EPO Board of Appeal provides rare and valuable guidance on interpretation of morality clauses under European law
A recent EPO Board of Appeal (BoA) decision (T 1553/22) considered the patentability of human-animal chimeras (organisms or tissues that contain at least two different sets of DNA) and found that an application that encompassed ways of integrating human cells into the brain and germ line of chimeras is offensive to human dignity.
The decision provides rare and valuable guidance on how the morality exclusion under Article 53(a) EPC should be interpreted in the context of biotechnological inventions.
Article 53(a) EPC states that European patents shall not be granted in respect of “inventions the commercial exploitation of which would be contrary to “ordre public” or morality”. It is supplemented by Rule 28(1) EPC, which sets out a non-exhaustive list of biotechnological inventions excluded from patentability, such as processes for cloning human beings and uses of human embryos for industrial or commercial purposes.
The patent application filed by applicant Regents of the University of Minnesota (EP16759528.9) related to methods for creating gene-edited pig embryos lacking the ETV2 gene (which encodes a transcription factor – a protein involved in converting or transcribing DNA into RNA – required for blood vessel and blood cell development), introducing human stem cells into the embryo, and then implanting the embryo into a pig to generate a chimera with humanised vasculature and blood cells for therapeutic purposes.
Data in the application as filed showed the successful deletion of ETV2 in pig embryos and the successful formation of humanised blood vessels following integration of human stem cells into the embryos. The applicant suggested that the methods could be used for various means, including to establish humanised vasculature in pigs and provide a source of tissue to help address the critical shortage of organs for transplantation.
Following the initial decision of the Examining Division (ED) to refuse the application having held that the claims related to the commercial exploitation of an invention that was contrary “ordre public” or morality, and thus breached Article 53(a) EPC, the applicant filed an appeal. The BoA issued a preliminary opinion in agreement with the ED but initiated oral proceedings for the sole purpose of hearing the appellant’s arguments.
The applicant argued that the ED’s assessment was unduly restrictive and not aligned with the requirements of Article 53(a) EPC or Recital 38 of the EU Biotech Directive (98/44/EC), and that the intended exploitation of the invention should be considered when reviewing such legal provisions. The applicant also argued that since the invention used pluripotent stem cells, which are not capable of creating a complete organism like totipotent stem cells, it fell outside the exclusion in Recital 38.
However, the BoA found that the claims related to chimeras were directed to subject-matter that offends against human dignity, and even if ways to prevent human cells integrating into the brain or germ line were available at the date of filing the application, they were not reflected in the technical features of the claims.
Thus, the BoA found no reason to dismiss ethical concerns (despite the potential therapeutic benefits of the invention), noting that the ED did not adopt an unduly restrictive approach. The BoA concluded that the invention should be excluded from patentability as it relates to human-animal chimeras in which human cell participation in the brain or germ line is a realistic probability.
Overall, T 1553/22 makes clear that provisions surrounding legal exclusions in Europe are not to be interpreted narrowly. The decision is also a reminder that careful claim drafting is necessary to avoid such exclusions, and although an invention may have the potential to provide significant therapeutic benefit, this cannot justify circumvention of fundamental ethical provisions provided for by European law.
Interestingly, the applicant obtained a US patent (US 11,673,928) for the invention but to only a single claim, limited to an ETV2-null pig cell, morula or blastocyst (i.e., tissues at various stages of embryo development) without reference to human cells or characteristics. However, in contrast to Europe, US patent law contains no statutory basis for the USPTO to deny patents on the basis of morally controversial biotechnological subject-matter, and it is likely that the narrower scope of the granted claim was the result of the various objections raised during prosecution (including enablement, indefiniteness and written description objections raised under 35 U.S.C. § 112).
Barker Brettell has a dedicated medical sector team who can assist and advise you on how to achieve the best protection for your innovation. To continue the conversation, please contact the authors of this article, Laura Riggall and Jennifer Atkinson, or your usual Barker Brettell attorney.
