Supreme Court's Breyer May Have To Sit Out Patent Case On Diagnostic Tests
07 December 2011 - 1:11AM
Dow Jones News
U.S. Supreme Court Justice Stephen Breyer may have to sit out a
high-stakes patent case Wednesday, thanks to a belated disclosure
that one of the parties has a new corporate owner.
The Supreme Court has been preparing to hear arguments in a case
involving Prometheus Laboratories Inc. that examines whether
companies and inventors should be allowed to patent medical
diagnostic tests, a key legal question in the growing field of
personalized medicine.
Prometheus on Tuesday informed the court that it has been
acquired by a subsidiary of Nestle S.A. According to Justice
Breyer's most recent financial disclosure report, he owns shares of
Nestle. In general, justices recuse themselves from cases in which
they have a financial interest in one of the litigants.
A court spokeswoman had no immediate comment on whether Justice
Breyer still holds the stock or what he might do in response to the
Prometheus disclosure.
If Justice Breyer still owns Nestle shares, it's possible he
could sell them and still participate in the court's
deliberations.
When the case first arrived at the court, Prometheus was a
privately held company. It became a Nestle subsidiary in July.
After the Nestle transaction closed, Prometheus did not file a new
corporate disclosure statement with the Supreme Court informing the
justices of the change in ownership.
A lawyer for the company confirmed that he provided the court
with the information Tuesday, but otherwise declined to
comment.
Breyer's absence could change the complexion of the case. In a
2006 dissent, he questioned the validity of certain types of
diagnostic-test patents. His dissent criticized the high court for
dismissing a case that raised the issue without announcing a
decision.
The Prometheus case, which gives the court a second chance to
rule on the issue, pits doctors and hospitals against the
biotechnology and pharmaceutical industries.
Companies are patenting more tests that help doctors set drug
dosages or determine whether a person can benefit from a particular
treatment. Screening tests that identify people's risk factors for
disease also are getting patented more frequently.
Leading medical groups argue that many of the new patents run
afoul of prohibitions on patenting abstract ideas or laws of
nature. They say patents like Prometheus's could impede the
practice of medicine and raise the costs of medical treatment.
Biotech and drug companies say patents on diagnostic tests have
spurred advances in personalized medicine, or tailoring treatments
to a person's unique biology. They say disallowing the patents
could discourage investment and stall progress.
At issue are two Prometheus patents for a test that helps
doctors set drug dosages for patients with Crohn's disease.
The company filed a patent-infringement lawsuit against the Mayo
Clinic, which wants to offer its own test. The clinic is arguing to
the Supreme Court that Prometheus improperly seeks to claim a
patent monopoly on the right to observe a natural phenomenon.
A federal trial judge in California ruled the Prometheus patents
invalid, but they were reinstated by a special appeals court in
Washington.
If the Supreme Court were to split 4-4 in the case, the appeals
court ruling for Prometheus would be affirmed.
Thousands of patents for diagnostic tests have been issued over
the last two decades and could be affected by the court's
ruling.
The case is Mayo Collaborative Services v. Prometheus
Laboratories Inc., 10-1150. A ruling is expected by the end of
June.