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PATENTS

Microbiome therapeutics and patent protection

Nature Biotechnology volume 38, pages 806–810 (2020)Cite this article

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Obtaining patent protection for microbiome therapeutics has been affected profoundly by the US Supreme Court decisions in Myriad and Mayo, which redefined the scope of which natural phenomena, including microbiome therapeutics, are patent eligible.

Microbiome therapeutics can be categorized in several ways, including by biological concept, therapeutic area or ‘bug status’. Of these categorizations, bug status is useful for positioning microbiome therapeutic companies, as microbiome companies generally operate in only one of the three bug-status arenas: ‘drugs from bugs’, ‘drugs for bugs’ or ‘bugs as drugs’. The first class, ‘drugs from bugs’, follows in the footsteps of traditional drug discovery in which the therapeutics are derived from microbial sources. Such therapeutics include metabolites and compounds, including bioactive molecules, excreted by bacteria of the microbiome. Companies that operate in this arena include Enterome, Second Genome and Kintai Therapeutics. ‘Drugs for bugs’ involves the administration of feedstuff for bacteria. The feedstuff moieties skirt the line between approved therapeutics and compositions classified as GRAS (generally recognized as safe). An example of a company in this space is Kaleido Biosciences, which is generating modified glycans that can stimulate the growth of certain groups of bacteria in the microbiome. The third class, ‘bugs as drugs’, involves the administration of one or more microorganisms. This class of microbiome therapeutics comes with unique patentability challenges and will be our focus here.

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Authors and Affiliations

  1. Nixon Peabody LLP, Boston, MA, USA

    Mark J. FitzGerald

  2. Vedanta Biosciences, Inc., Cambridge, MA, USA

    Erik J. Spek

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  1. Mark J. FitzGerald
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  2. Erik J. Spek
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Correspondence to Erik J. Spek.

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Competing interests

M.J.F. is a partner in the intellectual property group at Nixon Peabody LLP. E.J.S. is an employee of Vedanta Biosciences, Inc., a company developing therapies for diseases based on human microbiome-derived bacteria.

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FitzGerald, M.J., Spek, E.J. Microbiome therapeutics and patent protection. Nat Biotechnol 38, 806–810 (2020). https://doi.org/10.1038/s41587-020-0579-z

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