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24 maggio 2009

Human embryos: no – Human stem cells: yes. EPO vs. USPTO

Olga Capasso

On 25 November 2008, the Enlarged Board of Appeals (EBA) of the European Patent Office issued the Decision G 0002/06, known as the decision of the patentability of human stem cells. The case refers to a patent application filed by WARF (Wisconsin Alumni Research Foundation), rejected by the EPO Examination Division (also) because in conflict with Rule 28(c) EPC. In this short analysis, I only focused on the EBA's interpretation of such rule which, in compliance with art. 6(2)c of Directive 98/44 on the Protection of Biotechnological Inventions, states the unpatentability of biotechnological inventions referring to uses of human embryos for industrial or commercial purposes.

In 2006, the Technical Board of Appeals, having received an appeal petition from the Applicant, decided to submit general and interpretation questions to EBA. Therefore, such decision shall be useful for the purpose of interpretation in connection with pending and future patent applications.

It seems to be worthy reminding the specific content of claim 1 of WARF's patent application that is a cell culture comprising primate (including man) embryonic stem cells, provided with some specific characteristics, as listed in the claim itself.

The EBA decided that the prohibition of patenting products (in this case, human embryonic stem cell cultures) which, at the time of filing the patent application, could be prepared exclusively by a method which necessarily involved the use and consequent destruction of human embryos (as admitted by the applicant), is applicable also to cases in which such method is not specifically included in the claims. The EBA, in fact, pointed out as the mentioned rule does not mention the word "claims", but more generally does refer to "inventions", in the context of their exploitation. Therefore, still according to the EBA, limiting the application of such rule to cases where the use of human embryos is present in the claim wording would be incorrect; it is the technical teaching of the patent application as a whole that is to be considered. Otherwise, the applicability of such rule would be made dependent on claims' formal wording. Therefore, the EBA concluded that the examination to assess patentability according to Rule 28(c) should not focus exclusively on the claimed subject-matter, but should include all aspects which make the claimed subject-matter available to the public.

Moreover, the EBA considered as irrelevant the fact that technical developments were made after the filing date of the patent application, allowing cells to be obtained by methods not involving the destruction of human embryos. The use of human embryos (and their consequent destruction) was considered as an essential part of the industrial and commercial exploitation of the claimed invention. Still according to the EBA, when considering whether an invention complies with the rules providing for unpatentability of human embryos, technical developments which became publicly available only after the filing date cannot be taken into consideration. Any other conclusion would lead to a legal uncertainty. Such EBA way of argumentation is already known and applied, by way of example, when the sufficiency of description requirement is examined: such requirement must be met by the patent application disclosure as filed.

The Decision further examined in closer detail the significance of the use of embryos for the purpose of industrial or commercial exploitation, stating that their use as starting material for the generation of products of industrial application (that is, the claimed human embryonic stem cells) means actually a use for industrial purposes, and thus unpatentable. The wording of art. 6 of Directive 98/44, from which the EPC Rule was taken, has the meaning of considering as patentable only those inventions - for therapeutic or diagnostic purposes - which are applied to the human embryo and useful to it (see Recital 42 of said Directive: Whereas, moreover, uses of human embryos for industrial or commercial purposes must also be excluded from patentability; whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it).

By such Decision, the EPO provided a substantive interpretation of the exclusion of human embryos from patentability, including cases in which uses of human embryos are specific subject-matter of claims and cases in which they have to be necessarily used for obtaining the claimed matter, as well. The EBA pointed out that the purpose of the Rule in exam complies, in fact, with Directive 98/44, which is directed to specifically exclude human embryos from patentability, thus reaffirming its opposition to any unauthorised uses of the same (the German Bundespatentgericht issued recently the decision No. 3 Ni 42/04 of 5 December 2006 in agreement therewith).

The interpretation of EBA shall be of relevance for pending and future cases: as a matter of fact the restriction to patentability shall not apply to inventions concerning human stem cells (or cell cultures) in general, but only to those obtained by the use and destruction of human embryos. Consequently, inventions concerning human stem cells, not obtained by means of destruction of human embryos, are not excluded from patentability in accordance with Rule 28(c) EPC. This aspect may hopefully have some positive outcome on several EP pending patent applications.

The consequences the above may have on decisions of National Courts can hardly be foreseen.

What about the parallel WARF case in the USA? On 26 June 2008, after a re-examination procedure, the USPTO confirmed the issuance of two WARF patents, of the same family as the EP patent application. The former (US 5,483,780) refers to primate's cells and to a method for obtaining them from primate's blastocyst (the cell organisation stage during embryogenesis before the differentiation between embryo and nutritive tissues and implantation takes place), the latter (US 6,200,806) refers to human embryonic stem cells in pre-implantation phase.
The harmonisation of patent laws governing the biotech sector is still a daydream!

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