Human-porcine Chimera Patent Rejected Over Ethical Concerns
The European Patent Office (EPO) has rejected a patent application concerning methods for producing a human-porcine chimera, citing ethical concerns related to human dignity. The decision, T1553/22, underscores the complexities of balancing scientific innovation with moral considerations in biotechnology, particularly when dealing with human-animal chimeras. This ruling aligns with Article 53(a) of the European Patent Convention (EPC), which prohibits patents for inventions whose commercial exploitation would be contrary to “ordre public” or morality.
Background of the Patent Application
The patent application, number 16759528.9, focused on creating human-porcine chimeric animals to provide a source of human vasculature and blood. The method involved creating a non-human blastocyst, specifically porcine, lacking a developmental gene (ETV2) essential for blood vessel and blood cell development. Human pluripotent cells, possessing the missing ETV2 gene, were then introduced into this blastocyst.
Did You Know? …
chimeras are organisms composed of cells with distinct genotypes. The term originates from Greek mythology, referring to a fire-breathing hybrid creature.
Key Claims of the Application
- A chimeric non-human blastocyst expressing human ETV2 and lacking expression of said non-human animal ETV2, wherein the blastocyst is porcine.
- A chimeric non-human animal expressing human ETV2 and lacking expression of said non-human animal ETV2 wherein the non-human animal expresses human blood cells selected from the group consisting of white blood cells, red blood cells, platelets or a combination thereof and wherein the chimeric non-human animal is porcine.
- A method for producing a chimeric non-human animal expressing humanized vasculature and humanized blood.
Legal Framework and Ethical considerations
Article 53(a) EPC serves as the primary legal basis for the rejection. Rule 28(1) EPC supplements this, providing a non-exhaustive list of biotechnological inventions excluded from patentability, including processes for cloning human beings and uses of human embryos for industrial or commercial purposes. Furthermore,Directive 98/44 EC,used as a supplementary means of interpretation,states that processes that offend against human dignity,such as those producing chimeras from germ cells or totipotent cells of humans and animals,are also excluded from patentability.
The Board of Appeal referenced Recital 38 of the directive 98/44/EC, which addresses processes that offend human dignity, such as creating chimeras from germ cells or totipotent cells. While the application concerned pluripotent cells, the Board extended the ethical rationale to include the potential for human cells to integrate into the brain or germ line of the chimera, leading to human-like traits.
The Board of Appeal’s Decision
The applicant argued that the Examining Division was overly restrictive in applying Article 53(a) EPC and that the Directive 98/44/EC should be narrowly interpreted. They emphasized that their claims involved pluripotent cells, not the totipotent cells mentioned in Recital 38. However, the Board maintained that the “object and purpose” of the provision must be assessed to understand the underlying rationale.
The Board determined that Recital 38 provides guidance on interpreting exclusions based on “ordre public” and morality. the core concern was that human cells might integrate into the brain or germ cells, potentially resulting in a chimera with human-like capabilities. Despite the applicant’s evidence suggesting that human cells would not participate in the chimera’s brain or germ cells, the Board found the scientific literature indicated a real possibility of such integration, which could not be dismissed as mere speculation.
Pro Tip: …
When drafting patent applications involving sensitive biotechnologies, include specific limitations or disclaimers to address potential ethical concerns and exclude subject matter that might potentially be deemed offensive to human dignity.
Implications and Future Directions
This decision underscores the importance of carefully drafting patent applications to include suitable limitations or disclaimers that omit excluded subject matter. While biotechnologies aimed at providing option sources for human transplant and transfusion tissues hold significant value, navigating statutory exclusions is crucial to avoid infringing on human dignity. The ruling serves as a reminder that ethical considerations are paramount in the realm of biotechnology patents.
The decision emphasizes the need to consider the broader ethical implications of biotechnological inventions, particularly those involving human-animal chimeras. It highlights the ongoing debate surrounding the boundaries of scientific research and the protection of human dignity in the face of rapidly advancing technologies. As of 2023, public opinion remains divided on the ethics of human-animal chimeras, with concerns ranging from animal welfare to the potential blurring of species boundaries
1.
Summary of Key Points
| Aspect | Details |
|---|---|
| Patent Application | Methods for producing human-porcine chimeras |
| Reason for rejection | Ethical concerns under Article 53(a) EPC |
| Key Concern | Potential integration of human cells into the chimera’s brain or germline |
| Legal basis | article 53(a) EPC, Rule 28(1) EPC, Directive 98/44 EC |
| Applicant’s Argument | Narrow interpretation of Directive, use of pluripotent cells |
| Board’s Decision | Ethical concerns outweigh potential benefits, claims lack limitations |
Evergreen Insights: The Broader Context of Chimera research
Research into human-animal chimeras is driven by the potential to address critical shortages in organs for transplantation. according to the Health Resources & Services Governance, as of January 2024, over 100,000 people in the United States are awaiting organ transplants
2. Chimeras could potentially serve as a source of compatible organs, offering a solution to this pressing medical need. However, the ethical considerations surrounding such research remain a significant hurdle.
The debate over human-animal chimeras extends beyond patent law, encompassing broader societal values and ethical principles.The International Society for Stem Cell Research (ISSCR) provides guidelines for responsible stem cell research, including considerations for chimera research
3. These guidelines emphasize the need for careful oversight and public engagement to ensure that research is conducted ethically and responsibly.
Frequently Asked Questions About Human-Animal Chimeras
- What are the potential benefits of creating human-animal chimeras?
- Human-animal chimeras could potentially provide a source of organs for transplantation, advance our understanding of human development and disease, and serve as models for testing new therapies.
- What are the main ethical concerns associated with human-animal chimera research?
- ethical concerns include the potential for human cells to integrate into the animal’s brain or germline, the blurring of species boundaries, and the welfare of the animals involved.
- Are there any regulations governing human-animal chimera research?
- Regulations vary by country and institution. Many jurisdictions have guidelines and oversight committees to ensure that research is conducted ethically and responsibly.
- How do scientists prevent human cells from integrating into the brain or germline of a chimera?
- Researchers employ various techniques, such as using targeted gene editing to prevent human cells from developing into specific tissues or organs.
- what is the current status of human-animal chimera research?
- Research is ongoing in several countries, with a focus on developing methods for creating chimeras that can produce human organs for transplantation.
Disclaimer: This article provides general information and should not be considered legal or ethical advice. Consult with qualified professionals for specific guidance.
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