The question has been debated for
years but not addressed directly by
the U.S. Supreme Court—until this
week. It came up for consideration on
15 April thanks to a coalition of
clinicians, researchers, and legal activists who have waged a 4-year
legal campaign to invalidate one
company's patents on the genes
BRCA1 and BRCA2, used in diagnostic
tests to estimate cancer risk. The
challengers argue that human genes are "products of nature"—not
inventions—and so cannot be
patented. The defendant, Myriad
Genetics of Salt Lake City, argues that
its patents are valid because they
describe genes not as they occur in nature but as they exist after they
have been "isolated" from tissue. The oral argument in the case— Association for Molecular Pathology v.
Myriad Genetics Inc.—took the court deep into the territory of molecular
biologists. For more than an hour, the
justices quizzed the competing sides
about exons, introns, and cDNAs,
proposing several different metaphors
in an effort to squeeze the complex biology into a manageable legal mold.
At the end, it was clear that many of
the justices did not seem to like the
idea of patenting human genes. But
they struggled to find a way to
distinguish between what might be called artificial genes (patentable) and
"natural" genes (not patentable). The
decision, expected later this year and
from which there is no appeal, could
have an impact on hundreds of
companies and thousands of researchers. The first justices to attack the question
with a metaphor were Samuel Alito
and Ruth Bader Ginsburg. They
compared Myriad's patented genes to
a molecule taken from an imaginary
tree deep in the Amazon. Alito proposed that the leaves of this tree
contained a molecule with
"tremendous medicinal purposes. …
Let's say it treats breast cancer."
Questioning the lead attorney for the
challengers, Christopher Hansen of the American Civil Liberties Union, Alito
wanted to know whether a drug
made from these leaves would be
considered a product of nature and
for that reason unpatentable. Hansen
replied: "If we simply pick the leaf off the tree and swallow it, … I think it is
not patentable." Hansen suggested,
however, that an inventor might
instead get patents on a process for
extracting a molecule from the leaves
and giving it a new function as medicine.

Alito said that he considered Hansen's
response to be an important
concession, because, "Isolated DNA
has a very different function from the
DNA as it exists in nature. And
although the chemical composition may not be different, … it certainly is in
a different form." Hansen said that he
disagreed with this interpretation. Justice Elena Kagan challenged
Hansen to explain what economic
incentive would be left, if human gene
patents were ruled out, for any
company to do "what Myriad did" --
develop a genetic test for cancer risk. This "takes a lot of work and takes a
lot of investment," Kagan said. "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?" Hansen responded: "We know that would not have happened
in this case. … There were other labs
doing BRCA testing and Myriad shut all
that testing down." He added that the
"whole point" of the argument is that
"when you lock up a product of nature, it prevents industry from
innovating and making new
discoveries." Justice Antonin Scalia then pounced,
charging that Hansen had not answer
the question about incentives: "Why
would a company incur massive
investment if it cannot patent?"
Hansen said: "I think scientists look for things for a whole variety of reasons,
sometimes because they're curious
about the world." Kagan said that she
had "hoped" for a different answer—
such as that there were other patents
that could make the investment worthwhile. Justice Anthony Kennedy
noted that he, too, had expected to
hear that other kinds of patents—on
an industrial process, for example—
would provide the incentive. Kennedy
said: "I just don't think we can decide the case on the ground, oh, don't
worry about investment, it'll come." Hansen agreed with several justices
who suggested that it's not the
isolation of the gene, but the use of
the gene that's inventive and suitable
for patenting. "That's the whole point,
isn't it?" asked Justice Sonia Sotomayor. Hansen replied: "That's
exactly correct." The justices then focused on the
question of whether isolated DNA—
from which sequences that don't code
for proteins (introns) are removed—is
a human invention or a product of
nature. Myriad claims that the isolated DNA of BRCA1 and BRCA2 are its own
inventions. (An isolated DNA may also
be contained in a "complementary
DNA," or cDNA, with an identical
sequence, a useful format for
laboratory work.) Kennedy said that when he first looked at the case, "I
thought that maybe the cDNA was
kind of an economy-class gene" but
then realized that it wasn't; he seemed
confused. Sotomayor suggested that
the whole gene without the introns "is just not found in nature." Hansen
argued that while cDNAs are a
modified form of DNA, the process
used by Myriad to create them involves
"letting nature manipulate" the
sequence, "not the scientist manipulating" it. Scalia confessed,
"You've really lost me when you say
that it's nature that does the alteration
rather than the scientist." Midway through the proceedings, the
spokesperson for the Obama
administration, Solicitor General
Donald Verrilli, rose to present the
government's view. He said that
isolated DNA should not be patentable "because it is simply native DNA
extracted from the body." In contrast,
he added, cDNA should be patentable:
"cDNA is an artificial creation in the
laboratory that doesn't correspond to
anything in your body," Verrilli argued. The problem in his view
appears to be in the wording of
Myriad's patent claim. Soon, the court sought aid in another
metaphor—baking cookies. When
Myriad's attorney, Gregory Castanias,
rose to speak, Sotomayor said, "I can
bake a chocolate chip cookie using
natural ingredients … 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
product from those ingredients." Castanias argued that the combination
of materials in the Myriad invention
was original. But he ran into a series of
objections from Sotomayor based on
the cookie recipe. Stymied, he said:
"That's the problem with using the really simplistic analogies, with all due
respect." Castanias, seemingly in retreat, then
decided to resort to a simple metaphor
himself. "A baseball bat doesn't exist
until it's isolated from a tree," he said.
"But that's still a product of human
invention, to decide where to begin the bat and where to end the bat."
Justice Stephen Breyer challenged him,
noting that briefs filed by scientists
described how BRCA genes are
isolated by a natural process in the
body that clips away introns, unlike the making of a baseball bat. He
demanded to know whether this view
of the science was correct. Castanias
disagreed. Chief Justice John Roberts also
weighed in on the baseball bat, saying
that it is "quite different" from an
isolated gene. As Roberts read the
scientific briefs, he said, "you don't
have to invent the particular segment" of DNA that Myriad patented. "You just
have to cut it off." Castanias disagreed,
describing some of the research that
went into creating a cDNA version of
the BRCA genes in the lab. Roberts
remained skeptical: "I still don't understand … in what sense it's
different than just snipping along the
line." Before adjourning, the justices
explored the possibility of a
compromise decision. Sotomayor, for
example, asked Hansen: "Is there
some value to us striking down
isolated DNA and upholding the cDNA?" Hansen said that although this
was not exactly what his side was
seeking, it would help. He argued that
it would prevent companies like
Myriad from getting patents that can
be used to block research by others "on a part of the human body." The court will deliberate on all this and
is expected to render a decision by 30
June.

Madness