WASHINGTON, D.C. - (Mealey's) In a unanimous ruling June
13, the U.S. Supreme Court found that although complementary DNA, or "cDNA," is
patent-eligible, isolated DNA is not (The Association for Molecular
Pathology et al. v. Myriad Genetics Inc., No. 12-398, U.S. Sup.; See
5/6/13, Page 4) (lexis.com subscribers may access Supreme Court briefs and the opinion for this case).
The narrowly-tailored opinion authored by Justice
Clarence Thomas partly reverses a July 2011 Federal
Circuit U.S. Court of Appeals ruling in favor of respondent Myriad Genetics
Inc., owner of several patents for diagnostic tests relating to mutations along
the BRCA1 and BRCA2 genes.
"It is important to note what is not implicated by
this decision," the court wrote.
"First, there are no method claims before this Court . .
. . . Similarly, this case does not involve patents on new applications
of knowledge about the BRCA1 and BRCA2 genes. . . . 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,"
the court added.
BRCA1 and BRCA2 are two genes responsible for most cases
of hereditary *** and ovarian cancer. Myriad has sued to stop
competitors from offering genetic testing for the two genes and has sent
numerous cease-and-desist letters to laboratories, universities and
others. In 2009, several medical organizations and individuals -
including lead petitioner the Association for Molecular Pathology, along with
six patients diagnosed with or at risk of hereditary *** or ovarian cancer -
filed a complaint in the U.S. District Court for the Southern District of New
York against the U.S. Patent and Trademark Office (PTO), Myriad and the
directors of the University of Utah Research Foundation.
The petitioners alleged that 15 claims from seven Myriad patents are invalid
under Section 101 of the Patent Act because they cover products of nature, laws
of nature and abstract ideas. They also alleged that the effect of the
challenged patents is to preempt scientific inquiry and medical care to the
detriment of patients' health and scientific advancement, in violation of both
Article I, Section 8, clause 8, of the U.S. Constitution and the First
Amendment. The petitioners and Myriad subsequently cross-moved for
summary judgment, and the petitioners prevailed.
In granting the plaintiffs summary judgment, the
court construed the term "isolated DNA" as "a segment of DNA nucleotides
existing separate from other cellular components normally associated with
native DNA, including proteins and other DNA sequences comprising the remainder
of the genome." Accordingly, the court characterized the genes at issue
as "products of nature" and deemed the patents invalid pursuant to Gottschalk
v. Benson, 409 U.S. 63, 67 (1972) [an enhanced version of this opinion is available to lexis.com
subscribers], Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) [enhanced version] and other cases. Myriad appealed
to the Federal Circuit U.S. Court of Appeals, which in a divided July 2011
opinion, reversed, finding that the isolated DNA molecules as claimed do not
exist in nature and are thus subject to patent protection. The Federal
Circuit further found that the composition claims for the patents at issue that
are limited to "complementary DNA," or cDNA, are patent eligible because cDNA
is a synthesized genetic material that does not occur in nature but rather is
the product of considerable human creativity.
The plaintiffs filed a petition for writ of certiorari
with the Supreme Court, which granted the petition for the limited purpose of
vacating and remanding in light of its ruling in Mayo Collaborative Services
v. Prometheus Laboratories Inc. (No. 10-1150, U.S. Sup.). In another
divided ruling, the Federal Circuit in August 2012 again reversed the District
Court's ruling, reaffirming its earlier ruling upholding the challenged
composition claims and one of the method claims. The Federal Circuit also found
that isolated DNA molecules "are not found in nature" and are instead "obtained
in the laboratory and are man-made, the product of human ingenuity."
The plaintiffs submitted a second petition for writ of certiorari to the
high court, presenting three questions. On Nov. 30, the Supreme Court granted certiorari,
limited to the first question presented: "Are human genes patentable?"
Oral arguments were held April 15.
Siding with the petitioners with regard to isolated DNA,
the Supreme Court noted that the "location and order of the nucleotides existed
in nature before Myriad found them." Furthermore, the respondent did not
"create or alter" the genetic structure of native DNA. Uncovering the
precise location and genetic sequence of the BRCA1 and BRCA2 genes within
chromosomes 17 and 13 is insufficient to render the genes patentable as new
compositions of matter, according to the Supreme Court. Distinguishing the
instant dispute from Chakrabarty, the court wrote "Myriad did not create
"To be sure, it found an important and useful gene, but
separating that gene from its surrounding genetic material is not an act of
invention. Groundbreaking, innovative, or even brilliant discovery does not by
itself satisfy the §101 inquiry," it added.
The Supreme Court was similarly unmoved by Myriad's claim
at oral argument that by isolating DNA from the human genome, chemical bonds
are severed and a non-naturally occurring molecule results. The
respondent's argument is "simply not expressed in terms of chemical
composition," nor does Myriad "rely in any way on the chemical changes that
result from the isolation of a particular section of DNA" according to the
"Instead, the claims understandably focus on the genetic
information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon
the creation of a unique molecule, then a would-be infringer could arguably
avoid at least Myriad's patent claims on entire genes . . .by isolating a DNA
sequence that included both the BRCA1 or BRCA2 gene and one additional
nucleotide pair. Such a molecule would not be chemically identical to the
molecule 'invented' by Myriad. But Myriad obviously would resist that outcome
because its claim is concerned primarily with the information contained in the
genetic sequence, not with the specific chemical composition of a particular
molecule," the Supreme Court concluded.
Myriad prevailed with regard to cDNA, however, with the
Supreme Court affirming the Federal Circuit's finding that creation of a cDNA
sequence from messenger RNA results in an exons-only molecule that is not
naturally occurring. To that end, the Supreme Court rejected the
petitioners' contention that the nucleotide sequence of cDNA is dictated by
nature, and not a lab technician. "That may be so," the court wrote, "but
the lab technician unquestionably creates something new when cDNA is made."
"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," the Supreme Court added.
The petitioners are represented by Christopher A. Hansen,
Steven R. Shapiro, Sandra S. Park, Aden J. Fine and Lenora M. Lapidus of
American Civil Liberties Union Foundation in New York
and Daniel B. Ravicher and Sabrina Y. Hassan of Public Patent Foundation,
Benjamin N. Cardozo School of Law in New
The respondents are represented by Gregory A. Castanias and Jennifer L. Swize
of Jones Day in Washington; Brian M. Poissant
and Laura A. Coruzzi of Jones Day in New York;
Israel Sasha Mayergoyz and Dennis Murashko of Jones Day in Chicago; and Richard
M. Marsh, Benjamin G. Jackson and Matthew S. Gordon of Myriad in Salt Lake City.
The United States is
represented by Solicitor General Donald Verilli Jr. and Stuart F. Delery,
Malcolm L. Stewart, Beth S. Brinkmann, Ginger D. Anders, Scott R. McIntosh,
Mark R. Freeman and Melissa N. Patterson of the Department of Justice in Washington.
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