http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf
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
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 invents 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 "incentives 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 patents 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 characteristics 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 important 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. Myriad’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
entitled 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 endorsement 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.
(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 unquestionably 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.
THOMAS, J., delivered the opinion of the Court, in which
ROBERTS, C. J., and KENNEDY, GINSBURG, BREYER, ALITO, SOTOMAYOR, and KAGAN,
JJ., joined, and in which SCALIA, J., joined in part. SCALIA, J., filed an
opinion concurring in part and concurring in the judgment.
