Not Exactly Babe: European Patent Office Finds Method Involving Human-Pig Chimeras an Offence Against Human Dignity
The European Patent Office - Board of Appeals recently issued a decision, T 1553/22, denying patent protection to the University of Minnesota for inventive human-pig chimeras, and methods for producing such chimeras. A chimera is an organism with more than one distinct genotype. The purpose of creating such chimeras in the present method was to cause a pig to develop with human blood vessels and blood, which would then be available for use in humans, for example, to avoid the need for human sources (such as from a patient’s leg) for transplants to bypass blockages (such as in the heart, legs, or arms) or to create connections between arteries and veins for dialysis.
The application described a method that involved deleting a gene for blood vessel and blood cell development (ETV2 – a transcription factor for converting generalized cells) from animal cells, such as pig cells, creating ETV2-null cells. Human stem cells would then be introduced into blastocysts of the ETV2-null cells, creating hybrid cells; animal cells with human ETV2. The chimeric blastocysts would then be implanted in surrogate animals, with the result being a chimeric non-human animal capable of growing humanized vasculature and humanized blood.
The Board found claims to the process, and the resulting chimeric animal ran afoul of EPC Article 53(a), which prohibits granting patents that “the commercial exploitation of which would be contrary to ‘ordre public’ or morality.” In doing so the Board also cited Directive 98/44/EC of the European Parliament on the legal protection of biotechnological inventions. Recital 38 of that directive clearly stated that “processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability” as contrary to ordre public and morality.
The applicant’s attorneys tried to distinguish that clear statement on the basis that its inventive method used pluripotent cells, rather than totipotent cells. (Pluripotent cells and totipotent cells differ in their development potential – while totipotent cells have the potential to generate all types of cells, and indeed an entire organism, pluripotent cells cannot form extraembryonic tissues, for example supporting structures such as a placenta.) The Board did not find the distinction convincing, since in its view the reason for the prohibition on totipotent-based animal-human chimeras, that there is the potential to “form a brain with human-like cognitive abilities or human germ cells,” applies as well to chimeras formed from pluripotent cells. Since the applicant could not convincingly exclude this as a possibility, the appeal was dismissed with all of the claims disallowed.
One interesting wrinkle is that the University of Minnesota did obtain a US patent for this invention (US 11,673,928), but with only a single claim, limited to an ETV-null porcine cytoblast, without any mention (in the claim) of the introduction of human ETV2 (such as through a human stem cell). In the hearing before the EPO’s Examining Division a “limitation of the claims to parthenogenetic porcine blastocysts was seen as a possible solution to overcome” the failure to meet the requirements of Article 53(a), but the university choose to make a further appeal rather than exploring limiting its claims to ETV-null pig blastocysts.
Whether the genetically modified pigs of the future will fly, talk, or just supply spare parts for humans, the attorneys of Renner Otto will be there to provide expert advice on what is and is not patentable. Contact us for a complimentary consultation to see how we can help your business move your innovation forward.
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