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TITLE:  Over Patents, Another Outbreak
        U.S., Foreign Diagnostic Firms Compete for Rights to Virus Tests
SOURCE: The Washington Post, USA, by Michael Barbaro
        http://www.washingtonpost.com/wp-dyn/articles/A57444-2003May14.html
DATE:   May 15, 2003

------------------ archive: http://www.gene.ch/genet.html ------------------


Over Patents, Another Outbreak
U.S., Foreign Diagnostic Firms Compete for Rights to Virus Tests

A mysterious disease emerges almost overnight, jumping borders and
uniting scientists in a worldwide effort to identify the source. They
succeed. But before there is time to celebrate the collaboration, a
divisive race begins: to patent the virus and secure commercial rights to
a diagnostic test based on their discoveries.

It was the mid-1980s and the disease was AIDS. Today, history appears to
be repeating itself with SARS.

Scientists in the United States, Hong Kong and Canada are seeking patents
for the virus suspected to cause severe acute respiratory syndrome and
for its genetic code. If approved, the patents could translate into broad
rights over SARS testing, requiring any company selling a diagnostic tool
to pay the virus's owner royalties. The result could be years of legal
wrangling over who was first to discover the agent.

As companies around the world rush to develop tests for the deadly virus,
those competing claims could raise a host of legal concerns, complicating
development and distribution of a desperately needed tool. Despite the
risks, those companies say they are pressing ahead for reasons including
public service and the promise of future profits. Tests could be used on
an experimental basis while regulatory issues are being worked out, they say.

Without a rapid, reliable way to verify SARS cases, doctors cannot devise
a plan to combat the virus or to determine how far it has spread. SARS
symptoms -- fever, dry cough and muscle aches -- are strikingly similar
to more common infections like influenza, forcing many countries to
quarantine tens of thousands of people, perhaps needlessly.

Depending on how narrow the SARS patent claims are and how many are
ultimately granted, diagnostic companies may need to negotiate a daunting
patchwork of license agreements to either perform or market their tests,
executives and patent attorneys say.

"There may be confusion in the beginning over who owns what," said
Laurence McCarthy, chairman and chief technology officer of Herndon-based
Focus Technologies Inc., which is developing a laboratory test for the
virus. That, he said, could "make negotiations very difficult."

With the future of the virus unclear -- it could explode into a worldwide
pandemic or be contained within months -- diverting financial and
scientific resources toward the development of a SARS test could become
even riskier if companies face the prospect of a patent lawsuit after
spending millions on the process.

"If people think they are going to have liability down the road for
patent infringement, they may be reticent to invest" in SARS tests, said
Michael J. Shuster, an intellectual property lawyer with Fenwick & West
LLP in San Francisco. "There could be a chilling effect."

Yet, diagnostic companies are already seeking licenses to protect their
work. In the past 10 days, before the ink on the first round of patent
filings dried, executives began approaching applicants to discuss
potential agreements, say public health officials and diagnostic executives.

Two decades ago scientists working on the virus that causes AIDS butted
heads over patent rights. The French and the Americans clashed not only
over who discovered the virus but over who held the commercial rights to
a blood test that emerged from the research. The result was widespread
confusion among diagnostic companies over who owned the patent to their
AIDS tests.

The bitter dispute did not end until the spring of 1987, when President
Ronald Reagan and French Prime Minister Jacques Chirac brokered an
extraordinary agreement to split the patent rights and donate the
royalties to AIDS research.

"There is no change in the rush to patent discoveries this time," said
Barry R. Bloom, dean of the Harvard School of Public Health in Boston.
"But I would hope there is a change in the civility."

A SARS patent could net the United States a large -- and rapid --
financial payoff. Royalties from the AIDS antibody test yield millions of
dollars each year for both France and the United States.

With SARS, though, the financial stakes are not yet as high. The Food and
Drug Administration has not approved a diagnostic test, drug or vaccine
for the virus. But the groundwork is being laid for a protracted battle.
In the United States, the Centers for Disease Control and Prevention is
asking for a patent for the coronavirus believed to cause SARS and its
genetic code. Scientists in Hong Kong are seeking their own patent, and
Canadian scientists have filed a patent for the virus's genes.

In a briefing with reporters last week, CDC Director Julie L. Gerberding
said that U.S. public health officials fear they could be blocked from
researching the virus if it is patented by foreigners. "From our
standpoint, it's a protective measure to make sure that the access to the
virus remains open," she said.

Companies developing a test for SARS include Swiss drugmaking titan F.
Hoffmann-La Roche Ltd.; testing leader Abbott Laboratories of Abbott
Park, Ill., in partnership with Celera Diagnostics of Alameda, Calif.;
and Quest Diagnostics Inc. of Teterboro, N.J. On the smaller end, there
are Focus Technologies and EraGen Biosciences Inc. of Madison, Wis.

Most, if not all, of the companies plan to distribute and perform the
tests on an experimental basis, a shortcut that U.S. regulators allow in
designated laboratories as long as doctors and patients are aware a test
is investigational.

FDA Commissioner Mark B. McClellan has said the agency is working hard to
help manufacturers figure out how to validate their diagnostic tests. But
he said that to date, no manufacturer has formally applied for approval.
"I guarantee you we are going to work very quickly to get those through"
once applications are filed, McClellan said.

Companies caution that at this early stage, no test will be perfect.
Scientists may have decoded the genetic map of the virus, but much is
still unknown about SARS. For example, it is unclear at what stage of
infection the virus is detectable or how long it persists in the body --
information that will influence when and how often a person is tested.
Scientists are also unsure about what kind of material is ideal for
testing: a patient's blood, stool or a throat swab.

All of the diagnostic companies are relying on a rapid technology called
polymerase chain reaction, or PCR, that detects pieces of the
coronavirus. Doctors favor PCR because the alternative, antibody testing,
measures the body's response to the virus. Results from such tests can
take weeks, at which point an infection may have run its course and
perhaps even killed a patient. Quest says it is developing an antibody
test for in-house use.

The CDC has developed both types of tests itself, and it has already
distributed the antibody test to dozens of U.S. laboratories. But the
agency will not make enough tests to meet growing worldwide demand.

Commercial firms are moving quickly. Artus GmBh of Germany last month
distributed 6,000 test kits, developed in connection with the Bernhard
Nocht Institute in Hamburg, to researchers in Asia. EraGen and Focus
Technologies said last week that their tests are complete. Neither Celera
Diagnostics nor Quest will say when they expect to finish theirs.

A major hurdle for diagnostic companies is obtaining human samples of
SARS to test their technology against. The CDC has confirmed only a
handful of cases in the United States to date, creating a limited supply
of testing materials. Companies can request samples from outside the
country, but that can raise thorny legal questions.

"Thirty years ago, you sent a person out to the heart of Africa and he
picked up Ebola and brought it home in his luggage," said Peter
Heseltine, medical director for infectious diseases at Quest. "Not anymore."

The CDC is trying to help by offering companies samples of the virus. So
far, dozens have requested them, said James Hughes, the CDC's director of
infectious diseases. "We have very limited specimens to work with," he
said, something he called a "major constraint."

Roche has established a network of hospitals in Asia, including in Hong
Kong and Taiwan, that are sending the company samples of what are
believed to be SARS-infected stool and blood. The company hopes this
competitive advantage will lead to wide adoption of its test, which is
expected to be distributed to laboratories by the end of July.

Other companies are doing without human samples. EraGen, for example, has
so far tested its PCR technology with a synthetic version of the SARS
virus, while Quest has asked the CDC for human samples. In the long run,
regulators say, any company hoping for FDA approval of a diagnostic test
for SARS will have to prove its technology against a wide range of such
specimens.

As they wait to learn the fate of SARS patents, many say they will
proceed with their test development, confident no legal barrier is likely
to prevent the use of a vital public health tool.

"If multiple patents are filed, somehow, someway, there will be broad
access to the technology," said McCarthy of Focus Technologies. "This is
such a devastating disease, it's not only logical but morally imperative."