1. The Vienna Convention on the Law of Treaties
Overview
T 1553/22 × View decision
Abstract
In T 1553/22, the application concerned the generation of pig-human chimeric animals with the aim of using them as a source of human vasculature and blood. The appellant's arguments could be summarised as follows:
The examining division's approach to chimeras was unduly restrictive and was not in line with the requirements of Art. 53(a) EPC or R. 26(1) EPC, which provided that Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions be used as supplementary means of interpretation for patent applications concerning biotechnological inventions. While Recital 38 of the Directive 98/44/EC referred to the exclusion of chimeras involving human totipotent cells or germ cells from patentability, the claims in suit were directed to blastocysts and methods which involved pluripotent cells. Moreover, the purpose of the invention was to provide humanised vasculature in swine, suitable for transplantation, rather than providing chimeric animals in which human cells would be found in multiple organs. Art. 53(a) EPC was to be construed narrowly. It was the intended exploitation of the invention that was to be taken into account when analysing compliance with the requirements of Art. 53(a) EPC (see T 356/93, T 866/01 and T 315/03).
The examining division had refused the application for ethical reasons pursuant to Art. 53(a) in conjunction with R. 26(1) EPC and Recital 38 of the Directive 98/44/EC. It had also concluded that, although the invention was directed to the genetic modification of animals, the exclusion under R. 28(1)(d) EPC was not applicable because the outcome of the so-called "balancing test" developed in the jurisprudence for an objection under this provision was in favour of the invention.
The board held that if an invention corresponds to one of the examples set out in the non-exhaustive list of R. 28(1) EPC, there is no room for tests aimed at balancing possible risks associated with the implementation of the invention and its benefit for mankind. Without disregarding the principle of narrow interpretation of exceptions, the board took the view that the exclusion of Art. 53(a) in conjunction with R. 28(1) EPC may extend to other chimeras, where the rationale underlying the examples identified in Recital 38 is also applicable to the chimeras concerned. Thus, by means of R. 26(1) EPC a further special case is added to the non-exhaustive list of R. 28(1) EPC.
When considering the possible rationale underlying the specific exclusions of Recital 38, the board found that the reason why the chimeras identified in Recital 38 are regarded as offensive against human dignity is due to concerns that, in chimeras including human germ cells or totipotent cells, these human cells may integrate into the brain and/or develop into germ cells and result in a chimera with human or human-like capabilities.
This reason is straightforward for chimeras including totipotent cells, which in view of their developmental capability to form an entire organism may form a brain with human-like cognitive abilities or human germ cells. However the same reason applies to the application at hand, which concerned pluripotent cells, which despite lacking the ability to differentiate into totipotent cells or cells of the placenta, nevertheless have the ability to differentiate into neural cells or germ cells. Thus, if an invention relates to a situation where human cells might integrate into the chimera's brain, potentially giving the chimera human-like cognitive or behavioural capabilities, or into its germ line, potentially giving it the ability to pass on humanised traits, the board considers that the underlying rationale of Recital 38 of the Directive would be relevant and shall be taken into account in examining compliance with Art. 53(a) in conjunction with R. 28(1) EPC.
The board stated in its catchword that human-animal chimeras and processes to produce them are excluded from patentability in accordance with Art. 53(a) EPC if the invention offends against human dignity. This is the case for instance if it is not excluded that the human cells involved in the chimera integrate into the brain and/or develop into germ cells of the chimera, and result in a chimera with human or human-like capabilities.
1. The Vienna Convention on the Law of Treaties
In G 5/83 (OJ 1985, 64) the Enlarged Board stated that the provisions of the Vienna Convention do not apply to the EPC ex lege, since the former Convention applies only to treaties which are concluded by States after the entry into force of the Vienna Convention with regard to such States (Art. 4 Vienna Convention). At the time of conclusion of the EPC, the Vienna Convention was not in force. Nevertheless, there were convincing precedents for applying the rules for interpretation of treaties incorporated in the Vienna Convention to a treaty to which in terms they do not apply (see also G 2/12, G 2/13). The International Court of Justice did already apply principles expressed in the Vienna Convention to situations to which the Convention strictly did not apply, whilst the European Court of Human Rights, the Federal German Constitutional Court and the House of Lords (England) have also applied the principles of interpretation in Art. 31 and 32 of the Convention to treaties to which strictly they do not apply. After a careful study of the whole subject, the Enlarged Board of Appeal concluded that the European Patent Office had to do the same.
In J 10/98 (OJ 2003, 184) the Legal Board of Appeal stated that, although the Vienna Convention did not expressly apply to the interpretation of EPC, PCT or the Paris Convention, since it came into force at a later date than all of those treaties, in accordance with what had been recognised by the Enlarged Board of Appeal in decision G 5/83, its principles of interpretation were a valuable guide to the interpretation of all treaties executed both before and after it. In T 1173/97 (OJ 1999, 609) the board stated that although the Vienna Convention is not applicable to the EPC, it has considerable authority and has frequently been cited by the boards of appeal when applying principles laid down in it.