* Myriad Genetics sought to patent genes linked to cancer
* Decision expected by the end of June
* Myriad shares close down 3.8 percent
(Recasts lead, adds comment on ethics in paragraphs 14-15)
By Jonathan Stempel
Nov 30 The U.S. Supreme Court on Friday agreed
to decide whether human genes can be patented, a hotly contested
issue with broad practical and ethical consequences for the
future of gene-based medicine for millions of people worldwide.
The nation's highest court in a brief order agreed to review
a case over whether Myriad Genetics Inc may patent two
genes linked to hereditary breast and ovarian cancer.
In a 2-1 ruling on Aug. 16, a panel of the U.S. Federal
Circuit Court of Appeals in Washington, D.C., upheld the
biotechnology company's right to patent "isolated" genes that
account for most inherited forms of the two cancers.
That ruling also denied Myriad's effort to patent methods of
"comparing" or "analyzing" DNA sequences.
The appeal against Myriad and the University of Utah
Research Foundation was being pursued by a variety of medical
associations and doctors, led by the Association for Molecular
Pathology. Their case is being handled by lawyers for the
American Civil Liberties Union.
Myriad shares fell as much as 9 percent after the Supreme
Court agreed to hear the appeal and ended the trading session
down $1.13, or 3.8 percent, at $28.72 on the Nasdaq.
PLANNING OF MEDICAL CARE
Sandra Park, a lawyer for the ACLU Women's Rights Project
who worked on the appeal, in a phone interview called Friday's
decision to take the case a "huge step" toward ensuring the
provision of needed medical care and research and that patients
can access their own genetic information.
She estimated that more than 4,000 of the roughly 22,000
genes in the human genome have U.S. patents.
"For many people, understanding their genetic risk of
disease is crucial to planning medical care," she said. "People
need to understand that risk so they can plan for screening and
other major medical decisions with their doctors."
Supporters of Salt Lake City-based Myriad, in contrast, have
said denying patent protection could slow advances in
personalized medicine, which uses genetic tests to identify
specific therapies for individual patients.
Peter Meldrum, Myriad's chief executive, said in a statement
that the Supreme Court's ultimate decision could affect the
providing of medical treatment to hundreds of millions of
people. He said Myriad's own diagnostic test has helped nearly 1
million people learn about their risk of hereditary cancer.
"The discovery and development of pioneering diagnostics and
therapeutics require a huge investment and our U.S. patent
system is the engine that drives this innovation," he said.
Many outside groups supported the petitioners, including the
AARP, the American Medical Association, the American Society of
Human Genetics, the March of Dimes Foundation, the National
Breast Cancer Foundation and several women's health groups.
"Some critics say it is unjust to give a company a monopoly
over something as intrinsic to people's health as their genes,"
said Josephine Johnston, a research scholar at The Hastings
Center, a independent bioethics research institute in Garrison,
New York, who is not involved in the Myriad case.
"From an ethics perspective, one could argue that genes are
owned by everybody, and that patenting them amounts to a
commodification of an element of the human body," she added.
THE LAWS OF NATURE
The genes in question, BRCA1 and BRCA2, can be used to
detect risk of breast and ovarian cancer and aid in treatment
Women who test positive using Myriad's gene test,
BRACAnalysis, have an 82 percent higher risk of breast cancer
and 44 percent higher risk of ovarian cancer in their lifetimes.
But critics said Myriad's patents are illegal, prohibit
standard clinical testing of the BRCA1 and BRCA2 genes and
restrict scientific research and access to medical care.
The Federal Circuit ruled in Myriad's favor, by the same 2-1
vote, in July 2011.
Eight months later, the Supreme Court unanimously held, in a
case involving a blood test developed by Prometheus Laboratories
Inc, that companies could not patent observations about natural
A week after that decision, the Supreme Court set aside the
Myriad ruling and directed the Federal Circuit to revisit the
case, leading to the August panel ruling.
"Everything and everyone comes from nature, following its
laws, but the compositions here are not natural products,"
Circuit Judge Alan Lourie wrote for the panel majority in
August. "They are the products of man, albeit following, as all
materials do, laws of nature."
Circuit Judge William Bryson dissented, saying a ruling for
Myriad could pre-empt methods for whole genome sequencing.
THE WHIM OF A COURT
In a brief arguing against the patenting of genes, Dr. James
Watson, who helped discover the double helix structure of DNA,
said: "DNA's importance flows from its ability to encode and
transmit the instructions for creating humans.
"Life's instructions ought not be controlled by legal
monopolies created at the whim of Congress or the courts."
In opposing the latest appeal, Myriad said the Federal
Circuit applied the correct legal standard and that most of the
plaintiffs recruited to join the lawsuit lacked standing.
A decision by the Supreme Court is expected by the end of
The case is Association for Molecular Pathology et al v.
Myriad Genetics Inc et al, U.S. Supreme Court, No. 12-398.
(Reporting by Jonathan Stempel in New York; Additional
reporting by Bill Berkrot and Ransdell Pierson; Editing by Kevin
Drawbaugh, Carol Bishopric, Tim Dobbyn and Todd Eastham)