• slide1.jpg
  • slide2.jpg
  • slide3.jpg
  • slide4.jpg

US Supreme Court Decision – DNA is a product of nature and not 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, supra, at ___. The rule against patents on naturally occurring things has limits, however. Patent protection strikes a delicate balance between creating "incentives that lead to creation, invention, and discovery" and "imped[ing]the flow of information that might permit, indeed spur, invention." Id., at ___. This standard is used to determine whether Myriad's patents claim a "new and useful . . . composition of matter," @101, or claim naturally occurring phenomena. Pp. 10-11.

(b) Myriad's DNA claim falls within the law of nature exception. Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U. S. 303, is central to the patent-eligibility inquiry whether such action was new "with markedly different characteristics from any found in nature," id., at 310. Myriad did not create or alter either the genetic information encoded in the BRCA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the @101 inquiry. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible "new . . . composition[s] of matter," @101. Myriad's patent descriptions highlight the problem with its claims: They detail the extensive process of discovery, but extensive effort alone is insufficient to satisfy @101's demands. Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes. Finally, Myriad argues that the Patent and Trademark Office's past practice of awarding gene patents is entitled to deference, citing J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U. S. 124, a case where Congress had endorsed a PTO practice in subsequent legislation. There has been no such endorsement here, and the United States argued in the Federal Circuit and in this Court that isolated DNA was not patent eligible under @101. Pp. 12-16.

The complete Supreme Court Decision can be viewed here.