Page 70 - MI-2-3

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

production method employed. Nevertheless, one leeway The selected patents can be categorized based on their
in this restriction is that if a claim pertains to a specific respective claims that encompass three categories: Single
utilization of a gene, a patent encapsulating the specific phage, phage combination, and phage combination and
method of employing that gene may be eligible for a grant. method pertaining to its use. This taxonomy highlights
the diversity and depth of innovations within the natural
4. Overview of representative granted phage therapy landscape.
patents in phage therapy It might seem counterintuitive that many patents,

Despite the legal complexities, dozens of patents related particularly those concerning single phages or
to natural phage therapy have been granted. These straightforward phage combinations, have been granted
achievements underscore an intriguing interplay between within the current framework of biological product
biological ingenuity and legal constraints, demonstrating patentability. To delve deeper into this phenomenon,
the resilience and perseverance of researchers and a two-pronged analysis was conducted. First, the
stakeholders in this domain despite stringent barriers. temporal shifts in the prevalence of various phage patent
To illustrate this point, Table 1 presents a curated list categories were examined. It was found that patents for
of natural therapeutic phage-related patents granted to single, naturally occurring phages surfaced only once,
several representative companies in the industry in the in 2009. Meanwhile, patents for phage combinations
US and the patents’ corresponding registrations in the EU were predominantly granted in and before 2010, with
and Australia if exist. This compilation was meticulously a solitary exception granted in 2023. In contrast, the
made by screening the granted patents of these companies frequency of patents for phage combinations and their
through the US Patent and Trademark Office’s (USPTO) associated usage methods has remained consistent
website. The “Basic Search” option was used to sort for the from 2008 to 2023. Another trend among more recently
keyword “phage” and the phage-based companies’ names. granted patents is an increased likelihood of including
Once potential patents were found, a closer examination claims that specify sequence similarity thresholds.
of them was done by reading their abstracts and claims. Before 2014, no patents featured claims with such
Further refinement was applied to ensure that only patents thresholds. However, in 2014, Intralytix received two
pertaining to therapeutic phage applications and with patents (10517908-B2; 11253557-B2) that incorporated
successful grant status were included, resulting in a total of Restriction Fragment Length Polymorphism (RFLP)
21 patents. Patents regarding bioengineering modification DNA profiles, albeit with a vague threshold described
methods and manufacturing processes are not included as “substantially equivalent.” A pivotal shift occurred in
for their more obvious patentability and less relevance 2018 when Pherecydes secured a patent (10077431-B2)
to the biological nature of phage therapy. Following the with a defined 97% DNA sequence similarity threshold,
selection process on USPTO, another sorting process marking the first instance of a precise quantitative
was performed on Espacenet to link the selected patents threshold. Following this precedence, more subsequent
from the US to their corresponding applications in the patents established this standard in their claims, all
EU and Australia if exist. Note that there may be repeated setting thresholds at over 90% (Table 1).
corresponding patents for a single patent from the US Second, we conducted a comparative analysis between
in other regions. This is caused by various legal reasons the claims in the granted patents and their original
that are not of concern here. While A1 and A2 patents are applications to identify any rejected claims. Our analysis
recorded for the ones in the EU and Australia, focus should revealed that there was no blanket rejection of any specific
be emphasized on B-patents because A-patents represent type of claim. Instead, the granted patents typically exhibited
published patent applications, but only B-patents are a higher degree of specificity compared to their initial
granted. applications, often achieved by introducing additional
Overall, these 21 patents were exclusively held by four limitations within the scope of the claims. For example,
companies: Armata Pharmaceuticals, Intralytix, Locus in some instances, the sequence similarity thresholds
Bioscience, and Pherecydes Pharma. It is worth mentioning were raised (e.g., from 90% in 20210228659-A1 to 99% in
that although other organizations including SNIPR Biome, 11779617-B2). In others, the patented compositions were
Adaptive Phage Therapeutics, Eligo Biosciences, BiomX, amended to necessitate a minimum of two phages instead
Fixed Phage, and PhageLux possess a considerable number of just one (e.g., from 20200171108-A1 to 11253557-B2)
of patents in bacterial infection treatment, such patents are (Table A1 in Appendix). These adjustments underscore
not directly related to natural therapeutic phages or are not the importance of precision and clarity in patent claims to
yet granted. As such, they were excluded from this analysis. enhance their chances of approval.

Volume 2 Issue 3 (2025) 62 doi: 10.36922/mi.4758