By Donald Zuhn --
In March, the District Court for the Southern
District of New York found
the claims of
several of Myriad Genetics patents (directed to the BRCA1 and BRCA2 genes) invalid, ruling in favor of the plaintiffs in Association of
Molecular Pathology v. U.S. Patent and Trademark Office (see "Round One Goes to the ACLU"). Following the decision, we discussed
the parties' reaction to the outcome (see "AMP v. USPTO: What the Parties
Are Saying About the Decision"),
and then examined what others were saying or reporting about the decision (see
"AMP v. USPTO: What Everyone Else Is Saying"). With the deadline for appealing the lower court's decision less than two weeks away (defendants have until June 18 -- or 60 days
after judgment was entered on April 19 -- to file a notice of appeal), we take a second look at what others have been saying about the decision over the past two months.
• In "IP Position Critical to Biotech Investment: Looming Battle over Gene Patenting Could Jeopardize Medical Advances," Genetic Engineering & Biotechnology News contends that:
Whether patents are for genes encoding therapeutic proteins such as insulin and growth hormones, antibodies such as Herceptin® and Rituxan®, or mutated genes that are indicative of breast or ovarian cancer, precluding patents on this subject matter will halt the forward progress that has been made in the biotech industry over the past 30 years since [Diamond v.] Chakrabarty was decided.
The article suggests that "[i]n essence, the
lawsuit challenges the entire field of gene patenting when it seems that the
true question is whether our healthcare system provides access to specific
genetic tests (or therapeutics)."
If plaintiffs ultimately prevail, the article asks whether the
plaintiffs "next go after Genentech because it has patents and a market
for Herceptin for Her2 positive breast cancer; Pfizer and AstraZeneca, for
their patents on statins; Biogen-Idec for Rituxan for the treatment of certain
types of B-cell non-Hodgkin lymphoma; or Bristol-Myers Squibb, which sells
Erbitux?" With respect to the
impact the case might have on investment, Robert More of Frazier Healthcare
Ventures observes that he has "seen quite a few technologies over the
years that would be of potential great benefit to patients, but the
intellectual property was simply not there to support protecting the product
from fast followers in the market place," adding that "because of the
enormous sums of money required to discover, develop, test, and approve
anything in the healthcare sector, quite aside from the time it takes, IP is
critical." Mr. More also
suggests that "20 years or less of exclusivity . . . is a small price for
us to pay for innovation."
• In "How Gene Patents Harm Innovation,"
Forbes.com declares that the decision marks "the first battle in which the
future of medicine confronted the past -- and the future won." The article argues that:
Far from hurting biotech innovation, eliminating pure gene patents will greatly speed innovation in the biotech sector. Instead of tying up basic genetic information with patents, the biotech industry will have to become more like computer industry. It will compete on the quality of its machines and software algorithms, not by making scientific discoveries and locking up the information for decades with a patent. Numerous high-tech gene companies will be able to flourish thanks to superior technology.
• In "Who owns your genes?" a
San Francisco Chronicle editorial predicts that the case will eventually reach
the Supreme Court and advises that "[t]he high court should strike it
down," arguing that "[g]enes are the common property of humanity, not
the private fiefdoms of individual companies."
• In "End of Gene Patents Will Help Patients, Force Companies to Change," WIRED opines that "[w]hen you went to sleep last Sunday night [March 28th], 20 percent of your genome belonged to a researcher or company[, and o]ne day later, following federal district court judge Robert Sweet’s ruling, it belonged to you." Discussing the plaintiffs' case, the article states that:
Beyond the absurdity of gene patents -- imagine patenting gold, the human arm, or gravity -- [plaintiffs] said that patents had hurt patients, stifled business and stunted research. Myriad’s monopoly prevented women from getting second opinions on their breast-cancer gene tests. More broadly, existing gene patents dissuaded researchers from studying sections of the genome that were already claimed, and high licensing fees discouraged would-be entrepreneurs.
In the article, 23andMe CEO Linda Avey states that
"[m]y hope is that this ruling stands and companies will need to actually
innovate and create new advances based on genetic findings, not depend on
sole access to them." If the
decision stands, she predicts that "[r]ather than relying on obscure
patent language and legal strategies, companies will need to develop products
that are competitively positioned."
• In "The absurdity of patenting genes,"
The Guardian offers a few reasons "why gene patents like [Myriad's] are
stupid." While acknowledging
that "[p]atents are a sensible idea, because people are more likely to
invest in innovation if they believe it will give them a competitive advantage
over other people, and because patents allow people to share their discoveries
safely, instead of monetising their advantage by keeping a discovery
secret," the article states that "patents also act as a barrier to
innovation, and gene patents bring these disadvantages [sic] into stark
relief." On the
"chilling effect" gene patents alledgedly have on clinical activity and research,
the article states that:
Almost all basic science research on the BRCA1 breast cancer gene over the past 12 years has infringed Myriad's patent, and although the company has tended not to go after basic science researchers, they have never promised that they won't in the future, so this academic research on a major risk factor for a major killer -- the most common cancer in women worldwide -- continues only with Myriad's indulgence, making it risky work.
• In "Gene Patenting: Biotech Can Blame Itself for this PR Nightmare," BNET refers to the "60 Minutes" report on the case back in April (see "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story"), and asks:
[W]hy didn’t Myriad explain how much money they’ve spent developing life-saving diagnostics? Why didn’t they produce patient spokespersons who’ve been saved from cancer and think $3,200 is a pretty reasonable price to pay for it?
• In "Myriad elicits a genetics tempest," The Salt Lake Tribune quotes Myriad executive vice president and in-house legal counsel Richard Marsh as stating that:
In my mind I just cannot fathom the time, effort and cost it took us to try to get the testing to where it is today. Most of the plaintiffs in this case are academic centers, and I just cannot see an academic center spending hundreds of millions of dollars employing a thousand people all to try to promote the science.
• Finally, in "Elements of humanity should not be
a St. Petersburg Times editorial states that "for years companies have
been turning our genes into products, patenting them and keeping people from
accessing their own genetic information," and opines that "[t]hese
patents on nature should never have been granted." The article notes that "[t]he
[District Court's] ruling has thrown the biotech industry into a tizzy,"
but declares that "the judge's reasoning is airtight." On the issue of innovation, the piece
Biotech firms argue that they need the patents to spur investment in study. But this is a red herring. There are all sorts of ancillary parts of genetic research that are subject to patent and hugely profitable. Instead, the ruling will be a boon to genetic science and public health. Competition in the field of genetic testing will bring costs down, giving access to more people to know what disease proclivities they carry.
For information regarding this and other related topics, please see:• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'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