The patentability of natural phages as therapeutics in the United States

Abstract

The resurgence of phage therapy as a potent countermeasure against antimicrobial resistance has been accompanied by significant challenges in patent protection. This perspective paper examines the patentability of natural phages as therapeutics, focusing on the United States and extending to the European Union and Australia-jurisdictions at the forefront of this biotechnological innovation. We dissect the legal frameworks and identify the patent claims that have successfully navigated the complex intellectual property landscape. Our analysis reveals a dichotomy between the natural origin of therapeutic phages and the inventive steps required for patent eligibility. Despite hurdles, we highlight strategic innovations and specific patent claims that have been granted, suggesting a path forward for the commercialization and protection of phage therapy. We conclude with a call for a more adaptive legal framework to foster innovation and recognize the transformative potential of phage therapy in modern medicine.

Keywords

Phage therapy / Patentability / Natural phage / Biological invention / Legal regulation

Funding

This work is supported by a grant from the National Key Research and Development Program of China (2021YFA0911200).

Conflict of interest

Qimao Yang and Shiyi Zeng were interns at CreatiPhage Biotechnology. Biao Zhu is an employee of CreatiPhage and Nannan Wu is a cofounder of CreatiPhage Biotechnology. In addition, Nannan Wu is an Editorial Board Member of this journal but was not in any way involved in the editorial and peer-review process conducted for this paper, directly or indirectly. All authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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