Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (2013)
"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." --Thomas, J.
On June 13, 2013, the U.S. Supreme Court handed down its decision in Association for Molecular Pathology v. Myriad Genetics. In the opinion, authored by Justice Thomas, the Court unanimously held that "[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." The Court also held that because cDNA is not a product of nature and does not face the same patent eligibility hurdles as naturally occuring isolated DNA, typically it is eligible for patenting.
Myriad owns the patents containing the claims at issue in this case, which are directed to isolated DNAs and cDNAs covering the human genes BRCA1 and BRCA2, as well as certain mutations in those genes that are indicative of an increased risk of developing breast or ovarian cancer. Much of the opinion focuses on why the "mere isolation" of DNA from the genome is not adequate to make even newly formed and non-naturally occurring DNA molecules patent eligible. Though the Court acknowledges that the identification and discovery of the precise location of the BRCA1 and BRCA2 genes was important and useful, it swiftly concludes that the subsequent isolation of that genetic material failed to create something that constitutes an act of invention. It states that "[t]he location and order of the nucleotides existed in nature before Myriad found them" and that Myriad did not "create or alter the genetic structure of DNA." The Court then relies on its prior decisions in Diamond v. Chakrabarty, 447 U.S. 303 (1980), and Funk Brothers Seed Co. v. Kalo Inoculant Co., 33 U.S. 127 (1948), to conclude that Myriad's "discovery, by itself, does not render the BRCA genes 'new . . . composition[s] of matter,' . . . that are patent eligible." (Slip Op. at 12-13).
The opinion directly addresses and rejects the rationale articulated by the Federal Circuit when it held that the breaking of chemical bonds in the process of isolating DNA from the genome can create a chemical moiety that did not previously exist in nature:
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.
(Slip Op. at 14-15).
The beginning of the passage is a bit puzzling--because DNA is a chemical composition regardless of whether it is described as "GATC" or "a polymer comprising a series of alternating phosphate groups and deoxyguanosine, deoxyadenosine, deoxythymidine, or deoxycytidine monomers having the sequence . . . ." But the end of the passage clarifies that the Court considers the significance of the claimed DNA to relate to the information it contains, and that the differences in chemical structure between isolated and genomic DNA is inconsequential to patentability under § 101.
The Court also dismissed the notion that it should give any deference to the 30+ years of USPTO practice granting patents directed to isolated genes, particularly because the U.S. Solicitor General argued that the Patent Office should not grant patents directed to genes.
In its relatively brief analysis of the patent eligibility of cDNA molecules, the Court explains the difference it perceives between isolated genomic DNA and cDNA, stating that "creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring." Thus, a DNA sequence that is created in a lab and contains only the protein coding portion of the genomic sequence is adequate to meet the eligibility requirements of § 101. The Court addressed AMP's argument that cDNA should be held ineligible because the sequence of cDNA is determined by portions of the underlying gene sequence--not by an inventor. The Court rejected that argument, stating that even though cDNA retains naturally occurring exons, it is distinct from the genomic DNA from which it was derived and therefore not a product of nature.
Do Genetically Engineered DNA Molecules Provide a Path Forward?
While the Court chose not to express any opinion about whether genetically engineered DNA molecules are patent eligible, the opinion suggests a simple dispositive question for determining DNA patent eligibility under § 101: Is the sequence of a claimed DNA molecule (i.e., informational component) the same as the sequence information as it exists in nature? If the answer is yes, then the claimed DNA fails to meet the requirements of § 101. This analysis would seem to fit within the Court’s concluding statement and caveat concerning cDNA at the end of Section II of the opinion:
cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a "product of nature" and is patent eligible under § 101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.
(Slip. Op. at 17, emphasis added).
This seems to indicate that the Court views cDNA as patent eligible only if it includes at least two exons that are not directly adjacent to each other in the genomic sequence. However, if the claimed cDNA sequence--or any engineered DNA sequence for that matter--can be mapped directly to a naturally occurring DNA sequence, the claim will fail to satisfy § 101. While this test has almost the exact flavor of a novelty and nonobviousness analysis under 35 U.S.C. §§ 102 and 103, this type of § 101 analytical framework would not be surprising, considering that these statutory provisions have crept into the Court’s recent § 101 decisions (e.g., Mayo v. Prometheus).
The Patent Office has already issued a memorandum to the examining corps that directs examiners to begin issuing rejections under § 101 for claims to any naturally occurring nucleic acid sequences or fragments thereof. In some ways, however, this procedure may not place much additional burden upon the examiners, as the Office already performs sequence database searches for claims directed to defined biological sequences (albeit for purposes of examination under § 102 and § 103). The question may turn on whether examiners or applicants bear the burden of demonstrating that the claimed sequence is actually "naturally occurring" (barred by § 101) or simply just present in the prior art (eligible under § 101, but allegedly obvious under § 103). It will be interesting to see how the Patent Office develops additional guidelines and guidance documents in the wake of this decision.
The impact of this decision may not become apparent for some time. Certainly, it does mark a significant change to the examination of claims directed to nucleic acid sequences; however, many diagnostics and biotechnology companies do not rely exclusively on patents to isolated nucleic acid sequences. As long as claims to nucleic acid sequences are sufficiently tailored to avoid reading on a naturally occurring sequence, the Court’s decision provides room to continue to pursue patents directed to compositions of matter that include expression vectors, therapeutic nucleic acids, enzymatic nucleic acids, and chemically modified probes.