Biotechnology patenting: Limits of ordre public and morality provisions

AbstractThe world is experiencing explosive technological progress in biotechnology, leading to unprecedented benefits such as improved or new medicines, treatments, and processes with the potential to transform and save human lives. However, as novel technological frontiers are crossed, there have been increased concerns about how biotechnology inventions are granted or refused exclusive patent protection. Besides meeting patentability requirements, various countries consider most biotechnology inventions contrary to their ordre public and morality provisions and exclude them from protection using intellectual property rights. Notably, the meaning of these provisions is dynamic and varies from jurisdiction to jurisdiction, thus affecting the patentability of biotechnology inventions. Adopting the doctrinal research approach, we comparatively study various case laws, statutes, and legal sources from international, national and regional patent laws, including the impact of patent flexibilities on biotechnology inventions. Furthermore, we investigate the limit imposed by ordre public or morality provisions as grounds to refuse to grant biotechnology patents to benefit the community’s interest and invalidate it for the inventor. We review the current landscape for ordre public and morality limits on the patentable subject matter by analyzing relevant patent disputes and the impact of the decisions. We argue that ordre public and moral exclusions or exceptions have become entangled in Patent Law, so they must be interpreted and applied such that their outcomes do not hamstring patent granting for disruptive biotechnology inventions because of their more expansive ethical, societal, and legal effects. Moreover, this might require a critical demand to deal with controversial biotechnological issues on case-by-case decisions instead of a broad, inflexible, and comprehensive ban. While there is a need to adapt the ordre public and morality exclusions to accommodate biotech inventions, Patent Officers and Courts must be resourced to handle these exclusions. Most significantly, this study exposes the interplay and impact between patent laws as a commercial tool and the role of regulatory systems in the administration of biotechnology inventions. This is crucial to ensure fair and equal access to the merits of using biotechnologies for scientific development.