Issue 14 | January 24, 2019
8 min read

Patenting phages, part II: What makes something patentable?

Simply having a patent on something doesn’t actually protect your invention. That patent has to actually hold up in court. How is this determined, and what kind of chance do phages stand?

This week, we’re continuing a multi-part issue on patenting phage therapeutics (see part I here). Our main source for this article is a paper by Kelly Todd, Duke University School of Law J.D. / M.A. student.

What’s New

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Phage Futures 2019 is next week! Even if you’re not able to make it, we’ll be posting tweets (#PhageFutures2019) and keeping you up to date on which speaker is speaking, what people’s reactions are, and who’s up next. Check out our Phage Futures page to follow along next week!

Phage Futures

Phage TherapyBiotech

Mt. Sinai Hospital in NYC is now recruiting patients for a randomized, controlled, double-blind, Phase 1/2a phage therapy trial. The goal: test the safety and efficacy of Intralytix’s EcoActive phage collection on intestinal AIEC (adherent invasive E. coli) in Crohn’s Disease patients.

Clinical TrialsPhage Therapy

Dr. Saima Aslam and colleagues at IPATH / UCSD School of Medicine and Ampliphi Biosciences report on their use of IV phage therapy to treat biofilms associated with left ventricular assist devices (LVADs). This is now a protocol guiding clinical trials at IPATH.

Phage TherapyClinical Case ReportProtocols

Phage scientists! It’s time for the International Society for Viruses of Microorganisms (ISVM) elections. If you’re a member, you can run for: President-elect, Vice-President, Secretary, Secretary Assistant, Treasurer, or Private Partnership. Send 5-6 sentences on your interests/qualifications to membership@isvm.org by TOMORROW (Jan 25).

Scientific SocietyElections

Bacteria sometimes acquire “incorrect” CRISPR spacers in response to phage infection. Until now, no one knew whether these incorrect (“slipped”) spacers had a purpose. Simon A. Jackson, Peter Fineran and co. have just shown that slipped spacers can actually be beneficial to bacteria. Here’s the full paper and a ScienceDaily article about it.

CRISPRPhage Biology

Could phages help explain the mysteriously healing qualities of India’s Ganges river? If you’re looking to learn about some interesting phage-related history (and mystery), you may like this excerpt of the new book “Ganges: The Many Pasts Of A River” by Sudipta Sen.

PhageHistory

Research Technician

Locus Biosciences

Research Triangle Park, NC

Locus Biosciences is seeking a highly motivated and detail-oriented applicant to join our research and development team as a full-time Research Technician. This individual will be responsible for inventory tracking, media preparation, and carrying out research goals.

Phage Biotech MicrobiologyMolecular Biology

Research Associate

Locus Biosciences

Research Triangle Park, NC

Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join our research and development team as a full-time Research Associate. This position is well suited for those that can accomplish defined work, as well as assist in approaching and solving complex scientific problems.

Phage Biotech Molecular BiologyMicrobiologyBioinformatics

Scientist

Locus Biosciences

Research Triangle Park, NC

Locus Biosciences is seeking highly motivated applicants to join our research and development team as a full-time Scientist. This position is well suited for innovative scientists that have a desire to lead their scientific efforts from the bench and a passion to develop and pursue multiple avenues to complete research objectives.

Phage Biotech MicrobiologyDrug DevelopmentBioinformatics

Principal or Sr. Scientist

Locus Biosciences

Research Triangle Park, NC

Locus Biosciences is seeking highly motivated applicants to join our research and development team as a full-time Principal or Senior Scientist. This position is well suited for experienced scientists that have a desire to lead scientific efforts and pursue multiple avenues to complete research objectives.

Phage Biotech Drug DevelopmentMicrobiologyMolecular Biology

Community Board

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January 24, 2019

Update: Citrobacter phages for sea turtle

Phage Directory

We are still seeking Citrobacter phages to treat a sea turtle’s antibiotic-resistant shell infection. If you can help, please email staff@phage.directory!

Progress so far:
Good news! At least one phage active against the turtle’s Citrobacter strain has been found, and the FDA has given its approval to proceed with getting phages ready for this case.

Phage TherapyVeterinary Medicine
January 24, 2019

Seeking collaborators and guidance for new phage therapy center

Tribhuvan University

Gunaraj Dhungana
Kathmandu, Nepal

My name is Gunaraj Dhungana, I’m a Ph.D scholar from the central Department of Biotechnology, Tribhuvan University, Nepal. We have been working on the characterization and preparation of a phage bank to establish a phage therapy centre in Nepal. We are seeking collaborations and guidance to establish the centre. Please email me at grdhungana79@gmail.com if you are willing to offer advice or would like to talk about collaborating.

Phage Therapy

Patenting phages, part II: What makes something patentable?

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Phage microbiologist and co-founder of Phage Directory

Co-founder

Phage Directory, Atlanta, GA, United States

Jessica Sacher is a co-founder of Phage Directory and has a Ph.D in Microbiology and Biotechnology from the University of Alberta.

For Phage Directory, she takes care of the science, writing, communications, and business aspects.

Simply having a patent on something doesn’t actually protect your invention. That patent has to actually hold up in court. Patents may discourage someone from copying you, but they’re just a piece of paper until they’re tested in court.
So we should be using the word “patentable” to refer to something that, if patented, would be enforceable.

This week, we’re continuing a multi-part issue on patenting phage therapeutics (see part I here). Our main source for this article is a paper by Kelly Todd, Duke University School of Law J.D. / M.A. student.

What makes something patentable?

For something to be patentable, it needs to be an invention or discovery of something new and useful.

  • You can patent a new process / machine / manufacture / composition of matter.
  • You can patent a new and useful improvement of one of these.
  • You can NOT patent a law of nature / natural phenomenon / abstract idea.*

*An important exception

Recently, the US Supreme Court stated that if a law of nature / natural phenomenon / abstract idea involves an inventive concept, it may still be patentable. To find out if it is patentable, something called the Mayo/Alice test can be applied.

The Mayo/Alice test:
  1. Does the patent involve a law of nature / natural phenomenon / abstract idea?
  2. If yes, does it involve an inventive concept?
    • If yes, it may be patentable.
    • If no, it is not patentable.

The problem

There’s been a lot of confusion about what will and will not qualify as patentable under this new rule. Drug developers are confused, and so are the courts themselves. Since 2017, about 90% of patents subjected to the Mayo/Alice test have failed it, while some (very similar) patents have passed. This is concerning to many people patenting technologies in the life sciences, because they can’t be confident their patents will hold up.

Patenting a phage: it depends how you classify it

  • New composition of matter? (not likely acceptable if natural phage or directed evolution-modified phage, maybe acceptable if CRISPR-modified phage, though CRISPR engineering may be becoming “obvious” / may not hold up forever)
  • New method or process of producing a [modified] phage? (might fare better, but must be produced by more than just a “well-understood, routine, conventional activity already engaged in by the scientific community”)
  • New method or process of treating a condition, using a phage? (may be best option for phage patenting, if the patent were to describe the treatment of a condition that had never before been treated by that phage [may qualify as an inventive application of a natural product])

Throw everything at the wall and see what sticks?

Few phage patents have been filed, but those that have been filed employ vastly different patenting strategies, such as:

  • Patenting methods of treatment
  • Patenting phage enzymes instead of whole phages
  • Patenting use of phages in animals
  • Patenting phages directly

This diversity of phage patenting strategies may reflect the fact that no one yet knows what the best strategy is, when it comes to patenting phages.

Importantly, no case has been brought to court that directly addresses the patentability of phage therapy, so this uncertainty makes sense.

Does patent enforceability matter?

Having a patent (even if it has never been tested in court) can hold value as a signaling mechanism for investors. Therefore, patent enforceability may not matter all that much. Put another way, it may still be worth filing patents related to phages, even if their enforceability is hard to predict right now.

Thanks for reading!
– Jessica <>={

Next week, we’ll talk about ways of incentivizing investment in phages that go beyond patents. If you can’t wait until then, read Duke University School of Law J.D. student Kelly Todd’s article on phage patentability here.

References:

Kelly Todd, The Promising Viral Threat to Bacterial Resistance: The Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives, 68 Duke Law Journal 767-805 (2019)
Available at: https://scholarship.law.duke.edu/dlj/vol68/iss4/3

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