Exerpt from: DIA Daily enewsletter featuring summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. Subscribe to the DIA Daily.
Sign up for DIA's Global SmartBrief: Break through the information clutter with FREE, twice-weekly email publication that gives quick, easy-to-read summaries of articles relevant to you. Get the latest news in drug development innovations worldwide wherever you are on your laptop or smart phone with SmartBrief’s wireless compatibility.
The
Supreme Court on Monday heard arguments in a key case about whether or not
human DNA could be patented by biomedical firms. Media coverage portrayed the
justices as skeptical about the assertions of Utah-based Myriad Genetics Inc.,
which holds patents on two genes.
The AP (4/15, Holland) reports that the Supreme
Court "seemed worried" during Monday arguments "about the idea
of companies patenting human genes." Noting that the US Patent and
Trademark Office "has been awarding patents on human genes for almost 30
years," the AP adds that "opponents of Myriad Genetics Inc.'s patents
on two genes linked to an increased risk of breast and ovarian cancer say such
protection should not be given to something that can be found inside the human
body." Myriad argues that "the company's genes can be patented
because the DNA that Myriad isolated from the body has a 'markedly different
chemical structure' from DNA within the body."
The Wall Street Journal (4/16, Bravin,
Subscription Publication) reports that challengers to the Myriad patents,
including a medical researchers' group represented by the American Civil
Liberties Union, argue the genes themselves, like all natural products, cannot
be patented, but methods for isolating them or using them might be.
The New York Times (4/16, Liptak, Subscription
Publication) reports that in "lively" exchanges, the justices
"struggled to find a narrow way to rule on the momentous question of
whether human genes may be patented." Noting that the court's ruling
"will shape the course of scientific research and medical testing,"
and "may alter the willingness of businesses to invest in the expensive work
of isolating and understanding genetic material," the Times adds that the
Obama Administration, through Solicitor General Donald Verrilli Jr.,
"largely supported" the challengers, and argued that the court's
ruling last year in Mayo Collaborative Services v. Prometheus Laboratories
"suggested that the correct answer in the case argued Monday was that
merely isolating a gene was not sufficient for patent protection."
USA Today (4/16, Wolf) reports, "Using
analogies ranging from baseball bats to chocolate chip cookies, a majority of
justices said Myriad Genetics' isolation of the breast cancer genes was largely
a force of nature, not invention. At the same time, the justices indicated a
compromise could be in the works, siding with the company on its patent for a
type of DNA that goes beyond merely extracting the BRCA1 and BRCA2 genes from
the body."
The Washington Post (4/16, Barnes) reports,
"Even the normally confident justices expressed some trepidation as they
considered the complexities of patent law and the mysteries of
biochemistry." The Post notes that the justices' "caution is
warranted," as the ruling "could shape the future of medical and
genetic research and have profound effects on pharmaceuticals and genetically
modified crops."
The Los Angeles Times (4/16, Savage) reports,
"During the argument Monday, most of the justices questioned the decision
of the U.S. Patent and Trademark Office to grant Myriad Genetics a patent on
two isolated gene sequences that signal a high risk of breast or ovarian
cancer."
Bloomberg News (4/16, Stohr, Decker) reports
that "the case has ramifications for the growing field of personalized
medicine as well as efforts to map the human brain and discover new uses for
embryonic stem cells." Challengers to Myriad's patents include the
American Medical Association, Association for Molecular Pathology, and the American
College of Obstetricians and Gynecologists.
Politico (4/16, Norman) notes that "much
of the research community has bristled against patenting genes for decades,
even as the policy at the patent office has consistently favored it. The
American Medical Association weighed in against the practice, but some biotech
interests argue that outlawing the patenting of genes could discourage
companies from investing in genetic research."
In a second article, the Los Angeles Times (4/15, Brown) reports that,
according to Dr. Eric Topol, director of the Scripps Translational Science
Institute in La Jolla, "Myriad's patents on the genes 'have really held
back the field,' as the company has issued cease-and-desist letters to some
academic centers attempting to study the BRCA1 and BRCA2 genes." Topol
claimed that "Myriad's patents also have a chilling effect on genomics
research because the company's tight control over BRCA1 and BRCA2 test results
has prevented scientists from accessing useful data about genes and associated traits."
Although supporters claim that the "patent only covers isolated molecules
that are outside the body," ABC News (4/16, De Vogue) quotes Sandra Park,
a senior attorney with the ACLU, as stating: "The patents are framed as
covering and claiming the isolated genes. What that means is that the moment
the gene is removed from the cell, Myriad owns it. The scope of the patent is
incredibly broad." The ACLU argues "that although Myriad has not
exercised its authority to stop all research, it has a monopoly on clinical
testing in the U.S., and the ability to discourage research because
laboratories are dissuaded from pursuing scientific work that requires using
patented genes." In an amicus brief on behalf of the American Medical
Association and others, Lori B. Andrews, a professor from Chicago-Kent College
of Law, claimed that "patents on human genes impede the provision of health
care, thwart public health objectives, shackle innovation and violate ethical
tenets."
On its website, NBC News (4/15, Williams) reports that the
ACLU claims that Myriad's exclusive patent "creates a monopoly that denies
women the ability to seek a second opinion, based on another test of the
genetic material, and dissuades other laboratories from pursuing research on
the patented genes." The ACLU contends that, because Myriad's breast
cancer "test costs roughly $3,000, many women cannot afford it or lack the
necessary insurance coverage." Regarding availability of the test, Myriad
"says the cost of the test is covered by private insurance, Medicare, and
Medicaid."
The Salt Lake (UT) Tribune (4/16) reports that
"one area where ACLU attorney Christopher Hansen seemed to stumble was
when justices pressed him on whether invalidating gene-related patents would
mean companies and investors would be much less likely to pour money into
research and development. Hansen said that a company could get recognition for
its work and that money for research would always be available, a statement
that Kennedy said wasn't sufficient." The Tribune notes that "the
court is expected to rule before the end of the summer."
BBC News (4/16) reports that "the
ramifications of any decision by the Supreme Court are uncertain," but
"one thing is certain: A deeper understanding of how genes affect health
is already starting to transform medicine. It is helping to deliver targeted
drugs to the right patients as well as tests for cancer risk genes."
Also reporting on the story are Reuters (4/16, Hurley), McClatchy (4/16, Doyle), CNN (4/15, Mears), NPR (4/15, Totenberg), Daily Mail (UK) (4/16, Lawson), HealthDay (4/16, Steele), and MedPage Today (4/16, Pittman).
More Commentary. In a column for USA Today (4/15, Turley), George Washington
University law professor Jonathan Turley writes, "The Myriad case raises
fundamental questions on the meaning of property, including the treatment of
the human genome as akin to a Hoover vacuum. As the Supreme Court deliberates
over the very ownership of our genes, there has never been a national debate
over the commoditization of American life. If we do not want to live by the
leave of a new property class, we have fight for our rights."
In his Los Angeles Times (4/15, Healey) column, Jon
Healey writes that "the justices were clearly concerned about preserving
innovation in medicine and biotechnology," but "the issue presented
by Myriad Genetics' patents on the BRCA genes cuts both ways, leading to a
potential split among the justices." Healey notes that, "during
Monday's oral argument, several justices seemed worried about the implications
of allowing patents over something extracted from nature."
However, in a "Blowback" opinion piece in the Los Angeles Times (4/14, Meldrum), Peter D.
Meldrum, president and chief executive of Myriad Genetics, writes in support of
Myriad's patents on BRCA1 and BRCA2, which he claims "do not cover human
genes from anyone's body." Claiming that the patents were a "product
of creative, human ingenuity," Meldrum adds, "Without our patents,
our tests could not have been developed." He concludes that "the
issue before the Supreme Court is not about Myriad," but rather it
"is about the consequences to the life sciences - and for
innovation."
In his column for the Washington Post (4/16) , Dana Milbank writes
that "Based on the justices' questioning, there was little doubt that
corporations such as Myriad have a legitimate claim to the DNA in our bodies.
The argument was mostly about whether corporations own the material itself or
merely have the exclusive rights to use our genes for research and
commerce."
Sign up for DIA's Global SmartBrief: Break through the information clutter with FREE, twice-weekly email publication that gives quick, easy-to-read summaries of articles relevant to you. Get the latest news in drug development innovations worldwide wherever you are on your laptop or smart phone with SmartBrief’s wireless compatibility.
