By Donald Zuhn —

In an amicus brief filed last month in Association for Molecular Pathology v. Myriad Genetics, Inc., the
United States asks the Supreme Court to affirm the judgment of the Federal
Circuit that cDNA is patent-eligible and reverse the judgment of the appellate
court that isolated but otherwise unmodified DNA is patent-eligible.  The government argues that:

Synthesized genetic materials such as cDNA
are patent-eligible subject matter because they do not occur in nature but
instead are the product of significant human creativity.  By contrast, isolated but otherwise
unmodified DNA is not patent-eligible. 
The public's ability to study and use native DNA would be unduly
compromised if changes caused by the extraction of naturally-occurring substances
from their native environments were sufficient to trigger
patent-eligibility.  And while the
process of isolating DNA entails physical changes, those changes do not
significantly alter the structure or function of the relevant DNA segments.

The government explains
that "[c]reating cDNA requires significant manipulation and alteration of
naturally occurring genetic materials rather than simply the extraction of those
materials from their native environment," adding that "[i]ssuing patents
on cDNA creates no risk of preempting other uses of the raw materials from
which cDNA is created."  However,
the brief argues that "isolated but otherwise unmodified genomic DNA" molecules
— like DNA molecules claimed in Myriad's patents — are not patent eligible
because "[t]he process of isolation does not transform those molecules
into human-made inventions."  Thus,
"[i]solated DNA . . . is not patent-eligible because it has merely been
"isolated" — i.e., extracted
from its cellular environment and separated from extraneous material — rather
than significantly altered by human intervention."

To prevent claims to
isolated DNA from preempting the use of the underlying native DNA, the
government contends that "the mere act of culling a natural product from
its environment to exploit its preexisting natural qualities — however useful
those qualities may be — should be treated as insufficient to create
patent-eligible subject matter."  In
explaining the government's change in position on DNA molecules — before the
district court, the government had noted that "the USPTO's position" on
whether "DNA molecules" are patent-eligible "remains as set
forth in its utility guidelines" — the brief states that:

The district court's judgment in this case,
however, prompted the United States to reevaluate whether such patents are consistent
with the settled principle that patent protection does not extend to products
of nature.  Based on that review, the
United States concluded that, although the PTO has properly issued patents on
cDNA and other synthesized genetic materials, isolated DNA is not patent-eligible
subject matter.

In reassessing its
position, the government looked to the Supreme Court's decision in Mayo
Collaborative Services v. Prometheus Laboratories, Inc.  Although Mayo
concerned process claims rather than composition claims, the government argues
that the decision "provides
useful guidance for determining whether particular modifications to a naturally
occurring substance are sufficient
to render the modified substance patent-eligible."  And while "[n]ot every nuance of Mayo's
process-claim analysis applies
directly to patents directed to compositions of matter," the brief argues that "the law-of-nature and
product-of-nature exceptions to
Section 101 do, however, reflect the same basic principle:  a person
should not receive a patent for
simply discovering the existence and useful properties of something that already exists in nature."

In contrast with isolated
but otherwise unmodified genomic DNA, the government argues for the
patent-eligibility of cDNA molecules.  In
particular, the government states that:

With exceptions not relevant here (such as
retroviruses that use cDNA-like structures to replicate themselves), cDNA
molecules generally do not occur in nature, either in isolation or as
contiguous sequences contained within longer natural molecules.   . . .  To create cDNA, a scientist therefore does
not simply remove existing cDNA from its natural environment.

According to the
government, "cDNA is thus analogous to the genetically modified bacterium
in Chakrabarty."  Countering the petitioners' argument that
cDNAs are not patent-eligible because they contain the same protein-coding
information as DNA in the body, the government notes that:

[T]he properties of any product originally derived
from nature, including the bacterium in Chakrabarty,
can be traced to the operation of natural principles.  While the coding properties of cDNA
molecules' exons are determined by nature, those properties operate within a
molecule (a DNA strand with the regulatory and intron regions spliced out) that
does not exist in nature and that has increased utility relative to naturally occurring
genetic materials or isolated but unmodified DNA.  The fact that a cDNA incorporates nucleotide sequences
whose significance is derived from nature therefore does not mean that the
molecule as a whole is a product of nature.

As for Myriad's composition
claims, the brief points out that "[a]bsent the 'isolated' limitation,
claim 1 of the '282 patent, for example, would encompass the native BRCA1 gene
in the human body, which 'cod(es) for a BRCA1 polypeptide'," and that
"[i]n their pre-isolation form — i.e.,
as a portion of a larger native gene within a cell — the BRCA sequences clearly
are products of nature."

In addressing Myriad's
reliance on early lower-court decisions upholding patents on natural compounds
that have been so refined and purified through human intervention as to become
a substance different "in kind" from the natural product, the
government explains that:

Those decisions indicate that certain
purification processes — i.e.,
processes that involve human manipulation of a substance that has been removed
in impure form from its natural environment — may sometimes result in an
altered substance that has structural features and⁄or operative properties that
render the product markedly different from the impure substance that occurs in
nature.  For instance, cDNA could be
thought of as a "purified" gene, as it incorporates into a single
contiguous, synthetic molecule only the coding regions of the naturally
occurring gene.  But isolated DNA
reflects no such transformation. 
[Rather], isolated DNA has simply been removed from its natural
environment within the human body, with minor structural changes that have no
effect on its intrinsic properties . . . . 
To label the process of removing DNA from a cell
"purification," and to hold the culled DNA segments patent-eligible
on that ground, would "make patent eligibility depend simply on the
draftsman's art," without reference to the nature and extent of the
underlying transformation, or the consequences for the public's ability to use
the underlying substance.

In response to the argument
that Congress' failure to amend U.S. patent law to prohibit the patenting of
isolated DNA implies congressional approval of such patents, the government argues that "[i]n these circumstances, Congress's failure to enact
legislation abrogating the PTO's practice of issuing isolated DNA patents does
not give rise to any inference of congressional endorsement of the PTO's
interpretation."  The brief notes
that "although bills relating to patents on genetic materials have occasionally
been introduced in Congress, there is little 'evidence that Congress considered
. . . the precise issue presented before the Court.'"  In particular, the government explains that
"[b]ecause 'Congress takes no governmental action except by legislation,'
and bills can be proposed and rejected for any number of reasons, none of these
bills raises any inference that Congress approved the PTO's practice of granting
patents on isolated DNA."

As for the "concern
that invalidating patents on isolated DNA would unduly disturb the 'settled
expectations' of biotechnology patent holders and investors," the
government notes that "[a] patentee's legitimate expectations . . . are always tempered by the possibility that a court could subsequently disagree
with the PTO and hold that the patent is invalid under Section 101 or other
provisions of the Patent Act." 
Finally, with respect to the argument that isolated DNA should remain
patent-eligible in order to encourage biotech innovation, the government acknowledges
that "[t]he prospect of patent protection for isolated genomic DNA has
undoubtedly encouraged valuable discoveries," but counters that "[a]s
between the reliance interests of patent holders whose research efforts may have
been prompted in part by the PTO'ss patenting standards, and the public
interest in avoiding undue restrictions imposed by patents that effectively
preempt natural laws and substances, the interest of the public has
consistently been given precedence."

Patent Docs plans to review a number of the briefs filed in this case,
including the briefs on the merits filed by the petitioners and the
respondents, as well as several of the amicus
briefs that were filed.  According to the
docket for this case on the Supreme Court website, amicus briefs have been filed by the Juhasz Law Firm, P.C., the
American Medical Association et al., GeneDx
and Law Professors, the National Women's Health Network et al., Federation Internationale Des Conseils En Propriete
Intellectuelle, CLS Bank International, the United States, the International Center
for Technology Assessment et al., Genformatic
LLC, Academics in Law, Medicine, Health Policy and Clinical Genetics, James D.
Watson, Ph.D., Fifteen Law Professors, Sigram Schindler
Beteiligungsgesellschaft mbH, the AARP, Kali N. Murray and Erika R. George, the
Institute of Professional Representatives Before the European Patent Office
(EPI), the Ethics & Religious Liberty Commission of the Southern Baptist
Convention and Prof. D. Brian Scarnecchia, Eric S. Lander, the American
Intellectual Property Law Association, the Canavan Foundation et al., Professor Eileen M. Kane, Knowledge
Ecology International, and InVitae Corporation.

On Monday, the Supreme Court set argument for this case for April 15,
2013.