New Amicus Brief Filed on Behalf of Dr. Eric Lander in the Supreme Court in the Myriad (Gene Patent) Case

I am pleased to announce that Gideon SchorVern Noviel, and I filed an amicus brief on behalf of Dr. Eric S. Lander in a pending Supreme Court case that will address whether human genes are patentable.  The case is Association for Molecular Pathology v. Myriad Genetics, No. 12-398 and will be argued April 15, 2013.  Lander is a leading genomics researcher and is President and Founding Director of the Broad Institute of Harvard and MIT. We think the brief will play a key role in helping the Supreme Court chart a path through this legal thicket.  The full brief can be downloaded here http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.pdf. Here is an excerpt from the brief, the Summary of the Argument:

This case hinges on a scientific question: whether DNA fragments from a human chromosome are (1) products of Nature or (2) at least similar enough to products of Nature that they should not be considered “markedly different.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

The members of the Federal Circuit panel below agreed that the DNA of a whole human chromosome was a product of Nature. But the majority held that isolated DNA fragments of a human chromosome were not products of Nature.

Because the majority made (without citing scientific support) a foundational assumption that isolated DNA fragments of the human genome do not themselves routinely occur in Nature, it considered whether they are similar enough to products of Nature. Employing analogies, the panel members debated whether isolated DNA cleaved from a chromosome was akin to a leaf plucked from a tree, or a kidney surgically removed from a human body.

This reasoning-by-analogy was unnecessary because the majority’s foundational assumption is demonstrably incorrect: it is well-accepted in the scientific community that (a) chromosomes are constantly being broken into DNA fragments by natural biological processes that break the covalent bonds within DNA chains; (b) these DNA fragments are ubiquitous in the human body, both within cells and in cell-free blood, urine, sputum and stool; and (c) these fragments cover the entire human genome and, in particular, include the BRCA1 and BRCA2 genes claimed by Myriad’s patents. Myriad’s claims thus include DNA fragments that are unambiguously products of Nature.

Under this Court’s interpretation of 35 U.S.C. § 101, composition-of-matter patents on such pre-existing products of Nature are not permissible. Such products of Nature are “manifestations of . . . nature, free to all men and reserved exclusively to none.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).

A patent on a product of Nature would authorize the patent holder to exclude everyone from observing, characterizing or analyzing, by any means whatsoever, the product of Nature. This barrier is inherently insurmountable: one cannot study a product of Nature if one cannot legally possess it.  A molecule is one of the “basic tools” – indeed, the essential tool – for studying the molecule itself. Gottschalk v. Benson, 409 U.S. 63, 67 (1972). A patent on a molecule that is a product of Nature would thus authorize a patent holder to wall off an entire domain of Nature from observation.

Finally, the majority held that a decision that isolated DNA fragments of the human genome are patent-ineligible would disrupt long-settled expectations and could wreak havoc on the biotechnology industry. The majority’s concern is unfounded.

Most biotechnology products are protected by patents on non-natural DNA molecules, rather than naturally occurring genomic DNA. The biotechnology industry would not be substantially affected by a narrowly crafted decision here holding that (1)fragments of human genomic DNA are patent-ineligible where the scientific evidence is clear that the claimed molecules themselves are routinely found in Nature and where the process for purification or synthesis of such molecules is routine but (2) human cDNAs are patent-eligible, because these molecules do not occur in Nature and have clearly different functional properties from related products of Nature.

On the contrary, such a narrowly crafted decision would foster scientific progress and technological innovation by guaranteeing an unfettered ability to study a remarkable product of Nature – the human genome. This ability will lead to countless discoveries about human disease, as well as an outpouring of medical invention with enormous consequences for human health.

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