EPO Board of Appeal Decides Pig/Human Chimera Patent Offends Human Dignity

The EPO Board of Appeal (“BoA”) recently rejected a patent application relating to pig-human chimeras, concluding that the invention was contrary to morality and offensive to human dignity.

The application

The claims involved methods for generating pig-human chimeric animals. Essentially, human stem cells are introduced into a pig embryo, with the ultimate aim of using these pig-human chimeras as a source of human vasculature and blood.

Relevant Provisions

The following provisions on exclusions from patentability were at issue in this case:

1. Article 53(a) EPC: prevents the patentability of inventions which would be contrary to “ordre public” or morality if commercially exploited.
   
   
2. Rule 28(1) EPC: lists examples that would fall under Article 53(a) EPC, including for example “processes for cloning human beings”, “processes for modifying the germ line genetic identify of human beings” and “processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit”.
   
   
3. Recital 38 EU Biotech Directive: states that an example of a process which would “offend against human dignity” includes “processes to produce chimeras from germ cells or totipotent cells of human and animals” (emphasis added).

The Applicant’s Arguments

One of the applicant’s main arguments centred around Recital 38’s reference to totipotent cells. The applicant argued that, as the application involved the use of only pluripotent rather than totipotent cells, it was not specifically excluded under Recital 38.

The BoA’s Decision

The BoA considered the distinction between totipotent and pluripotent cells. It noted that:

• Totipotent cells are capable of “form[ing] an entire organism” and, in a…