The United States Files Its Amicus Brief In Myriad

18 June 2012 PharmaPatents Blog

The briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case) were due last Friday, June 15, 2012. While the views of the parties and other amici may be of interest to the Federal Circuit, I am particularly interested in the position taken in the U.S. Department of Justice’s amicus brief. It is disappointing but not surprising that the United States asserts that the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. supports its position that isolated genomic DNA is not patent-eligible under 35 USC § 101.

Sticking To Its Story

The United States brief sticks to its original position and asserts that the Supreme Court decision in Mayo v. Prometheus makes it even stronger:

[U]nlike cDNA, isolated but otherwise unmodified DNA molecules are not patent-eligible because they are “‘products of nature,’” not “‘humanmade inventions.’” …. Patent protection is not available to those who simply discover existing aspects of nature, even if the discovery requires arduous work, represents keen scientific insight, and is of great value to society. Mayo underscores this fundamental limitation on patent protection.

The Public’s Freedom To Use Products Of Nature

The United States acknowledges that Mayo does not directly address the issues raised in Myriad, but argues that it provides “indirect” guidance on the central issue of whether the differences “between isolated and genomic DNA are significant enough to render isolated DNA ‘markedly different’ for § 101 purposes.” In particular, the United States takes the position that a central inquiry in Mayo was whether the claims “tied up” the use of the underlying law of nature, and so the central inquiry in Myriad should be whether the isolated DNA claims effectively prevent the public from studying and making use of a product of nature.

The United States answers this inquiry:

[P]atents on isolated but otherwise unmodified DNA would significantly impair the public’s ability to study and make use of genomic DNA.

The United States also takes this interesting position:

If the process of removing the product from its natural environment necessarily results in creation of the patented composition . . . the patent on the composition is in practical effect a patent on the product of nature itself.

The United States rejects the “breaking covalent bonds” test that Judge Lourie relied upon to uphold the isolated DNA claims.  Instead, the United States urges that the proper test is whether the differences “are sufficient to leave the public free to study the native … genes.”

Incentives Of The Patent System Do Not Outweigh The Limitations Of § 101

The United States reads Mayo as indicating that any need for financial incentives to make “DNA discoveries” by granting patent protection to isolated DNA does not outweigh the more fundamental limitations on patent-eligibility embodied in § 101.

The potential incentive effects . . . do not alter the boundaries the Supreme Court has set between unpatentable products of nature and patentable creations of man.

These arguments appear to be drawn directly from the Supreme Court’s Mayo decision, where Justice Breyer was not impressed by concerns that “denying patent coverage here will interfere significantly with the ability of medical researchers to make valuable discoveries, particularly in the area of diagnostic research.”

Where Are The Facts?

I think the United States did a good job of explaining why Mayo supports its position in Myriad, even if I disagree. Moreover, by presenting preemption-type arguments, the United States aligns its position with Supreme Court precedent that reaches back before Prometheus. Still, the United States makes its case by asserting facts that may not be supported by the record, and that certainly would be disputed by Myriad and others who support the patent-eligibility of isolated, genomic DNA.

Where is the evidence that patents to ”isolated but unmodified DNA would significantly impair the public’s ability to study and make use of genomic DNA”?

Where is the evidence that a patent on a product “removed from its natural environment” would “in practical effect [be] a patent on the product of nature itself”?

It is these issues that the Federal Circuit will have to address when it revisits its decision in Myriad.

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