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In the landscape of scientific innovation, biotechnology represents one of the most promising, but also one of the most ethically insidious fields. The evolution of science, which pushes the boundaries of what is technically possible, forces institutions to confront increasingly complex moral dilemmas. At the centre of this debate is the European Patent Office (EPO), which increasingly acts as a kind of gatekeeper, called upon to balance the promotion of innovation with respect for fundamental ethical values. A recent decision by the EPO, which rejected a patent for the creation of human-pig chimeras, highlighted the fragility of this ethical line, setting a precedent that could define the future of research and patenting in the life sciences.
The case concerns a patent application filed by the University of Minnesota in 2016, focusing on a method to produce a chimera by integrating human pluripotent stem cells into pig embryos. The innovation, which involves the use of a specific genetic modification in the pig (deletion of the ETV2 gene responsible for the generation of stem cells and blood vessels), would make it possible to generate a pig equipped with human blood vessels and blood cells that can be used to treat human diseases. At the same time, these chimeras could lead to the production of immunologically compatible pig organs, an application that could revolutionise transplantation and solve the dramatic shortage of donors.
However, the EPO Examination Section raised important ethical objections, leading to the rejection of the patent in 2022. The decision was upheld on appeal in September 2024. The core of the problem lies in Article 53(a) of the European Patent Convention (EPC), which excludes from patentability inventions considered “contrary to public policy or morality”. This clause, which is also regulated in Europe by Directive 98/44/EC on biotechnological inventions, is intended to act as an ethical safeguard. The crucial issue, according to the EPO Board of Appeal, was that the patent application did not explicitly exclude the possibility of human cells being integrated into the brain and/or germ cells of the chimera, resulting in the creation not only of a physical hybrid, but of an organism that could potentially have human consciousness or transmit human genes. This scenario, judged to be a realistic possibility and not merely a hypothesis, was seen as a violation of human dignity.
The ethical conflict that has arisen from the patenting of man-pig chimeras, however, has more than one precedent.
The EPO’s case law on the patentability of living beings is constantly evolving, and the balancing act between science and morality has resulted in very different cases.
One of the best known precedents is the 1992 case of the “Oncomouse”. The EPO, after initial opposition, granted the patent for a genetically modified mouse for cancer research. The motivation was a careful “weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other”. The EPO felt that the suffering of the few animals involved was justified by the considerable potential benefit to cancer research, which would save lives and reduce the total number of experiments on other animals. This case laid the foundation for an ethical analysis that balances scientific benefits with animal welfare.
In another case in 2012, the EPO examined a patent for a method of detecting cancer cells in non-transgenic mice. Once again, it had to consider whether the suffering of the animals was justified. The decision was in favour of the patent, as the method, while causing suffering to the mice, made it possible to reduce the overall number of animals used in research.
But the ethical pendulum swung with the case of a 2020 patent on a pharmaceutical product obtained from rabbits which involved injecting the smallpox virus into their skin to generate an inflammatory response. The skin could then be used to produce the pharmaceutical product. However, too many animals (6 to 10) had to be treated (and subsequently killed) to obtain a single tablet. The EPO, in this case, refused the patent, stating that “the benefit to mankind is not such as to outweigh the suffering of the animals”.
Case law has thus made it clear that, to be acceptable, animal suffering must be proportional to a significant medical benefit, a concept that has recently found a stricter application than in the past.
Besides the concept of animal welfare, the question of patentability becomes even thornier when it touches human life. Stem cells are another ethical battleground. EPO case law, in line with European regulations, states that inventions requiring the destruction of human embryos for commercial or industrial purposes are not patentable. The Court of Justice of the European Union confirmed this position in a landmark ruling (C 34/10 of 18/11/2011), consolidating the idea that human life, even in its early stages, cannot be treated as a commodity.
However, the picture is more nuanced for other cell types. Pluripotent stem cells, which cannot develop into a complete individual, can be patented provided they meet the criteria of novelty and industrial application. This distinction shows how patent law is forced to follow the frenetic pace of research, trying to define increasingly nuanced boundaries.
The decision on human-pig chimeras fits into this context, but shifts the focus from a single cell to a hybrid organism. The rejection of the patent for violation of human dignity is a strong signal: although an element isolated from the human body can be patented if produced by a technical process, the integration of human elements into an animal organism raises questions of identity and ownership that go far beyond mere innovation.
In a world where biotechnology promises to solve the greatest medical challenges, the EPO’s decision reminds us that not everything that is technically feasible is ethically acceptable. Although they are fluctuating concepts that are open to interpretation, morality and public order remain a necessary boundary. The EPO, with its decision, offers no definitive answers, but poses a fundamental question: in an age of unlimited progress, what limits are we willing to draw to protect what defines our very humanity?