TRANS-LUDZIE orzeczenie Sądu Najwyższego USA - tekst in English.pdf

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(Slip Opinion)
OCTOBER TERM, 2012
Syllabus
1
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See
United States
v.
Detroit Timber & Lumber Co.,
200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
Syllabus
ASSOCIATION FOR MOLECULAR PATHOLOGY
ET AL
.
v.
MYRIAD GENETICS, INC.,
ET AL
.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE FEDERAL CIRCUIT
No. 12–398.
Argued April 15, 2013—Decided June 13, 2013
Each human gene is encoded as deoxyribonucleic acid (DNA), which
takes the shape of a “double helix.” Each “cross-bar” in that helix
consists of two chemically joined nucleotides. Sequences of DNA nu-
cleotides contain the information necessary to create strings of amino
acids used to build proteins in the body. The nucleotides that code
for amino acids are “exons,” and those that do not are “introns.” Sci-
entists can extract DNA from cells to isolate specific segments for
study. They can also synthetically create exons-only strands of nu-
cleotides known as complementary DNA (cDNA). cDNA contains only the
exons that occur in DNA, omitting the intervening introns.
Respondent Myriad Genetics, Inc. (Myriad), obtained several pa-
tents after discovering the precise location and sequence of the
BRCA1 and BRCA2 genes, mutations of which can dramatically in-
crease the risk of breast and ovarian cancer. This knowledge allowed
Myriad to determine the genes’ typical nucleotide sequence, which, in
turn, enabled it to develop medical tests useful for detecting muta-
tions in these genes in a particular patient to assess the patient’s
cancer risk. If valid, Myriad’s patents would give it the exclusive
right to isolate an individual’s BRCA1 and BRCA2 genes, and would
give Myriad the exclusive right to synthetically create BRCA cDNA.
Petitioners filed suit, seeking a declaration that Myriad’s patents are
invalid under 35 U. S. C. §101. As relevant here, the District Court
granted summary judgment to petitioners, concluding that Myriad’s
claims were invalid because they covered products of nature. The
Federal Circuit initially reversed, but on remand in light of
Mayo
Collaborative Services
v.
Prometheus Laboratories, Inc.,
566 U. S. ___,
the Circuit found both isolated DNA and cDNA patent eligible.
2
ASSOCIATION FOR MOLECULAR PATHOLOGY
v.
MYRIAD GENETICS, INC.
Syllabus
Held:
A naturally occurring DNA segment is a product of nature and
not patent eligible merely because it has been isolated, but cDNA is
patent eligible because it is not naturally occurring. Pp. 10–18.
(a) The Patent Act permits patents to be issued to “[w]hoever in-
vents or discovers any new and useful . . . composition of matter,”
§101, but “laws of nature, natural phenomena, and abstract ideas”
“ ‘are basic tools of scientific and technological work’ ” that lie beyond
the domain of patent protection,
Mayo, supra,
at ___. The rule
against patents on naturally occurring things has limits, however.
Patent protection strikes a delicate balance between creating “incen-
tives that lead to creation, invention, and discovery” and “imped[ing]
the flow of information that might permit, indeed spur, invention.”
Id.,
at ___. This standard is used to determine whether Myriad’s pa-
tents claim a “new and useful . . . composition of matter,” §101, or
claim naturally occurring phenomena. Pp. 10–11.
(b) Myriad’s DNA claim falls within the law of nature exception.
Myriad’s principal contribution was uncovering the precise location
and genetic sequence of the BRCA1 and BRCA2 genes.
Diamond
v.
Chakrabarty,
447 U. S. 303, is central to the patent-eligibility inquiry
whether such action was new “with markedly different characteris-
tics from any found in nature,”
id.,
at 310. Myriad did not create or
alter either the genetic information encoded in the BCRA1 and
BCRA2 genes or the genetic structure of the DNA. It found an im-
portant and useful gene, but groundbreaking, innovative, or even
brilliant discovery does not by itself satisfy the §101 inquiry. See
Funk Brothers Seed Co.
v.
Kalo Inoculant Co.,
333 U. S. 127. Finding
the location of the BRCA1 and BRCA2 genes does not render the
genes patent eligible “new . . . composition[s] of matter,” §101. Myri-
ad’s patent descriptions highlight the problem with its claims: They
detail the extensive process of discovery, but extensive effort alone is
insufficient to satisfy §101’s demands. Myriad’s claims are not saved
by the fact that isolating DNA from the human genome severs the
chemical bonds that bind gene molecules together. The claims are
not expressed in terms of chemical composition, nor do they rely on
the chemical changes resulting from the isolation of a particular DNA
section. Instead, they focus on the genetic information encoded in the
BRCA1 and BRCA2 genes. Finally, Myriad argues that the Patent
and Trademark Office’s past practice of awarding gene patents is en-
titled to deference, citing
J. E. M. Ag Supply, Inc.
v.
Pioneer Hi-Bred
Int’l, Inc.,
534 U. S. 124, a case where Congress had endorsed a PTO
practice in subsequent legislation. There has been no such endorse-
ment here, and the United States argued in the Federal Circuit and
in this Court that isolated DNA was not patent eligible under §101.
Pp. 12–16.
Cite as: 569 U. S. ____ (2013)
Syllabus
3
(c) cDNA is not a “product of nature,” so it is patent eligible under
§101. cDNA does not present the same obstacles to patentability as
naturally occurring, isolated DNA segments. Its creation results in
an exons-only molecule, which is not naturally occurring. Its order of
the exons may be dictated by nature, but the lab technician unques-
tionably creates something new when introns are removed from a
DNA sequence to make cDNA. Pp. 16–17.
(d) This case, it is important to note, does not involve method
claims, patents on new applications of knowledge about the BRCA1
and BRCA2 genes, or the patentability of DNA in which the order of
the naturally occurring nucleotides has been altered. Pp. 17–18.
689 F. 3d 1303, affirmed in part and reversed in part.
T
HOMAS
, J., delivered the opinion of the Court, in which R
OBERTS
,
C. J., and K
ENNEDY
, G
INSBURG
, B
REYER
, A
LITO
, S
OTOMAYOR
, and K
AGAN
,
JJ., joined, and in which S
CALIA
, J., joined in part. S
CALIA
, J., filed an
opinion concurring in part and concurring in the judgment.
Cite as: 569 U. S. ____ (2013)
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the
preliminary print of the United States Reports. Readers are requested to
notify the Reporter of Decisions, Supreme Court of the United States, Wash-
ington, D. C. 20543, of any typographical or other formal errors, in order
that corrections may be made before the preliminary print goes to press.
1
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]
J
USTICE
T
HOMAS
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 rea-
sons 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
2
ASSOCIATION FOR MOLECULAR PATHOLOGY
v.
MYRIAD GENETICS, INC.
Opinion of the Court
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 Pa-
thology
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 de-
scribed in 1953. Each “cross-bar” in the DNA helix con-
sists 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 infor-
mation 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 tran-
scription, 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 complemen-
tary 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 nucleo-
tides form an inverse image of the DNA strand from which

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