ACLU Gene Patents Challenge - Bilski Preview

Inherently Sarnoff Blog
Professor Josh Sarnoff
August 27, 2009

Lori Andrews and I today filed a motion and an amicus brief on behalf of the American Medical Association, the American Society of Human Genetics, the American College of Obstetricians and Gynecologists, the American College of Embryology, and the Medical Society of the State of New York in Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, et al., No. 09 Civ. 4515 (RWS) -- the lawsuit filed by the ACLU and the Public Patent Foundation challenging the BRCA1 and BRCA2 gene patents owned by Myriad Genetics. (I discussed the case earlier this summer on the Kojo Nnamde Show, with Hans Sauer of the Biotechnology Industry Organization and  Shobita Parthasarathy of the U. of Michigan.) The case will provide a good opportunity for the courts to resolve whether isolated natural materials and discovered medical phenomena are patentable subject matter. We argued that in a series of cases over the past 150 years, the Supreme Court has held that one cannot patent (1) products of nature, or materials isolated from products of nature if those materials behave in the same way they would in nature, or (2) discovered laws of nature or mathematics, or applications of those laws lacking significant (i.e., creative) “post-solution activity.” We also explained how some of the claims at issue (the sequence claims) cover the natural materials and being "isolated" does not change them nor give them new properties, and how other claims (the correlation claims) cover the mental act of recognizing or comparing information, however obtained. Finally, we explained how these patents have interfered with our clients' research and have prevented proper medical care, and why they violate both medical and scientific ethical tenets.

The brief is a good preview for my forthcoming Supreme Court amicus brief in Bilski v. Doll, as it demonstrates in the contexts of products of nature and natural phenomena the relevant patentable subject matter requirement that there must be invention in the application of scientific principles, naturally occuring materials, and abstract ideas. Historic ethical obligations required treating previously known or newly discovered science, nature, and ideas as not only "free for all to use" but also as if they were already in the prior art (once disclosed, e.g., in a patent application). Thus, in order for there to be any patent-eligible "invention" there must necessarily be some other "inventive concept" (using the terminology of Parker v. Flook) in the application itself of the discovered science, nature, and ideas, even if the application is novel. Simply isolating the natural genetic material is not sufficient to be called "invention," given that the discovery of the natural material must be treated as if it were already known. Similarly, claiming the isolated genetic sequence information or variants of it (in mutations) is not an invention once that information is requiredto be treated as public domain information (as natural phenomena). And claiming the acts of comparing the actual genetic sequence disclosed in the patent to another (potentially mutated) sequence is not an invention, given that there is no creativity in doing so once the sequence information is treated as in the public domain -- recognizing that one of these things is not like the others is trivial even if highly useful. (It also destroys the quid pro quo of the patent system -- an enabling disclosure where people can use the information -- if not the physical implementation -- in exchange for patent rights. Note that this is different from but the mirror image of the bargain-destroying problem caused by the lack of a meaningful research exception, when people can't use the information disclosed in the patent to sequentially innovate because they can't use physical embodiments that are necessary to research. Although combinatorial chemistry and biology may minimize that problem, some of the patents at issue in the AMP v. PTO case actually prohibit "analyzing" sequence information, however it might be obtained.)

Chris Holman (a friend and a colleague on a recent paper entitled Recent Developments Affecting the Enforcement, Procurement, and Licensing of Research Tool Patents, the draft of which is on SSRN and the final is published at 23 Berkeley Tech. L. J. 1299 (2008)) has provided a good short summary of the ACLU's motion for summary judgment that our amicus brief supports on his Holman's Biotech IP Blog. Chris appears to recognize that the Supreme Court precedents before Diamond v. Chakrabarty (which as discussed in our amicus brief did not change the law in this regard) require more than "mere isolation" in order to claim a patent-eligible application of a product of nature. Chris also correctly notes that the Patent Office has for a long time treated mere isolation as sufficient human creativity and difference from the natural material to constitute a patent-eligible invention. So we will have to see if the District Court (and ultimately perhaps the Supreme Court) is willing to disregard various appellate court decisions (pre-dating and of the Federal Circuit) and the PTO policies that contravene the Supreme Court precedents, when the consequence is to eliminate thousands of claims in a very important industry. For the reasons explained in the medical association amicus brief, there are good policy reasons to do so because these patents cause real harm.

This case also reflects another "industry battle," this time not IT or generics against pioneering PhRMA, but the medical treatment/scientific research community (and the patient and consumer community as the ultimate beneficiaries) against the biotech/scientific research community. And it is precisely the tension in the scientific community (which spans both industries) that makes this so fascinating. As the amicus brief discusses, scientists had an ethical duty (deriving from the morality of religion) not to subject to private property rights their discoveries of nature -- which duty remains reflected in the patent law requirement that such discoveries must be treated as prior art if disclosed. As William Robinson stated over a century ago in his celebrated Patent Law treatise, "To benefit by the discoveries of his fellow-men is thus not only a natural right, it is also the natural duty which every man owes to himself and to society; and the mutual universal progress thence resulting is the fulfillment of the earthly destiny of the human race.” As Lord Camden said a century earlier, scientists are "entrusted by Providence with the delegated power of imparting to their fellow creatures that instruction which heaven meant for universal benefit; they must not be niggards to the world, or hoard up for themselves the common stock." Are scientists who seek to (and often successfully) patent their natural discoveries bad people?

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