In an interlocutory referral [PDF] of law from the Technical Board of Appeal, the European Patent Office’s Enlarged Board of Appeal upheld the July 2004 decision of the Examining Division rejecting European patent application EP19960903521 [PDF] entitled Primate Embryonic Stem Cells under Article 53(a) and Rule 28(c) [formerly 23d(c)] of the European Patent Convention.

The invention covered “A cell culture comprising primate embryonic stem cells” which, at the time, required the use and destruction of human embryos as starting material. This was found to be contrary to the Article 53(a) of the EPC which provided subject matter exceptions for “inventions the commercial exploitation of which would be contrary to ‘ordre public’ or morality” and more specifically Rule 28(c) which prohibited inventions for “uses of human embryos for industrial or commercial purposes.”

As a preliminary matter, the Board found it lacked explicit authority to refer these questions to the European court of Justice regarding interpretation of European Union Law under Article 234 of the Treaty Establishing The European Community, in part because it was a tribunal of an international organization, not of a EU member state.

The Board considered whether EPC Rule 28(c) “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?”

Noting that the EPC Rule 28(c) prohibition refers to “invention,” not claims, the Board concluded use of the undefined “embryo” need not be claimed to violate the provision. Instead, in the context of the protection of human dignity from which the rule derived, it was the performance of the invention that was at issue, since, to be used as claimed the stem cells must first be created, and the teaching of the application involved destruction of an embryo.

Turning to the “industrial or commercial purposes” requirement of EPC Rule 28(c), the Board found the ordinary way commercially to exploit the claimed invention required making it, even when the product is used for further research, and patent rights serve to prevent others from exploiting the invention by making it. Thus making the claimed invention involved the destruction of human embryos during the industrial or commercial exploitation of the invention and violated EPC Rule 28(c). In response to the applicant’s argument that the amendment of the language of the Rule from “methods” to “industrial or commercial purposes” indicated a narrowing of the prohibition, the Board noted the legislative history indicated this was done to distinguish inventions for therapeutic or diagnostic purposes beneficially applied to the human embryo, which are not prohibited.

Lastly, the Board found it was not relevant that after the filing date the same products could be obtained without having to destroy an embryo.

The Board made clear its decision did not touch upon the patentability of human stem cells in general, only those cellular inventions necessarily requiring the destruction of embryos for their creation.