Bioethics of Patents and Licensing

Ebrahim-Bioethics-of-Patents-Licensing

Modern biomedical, biotechnology, and pharmaceutical sciences and technology have produced astounding advances and continue to do so. However, these fields are only beginning to grapple with bioethics and patent law intersections, which began with discussions about the morality exception to patentability (a legal standard) and have shifted to ethical licenses (forms of private governance). This Article provides a socially responsible framework for incorporating bioethics into patents and their licensing—termed bioethical licensing—that considers bioethics principles as paramount to private restrictions on ethical licenses. In applying this framework to countries with religious bodies of law, bioethical licensing has significant ability to align private governance with those societies’ public interests. Contrary to prevailing characterizations of ethical licensing as a gatekeeper for patent holders, bioethical licensing in alignment with a religion-driven legal system promotes socially responsible innovation that balances private discretion and public interests.

As commonly understood, patent license mechanisms concern the governance and use of patents. Unlike a government’s role in, and policies for, patent licensing, such as through compulsory licensing, ethical licensing addresses private governance that directs use for good as a form of private ordering. This Article, however, challenges this conception (when applied to biomedical, biotechnology, and pharmaceutical innovations) as being unconcerned with socially responsible considerations, both on a normative and a religious level. At a normative level, bioethical licensing should embody socially responsible values centered around restriction against societal dangers. At a religious level, the virtues of bioethical licensing are magnified by socially responsible innovation consonant with underlying value systems, as illuminated by this Article’s emphasis on alignment with religious bodies of law. Building on these insights, this Article sketches the contours of balanced bioethical licensing approaches in countries with religious bodies of law.

PDF: https://journals.law.unc.edu/ncjolt/wp-content/uploads/sites/4/2025/04/Ebrahim-Bioethics-of-Patents-Licensing.pdf

Author: Tabrez Y. Ebrahim

Volume 26, Issue 3