By
Donald Zuhn —
Last
week, the District Court for the Southern District of New York ruled in favor
of the plaintiffs in Association of
Molecular Pathology v. U.S. Patent and Trademark Office, finding the claims
of several patents directed to the BRCA1 and BRCA2 genes invalid as
encompassing non-statutory subject matter (see
"Round One Goes to the ACLU"). On Thursday, we discussed the parties'
reaction to the decision (see "AMP
v. USPTO: What the Parties Are Saying About the Decision"). Today, we take a look at what others
have been saying or reporting about the decision.
•
In "US Judge Strikes Down Patent on Cancer Genes,"
the Associated Press reports on
comments made by Dr. Mary-Claire King,
the University of Washington scientist who demonstrated in 1990 that a single
gene on chromosome 17, later known as BRCA1, was responsible for many breast
and ovarian cancers. According to
the AP report, Dr. King called the ruling "very good news for women who
are potential carriers" of cancer genes and their families, saying that
the decision "will open the door to truly competitive testing," and
"will allow the science to drive the field instead of the monopolistic
approach that has dominated."
In the article, Dr. King contends that gene patenting "makes no
sense," and was "like patenting one's thumb."
•
In "Judge Invalidates Human Gene Patent,"
The New York Times reports that Bryan
Roberts, a Silicon Valley venture capitalist, believes the decision will push
more gene discovery research to universities, saying that "[t]he
government is going to become the funder for content discovery because it's
going to be very hard to justify it outside of academia." The
Times also notes that Dr. Kenneth Chahine, a visiting law professor at the
University of Utah who filed an amicus
brief in support of Myriad, predicts that if the decision is upheld, "[t]he
[biotech] industry is going to have to get more creative about how to retain
exclusivity and attract capital in the face of potentially weaker patent
protection."
•
In a statement
released by the Biotechnology Industry Organization (BIO), BIO President and
CEO Jim Greenwood notes that "[a]s explained in the ruling [on March 29],
the District Court's determination is only a preliminary step in the legal
process that does not affect how the U.S. Patent and Trademark Office (PTO)
evaluates patent applications relating to DNA-based inventions." Mr. Greenwood also notes that "[f]rom
the mass production of life-saving medicines by cell cultures to the screening
of our blood supply for life-threatening viruses, patented DNA molecules have
been put to countless uses that have benefited society," contending that
"[p]reparations of isolated and purified DNA molecules, which alone can be
put to use in these ways, are patentable because they are fundamentally
different from anything that occurs in nature."
•
In "Is the DNA Patent Dead?",
CNNMoney.com opines that while
"[b]iotech companies argue that a judge's ruling against DNA patents will
slow their life-saving work," they should instead "move quickly to
come up with a better, more collaborative way to protect and share
findings," arguing that it was "[t]ime to get creative." The CNNMoney
report states that:
The issue of patenting an "isolated"
gene, which is a copy of a "real" gene, has always stretched
credulity. For years it has
angered researchers and patient groups who want a system that does not create
gene monopolies that can hinder further research into the genetic roots of
disease, can charge exorbitant prices for tests, and can block attempts by
patients to get second opinions on diagnostic tests that remain in many cases
experimental.
The
report also states that:
The whole framework around grabbing
control [of genes] revolved around creative lawyering, with companies over the
last few years figuring out ways to adopt intellectual property laws better
suited for, say, toasters — or man-made drugs — than to biological structures
that seem to be more like leaves or sunshine. Now it's time for that innovative spirit to move away from
the general counsel's office and back to the lab.
In
an acknowledgement (however slight) of Myriad's position, CNNMoney quotes Myriad General Counsel Richard Marsh as saying that
"[t]he patent system works."
Without gene patents, Mr. Marsh asks "who is going to do the work
and spend the money to make this product accessible to people?"
•
In "The Court Ruling That Says 'You Can't Patent Nature',"
the DailyFinance reports on comments
made by Daniel Ravicher, the executive
director of the Public Patent Foundation (PubPat) and co-counsel for plaintiffs
in AMP v. USPTO, who says that "Judge
Sweet's decision thoroughly analyzes the law and the science. You cannot patent nature. We fully expect the decision will be
upheld on appeal." The report
also quotes James Love, co-chair of the intellectual property committee of the
Trans Atlantic Consumer Dialogue and director of Knowledge Ecology
International, as arguing that Myriad's patents "were anti-science,
anti-innovation, and anti-consumer."
•
In "AMP's Victory Has 'Very Limited' Legal Effect But Carries 'Far-Reaching
Implications',"
GenomeWeb reports that Barbara
Caulfield, a
patent lawyer with Dewey & LeBoeuf who filed an amicus brief in support of the plaintiffs, called the decision
"ground-breaking," adding that "[n]ow all naturally occurring
gene patents are invalid by the reasoning of this opinion. This is really a sea change for patents
in life sciences."
•
In a New York Times article entitled
"In Patent Fight, Nature, 1; Company, 0,"
the newspaper reports that Dr. Wendy Chung,
a genetics professor at Columbia University and a plaintiff in the case, opined
that "[i]f this holds up on appeal, this is a game changer."
•
In "After Patent on Genes Is Invalidated, Taking Stock," The New York Times also reports on comments made by Dr. James Evans,
a professor of genetics at the University of North Carolina School of Medicine,
who asserts that there is thriving competition with regard to testing for
mutations that cause cystic fibrosis or Huntington's disease despite the fact
that no biotech company has exclusivity.
Dr. Evans states that "[i]t's quite demonstrable that in the
diagnostic area, one does not need gene patents in order to see robust
development of these tests."
•
In "Could Biotechs Survive Without Gene Patents?"
the Palm Beach Post quotes John Ball,
executive vice president of the American Society for Clinical Pathology
(and another plaintiff in the case), as saying that the decision is "good for
patients and patient care, it's good for science and scientists. It really opens up things."
•
In "Judge Rules Gene Patents Invalid,"
UPI.com reports that Myriad President
and CEO Peter Meldrum believes that "[i]f the federal circuit court
upholds this decision it, unfortunately I think, would be very bad for the
biotech industry."
•
In "Myriad Ruling: Just BRCA Genes or Underpinnings of Biotech?"
BioWorld reports on a suggestion by
Beth Arnold of
Foley Hoag LLP that although the District Court's ruling was specific to genes,
the rationale in the case could extend to patents covering other biological molecules, such
as polypeptides or siRNAs. BioWorld also reports that JMP
Securities analyst Charles Duncan believes, based on discussions he has had with a number
of intellectual property experts, that the Federal Circuit is "not
necessarily going to support" Judge Sweet's opinion.
•
In "Gene Patents Are the Talk of the Town Following Surprise Court Ruling,"
the Los Angeles Times reports that
Dr. Lisa Haile of DLA Piper also believes
that the decision is not just about gene patents, but rather suggests that if
DNA cannot be patented because it is created by nature, then proteins, enzymes,
bacteria, and other biological entities may also be unpatentable natural
products. In the article, Dr.
Haile states that "[t]hat's where I think this [decision] could get blown
out of proportion." The Times also reports that American
Civil Liberties Union (ACLU) attorney Sandra Park states that the gene
patenting issue "is not a partisan issue," arguing that "[a] lot
of very conservative religious folks have come out against gene patents because
they believe God has given us these genes, and they should not be parsed out
for patents."
•
In "When One Patent Means So Much,"
The Motley Fool notes that on the day
after the decision, Myriad's stock fell 5%. On Tuesday, Myriad stock (MYGN) closed at $23.44 after
opening at more than $25 on March 29 (the day of the decision). When assessing potential losers as a result of the decision,
The Motley Fool speculates that:
Universities will also be big losers if
all gene patents are invalidated because they hold many of the patents, which
they license out to drug and genetic-testing companies. Investors can't buy shares in public
and most private universities, but they do indirectly benefit from the royalties
that flow into universities. Much
of the basic science is carried out at universities, and the loss of royalty
income may affect the ability to perform the basic research that drug companies
base their drug discovery on.
For
information regarding this and other related topics, please see:
• "'60 Minutes' and 'Newshour' Take Different Apporaches to Covering Gene Patenting Story," April 5, 2010
• "AMP
v. USPTO: What the Parties Are Saying About the Decision,"
April 1, 2010
• "Caught
in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims,"
March 30, 2010
• "Round
One
Goes to the ACLU," March 29, 2010
•
"Debating
Gene Patents – Round Four," February 10, 2010
• "Newsweek
= Newspeak on Gene Patenting," February 8, 2010
• "Everybody
Knows — The Boston Globe Weighs in on Gene Patenting,"
February 1, 2010
• "The
USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
•
"Top
Stories of 2009: #4 to #1," January 4, 2010
•
"Gene
Patenting: Australian Potpourri," December 28, 2009
•
"Science
Progress Article Examines Impact of Gene Patents on Research,"
December 21, 2009
•
"Gene
Patenting Debate Continues – Round Three," December 17, 2009
•
"BRCA
Patent Suit to Continue in Southern District of New York,"
November 2, 2009
•
"Empirical
Research Fails to Support Gene Patenting Ban," October 22,
2009
•
"The
Tragedy of a Bad Idea," August 25, 2009
•
"Gene
Patenting Debate Continues – Round Two," August 4, 2009
•
"The
Unwanted Consequences of Banning Gene Patenting," June 16, 2009
•
"Falsehoods,
Distortions and Outright Lies in the Gene Patenting Debate,"
June 15, 2009
•
"Gene
Patenting Debate Continues," June 9, 2009
•
"Association
for Molecular Pathology v. U.S. Patent and Trademark Office,"
May 17, 2009
•
"Court
Report: Special Edition," May 13, 2009
In a recent notice in the Federal
Patent Docs 