(c) cDNA is not a “product of nature,” so it is patent eligible under §101. 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. 124, a case where Congress had endorsed a PTO practice in subsequent legislation. 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. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes. 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. 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. 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. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible “new. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry. Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. 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’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. (b) Myriad’s DNA claim falls within the law of nature exception. composition of matter,” §101, or claim naturally occurring phenomena. This standard is used to determine whether Myriad’s patents claim a “new and useful. Patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped the flow of information that might permit, indeed spur, invention.” Id., at _. The rule against patents on naturally occurring things has limits, however. 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 _. (a) The Patent Act permits patents to be issued to “hoever invents or discovers any new and useful. 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. _, the Circuit found both isolated DNA and cDNA patent eligible. The Federal Circuit initially reversed, but on remand in light of Mayo Collaborative Services v. As relevant here, the District Court granted summary judgment to petitioners, concluding that Myriad’s claims were invalid because they covered products of nature. Petitioners filed suit, seeking a declaration that Myriad’s patents are invalid under 35 U. S. C. 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. 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. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. cDNA contains only the exons that occur in DNA, omitting the intervening introns. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). 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. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids used to build proteins in the body. 12–398. Argued April 15, 2013-Decided June 13, 2013Įach 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.
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