Brief of Amici Curiae AMA, ACMG, ASHG, APHMG, and Mayo Clinic in Support of Respondents (Oct. 2, 2009)

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Brief of Amici Curiae American Medical Association, the American College of Medical Genetics, the American Society of Human Genetics, the Association of Professors of Human and Medical Genetics, and Mayo Clinic in Support of Respondents (Oct. 2, 2009)

  • Interest
    • "A basic tenet of medical ethics is that discoveries should and advances in medical care should be shared freely and disseminated openly."
    • Join with the government
Amici join with the government in appealing from the non-medical decision below because the Federal Circuit has more recently used its “machine or transformation” test to approve patents that cover physicians' mental impressions, in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 2009 WL 2950232 (Fed. Cir. Sept. 16, 2009).
  • Ruling conflicts with ethical duty and Supreme Court case law
  • If construed too broadly, Section 101
    • Blocks spread of medical knowledge
    • Creates unfair monopolies
    • Harms patients
    • Drives up the cost of healthcare

Argument

I. The Federal Circuit's “Machine or Transformation” Test Must Be Applied Properly

  • Instructive, not determinative
  • Driven instead by more fundamental, historical standards
  • "it also cannot trump long- applied limits against patent claims that try to pree- mpt the use of fundamental principles"
    • Earth and sun
    • DNA double helix
Both processes - which undoubtedly have particular machines and/or transformations that are core to their execution - are unpatentable if they are not limited to some particular application of the principle, because they would cover, and thus “preempt,” every possible implementation that could come from recognizing the fundamental principle. See Gottschalk v. Benson, 409 U.S. 63, 71-72 (1972).

II. Public Policy is Well Served by Current Limits on Patentable Subject Matter, Which Preclude Patenting Scientific Data

  • Patents on scientific principles raise ethical concerns for physicians
  • Patents solely on scientific facts threaten to stifle innovation, including the development of personalized medicine, and to increase health care costs
  • Patents on scientific principles erode physicians' ability to provide quality patient care
    • Thomas Jefferson
If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea, which an individual may exclusively possess as long as he keepsit to himself; but the moment it is divulged, it forces itself into the possession of every one, and the receiver cannot dispossess himself of it.
  • L. Lessig, The Future of Ideas: The Fate of the Commons in a Connected World 94 (2001)
Such is the nature of scientific fact; once known, it must be considered. Quality patient care demands that a physician consider test results in light of, among other things, current medical knowledge.

Conclusion: Amici support the conclusion of the Federal Circuit, but caution that the “machine or transformation” test not be allowed to override the Court's traditional standards for patentable subject matter.