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Blood-Test Case at Top U.S. Court May Send Patent ‘Shock Waves’

December 6, 2011
By

Computer, drug and biotechnology
companies have a message for the U.S. Supreme Court as it
prepares for arguments this week on patents for diagnostic
medical tests: Be careful.

Companies, trade groups and lawyers have filed more than
two dozen legal briefs, many warning that the court’s ruling
might have widespread, unintended ramifications. Each side in
the case, which pits Nestle SA (NESN)’s Prometheus unit against the
Mayo Clinic, says a defeat might stifle innovation.

“The claims have to do with diagnostic methods, but it has
the potential to touch industries we don’t know about,” said
Erika Arner, a Washington lawyer who filed a brief asking the
the court not to restrict software and computer patents.

Because the court will consider the most fundamental
question in patent law — what can be patented — the ruling
“will or could have shock waves across all industries,” said
Arner, who represents SAP America Inc., a business-software
maker based in Newtown Square, Pennsylvania.

The case is the second at the Supreme Court since 2010
concerning what types of inventions are eligible for legal
protection. The latest case, to be heard on Dec. 7, will test
the longstanding principle that natural phenomenon can’t be
patented. A lower court ruled that two patents now owned by
Prometheus were potentially valid because they involve the
application of a law of nature, not the law itself.

Stomach Medicine

The patents cover a method for determining the proper
dosage of thiopurine, a stomach medicine, based on the rate at
which particular patients metabolize the drug. Doctors can use
the method, which involves testing blood for metabolites, to
maximize effectiveness and limit toxic side effects while
treating Crohn’s disease and other inflammatory bowel illnesses.

Prometheus is suing two units of the Mayo Clinic, the not-
for-profit medical practice based in Rochester, Minnesota. Mayo
licensed the patents until 2004, when it created its own test.

Mayo contends the patents would give Prometheus a monopoly
over all uses of the natural relationship between the
metabolites created by thiopurine and the drug’s impact on the
human body. The patents are so broad they would bar doctors
familiar with the Prometheus method from even thinking about the
connection between metabolite levels and the proper dosage for a
patient, Mayo’s lawyers say.

The case is about “how far can patents intrude into a
doctor’s thought processes when a doctor is ordering a routine
test from a lab and then thinking about the results in the
context of patient treatment,” said Jonathan Singer, a lawyer
at Fish Richardson PC in Minneapolis who represents Mayo.

Scientific Principles

Prometheus counters that its patents concern concrete
applications of scientific principles, which the Supreme Court
has long said fall within the scope of the U.S. Patent Act.

The patents cover “processes which apply that knowledge in
a series of physical steps that enable physicians to improve
patient treatment,” Prometheus argued in court papers. Nestle,
based in Vevey, Switzerland, acquired Prometheus this year.

The case may have its greatest impact on the field of
personalized medicine, an emerging practice that involves
determining whether a patient is genetically susceptible to a
particular disease or would be especially responsive to certain
treatments. Two companies focusing on that field, Myriad
Genetics Inc. (MYGN)
and Novartis AG (NOVN), are backing Prometheus.

“The important and developing industry of personalized
medicine would be seriously jeopardized if such substantial and
innovative contributions to science and medicine were denied
patent protection at the doorway of the Patent Act,” Myriad
said in a court filing.

Opposing View

The American Medical Association says the exact opposite is
the case. “Patents on scientific observations threaten to
stifle innovation, including the development of personalized
medicine,” the AMA and 10 other medical groups said in a court
filing backing Mayo.

Mayo also has the support of Verizon Communications Inc. (VZ),
Hewlett-Packard Co. (HPQ), Laboratory Corporation of America and AARP,
which represents older Americans. Prometheus has backing from
trade groups for the drug and biotechnology industries.

The Obama administration is urging the court to take a
middle ground. The government says the Prometheus process
probably isn’t the type of genuine innovation that would warrant
legal protection. At the same time, the administration says the
types of methods involved in the case should at least be
eligible for patent coverage.

Mixing Chemical Substances

“The mixing of chemical substances for a useful result is
a quintessential patent-eligible process,” the government
argued in court papers. A ruling declaring those types of
methods ineligible “would cast doubt on a host of patents for
transformative medical processes that are novel and non-
obvious.”

The high court would be wise to continue to act with
caution in patent cases, says Adam Mossoff, a patent-law expert
who teaches at George Mason University School of Law in
Arlington, Virginia.

“The Supreme Court does not want to formulate a rule that
inadvertently prevents the next wave of innovation,” Mossoff
said. “The potential error cost to future innovation is very
high in these cases.”

The case is Mayo Collaborative Services v. Prometheus
Laboratories, 10-1150.

To contact the reporters on this story:
Greg Stohr in Washington at
gstohr@bloomberg.net;
Susan Decker in Washington at
sdecker1@bloomberg.net.

To contact the editor responsible for this story:
Mark Silva at
msilva34@bloomberg.net;
Michael Shepard at
mshepard7@bloomberg.net.

<!—->

Article source: http://www.bloomberg.com/news/2011-12-05/blood-test-case-at-top-u-s-court-may-send-patent-shock-waves-.html

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