Association for Molecular Pathology v. Myriad Genetics Inc., No. 12-398; U.S. Supreme Court; opinion by Thomas, J.; partial concurrence by Scalia, J.; decided June 13, 2013. On certiorari to the U.S. Court of Appeals for the Federal Circuit.
Each human gene is encoded as deoxyribonucleic acid (DNA), which takes the shape of a "double helix." Each "cross-bar" in that helix consists of two chemically joined nucleotides. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids used to build proteins in the body. The nucleotides that code for amino acids are "exons," and those that do not are "introns." Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns.
Respondent Myriad Genetics Inc. obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes' typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient's cancer risk. If valid, Myriad's patents would give it the exclusive right to isolate an individual's BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA. Petitioners filed suit, seeking a declaration that Myriad's patents are invalid under 35 U.S.C. § 101. As relevant here, the district court granted summary judgment to petitioners, concluding that Myriad's claims were invalid because they covered products of nature. The federal circuit initially reversed, but on remand in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. —, the circuit found both isolated DNA and cDNA patent eligible.
Held: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring. Pp. 10-18.
(a) The Patent Act permits patents to be issued to "[w]hoever invents or discovers any new and useful … composition of matter," § 101, but "laws of nature, natural phenomena, and abstract ideas" "are basic tools of scientific and technological work" that lie beyond the domain of patent protection, Mayo, 566 U.S.at —. The rule against patents on naturally occurring things has limits, however. Patent protection strikes a delicate balance between creating "incentives that lead to creation, invention, and discovery" and "imped[ing] the flow of information that might permit, indeed spur, invention." Id. at —. This standard is used to determine whether Myriad's patents claim a "new and useful … composition of matter," § 101, or claim naturally occurring phenomena. Pp. 10-11.
(b) Myriad's DNA claim falls within the law of nature exception. Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U.S. 303, is central to the patent-eligibility inquiry whether such action was new "with markedly different characteristics from any found in nature," id. at 310. Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative or even brilliant discovery does not by itself satisfy the § 101 inquiry. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible "new … composition[s] of matter," § 101. Myriad's patent descriptions highlight the problem with its claims: They detail the extensive process of discovery, but extensive effort alone is insufficient to satisfy § 101's demands. Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes. Finally, Myriad argues that the Patent and Trademark Office's past practice of awarding gene patents is entitled to deference, citing J.E.M. Ag Supply Inc. v. Pioneer Hi-Bred Int'l Inc., 534 U.S. 124, a case where Congress had endorsed a PTOpractice in subsequent legislation. There has been no such endorsement here, and the United States argued in the federal circuit and in this court that isolated DNA was not patent eligible under § 101. Pp. 12-16.
(c) cDNA is not a "product of nature," so it is patent eligible under § 101. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA. Pp. 16-17.
(d) This case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Pp. 17-18.
689 F.3d 1303, affirmed in part and reversed in part.