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 nucleotides 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.” Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides 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 patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase 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 mutations 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. 66, 132 S. Ct. 1289, 182 L. Ed. 2d 321, the Circuit found both isolated DNA and cDNA patent eligible.
[1974] 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. 589-596, 186 L. Ed. 2d, at 133-137.
(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 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 92, 132 S. Ct. 1289, 182 L. Ed. 2d 321, 339-340. 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. 589-590, 186 L. Ed. 2d, at 133-134.
(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, 100 S. Ct. 2204, 65 L. Ed. 2d 144, is central to the patent-eligibility inquiry whether such action was new “with markedly different characteristics from any found in nature,” id., at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144. Myriad did not create or alter either the genetic information 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 §101s 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 PTO 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, 122 S. Ct. 593, 151 L. Ed. 2d 508, 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. 590-594, 186 L. Ed. 2d, at 134-136.
(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. 594-595, 186 L. Ed. 2d, at 136-137.
(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. 595-596, 186 L. Ed. 2d, at 137.
689 F. 3d 1303, affirmed in part and reversed in part.
128Thomas, 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, post, p. 596.
JUSTICE Thomas delivered the opinion of the Court.
Respondent Myriad Genetics, Inc. (Myriad), discovered the precise location and 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 [1975] 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 genome consists of approximately 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 ribosomes which of the 20 possible amino acids to synthesize or provides a stop signal that ends amino acid production.
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 nucleotides, can result in the elimination, misplacement, or duplication of entire genes. Some mutations [1976] are harmless, but others can cause disease or increase the risk of disease. As a result, the study of genetics can lead to valuable 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.
whether the patient has an increased risk of cancer.
Technically, there is no “typical” gene because nucleotide sequences vary between individuals, sometimes dramatically. Geneticists refer to the most common variations of genes as “wild types.”
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. See id., at 1309, and n. 1 (noting 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.
At issue are claims 1, 2, 5, 6, and 7 of U. S. Patent 5,747,282 (the ’282 patent), claim 1 of U. S. Patent 5,693,473 (the ’473 patent), and claims 1, 6, and 7 of U. S. Patent 5,837,492 (the ’492 patent).
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 containing both exons and introns. See id., at 779 (stating that SEQ ID NO:1’s “MOLECULE TYPE:” is “cDNA”). As a result, 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 (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 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, 127 S. Ct. 764, 166 L. Ed. 2d 604 (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 remanded the case in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. 66, 132 S. Ct. 1289, 182 L. Ed. 2d 321, 330 (2012). See Association for Molecular Pathology v. Myriad Genetics, Inc., 566 U. S. 902, 132 S. Ct. 1794, 182 L. Ed. 2d 613 (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 Myriad’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 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 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 eligible. 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 product 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. Moreover, 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 568 U. S. 1045, 133 S. Ct. 694, 184 L. Ed. 2d 496 (2012).
Myriad continues to challenge Dr. Ostrer’s Declaratory Judgment Act standing in this Court. Brief for Respondents 17-22. But we find that, under the Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 S. Ct. 764; 166 L. Ed. 2d 604 (2007), Dr. Ostrer has alleged sufficient facts “under all the circumstances, [to] show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” Id., at 127, 127 S. Ct. 764; 166 L. Ed. 2d 604 (internal quotation marks omitted).
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 70, 132 S. Ct. 1289, 182 L. Ed. 2d 321, 326-327 (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 71, 132 S. Ct. 1289, 182 L. Ed. 2d 321, 327. 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 [1979] premised upon them.” Id., at 86, 132 S. Ct. 1289, 182 L. Ed. 2d 321, 336. This would be at odds with the very point of patents, which exist to promote creation. Diamond v. Chakrabarty, 447 U. S. 303, 309, 100 S. Ct. 2204, 65 L. Ed. 2d 144 (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 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 71, 132 S. Ct. 1289, 182 L. Ed. 2d 321, 327. 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, invention.” Id., at 92, 132 S. Ct. 1289, 182 L. Ed. 2d 321, 339-340. We must apply this well-established standard to determine whether Myriad’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 Myriad create or alter the genetic structure of DNA. Instead, 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 found in nature,” 447 U. S., at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the additional plasmids and resultant “capacity for degrading oil.” Id., at 305, n. 1, 100 S. Ct. 2204, 65 L. Ed. 2d 144. 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, 68 S. Ct. 440, 92 L. Ed. 588, 1948 Dec. Comm'r Pat. 671 (1948), 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 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.
Notwithstanding Myriad’s repeated use of the phrase “present invention,” it is clear from the text of the patent that the various discoveries are the “invention.”
“Starting from a region on the long arm of human chromosome 17 of the human genome, 17q, which has a size estimated at about 8 million base pairs, a region which contains a genetic locus, BRCA1, which causes susceptibility to cancer, including breast and ovarian cancer, has been identified.” Ibid.
Myriad first identified groups of relatives with a history of breast cancer (some of whom also had developed ovarian cancer); because these individuals were related, scientists knew that it was more likely that their diseases were the result of genetic predisposition rather than other factors. Myriad compared sections of their chromosomes, looking for shared genetic abnormalities not found in the general population. It was that process which eventually enabled Myriad to determine where in the genetic sequence the BRCA1 and BRCA2 genes reside. See, e.g., id., at 749, 763-775.
Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds 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, 122 S. Ct. 593, 151 L. Ed. 2d 508 (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 less isolated DNA. §634, 118 Stat. 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 [1981] 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.
Myriad also argues that we should uphold its patents so as not to disturb the reliance interests of patent holders like itself. Brief for Respondents 38-39. Concerns about reliance interests arising from PTO determinations, insofar as they are relevant, are better directed to Congress. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 88-90, 132 S. Ct. 1289, 182 L. Ed. 2d 321 (2012).
C
cDNA does not present the same obstacles to patentability as naturally 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.
Some viruses rely on an enzyme called reverse transcriptase to reproduce by copying RNA into cDNA. In rare instances, a side effect of a viral infection of a cell can be the random incorporation of fragments of the resulting cDNA, known as a pseudogene, into the genome. Such pseudogenes serve no purpose; they are not expressed in protein creation because they lack genetic sequences to direct protein expression. See J. Watson et al., Molecular Biology of the Gene 142, 144, fig. 7-5 (6th ed. 2008). Perhaps not surprisingly, given pseudogenes’ apparently random origins, petitioners “have failed to demonstrate that the pseudogene consists of the same sequence as the BRCA1 cDNA.” Association for Molecular Pathology v. United States Patent and Trademark Office, 689 F. 3d 1303, 1356, n. 5 (CA Fed. 2012). The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.
We express no opinion whether cDNA satisfies the other statutory requirements of patentability. See, e.g., 35 U. S. C. §§102, 103, and 112; Brief for United States as Amicus Curiae 19, n. 5.
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 patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents, “were well 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.
Concur by:Scalia
Concur
JUSTICE Scalia, concurring in part and concurring in the judgment.
I join the judgment of the Court, and all of its opinion except Part I-A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, [1982] having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.