Gorman John Marshall Ip Biotech Symposium 4 15 11 2 Final

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When the fields of intellectual property law and biotechnology intersect, most analysis is driven by economic and ethical issues. This article examines these factors, but in relation to the emerging …

When the fields of intellectual property law and biotechnology intersect, most analysis is driven by economic and ethical issues. This article examines these factors, but in relation to the emerging security threat posed by biohackers, or do-it-yourself (“DIY”) scientists, who operate free from oversight and industry norms at the fringes of the biotechnology community. Public health risks are poised to grow as these citizen-scientists race for lucrative discoveries in the new frontier of synthetic biology. This article proposes that the existing paradigm adjust accordingly to leverage regulatory compliance from the most ambitious biohackers looking to benefit from patent protection. The U.S. government could bring aspiring entrepreneurial biohackers into the fold by making non-institutional patent applicants undergo Center for Disease Control biosafety training, personnel screening, and lab registration one year prior to receiving patent application eligibility in order to reduce some of the potential risk of these unmonitored labs present.

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  • 1. Patent Office as Biosecurity Gatekeeper: Fostering Responsible Science and Building Public Trust in DIY Science 10 J. Marshall Rev. Intell. Prop. L. 423 (2011) April 15, 2011 Review of Intellectual Property Law Symposium: “Biotechnology and Health-Related Issues in IP Law” The John Marshall Law School, Chicago, IL
    Brian J. Gorman
    Director, Biosecurity Commons
    Assistant Professor, Towson University
  • 2. Thesis:
    Modify Patent Eligibility for Biohackers and Do-It-Yourself Scientists to reduce risks of negligent & malevolent use of synthetic biology.
  • 3. Proposal
    Establish the U.S. Patent Office as a Gatekeeper for entrepreneurial DIY synthetic biology.
    Mandate that biohacking patent seekers comply with security requirements 1 year prior to applying for patents in synthetic biology.
    a.) Lab registration to help the F.B.I. distinguishthe legitimate network of DIY science from others, and
    b.) CDC biosafety training for amateurs interested in following the synthetic biology gold rush, and
    c.) Basic personnel reliability screening to identify individuals who should neither be trusted to work with synthetic biology nor hold patents in the area.
  • 4. Activities of Concern
    Synthetic Biology.
    -“the use of advanced science and engineering to make or redesign living organisms, such as bacteria, so that they can carry out specific functions. Synthetic biology involves making new genetic code, also known as DNA, that does not already exist in nature.”
  • 5. What’s at Risk?
    The “science that may cure some of our worst diseases could be used to create the world’s most frightening weapons.”
    --Central Intelligence Agency, The Darker Bioweapons Future,(2003).
    Synthetic biology could, “mindlessly screw up the unity of life on earth.”
    --SynbiosafeE-Conference: Online Community discussion on the Societal Aspects of Synthetic Biology, (2008).
  • 6. Source of Risk
    “’—biohackers’ around the world are setting up labs in their garages, closets and kitchens—from professional scientists keeping a side project at home to individuals who have never used a pipette before. They buy used lab equipment online, … and incubate tubes of genetically engineered Escherichia coli in their armpits.”
    -- Ledford, Lifehackers: Amateur Hobbyists Are Creating Home-brew Molecular-Biology Labs, but Can They Ferment A Revolution?, NATURE (2010).
  • 7. DIY Interest in Synthetic Biology is Growing
    “Many biohackers are keen to tackle projects that involve engineering cells by piecing together new genetic circuits, an approach called ―synthetic biology.”
    --Ledford, Nature, (2010).
    “Members of this informal network of wannabe biologists, entrepreneurs and artists are buying bacteria online, cobbling together discarded equipment, and holding parties to transect DNA and exchange live cultures.”
    -- Julian Guthrie, Do-It-Yourself Biology on Rise,
    S.F. CHRON.(2009).
  • 8. Investment SpeculationAbout the Future of Biotechnology
    “I think there is a potential for another bubble over the next decade. . . . there is one I am particularly interested in and that is biotech . . . . I think we are on the cusp of a decade of remarkable breakthroughs which will change the way we do medicine. . . . breakthroughs will come via large firms, others will be in smaller companies .
    --John Mauldin, The Coming Biotech Bubble, INVESTOR‘S INSIGHT (2010).
  • 9. Expert Opinion Consistent with Investor Speculation
    --“We‘re going to see a lot more at the garage level that will produce a variety of products in the marketplace, one way or another.”
    --Rob Carlson, Ph.D.
  • 10. Comparative Risk Matrix Guidance Tool
  • 11. Cautionary Views of Synthetic Biology
    Popular Opinion:
    52% of the population polled believed that synthetic biology should be regulated by the government, and
    33% thought such science should be banned altogether.
    -- Hart Research Associates, Awareness and Impressions of Synthetic Biology: A Report of Findings Based on a Survey Among Adults (2010).
  • 12. Issue Under Review by the USG
    “…the government will need to monitor the growth and capacity of researchers outside of institutional settings. This effort may require the government to expand current oversight or engagement activities with these non-institutional researchers.”
    Actually sympathetic to biohackers and not proposing immediate action.
    --Presidential Commission for the Study of Bioethical Issues, New Directions: The Ethics of Synthetic Biology and Emerging Technologies (2010) .
  • 13. The Governance Challenge
    Biohackers work in nontraditional and unregulated venues beyond reach of institutional rules, regulations and norms.
    Thus, the FBI has adopted a “neighborhood watch” stance encouraging DIY scientists to monitor and report any threatening behavior.
    -- Ledford, NATURE (2010).
  • 14. Why is Bio-hacking a Problem Now?
    The anticipated growth of synthetic biology may fuel a gold rush effect in science in unregulated environments.
    Increased exposure to negligence from novice and experts working in garage labs.
    Terrorists can get a free ride from the movement.
    Synthetic biology is the ultimate attractive nuisance for amateurs.
  • 15. Toward a Remedy
    1. Require lab registration of patent applicants working on synthetic biology.
    Foster a culture of responsibility and cooperation with regulatory authorities.
    2. Biosafety Training for Bio-hackers.
    Reduce lab errors and encourage responsible research.
    3. Minimal personnel reliability standards
    Restrict Felons
    Mental health standards?
    +?
    Discussions underway in USG regarding “personnel reliability” for biodefense researchers.
  • 16. Compatibility with The America Invents Act
    Patent Office gate keeping is consistent with the America Invents Act.
    Rewarding first-to-file patent applications encouragesthe biohackingentrepreneur to comply with registration, safety, and vetting requirements well in advance of pursuing breakthroughs in synthetic biology.
    The additional demands on the USPO can be offset by fees which the Act would allow the Office to collect.
  • 17. Patent Office as Biosecurity Gatekeeper: Fostering Responsible Science and Building Public Trust in DIY Science 10 J. Marshall Rev. Intell. Prop. L. 423 (2011) April 15, 2011 Review of Intellectual Property Law Symposium: “Biotechnology and Health-Related Issues in IP Law” The John Marshall Law School, Chicago, IL
    Brian J. Gorman
    Director, Biosecurity Commons
    Assistant Professor, Towson University