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.
Isolated DNA
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.
cDNA
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.
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