WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court on April 15 appeared
skeptical of claims that native DNA is patentable during oral arguments in a
case closely watched by the medical community and biotech industry (The
Association for Molecular Pathology, et al. v. Myriad Genetics Inc., No.
12-398, U.S. Sup.; See 12/17/12, Page 5) (lexis.com subscribers may access Supreme Court briefs for this case).
In what she deemed an "analytical problem," Justice Sonia
Sotomayor mused, "I find it very, very difficult to conceive how you can patent
a sequential numbering system by nature, in the same way that I have a problem
in thinking that someone could get a patent on the computer binary code merely
because they throw a certain number of things on a piece of paper in a certain
"I always thought that to have a patent you had to take
something and add to what nature does. So how do you add to nature when
all you are doing is copying its sequence?" she asked.
Products Of Nature
Respondent Myriad Genetics Inc. received several patents
for diagnostic tests for mutations along BRCA1 and BRCA2, two genes responsible
for most cases of hereditary breast and ovarian cancer. It 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 breast 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) and patent holders
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. at 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.
2nd Petition Filed
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?"
Arguing for the petitioners, attorney Christopher A.
Hansen said that while Myriad "deserves credit" for having "unlocked" the
secrets of BRCA1 and BRCA2, "the genes themselves . . . where they start and
stop, what they do, what they are made of, and what happens when they go wrong
are all decisions that were made by nature, not by Myriad." Although
conceding that a process for extracting naturally occurring things can
sometimes be patentable, Hansen drew a distinction where the new product is
"something different" and has "taken on a new function."
Justice Elena Kagan expressed concern, however, about the
potential for decreased incentive among biotechnology firms should the Supreme
Court overrule the Federal Circuit a second time. "If you assume that it
takes a lot of work and takes a lot of investment to identify this gene, but
the gene is not changed in composition, and . . . discovering uses for that
gene would not be patentable even if those uses are new, what does Myriad get
out of this deal?" she asked.
"Why shouldn't we worry that Myriad or companies like it
will just say, well, you know, we're not going to do this work anymore," she
In response, Hansen argued that Myriad's virtual monopoly
on the BRCA1 and BRCA2 tests has already had a detrimental effect. "The
whole point of the product of nature doctrine is that when you lock up a
product of nature, it prevents industry from innovating and making new
discoveries," he said.
"That's the reason we have the product of nature
doctrine, is because there may be a million things you can do with the BRCA
gene, but nobody but Myriad is allowed to look at it and that is impeding
science rather than advancing it," he added.
Attorney Gregory A. Castanias, arguing for Myriad, opened
his remarks by citing Section 103A of the Patent Act, which counsels that
"patentability shall not be negated by the manner in which the invention was
created." He next indicated his disagreement with Justice Sotomayor's
assessment that there is "nothing additive" about Myriad's patents, telling the
Supreme Court that "what Myriad inventors created in this circumstance was a
new molecule that had never before been known to the world." Justice
Sotomayor continued to express skepticism, however.
"I can bake a chocolate chip cookie using natural
ingredients - salt, flour, eggs, butter - and I create my chocolate chip
cookie. And if I combust those in some new way, I can get a patent on
that. But I can't imagine getting a patent simply on the basic items of
salt, flour and eggs, simply because I've created a new use or a new product
from those ingredients. Explain to me why gene sequences, whether in the
actual numbers, why gene sequences are not those basic products that you can't
patent," she said.
'Not Given By Nature'
In response, Castanias argued that isolated DNA "is
actually a different structure" than native DNA. The chemical composition
of the isolated DNA has 5,914 nucleotides, according to Castanias, while the
genome itself has more than 3 billion nucleotides.
"It's arranged in the way set forth - as set forth
in the SEQ IDs [sequence identifications] number 1 and 2. Number 2 is the
so-called genomic DNA, SEQ ID number 1 is the . . . cDNA molecule. When
you look at those particular sequences, there was invention in the decision of
where to begin the gene and where to end the gene. That was not given by
nature," Castanias added.
Solicitor General Donald B. Verilli, Jr. arguing on
behalf of the U.S.
government, noted the "necessary balance" between "encouraging individual
inventors and keeping the basic building blocks of innovation free for all to
use." However, "isolated DNA falls on the ineligible side of that divide
because it is simply native DNA extracted from the body," Verilli told the
"The claim that isolated DNA is a human invention rests
entirely on the fact that it is no longer connected at the molecular level to
what surrounded it in the body. But allowing a patent on that basis would
effectively preempt anyone else from using the gene itself for any medical or
scientific purpose. That is not true about a patent on cDNA. A
patent on cDNA leaves the isolated DNA available for other scientists and other
- and others in the medical profession to try to generate new uses," he added.
The petitioners are represented by 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 York.
The respondents are represented by
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 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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