The Free Speech Implications of Gene Patents

61px-dna-splitLast week, the ACLU and Cardozo Law School’s Public Patent Foundation (PPF) filed a lawsuit in the S.D.N.Y., challenging the constitutionality and validity of Myriad Genetics’ patents for BRCA1 and BRCA2 gene mutations, which are linked to an increase risk of breast and ovarian cancer.  Plaintiffs, a collective of breast cancer and women’s health groups, individual breast cancer patients, and scientific associations, sued the U.S. Patent and Trademark Office, patent owner Myriad Genetics, and directors of the University of Utah Research Foundation.  The lawsuit asserts that the USPTO granted a patent on the association between mutations conferring an increased risk of cancer and, in turn, patented “an idea, a scientific fact, or a piece of knowledge.”  According to the complaint, patenting genetic sequences violates the First Amendment because it hinders the free flow of information.

Although the controversy over BRCA genes isn’t new, the case is groundbreaking.  As PPF’s Daniel Ravicher explained in this month’s The Cancer Letter, no court case in the U.S. has “ever questioned whether genes can be patented.”   The lawsuit calls into question the constitutionality of “thousands of patents covering human genes.”  Although plaintiffs could have challenged other patents, they chose the BRCA ones because, as Ravicher notes, “these are offensive patents, and they have a large impact.”  ACLU’s science advisor Tania Simoncelli explains that Myriad’s control over the BCRA genes hampers clinical research given its exclusive right to prevent anybody from looking at the genes in research.  The patent also impairs patient access to the tests, which can cost over $3,000.

Do gene patents restrict the exchange of ideas in practice?  Harry Ostrer, NYU School of Medicine’s Director of the Human Genetics Program, explained to The New York Times that his laboratory, and others like it, would focus on unsolved mysteries in BRCA gene variants if they did not face the risk of a patent lawsuit from Myriad.  A 2006 report from the National Research Council, however, found that patented biomedical research “rarely imposes a significant burden” for researchers.  Europe’s experience may be instructive: European law precludes patent holders from exercising patents when their IP is being used for research.  Whatever the European example may teach us about gene patentability’s impact on research, this is surely a case to watch.

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4 Responses

  1. A.J. Sutter says:

    Is there a brief available yet on this case? In the meantime, some ignorant questions/comments, from a non-litigator:

    (a) Is the patentable subject matter argument really a Constitutional question, rather than a statutory one? Granting inventors “the exclusive right to their … discoveries” when those discoveries are laws of nature doesn’t seem to go against the Constitution per se.

    (b) One particular comment in the complaint seems outright mistaken, namely “One of the conditions for receiving a patent is to disclose publicly all information about the patented thing” (@25). That is quite different from the actual standard in 35 USC 112.

    Moreover, I’m not sure I see what’s distinctive about this patent from others, at the Constitutional level. E.g., suppose I have a patent on an electronic gizmo, and a competitor uses that gizmo without a license in connection with developing an improvement, combination or another product for possible commercial use. Before the commercial release of the product, competitor publishes information about its research (possibly even after deciding that it doesn’t want to patent the improvement). Leaving aside the question of damages for the moment, does competitor’s unlicensed use become non-infringing simply because of the First Amendment?

  2. A.J. Sutter says:

    BTW, I’m not disupting whether patents ever do, as a practical matter, impede medical research or other types of socially-valuable research and innovation. But there’s nothing inconsistent with both rejecting the conservative philosophical position of IPWatchdog and questioning the legal basis of ACLU’s arguments, especially the Constitutional ones.

  3. Rick says:

    So have they reached a verdict on this case yet? Or is it still in proceedings? And I have a potentially really dumb question, what do patents that are for genetic research look like? I’d imagine that they wouldn’t have patent drawings, or do they? I really don’t know, if someone could shed light on this that would be great!