Download The Supreme Court Takes on the Patent Eligibility of Human Genes

Original Article
32 Biotechnology Law Report 1
Number 4, 2013
# Mary Ann Liebert, Inc.
DOI: 10.1089/blr.2013.9912
The Supreme Court Takes On the Patent
Eligibility of Human Genes:
AMP v. Myriad
By DALILA ARGAEZ WENDLANDT* and JOSEPH VAN TASSEL
I
n AMP v. Myriad, the Supreme Court will address
the question of whether human genes are patentable.
More specifically, the issue presented is whether isolated DNA molecules should be considered products
of human invention and patent-eligible subject matter
or should instead be considered products of nature and
thus ineligible for patent protection. The answer to this
question has far-reaching implications, not only for
human DNA claims, but also for claims directed to
plant and animal DNA. Importantly, the Court’s decision has the potential to invalidate thousands of issued
patents claiming DNA molecules and to affect the balance of incentives and limitations imposed by the patent system on genetic research. Although we cannot be
certain how the Supreme Court will rule on this issue,
the questions posed at oral arguments offer some
insight.
In this article, we first examine the opinion of the
Court of Appeals for the Federal Circuit, in which the
majority held that claims to isolated DNA molecules
are patent eligible. Next, we summarize the arguments
made by the parties and by the United States in their
briefs to the Supreme Court. Finally, we examine the
questions asked by the Justices at oral argument, looking for hints on how the Court might ultimately rule.
to assess more accurately their hereditary risk of developing these cancers and inform their decisions as
to whether to undergo preventative measures, such as
prophylactic surgery.
Plaintiffs originally1 included several institutions,
physicians, researchers, and patients that wanted to
conduct (or undergo) clinical BRCA testing or conduct
genetic research, but allegedly were stymied by
Myriad’s patent protection. Plaintiffs brought suit
against Myriad, seeking a declaration that its BRCA
patents claims were invalid, arguing that they were
drawn to ineligible subject matter under 35 U.S.C. x
101.2
To assist in understanding the challenged claims
and the court’s reasoning, the Federal Circuit’s opinion
included a short primer on genetics.3 It explained that
humans have about 22,000 genes, which serve as the
code for building the proteins that give us substance
and life. This genetic code is formed by the particular
sequence of four nucleotide base units—adenine, thymine, cytosine, and guanine—that make up a deoxyribonucleic acid (DNA) molecule. DNA typically exists,
as it does in the naturally occurring chromosomes of a
cell, as two complementary strands intertwined in a
double helix.
The genetic code contained in the ‘‘native’’ or ‘‘genomic’’ DNA is effectuated though a process in which
a complementary messenger ribonucleic acid (mRNA)
molecule is created and then translated into the
encoded protein. RNA has a different sugar phosphate
BACKGROUND
Defendant Myriad Genetics, Inc. owns several patents containing ‘‘composition of matter’’ claims directed to two ‘‘isolated’’ human genes, BRCA1 and
BRCA2, as well as mutations in these genes, which
are associated with an increased risk of breast and
ovarian cancers. Early detection of these mutations
through diagnostic genetic testing may allow patients
1
The Federal Circuit concluded that only one physician plaintiff
had standing to maintain this declaratory judgment action. See
Ass’n for Molecular Pathology v. U.S. Patent & Trademark
Office (‘‘Myriad’’), 689 F.3d 1303, 1323 (Fed. Cir. 2012).
2
35 U.S.C. x 101 provides: ‘‘Whoever invents or discovers any
new and useful process, machine, manufacture, or composition
of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements
of this title.’’
3
See Myriad, 689 F.3d at 1310–4.
*The authors are Intellectual Property Litigation Partner
(DAW) and Intellectual Property Litigation Associate ( JVT),
Ropes & Gray, LLP, Boston, MA.
1
2
Biotechnology Law Report Volume 32, Number 4
backbone than DNA and uses the nucleotide uracil in
place of thymine.
Genes carry sequences of nucleotides that do not
code for a protein (introns) that are interspersed between segments of DNA that code for a particular protein (exons). Using well-established laboratory
techniques, particular segments of naturally occurring
DNA, such as a gene, can be extracted from the
remaining chromosomal DNA to obtain an isolated
DNA segment. This isolated segment of native DNA
contains both exons and introns.
Through a number of cellular processes, mRNA
contains only exons, or only the portions of a gene sequence that code for a particular protein. Complementary DNA (cDNA) is a type of synthetic DNA
molecule that is produced from an mRNA molecule
template. Because cDNA is synthesized from
mRNA, cDNA contains only the exons from a chromosomal gene sequence.
Myriad’s claims encompassed both cDNA and isolated DNA molecules. Further, with respect to isolated
native DNA molecules, the claims covered both relatively long nucleotide sequences (i.e., the entire
gene) and truncated sequences, as short as 15 nucleotides, that represent only a portion of the gene.
According to Judge Moore, who wrote a separate concurrence with the Federal Circuit majority, these
shorter sequences have useful functions as primers
(serving a starting point for DNA synthesis) or as
probes (detecting the presence of a particular nucleotide sequence).4 The question presented in this case
is whether an isolated DNA molecule, representing either an entire gene or a portion of a gene, or a cDNA
molecule is eligible for patent protection.
THE FEDERAL CIRCUIT OPINION
The district court for the Southern District of New
York held for the plaintiffs, concluding all of the challenged composition claims were drawn to ineligible subject matter and thus invalid under x 101.5 On the first
appeal, the Federal Circuit reversed with respect to
these claims, finding that Myriad’s composition claims
to ‘‘isolated’’ DNA molecules were directed to patenteligible subject matter.6 Following this decision, the
Supreme Court decided Mayo Collaborative Services
v. Prometheus, Inc., 132 S.Ct. 1289 (2012),7 and it subsequently granted the plaintiffs’ petition for certiorari,
vacated the decision below, and remanded Myriad to
the Federal Circuit for reconsideration in light of Mayo.8
On remand, the same Federal Circuit panel, consisting of Circuit Judges Lourie, Moore, and Bryson,
agreed that cDNA was patent eligible under x 101
but split over the question of whether isolated segments of native DNA could enjoy patent protection.
The panel majority (Lourie and Moore) concluded
that such isolated DNA molecules were patent eligible
under x 101.
First, the panel unanimously agreed that cDNA
molecules were patent eligible compositions of matter.
Writing for the majority, Judge Lourie noted that the
claimed cDNAs were ‘‘especially distinctive, lacking
the noncoding introns present in naturally occurring
chromosomal DNA’’ and that they were ‘‘even more
the result of human intervention into nature’’ than is
regular isolated DNA.9 In her concurrence, Judge
Moore explained that cDNA claims were the easiest
to analyze because the claimed cDNA sequences
do not exist in nature. Moreover, she reasoned, it
has different (albeit complementary) nucleotide sequence than the mRNA template used to construct
it and has a different chemical structure than the
mRNA template.10 Likewise, Judge Bryson stated
that ‘‘[t]he end product is a human-made invention
with distinct structure because the introns that are
found in the native gene are removed from the
cDNA segment. Additionally, the cDNA has a utility
not present in the naturally occurring BRCA DNA and
mRNA.’’11
This unanimity dissolved, however, when it came to
the question of whether isolated DNA molecules,
extracted from native DNA, should be patent eligible.
Concluding that these molecules were patentable
under x 101, Judge Lourie focused on the fact that
the isolated DNAs exist in a chemical form distinct
4
Id. at 1342 (Moore, J., concurring).
Id. at 1308 (citing Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010)).
6
See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office (‘‘Myriad’’), 653 F.3d 1329, 1333–4 (Fed. Cir.
2011). The plaintiffs also challenged several of Myriad’s
method claims directed toward the screening of cancer therapeutics via changes in cell growth rates and toward the comparison of DNA sequences. Id.
7
Mayo held that a diagnostic method was not patent eligible because it did not add ‘‘enough’’ additional elements to the
claimed natural law—the correlation between metabolite concentrations in the blood and the toxicity/efficacy of the therapeutic. In Mayo, other than the claimed natural law, the
elements were well understood, conventional, and routine
steps engaged in by physicians prior to use of the claimed diagnostic method. Such well-understood, conventional, and routine
steps, the Court held, were insufficient to make the claimed law
of nature patent eligible. See Mayo Collaborative Services v.
Prometheus, Inc., 132 S. Ct. 1289 (2012).
8
See Myriad, 689 F.3d at 1308 (citing 132 S. Ct. 1794 (2012)).
As discussed supra, Mayo addressed the exception to patent eligibility of method claims that attempt to patent natural laws.
Because plaintiffs had challenged both Myriad’s isolated
DNA composition claims and its method claims, it was not
clear to what extent the Federal Circuit should consider the
challenges to the composition claims in light of Mayo.
9
Id. at 1329.
10
Id. at 1340 (Moore, J., concurring).
11
Id. at 1356 (Bryson, J., concurring in part dissenting in part).
5
Biotechnology Law Report Volume 32, Number 4
from that of DNA as it exists in the body. For example,
Judge Lourie noted, the isolated DNA molecule is orders of magnitude smaller than the naturally occurring
DNA molecule containing the gene.12 Isolated DNA is
patent eligible, according to Judge Lourie, because it ‘‘results from 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.’’13 It has been ‘‘chemically
cleaved’’ from its native chemical combination with
other genetic materials and thus is not merely a purified
form of a natural material, but rather a distinct chemical
entity.14 Thus, the isolated molecule is shorter and has
different ends than the naturally occurring molecule.
Importantly, he adopted a chemical perspective in assessing whether the isolated DNA is ‘‘markedly different’’
from the naturally occurring DNA, holding that as a
chemical matter, the isolated DNA was manipulated by
human hands (that is, it was cleaved from its native environment) and thus was patent eligible.15 He declined
to view the claimed isolated DNA from the perspective
of its genetic informational content. From that genetic
perspective, the informational content of the isolated
DNA molecule is identical to the informational content
of the DNA molecule in its native state.16 Judge Lourie’s
reasoning on the issue of patent eligibility did not differ
between isolated DNA segments that claimed the whole
gene versus smaller nucleotide sequences. In both cases,
Judge Lourie held, human intervention through cleaving
was required.
Judge Moore agreed that isolated DNA molecules
were patent eligible, but her reasoning differed
depending on whether the claimed isolated molecules
were short nucleotide sequences or relatively longer
ones, such as one encompassing an entire gene. For
shorter sequences, she emphasized that ‘‘it is not the
chemical change alone, but that change combined
with the different and beneficial utility that leads me
to conclude that small isolated DNA fragments are
patentable subject matter.’’17 She reasoned that by defining what parts of the overall DNA molecule should
be retained and what parts should be discarded, these
smaller sequences are new products, having a function
as a primer or a probe, that are entirely different from
that of the full gene.18 For longer sequences, however,
she noted that isolated DNA segments that code for an
entire gene are too large to be suitable for primers or
probes and thus do not have this additional, new utility.19
Nonetheless, she concluded that such longer sequences should remain patent eligible, asserting that
it was for Congress, not the courts, to upset longstanding judicial and Patent and Trademark Office precedent allowing patents for isolated DNA molecules.20
She noted that the PTO had issued patents on these
types of claims for more than 30 years, resulting in
thousands of patents on isolated DNA.21 Recognizing
that she might reach a different result if she had a
‘‘blank canvas’’ to address the patent eligibility of a
3
whole gene, she found the genes patentable in order
not to disturb the long-standing PTO practice and
the settled expectations resulting therefrom.
Finally, Judge Bryson contended that isolated DNA
segments that have the same sequence of nucleotides
found in a naturally occurring DNA molecule are not
materially different from the native molecule.22
Accordingly, he argued, isolated DNA should be ineligible patent subject matter. He asserted that there is
no magic in the breaking of a chemical bond or in isolating a naturally occurring piece of a larger whole. He
analogized a claim to an isolated DNA segment to a
claim to a leaf snapped from a tree or a kidney removed from the human body. None of these items,
he contended, becomes a patentable invention simply
because it has been separated from its natural state.23
Instead, he argued that the court should have adopted
a genetic perspective (which focuses on the identical
nature of the sequence and the informational content
of this sequence) rather than a chemical perspective
(which focuses on the fact the molecule has been
cleaved and has different terminal groups).24
BRIEFS OF THE PARTIES
AND OF THE UNITED STATES
TO THE SUPREME COURT
In their brief, authored by attorneys from the Public
Patent Foundation and the American Civil Liberties
Union Foundation, the plaintiffs/petitioners argued
that isolated DNA molecules are not patent eligible
under x 101 because they are products of nature.25
The plaintiffs/petitioners acknowledged that genes
are chemical compositions, but argued that they are
unique because they ‘‘embody the information and
the instructions the body uses to function.’’26
Petitioners argued that three ways to evaluate
whether a patent impermissibly claims natural phenomena are discernible from Supreme Court
12
Id. at 1328.
Id.
14
Id. at 1329.
15
Id. at 1330.
16
Id.
17
Id. at 1342 (Moore, J., concurring).
18
Id. (Moore, J., concurring).
19
Id. at 1343 (Moore, J., concurring).
20
Id. at 1343–7 (Moore, J., concurring).
21
Id. at 1344 (Moore, J., concurring).
22
Id. at 1350 (Bryson, J., dissenting).
23
Id. at 1352–3 (Bryson, J., dissenting).
24
Id. at 1352 (Bryson, J., dissenting).
25
Brief for Petitioners, Ass’n for Molecular Pathology v. U.S.
Patent & Trademark Office (‘‘Myriad’’), 133 S.Ct. 694
(2013)(No. 12-398), 2013 WL 353961 at *23–4.
26
Id. at *5.
13
4
precedent. According to the petitioners to make this
evaluation, the proper questions are: (1) whether the
patented composition has ‘‘markedly different’’ characteristics from any found in nature;27 (2) whether
the patent is based on an inventive concept;28 and
(3) whether the patent preempts the use of the underlying product of nature and forecloses future innovation out of proportion to the patentee’s contribution.29
First, petitioners argued, isolated DNA does not
have markedly different characteristics from naturally
occurring DNA.30 When determining whether a
claimed composition has markedly different characteristics from a natural product, petitioners claimed
that one must examine both the structure and the function of the composition.31 They characterized the
structural difference between native and isolated
DNA as ‘‘minor chemical changes incidental to isolation’’ and asserted that the Court should not make the
breaking of covalent bonds (that is, the cleaving process) the sole criterion for determining patent eligibility.32 More importantly, they argued, was that
isolated DNA serves the same basic function as genomic DNA—to code for particular proteins and transmit information about a person’s heredity.33
Second, petitioners asserted that patents claiming
isolated DNA molecules are not based on any inventive concept, but rather, claim products and laws of
nature.34 Petitioners argued that ‘‘[t]he claimed composition is a discovery of nature’s handiwork’’—i.e.,
the fact that this DNA sequence codes the BRCA protein and is related to one’s hereditary risk of developing certain diseases.35 They declared that Myriad did
not invent the isolated DNA molecule, the characteristics of the DNA that are incidental to its isolation, or
the length, composition, or function of the BRCA
genes; instead, these functions were determined by
human biology.36 Thus, petitioners concluded, there
was no inventive concept.
Third, petitioners alleged that claims to ‘‘isolated
DNA impermissibly preempt[s] scientific and medical
work, far beyond what Myriad’s contribution can justify.’’37 They argued that genes and DNA molecules
are fundamental ‘‘building blocks’’ upon which further
innovations are built.38 They claimed that the Myriad
BRCA patents have deterred scientific research as well
as the discovery of new or refined treatments.39 For
this reason and the two above, petitioners contended
that isolated DNA molecules should not be patent
eligible.
Additionally, the petitioners argued that because the
Myriad BRCA patents were not limited to cDNA molecules, the Court need not and should not reach the
question of the patent-eligibility of cDNA.40 If the
Court chooses to address this question, however, petitioners asserted that it should find cDNA ineligible for
patent protection as well. They stressed that cDNA
fails the same three criteria discussed above: (1) it is
not markedly different from genomic DNA because
Biotechnology Law Report Volume 32, Number 4
it serves the same basic function—encoding the same
proteins—and it allegedly can occur in nature in the
form of ‘‘pseudogenes’’; (2) nature dictates what portions of the gene are coding and which are not, so
there is no inventive concept; and (3) patenting cDNA
would preempt the use of a basic scientific tool that
would serve as the basis for many additional genetic discoveries.41
Finally,42 petitioners argued that when deciding the
issue of patent eligibility of isolated DNA, past or current PTO practice should be irrelevant.43 They noted
that the Court had rejected a similar argument based
on industry reliance on established practices in its recent decision in Mayo.44
In its brief, the United States split the difference. It
argued that synthesized genetic materials, such as
cDNA, are patent-eligible subject matter, whereas
isolated but otherwise unmodified DNA is not patent
eligible.45 The government also argued that the Court
should not give weight to the PTO practice of granting patents on DNA-based claims or to the reliance
interests in such patents.46
First, the United States asserted that cDNA should
be patent eligible under x 101 ‘‘because it must be synthesized from other genetic materials, a process that
involves significant manipulation and leaves the public free to exploit the underlying natural substances
used to create cDNA.’’47 It noted that, with rare exceptions, cDNA molecules do not occur naturally and
must be synthesized in a laboratory.48 Because of
this fact, the government asserted, there is no risk
27
Id. at *23 (citing Diamond v. Chakrabarty, 447 U.S. 303, 310
(1980)).
28
Id. at *23–24 (citing Mayo, 132 S.Ct. at 1294).
29
Id. at *24 (citing Mayo, 132 S.Ct. at 1301–3).
30
Id. at *28–35.
31
Id. at *28.
32
Id. at *33–4.
33
Id. at *35.
34
Id. at*35–40.
35
Id. at *37.
36
Id. at *39.
37
Id. at *41.
38
Id. at *40–1.
39
Id. at *43–7.
40
Id. at *48.
41
Id. at *49–53.
42
Petitioners also included an argument that patent claims on
isolated DNA violate the First Amendment because they grant
exclusive control over a body of knowledge. Id. at *55–9.
43
Id. at *53–4.
44
Id. at *54 (citing Mayo, 132 S.Ct. at 1304–5).
45
See Brief for United States as Amicus Curiae, Ass’n for
Molecular Pathology v. U.S. Patent & Trademark Office
(‘‘Myriad’’), 133 S.Ct. 694 (2013)(No. 12-398), 2013 WL
390999 at *9.
46
Id. at *11.
47
Id. at *12.
48
Id. at *18.
Biotechnology Law Report Volume 32, Number 4
that granting patent protection for cDNA molecules
will ‘‘tie up’’ other uses of the natural raw materials involved in the creation of cDNA.49
In contrast, genomic DNA that has been isolated
should not be patent eligible, argued the United States,
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.’’50 In other words, the differences between isolated DNA and genomic DNA are
simple and necessary consequences of removing the
DNA from its natural environment. This process is
necessary, according to the government, to exploit
and study DNA, and, accordingly, isolated DNA
claims threaten to preempt the use of the underlying
natural DNA.51,52 It contended that the structural differences between isolated DNA and native DNA
(length and the terminal groups) were minor and do
not render isolated DNA ‘‘markedly different.’’53
Moreover, it argued, the claimed additional utility of
an isolated DNA molecule does not make this molecule ‘‘markedly different’’ because this utility is
based on the inherent natural properties that it shares
with native DNA.54
Finally, the United States argued that ‘‘neither the
PTO’s practice of issuing patents for isolated DNA,
nor Congress’s failure to overturn that practice, provides sufficient reason to hold that isolated DNA is patent-eligible.’’55 Claiming that there was no ‘‘highly
visible’’ formal administrative action that thoroughly
explained the PTO’s interpretation of the statute before the agency began issuing these DNA-based patents, the government asserted that there is little
evidence that Congress had considered this precise
question.56 Further, it argued, ‘‘no court had ever specifically upheld the patent-eligibility of isolated DNA
until the court of appeals ruled in this case.’’57 The
government also noted that although a ruling that isolated DNA is not eligible for patent protection might
upset settled industry expectations, the Court has a
duty to consider the public interest in ‘‘avoiding
undue restrictions imposed by patents that effectively
preempt natural laws and substances.’’58
Myriad responded in its brief by arguing first that
the Court should dismiss the case for lack of subject
matter jurisdiction.59 But if it did reach the merits,
Myriad argued, the Court should affirm the decision
below and rule that isolated DNA is patent eligible
as a product of human invention.60 Myriad based
this argument on the statutory text of x 101 and its assertion that the ‘‘implicit exception’’ to the scope of
patent-eligible subject matter—excluding laws of nature, natural phenomena, and abstract ideas—only
bars things that lack human invention. Moreover,
Myriad argued, the Court should give weight to the
established PTO practice of allowing such DNAbased claims and avoid disrupting the longstanding industry reliance on these patents. Finally, Myriad con-
5
tended that the approaches advocated by the United
States and by the petitioners were misguided.
First, Myriad noted that its claims to isolated DNA
were statutorily patent eligible because each claim is
directed to a ‘‘chemical ‘composition of matter,’ or a
‘new and useful improvement thereof.’’’61
Next, it argued that the claims did not fall under the
‘‘implicit exception’’ to patent eligibility that prevents
patent claims on, among other things, natural phenomena.62 According to Myriad, the question that defines
the boundary between eligible and ineligible subject
matter is simply (and solely) whether the claimed composition is a product of human invention.63 In other
words, the patent-eligibility question is ‘‘whether the
claimed composition is a product of human ingenuity
‘having distinctive name, character, and use’ from
naturally-occurring starting materials.’’64 But, Myriad
asserted, x 101 should be interpreted broadly, and
require only a small modicum of human invention or
human ingenuity, because to require more would risk
having the x 101 eligibility inquiry merge with the x
103 nonobviousness inquiry.65
Applying this standard, Myriad argued that its isolated DNA claims were patent eligible. It asserted that
‘‘[o]nly by human intervention have the claimed molecules come about.’’66 Additionally, Myriad claimed
that the new, isolated molecules have ‘‘significant utility’’ not present in native DNA, such as probes and
primers, that allow doctors and researchers to determine a patient’s hereditary predisposition to developing breast and ovarian cancers.67 Myriad claimed
that this new utility is the result of human ingenuity
49
Id. at *18–9.
Id. at *12.
51,52
Id.
53
Id. at *22.
54
Id. at *23–4.
55
Id. at *26.
56
Id. at *28.
57
Id. at *30
58
Id. at *33.
59
Brief for Respondents, Ass’n for Molecular Pathology v. U.S.
Patent & Trademark Office (‘‘Myriad’’), 133 S.Ct. 694
(2013)(No. 12-398), 2013 WL 860315 at *17–22. Myriad argued that the Court lacks declaratory judgment jurisdiction
over the one remaining petitioner (Dr. Ostrer) because Ostrer
never had a ‘‘real and immediate’’ dispute with Myriad, and
even if he did at one point, his case was mooted once Ostrer
changed jobs and moved to a different institution. Id.
60
Id. at *15–7.
61
Id. at *23.
62
Id.
63
Id. at *23–8.
64
Id. at *23 (quoting Chakrabarty, 447 U.S. at 309–10)(some
internal quotation marks omitted).
65
Id. at *26–7.
66
Id. at *34.
67
Id. at *35.
50
6
Biotechnology Law Report Volume 32, Number 4
and is ‘‘the quintessential mark of patent-eligible subject matter.’’68
Further, Myriad contended that the Supreme Court
‘‘has emphasized that a consistent and longstanding
USPTO practice is entitled to substantial weight in
interpreting and applying x 101.’’69 It asserted that
the PTO has issued nearly 3,000 patents on isolated
DNA molecules over the past 30 years and argued
that Congress took no action to halt or modify this
practice, despite numerous opportunities to do so.70
Myriad also responded to the arguments made by
the United States and by the petitioners in their respective briefs. Myriad asserted that the U.S. position, distinguishing between the patent eligibility of cDNA and
isolated DNA, was mistaken. Noting first that this position was at odds with the PTO, the agency with the
relevant expertise in this area, Myriad also argued
that this position finds no support in the law and
would disrupt the enormous reliance interests in thousands of issued patents.71
Myriad similarly responded to the alleged flaws in
the petitioners’ arguments. It asserted that the threepart test promoted by the petitioners was too cumbersome and represented a misreading of the Supreme
Court’s precedent.72 Importantly, Myriad argued that
the petitioners focus primarily on the similarities between the claimed isolated DNA and native DNA,
whereas the proper inquiry focuses on the differences.73 Myriad noted that ‘‘modest changes introduced by man may confer ‘significant’ utilities that
make a composition patent-eligible.’’74 Finally,
Myriad also addressed several alleged mischaracterizations of its patent claims and of scientific facts, as
well as arguing that the petitioners often conflated
questions patent eligibility under x 101 with questions
of patentability under other statutory sections such as
xx 103 and 112.
suggested by Justice Sotomayor and petitioner’s counsel, that the concern over incentives could be assuaged
by the fact that the novel use of a natural composition
could be patented even if the composition itself could
not.76 According to Justice Sotomayor, ‘‘in isolation,
[the natural product] has no value. It’s just sitting
there.’’77 The United States also argued, in response
to questions about the proper balance of incentives,
that it was for the Court to apply the legal principles
set by its precedents, not to optimize the incentives
for a particular industry, stating that this balancing
was Congress’s prerogative.78
Throughout the oral argument, the Justices also
made use of several analogies when addressing this
patentability issue. Justice Alito proposed an analogy
to a plant growing in the Amazon, whose leaves are
discovered to have powerful medicinal purposes
when eaten. Several of the other Justices returned to
this analogy, including Justice Kagan who returned
to this analogy twice. She suggested that one might
be able to get a patent for the use of this plant, but
not for the leaves/composition itself, even if it took
much effort and ingenuity to find the plant.79 Justice
Breyer also used the medicinal plant analogy, assuming in his followup question that one could not get a
patent on the composition itself.80 Justice Sotomayor
proposed an analogy suggesting that isolated DNA
segments might be like the basic ingredients (flour,
sugar, etc.) that go into baking chocolate chip cookies,
and that these basic, natural building blocks should not
be eligible for patent protection.81 Similarly, Chief
Justice Roberts posed questions based on an analogy
to a wooden baseball bat. Although the bat is made
from a material found in nature, Chief Justice Roberts
posited that making it required more than mere isolation, something more than merely the ‘‘snipping’’ off
the ends that is involved in isolating the DNA segments.82 He did not appear to give much weight to
the answer given by Myriad’s counsel that the
ORAL ARGUMENTS AT THE
SUPREME COURT
68
The questions posed by the Justices at oral argument may offer some insight into how the Court
might ultimately rule in this case. The Justices’ questions suggested skepticism as to whether claims directed to isolated DNA molecules should be eligible
for patent protection, although this doubt seemed
less pronounced with regard to the patent eligibility
of cDNA.
Most of the Justices’ questions centered on the eligibility of isolated segments of naturally occurring
DNA. Justices Kagan and Scalia asked about the effect
of not permitting patents on isolated genes on the incentives for companies to perform this kind of
research—identifying and isolating genes.75 But
most of the Justices appeared to accept the answer,
Id.
Id. at *30 (citing J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred
Int’l, Inc., 534 U.S. 124, 145 (1996)).
70
Id. at *30–1.
71
Id. at *35–9.
72
Id. at *39–50.
73
Id. at *40.
74
Id. at *44.
75
Oral Argument Tr., Ass’n for Molecular Pathology v. U.S.
Patent & Trademark Office (‘‘Myriad’’), 133 S.Ct. 694
(2013)(No. 12-398) at 10–5.
76
Id. at 16.
77
Id.
78
Id. at 32.
79
Id. at 32, 43.
80
Id. at 49.
81
Id. at 35–6.
82
Id. at 41.
69
Biotechnology Law Report Volume 32, Number 4
invention consisted of knowing where to snip the DNA
strand, making the molecule itself patent eligible.83
Justice Kagan asked Myriad’s counsel whether the
first person who isolated chromosomes could have
gotten a patent on them.84 Her line of questioning
appeared directed to the point that there may be no
principled difference between an isolated segment of
DNA and another, larger isolated part of the human
body.85 Justice Sotomayor later jumped in and sought
to know the difference for patent eligibility purposes
between snipping off a piece of a DNA segment and
snipping off a piece of a liver or kidney.86 None of
the Justices’ questions seemed to suggest that they believed that the mere act of isolating a natural substance, such as a DNA segment, from a larger whole
was sufficient to make the isolated substance itself patent eligible.
The Justices also did not appear to give much
weight to Myriad’s argument that the Court should respect the decision made by the PTO, reflected in its
Utility Guidelines, to grant patents for isolated DNA
molecules because the PTO is ‘‘the agency that sits
at the intersection of law and science.’’87 Justice Ginsberg noted that the strength of this presumption of respect for the agency practice was diluted by the fact
that the United States adopted an opposing position
as amicus curiae.88
The questions raised by the Justices regarding
cDNA, in contrast, suggest an outcome different than
for the isolated gene claims. Justice Sotomayor emphasized in her questions to petitioners’ counsel that
cDNA was created in a laboratory and is not a natural
product but rather is a product of human invention.89
7
After Justice Breyer also noted that this molecule is
different from any that occurs in nature, Justice Sotomayor responded to the argument made by petitioner’s
counsel that it was not markedly different from natural
DNA by asserting that the argument went to obviousness rather than to patent eligibility.90 Further, Justice
Kennedy asked a series of questions that led to the
concession that it was somewhat easier to work with
cDNA than isolated DNA to make other humandesigned DNA molecules.91 In one instance, Chief
Justice Roberts also had Myriad’s counsel quickly assume that cDNA would be patentable when seeking an
answer to his question about the patent eligibility of
isolated DNA.92 No questions suggested doubt as to
the patent eligibility of cDNA, although concerns regarding whether such claims are obvious remain.
CONCLUSION
All in all, the tone and content of the questions
posed by the Justices at oral argument suggest that
the Court may be leaning toward agreement with the
position advocated by the United States, ruling that
cDNA molecules are patent eligible and isolated segments of native DNA are not. Although this outcome
would disrupt the expectation of many current patent
owners, it is not clear what effect, if any, such a ruling
would have on the incentives and protection afforded
to genetic research moving forward.93
83
Id. at 43.
Id. at 52. (Justice Kagan noted that a chromosome is certainly
a useful thing and would thus meet the other x 101 requirements).
85
Id. at 54.
86
Id. at 56.
87
Id. at 51.
88
Id. 51–2.
89
Id. at 17.
90
Id. at 18–9.
91
Id. at 20.
92
Id. at 42 (‘‘Okay. You’ve got the cDNA.’’).
93
Id. at 24 ( Justice Sotomayor wondered whether it really matters if only cDNA and not isolated DNA is patent eligible).
84