569 U.S. 576 (133 S. Ct. 2107 (2013))
Respondent Myriad Genetics, Inc. discovered the precise location and sequence of the BRCA1 and BRCA2 genes.1 Mutations in these genes can dramatically increase an individual's risk of developing breast and ovarian cancer.2 Myriad obtained several patents after its discovery.3 These included U.S. Patent 5,747,282, U.S. Patent 5,693,473, and U.S. Patent 5,837,492.4
The average American woman has a 12- to 13-percent risk of developing breast cancer.5 For women with BRCA mutations the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer.6 Myriad identified the exact location of the BRCA1 and BRCA2 genes on chromosomes 17 and 13.7 Chromosome 17 has approximately 80 million nucleotides and chromosome 13 has approximately 114 million nucleotides.8 Within those chromosomes the BRCA1 and BRCA2 genes are each about 80,000 nucleotides long.9 If just exons are counted the BRCA1 gene is only about 5,500 nucleotides long and the BRCA2 gene is about 10,200 nucleotides long.10
Claims 1, 2, 5, and 6 from the '282 patent are representative.11 Claim 1 asserts a patent on an isolated DNA coding for a BRCA1 polypeptide with the amino acid sequence set forth in SEQ ID NO:2.12 Claim 2 asserts a patent on the isolated DNA with the nucleotide sequence set forth in SEQ ID NO:1.13 SEQ ID NO:1 lists only the cDNA exons in the BRCA1 gene.14 Claims 5 and 6 assert patents on any isolated DNA having at least 15 nucleotides of the sequences in claims 1 and 2 respectively.
After obtaining the patents Myriad sent letters asserting infringement to the University of Pennsylvania's Genetic Diagnostic Laboratory and to petitioner Dr. Harry Ostrer.15 Ostrer had been sending patient DNA samples to the laboratory for testing.16 The laboratory agreed to stop testing.17 Myriad filed patent infringement suits against other entities performing BRCA testing.18 Those suits resulted in settlements requiring the defendants to cease the allegedly infringing activity.19
Petitioner Ostrer along with medical patients advocacy groups and other doctors filed suit in the Southern District of New York.20 They sought a declaration that Myriad's patents are invalid under 35 U.S.C. §101.21 The district court denied Myriad's motion to dismiss for lack of standing.22 It granted summary judgment to petitioners on the composition claims concluding they covered products of nature.23 The Federal Circuit initially reversed.24 After this Court decided Mayo Collaborative Services v. Prometheus Laboratories Inc. the case was remanded.25 On remand the Federal Circuit affirmed in part and reversed in part holding both isolated DNA and cDNA patent eligible under §101 with each panel member writing separately on the rationale for isolated DNA. The Supreme Court granted certiorari.26
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?27
Section 101 of the Patent Act permits patents on new and useful compositions of matter. Yet the Court has long recognized an implicit exception for laws of nature natural phenomena and abstract ideas.28 These are basic tools of scientific work that must remain free for all to use.29 Patent eligibility therefore turns on whether the claimed invention is a product of human ingenuity with markedly different characteristics from anything found in nature as illustrated by the modified bacterium in Chakrabarty.30 Alternatively it may merely reflect a discovery of natural phenomena without alteration of genetic information or structure.31 The rule requires careful attention to the distinction between extensive research efforts that uncover existing sequences and true inventive acts that create something new.32 This ensures that the delicate balance between incentivizing discovery and avoiding impediments to future innovation is maintained.33
No. Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes on chromosomes 17 and 13.34 Myriad did not create or alter the genetic information encoded in those genes or the genetic structure of the DNA itself.35 Myriad's claims focus on the informational content of the nucleotide sequences rather than any chemical changes resulting from severing bonds during isolation.36 The patents would grant exclusive rights to isolate the genes by breaking covalent bonds that connect DNA to the rest of the genome.37
The location and order of the nucleotides existed in nature before Myriad's discovery.38 Extensive effort alone cannot satisfy the demands of section 101.39 Therefore the isolated DNA segments remain products of nature ineligible for patent protection under the established rule.40
A naturally occurring DNA segment is not patent eligible under 35 U.S.C. §101 merely because it has been isolated from the surrounding human genome.41
Related opinions on this issue
Justice Scalia filed a concurring opinion.42 He joined the judgment of the Court and all of the opinion except Part I-A and some portions of the rest of the opinion going into fine details of molecular biology.43 He was unable to affirm those details on his own knowledge or belief.44
It sufficed for him 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.45 He also affirmed that complementary DNA is a synthetic creation not normally present in nature.46
Whether 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, is patent eligible under 35 U.S.C. §101?47
Complementary DNA created in the laboratory through reverse transcription of messenger RNA results in an exons-only molecule that does not occur naturally.48 The introns present in genomic DNA have been removed during the synthetic process.49 Although the order of the exons may be dictated by nature the lab technician creates something new when introns are eliminated.50 This renders cDNA distinct from the DNA from which it was derived and therefore outside the product-of-nature exception to section 101.51 This distinction holds except in the rare instance of very short strands where no introns exist to remove.52 In that case the synthetic molecule may be indistinguishable from natural DNA.53
Yes. Myriad's patents encompass the exclusive right to synthetically create BRCA cDNA.54 This molecule is produced in the laboratory from mRNA.55 It contains only the exon sequences and omits the intervening introns found in natural DNA.56
Because cDNA is not naturally occurring and results from human intervention that removes non-coding regions it qualifies as a composition of matter created by the lab technician rather than a mere product of nature.57 The Federal Circuit correctly recognized that cDNA cannot be isolated from nature but must instead be created in the laboratory.58 This satisfies the requirements of section 101.59
Synthetically created cDNA is patent eligible under 35 U.S.C. §101 because it is not naturally occurring.60