1.1. Principles of interpretation of the Vienna Convention
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.
1.1.3 Interpretation of exclusions from patentability under the Vienna Convention
In G 1/07 (OJ 2011, 134) the appellant had submitted that exclusions to patentability had to be construed narrowly according to Art. 31 and 32 of the Vienna Convention. The Enlarged Board held that no general principle of narrow interpretation of exclusions from patentability which would be applicable a priori to the interpretation of any such exclusions can be derived from the Vienna Convention. Rather, the general rule in Art. 31, point 1, of the Vienna Convention that a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose must apply to the exclusion clauses contained in the EPC in the same manner as to any other provision. If the interpretation of the provision concerned according to these principles of interpretation leads to the result that a narrow interpretation is the right approach then and only then is such restrictive meaning to be given to it.
In G 2/12 and G 2/13 the Enlarged Board came to the conclusion that whilst there is no general notion of an obligatorily restrictive construction of exceptions to patentability, for example, such as that adopted by the Court of Justice of the European Union (CJEU) when insisting on a narrow interpretation of exceptions to or derogations from fundamental EC Treaty principles embodied in the four freedoms (Judgment of 21 June 1974, C 2-74, Jean Reyners v. Belgian State, ECJ 1974, 631), such a narrow interpretation might well result from applying the general principles of interpretation to a specific provision with regard to specific legal and factual circumstances. Please note that the interpretation of Art. 53(b) EPC given in G 2/12 was abandoned in G 3/19 in view of Art. 31(4) Vienna Convention.
G 1/07 made reference to Opinion G 1/04, OJ 2006, 334 (point 6 of the Reasons). In that Opinion, the Enlarged Board stated – with reference to decisions of the boards of appeal having acknowledged the existence of such an a priori principle – that the "frequently cited principle", according to which exclusion clauses from patentability laid down in the EPC are to be construed in a restrictive manner, does not apply without exception. In that Opinion concerning the definition of the term diagnostic methods practised on the human or animal body, the Enlarged Board came to its conclusion that the said exclusion was indeed to be interpreted narrowly only after a thorough examination of the wording and the purpose of the exclusion clause concerned. The same approach was also taken in the Enlarged Board's decision G 2/06 (OJ 2009, 306). There, the Enlarged Board was concerned with the interpretation of the exclusion from patentability of biotechnological inventions relating to uses of human embryos for industrial or commercial purposes under R. 28(c) EPC (and the corresponding Art. 6(2) of the EC Directive on the legal protection of biotechnological inventions). The Enlarged Board made no reference to the existence of a principle of narrow construction of exceptions from patentability. Instead, as a method for interpreting the extent of the prohibition the Enlarged Board went directly to the rules of interpretation laid down in the Vienna Convention, i.e. it looked at the terms of the provision and its object and purpose (point 16 of the Reasons). No mention was made in that decision of any narrow or restrictive view which would have to be taken because the said prohibition was an exception to patentability. The Enlarged Board decided to proceed in the same way in G 1/07.
- T 1553/22