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Microbes & Immunity

PERSPECTIVE ARTICLE
The patentability of natural phages as

therapeutics in the United States

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1
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Qimao Yang , Shiyi Zeng , Biao Zhu , Tongyu Zhu * , and Nannan Wu 1,2,3 *
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1 CreatiPhage Biotechnology Co., Ltd., Shanghai, China
2 Fudan University Phage Institute, Zhongshan Hospital, Shanghai Medical College, Fudan University,
Shanghai, China
3 Shanghai Public Health Clinical Center, Shanghai Institute of Phage, Fudan University, Shanghai,
China

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
*Corresponding authors: required for patent eligibility. Despite hurdles, we highlight strategic innovations
Nannan Wu and specific patent claims that have been granted, suggesting a path forward for the
(wunannan@shphc.org.cn) commercialization and protection of phage therapy. We conclude with a call for a
Tongyu Zhu
(tyzhu@fudan.edu.cn) more adaptive legal framework to foster innovation and recognize the transformative
potential of phage therapy in modern medicine.
Citation: Yang Q, Zeng S, Zhu B,
Zhu, T, Wu, N. The patentability
of natural phages as therapeutics Keywords: Phage therapy; Patentability; Natural phage; Biological invention; Legal
in the United States. Microbes &
Immunity. 2025;2(3):60-71. regulation
doi: 10.36922/mi.4758
Received: September 4, 2024
Revised: October 19, 2024 1. Introduction
Accepted: November 10, 2024 The advent of antimicrobial resistance has propelled phage therapy back into the spotlight,
Published online: December 2, offering a biological solution to the crisis. As the field advances, so does the complexity
2024 of securing intellectual property (IP) rights. Upon a thorough examination of the IP
Copyright: © 2024 Author(s). landscape within the realm of burgeoning biotechnologies, the topic of phage therapy
This is an Open-Access article patentability emerges as a particularly intriguing one. The natural origin of therapeutic
distributed under the terms of the
Creative Commons Attribution phages poses significant hurdles in securing patent protection for related products
License, permitting distribution, and inventions. This lack of robust IP safeguards acts as a deterrent for commercial
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and reproduction in any medium, enterprises, hindering their investment in promoting and advancing phage therapy.
provided the original work is
properly cited. This perspective paper provides an in-depth analysis of the patentability of natural
Publisher’s Note: AccScience phages as therapeutics, with a focus on the United States (US), then extending to the
Publishing remains neutral with European Union (EU) and Australia. We explore legal challenges and identify strategies
regard to jurisdictional claims in
published maps and institutional that have led to successful patent grants and draw parallels between the patentability
affiliations. challenges faced by natural phages, oncolytic viruses, and other microbes, offering

Volume 2 Issue 3 (2025) 60 doi: 10.36922/mi.4758