ASSOCIATION FOR MOLECULAR PATHOLOGY v. MYRIAD GENETICS
The Association for Molecular Pathology along with several other medical associations, doctors and patients sued the United States Patent and Trademark Office (USPTO) and Myriad Genetics to challenge several patents related to human genetics. The patents cover the BRCA1 and BRCA2 genes and certain mutations that indicate a high risk of developing breast cancer. The suit also challenged several method patents covering diagnostic screening for the genes. Myriad argued that once a gene is isolated, and therefore distinguishable from other genes, it could be patented. By patenting the genes, Myriad had exclusive control over diagnostic testing and further scientific research for the BRCA genes. Petitioners argued that patenting those genes violated §101 the Patent Act because they were products of nature. They also argued that the patents limit scientific progress. §101 limits patents to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”
The district court granted summary judgment in favor of petitioners, holding that isolating a gene does not alter its naturally occurring fundamental qualities. The U.S. Court of Appeals for the Federal Circuit reversed, holding that isolated genes are chemically distinct from their natural state in the human body. In March 2012, Petitioners sought certiorari; the U.S. Supreme Court vacated the Federal Circuit judgment and remanded for further consideration in light of Mayo Collective Services v. Prometheus Laboratories. On remand, the Federal Circuit again upheld the patentability of the BRCA genes.
Does §101 of the Patent Act allow patents on human genes?
Legal provision: Patent Act
Yes and no. Justice Clarence Thomas delivered the opinion for the 9-0 majority. The Supreme Court held that naturally occurring gene sequences, and their natural derivative products, are not patent eligible. Under §101 of the Patent Act, the discovery of natural products does not warrant a patent. However, the Court also held that the creation of a new product in a lab exempts that product from being a product of nature. Therefore, gene sequences refined by synthetic processes to create molecules that do not occur naturally are patent eligible.
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, Washington, D. C. 20543, of any typographical or other formal errors, in order that corrections may be made before the preliminary print goes to press.
SUPREME COURT OF THE UNITED STATES
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 genome 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 nucleotides, 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 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 12to 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 chromosome 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 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 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 remanded 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 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 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 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 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, invention.” Id., at ___ (slip op., at 23). 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 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 “capacity 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. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical 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. 7C
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. 9III
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 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.
1 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.”
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).
3 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., 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.” 549 U. S. 118, 127 (2007) (internal quotation marks omitted).
4 The full relevant text of the Detailed Description of the Patent is as follows: “It is a discovery of the present invention that the BRCA1 locus which predisposes individuals to breast cancer and ovarian cancer, is a gene encoding a BRCA1 protein, which has been found to have no significant homology with known protein or DNA sequences. . . . It is a discovery of the present invention that mutations in the BRCA1 locus in the germline are indicative of a predisposition to breast cancer and ovarian cancer. Finally, it is a discovery of the present invention that somatic mutations in the BRCA1 locus are also associated with breast cancer, ovarian cancer and other cancers, which represents an indicator of these cancers or of the prognosis of these cancers. The mutational events of the BRCA1 locus can involve deletions, insertions and point mutations.” App. 749. 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.”
5 “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.
6 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.
7 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. ___, ___ (2012) (slip op., at 22–24).
8 Some viruses rely on an enzyme called reverse transcriptase to reproduce by copying RNA into cDNA. In rare instances, a side effect ofa 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.
9 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.
SUPREME COURT OF THE UNITED STATES
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 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, 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.
ORAL ARGUMENT OF CHRISTOPHER A. HANSEN ON BEHALF OF THE PETITIONERS
Chief Justice John G. Roberts: We'll hear argument first this morning in Case 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.--
Christopher A. Hansen: Mr. Chief Justice, and may it please the Court:
One way to address the question presented by this case is what exactly did Myriad invent?
And the answer is nothing.
Myriad unlocked the secrets of two human genes.
These are genes that correlate with an increased risk of breast or ovarian cancer.
But the genes themselves, their -- where they start and stop, what they do, what they are made of, and what happens when they go wrong are all decisions that were made by nature, not by Myriad.
Now, Myriad deserves credit for having unlocked these secrets.
Myriad does not deserve a patent for it.
Justice Ruth Bader Ginsburg: Mr. Hansen, Respondents say that isolating or extracting natural products, that has long been considered patentable, and give -- examples were aspirin and whooping cough vaccine.
How is this different from -- those start with natural -- natural products.
Christopher A. Hansen: Well, in -- in essence, Your Honor, everything starts with a natural product.
And this Court has said repeatedly that just extracting a natural product is insufficient.
For example, this Court has used the example of gold.
You can't patent gold because it's a natural product.
The examples that you cite all involve further manipulation of a product of nature, so that the product of nature is no longer what it was in nature; it's become something different, and in many instances has taken on a new function.
Chief Justice John G. Roberts: Do you dispute that you can patent, however, a process for extracting naturally-occurring things?
Christopher A. Hansen: --Of course.
I think that is totally acceptable.
And what's interesting in this case is, the process that Myriad uses to extract the genes is not at issue in this case.
It's a process that's used by geneticists every day all over this country.
It is routine, conventional science.
Chief Justice John G. Roberts: So isn't that -- why isn't that a way to in effect have patent protection for the product?
Does somebody who wants to use the product, the DNA -- extracted DNA in this case have to find a new process from -- to extract it if they want to have it available?
Christopher A. Hansen: Well, the -- the process by which it's extracted is now very routine.
Chief Justice John G. Roberts: Oh, no -- yes, I know.
I'm assuming it isn't, that they discover this process and it leads to a -- a particular product.
Does anybody who wants to use the product either have to get a license for the process or find a different way of extracting it?
Christopher A. Hansen: I think they have to find a different way of extracting it, in the same way that finding a method of extracting gold does entitle you to a patent on the method of extracting gold, it may also entitle you to a patent on the use of gold.
For example, if you find a new way of using gold to make earrings, or if you find a new way of using DNA to do something, you may be entitled to a patent on that, because--
Justice Sonia Sotomayor: Can you tell me why their test wasn't given a patent?
I know the method of extraction wasn't, and why.
Why would the tests -- would the tests be subject to a patent?
Christopher A. Hansen: --The tests are also routine and conventional science, but in this particular case, there were some method claims that we challenged.
The method claims in this case involved taking the genes that you extracted from the woman and the gene that you -- the way you think it should be, and simply looking back and forth to see if they're the same or different.
And the Federal Circuit that -- found that that was an abstract idea, and not patentable.
And, in fact, that's--
Justice Antonin Scalia: Well, I'm curious as to why the methodology of extracting the gene has not been patented.
You say everybody -- everybody uses it.
Why wasn't that patented?
Christopher A. Hansen: --The original -- the original methodology was patented, and is -- is patentable.
In fact, if they came up with a new process, it would be patentable.
But it has -- but that -- it has been very freely licensed.
In fact, the patent may now have expired.
And so it's used all over the country every day.
Justice Samuel Alito: Can I take you back to -- to Justice Ginsburg's question, because I'm -- I don't -- I'm not sure you got at what troubles me about that.
Suppose there is a substance, a -- a chemical, a molecule in the -- the leaf -- the leaves of a plant that grows in the Amazon, and it's discovered that this has tremendous medicinal purposes.
Let's say it -- it treats breast cancer.
A new discovery, a new way -- a way is found, previously unknown, to extract that.
You make a drug out of that.
Your answer is that cannot be patent -- patented; it's not eligible for patenting, because the chemical composition of the -- of the drug is the same as the chemical that exists in the leaves of the plant.
Christopher A. Hansen: If there is no alteration, if we simply pick the leaf off of the tree and swallow it and it has some additional value, then I think it is not patentable.
You might be able to get a method patent on it, you might be able to get a use patent on it, but you can't get a composition patent.
Justice Samuel Alito: But you're making -- you keep making the hypotheticals easier than they're intended to be.
It's not just the case of taking the leaf off the tree and chewing it.
Let's say if you do that, you'd have to eat a whole forest to get the -- the value of this.
But it's extracted and -- and reduced to a concentrated form.
That's not patent -- that's not eligible?
Christopher A. Hansen: --No, that may well be eligible, because you have now taken what was in nature and you've transformed it in two ways.
First of all, you've made it substantially more concentrated than it was in nature; and second, you've given it a function.
If it doesn't work in the diluted form but does work in a concentrated form, you've given it a new function.
And the -- by both changing its nature and by giving it a new function, you may well have patent--
Justice Samuel Alito: Well, when you concede that, then I'm not sure how you distinguish the isolated DNA here, because it has a different function.
Will you dispute that?
Isolated DNA has a very different function from the DNA as it exists in nature.
And although the chemical composition may not be different, it -- it certainly is in a different form.
So what is the distinction?
Christopher A. Hansen: --Well, I don't think it has a new function, Your Honor, with respect.
I believe that what -- Myriad has proffered essentially three functions for the DNA outside the body as opposed to inside the body.
The first is we can look at it.
And that's true, but that's not really a new function.
That's simply the nature of when you extract something you can look at it better.
The second two rationales that Myriad has proffered are that it can be used as probes and primers.
Three of the -- three of lower court judges found that full-length DNA, which all of these patent claims include, cannot be used as probes and primers.
But more important, finding a new use for a product of nature, if you don't change the product of nature, is not patentable.
If I find a new way of taking gold and making earrings out of it, that doesn't entitle me to a patent on gold.
If I find a new way of using lead, it doesn't entitle me to a new -- to a patent on lead.
Justice Anthony Kennedy: From what you know and from what the record shows, would the process of tagging the isolated DNA be patentable?
The process of tagging, we just don't know about that or is there a patent on that?
Christopher A. Hansen: The very patents in this case include claims on -- on DNA that is tagged so that it can be used as a probe.
We have not challenged that.
We are not asking the Court to strike down that.
Justice Anthony Kennedy: Under our -- our law, is a patent ever divisible so that if it's valid in part but invalid in another part, it can still stand as to the part?
Christopher A. Hansen: No, it is not permissible under patent law to do essentially a narrowing -- narrowing construction of the -- of the claim.
Justice Anthony Kennedy: But if you haven't challenged this, then -- then where are we with respect to the tagging?
I don't quite understand.
Because the -- the entire patent which includes tagging would fail under your argument.
Christopher A. Hansen: Oh, I'm sorry, no.
The claims that we are challenging do not -- are not limited to tagging, are not limited to use as probes.
There are other claims that we are not challenging that are limited to probes.
Those would remain, but the -- but the claims that we're challenging would in fact be struck down, because they're not so limited.
Justice Sonia Sotomayor: Then -- then explain when you said you can't narrow.
You said earlier you can't narrow.
Christopher A. Hansen: --Yes.
If a claim reaches something that is both impermissible and permissible, it -- the claim is invalid, period.
Justice Sonia Sotomayor: All right, that individual claim is invalid.
Christopher A. Hansen: That individual claim.
Justice Sonia Sotomayor: But the patent with respect to claims that are not invalid would still stand.
Christopher A. Hansen: That is correct, Your Honor.
Justice Sonia Sotomayor: The primers and probes stand.
Christopher A. Hansen: Would -- would still remain.
Even if you were to rule for Petitioners, you would not have to rule concerning the use of DNA as a probe or a primer.
Justice Elena Kagan: Mr. Hansen, could you tell me what you think the incentives are for a company to do what Myriad did?
If you assume that it takes a lot of work and takes a lot of investment to identify this gene, but the gene is not changed in composition, and what you just said is that discovering uses for that gene would not be patentable even if those new -- even if those uses are new, what does Myriad get out of this deal?
Why shouldn't we worry that Myriad or companies like it will just say, well, you know, we're not going to do this work anymore?
Christopher A. Hansen: Well, we know that would not have happened in this particular case, Your Honor.
We know that there were other labs looking for the BRCA genes and they had announced that they would not patent them if they were the first to find it.
We also know that prior to the patent actually being issued, there were other labs doing BRCA testing and Myriad shut all that testing down.
So we know in this particular case that problem would not have arisen.
But the point of the whole -- the whole point of the product of nature doctrine is that when you lock up a product of nature, it prevents industry from innovating and -- and making new discoveries.
That's the reason we have the product of nature doctrine, is because there may be a million things you can do with the BRCA gene, but nobody but Myriad is allowed to look at it and that is impeding science rather than advancing it.
Justice Antonin Scalia: But you still haven't answered her question.
Why would a company incur massive investment if it -- if it cannot patent?
Christopher A. Hansen: Well, taxpayers paid for much of the investment in Myriad's work, but--
Justice Antonin Scalia: You're still not answering the question.
Christopher A. Hansen: --But -- yeah.
But I think scientists look for things for a whole variety of reasons, sometimes because they're curious about the world as a whole; sometimes because--
Justice Antonin Scalia: Curiosity is your answer.
Justice Elena Kagan: I thought you were going to--
Christopher A. Hansen: --Sometimes, because they want a Nobel Prize.
Justice Elena Kagan: --I thought you were going to say something else, Mr. Hansen, and I guess I -- I hoped you were going to say something else, which is that, notwithstanding that you can't get a patent on this gene, that -- that there are still, you know, various things that you could get a patent on that would make this kind of investment worthwhile in the usual case.
But if that's the case, I want to know what those things are rather than you're just saying, you know, we're supposed to leave it to scientists who want Nobel Prizes.
And I agree that there are those scientists, but there are also, you know, companies that do investments in these kinds of things that you hope won't just shut them down.
Christopher A. Hansen: --Let me give a specific example that may be helpful in doing a better job of answering the question.
One of the -- one of the amici has worried a lot about whether a decision for the Petitioners in this case would invalidate recombinant DNA.
Recombinant DNA is in fact what all the major innovations in the industry are doing these days.
It's DNA where the scientist decides the sequence rather than nature deciding the sequence.
There is nothing in our position that would prevent recombinant DNA from being patented, but there is -- it is the cases that if the patents are upheld, recombinant DNA is frustrated.
People can't use pieces of the BRCA gene to recombine them and find new treatments and find new diagnoses and find new things that will advance medicine and science as a result of these patents.
It's a perfect example of what the point of the product of nature doctrine is.
Justice Antonin Scalia: Yes.
But, of course, to profit from -- from that recombinant DNA, you have to not just isolate the gene, but then you have to do something with it afterwards.
So you really haven't given us a reason why somebody would try to isolate the gene.
Christopher A. Hansen: Well--
Justice Antonin Scalia: I mean, sure, yes, I can do stuff with it afterwards, but so can everybody else.
What advantage do I get from being the person that or the company that isolated that -- that gene.
You say none at all.
Christopher A. Hansen: --No, I think you get enormous recognition, but I don't think--
Justice Antonin Scalia: Well, that's lovely.
Christopher A. Hansen: --But I think that we know that that's sufficient.
We know it's sufficient with respect to these two genes.
We also know it's sufficient with respect to the human genome.
Justice Anthony Kennedy: Well, I'm not sure the Court can decide the case on -- on that basis.
I'm sure that there are substantial arguments in the amicus brief that this investment is necessary and that -- and that makes sense.
To say, oh, well, the taxpayers will do it, don't worry, is I think an insufficient answer.
As Justice Kagan's follow-up questions indicated, I thought you might say, well, there are process patents that they can have, that this is sufficient.
Christopher A. Hansen: And that's certainly true.
Justice Anthony Kennedy: But I -- I just don't think we can decide the case on the ground, oh, don't worry about investment, it'll come.
I -- I just don't think we can do that.
It may be that the law allows you to prevail on the fact that this is -- occurs in nature and there's nothing new here, but that's quite different.
Christopher A. Hansen: And it is certainly true, as Your Honor suggests, that one of the incentives here is a process patent or a development patent.
If you -- if you've isolated the gene and you find a new use for it, you could get a patent on the new use for the patent.
Justice Sonia Sotomayor: That's the whole point, isn't it?
The isolation itself is not valuable; it's the use you put the isolation to.
That's the answer, isn't it?
Christopher A. Hansen: That's exactly correct.
Yes, that is the answer.
Justice Sonia Sotomayor: And so, that is the answer, which is in isolation it has no value.
It's just nature sitting there.
Christopher A. Hansen: Interestingly, it has one value.
And that is you can look at it to see if there's a mutation in it.
And when you find a mutation in the isolated gene, you write back to the woman who provided the sample and you say to her: Because the isolated gene is the same as the gene in your body, I can tell you that there's a mutation in your body.
Justice Sonia Sotomayor: That's a failure of the patent law.
It doesn't patent ideas.
Christopher A. Hansen: And it shouldn't patent ideas, and -- but it also makes the point that isolated gene and the gene in the body are the same.
Justice Sonia Sotomayor: Can we go to -- can we go to cDNA a moment?
Christopher A. Hansen: Sure.
Justice Sonia Sotomayor: That is artificially created in the laboratory, so it's not bound in nature.
It's not taking a gene and snipping something that's in nature.
And yet you claim that can't be patented.
The introns are taken out, the exons are left in, and they're sequenced together.
Give me your brief argument on that.
I read your brief, but it is not a product of nature; it's a product of human invention.
Christopher A. Hansen: There are two big differences between cDNA and DNA.
The first is exactly the one Your Honor just discussed, which is that the introns, the noncoding regions, have been removed.
That is done in the body, by the body.
That's done in the process of DNA going to mRNA.
What the scientist does who's creating the cDNA is they take the mRNA out of the body and then they simply have the natural nature-driven nucleotide binding processes complement the mRNA.
So that if the mRNA has a C, the scientist just puts the corresponding nucleotide in there and nature causes them to bind up.
The scientist does not decide--
Justice Stephen G. Breyer: I know, but I don't see the answer, because I gather, if I -- if I've read it correctly, that when you have an R -- the messenger RNA does not have the same base pairs.
There's a U or something instead of an A or whatever it is.
Christopher A. Hansen: --Yes.
Justice Stephen G. Breyer: So when you actually look, if you could get a super-microscope and look at what they have with the cDNA, with their cDNA, you would discover something with an A, not a U.
Is it AU?
Is that the one?
Christopher A. Hansen: Yes.
Justice Stephen G. Breyer: Okay.
So -- so you would discover something with an A there, you see, and you wouldn't discover something with a U there.
And there is no such thing in nature as the no-introns AGG, whatever, okay?
It's not there.
That's not truly isolated DNA.
But you can go look up the Amazon, wherever you want.
Hence the question.
Now, on that one, how?
How is that found in nature?
The answer is it isn't.
Christopher A. Hansen: Well, but I would suggest, Your Honor, that the question is not whether it is identical to something in nature.
The question is whether there was a human invention involved, whether it is markedly different from what is found in nature.
Justice Sonia Sotomayor: But that goes to obviousness.
That does not in my mind go to the issue of whether it's patent eligible.
You may have a very strong argument on obviousness, but why does it not -- it's creating something that's not found in nature at all.
Christopher A. Hansen: The sequence of the nucleotides is dictated by nature.
The order that they go in is dictated by nature.
Justice Sonia Sotomayor: Well, that's a separate question--
Christopher A. Hansen: It is true--
Justice Sonia Sotomayor: --about whether this claim is too expansive because it's claiming every 15 nucleotides and nature produces 15 randomly.
But assuming the claim was for the entire mutated gene and not the small snippet that they want to capture the whole gene with, that's -- that whole gene without the introns is just not found in nature.
Christopher A. Hansen: --It is not -- the -- the exons with the exact same composition and in the exact same order are found in nature, and the question is whether when the body removes the introns, has the body made something markedly different than what is in nature, and it is our view--
Justice Anthony Kennedy: When I first looked at this case, I -- I thought that maybe the cDNA was kind of an economy class gene, was -- it wasn't.
But my understanding is that it may have a functionality that the -- the DNA isolate does not, easier to tag, et cetera.
That may be incorrect for the record, but that was my present understanding.
Christopher A. Hansen: --It is somewhat easier to work with cDNA to make recombinant DNA, and it's recombinant DNA that is the place where all of the innovation and all the efforts are taking place.
And if we lock--
Justice Anthony Kennedy: Is all the tagging done on recombinant DNA?
Christopher A. Hansen: --All of the change -- all of the useful things that we are inventing is done -- is done through the process of recombinant DNA.
And if we lock up the cDNA, it makes it harder to do the recombinant DNA.
So that if someone owns all the cDNA, I can't do recombinant DNA using what the company owns.
Justice Ruth Bader Ginsburg: Mr. Hansen, you answered my initial question by saying they start -- everything starts with a national -- natural product, but these others, the examples that I gave, you said they involve manipulation.
The -- the cDNA can't be characterized as involving manipulation?
Christopher A. Hansen: It certainly -- there's -- there is some manipulation, although it's -- it's letting nature manipulate, not doing -- not the scientist manipulating.
But it -- what the other factor that distinguishes aspirin and the other examples you use from cDNA is that they have -- the alteration of the substance has also altered the function, and cDNA has exactly the same function as DNA with the exception of Justice Kennedy's, that it's easier to use with.
Justice Antonin Scalia: Do you -- you've really lost me when you say that it's nature that does the alteration rather than the scientist.
I mean, whenever a scientist does an alteration, he does it, you know, by some force of nature.
Christopher A. Hansen: No--
Justice Antonin Scalia: I mean, he doesn't do it unnaturally, does he?
I mean, there's some--
Christopher A. Hansen: --Well, let me try an analogy, Your Honor, that might be helpful.
In our view, it's like Funk Brothers in the sense that the five bacteria in Funk Brothers didn't sit together in nature.
The scientists took them and put them together in nature.
Here the scientist takes the exons and lets the natural processes of the body put them together in -- in the laboratory.
It's exactly the same as Funk Brothers.
If I could reserve the remainder of my time, Your Honor.
Justice Stephen G. Breyer: Can I ask a question, which I don't think will be taken from your time.
Christopher A. Hansen: Sure, of course.
Justice Stephen G. Breyer: But I have to ask you this.
Look, you say don't reach the cDNA issue and the reason is because of the nature of the claim.
Okay, I look at their claim.
Their claim says they want
"the isolated DNA of claim 1 wherein said DNA has the nucleotide sequence set forth in SEQ ID No. 1. "
Then we turn to that and the first thing it says right there is it says, “ The molecule involved is ” -- “ Molecule type: cDNA ”.
And then it has a long list and that long list is a list of the basis, okay.
So molecule type, cDNA.
So they say what do you mean they aren't claiming cDNA?
That's what they say they're claiming.
Christopher A. Hansen: No--
Justice Stephen G. Breyer: Because of the word “ wherein ”.
So I go back to the “ wherein ” in Prometheus and the “ wherein ” -- you read “ wherein ” as in context, and in this context you mean to say that a person who makes isolated DNA that has lots of introns in it as well as the sequence is going to be an infringer under claim 2?
Christopher A. Hansen: --Yes, Your Honor.
Justice Stephen G. Breyer: Is there any support for that other than the treatise that you cited?
Christopher A. Hansen: There--
Justice Stephen G. Breyer: I mean, I looked at that and it said read the “ wherein ” depending on context.
Christopher A. Hansen: --Well, that certainly--
Justice Stephen G. Breyer: And then depending on -- okay.
Then you got -- you heard what I said, so I want to know is there anything else I should read?
Christopher A. Hansen: --Yes.
The other support for it is the definition of the DNA in the patent itself, which we cite, which says that whenever we use the term “ DNA ” we mean both.
Justice Stephen G. Breyer: Yes, I saw that.
I saw that.
Chief Justice John G. Roberts: Thank you, counsel.
Christopher A. Hansen: Thank you, Your Honor.
Chief Justice John G. Roberts: General Verrilli?
ORAL ARGUMENT OF DONALD B. VERRILLI, JR., FOR THE UNITED STATES, AS AMICUS CURIAE, SUPPORTING NEITHER PARTY
Donald B. Verrilli Jr: Mr. Chief Justice, and may it please the Court:
Enforcing the distinction between human invention and a product of nature preserves a necessary balance in the patent system between encouraging individual inventors and keeping the basic building blocks of innovation free for all to use.
Isolated DNA falls on the ineligible side of that divide because it is simply native DNA extracted from the body.
The claim that it is a--
Justice Sonia Sotomayor: Are we fighting over nothing?
Are you fighting over nothing?
If -- if they can patent this cDNA in the way they have, what does it matter, since it appears as if research has to rely on the cDNA to be effective?
Donald B. Verrilli Jr: --I actually think that -- I think we're -- we're fighting about something of importance.
That question gets right to it.
I want to answer the question directly, Your Honor.
I'd like to make a prefatory point before doing so.
The claim that isolated DNA is a human invention rests entirely on the fact that it is no longer connected at the molecular level to what surrounded it in the body.
But allowing a patent on that basis would effectively preempt anyone else from using the gene itself for any medical or scientific purpose.
That is not true about a patent on cDNA.
A patent on cDNA leaves the isolated DNA available for other scientists and other -- and others in the medical profession to try to generate new uses.
Justice Elena Kagan: Mr. Hansen -- Mr. Hansen just said that to do recombinant technology, you have to use the cDNA rather than the native D -- the isolated DNA.
Do you disagree with that?
Donald B. Verrilli Jr: That's not my understanding, Justice Kagan.
My understanding is that you -- that the native DNA can be used for recombinant DNA without the step of cDNA.
We do think cDNA is important and the position of the United States is that cDNA is patent eligible.
Justice Anthony Kennedy: Well, suppose his understanding is correct.
Suppose your misunderstanding -- suppose your understanding is not correct.
Donald B. Verrilli Jr: --Our position, though, is that cDNA is patent eligible because we think, unlike the isolated DNA which is just taken from your body, cDNA is an artificial creation in the laboratory that doesn't correspond to anything in your body.
Justice Ruth Bader Ginsburg: But Mister -- General Verrilli, I got the distinct impression from your brief that your view was that, although the cDNA may be patentable, it might very well be rejected as obvious.
Donald B. Verrilli Jr: That's true now, Justice Ginsburg, but obviousness is determined at the time that the patent is issued, so what may be true now might not have been true at the time the patents were initially issued.
Justice Sonia Sotomayor: I understand--
Chief Justice John G. Roberts: But I -- I thought the basic general approach here was we have a very expansive view of what is patent eligible and then we narrow things through things -- issues like obviousness and so on.
Why -- wouldn't it make more sense to address the questions at issue here in the obviousness realm?
Donald B. Verrilli Jr: --That's a little--
Chief Justice John G. Roberts: If you got something that's big, it seems to me pretty obvious that you could take a smaller part of it; that the idea -- a smaller part of something that's bigger is obvious.
Now, yes, you can have a patent on the process of extracting that small part, but I don't understand how a small part of something bigger isn't obvious.
And if it is, I don't understand why this -- these issues aren't addressed at that stage.
Donald B. Verrilli Jr: --Well, I think my answer to that, I guess, Your Honor, would -- would point first to Mayo, in which the Court recognized that the threshold test under Section 101 for patent eligibility does do work that the obviousness test and a novelty test and a specification test do not do; and the work that it does here, I would respectfully submit, is to ensure that the natural substance, the product of nature itself, is not subjected effectively to a monopoly, because if it can be deemed to be a human invention solely as a result of the change that occurs when you extract it from the body, then that means, as a -- as a practical matter that you have granted a patent on the gene itself because no one else can extract it because extracting it is isolating it; isolating it violates the patent.
And so as a result of that, no one else can try to develop competing tests for breast cancer, no one else can try to use this gene for recombinant DNA.
Chief Justice John G. Roberts: I'm -- I'm not sure that's responsive to my concern.
Your answer said well, here are a lot of reasons why this shouldn't have patent protection.
My question goes to whether we ought to focus on those reasons at the eligibility stage or at the obviousness stage.
Donald B. Verrilli Jr: Well, the Court identified in Chakrabarty and then reiterated in Mayo that -- that it is -- that the right answer to that question, Your Honor, is to focus on them at the eligibility stage, because the -- because getting the balance right is of critical importance.
Justice Samuel Alito: Well, the issue here is a very difficult one.
It's one on which the Government has changed its position; isn't that correct?
Donald B. Verrilli Jr: Yes, Your Honor.
Justice Samuel Alito: It seems that there is disagreement within the Executive Branch about it.
This case has been structured in an effort to get us to decide this on the broadest possible ground, that there's no argument, that it's just about 101, it's not about any other provision of the Patent Act.
Why -- why should we -- why should we do that?
We have claims that if patent eligibility is denied here it will prevent investments that are necessary for the development of new drugs or it will lead those who develop the new drugs, new diagnostic techniques, to keep those secret, not disclose them to the public.
Why -- why should we jump in and -- and decide the broadest possible question?
Donald B. Verrilli Jr: Well, I would -- again, I would point the Court to what the Court said last term in Mayo, which is that the determination of patent eligibility really is a double-edged sword.
And it may be that in a -- in a particular case, maybe this case, although we are not expressing a view on it, you could sort the issue out on some of the other criteria, but that won't generally be true, and the proposition of whether you can patent the gene itself is a question we think of fundamental importance, and it raises exactly the two-edged sword concern that led the Court to conclude what it did in Mayo.
And Mayo was a situation very much -- I'm sorry.
Justice Ruth Bader Ginsburg: General Verrilli, there's an assertion made in Respondents' brief that the United States would be in a singular position.
That is, they suggest that in every other industrialized nation this could be subject -- could be patentable.
Donald B. Verrilli Jr: Yes, and that--
Justice Ruth Bader Ginsburg: Is that so?
Donald B. Verrilli Jr: --No.
I think the picture is much more complicated than that.
In many other nations it wouldn't be patentable and the patent law is different from nation to nation.
I'll give one example I think helps illustrate the point.
In Germany and France, for example, you can get a patent on isolated genomic DNA but only for a particular use.
So you would get what is the equivalent of a use patent, which is a patent that we would think under our patent laws is acceptable, too.
If you -- just as with the question that Justice Alito asked earlier about identifying a -- a useful substance in a plant in the Amazon, if you isolate that and it proves to have therapeutic effects, you can get a patent on that use of it, but what you can't do is get a patent on the substance itself so that no one else can explore it for different uses and for -- and for different therapeutic purposes or to try to recombine it and turn it into a -- an even more therapeutic -- therapeutically valuable substance.
Justice Sonia Sotomayor: --I understand why you are saying cDNA is patentable as a subject matter.
I am looking at the way the claim is phrased, however, and it says that it's patenting a DNA segment 15 nucleotides long or longer.
The reality is that 15 nucleotides doesn't necessarily bridge a sequence that goes between exons.
It -- it can -- one exon can be 15 or more sequences long.
So are you arguing that this claim as written is sustainable?
Donald B. Verrilli Jr: --Your Honor, as a -- I am going to invoke my privilege as an amicus in this situation.
I think that's a fight between the parties.
The point that we wanted to make is that as a conceptual matter cDNA is patent eligible.
Justice Sonia Sotomayor: So you are not taking the position that this claim as written is patentable?
Donald B. Verrilli Jr: That's right, Your Honor.
We're just saying as a conceptual matter that we think cDNA is a creation of the lab, it's an artificial creation; it's as a general matter patent eligible.
Justice Sonia Sotomayor: Because as I understand it, 15 nucleotides long exists naturally in nature.
They get reproduced in that sequence of 15.
Donald B. Verrilli Jr: That -- that may well be right, Your Honor.
As I said, we're not taking a position on the particulars.
But if I -- just to return to the point that Justice Alito made, the Court really was faced with a similar situation in Mayo.
On the one side you had the -- the industry coming in and saying: Look, we have got a lot of reliance issue, PTO has issued more than 150,000 patents here.
You are going to really disrupt those reliance issues.
On the other side you had the American Medical Association, as you have here, coming in and saying: Actually, these patents inhibit much more innovation than they incent.
And what the Court said is that -- as Justice Kennedy alluded to earlier, that the Court's not in a position to resolve that dispute conclusively.
It doesn't have the institutional wherewithal to do it.
But what the Court is in a position to do is to apply the general principles of law as they were articulated in Mayo, and then if there needs to be a particular different set of rules for the biotech industry, Congress can provide that different set of rules.
Justice Elena Kagan: General Verrilli, could I understand what you said, because I think it might be a little bit different from Mr. Hansen and I just want to understand your position.
You said that a company can't get a -- a patent on the thing, but can get it on the uses.
So, if I find this plant, let's say, in the Amazon and I can't get a patent on the thing itself, but can I get a patent when I discover that if you eat this plant it has therapeutic effects?
Donald B. Verrilli Jr: May I answer briefly, Mr. Chief Justice?
Chief Justice John G. Roberts: Briefly, please.
Donald B. Verrilli Jr: Yes, you certainly can, and that illustrates the difference.
That patent is just for the use; it doesn't tie up all other potential uses of the substance and that's the key.
Chief Justice John G. Roberts: Thank you, General.
ORAL ARGUMENT OF GREGORY A. CASTANIAS ON BEHALF OF THE RESPONDENTS
Gregory A. Castanias: Mr. Chief Justice, and may it please the Court:
It is now 33 years after Chakrabarty, 31 years after the first isolated gene molecule patents issued, and 12 years after the Patent and Trademark Office issued its carefully reasoned Utility Guidelines confirming that new isolated gene molecules are eligible for patents, and it's almost 16 years after Myriad's patents began to issue, Patents which -- yes.
Justice Sonia Sotomayor: Is that on the basis of a new extraction process?
Gregory A. Castanias: On a -- a new extraction process, no.
Most of the processes are known.
But that's not relevant to patent eligibility or, for that matter, patentability.
As the last sentence, Justice Sotomayor, of Section 103A says,
"Patentability shall not be negated by the manner in which the invention was created. "
Justice Sonia Sotomayor: I -- I have a sort of analytical problem.
I find it very, very difficult to conceive how you can patent a sequential numbering system by nature, in the same way that I have a problem in thinking that someone could get a patent on the computer binary code merely because they throw a certain number of things on a piece of paper in a certain order.
I always thought that to have a patent you had to take something and add to what nature does.
So how do you add to nature when all you are doing is copying its sequence?
Gregory A. Castanias: Well, I guess I'll--
Justice Sonia Sotomayor: How do you add to it besides process or use?
Gregory A. Castanias: --Sure.
Well, Justice Sotomayor, I guess I'll take issue with the notion that there is nothing additive here.
What Myriad inventors created in this circumstance was a new molecule that had never before been known to the world.
Now remember, genes are themselves human constructs.
And this points up some of the serious analytical problems with the Product of Nature Doctrine as the line-drawing exercise that you've asked General Verrilli and Mr. Hansen to engage in has illustrated.
Now, the line-drawing is what is the product of nature to start with?
Is it me?
Is it the genome?
Is it the chromosome?
Is it the -- and the gene ultimately--
Justice Sonia Sotomayor: Look, I can bake--
Gregory A. Castanias: --is what was defined.
Justice Sonia Sotomayor: --I can bake a chocolate chip cookie using natural ingredients -- salt, flour, eggs, butter -- and I create my chocolate chip cookie.
And if I combust those in some new way, I can get a patent on that.
But I can't imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I've created a new use or a new product from those ingredients.
Gregory A. Castanias: And that's--
Justice Sonia Sotomayor: Explain to me--
Gregory A. Castanias: --Sure.
Justice Sonia Sotomayor: --why gene sequences, whether in the actual numbers, why gene sequences are not those basic products that you can't patent.
Gregory A. Castanias: Okay.
I'll start by -- by showing you how this is actually a different structure.
It actually has an entirely different chemical name when you give it the C--
Justice Sonia Sotomayor: That's the cDNA.
Gregory A. Castanias: --No, no, no.
That's absolutely true with regard to the isolated molecule as well.
Because if you were to write it out in those -- those interminable chemical equations that we had to do in high school, it's a “ C ” very different, “ H ” very different.
Justice Sonia Sotomayor: So I put salt and flour, and that's different?
Gregory A. Castanias: Well, that is -- that is the combination, yes, of two different things, and that's sort of like -- that's sort of like--
Justice Sonia Sotomayor: So if I take them apart, now you can get a patent on the salt and now you can get a patent on the flour?
Gregory A. Castanias: --Well, they were apart before, but they were both old.
But that's the problem with using the really simplistic analogies, with all due respect, Your Honor, about you know, like coal--
Justice Sonia Sotomayor: Well, I guess--
Gregory A. Castanias: --like leaves and that sort of thing.
Justice Samuel Alito: Why is the chemical composition in the isolated DNA different?
You were about to explain that.
Gregory A. Castanias: Yes, thank you, Justice Alito.
It -- it's got 5,914 nucleotides.
The genome itself has over 3 billion.
It's arranged in the way set forth -- as set forth in the SEQ IDs number 1 and 2.
Number 2 is the so-called genomic DNA, SEQ ID number 1 is the, as Justice Breyer understood, the cDNA molecule.
When you look at those particular sequences, there was invention in the decision of where to begin the gene and where to end the gene.
That was not given by nature.
Justice Antonin Scalia: Well, well, well, well, this is something I was going to ask you.
I -- I assume that it's true that -- that those abridged genes, whatever you want to call them, do exist in the body.
That they do exist.
You -- you haven't created a type of gene that does -- does not exist in the body naturally.
Gregory A. Castanias: --But we've -- I'll -- I'll use my own simplistic analogy which we offered in our brief and which we offered to the lower court.
A baseball bat doesn't exist until it's isolated from a tree.
But that's still the product of human invention to decide where to begin the bat and where to end the bat.
Justice Stephen G. Breyer: Well, that's true, but then you were saying something that I just didn't understand, because I thought the -- the scientists who had filed briefs here, as I read it, said it's quite true that the chromosome has the BRCA gene in the middle of it and it's attached to two ends.
But also in the body, perhaps because cells die, there is isolated DNA.
And that means that the DNA strand, the chromosome strand is cut when a cell dies, and then isolated bits get around, and there may be very few of them in the world, but there are some, by the laws of probability, that will in fact match precisely the BRCA1 gene.
Now, have I misread what the scientists told us, or are you saying that the scientists are wrong?
Gregory A. Castanias: Well, I will tell you that--
Justice Stephen G. Breyer: I probably misread it.
There's a better chance that I've misread it.
Gregory A. Castanias: --Well, no, I think -- I think you may have read some of the submissions correctly, Justice Breyer.
I think that's a question--
Justice Stephen G. Breyer: Well, which one have I not read--
Gregory A. Castanias: --I think that's a question of some dispute in this record.
Justice Stephen G. Breyer: --So, in other words, you're saying that the Lander brief is wrong.
Gregory A. Castanias: Well, what I will tell you--
Justice Stephen G. Breyer: I want to know, because I have to admit that I read it and I did assume that as a matter of science it was correct.
So I would like to know whether you agree, as a matter of science, that it is correct, not of law, but of science, or if you are disagreeing with it, as a matter of science.
Gregory A. Castanias: --What I will tell you is that what are called pseudogenes--
Justice Stephen G. Breyer: I'd like a yes or no answer.
Gregory A. Castanias: --Yes.
So the answer -- I would say the answer is no, because there is no evidence--
Justice Stephen G. Breyer: Was the answer no, you do not disagree with it?
I wonder, I disagree or I do disagree?
Gregory A. Castanias: --I do disagree with it with the following--
Justice Stephen G. Breyer: As a matter of science.
Gregory A. Castanias: --As a matter of science with the following -- okay.
Justice Stephen G. Breyer: Okay.
If you are saying it is wrong, as a matter of science, since neither of us are scientists, I would like you to tell me what I should read that will, from a scientist, tell me that it's wrong.
Gregory A. Castanias: You want me to tell you something from a scientist that you should read that tells you that it is wrong?
Justice Stephen G. Breyer: No, I need to know--
Gregory A. Castanias: I think you could look at the declaration in the -- the Joint Appendix for Dr. Kay, for example.
Dr. Kay's declaration appears at -- starting at page 370.
You'll find an extensive discussion in there of the technology here and -- and of the genetics.
But, Justice Breyer, just to explain the finishing thought, what -- what Dr. Lander says in his brief is that these pseudogenes, which are un -- undifferentiated fragments, exist in the body.
What hasn't been brought to the -- to the forefront is something that is new and useful and available to the public for -- for allowing women to determine whether they have breast or ovarian--
Chief Justice John G. Roberts: Can I--
Gregory A. Castanias: --mutations that are likely to result in cancer.
Yes, Mr. Chief Justice?
Chief Justice John G. Roberts: --Can I get back to your baseball bat example?
Gregory A. Castanias: Sure.
Chief Justice John G. Roberts: My understanding -- my understanding is that here, what's involved, obviously through scientific processes, but we're not talking about process.
Here, what's involved is snipping.
You've got the thing there and you snip -- snip off the top and you snip off the bottom and there you've got it.
The baseball bat is quite different.
You don't look at a tree and say, well, I've cut the branch here and cut it here and all of a sudden I've got a baseball bat.
You have to invent it, if you will.
You don't have to invent the particular segment of the -- of the strand; you just have to cut it off.
Gregory A. Castanias: Well, I -- I guess I'll even take issue with that, because the -- the story of how the SEQ ID number 2, the genomic DNA segment came about is exactly the opposite of that.
If you look, for example, at page 488 of the Joint Appendix, that's the declaration of one of the inventors, Donna Shaddick, at paragraph 27, what -- what she explains is that the Myriad inventors first created the cDNA, which we agree at least on that score with the Solicitor General, is indeed eligible for patenting.
But then -- and by the way, that cDNA was created from hundreds of different patient samples to create what was called a consensus sequence.
Chief Justice John G. Roberts: Okay.
You've got the cDNA.
Gregory A. Castanias: And then what the -- what the Myriad inventors then did to create what is called SEQ ID number 2 and what is claimed in claim 1 of the '282 patent is to take -- actually manipulate that further to add in the introns.
It was in -- actually, the inventive process was additive.
Now, ultimately, again, going back to the last sentence of section 103, the patentability should not be negative -- or negated by the manner in which an invention was made, maybe that shouldn't matter.
But it is a--
Chief Justice John G. Roberts: I still don't understand what -- in what sense it's different than just snipping along -- along the line.
Gregory A. Castanias: --Well, first of all, you wouldn't even know where to snip until the Myriad invention.
That's the first problem.
Chief Justice John G. Roberts: Okay.
So that's a particular -- where you snip.
We're talking about though the patentability of what's left--
Gregory A. Castanias: Right.
Chief Justice John G. Roberts: --after you've snipped it.
Gregory A. Castanias: And -- and that is indeed a product of human ingenuity and that has substantial new uses.
Now, my friends on the other side have said--
Justice Elena Kagan: Mr. Castanias, go back to Justice Alito's plant in the Amazon, right, because it takes a lot of ingenuity and a lot of effort to actually find that plant, just as it takes a lot of effort and a lot of ingenuity to figure out where to snip on -- on the genetic material.
But are you -- are you saying that you could patent that plant because it takes a lot of effort and a lot of ingenuity to find it?
Gregory A. Castanias: --The plant itself, I think not, Justice Kagan, but I think the question that was -- that was posed was whether I could take an extract from that plant.
Justice Elena Kagan: Well, but can you patent the thing itself?
Gregory A. Castanias: The thing itself I would -- in that hypothetical, I would say the answer is no.
Justice Elena Kagan: Even though you know you have to extract the plant itself--
Gregory A. Castanias: It's a lot of--
Justice Elena Kagan: --from the Amazon forest.
Gregory A. Castanias: --Ah, but you see, now you're adding the manipulation--
Justice Elena Kagan: I'm not -- I mean, I don't know what manipulation means.
I mean, you have to take the plant and uproot it, all right?
Gregory A. Castanias: --Okay.
Justice Elena Kagan: And carry it away and isolate it.
Can you now patent the thing itself?
You've now taken it out of the Amazon forest.
Can you now patent it?
Gregory A. Castanias: Well, what I -- what I haven't done is isolated a new thing.
All I have done is isolate the plant from the forest.
And that's the distinction I think I'm trying to get across to the Court, not particularly well at least in my colloquy with Justice Breyer, but I'll try again.
And that is that what -- what was, quote, merely snipped out of the body here is fundamentally different in kind from what was in -- what is in the body.
The most important reason it's different in kind is that it cannot be used in the body to detect the risk of breast and ovarian cancers.
Justice Elena Kagan: Well, the plant in the forest can't be used for any purpose either.
It only has a use when it's taken out -- you know, when it's uprooted and taken out of the forest.
But it's still the same thing.
And I guess what you haven't gotten me to understand is how this is different than that.
It's still the same thing, but now that you've isolated it, it in fact has lots of great uses.
Gregory A. Castanias: Well, I think there are two ways -- two ways to look at that.
First of all, if you want to look at it from the -- the perspective of the so-called product of nature doctrine, which I think has some very dangerous consequences if it's not cabined and understood correctly -- but if you look at it strictly from a product of nature doctrine, you could say, well, that's the same plant and it says in the 1930 legislative history of the Plant Patent Act that plants that are unmanipulated by the hand of man are not eligible for patents, and that's fine, in terms of their breeding and genetics and that sort of thing.
But the product of nature doctrine is troublesome for this reason: Modern medicine -- go beyond just the isolated DNA patents here.
Modern medicine, particularly the area of personalized medicine, is trying to get to a point where what we are administering to individual patients is giving them the opportunity to mimic the actions of the body.
And -- so actually, the goal of medicine is to get closer to nature, rather than farther away.
And anything that takes the product of nature doctrine beyond the simple truism that the product of nature is something that is not a human invention, then that's very dangerous, not just for our case--
Justice Anthony Kennedy: But when you -- when you isolate the DNA, that by itself cannot be used as -- as a probe until you add tags and -- and other chemicals that make it a probe.
Gregory A. Castanias: --As a probe, that's true.
As a primer, that wouldn't be required.
Justice Anthony Kennedy: So it seemed to me your -- your answer was not quite accurate when you said, well, it can't be used in the body to detect breast cancer.
Neither can the isolate without some additions.
Gregory A. Castanias: Well, since this Court -- I'm sorry.
Justice Anthony Kennedy: Now, if it's -- if it's the process or the additions that make it patentable, fine.
But you're say that the moment it's snipped, it's patentable, and that it seems to me was -- was the point of Justice Kagan's question.
Gregory A. Castanias: Well, I -- I will say that that is the final inventive act.
It's not the only inventive act.
It's the final inventive act.
If -- if indeed you were creating it--
Justice Ruth Bader Ginsburg: Do you concede--
Gregory A. Castanias: --I'm sorry.
Justice Ruth Bader Ginsburg: --Do you concede at least that the decision in the Federal Circuit, that Judge Lourie did make an incorrect assumption, or is the Lander brief inaccurate with respect to that, too?
That is, Judge Lourie thought that isolated DNA fragments did not exist in the human body and Dr. Lander says that--
Gregory A. Castanias: No, what -- I think Justice -- Judge Lourie was exactly correct to say that there is nothing in this record that says that isolated DNA fragments of BRCA1 exist in the body.
Neither does Dr. Lander's brief, for that matter.
And for that matter, those isolated fragments that are discussed in Dr. Lander's brief again are -- are what are known not -- not in any way as isolated DNA, but as pseudogenes.
They're typically things that have been killed off or mutated by a virus, but they do not--
Justice Samuel Alito: But isn't this just a question of probability?
To get back to your baseball bat example, which at least I -- I can understand better than perhaps some of this biochemistry, I suppose that in, you know, I don't know how many millions of years trees have been around, but in all of that time possibly someplace a branch has fallen off a tree and it's fallen into the ocean and it's been manipulated by the waves, and then something's been washed up on the shore, and what do you know, it's a baseball bat.
--is that what Dr. Lander is talking about?
Gregory A. Castanias: --That's pretty much the same as what he's talking about, is that there might be something that was out there somewhere.
But -- but that's really -- the search for this sort of thing that might be very similar to the thing but never was known before.
The patent law has taught -- the patent law is all about pushing the frontiers.
Justice Stephen G. Breyer: --All right.
So, when you are on that, that's good.
A more basic question to me is when you use the word “ dangerous ”.
I had thought -- and you can -- I'd be interested in your view -- that the patent law is filled with uneasy compromises, because on the one hand, we do want people to invent; on the other hand, we're very worried about them tying up some kind of whatever it is, particularly a thing that itself could be used for further advance.
And so that the compromise that has been built historically into this area is: Of course, if you get a new satisfying process to extract the sap from the plant in the Amazon, patented.
Of course, if you get the sap out and you find that you can use it, you manipulate it, you use it, you figure out a way to use it to treat cancer, wonderful, patented.
But what you can't patent is the sap itself.
Now, in any individual case that might be unfortunate or fortunate.
But consider it in the mine run of things.
It's important to keep products of nature free of the restrictions that patents there are, so when Captain Ferno goes to the Amazon and discovers 50 new types of plants, saps and medicines, discovers them, although that expedition was expensive, although nobody had found it before, he can't get a patent on the thing itself.
He gets a patent on the process, on the use of the thing, but not the thing itself.
Now, that's my understanding of what I'd call hornbook patent law, which you I confess probably understand better than I.
Gregory A. Castanias: Well--
Justice Stephen G. Breyer: And I would like you to express your view on that, because that's the framework that I am bringing to the case.
Gregory A. Castanias: --I -- I will offer the view, Justice Breyer:
First of all, in this Court's decision in Brenner v. Manson, followed repeatedly by the Federal Circuit, it has been hornbook patent law, to use your term, that you do not need to -- to call out the utility of an invention in a particular claim.
What you do have to do is have utility for the invention itself described in the specification.
And that's what the Patent Office looked to in its Utility Guidelines in 2001.
But ultimately, neither -- I think this case is very -- very easily decided on a straightforward ground that does not require the Court to go making fine distinctions between cDNA and DNA.
And that ground is this: The reasoned Utility Guidelines issued in 2001 by the Patent Office, who has not, in a very significant decision, joined the brief of the Solicitor General in this case -- and which they continue to apply under Section 2107 of the Manual of Patent Examining Procedure, these guidelines not only tell examiners what to do, but in the Federal Register they had notice and comment and 23 specific reasoned, supported by case law, supported by science, responses to the objectors.
Almost every objection that is made to our patents here was made there and answered there.
The PTO issued those guidelines to the public.
They have been relied on now for 12 years, and they confirm a practice that has been in place much longer than that.
And if you take -- whether you can call it the Skidmore deference or just giving respect to the agency that sits at the intersection of law and science -- Justice Breyer, as your opinion for the Court in Dickinson v. Zurko pointed out -- those -- that decision by the Patent Office is entitled to respect, the reliance that has been placed--
Justice Ruth Bader Ginsburg: --Even though -- even though the Government has disavowed it, even though the Government, representing the United States--
Gregory A. Castanias: --Even so, and -- and the reason for that is--
Justice Ruth Bader Ginsburg: --At least that the strength of the presumption would be diluted.
Gregory A. Castanias: --I think you can dilute it a little bit, but you can't take away the fact that it is a 30-plus year practice that the Patent Office, despite the executive's position in this Court and in the Federal Circuit, continues to follow.
Justice Elena Kagan: Mr. Castanias, could I take you away from the deference point and just ask again about the -- the kind of law that you would have us make.
Do you think that the first person who isolated chromosomes could have gotten a patent on that?
Gregory A. Castanias: I think in theory that is possible, but I should say this: Because this case is about Section 101, I'm trying -- I'm answering your question as though it's about 101, patent eligibility.
Justice Elena Kagan: Yes.
Gregory A. Castanias: Would it be obvious, would it be novel?
I'm not sure.
Those are different -- those are different analytical structures.
Justice Elena Kagan: Right.
Gregory A. Castanias: But would it -- and I think really, the -- the statute does the work here.
It is new and useful composition of matter--
Justice Elena Kagan: But the first--
Gregory A. Castanias: --if it had use.
If it had a new utility, then yes.
Justice Elena Kagan: --I'm sorry, because -- because -- because, like Justice Breyer, I consider uses -- patents on uses in a different category.
So I'm just asking, could you patent the isolated chromosome?
Gregory A. Castanias: Again, I -- I perhaps am not making myself as clear as I should.
In Section 101, a patent claim must be shown to be useful; and that -- that is a utility that it has to be shown--
Justice Elena Kagan: Yes.
Chromosomes are very useful.
Gregory A. Castanias: --in any case.
Justice Elena Kagan: The first person who found a chromosome and isolated it, I think we can all say that that was a very useful discovery.
And the question is, can you then -- can the person who found that chromosome and isolated it from the body, could they have gone to the PTO?
Gregory A. Castanias: If they -- if--
Justice Elena Kagan: And the PTO seems very patent happy, so could, you know, would -- would they have had a good patentability argument?
Gregory A. Castanias: --I think if -- to get through the Section 101 gateway, if that chromosome had a specific substantial and credible utility, in other words, it could be used in some--
Justice Elena Kagan: Yes, of course it does.
Gregory A. Castanias: --diagnostic way in the way that we're talking about here, then yes, it would pass through the Section 101 gate.
Whether it would pass through the Section 102 gate or the 103 gate, I don't have any opinion on.
Justice Elena Kagan: Would -- would -- okay.
Gregory A. Castanias: And then there's the further--
Justice Elena Kagan: And that's interesting--
Gregory A. Castanias: --Sure.
Justice Elena Kagan: --because then it's not a question about, you know, breaking these covalent bonds or whatever Judge Lourie thought it was about.
So, you know, if -- if not DNA, if -- if not the -- the more smaller unit in the chromosome, you know, we could just go up from there and talk about all kinds of parts of the human body, couldn't we?
Couldn't we get to, you know, the first person who found a liver?
Gregory A. Castanias: I -- I think -- I think, Justice Kagan, you're really putting your finger on the problem with this, again, I -- I keep wanting to refer to as the so-called Product of Nature Doctrine because I don't believe that as a separate doctrine it really exists.
It's just the flip side of the coin of something that shows a lack of invention.
And, of course, that's where Section 103 comes into full force as the Chief Justice mentioned earlier in the argument.
Section 103 allows you to make comparisons to what was old and what was new.
I don't think the organ, the liver, gets past 103 in that circumstance even if you say, well--
Justice Stephen G. Breyer: You are saying it gets past 101.
Gregory A. Castanias: --Even if it gets through the 101--
Justice Stephen G. Breyer: Well, that's -- that's the problem.
I mean, all parts of the human body?
Anything from inside the body that you snip out and isolate?
Gregory A. Castanias: --No.
Justice Stephen G. Breyer: And it gets through 101?
Does it have to -- I mean, that's actually what's bothering me.
Gregory A. Castanias: Okay.
So let -- let me try to help you with that.
Because -- because the distinction is between the liver or the kidney, which was the one brought up in the federal circuit opinion, but liver, kidney, you know, gallbladder, pick your organ.
But it's the same thing.
It is the same thing when it's inside the body and it's out.
That's where our--
Justice Sonia Sotomayor: --But you're not suggesting if you cut off a piece of the liver or a piece of the kidney that that somehow makes that piece patentable.
Gregory A. Castanias: --No.
It's the same thing.
Justice Sonia Sotomayor: So what's the difference?
I mean, if you cut off a piece of the whole in the kidney or liver, you're saying that's not patentable, but you take a gene and snip off a piece, that is?
What's the difference between the two--
Gregory A. Castanias: I would say that -- I would say that under -- under your existing decisions in Chakrabarty, J.E.M., that set forth a broad understanding of Section 101 and an understanding of what is within the limited exception, then what -- I -- I would -- I mean, honestly, I think that Section 103 does this work better than Section 101, but to the point of Section 101, there's -- there is nothing different about that piece in the body.
Justice Stephen G. Breyer: Ah.
Then -- then watch what you're doing.
That's very, very interesting, because, really, we are reducing, then, 101 to anything under the sun, and -- and that, it seems to me, we've rejected more often than we've followed it.
And particularly with a thing found in nature doctrine, because, of course, it doesn't just -- human kidneys and so forth.
Everything is inside something else.
Plants, rocks, whatever you want.
And so everything will involve your vast taking something out of some other thing where it is, if only the environment.
And it's at that point that I look for some other test than just that it was found within some other thing.
Gregory A. Castanias: And I think, Justice Breyer, there is where I've -- I've tried to explain to you about the different functions, the different values.
If you think about patents as economic instruments, the different economic values that come out of this, the different things that patients now have as a result of this human ingenuity, they didn't have the BRCA1 isolated gene before the Myriad invention.
Justice Anthony Kennedy: Well, we could have said that with atomic energy, with electric, but so far the choice -- electricity -- but so far the choice of the patent was that we have a uniform rule for all industries.
Gregory A. Castanias: Right, but in--
Justice Anthony Kennedy: And -- and that avoids giving special industries special subsidies, which is very important it seems to me.
Let me ask you this, and it's consistent with my -- my preface.
If we were to accept the Government's position that the DNA is not patentable but the cDNA is, would that give the industry sufficient protection for innovation and research?
And if not, why not?
Gregory A. Castanias: --The -- the problem of making that decision now is that so much has happened since these gene patents issued and since the utility guidelines.
I can't tell you for a certainty whether it will hurt the industry as a general matter to not have isolated gene but only have cDNA patents.
But here's what I think it will hurt, and I think it ultimately will hurt the doctrine that this Court comes out of this case with.
Because what you will then be asking litigants to do and courts to do is to draw fine distinctions under Section 101 between, well, how much more manipulation.
My friend on the other side used the term, in response to Justice Ginsburg,
"further manipulation is required to take it out of the product of nature. "
He -- he said no alteration, to Justice Alito, would make it a product of nature.
But there's no dispute in this case that there has been some alteration of the isolated DNA molecules.
And that brings me back to the utility guidelines.
This line was drawn.
It was drawn by an expert agency that sits at the intersection of law and science, and it has said, without any apparent -- other than the declarations and amicus briefs that have been put into this case -- without any apparent effect on the explosion in biotechnology and the successful, economically successful, technologically successful, and life-saving industry that is at the heart of these inventions.
That has not -- those -- that parade of horribles has not happened.
And you don't have to hypothesize at this point because you've got all of these years of experience between the time these patents issued and the time that this -- this challenge belatedly came along.
Justice Breyer, a point about no impermissible preemption before I sit down.
Your opinion for the Court in Mayo made that very much an important point, but I think what you -- what is important to understand here is that these patent claims aren't for methods.
They don't prevent -- present that problem that the Court identified in that argument and in the argument in Bilski.
These are for specific molecules that exist in the physical world.
That -- that concern that is present with method claims is not here, these patents cover -- these patent claims cover only what is claimed and no more.
There is no risk of a natural law or a physical phenomenon like energy or electricity, neither of which falls within the statutory categories.
There is no risk of anything being preempted other than what the claims properly claim, which are human-made inventions of isolated molecules.
And I think one last point to close on.
It's important to note that molecules have been patented for a very long time.
That's what drugs are.
And drugs are often made by taking one molecule and another molecule, both of which are known, reacting them in a test tube, which is a very common thing, reactions have been around 100 years just like snipping has been, but they make something new and useful and life saving from that.
Chief Justice John G. Roberts: Well, I don't understand how this is at all like that, because there you're obviously combining things and getting something new.
Here you're just snipping, and you don't have anything new, you have something that is a part of something that has existed previous to your intervention.
Gregory A. Castanias: Well, again, Mr. Chief Justice, I -- I -- the discussion we had earlier, the -- in -- in fact, the sequence that's claimed in Claim 1 of the '282 patent was not created by snipping.
If I can just conclude with one more sentence?
Chief Justice John G. Roberts: Sure.
Gregory A. Castanias: Only once it was created can a scientist ever know how and where to make the decision to snip.
Chief Justice John G. Roberts: Thank you, counsel.
Mr. Hansen, you have three minutes remaining.
REBUTTAL ARGUMENT OF MR. HANSEN ON BEHALF OF THE PETITIONERS
Christopher A. Hansen: Thank you, Your Honor.
Justice Sonia Sotomayor: Is there some value to us striking down isolated DNA and upholding the cDNA?
If we were to do what the Government is proposing in this case, what's the consequences?
Christopher A. Hansen: Of -- of course there would be value in that in the sense that -- that, A, it reinforces the Product of Nature Doctrine, but more importantly, the effect of the patents in this case allows Myriad to stop all research on a part of the human body.
If you uphold the patents in this case, Myriad can -- has the authority given it by the Government to stop anyone from doing research on a piece of the human body.
That would be a significant advance, if you were to -- to make it clear that was impermissible.
Justice Sonia Sotomayor: Now, how do you understand Judge Bryson's dissent with respect to cDNA?
I think he's saying that a gene created from -- into cDNA as a whole is okay, but that he had a problem with the description of that claim because it included 15 nucleotide long segments or fragments which he says reoccur in nature.
Christopher A. Hansen: Well, and yes, I -- I agree, Your Honor, that he was focusing on Claims 5 and 6, which are the ones that include 15 nucleotides or -- or longer.
Justice Sonia Sotomayor: Now, I'm making your job harder.
How could they write it to do what he thinks would be patentable?
Christopher A. Hansen: Well, all--
Justice Sonia Sotomayor: So assuming we believe that there is some human invention in this process; whether it's obvious or not, separate question.
But he's not creating -- the cDNA is not in nature naturally.
So make that assumption.
Make the assumption that they can make a claim for it.
How do we avoid his problem?
Christopher A. Hansen: --Well--
Justice Sonia Sotomayor: I know you are helping your adversary by answering this question.
Christopher A. Hansen: --That's fine, Your Honor.
I think that the -- all of the claims in this case, all nine claims that we are challenging include both fragments and the whole gene.
So I don't think there is anything you can do with respect to these nine claims.
Justice Sonia Sotomayor: I am putting that aside.
Christopher A. Hansen: I think by saying that when genes are transformed in such a way that the scientist decides their sequence rather than the nature deciding their sequence--
Justice Sonia Sotomayor: Only if they do a recombinant DNA, that's what you are saying.
Christopher A. Hansen: --Right, right.
Now I don't think cDNA is recombinant DNA, that's what we've argued, but that's -- that's at least one plausible way of looking at it.
The genes in this case, the patents on the genes in this case cover the genes of every man, woman, and child in the United States.
And as I just said, it gives the -- the government has given Myriad the authority to stop research on every one of our genes.
That simply can't be right.
And I would like to make one other point with respect to Dr. Lander's brief.
On page 16 of Dr. Lander's brief he discusses specifically that the BRCA genes appear in the body with covalent bonds in fragments.
There isn't any real -- there isn't any scientific dispute about that fact.
Chief Justice John G. Roberts: Why don't you take another minute.
You weren't afforded an opportunity to use the time you were reserved.
Christopher A. Hansen: Well, I guess the only other thing I would say, Your Honor, is to respond to what I may have left a misimpression with Justice Kagan's questions.
We agree that you could get a patent on a use of the leaf that is pulled out of the Amazon or a plant that is pulled out of the Amazon.
We don't dispute that.
We don't think you cannot get a patent on the plant itself just because you pulled it out of the ground and took it to the United States.
Chief Justice John G. Roberts: Thank you, counsel.
The case is submitted.
Chief Justice John G. Roberts: Justice Thomas has our opinion this morning in case 12 -398, the Association for Molecular Pathology versus Myriad Genetics.
Justice Clarence Thomas: This case comes to us on a writ of certiorari to United States Court of Appeals for the Federal Circuit.
Each human gene is encoded with DNA, or as DNA which takes the shape of a double helix.
DNA is used to create strings of Amino acids that build proteins in the body.
Scientists can extract DNA from cells and isolate specific segments.
They can also synthetically creates strands of DNA containing only the portions of DNA that are actually used to create strings of amino acids.
These synthetic DNA molecules are known as complimentary DNA or cDNA.
The question in this case is whether DNA and cDNA are eligible for patent protection.
Respondent Myriad Genetics, found the precise sequence and location of the human genome of two genes or on the human genome of two genes called BRCA1 and BRCA2.
Mutations in these genes are dramatic or can dramatically increase the risk of breast and ovarian cancers developing.
This knowledge enabled Myriad to develop medical test useful for detecting mutations in those genes and is thereby assessing a patient's risk of developing cancer.
Once it found these genes Myriad sought and obtained several patents.
These patents gave Myriad the exclusive right to isolate an individual's BRCA1 and BRCA2 genes and the exclusive right to synthetically create cDNA based on these genes.
Petitioners filed a lawsuit seeking a declaration that Myriad's patents are invalid.
The District Court agreed and invalidated Myriad's patents, but the Federal Circuit reversed, finding both isolated DNA and cDNA patent eligible.
In an opinion filed with the clerk today we affirm in part and reverse in part.
Section 101 of the Patent Act states “That who ever invents or discovers any new and useful composition of matter may obtain a patent” subject to other requirement is not an issue here.
In interpreting this language we have long held that so called “Products of nature are not patentable because something that already exists in nature is a not a new invention.
But we have also recognized that the rule against patents on naturally occurring things does have limits, because at some level everything comes from nature.
Patent protection strikes a delicate balance between creating incentives that lead to creation, invention and discovery on the one hand and impeding flow of information that might permit and spur invention on the other.
Applying these principles we must determine whether Myriad's patents claim a new and useful composition of matter or instead claim naturally occurring phenomena.
Myriad's DNA claim falls within the products of nature exception and are not eligible for patent protection.
Myriad's principal contribution was uncovering the precise location and sequence of BRCA1 and BRCA2 genes.
Myriad did not create or altered the genetic information encoded in the two genes or the genetic structure of the DNA itself.
It identified important and useful genes but this discovery, ground breaking as it was, does not by itself satisfy the Section 101 inquiry.
We, therefore, conclude that nearly finding the location of the BRCA 1 and BRCA2 genes does not render the genes patent eligible, new compositions of matter under Section 101.
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.
Consequently Myriad's patent on BRCA gene -- on the BRCA gene, are invalid.
We reach different conclusion how ever with respect to cDNA.
In our view, cDNA is not a product of nature and is therefore patent eligible under Section 101.
In order to create cDNA, portions of natural DNA must be eliminated from the naturally occurring gene.
The result is a molecule that contains only the portions of the DNA sequence that create proteins.
Because cDNA is not naturally occurring but is instead the product of human ingenuity, we conclude that cDNA is distinguishable from not patentable products of nature.
For these reasons and others set forth in our opinion, we affirm the judgment of the Federal Circuit in part and reverse in part.
The opinion of the Court is unanimous.
Justice Scalia has filed an opinion concurring in part and concurring in the judgment.