2.2.2 Assessment of an objection according to Article 53(a) EPC
T 2510/18 × View decision
Abstract
Dans l'affaire T 2510/18, il s'agissait de déterminer si une invention dérivée de recherches sur des remèdes traditionnels dans des conditions alléguées de tromperie et d'abus de confiance à l‘égard de populations autochtones allait contre les bonnes mœurs et l'ordre public. Le brevet en cause avait pour objet une molécule, la Simalikalactone E (SkE), qui peut être extraite de la plante Quassia amara, ainsi que son utilisation comme médicament dans la prévention et le traitement du paludisme. Il a été reconnu dans le brevet que la plante Quassia amara avait été utilisée en médecine traditionnelle contre les fièvres et le paludisme dans tout le nord-ouest de l'Amazonie et jusqu'en Amérique centrale. L'intimé (titulaire du brevet) a identifié et isolé la SkE en utilisant un procédé spécifique à partir de feuilles (matures séchées) de Quassia amara. Cette molécule s'est avérée active contre le paludisme.
Les requérants soutenaient que l'exploitation commerciale de l'invention revendiquée était contraire aux bonnes mœurs et à l'ordre public selon l'art. 53a) CBE, dans la mesure où elle n'était pas conforme à la morale ni à l'ensemble des normes acceptées et profondément ancrées dans la culture européenne. Ces normes concernent celles qui encadrent la recherche avec les communautés autochtones et locales ainsi que l'utilisation de leurs savoirs traditionnels. Il n'était pas contesté qu'au début des années 2000, l'intimé a mené des recherches sur les remèdes traditionnels antipaludiques auprès des populations de la Guyane française. Les chercheurs ont étudié ces remèdes traditionnels et ont par la suite concentré leurs efforts sur l'étude de la plante Quassia amara. Les chercheurs sont ainsi parvenus à l'identification d'une molécule antipaludique, la SkE.
Selon les requérants, les comportements contraires aux normes acceptées, notamment celles qui encadrent la recherche avec les communautés autochtones ainsi que l'utilisation de leurs savoirs traditionnels, constituaient une tromperie à l'égard des communautés autochtones et locales et un abus de leur confiance pour le développement de l'invention en cause. En effet, c'était grâce à l'apport des savoirs traditionnels que les chercheurs de l'intimé sont parvenus à identifier la molécule SkE. Néanmoins, les membres des communautés autochtones contactés par l'intimé n'ont pas été informés de manière complète et transparente de la nature du projet de recherche, de ses objectifs, du dépôt du brevet, et d'autres risques et avantages du projet pour les membres des communautés et leurs savoirs. Pour les requérants, "l'invention" comprenait les étapes préalables au développement de l'invention et requises pour son exploitation, à savoir la manière dont la SkE avait été découverte par l'intimé. Donc, le comportement de l'intimé pendant le développement de l'invention (tromperie et abus de confiance, etc) était lié à l'exploitation commerciale de l'invention. Il fallait alors examiner ce comportement pour le respect des bonnes mœurs et de l'ordre public dans le cas d'espèce de l'invention revendiquée.
La chambre n'a pas partagé cette approche. Comme indiqué par l'intimé, aucune des allégations des requérants ne concernaient l'exploitation commerciale de l'invention, condition préalable pour conclure que l'invention serait exclue en vertu de l'art 53 CBE. Au contraire, l'invention revendiquée dans la requête principale concernait: la molécule SkE (revendication 1), un médicament comprenant la molécule SkE (revendications 2 à 6), et le procédé d'isolement de la SkE selon la revendication 1 à partir des feuilles de Quassia amara (revendications 7 et 8).
Comme l'a fait valoir l'intimé, l'exploitation commerciale de cette molécule, du médicament la comprenant et de son procédé d'isolement n'était pas contraire à la morale, aux bonnes mœurs ou à l'ordre public. Bien au contraire, il y avait un grand besoin de médicaments contre le paludisme, et trouver de nouveaux médicaments antipaludiques était une mission dont le but était de soigner les populations à risques et de sauver des vies. G 2/06 est invoquée sans succès par les requérants; la chambre estime que le développement d'une invention est distinct de son exploitation commerciale une fois qu'elle a été réalisée. Aucune preuve n'a été apportée par les requérants que l'isolement de la molécule SKE et son administration seraient contraires à l'ordre public ou aux bonnes mœurs. La chambre a finalement conclu que le motif tiré de l'art. 53a) CBE ne s'opposait pas au maintien du brevet.
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.
The issue of morality and "ordre public" had been raised in T 356/93 (OJ 1995, 545), in connection with plants. The object of the invention was plants and seeds resistant to a particular class of herbicides so that they could be selectively protected against weeds and fungal diseases. This was achieved by stably integrating into the genome of the plants a heterologous DNA encoding a protein capable of inactivating or neutralising the herbicides. The patent was opposed under Art. 53(a) EPC 1973, in particular on the grounds that the exploitation of the invention was likely to cause serious damage to the environment.
The board held that the concept of morality was related to the belief that some behaviour was right and acceptable whereas other behaviour was wrong, this belief being founded on the totality of the accepted norms which were deeply rooted in a particular culture. For the purposes of the EPC, the culture in question was the culture inherent in European society and civilisation. Accordingly, inventions the exploitation of which was not in conformity with the conventionally accepted standards of conduct pertaining to this culture were to be excluded from patentability as being contrary to morality.
The board found that none of the claims related to subject-matter which could lead to a misuse or destructive use of plant biotechnological techniques because they concerned activities (production of plants and seeds, protection of plants from weeds or fungal diseases) and products (plant cells, plants, seeds) which could not be considered to be wrong as such in the light of the conventionally accepted standards of conduct of European culture. Plant biotechnology per se could not be regarded as being more contrary to public morality than traditional selective breeding.
In T 315/03 the board found that in the assessment of an Art. 53(a) EPC 1973 objection, no single definition of morality based on e.g. economic or religious principles represents an accepted standard in European culture. Opinion poll evidence was of very limited value for the reasons given in T 356/93 (OJ 1995, 545), where many drawbacks were identified, ranging from the type and the number of questions posed within one poll, through the size and representative nature of the cross-section of the population polled, to the manner of interpretation of the results obtained.
In T 356/93 the board defined the concept of "ordre public" as covering the protection of public security and the physical integrity of individuals as part of society. It also encompassed the protection of the environment. Accordingly, inventions the exploitation of which was likely to seriously prejudice the environment were to be excluded from patentability as being contrary to "ordre public". However, a decision in this respect presupposes that the threat to the environment be sufficiently substantiated at the time the decision is taken by the EPO.
In the specific case the board held that, although the documents submitted by the appellant (opponent) provided evidence of possible hazards from the application of genetic engineering techniques to plants, they did not lead to the definite conclusion that the exploitation of any of the claimed subject-matter would seriously prejudice the environment.
Regarding the compatibility with Art. 53(a) EPC 1973 of an invention involving genetically modified, herbicide-resistant plants, see also T 475/01.
In T 866/01 the invention related to euthanasia compositions which were used for producing humane death in "lower animals". The proprietor argued that the avowed use of the invention's teaching indicated in the patent ("bestimmungsgemäßer Gebrauch der erfindungsgemäßen Lehre") was the use of the claimed composition for mercy killing of lower animals and that this particular intended use did not infringe "ordre public" or morality. It was, in the proprietor's opinion not sufficient for an objection under Art. 100(a) and 53(a) EPC that the invention could also be exploited in a way that would infringe principles of morality or "ordre public". The board noted that no evidence had been provided that euthanasia of lower animals under the particular conditions described in the application would obviate any ethically based constitutional or other rules. The board therefore held that in the circumstances of the present case, Art. 53(a) EPC provided no legal basis for denying absolute substance protection for the claimed composition per se on the grounds that, with the exception of the intended use or exploitation, one or more of several or even all conceivable other exploitations or uses of the claimed composition (falling within the scope of protection) would be or could be regarded as breach of the principles of "ordre public" or morality, even if such conceivable exploitation might constitute a serious breach of the principle of "ordre public", such as a criminal offence including the killing of humans. The board noted that the mere possibility of abuse of the invention was not sufficient to deny patent protection pursuant to Art. 53(a) EPC.
- T 2510/18
- T 1553/22