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IP Insight
Cadwalader, Wickersham & Taft LLP
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Recent Intellectual Property Caselaw and Developments of Interest
September 2011
Federal Circuit Holds Isolated DNA Is Statutory
Subject Matter Under S101
By Karen Axt
Assoc. Molec. Pathol. v. USPTO, Myriad Genetics et al., 10-1406 (Fed. Cir., July 29,
2011)
In a decision long awaited by the biotechnology industry, the Federal Circuit has
held that claims to isolated DNA are patent-eligible subject matter under 35 USC
§101 as compositions of matter that do not occur in nature, reversing the lower
court ruling. Assoc. Molec. Pathol. v. USPTO (Myriad Genetics), 10-1406 (Fed.
Cir. July 29, 2011). The asserted composition claims are directed to isolated DNA
related to the BRCA1 or BRCA2 gene. Mutations or alterations in the BRCA genes
have been found to be associated with particular types of breast cancer, and the
characterization and isolation of the genes was critical in developing diagnostic
screens for cancer and potential therapeutic products.
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IP Insight September 2011
2
Summary
While all members of the Myriad panel
agreed that cDNA was patent eligible
subject matter because it is man-made in
the laboratory and does not include the
non-coding introns, the panel did not agree
entirely on whether or why isolated DNA
was statutory subject matter under §101,
hence the decision is a plurality decision; the
decision includes the opinion of the Court
(J. Lourie), a concurrence (J. Moore) and a
dissent (J. Bryson).
The opinion of the Myriad Court relies on
the observation that isolated DNA is cleaved
from the larger native (chromosomal) DNA
by breaking chemical bonds and therefore
exists in a distinct chemical form. The Court
determined that isolated DNA molecules
are markedly different from DNA molecules
that exist in nature. The Court opinion and
concurring opinions relied in part on the
long-standing Patent Office practice of
issuing patents for isolated DNA, stating:
“The Supreme Court has repeatedly stated
that changes to longstanding practice should
come from Congress, not the courts.” Slip
Op. at 47 (citation omitted). The concurrence
found the composition claims to cDNA to be
an easy analysis in favor of patent eligible
subject matter, claims to short fragments
of isolated DNA to be a bit more difficult,
and claims to isolated DNA containing a
full gene sequence to potentially fall either
way, because while technically a different
structure, its utility is tied up in the parent
structure. The dissent did not find the fact
that covalent bonds had to be cleaved
to extract a gene from a genome to be a
compelling basis for finding the isolated
DNA to be a “different material” under §101
compared to what is found in nature. Rather,
the dissent opined that isolating a gene was
“akin to snapping a leaf from a tree,” because
the boundaries of the gene are predefined by
nature, which determines in the transcription
process the starting and stopping point for
the gene.
The Myriad panel agreed: (1) that at
least one plaintiff had standing to challenge
the validity of Myriad’s patents and satisfy
the jurisdictional requirements for declara-
tory judgment actions, (2) to affirm that the
claimed methods for comparing or analyz-
ing steps fall outside the scope of patent
eligibility under §101 because they included
no transformation and were merely directed
to abstract mental processes, and (3) to
reverse the holding that a claim to a method
for screening which included “growing” and a
“determining” steps in addition to a “compar-
ing” step, was not statutory subject matter
under §101.
Background
The Supreme Court has stated that §101
should be construed broadly. “Congress
intended statutory subject matter to ‘include
anything under the sun that is made by man.’
” Diamond v. Chakrabarty, 447 U.S. 303,
309 (1980) (emphasis added).
The Supreme Court has added three
exceptions to subject matter eligibility: “laws
of nature, physical phenomena, and abstract
ideas,” describing them as “part of the store-
house of knowledge of all men ... free to
all men and reserved exclusively to none.”
Chakrabarty, 447 U.S. at 309 (quoting Funk
Bros. Seed Co. v. Kalo Inoculant Co., 333
U.S. 127, 130 (1948). These exceptions
also preclude the patenting of “products of
