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

a roadmap for future research and commercialization subject matter. This test outlines a framework for assessing
efforts. patent eligibility in cases involving controversial subject
matters.
2. Patentability in the US

In the US, the patentability of natural phages has been fraught 3. Patentability in the EU and Australia
with debate. Traditionally, a discovery must fulfill the criteria In the EU, the European Patent Convention (EPC) serves
of “any new and useful process, machine, manufacture, or as the cornerstone legislation outlining the criteria for
composition of matter, or any new and useful improvement patentability, and it is complemented by the European
thereof” (35 U.S.C. 101) to be eligible for being granted a Biotech Directive, which provides additional clarity for
patent. Concurrently, the discovery must not encompass laws biological inventions. Specifically, Rule 27 (a) and Rule
of nature, natural phenomena, and abstract ideas. Given 29 (2) of the EPC allow the patentability of biological
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these parameters, obtaining patents for natural phages has isolates and products derived from technical processes,
historically been inherently challenging due to the debatable even if they naturally exist. While European patents
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nature of whether their use in killing bacteria constitutes a cannot be granted to plant or animal varieties and their
creative invention or merely a manifestation of natural laws, production processes, Article 53 (b) offers exceptions
and whether it falls under the category of an abstract idea. for microbiological processes and related products.
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As discussed by Todd, three significant cases have further Furthermore, Article 54(4) enables the patentability of
complicated the patentability of phages. inventions claiming novel substances or compositions
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First, in the landmark case of Mayo Collaborative for therapeutic purposes that were previously unknown.
Services v. Prometheus Laboratories, Inc., 566 U.S. These provisions open abundant spaces for patenting
66 (2012), the Supreme Court of the US ruled that a patent inventions related to phage therapy, encompassing claims
claiming a method of determining the proper dosage of a based on genetic identity, phage cocktail compositions,
drug was invalid. The court deemed that the patent merely phage-derived products, and numerous other aspects.
recited a natural law that a high dosage of the drug may be However, Article 53(c) of the EPC excludes “methods
dangerous while a low dosage may be ineffective. Relating for treatment of the human or animal body by surgery or
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this to phage therapy, courts may similarly conclude that therapy and diagnostic methods practiced on the human
phage therapy merely involves applying a natural principle, or animal body,” with the exception of products such as
whereby a phage is utilized to kill its host bacteria. Second, substances or compositions used in those processes.
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in the case of Assoc. For Molecular Pathology v. Myriad This provision raises queries regarding the extent of
Genetics, Inc., 569 U.S. 576 (2013), the Supreme Court its limitation and introduces a degree of uncertainty
ruled that the DNA sequences patented by Myriad were surrounding the patentability of therapeutic biological
invalid because one cannot patent something naturally inventions, including those related to phage therapy.
occurring. Conversely, the court upheld the patentability
of cDNA derived from those DNA sequences, as the In Australia, the legal framework governing the
cDNA was artificially created. This ruling casts again patentability of inventions pertaining to phage therapy
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doubt on the patentability of natural phages and their falls under the umbrella of biological inventions, and IP
DNA, simultaneously offering hope for genetically or Australia stipulates that biological materials are patentable
chemically modified phages that are out of the scope of only if they have been isolated from their natural state or
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natural occurrence and endow the patented therapy with synthetically/recombinantly produced. Beyond directly
an inventive step. More details regarding the patentability patenting biological materials, Australia recognizes the
of novel technologies, including phage therapy, are patentability of methods and processes that involve the
illuminated in the third case, Alice Corp. v. CLS Bank Int’l, application of these materials. IP Australia provides
573 U.S. 208 (2014), which led to the establishment of the a comprehensive array of examples showcasing the
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Mayo/Alice test. The ruling in this case invalidated a patent breadth of biological inventions that can be patented,
pertaining to a computerized trading platform, deeming offering insights into the potential for granting patents
it as an abstract idea. Subsequently, this case gave rise to related to phage therapy. This includes but is not limited
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the Mayo/Alice test, which employs a two-step process to, inventions claiming genetic modifications, cocktail
to evaluate the eligibility of a patent. Initially, it examines compositions, methods utilizing these compositions,
whether the patent merely delineates a natural law. If phage delivery techniques, and phage-derived products.
affirmative, the subsequent step involves assessing whether However, it is crucial to note that patents asserting claims
the patent incorporates an inventive concept sufficient to related to the genetic identity of naturally occurring DNA
transform the ineligible abstract idea into a patent-eligible and gene sequences are not permissible, regardless of the

Volume 2 Issue 3 (2025) 61 doi: 10.36922/mi.4758