Copyright at the Bedside: Should We Stop the Spread?
|Written by Robin Feldman (left)
U.C. Hastings College of Law
John Newman (right)
Research Fellow, Univ. of CA San Francisco
Posted: July 28, 2013 @ 8:30 am
In December of 2011, we published an article in the New England Journal of Medicine describing the current crisis in cognitive testing. Doctors and medical researchers are scrambling to adapt to the recent assertion of copyrights in a popular screening method that has been used for decades to measure cognitive impairment. Although the assertion of this particular set of rights is relatively new, doctors are increasingly facing copyright claims in a variety of tests, including those for depression and for pain.
In the New England Journal article, we tried to encourage the creation of a cultural norm in the field of medicine, in which medical researchers would ensure continued availability of their tests through appropriate open access licensing for any copyrights that might exist. In this companion piece, we consider the legal side of the question. Although copyrights in medical testing are being asserted frequently, are those rights valid, and should they be upheld in whatever courts eventually hear the issue?
As fascinating as the theoretical challenges may be, the question of copyright in medical testing has immediate, practical ramifications. Doctors and researchers are quietly acquiescing to the demands of those asserting copyright in medical tests, for fear of becoming entwined in lengthy and expensive legal proceedings that could result in a costly judgment. Such fear could easily become a self-fulfilling prophecy if it prompts the creation of an industry norm for licensing medical tests. Courts and legislators have been known to defer to industry custom, even when they harbor some doubts about the wisdom of the underlying logic.
The challenging thread running through all of this is that medical tests of this kind stand at the boundary between patent and copyright, raising the mind-bending question of how to conceptualize a process, which is the purview of patent, when that process consists of nothing more than words, which is normally the purview of copyright.
Copyright protects the way in which an author chooses to express an idea or a set of facts, but not the idea or facts themselves. Thus, writing a textbook that teaches and explains chemistry does not give the author rights in the formulas explained, although it may give the author rights in the particular way in which the formulas are explained.
In a similar vein, copyright protection does not extend to things such as systems, procedures, and methods of operation. Not only are these analogous to underlying ideas and formulas, they are also the purview of patent law. Granting copyrights to these would create a backdoor method for allowing those unable to meet the more rigorous requirements of patent law to block access to these nonetheless.
The words of medical tests should be entirely beyond the subject of copyright. They are a system, a method of going about something: a process for determining the level of brain functioning. If they represent sufficient novelty and meet the other requirements of patentability, the person who designed the test can seek a patent on a method of determining cognitive functioning. From the perspective of copyright, however, the test itself lies outside the protection of copyright, regardless of what form the test is embodied in. One way to look at the issue would be the following: it does not matter if one writes it down, says it, sings it as a song, or does it as a dance routine. A medical test is a process, and processes are not the subject of copyright.
In addition to copyright claims, PAR also asserts trade secret claims. In particular, the PAR site suggests that the usefulness and validity of the tests would be compromised if the tests became available to the public. This is a surprising claim. The possibility that a patient might cheat on the test by remembering the answers would not be of concern in a clinical setting, at least not for cognitive mental testing. If a patient can remember answers in that manner, it is likely that their cognitive function is normal.
Nevertheless, PAR insists that purchasers may not reveal the test questions or any other materials. Purchasers are not even permitted to tell the patient what the results were.  The PAR website notes further that the Department of Health & Human Services has provided guidance in a letter stating that it is not a violation of HIPAA to refrain from providing an individual’s health information if doing so would disclose trade secrets.
Suggesting that the information in the MMSE test constitutes a trade secret is somewhat odd. To satisfy the secrecy requirement in trade secret, one must ordinarily show that the protected information gives the owner an advantage over competitors. The appropriate question is whether the test itself is well known by competitors, which in this case would mean competitors in the field of medicine. Given how widely the test is known, it would be difficult to establish that it constitutes a trade secret, at least not in the way that secrecy is ordinarily measured for the purposes of trade secret protection. How can something be a trade secret if everyone in the trade knows it?
Attempts to assert copyright and trade secret in cognitive medical testing should be rejected by the courts that eventually face the issue. When a medical test consists of nothing but words, asserting copyright in those words serves as a back door approach for using copyright to gain control of a process—something that is the proper purview of patent law, rather than copyright. The logic would apply in all such testing, but the assertion of copyright in the Mini-Mental State Exam, is particularly inappropriate. Much of the value of the test flows from its adaptation as an industry standard, rather than the labor of the authors. In addition, the fact that the authors permitted the work to be used freely for decades has created the expectation in users that work would be freely available and has encouraged its adoption as the industry standard. After standing silent for decades, the authors cannot now decide that the test provides a convenient vehicle for monetization.
Undoubtedly, this issue will make its way to the steps of the courthouse sometime soon. We hope that the judges who are faced with these decisions will recognize that attempted assertion of copyrights in this context is a distortion of the logic underlying both patent and copyright. Equally important, these copyright assertions threaten to harm both medical research and the delivery of medical care for everyone.
EDITORIAL NOTE: This is an executive summary of a longer work by the same title published in the Stanford Technology Law Review: Copyright at the Bedside: Should We Stop the Spread?, 16 Stan. Tech. L. Rev. 623 (2013).
. John Newman & Robin Feldman, Copyright and Open Access at the Bedside, 365 New Eng. J. of Med. 2449 (Dec. 29, 2011). Although the New England Journal of Medicine accepts only two author names, C. Bree Johnston was an essential author of that article, as well as this one.
. Appendix “A” contains a chart of mental state tools for which some form of copyright has been asserted.
. With open source licensing as a general matter, others are free to copy and use the work, as long as any improvements created are made as freely available as the original work.
. For examples of courts deferring to industry custom despite underlying concerns, see Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002) (“[C]ourts must be cautious before adopting changes that disrupt the settled expectations of the inventing community.”); Ass’n for Molecular Pathology v. USPTO, 653 F.3d 1329, 1368 (Fed. Cir. 2011) (Moore, J., concurring) (“The settled expectations of the biotechnology industry—not to mention the thousands of issued patents—cannot be taken lightly and deserve deference.”); Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir. 2010) (“[A] determination of whether the limitation [of a patent claim] is sufficiently definite is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area).”) (internal citations omitted). For literature discussing the logic of acceding to industry custom, see Gideon Parchomovsky & Alex Stein, Torts and Innovation, 107 Mich. L. Rev. 285 (2008) (arguing that courts’ reliance on industry custom chills innovation); James Gibson, Risk Aversion and Rights Accretion in Intellectual Property Law, 116 Yale L. J. 882 (2007) (arguing that risk aversion causes over-licensing, which in turn creates “doctrinal feedback” and a subsequent expansion of intellectual property rights); Jennifer E. Rothman, The Questionable Use of Custom in Intellectual Property, 93 Va. L. Rev. 1899 (2007) (arguing that reliance on custom and “best practices” in intellectual property law leads to expansion of owners’ rights at expense of users). Cf. John E. Calfee & Richard Craswell, Some Effects of Uncertainty on Compliance with Legal Standards, 70 Va. L. Rev. 965 (1984) (arguing that uncertainty in legal standards leads to over-compliance by economic actors who modify their behavior beyond what is socially optimal.)
. William F. Patry, Patry on Copyright, § 4:42 (updated Feb. 2012).
. 17 U.S.C. § 102(b) (noting that copyright does not extend to “any idea, procedure, system, method of operation, concept, principle, or discovery, regardless of form in which it is described, explained, illustrated or embodied”). See, e.g., Sparaco v. Lawler, Matusky, Skelly, Eng’rs LLP, 303 F.3d 460, 468 (2d Cir. 2002); Attia v. Soc’y of N.Y. Hosp., 201 F.3d 50, 54 (2d Cir. 1999); Alexander v. Irving Trust Co., 228 F.2d 221 (2d Cir. 1955); Reyher v. Children’s Television Workshop, 533 F.2d 87 (2d Cir. 1976).
. See Thomas G. Field, Jr., Should Copyright Protect Evaluative Tools? IP Frontline (Jan. 11, 2012) (op/ed arguing that “[a]s seen from the perspective of Baker, the MMSE is the art; it describes nothing; its object is use, not explanation”) available at https://www.ipfrontline.com/depts/article.aspx?id=26212&deptid=4
. PAR Frequently Asked Questions, http://www4.parinc.com/Faqs.aspx (last visited May 4, 2013).
. See PAR Frequently Asked Questions, http://www4.parinc.com/Faqs.aspx (last visited May 4, 2013).
. See HIPPA Statement, http://www4.parinc.com/webuploads/staticpages/ HIPAA_Statement.pdf (last visited May 4, 2013) (citing the following as language from a US Department of Health and Human Services letter:
“Any requirement for disclosure of protected health information pursuant to the Privacy Rule is subject to section 1172(e) of HIPAA ‘protection of trade secrets.’ As such, we confirm that it would not be a violation of the Privacy Rule for a covered entity to refrain from providing access to an individual’s protected health information, to the extent that doing so would result in a disclosure of trade secrets.”).
. This issue has been explored by one of the authors in Robin Feldman, Intellectual Property Wrongs, STANFORD J. L. BUS. & FIN. (forthcoming), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2127558.
. Morlife, Inc. v. Perry, 66 Cal Rptr. 2d 731 (Cal. Ct. App. 1997). See also Am. Paper & Packaging Products, Inc. v. Kirgan. 228 Cal. Rptr. 713 (Cal. Ct. App. 1986).
About the Authors
Robin Feldman is a Professor of Law at U.C. Hastings, Director of the UC Hastings LAB Project, and has served as the Chair of the Antitrust Section of the American Association of Law Schools. Professor Feldman’s first book, The Role of Science in Law, was published by Oxford University Press in 2009. Her second book, Rethinking Patent Law, is forthcoming in 2012 from Harvard University Press. Professor Feldman received a bachelor's degree from Stanford University graduating Phi Beta Kappa, and a J.D. from Stanford Law School, graduating the Order of the Coif and receiving the Urban A. Sontheimer Award for graduating second in the class.
John Newman is a Research Fellow in the Division of Geriatrics at the University of California San Francisco. He completed undergraduate work at Yale University before obtaining an MD and PhD at the University of Washington. He trained in Internal Medicine and Geriatrics at UCSF. His interests include laboratory investigation of the basic science of aging, and promoting responsible application of copyright in medical care and research.