[Ip-health] California federal courts invalidates patents on prenatal gene test

Krista L. Cox krista.l.cox at gmail.com
Fri Nov 8 11:48:23 PST 2013


California Moves Shake Up Prenatal Gene Testing Market
Eliot Marshall

Two decisions in California last week promise to give a boost to a new
technique for prenatal genetic testing, opening the field to increased
competition and expanding the market for the tests.

On 30 October, a federal district court judge in San Francisco invalidated
a patent owned by Sequenom of San Diego on a novel test for Down syndrome
that sieves fetal DNA from a mother's blood and checks it for risky
abnormalities. Three other companies planning to offer similar blood tests,
which obviate the need for taking samples from the womb, now won't worry as
much about being sued over patents. In a separate windfall, California
agreed on 1 November to subsidize these fetal DNA tests—known as
noninvasive prenatal testing—through the state's genetic diseases program,
which screens about 400,000 women a year.

The decision to nullify Sequenom's U.S. patent (number 6,258,540) seems to
have rattled investors, with the company's stock price dropping 23% on 31
October. Company executives issued statements saying that they "vigorously"
disagree with the ruling, which "misapplies or ignores the controlling
law," and will appeal.

In her opinion, Judge Susan Illston of the federal court for northern
California wrote that, in light of recent U.S. Supreme Court decisions,
Sequenom should never have received a patent in 2001 on its prenatal
testing methods. They are based on work done in the late 1990s by Yuk-Ming
Dennis Lo of the Chinese University of Hong Kong and James Stephen
Wainscoat, then of the University of Oxford in the United Kingdom, who
developed a way to use paternal DNA to isolate cell-free fetal DNA
circulating in a pregnant woman's bloodstream, making invasive procedures
such as amniocentesis unnecessary. The DNA can then be checked for
chromosomal ab normalities such as trisomy 21—the cause of Down syndrome.

But Illston wrote that Sequenom's patent was built on discoveries that for
the most part were not very inventive, citing the Supreme Court's 2009
rejection of a blood test patent held by Prometheus Laboratories of San
Diego. Sequenom was trying to claim ownership of lab processes such as
amplifying DNA fragments that were already "well-understood" and "routine"
when the patent was issued, she wrote. The exception was Sequenom's novel
use of paternal DNA as a screening tool. But DNA is "a natural phenomenon,"
she decided, and therefore not patentable. In June, the Supreme Court had
denied claims on the BRCA breast cancer genes held by Myriad Genetics of
Salt Lake City for the same reason, and Illston cited the Myriad decision
to buttress her conclusion.

"It's a huge victory for us and for the entire field," says Ken Song, CEO
of Ariosa Diagnostics of San Jose, California, the firm that started this
legal brawl. Ariosa, Sequenom, and two other California companies are
offering similar cell-free prenatal tests. Ariosa was the first to sue, in
2011, seeking to prevent Sequenom from coming after it for patent
infringement. An initial decision favored Ariosa, was appealed to a higher
court, and came back to Illston's court for a second review in light of
recent Supreme Court decisions.

If Illston's decision stands, the court ruling is a "big deal for the
field" of DNA testing, says Henry Greely, an expert on law and bioethics at
the Stanford University Center for Law and the Biosciences in Palo Alto,
California. Limiting the reach of patent claims in this way will be good
for public health, he argues. "This will help keep the prices down and
provide a driver for general competition," Greely predicts.

Some worry that the decision could scare potential investors away from the
diagnostics industry. Ariosa's Song doesn't think so. A former venture
capitalist, he says he's confident investors can live with the rule
changes. They won't "give you a bunch of money because you have a patent on
a protein or marker," Song suggests. Instead, he says, they will have to
vet the feasibility of business plans more carefully. Song acknowledges
that he has patents, too, but insists they're solid ones, based on
"technology we developed ourselves."

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