By
Kevin E. Noonan —
On Halloween, Myriad
Genetics filed its brief in opposition to plaintiffs' petition for certiorari in Association for Molecular Pathology
v. Myriad Genetics, Inc. (plaintiffs nominally
being the Association for Molecular Pathology et al., but actually the American Civil
Liberties Union and the Public Patent
Foundation). In doing so, Myriad no doubt understands the
position of the boy encountered by St. Augustine who was trying to empty the
ocean into a hole in the sand on the beach; in reality, Myriad faces not only
petitioners by the plethora of amici from
a variety of academics, patients, doctors, and civil liberties groups clamoring
for the Court to grant cert. (see "AMP v. Myriad Briefed and Distributed for Conference").
Petitioners
presented three questions to the Court, all countered by Myriad in its
respondents' brief:
1. Are human genes patentable?
2. Did
the court of appeals err in upholding a method claim by Myriad that is
irreconcilable with this Court's ruling in Mayo Collaborative
Services v. Prometheus Labs., Inc., 132 S.
Ct. 1289 (2012)?
3. Did
the court of appeals err in adopting a new and inflexible rule, contrary to
normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc.,
549 U.S. 118 (2007), that petitioners who have been indisputably deterred by
Myriad's "active enforcement" of its patent rights nonetheless lack
standing to challenge those patents absent evidence that they have been
personally and directly threatened with an infringement action?
Myriad's brief begins by setting out the
context in which this case was brought, long (~30 years) after the U.S. Patent and
Trademark Office began granting patents on isolated genes. Citing the PTO's "specific expertise in
issues of patent law" (and reminding the Court that it was content to rely
on that expertise as recently as its decision in J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred Int'l. Inc.), the brief
recites not only a brief history of gene patenting but also instances where
the Office established rules to ensure that such claims were properly within
the scope of 35 U.S.C. §§
101 and 112 (i.e., the 2001 Utility Guidelines). And the brief reminds the Court that the
biotechnology industry has relied on the determination that genes are
patent-eligible during that time, and the societal benefits that have accrued
as a result. Turning specifically to Myriad,
the brief recounts how it was that the company isolated the genes and then
determined which mutations were relevant to a breast or ovarian cancer diagnosis,
and the extent to which these accomplishments required human ingenuity, effort, and invention. The brief sets forth the
accolades Myriad (rightfully) received for this achievement, and then discusses
the extent to which the protection Myriad obtained from its patents was
commensurate in scope with its contributions.
Importantly, the brief also rebuts some of
the untruths espoused by petitioners and their amici, regarding the effects of
the Myriad patents on the field and particularly the efforts of others,
unimpeded by Myriad's patents, to undertake genetic experimentation including
the Human Genome Project and continuing into the present day with individual
genome sequencing. In so doing, the brief
lays to rest another misstatement by petitioners (no doubt motivated by the
effect the argument had on Judge Bryson at the Federal Circuit), that Myriad's
claims would somehow interfere with such individual genomic sequencing, citing
Chris Holman's 2012 law review article, "Will Gene Patents Derail the Next
Generation of Genetic Technologies?: A reassessment of the Evidence Suggests
Not," 80 UMCK 563, as well as noting alternative technologies by which
mutations in the BRCA1 and BRCA2 genes could be detected that would not
infringe Myriad's claims (without accentuating for the Court that these
technologies could not be so used if Myriad had not identified the mutations in
the first place).
Following this introduction, the brief
sets forth the proceedings in the District Court and Federal Circuit below before
returning to its argument countering petitioners and their amici. In so doing, the
brief highlights for the Court the political motivations behind this case,
stating that "[p]laintiffs' counsel hand-selected the challenged claims. As part of a strategy of 'pick[ing] one case' for a broad assault on all
patents covering similar subject matter." Thereafter the brief provides the Court with "corrections of
petitioners' misstatements," necessary not only to prevent the Court from
relying on these falsehoods but for provoking in the Justices the question of
why plaintiffs' petition is based on such misstatements in the first
place. These include:
1. The first question presented bears no relation to the uncontroverted
facts of this case. Petitioners seek to present this case as asking whether "human
genes" are patent-eligible. Of course, the genetic material naturally
existing in every human being is not an "invention," i.e., it is not
the product of human ingenuity. But this case does not involve claims to such "native"
human genes. The challenged composition claims are instead narrowly drawn to
specific, defined DNA molecules, isolated by human scientists in laboratories,
that do not naturally occur. As Judges Lourie and Moore explained, molecules of
isolated BRCA1 and BRCA2 DNA are chemical "composition[s] of matter"
that are just as deserving of patent eligibility as any other human-made
molecule. Indeed, numerous pharmaceutical and biotechnical inventions are
claimed as specified molecules. This perhaps explains petitioners' insistence
on framing their first question as "Are human genes patentable?",
instead of addressing the question actually presented to and answered by the
lower courts regarding the patent-eligibility of molecules defined, cultivated,
and isolated by men and women through the application of human ingenuity.
2. Petitioners
also contend that "[s]tandard isolation results in random DNA fragments
that are identical to those that exist naturally in the body." . . . By
definition, however, an "isolated" DNA molecule has been removed from
its naturally occurring environment. . . . A molecule cannot simultaneously be "removed
from its naturally occurring environment" and "exist naturally in the
human body" — its naturally occurring environment. As Judge Lourie explained
in his lead opinion: "It is undisputed that Myriad's claimed isolated DNAs
exist in a distinctive chemical form — as distinctive chemical molecules — from
DNAs in the human body," because of "human intervention to cleave or
synthesize a discrete portion of a native chromosomal DNA, imparting on that
isolated DNA a distinctive chemical identity as compared to native DNA." . . . Petitioners' belated factual claim
that covalent bonds of DNA molecules may be broken in the body . . . is
irrelevant. This assertion omits critical elements of the definition of "isolated"
DNA. Isolated DNA is not merely DNA that has had bonds broken; the breaking of
covalent bonds, while important, is but one part. Isolation further requires
separation of the specific DNA of interest from the rest of the DNA in the body
and even the rest of the fragmented DNA that may be present in a test tube
outside the body. Even setting aside the human-engineered initial fragmentation
breaking the covalent bonds, such specific, precisely defined (i.e., targeted)
separation does not naturally occur in the body. Thus, it is a contradiction in
terms to say that "isolated" DNA exists within the body. . . .
3. Contrary to
petitioners' cursory and unsupported assertions, neither Myriad nor its patents
hinder research of BRCA genes. One named plaintiff concedes that she "could
sequence the BRCA1 and BRCA2 genes for purely research purposes," and has
been doing so without impediment. . . . The undisputed facts further demonstrate
that 18,000 researchers have conducted studies on BRCA1/2 genes, over 8,000
relevant papers have been published on BRCA1/2 genes, and over 130 clinical
trials regarding BRCA1/2 genes have commenced since Myriad publicly disclosed
its inventions. . . . Moreover, multiple laboratories provide "second
opinions" regarding BRCA1/2 test results. In short, Myriad's patents do
not hinder research. . . .
4. Petitioners
allege that Myriad has "stopped other laboratories from creating and
offering new and improved testing procedures" and has "the right to
exclude the rest of the scientific community from examining the
naturally-occurring genes of every person in the United States." . . . These statements are false. The
challenged claims do not preempt, preclude, or prohibit others from creating and
offering new and improved testing services. To the contrary, Myriad's
composition claims are limited to the precise isolated molecules it created and
that are recited in the patents. These claims do not preempt or preclude other
technologies that have been developed and are currently being used to study the
human genome and identify genetic mutations to assess a patient's cancer
predisposition — e.g., gene expression profiles, whole-genome sequencing,
untargeted single-molecule sequencing, and protein-truncation testing. . . . These
technologies "sequence" DNA without the need for "isolation."
In fact, earlier in this case (January
2010), petitioners stated: "It is only humans' inability — currently — to
sequence DNA while it is in the body that requires scientists to isolate it." . . . This falsely suggests there are
only two options: sequence in the body or sequence "isolated" DNA. While DNA still cannot be sequenced in the body, DNA extracted from the body
but not "isolated" can be, and has been, sequenced. For example,
random sequencing and protein-truncation testing have been used for years to
identify genomic variations, including BRCA mutations. More recently, multiple
companies, e.g., Oxford Nanopore and Pacific Biosciences, have developed
single-molecule technologies that can perform untargeted sequencing of DNA,
which may include BRCA genes, without infringing the challenged claims.
5. Petitioners
contend that the challenged composition claims "define[] the gene
according to how it functions in the body — i.e., that it codes for and produces
a polypeptide or protein." . . . That
is untrue. Each claim is a specific, defined molecule isolated from the
body; none is claimed in terms of its "function." Terms such as "encoding"
or "coding for" are commonly used in DNA patent claims to recite
physical structure, not function — they are "structural terms" that
define Myriad's human-made molecules. . . . Petitioners' contentions to the
contrary, like their insistence upon redefining the question presented as "Are
human genes patentable?", reflect a misunderstanding of basic scientific
principles, well-established case law, and the nature of the composition claims
at issue; at a minimum, they demonstrate that the petition is grounded on
disputed antecedent facts.
(citations omitted, emphasis added).
Having dispensed with (or at a minimum
bringing the Court's attention to these fanciful misstatements, the brief then sets
forth Myriad's reasons the Court should deny the writ. Put simply, Myriad argues that the Federal
Circuit has properly applied Supreme Court precedent in Chakrabarty, Mayo, and MedImmune in reaching its decision below
and that the case is not in the proper posture for the Court to intervene. Applying each line of precedent in turn,
Myriad argues that the Federal Circuit applied the Court's § 101 jurisprudence regarding the
composition of matter claims to isolated genes, specifically the rubrics set
forth in the seminal Chakrabarty
case. Myriad argues that "faithfully
applying Chakrabarty in view of Mayo," the Federal Circuit came to
the correct conclusion that the isolated DNA claims recited patent-eligible
subject matter. The brief characterizes
the Court's J.E.M. case as being "on
all fours" with this case, because there the Court decided plants were
patent-eligible because §
101 should be given "broad scope and applicability" and the PTO have
been granting utility patents on plants (~1800 patents) for 16 years (in
contrast, the brief notes that the PTO has been granting patents on isolated
DNA for 30 years and there are ~40,000 isolated DNA patents). Citing Festo
Corp. v. Shoketsu Kinzoku Kogyo Kabushki Co. (applicable here through the
auspices of Judge Moore's citation of the precedent in her concurring opinion
below), "[t]o change so substantially the rules of the game now [] could
very well subvert the various balances the PTO sought to strike when issuing
the numerous patents which have not yet expired" (covering isolated DNA,
an argument that will resonate only insofar as the Court believes that the PTO's
decisions deserve some deference).
The brief next argues that the Federal Circuit's
decision is not in conflict with any Supreme Court precedent, including Mayo, Chakrabarty, Funk Bros. Seed Co.,
and American Fruit Growers, Inc. In distinguishing Mayo, the brief also
addresses the "preemption" argument advanced in petitioners' brief,
reminding the Court that "all patent claims are preemptive." The concerns enunciated by the Court in Mayo regarding preemption are not
implicated here on the facts, including that diagnosing risk for breast and
ovarian cancer based on the presence of BRCA mutations can be accomplished
using several alternative, non-infringing methods. The other three Court decisions are
consistent with the Federal Circuit opinion below based on their facts,
according to Myriad's brief, and in this regard point to another misstatement
by petitioners:
In arguing that the results in Funk Brothers and American Fruit Growers
should govern, petitioners mischaracterize the claims here as merely a "blueprint"
for "coding for" the genetic material in the body; under this view,
petitioners say, the patents claim only a natural function. . . . This is
factually incorrect and mischaracterizes the claim language. The patents do not
claim the compositions with reference to their functions; and the "coding
for" language is a structural, not a functional, limitation in the claims. See In re Deuel, 51 F.3d at 1557-58. The composition claims are limited to claims for a specific, precisely defined
composition with a specific, non-naturally occurring structure — a particular,
human-defined, isolated DNA molecule. . . . As the Federal Circuit ruled, the
claims are directed to a specific and new chemical entity that does not exist
in nature and that has uses unrelated to how the "code" operates in
the body (unlike natural DNA "exist[ing] in the body as one of forty-six
large, contiguous DNA molecules," the claims are drawn to "a
free-standing portion;" . . . the claims "are truncations" that "are
not naturally produced without the intervention of man").
(citations
omitted).
Having rebutted petitioners'
argument regarding the patent eligibility of the composition of matter claims,
the brief then turns to the other two questions presented. Regarding the screening method claim (claim
20 of U.S. Patent No. 5,747,282), the brief rebuts yet
another factual misstatement: that [petitioners] proclaim — without record
support — that 'transformed cells containing altered DNA are conventional
products widely available for purchase.'" Rather, the brief properly informs the Court that the cells are "a
transformed eukaryotic host cell containing an altered BRCA1 gene causing
cancer" which is "a new and useful product of human ingenuity,"
and thus can be distinguished from the Mayo claims because it recites something
that is neither a product nor a law of nature and in so doing Claim
20 does "significantly
more than describe a natural law." In addition, the brief corrects the petitioners "overstatement"
that this claim would prevent "any researcher from engaging in this
science to find a cancer treatment" by noting that the claim "is tied
to specific host cells transformed
with specific genes and grown in the presence or absence of a specific type of
therapeutic," reducing the temperature of petitioners hyperbolic arguments
to comport with reality (emphasis in original).
Finally,
the brief addresses the jurisdictional issue, substantially repeating the
evidence that the one plaintiff found to have standing, Dr. Harry Ostrer, may
have destroyed that standing by moving from NYU (which supported his for-profit
diagnostic activities) to Montefiore Hospital, which does not (or, more
properly, petitioners have not presented any evidence that Montefiore would do
so).
The
brief ends with a section presenting six reasons why this case is not a good "vehicle"
for review by the Court. In truncated
versions, these are:
First, this case represents an abstract
challenge to Myriad's patents. Petitioners alone selected the particular claims
to challenge, leaving unchallenged several claims that they concede will
continue to impede BRCA sequencing and other conduct in which they seek to
engage . . . . Accordingly, there exist significant issues of redressability,
yet another antecedent jurisdictional problem with the petition. See, e.g., Lujan v. Defenders of Wildlife,
504 U.S. 555, 561 (1992).
Second, Myriad was unable to assert
counterclaims of infringement because no plaintiff was actually conducting any
BRCA-related testing services; accordingly, this Court's review would be
inhibited because the exact scope of the challenged claims has not been
defined. The district court performed only limited claim construction, and
without infringement assertions the courts had no reason to determine the
precise scope of the claims' exclusionary rights. . . . Moreover, much of
petitioners' effort to obtain this Court's review is premised on their
unsubstantiated speculation that Myriad's claims will inhibit those "who
want to undertake testing and research involving the patented genes in order to
improve diagnosis and treatment for patients" and will "exclude the
rest of the scientific community from examining the naturally-occurring genes
of every person in the United States." . . . Such assertions have never been
tested in any adversary proceeding. And had they been tested, they would have
been exposed as false, for several non-infringing technologies for determining
a patient's cancer predisposition are currently available. . . . Likewise, with no
review of the form of testing petitioners might utilize, to determine whether
such testing would infringe, there has been no analysis of what the claims do
not cover, e.g., whole-genome sequencing.
Third, as to the patent-eligibility of the
challenged composition claims, there is not a single opinion for the panel. Petitioners seek to make this a reason for review. . . . But, had there been a true
need to reconcile divergent judicial viewpoints, it would have been appropriate
for petitioners to first seek en banc review from that court. . . . For whatever
reasons, they did not.
Fourth, the relevance of patenting isolated
human DNA is ever diminishing in light of the publication of the entire human
genome in 2001 (several years after the 1994 and 1995 filing dates of the
patents-in-suit), thus presenting arguable bars to patentability under other
provisions of the Patent Act (such as obviousness under § 103) for any claims
to isolated human DNA molecules sought after that date. Further, such patents
issued before the 2001 publication of the entire human genome will soon
expire — Myriad's patents-in-suit all expire by 2015. Thus, the unique facts of this
case, presenting issues unlikely to recur, make it an inappropriate candidate
for certiorari.
Fifth and finally, despite over 30 years of
isolated DNA patents, this case is the first and still only appellate decision
to address the patent-eligibility of such compositions. In nonetheless
challenging these ruling, a change in the settled understanding of § 101 that
allows patents on isolated genetic molecules. . . . Such efforts, particularly
with the deeply settled reliance interests of the technology and investing
communities at stake, should be addressed to Congress, not the courts. . . . Moreover, any consideration of the settled expectations that isolated molecules
are patent-eligible should take into account the consequences of a legal rule
that would apply far beyond the realm of human DNA. Many biotechnology
companies' intellectual-property endeavors, and the investors on which those
companies rely, depend on patents covering isolated DNA corresponding to
non-human genes. . . . Altering the expectations that these useful developments
will be patent-protected is the role of policymaking, not adjudication.
(citations omitted).
The
best that can be said is that Myriad has countered every misstatement and done
its best to inform the Court regarding the facts, the law, and the consequences
of granting certiorari here. It remains
to be seen whether the Court will be able to resist the siren song of this
politically charged question, or will dive headfirst into another foray of
trying to be the final arbiter of the scope and direction of American
innovation.
In a notice published last week
The notice on the
Patent Docs 