Supreme Court UNANIMOUSLY Says Human Genes Are Not Patentable

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.

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 alto gether. 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 valu able medical breakthroughs. 

This case involves patents filed by Myriad after it made  one such medical breakthrough. Myriad discovered the  precise location and sequence of what are now known as  the BRCA1 and BRCA2 genes. Mutations in these genes   can dramatically increase an individual's risk of developing breast and ovarian cancer. The average American  woman has a 12- to 13-percent risk of developing breast  cancer, but for women with certain genetic mutations, the  risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer.

Before Myriad's discovery of the BRCA1 and BRCA2  genes, scientists knew that heredity played a role in establishing a woman's risk of developing breast and ovarian  cancer, but they did not know which genes were associated  with those cancers.

 

Myriad identified the exact location of the  e BRCA1 and  BRCA2 genes on chromosomes 17 and 13.

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.

                         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." 

We have "long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable." Mayo,   566 U. S., at ___ (slip op., at 1) (internal quotation marks  and brackets omitted). Rather, --they are the basic tools of  scientific and technological work'" that lie beyond the  domain of patent protection. Id., at ___ (slip op., at 2). As  the Court has explained, without this exception, there  would be considerable danger that the grant of patents  would "tie up" the use of such tools and thereby "inhibit  future innovation premised upon them." Id., at ___ (slip  op., at 17). This would be at odds with the very point  of patents, which exist to promote creation. Diamond v.  Chakrabarty, 447 U. S. 303, 309 (1980) (Products of nature are not created, and --manifestations . . . of nature  [are] free to all men and reserved exclusively to none'"). 

The rule against patents on naturally occurring things  is not without limits, however, for "all inventions at some  level embody, use, reflect, rest upon, or apply laws of  nature, natural phenomena, or abstract ideas," and "too  broad an interpretation of this exclusionary principle  could eviscerate patent law." 566 U. S., at ___ (slip op., at 

2). As we have recognized before, patent protection strikes  a delicate balance between creating "incentives that lead  to creation, invention, and discovery" and "imped[ing] the  flow of information that might permit, indeed spur, in vention." Id., at ___ (slip op., at 23). We must apply this  well-established standard to determine whether 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.

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.

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.

It is important to note what is not implicated by this  decision. First, there are no method claims before this  Court. Had Myriad created an innovative method of  manipulating genes while searching for the BRCA1 and  BRCA2 genes, it could possibly have sought a method pat ent. But the processes used by Myriad to isolate DNA  were well understood by geneticists at the time of Myriad's  patents "were well understood, widely used, and fairly  uniform insofar as any scientist engaged in the search for  a gene would likely have utilized a similar approach," 702   F. Supp. 2d, at 202--203, and are not at issue in this case. 

Similarly, this case does not involve patents on new  applications of knowledge about the BRCA1 and BRCA2  genes.  Judge Bryson aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences,  Myriad was in an excellent position to claim applications  of that knowledge. Many of its unchallenged claims are  limited to such applications." 689 F. 3d, at 1349. 

Nor do we consider the patentability of DNA in which  the order of the naturally occurring nucleotides has been  altered. Scientific alteration of the genetic code presents a  different inquiry, and we express no opinion about the  application of -101 to such endeavors. We merely hold  that genes and the information they encode are not patent  eligible under -101 simply because they have been isolated  from the surrounding genetic material. 

* * * 

For the foregoing reasons, the judgment of the Federal  Circuit is affirmed in part and reversed in part.