Written by Hanna Engstrom, SLS LLM ’25, CLB student fellow

In vitro gametogenesis (IVG) is the process of creating eggs or sperm from somatic cells, and it is no longer science fiction. Researchers have successfully generated fully functional egg and sperm cells from mouse pluripotent stem cells, which were capable of producing offspring.[1]  For humans, however, the complete in vitro development of functional gametes has not yet been achieved. Current estimates suggest that creating viable human sperm or eggs could happen within the next 2-3 years, while others think that it is closer to 10 years away.[2]

IVG holds the potential to transform reproductive medicine, offering possibilities for same-sex reproduction, fertility extension, and multiple embryo testing at once for a wide range of genetic traits or conditions. However, while IVG is legally untested territory in many jurisdictions, the European Union’s biotechnology patent law provides a structured framework for evaluation.

Under the EU Biotechnology Directive (98/44/EC), the patentability of biotechnological inventions is subject to both technical and ethical constraints. IVG does not involve human embryos, it uses reprogrammed adult cells to generate gametes, so it is possible that it escapes the strict exclusion in Article 6(2)(c), which bans patents involving the use of human embryos for industrial or commercial purposes. The European Court of Justice (ECJ) clarified in Brüstle v. Greenpeace made clear that this clause extends to any entity with the potential to develop into a human being, even if the destruction of the embryo (it regarded human embryonic stem cells) occurred outside the claimed invention. But as IVG does not involve the use of embryos, and sperms or eggs does not have the inherent capacity to develop into a human being, it seems to circumvent the Brüstle doctrine.

That does not mean IVG patents are a guaranteed safe passage. They still must survive the broader ethical filter in Article 6(1), which prohibits patents deemed contrary to “ordre public” or morality. The ECJ has interpreted this narrowly, applying it only to inventions that pose a serious threat to core societal values. For example, in Monsanto v. Cefetra (C‑428/08), the Court confirmed that public controversy alone is not enough to block a patent. That is encouraging for IVG, but not conclusive.

IVG presents a dual opportunity; it could be a therapeutic tool for infertility, or a vehicle for commodification of gametes. If the technology is used to support individual reproductive autonomy, for example by helping someone have a genetically related child, it aligns with existing EU norms around fertility treatment and gamete donation. But if IVG becomes a platform for industrial-scale gametes production, especially with no structured oversight or ethical guidelines, it may provoke backlash grounded in human dignity and reproductive ethics.

The EU has already shown sensitivity around the procurement and commercialization of human eggs, imposing strict consent and compensation rules.[3] IVG might bypass physical egg extraction, but it would likely increase concerns about commodification if it leads to a mass-production gamete factory with low costs and high supply.

Human dignity, a cornerstone of EU legal reasoning (as reaffirmed in Brüstle, ISCC, and Omega Spielhallen), remains the wild card. The Court has used the concept to uphold restrictions on biotech innovation where potential human life is at stake. Whether IVG promotes dignity, by enabling more people to reproduce, or threatens it, by reducing reproductive material to industrial goods, will shape its legal future.

[1] See Hayashi et al., Reconstitution of the Mouse Germ Cell Specification Pathway in Culture by Pluripotent Stem Cells, 146 Science 351 (2011).

[2] Human Fertilisation & Embryology Auth., Authority Meeting: 22 January 2025, at 69 (2025), https://www.hfea.gov.uk/media/qgmfzsmo/2025-01-22-authority-papers.pdf.

[3] Obstet Gynecol Int. 2012 Jan 4;2012:686253. doi: 10.1155/2012/686253 The Ethical, Legal, and Social Issues Impacted by Modern Assisted Reproductive Technologies Paul R Brezina , Yulian Zhao  https://pmc.ncbi.nlm.nih.gov/articles/PMC3261493/?utm