(Photo: Karen Bleier, AFP/Getty Images)
By Richard Wolf, USA TODAY
WASHINGTON -- The Supreme Court expressed grave doubts Monday about
the legality of a company's exclusive patent on the genes that can
identify an increased risk of breast and ovarian cancer.
analogies ranging from baseball bats to chocolate chip cookies, a
majority of justices said Myriad Genetics' isolation of the breast
cancer genes was largely a force of nature, not invention.
same time, the justices indicated a compromise could be in the works,
siding with the company on its patent for a type of DNA that goes beyond
merely extracting the BRCA1 and BRCA2 genes from the body.
the court strikes down the broader patent, it would be a victory for a
coalition of doctors, geneticists, researchers, women's groups and
cancer patients who have fought for four years to open up research into
the genetic markers for breast and ovarian cancer.
much that decision would hinder research and development by the
biotechnology industry remains in doubt, depending on whether the court
finds a compromise that allows some of Myriad's work to be considered
At its most basic level, the question before the court was: Can genes be patented?
1984, the U.S. Patent and Trademark Office has granted more than 40,000
patents tied to genetic material. Armed with those patents since the
late 1990s, Myriad has tested more than 1 million women for mutations
that often lead to breast and ovarian cancer.
Most women who want
testing must pay its price - $3,340 for the breast cancer analysis and
$700 for an additional test, called BART, which picks up a genetic link
in about 10% of women who test negative the first time. Myriad officials
say about 95% of its patients receive insurance coverage, often without
co-payments, so most patients pay only about $100.
Sotomayor likened Myriad's claim to a patent on the ingredients used to
make chocolate chip cookies, such as sugar and flour. Chief Justice John
Roberts said it was not akin to patenting a baseball bat extracted from
a tree, since considerable work is involved in making the bat.
have to invent it," Roberts said of the baseball bat. When it comes to
the isolated gene used to find mutations that can cause breast or
ovarian cancer, he said, "You just have to snip it off."
parade of analogies extended from plants in the Amazon to organs in the
body as the justices - experts in the law, but not science - attempted
to determine how much ingenuity was involved in Myriad's nearly
20-year-old discovery. The general conclusion was that Myriad deserved
credit for the process of isolating the gene and its use - but not the
The justices seemed to align themselves with the
position taken by the Department of Justice, which split with the
government's patent office -- labeled "patent-happy" by Justice Elena
Kagan. Solicitor General Donald Verrilli sided with the patent's
challengers, coordinated by the American Civil Liberties Union, but
indicated a lesser portion of Myriad's claim would be acceptable.
patent law is filled with uneasy compromises," said Justice Stephen
Breyer, the court's patent expert and author of its most recent case
invalidating a patent on the basis that it involved a law of nature.
While the process and use of natural phenomena often can be patented, he
said, a patent is more difficult to get for "the thing itself."
of the court's most conservative justices appeared to support Myriad's
claim. Justice Samuel Alito said isolated DNA "has a very different
function" from DNA that exists in nature. He and Justice Antonin Scalia
worried that without the benefit of a patent, companies would not
conduct valuable research.
But a majority seemed to agree with
Justice Sonia Sotomayor's description of the breast cancer gene isolated
by Myriad. "In isolation, it has no value," she said. "It's just nature