The EPO Board of Appeal comments on the scope of the morality exclusion from patentability

The recent decision, T1553/22 of the Board of Appeal required the Board to consider the scope of the exclusions from patentability under Article 53(a) EPC.

The invention in this case related to methods for producing a human-pig chimera, capable of producing human blood cells and vessels, as well as the chimeric animal itself. The claimed method involves the generation of a pig blastocyst lacking the gene ETV2 required for the development of the blood system, and injecting the pig blastocyst with human pluripotent cells comprising the ETV2 gene. The resulting human-pig chimera is able to produce humanized vasculature and blood.

Whilst human-animal chimeras are not mentioned in Rule 28 EPC, they are mentioned in Recital 38 of the EU Biotech Directive which excludes from patentability processes which offend against human dignity and lists “processes to produce chimeras from germ cells or totipotent cells of humans and animals”.  The Recital does not, however, specifically mention chimeras produced using pluripotent cells (which are not capable of on their own of producing an entire organism, in contrast to totipotent cells which are capable of dividing into all cell types to produce an entire organism).

The Applicant therefore argued on appeal that because the claimed invention was directed to blastocysts comprising human pluripotent cells, the exclusion under Recital 38 does not apply. Furthermore, exclusions to patentability, for example under Article 53(a), are to be interpreted narrowly.

The Board of Appeal, in undertaking an analysis of the legal framework applicable to the case,  confirmed that the EPC provisions for the protection of biotechnological inventions should be understood in light of the EU Biotech Directive. The list of exemptions provided in Rule 28(1) EPC, namely the use of human embryos for commercial purposes, modifying the germ line of a human, methods for cloning human beings, and modifying the genetic identity of animals, and in Recital 38 of the Biotech Directive were non-exhaustive lists of exclusions, for guidance purposes.

Furthermore, the Board confirmed, in line with recent Enlarged Board of Appeal decisions (see G2/12), that the principle of narrow interpretation of exclusions from patentability cannot be generally applied a priori, and that the “object and purpose” of such exclusions must be considered. Whilst the Board agreed that Recital 38 does not apply directly to the claimed invention, in considering the rationale underlying Recital 38 they found that the exclusion of chimeras made using human totipotent or germ cells was based on concerns that such cells may integrate into the germ line or brain of the chimeric animal and generate an animal with human or human-like capabilities, which would be offensive against human dignity.

Following a review of the scientific evidence available at the time of filing, the Board concluded, using the balance of probabilities, that there was a real possibility that using pluripotent human cells to produce a chimeric animal according to the invention could generate an animal with human or human-like capabilities. Despite the obvious medical benefits of the invention, the Board further clarified that balancing tests between animal suffering and medical benefit were only relevant for inventions related to the genetic modification of animals under of Rule 28(1)(d) EPC, and that there can be no room for manoeuvre for inventions excluded for being offensive to life or human dignity.

This decision confirms that the morality exceptions to patentability under Article 53(a) may extend beyond the specific examples listed in Rule 28(1) EPC and Recital 38 of the EU Biotech Directive, and that the EPO will consider the purpose behind the exclusions rather than interpreting the exclusions narrowly as a rule. An understanding of the object and purpose behind the exclusions is needed, in order to draft patent applications and include any necessary embodiments or technical language which show that the invention can be achieved without falling into the object of the exclusions from patentability.

This article was prepared by Trainee Patent Attorney Delphine Lauté-Caly and Partner Punita Shah.