Page 75 - MI-2-3

Microbes & Immunity Natural phage patentability in the U.S.

5. Comparative analysis of patentability in combinations and methods pertaining to their usages
oncolytic viruses and microbial therapies may be useful. The perspective here reaffirms the critical
need to protect IP while nurturing innovation. Resolving
Phage products, oncolytic viruses, and other microbial the patentability issues regarding phage therapy also has
therapies exhibit similar biological characteristics, which immense economic implications. Stronger IP protections
subject them to analogous legal complexities in the realm of are positively correlated with pharmaceutical investments
patentability. Consequently, advancements in patentability and R&D expenses in general. This is expected to hold
10
within these related fields can provide significant insights in phage therapy, encouraging its market dynamics and
and value for the progression of phage therapy patentability. promoting its sources of funding for advancements.
Preliminary patent searches reveal the presence of several Furthermore, the patentability issues resonate with
oncolytic virotherapy-related patents in the US and EU, current regulatory hurdles revolving around phage
primarily falling into two categories: methods of treatment therapy. For instance, as the FDA classifies phage therapy
using oncolytic virotherapy and patents for recombinant as a biological product, patenting it must align with
oncolytic viruses with distinct characteristics. Notable the relevant regulatory framework to facilitate broader
examples of granted patents include US10238698B2, which market access and clinical application. Only by carefully
11
is associated with EP2806883B1 and relates to treatment analyzing existing patents, adhering to the principles
methodologies, and US9862932B2, which is associated of specificity and innovation established by precedent
with EP3473708B1 and concerns genetic recombination. cases, and learning from the progress made in similar
These granted patents bolster the prospects for achieving therapeutic areas such as oncolytic virotherapy and other
patentability in phage therapy through claims involving microbial therapies can the full potential of phage therapy
genetic modifications and innovative methodologies, as to revolutionize global health be unlocked, transforming
previously discussed. In the past decade, there has been this century-old therapy into a cornerstone of modern
a notable increase in the prevalence of patents related to medicine.
phages with biochemical modifications or conjugations
such as encapsulating phage compositions in polymer Looking into the times ahead, it can be argued that
microcapsules for delivery and binding phages to a plurality the future of phage therapy patentability lies in fostering
of particles to enhance performance, reflecting a strategic a more dynamic and adaptive legal framework. Countries
shift in patent applications to address the legal challenges. with more flexibility can serve as examples for others,
potentially leading to a more uniform and encouraging
While comprehensive reviews on the patentability global patent environment for phage therapy. With more
in therapeutic phages and oncolytic viruses are scarce, upcoming innovations and biological discoveries, the field
FitzGerald and Spek provide an exhaustive analysis of of phage therapy will eventually welcome more diverse and
patent protection in microbial therapies, specifically mind-altering technologies.
concerned with various bacterial therapies including
therapeutics based on fecal microbiota transplantation, Acknowledgments
defined bacterial consortia, single commensal bacterial
strains, and single engineered bacterial strains. The review We thank members of the Shanghai Institute of Phage and
9
echoes similar concerns about the challenges posed by the CreatiPhage Biotechnology for thoughtful discussions.
current US legal framework but also outlines potential Funding
future trajectories. These include the ongoing evolution of
legal patent guidelines and the development of innovative This work is supported by a grant from the National
approaches that are in harmony with regulatory principles. Key Research and Development Program of China
The analysis further highlights the progress made by (2021YFA0911200).
key companies in their respective therapeutic areas,
underscoring the dynamic nature of the field and the Conflict of interest
potential for further advancements in patentability. Qimao Yang and Shiyi Zeng were interns at CreatiPhage

6. Conclusion Biotechnology. Biao Zhu is an employee of CreatiPhage and
Nannan Wu is a cofounder of CreatiPhage Biotechnology.
The legal complexities surrounding phage therapy In addition, Nannan Wu is an Editorial Board Member of
patentability, stemming from its reliance on natural this journal but was not in any way involved in the editorial
elements, have not extinguished innovation within the and peer-review process conducted for this paper, directly
field. Despite some challenges, examples of granted or indirectly. All authors declare that the research was
patents showcase how targeting aspects such as phage conducted in the absence of any commercial or financial

Volume 2 Issue 3 (2025) 67 doi: 10.36922/mi.4758