BRCA - Statement of Support: Joshua Sarnoff

Document Date: May 13, 2009

Joshua Sarnoff is a Professor of the Practice of Law at the Washington College of Law, American University. Professor Sarnoff has filed numerous amicus briefs in the United States Supreme Court on important patent law issues, including a brief for AARP in the LabCorp v. Metabolite case challenging the diagnostic patent at issue as the unpatentable discovery of a natural medical phenomenon.

For centuries, a fundamental premise of the patent law system was that patents would not issue for discoveries of science, nature, and abstract ideas. These fundamental and pre-existing things and concepts were not considered to be the products of human creativity. Even when their discovery involved large investments of time, energy, and creativity, these things and concepts were to be treated (as reiterated by a seminal 1980 Supreme Court case holding that newly created life forms are patentable) as “free to all men and reserved exclusively to none.” The result was a public domain of science, nature, and ideas upon which all could build, and the result was continuous, dramatic progress in the development of science and technology. Not only was this public domain free from patent rights a good idea, it was once considered to be a moral duty. As a celebrated 19th Century scholar of American patent law stated, “[t]o 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.”

Even though the law that discoveries of science, nature, and abstract ideas are not patentable has remained constant in the U.S. Congress and the Supreme Court, since the 1990s the Patent and Trademark Office has been issuing patents on newly discovered genetic sequences, prompted by interpretations of the U.S. Court of Appeals for the Federal Circuit that isolating and purifying genetic sequences results in “new” human creations that do not exist in nature. But this approach is flatly contradicted by earlier Supreme Court cases holding that natural materials – and even synthetic materials that are essentially similar to natural materials — do not become patentable unless they possess significant new functions than those possessed in their natural condition. Simply obtaining the same material in a more useful form than its natural condition was not enough. Thus, for decades, thousands of patents on genetic sequences have been issued, but all of them should be considered invalid. Such patents have deterred important scientific and health-related innovation, reduced the availability of (often better) medical treatments, and imposed substantial costs on all participants in the health-care system. All such harms should have been avoided, as no such patents were validly issued.

Moreover, even if isolated and purified genetic sequences were somehow properly considered to be patentable types of inventions, another patent law doctrine (that of obviousness) suggests that society has suffered needlessly from the patented genetic sequences that were improperly issued. Since 1995, the Federal Circuit (and consequently the Patent and Trademark Office) has imposed a very limited test for showing that genetic sequences are obvious and thus unpatentable. But the Supreme Court has recently held that the Federal Circuit’s test of obviousness has been unduly restrictive (contrary to long-standing Supreme Court precedent), and the Federal Circuit has now recognized that the Supreme Court’s holding “unambiguously discredited” the Federal Circuit’s earlier, constrained view of obviousness. Further, as the Supreme Court explained, the reason for the obviousness standard is that obvious patents withdraw “what is already known into the field of [their] monopoly and diminish[] the resources available to skillful men.” Stated differently, obvious patents (including gene sequence patents) tax the public for access to knowledge that needs no such patent incentives to be developed and disclosed. Such patents provide no present innovation benefits, but rather only discourage future innovation and impose high costs on manufacturers, purchasers, and independent creators.

This case — filed by the ACLU and the Public Patent Foundation on behalf of scientific and medical organizations and practitioners — represents a tremendous opportunity to make clear that the law does not authorize such genetic sequence patents, or patents on thoughts correlating genetic mutations to potential diseases. It targets the genetic sequence and diagnostic patents that have been “poster children” for the harms that such patents can impose – restricting research, preventing needed medical diagnoses, and imposing high costs on those who can afford to pay for access. But more importantly, it seeks a declaration that will apply to all genetic sequence and diagnostic patents based on discoveries of natural medical phenomena: that the law remains what it has been for centuries, and that discoveries of science, nature, and abstract ideas remain unpatentable even in the context of modern biotechnology. A clear declaration to this effect will restore and protect the public domain of science, nature, and ideas, from which we all benefit.

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