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
The Public's Freedom To Use Products Of
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 ...
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
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 areaof diagnostic
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 decsion in Myriad.
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