Donor consent 

The invention in T 1213/05 related to the human BRCA1 gene isolated from the genome, mutant forms of that gene and its use in the diagnosis of predisposition to breast and ovarian cancer. Appellant II submitted that the lack of proof that the donors of the cells had given previous informed consent to the commercial exploitation of the research results by patents as well as a benefit sharing agreement meant that the initial obtaining of these research results involved a violation of ordre public or morality as referred to in Art. 53 a) EPC.

The board disagreed. The EPC contained no provision establishing a requirement for applicants to submit evidence of previous informed consent of the donor of the cells or a benefit sharing agreement. That the legislator had not provided for a procedure of verifying such informed consent could also be deduced from the Biotech Directive, which had to be used as supplementary means of interpretation (R. 23b (1) EPC 1973, R. 26(1) EPC).

In addition, the board referred to ECJ judgment C-377/98 concerning the application for annulment of the Directive, where the Court had rejected the plea of the Kingdom of the Netherlands that the absence of a provision requiring verification of the consent of the donor or recipient of products obtained by biotechnological means undermined the right to self-determination. The Directive concerned only the grant of patents and therefore did not extend to activities before and after grant, whether they involved research or the use of the patented products.

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