On 22nd May 2024, Professor Aisling McMahon gave an invited research seminar on her research on the “Patents & Bioethics within the European Biotechnology Directive: The Case of Human Embryo Models – Asking the Wrong Questions amidst Institutional Inertia?” at the ‘Law and Futures’ Seminar Series at Newcastle Law School, Newcastle University.
In Europe, Article 6 of the Biotechnology Directive 98/44EC states that inventions will be considered unpatentable where their commercial exploitation is against morality or ordre public (the general morality provision). Whilst Art 6(2) provides a non-exhaustive list of four types of inventions that are excluded from patentability on this basis, including ‘uses of human embryos for industrial and commercial purposes’ (Art 6(2)(c)). However, as science has developed, questions have arisen over what constitutes a ‘human embryo’ for this purpose and thus, what would be excluded from patentability. Focusing on existing decisions on Art 6(2) including in the context of the patentability of human embryonic stem cell technologies and parthenotes, Professor McMahon examined the application of Art 6 of the Directive to date, and how this might apply to questions around the patentability of emerging ‘embryo model’ technologies. She argued that there has been limited meaningful engagement with the broader potential bioethical issues posed by patent grant and use of patents over such technologies in Europe. Using existing cases and focusing on human embryo models as a case study, this paper argues that often the wrong questions are being asked within European patent law from a bioethics perspective. It made the case for why it is vital there is deeper and more nuanced consideration of the bioethical interests at stake in such contexts, and that such consideration should encompass questions around patent grant and use stages over embryo model and related technologies.
Professor McMahon is the Principal Investigator on the ERC funded PatentsInHumans Project. You can find out more about the PatentsInHumans project by visiting the project website: www.patentsinhumans.eu