1374/04.

The patent application at the centre of the referral (the so-called “WARF Stem Cell Patent”) relates to cultures comprising primate (including human) embryonic stem cell cultures. The claims of the application are directed to the cultures themselves, rather than to a method of generating these cultures. However, the only method disclosed in the application for the generation of the cultures requires the dissociation of a pre-implantation embryo (a supernumerary embryo from an IVF procedure).

The Examining Division of the EPO refused the application on the ground that the use of an embryo is an indispensable part of the disclosed invention. The use of an embryo as the starting material for the generation of a product of industrial application was considered to equal industrial use of this embryo and such use contravenes Art. 53(a) and Rule 28(c) EPC (formerly Rule 23d(c) EPC).

Rule 28(c) EPC states:

“Under Article 53(a), European Patents shall not be granted in respect of biotechnology inventions which, in particular, concern the following… (c) uses of human embryos for industrial of commercial purposes.”

The decision to refuse the application was appealed by the applicant, who submitted, amongst other things, that the Examining Division had interpreted Rule 28(c) EPC too broadly.

The applicant asserted that the correct interpretation confines the exclusion in Rule 28(c) to claims directed to uses of human embryos, and that products resulting from the use of human embryos were intended to be omitted from this exclusion. The Technical Board of Appeal upheld the decision of the Examining Division, and referred four questions to the EBA, stating:

“the Board considers the question of the patentability of human embryonic stem cells and of the conditions therefore as being an outstandingly important point of law within the meaning of Art. 112(a) EPC, for which a decision by the EBA is required. The patentability of human embryonic stem cells is a highly critical matter which is passionately debated … A decision on the matter by the EBA will lay basic and reliable ground to the treatment of other cases concerning the patenting of human embryonic stem cells”.

The decision of the Enlarged Board of Appeal was published on 25 November 2008 and it confirms that Rule 28(c) EPC (formerly Rule 23d(c) EPC) applies to all pending application, including those filed before the entry into force of the rule and that the Rule 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. The Enlarged Board considered that the legislators of both the European Patent Convention and the Biotechnology Directive had intended to exclude such inventions from patentability. Finally, it was confirmed that 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.

Where Now?

It is clear that any invention concerning embryonic stem cells which involves the destruction of a human embryo will be excluded from patentability by Rule 28(c) EPC. Accordingly, a patent application which only describes methods for obtaining embryonic stem cells that involve the destruction of a human embryo will be not be granted. This is the case even if the claimed subject matter is not directed to the method.

Position in the UK

Following publication of the G2/06 decision, practice at the UK Intellectual Property Office (UK IPO) in the area of the patentability of stem cells has been reconsidered.  A Practice Notice was issued from the UK IPO on 3 February 2009, which states that the UK IPO will not grant patents for processes for obtaining stem cells from human embryos, on the basis that uses of human embryos for industrial or commercial purposes are not patentable inventions; but that patents will continue to be granted for inventions involving pluripotent human embryonic stem cells (i.e. those that do not have the potential to develop into an entire human body), provided they satisfy the normal requirements for patentability, and provided that at the filing or priority date of the patent, the invention could be obtained by means other than the destruction of human embryos.

In view of recent reports that scientists at the universities of Edinburgh and Toronto have generated stem cells by reprogramming skin cells taken from human adults, it would seem that, rather than being a nail in the coffin of patent protection in the area of stem cell technology, the stance taken by the UK IPO reflects the direction in which this exciting field is moving.

Kate McNamara 12 Mar 2009

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