H. Interpretation of the EPC
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.
H. Interpretation of the EPC
On the interpretation of provisions of the EPC, the EPC itself provides relatively little guidance. There is the Protocol on the Interpretation of Art. 69 EPC of 5 October 1973 as revised by the Act revising the EPC of 29 November 2000. This deals with the extent of protection under Art. 69 EPC. Otherwise, the EPC contains only regulations like the hierarchy of legal provisions (Art. 150(2) and 164(2) EPC) and the equal authenticity of the EPC in its three official language versions (Art. 177 EPC). Art. 125 EPC is not concerned with the interpretation of the EPC but serves merely as a "fill-in" in case of missing procedural provisions. The EPC itself thus contains no general rules for its interpretation, and one must look outside the terms of the Convention itself for such rules (G 2/12, G 2/13, OJ 2016, A27 and OJ 2016, A28).
As an international treaty, the EPC has to be interpreted in accordance with the rules of interpretation developed in the so-called "law of nations" or public international law. To the traditional kind of international treaty which regulates legal relations between States had to be added the treaty which directly creates and defines rights and duties for individuals and corporate bodies (G 5/83, OJ 1985, 64; G 2/12, G 2/13).
In the interpretation of international treaties which provide the legal basis for the rights and duties of individuals and corporate bodies it is necessary to pay attention to questions of harmonisation of national and international rules of law. The boards of appeal may take into consideration decisions and opinions given by national courts in interpreting the law (see G 5/83, OJ 1985, 64; see also G 2/12, G 2/13). Nevertheless, in the proceedings before the European Patent Office, such considerations do not exonerate a board of appeal from its duty as an independent judicial body to interpret and apply the EPC and to decide in last instance in patent granting matters. TRIPS provisions, like decisions of the European and International Courts of Justice and national decisions, are elements to be taken into consideration by the boards of appeal but are not binding on them (T 154/04, OJ 2008, 46). See also J 14/19.
Although the European Patent Organisation is not a party to the Vienna Convention on the Law of Treaties concluded on 23 May 1969 (hereinafter Vienna Convention), the principles of interpretation of Arts. 31 and 32 of the Vienna Convention are to be applied to the interpretation of the EPC even though its provisions do not apply to the EPC ex lege (G 5/83, G 2/08 date: 2010-02-19, OJ 2010, 456). The boards of appeal thereby refer to legal sources outside the EPC, including, for example, above-mentioned Vienna Convention and the TRIPS Agreement. Thus the boards of appeal may be guided in their decisions by the provisions of other international instruments. However, they have no obligation to apply them directly (G 2/02 and G 3/02, OJ 2004, 483).