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F A L L 2 0 1 3
the laboratory known as complementary
DNA (cDNA); this cDNA is also useful
for research and further innovation.
Inventors at Myriad discovered the
precise location and sequence of two
human genes, known as BRCA1 and
BRCA2, mutations of which can sub-
stantially increase the risks of breast and
ovarian cancer in those patients in which
the mutations are present. The inven-
tors isolated the genes from the human
genome and developed tests to determine
if individuals have the genetic mutations
and therefore the increased cancer risk.
The tests require the DNA to be isolated
before testing can occur.
Myriad obtained a number of patents
based on this discovery, including
patents claiming the isolated DNA cod-
ing and isolated cDNA coding for the
BRCA1 and BRCA2 genes. With these
patents, Myriad asserted the exclusive
right to administer the genetic tests for
the mutations of these genes that would
indicate an increased cancer risk.
The PTO has been issuing these
types of patents since Chakrabarty.
Specifically, isolated DNA and cDNA
do not exist in nature separated and
isolated from the remainder of the
human genome. Therefore, they are
not naturally occurring and qualified
for patents as "manufactures" or
"compositions of matter."
A group of doctors and patients, led
by the American Civil Liberties Union,
sued Myriad and the PTO, seeking a
declaration that the claims of the patents
were invalid and that these inventions
were not eligible for patent protection. If
the court agreed with the plaintiffs, they
would be free to administer the tests at
facilities not administered by Myriad,
and they would not have to pay license
fees to Myriad for performing such tests.
Supreme Court Opinion
When the case finally reached the
Supreme Court, Justice Thomas wrote
for a unanimous Court that claims to
isolated DNA are not patent eligible,
while claims to the synthetically created
cDNA are.
His analysis started with the text
of 101, but then recognized several
judicially created exceptions to the broad
wording of the statute: laws of nature,
natural phenomena and abstract ideas.
Without this exception, there would
be considerable danger that the grant
of patents would "tie up" the use of
[basic tools of scientific and techno-
logical work] and thereby "inhibit fu-
ture innovation premised upon them."
In its reasoning regarding the isolated
DNA, the Court reasoned that Myriad
did not create anything. Its principal
contribution was uncovering the precise
location and genetic sequence of the
BRCA1 and BRCA2 genes. The Court
determined that "separating [those]
gene[s] from [the] surrounding genetic
material is not an act of invention." The
extensive effort indicated by Myriad does
not warrant a patent under 101.
The Court did recognize that cDNA
is a different matter. Isolated cDNA se-
quences do not exist within nature or the
human body. They retain some charac-
teristics of naturally occurring DNA, but
are sufficiently distinct to warrant patent
One thing to note about this case is the
fact that the plaintiffs did not acquire
the relief initially sought. In the original
complaint, the plaintiffs also challenged
Myriad's claims to methods of screening
cancer patients. It pursued these claims
through most of the litigation, arguing
that they were directed to abstract ideas
and were thus not patent eligible. The
Federal Circuit upheld these method
claims and the Supreme Court declined
to review that decision. Thus, the win is
in a sense a Pyrrhic victory: the claims
to methods of screening cancer patients
for the genetic mutation remain in force.
Nobody else can practice these methods
without infringing the claims.
The historical underpinnings for a
patent system generally stem from the
desire to encourage investment in inno-
vation and also to encourage disclosure
of innovative discoveries and advance-
ments. In exchange for disclosure of new
inventions, patents permit innovators to
exclude competition for a limited time
and to charge monopoly profits dur-
ing the limited term of the patent. The
Myriad opinion instead seems to suggest
that patents inhibit rather than encour-
age research.
How will this opinion affect the bio-
technology industry? Given the extensive
costs of research in these areas, will
companies continue to make large scale
investments? Following recent Supreme
Court opinions on patentable subject
matter, including Myriad, it seems that
patents in the area of personalized
medicine will be difficult to obtain and
enforce. Further, many biotechnology
companies are working on ways to grow
organs that can be transplanted into the
human body to replace defective organs.
The goal is for these organs to be as
similar to the natural organs as possible.
This opinion seems to indicate that such
organs could not be patented.
As far as specific guidance, the
Supreme Court opinion did not provide a
great deal of help. The Court specifically
noted that it was not considering the
patent eligibility of DNA where the order
of the naturally occurring nucleotides
has been altered. Where is the line? How
different, how "inventive" does the new
molecule or sequence need to be to be
The Court also noted that no method
claims were at issue. Innovative methods
of manipulating genes would appear to
still be patent eligible. Further, no ap-
plications of knowledge about the genes
were at stake. If the claims were limited
to such applications, they would presum-
ably also be patent eligible.
The Supreme Court has been review-
ing a number of recent cases regarding
patent eligibility. It has come down on
the side of ineligibility in each one,
thereby limiting the subject matter that
can be patented. Will the Court continue
to limit what can be patented or will it
now let the dust settle for a while?