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Stem Cells, Patents and Public Policy: Ruling of EBoA on WARF/Thomson application

By Bartolus

The European Patent Office's Enlarged Board of Appeal (EPoA) ruled on November 25th 2008 that it is impossible to grant patent protection to a certain stem cell application for reasons of public policy.

Back in 1995 the Wisconsin Alumni Research Foundation (WARF) filed an application with the EPO for a patent for a method for obtaining embryonic stem cell cultures from primates, including humans.

On July 13th 2004, an EPO Examining Division refused to grant a patent for the application on the grounds that it was found to be incompatible with the European Patent Convention (EPC). A principal reason for the refusal was that the method of obtaining stem cells used as the starting material a primate (including human) embryo which was destroyed in the process.

Then, in 2005 the Technical Board of Appeal competent in the case referred a number of points of law to the EPO's supreme judicial body, the Enlarged Board of Appeal, which is in charge of ensuring uniform application of the patent law.

The EBoA decided that patent protection could not be given to such a method because it necessarily involves the use and destruction of human embryos. The EBoA held that a patent could not be granted to protect an invention the commercial exploitation of which is contrary to public policy or public morality. It also held that the EPC prohibits patenting on uses of human embryos for industrial or commercial purposes. By the same token, the EPoA held that the provisions Directive 98/44/EC on the legal protection of Biotechnological inventions also provides that patents shall not be granted for inventions concerning uses of human embryos for industrial or commercial purposes. The EBoA must apply Directive 98/44/EC as it forms part of the EPC since 1999 and is applied by the EPO.

The ruling of the EPoA seems a narrow one. It made no determination of the patentability of claims based on any of the traditional criteria used to assess patentability ? usefulness, novelty and non-obviousness. It makes clear that its decision does not address the question of patentability in general of inventions relating to human stem cell cultures.

The issue came up as to whether the EPoA should and could refer a question to the Court of Justice under Article 234 EC. It ruled that it could not do so as no legal and institutional links existed between it and the Court of Justice. Consequently, it was most unlikely that the Court of Justice would consider that the EBoA was a court or tribunal of a member State of the EU. It thus distinguished its situation from that of the Benelux Court which was in issue in Case C-337/95 Dior v. Evora, paragraph 31.

Full post as published by EU Law Blog on November 29, 2008 (boomark / email).