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SUPREME COURT OF THE UNITED STATES
_________________
No. 12–398
_________________
ASSOCIATION FOR MOLECULAR PATHOLOGY,
et al., PETITIONERS
v. MYRIAD GENETICS, INC.,
et al.
on writ of certiorari to the united states
court of appeals for the federal circuit
[June 13, 2013]
Justice Thomas delivered the opinion of the
Court.
Respondent Myriad Genetics, Inc. (Myriad),
discovered the precise location and sequence of two human genes,
mutations of which can substantially increase the risks of breast
and ovarian cancer. Myriad obtained a number of patents based upon
its discovery. This case involves claims from three of them and
requires us to resolve whether a naturally occurring segment of
deoxyribonucleic acid (DNA) is patent eligible under 35
U. S. C. §101 by virtue of its isolation from the
rest of the human genome. We also address the patent eligibility of
synthetically created DNA known as complementary DNA (cDNA), which
contains the same protein-coding information found in a segment of
natural DNA but omits portions within the DNA segment that do not
code for proteins. For the reasons that follow, we hold that a
naturally occurring DNA segment is a product of nature and not
patent eligible merely because it has been isolated, but that cDNA
is patent eligible because it is not naturally occurring. We,
therefore, affirm in part and reverse in part the decision of the
United States Court of Appeals for the Federal Circuit.
I
A
Genes form the basis for hereditary traits in
living organisms. See generally
Association for Molecular
Pathology v.
United States Patent and Trademark Office,
702 F. Supp. 2d 181, 192–211 (SDNY 2010). The human ge- nome
consists of approximately 22,000 genes packed into 23 pairs of
chromosomes. Each gene is encoded as DNA, which takes the shape of
the familiar “double helix” that Doctors James Watson
and Francis Crick first described in 1953. Each
“cross-bar” in the DNA helix consists of two chemically
joined nucleotides. The possible nucleotides are adenine (A),
thymine (T), cytosine (C), and guanine (G), each of which binds
naturally with another nucleotide: A pairs with T; C pairs with G.
The nucleotide cross-bars are chemically connected to a
sugar-phosphate backbone that forms the outside framework of the
DNA helix. Sequences of DNA nucleotides contain the information
necessary to create strings of amino acids, which in turn are used
in the body to build proteins. Only some DNA nucleotides, however,
code for amino acids; these nucleotides are known as
“exons.” Nucleotides that do not code for amino acids,
in contrast, are known as “introns.”
Creation of proteins from DNA involves two
principal steps, known as transcription and translation. In
transcription, the bonds between DNA nucleotides separate, and the
DNA helix unwinds into two single strands. A single strand is used
as a template to create a complementary ribonucleic acid (RNA)
strand. The nucleotides on the DNA strand pair naturally with their
counterparts, with the exception that RNA uses the nucleotide base
uracil (U) instead of thymine (T). Transcription results in a
single strand RNA molecule, known as pre-RNA, whose nucleotides
form an inverse image of the DNA strand from which it was created.
Pre-RNA still contains nucleotides corresponding to both the exons
and introns in the DNA molecule. The pre-RNA is then naturally
“spliced” by the physical removal of the introns. The
resulting product is a strand of RNA that contains nucleotides
corresponding only to the exons from the original DNA strand. The
exons-only strand is known as messenger RNA (mRNA), which creates
amino acids through translation. In translation, cellular
structures known as ribosomes read each set of three nucleotides,
known as codons, in the mRNA. Each codon either tells the ribosomes
which of the 20 possible amino acids to synthesize or provides a
stop signal that ends amino acid production.
DNA’s informational sequences and the
processes that create mRNA, amino acids, and proteins occur
naturally within cells. Scientists can, however, extract DNA from
cells using well known laboratory methods. These methods allow
scientists to isolate specific segments of DNA—for instance,
a particular gene or part of a gene—which can then be further
studied, manipulated, or used. It is also possible to create DNA
synthetically through processes similarly well known in the field
of genetics. One such method begins with an mRNA molecule and uses
the natural bonding properties of nucleotides to create a new,
synthetic DNA molecule. The result is the inverse of the
mRNA’s inverse image of the original DNA, with one important
distinction: Because the natural creation of mRNA involves splicing
that removes introns, the synthetic DNA created from mRNA also
contains only the exon sequences. This synthetic DNA created in the
laboratory from mRNA is known as complementary DNA (cDNA).
Changes in the genetic sequence are called
mutations. Mutations can be as small as the alteration of a single
nucleotide—a change affecting only one letter in the genetic
code. Such small-scale changes can produce an entirely different
amino acid or can end protein production altogether. Large changes,
involving the deletion, rearrangement, or duplication of hundreds
or even millions of nu- cleotides, can result in the elimination,
misplacement, or duplication of entire genes. Some mutations are
harmless, but others can cause disease or increase the risk of
disease. As a result, the study of genetics can lead to valu- able
medical breakthroughs.
B
This case involves patents filed by Myriad
after it made one such medical breakthrough. Myriad discovered the
precise location and sequence of what are now known as the BRCA1
and BRCA2 genes. Mutations in these genes can dramatically increase
an individual’s risk of developing breast and ovarian cancer.
The average American woman has a 12- to 13-percent risk of
developing breast cancer, but for women with certain genetic
mutations, the risk can range between 50 and 80 percent for breast
cancer and between 20 and 50 percent for ovarian cancer. Before
Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists
knew that heredity played a role in establishing a woman’s
risk of developing breast and ovarian cancer, but they did not know
which genes were associated with those cancers.
Myriad identified the exact location of the
BRCA1 and BRCA2 genes on chromosomes 17 and 13. Chromosome 17 has
approximately 80 million nucleotides, and chro- mosome 13 has
approximately 114 million.
Association for Molecular
Pathology v.
United States Patent and Trademark Office,
689 F.3d 1303, 1328 (CA Fed. 2012). Within those chromosomes, the
BRCA1 and BRCA2 genes are each about 80,000 nucleotides long. If
just exons are counted, the BRCA1 gene is only about 5,500
nucleotides long; for the BRCA2 gene, that number is about 10,200.
Ibid. Knowledge of the location of the BRCA1 and BRCA2 genes
allowed Myriad to determine their typical nucleotide
sequence.[
1] That information,
in turn, enabled Myriad to develop medical tests that are useful
for detecting mutations in a patient’s BRCA1 and BRCA2 genes
and thereby assessing whether the patient has an increased risk of
cancer.
Once it found the location and sequence of the
BRCA1 and BRCA2 genes, Myriad sought and obtained a number of
patents. Nine composition claims from three of those patents are at
issue in this case.[
2] See
id., at 1309, and n. 1 (noting composition claims).
Claims 1, 2, 5, and 6 from the ’282 patent are
representative. The first claim asserts a patent on “[a]n
isolated DNA coding for a BRCA1 polypeptide,” which has
“the amino acid sequence set forth in SEQ ID NO:2.”
App. 822. SEQ ID NO:2 sets forth a list of 1,863 amino acids that
the typical BRCA1 gene encodes. See
id., at 785–790.
Put differently, claim 1 asserts a patent claim on the DNA code
that tells a cell to produce the string of BRCA1 amino acids listed
in SEQ ID NO:2.
Claim 2 of the ’282 patent operates
similarly. It claims “[t]he isolated DNA of claim 1, wherein
said DNA has the nucleotide sequence set forth in SEQ ID
NO:1.”
Id., at 822. Like SEQ ID NO:2, SEQ ID NO:1 sets
forth a long list of data, in this instance the sequence of cDNA
that codes for the BRCA1 amino acids listed in claim 1.
Importantly, SEQ ID NO:1 lists only the cDNA exons in the BRCA1
gene, rather than a full DNA sequence contain- ing both exons and
introns. See
id., at 779 (stating that SEQ ID NO:1’s
“MOLECULE TYPE:” is “cDNA”). As a re- sult,
the Federal Circuit recognized that claim 2 asserts a patent on the
cDNA nucleotide sequence listed in SEQ ID NO:1, which codes for the
typical BRCA1 gene. 689 F. 3d, at 1326, n. 9;
id.,
at 1337 (Moore, J., concurring in part);
id., at 1356
(Bryson, J., concurring in part and dissenting in part).
Claim 5 of the ’282 patent claims a subset
of the data in claim 1. In particular, it claims “[a]n
isolated DNA having at least 15 nucleotides of the DNA of claim
1.” App. 822. The practical effect of claim 5 is to assert a
patent on any series of 15 nucleotides that exist in the typical
BRCA1 gene. Because the BRCA1 gene is thousands of nucleotides
long, even BRCA1 genes with substantial mutations are likely to
contain at least one segment of 15 nucleotides that correspond to
the typical BRCA1 gene. Similarly, claim 6 of the ’282 patent
claims “[a]n isolated DNA having at least 15 nucleotides of
the DNA of claim 2.”
Ibid. This claim operates
similarly to claim 5, except that it references the cDNA-based
claim 2. The remaining claims at issue are similar, though several
list common mutations rather than typical BRCA1 and BRCA2
sequences. See
ibid. (claim 7 of the ’282 patent);
id., at 930 (claim 1 of the ’473 patent);
id.,
at 1028 (claims 1, 6, and 7 of the ’492 patent).
C
Myriad’s patents would, if valid, give
it the exclusive right to isolate an individual’s BRCA1 and
BRCA2 genes (or any strand of 15 or more nucleotides within the
genes) by breaking the covalent bonds that connect the DNA to the
rest of the individual’s genome. The patents would also give
Myriad the exclusive right to synthetically create BRCA cDNA. In
Myriad’s view, manipulating BRCA DNA in either of these
fashions triggers its “right to exclude others from
making” its patented composition of matter under the Patent
Act. 35 U. S. C. §154(a)(1); see also §271(a)
(“[W]hoever without authority makes . . . any
patented invention . . . infringes the
patent”).
But isolation is necessary to conduct genetic
testing, and Myriad was not the only entity to offer BRCA testing
after it discovered the genes. The University of
Pennsylvania’s Genetic Diagnostic Laboratory (GDL) and others
provided genetic testing services to women. Petitioner Dr. Harry
Ostrer, then a researcher at New York University School of
Medicine, routinely sent his patients’ DNA samples to GDL for
testing. After learning of GDL’s testing and Ostrer’s
activities, Myriad sent letters to them asserting that the genetic
testing infringed Myriad’s patents. App. 94–95 (Ostrer
letter). In response, GDL agreed to stop testing and informed
Ostrer that it would no longer accept patient samples. Myriad also
filed patent infringement suits against other entities that
performed BRCA testing, resulting in settlements in which the
defendants agreed to cease all allegedly infringing activity. 689
F. 3d, at 1315. Myriad, thus, solidified its position as the
only entity providing BRCA testing.
Some years later, petitioner Ostrer, along with
medical patients, advocacy groups, and other doctors, filed this
lawsuit seeking a declaration that Myriad’s patents are
invalid under 35 U. S. C. §101. 702 F. Supp.
2d, at 186. Citing this Court’s decision in
MedImmune,
Inc. v.
Genentech, Inc.,
549 U.S.
118 (2007), the District Court denied Myriad’s motion to
dismiss for lack of standing.
Association for Molecular
Pathology v.
United States Patent and Trademark Office,
669 F. Supp. 2d 365, 385–392 (SDNY 2009). The District Court
then granted summary judgment to petitioners on the composition
claims at issue in this case based on its conclusion that
Myriad’s claims, including claims related to cDNA, were
invalid because they covered products of nature. 702 F. Supp.
2d, at 220–237. The Federal Circuit reversed,
Association
for Molecular Pathology v.
United States Patent and
Trademark Office, 653 F.3d 1329 (2011), and this Court granted
the petition for certiorari, vacated the judgment, and re- manded
the case in light of
Mayo Collaborative Services v.
Prometheus Laboratories, Inc., 566 U. S. ___ (2012).
See
Association for Molecular Pathology v.
Myriad
Genetics, Inc., 566 U. S. ___ (2012).
On remand, the Federal Circuit affirmed the
District Court in part and reversed in part, with each member of
the panel writing separately. All three judges agreed that only
petitioner Ostrer had standing. They reasoned that Myriad’s
actions against him and his stated ability and willingness to begin
BRCA1 and BRCA2 testing if Myr- iad’s patents were
invalidated were sufficient for Article III standing. 689
F. 3d, at 1323;
id., at 1337 (opinion of Moore, J.);
id., at 1348 (opinion of Bryson, J.).
With respect to the merits, the court held that
both isolated DNA and cDNA were patent eligible under §101.
The central dispute among the panel members was whether the act of
isolating DNA—separating a specific gene or sequence
of nucleotides from the rest of the chromosome—is an
inventive act that entitles the individual who first isolates it to
a patent. Each of the judges on the panel had a different view on
that question. Judges Lourie and Moore agreed that Myriad’s
claims were patent eligible under §101 but disagreed on the
rationale. Judge Lourie relied on the fact that the entire DNA
molecule is held together by chemical bonds and that the covalent
bonds at both ends of the segment must be severed in order to
isolate segments of DNA. This process technically creates new
molecules with unique chemical compositions. See
id., at
1328 (“Isolated DNA . . . is a free-standing
portion of a larger, natural DNA molecule. Isolated DNA has been
cleaved (
i.e., had covalent bonds in its backbone chemically
severed) or synthesized to consist of just a fraction of a
naturally occurring DNA molecule”). Judge Lourie found this
chemical alteration to be dispositive, because isolating a
particular strand of DNA creates a nonnaturally occurring molecule,
even though the chemical alteration does not change the
information-transmitting quality of the DNA. See
id., at
1330 (“The claimed isolated DNA molecules are distinct from
their natural existence as portions of larger entities, and their
informational content is irrelevant to that fact. We recognize that
biologists may think of molecules in terms of their uses, but genes
are in fact materials having a chemical nature”).
Accordingly, he rejected petitioners’ argument that isolated
DNA was ineligible for patent protection as a product of
nature.
Judge Moore concurred in part but did not rely
exclusively on Judge Lourie’s conclusion that chemically
breaking covalent bonds was sufficient to render isolated DNA
patent eligible.
Id., at 1341 (“To the extent the
majority rests its conclusion on the chemical differences between
[naturally occurring] and isolated DNA (breaking the covalent
bonds), I cannot agree that this is sufficient to hold that the
claims to human genes are directed to patentable subject
matter”). Instead, Judge Moore also relied on the United
States Patent and Trademark Office’s (PTO) practice of
granting such patents and on the reliance interests of patent
holders.
Id., at 1343. However, she acknowledged that her
vote might have come out differently if she “were deciding
this case on a blank canvas.”
Ibid.
Finally, Judge Bryson concurred in part and
dissented in part, concluding that isolated DNA is not patent eli-
gible. As an initial matter, he emphasized that the breaking of
chemical bonds was not dispositive: “[T]here is no magic to a
chemical bond that requires us to recognize a new prod- uct when a
chemical bond is created or broken.”
Id., at 1351.
Instead, he relied on the fact that “[t]he nucleotide
sequences of the claimed molecules are the same as the nucleotide
sequences found in naturally occurring human genes.”
Id., at 1355. Judge Bryson then concluded that genetic
“structural similarity dwarfs the significance of the
structural differences between isolated DNA and naturally occurring
DNA, especially where the structural differences are merely
ancillary to the breaking of covalent bonds, a process that is
itself not inventive.”
Ibid. More- over, Judge Bryson
gave no weight to the PTO’s position on patentability because
of the Federal Circuit’s position that “the PTO lacks
substantive rulemaking authority as to issues such as
patentability.”
Id., at 1357.
Although the judges expressed different views
concerning the patentability of isolated DNA, all three agreed that
patent claims relating to cDNA met the patent eligibility
requirements of §101.
Id., at 1326, and n. 9
(recognizing that some patent claims are limited to cDNA and that
such claims are patent eligible under §101);
id., at
1337 (Moore, J., concurring in part);
id., at 1356 (Bryson,
J., concurring in part and dissenting in part) (“cDNA cannot
be isolated from nature, but instead must be created in the
laboratory . . . because the introns that are found in
the native gene are removed from the cDNA segment”).[
3] We granted certiorari. 568
U. S. ___ (2012).
II
A
Section 101 of the Patent Act provides:
“Whoever invents or discovers any
new and useful . . . composition of matter, or any new
and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.” 35
U. S. C. §101.
We have “long held that this provision
contains an important implicit exception[:] Laws of nature, natural
phenomena, and abstract ideas are not patentable.”
Mayo, 566 U. S., at ___ (slip op., at 1) (internal
quotation marks and brackets omitted). Rather,
“ ‘they are the basic tools of scientific and
technological work’ ” that lie beyond the domain
of patent protection.
Id., at ___ (slip op., at 2). As the
Court has explained, without this exception, there would be
considerable danger that the grant of patents would “tie
up” the use of such tools and thereby “inhibit future
innovation premised upon them.”
Id., at ___ (slip op.,
at 17). This would be at odds with the very point of patents, which
exist to promote creation.
Diamond v.
Chakrabarty,
447 U.S.
303, 309 (1980) (Products of nature are not created, and
“ ‘manifestations . . . of nature [are]
free to all men and reserved exclusively to
none’ ”).
The rule against patents on naturally occurring
things is not without limits, however, for “all inventions at
some level embody, use, reflect, rest upon, or apply laws of
nature, natural phenomena, or abstract ideas,” and “too
broad an interpretation of this exclusionary principle could
eviscerate patent law.” 566 U. S., at ___ (slip op., at
2). As we have recognized before, patent protection strikes a
delicate balance between creating “incentives that lead to
creation, invention, and discovery” and “imped[ing] the
flow of information that might permit, indeed spur, in-
vention.”
Id., at ___ (slip op., at 23). We must apply
this well-established standard to determine whether Myr-
iad’s patents claim any “new and useful . . .
composition of matter,” §101, or instead claim naturally
occurring phenomena.
B
It is undisputed that Myriad did not create or
alter any of the genetic information encoded in the BRCA1 and BRCA2
genes. The location and order of the nucleotides existed in nature
before Myriad found them. Nor did Myr- iad create or alter the
genetic structure of DNA. In- stead, Myriad’s principal
contribution was uncovering the precise location and genetic
sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.
The question is whether this renders the genes patentable.
Myriad recognizes that our decision in
Chakrabarty is central to this inquiry. Brief for
Respondents 14, 23–27. In
Chakrabarty, scientists
added four plasmids to a bacterium, which enabled it to break down
various components of crude oil. 447 U. S., at 305, and
n. 1. The Court held that the modified bacterium was
patentable. It explained that the patent claim was “not to a
hitherto unknown natural phenomenon, but to a nonnaturally
occurring manufacture or composition of matter—a product of
human ingenuity ‘having a distinctive name, character [and]
use.’ ”
Id., at 309–310 (quoting
Hartranft v.
Wiegmann,
121 U.S.
609, 615 (1887); alteration in original). The
Chakrabarty bacterium was new “with markedly different
characteristics from any found in nature,” 447 U. S., at
310, due to the additional plasmids and resultant “capac- ity
for degrading oil.”
Id., at 305, n. 1. In this
case, by contrast, Myriad did not create anything. To be sure, it
found an important and useful gene, but separating that gene from
its surrounding genetic material is not an act of invention.
Groundbreaking, innovative, or even brilliant
discovery does not by itself satisfy the §101 inquiry. In
Funk Brothers Seed Co. v.
Kalo Inoculant Co.,
333 U.S.
127 (1948), this Court considered a composition patent that
claimed a mixture of naturally occurring strains of bacteria that
helped leguminous plants take nitrogen from the air and fix it in
the soil.
Id., at 128–129. The ability of the bacteria
to fix nitrogen was well known, and farmers commonly
“inoculated” their crops with them to improve soil
nitrogen levels. But farmers could not use the same inoculant for
all crops, both because plants use different bacteria and because
certain bacteria inhibit each other.
Id., at 129–130.
Upon learning that several nitrogen-fixing bacteria did not inhibit
each other, however, the patent applicant combined them into a
single inoculant and obtained a patent.
Id., at 130. The
Court held that the composition was not patent eligible because the
patent holder did not alter the bacteria in any way.
Id., at
132 (“There is no way in which we could call [the bacteria
mixture a product of invention] unless we borrowed invention from
the discovery of the natural principle itself”). His patent
claim thus fell squarely within the law of nature exception. So do
Myriad’s. Myriad found the location of the BRCA1 and BRCA2
genes, but that discovery, by itself, does not render the BRCA
genes “new . . . composition[s] of matter,”
§101, that are patent eligible.
Indeed, Myriad’s patent descriptions
highlight the problem with its claims. For example, a section of
the ’282 patent’s Detailed Description of the Invention
indicates that Myriad found the location of a gene associated with
increased risk of breast cancer and identified mutations of that
gene that increase the risk. See App. 748–749.[
4] In subsequent language Myriad explains
that the location of the gene was unknown until Myriad found it
among the approximately eight million nucleotide pairs contained in
a subpart of chromosome 17. See
Ibid.[
5] The ’473 and ’492 patents contain
similar language as well. See
id., at 854, 947. Many of
Myriad’s patent descriptions simply detail the
“iterative process” of discovery by which Myriad
narrowed the possible locations for the gene sequences that it
sought.[
6] See,
e.g.,
id., at 750. Myriad seeks to import these extensive research
efforts into the §101 patent-eligibility inquiry. Brief for
Respondents 8–10, 34. But extensive effort alone is
insufficient to satisfy the demands of §101.
Nor are Myriad’s claims saved by the fact
that isolating DNA from the human genome severs chemical bonds and
thereby creates a nonnaturally occurring molecule. Myr- iad’s
claims are simply not expressed in terms of chemical composition,
nor do they rely in any way on the chemi- cal changes that result
from the isolation of a particular section of DNA. Instead, the
claims understandably focus on the genetic information encoded in
the BRCA1 and BRCA2 genes. If the patents depended upon the
creation of a unique molecule, then a would-be infringer could
arguably avoid at least Myriad’s patent claims on entire
genes (such as claims 1 and 2 of the ’282 patent) by
isolating a DNA sequence that included both the BRCA1 or BRCA2 gene
and one additional nucleotide pair. Such a molecule would not be
chemically identical to the molecule “invented” by
Myriad. But Myriad obviously would resist that outcome because its
claim is concerned primarily with the information contained in the
genetic
sequence, not with the specific chemical composition
of a particular molecule.
Finally, Myriad argues that the PTO’s past
practice of awarding gene patents is entitled to deference, citing
J. E. M. Ag Supply, Inc. v.
Pioneer
Hi-Bred Int’l, Inc.,
534 U.S.
124 (2001). See Brief for Respondents 35–39, 49–50.
We disagree.
J. E. M. held that new plant breeds were
eligible for utility patents under §101 notwithstanding
separate statutes providing special protections for plants, see 7
U. S. C. §2321
et seq. (Plant Variety
Protection Act); 35 U. S. C. §§161–164
(Plant Patent Act of 1930). After analyzing the text and structure
of the relevant statutes, the Court mentioned that the Board of
Patent Appeals and Interferences had determined that new plant
breeds were patent eligible under §101 and that Congress had
recognized and endorsed that position in a subsequent Patent Act
amendment. 534 U. S., at 144–145 (citing
In re
Hibberd, 227 USPQ 443 (1985) and 35 U. S. C.
§119(f)). In this case, however, Congress has not endorsed the
views of the PTO in subsequent legislation. While Myriad relies on
Judge Moore’s view that Congress endorsed the PTO’s
position in a single sentence in the Consolidated Appropriations
Act of 2004, see Brief for Respondents 31, n. 8; 689
F. 3d, at 1346, that Act does not even mention genes, much
less isolated DNA. §634, 118Stat. 101 (“None of the
funds appropriated or otherwise made available under this Act may
be used to issue patents on claims directed to or encompassing a
human organism”).
Further undercutting the PTO’s practice,
the United States argued in the Federal Circuit and in this Court
that isolated DNA was
not patent eligible under §101,
Brief for United States as
Amicus Curiae 20–33, and
that the PTO’s practice was not “a sufficient reason to
hold that isolated DNA is patent-eligible.”
Id., at
26. See also
id., at 28–29. These concessions weigh
against deferring to the PTO’s determination.[
7]
C
cDNA does not present the same obstacles to
patentability as naturally occurring, isolated DNA segments. As
already explained, creation of a cDNA sequence from mRNA results in
an exons-only molecule that is not naturally occurring.[
8] Petitioners concede that cDNA
differs from natural DNA in that “the non-coding regions have
been removed.” Brief for Petitioners 49. They nevertheless
argue that cDNA is not patent eligible because “[t]he
nucleotide sequence of cDNA is dictated by nature, not by the lab
technician.”
Id., at 51. That may be so, but the lab
technician unquestionably creates something new when cDNA is made.
cDNA retains the naturally occurring exons of DNA, but it is
distinct from the DNA from which it was derived. As a result, cDNA
is not a “product of nature” and is patent eligible
under §101, except insofar as very short series of DNA may
have no intervening introns to remove when creating cDNA. In that
situation, a short strand of cDNA may be indistinguishable from
natural DNA.[
9]
III
It is important to note what is
not
implicated by this decision. First, there are no method claims
before this Court. Had Myriad created an innovative method of
manipulating genes while searching for the BRCA1 and BRCA2 genes,
it could possibly have sought a method pat- ent. But the processes
used by Myriad to isolate DNA were well understood by geneticists
at the time of Myriad’s patents “were well understood,
widely used, and fairly uniform insofar as any scientist engaged in
the search for a gene would likely have utilized a similar
approach,” 702 F. Supp. 2d, at 202–203, and are
not at issue in this case.
Similarly, this case does not involve patents
on new
applications of knowledge about the BRCA1 and BRCA2
genes. Judge Bryson aptly noted that, “[a]s the first party
with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an
excellent position to claim applications of that knowledge. Many of
its unchallenged claims are limited to such applications.”
689 F. 3d, at 1349.
Nor do we consider the patentability of DNA in
which the order of the naturally occurring nucleotides has been
altered. Scientific alteration of the genetic code presents a
different inquiry, and we express no opinion about the application
of §101 to such endeavors. We merely hold that genes and the
information they encode are not patent eligible under §101
simply because they have been isolated from the surrounding genetic
material.
* * *
For the foregoing reasons, the judgment of the
Federal Circuit is affirmed in part and reversed in part.
It is so ordered.