[Ip-health] U.S. Supreme court rejects two medical test patents

Joao Carapinha joao at carapinha.com
Wed Mar 21 07:35:19 PDT 2012

U.S. Supreme court rejects two medical test patents

The U.S. Supreme Court rejected two patents on a method for monitoring
a patient's blood to determine the best dosage for a drug, a decision
that may affect the profitability of personalized medicine.

The justices unanimously overturned on Tuesday a ruling by a U.S.
appeals court that allowed the patents for Nestle SA unit Prometheus,
with the high court saying that companies could not patent
observations about a natural phenomenon.

The patent challenge, brought by a unit of the Mayo Clinic, had been
closely watched because it could affect the burgeoning field of
personalized medicine, which can also involve determining whether a
patient is genetically susceptible to a disease or which patient would
respond best to which treatment.

The Supreme Court's opinion, written by Justice Stephen Breyer,
concluded that Prometheus' process for monitoring a patient, and
adjusting dosage as needed, could not be patented.

"We conclude that the patent claims at issue here effectively claim
the underlying laws of nature themselves. The claims are consequently
invalid," Breyer wrote in the 24-page opinion.

The biotech industry warned the Supreme Court's ruling could threaten
hundreds or thousands of exiting patents, and deter future patent
applications for personalized medicines, many of which are the product
of lengthy and expensive research.

"We are surprised and disappointed in the Court's decision," said Hans
Sauer, a deputy general counsel for the Biotechnology Industry

Other patent experts contacted by Reuters also said the ruling could
have a chilling effect on similar patents.

In the Prometheus process, doctors are told to monitor patients taking
synthetic thiopurine compounds to treat gastrointestinal disorders
such as Crohn's disease and other auto-immune illnesses.

The goal is to hit certain levels to ensure the best outcome with the
fewest side effects. Prometheus markets a diagnostic test that uses
the technology covered by the two patents.

A unit of the Mayo Clinic, based in Rochester, Minnesota, argued that
the method used to determine dosage was akin to a natural phenomenon
and thus not eligible to be patented.

The fight began in 2004, when Mayo, which had been a Prometheus
customer, said it would begin using its own version of the $260 test.
Prometheus sued for patent infringement, and Mayo's test has never
come to market.

Mayo won the first round when a district court invalidated the
patents. But the U.S. Court of Appeals for the Federal Circuit, which
hears patent appeals, twice held that Mayo was wrong and ruled that
the method Prometheus came up with was a "transformation" that could
be patented.

The American Medical Association and 10 other medical groups supported
Mayo, while trade groups for the drug and biotechnology industries
supported Prometheus.

Courtenay Brinckerhoff, a Foley & Lardner LLP patent expert, said that
there could be less funding for research because of this decision.
"This is a disruption of the status quo," she said.

But Bruce Wexler, a patent litigation expert with the law firm Paul
Hastings LLP, said the top court's decision should have a limited
effect because the court itself sought to refrain from straying much
beyond the patents in the lawsuit and precedent.

"The Supreme Court in this opinion made the decision depend
specifically on the facts and its prior precedent rather than make a
broad pronouncement about a technical field of science," he wrote in
an email.

Breyer, for his part, argued that allowing the Prometheus patents
could potentially stifle innovation.

"This court has repeatedly emphasized a concern that patent law not
inhibit future discovery by improperly tying up the use of laws of
nature and the like," he wrote in the decision.

"Rewarding with patents those who discover laws of nature might
encourage their discovery. But because those laws and principles are
'the basic tools of scientific and technological work,' ... there is a
danger that granting patents that tie up their use will inhibit future
innovation," he wrote.

Experts are also watching legal battles over patents held by Myriad
Genetics. Last July, the U.S. Court of Appeals for the Federal Circuit
allowed Myriad to patent two genes that account for most inherited
forms of breast and ovarian cancer.

The case has been appealed to the Supreme Court, which has not said if
it would take it up.

Nestle bought San Diego-based Prometheus in July 2011, making it part
of Nestle Health Science.

The Supreme Court case is Mayo Collaborative Services v. Prometheus
Laboratories, No. 10-1150.

(Reporting by Diane Bartz and James Vicini; Editing by Lisa Von Ahn
and Tim Dobbyn)

João L. Carapinha

Pharmaceutical Policy Analyst

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