The gene patenting issue's road through the U.S court system has been long, full of curves and detours. It took an encouraging turn on Wednesday, however, when the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PPF) announced that they will petition the Supreme Court to rule on the high-profile case involving Myriad Genetics and its patents on human genes associated with breast, ovarian and other forms of cancer.
Myriad's patents on the BRCA 1 and BRCA 2 genes prohibit all other unauthorized companies, testers, and medical practitioners from screening, analyzing and reporting findings related to these genes. Exclusive rights over the genes themselves give Myriad a monopoly on the current and future testing market, and have made screening prohibitively expensive for many. This has fueled outrage amongst women's health groups and patient organizations since 10 percent of all breast cancer cases are related to screenable mutations on these genes, and those who carry the mutations have an 85 percent risk of developing cancer. Various environmental, public interest, and human rights groups have additionally objected on the grounds that genes are naturally occurring products of nature and represent, as UNESCO puts it, the "common heritage of humanity."
Judicial intervention started out 2009 in the favor of gene patent opponents when New York District Court Judge Robert Sweet ruled that genes are naturally occurring subject matter and thus unpatentable. Much to the chagrin of ACLU, PPF and the thousands of plaintiffs that they represent, the bulk of this ruling was overturned this past July by a Federal Appeals court - a decision that refortified Myriad's stranglehold over BRCA 1 and 2. The three-judge panel's decision to uphold Myriad's patents came despite an amicus brief filed by the U.S. Department of Justice stating that naturally occurring genes should not be eligible for patenting.
According to ACLU attorney Sandra Park, the announcement of the Supreme Court appeal in October is meant to coincide with National Breast Cancer Awareness Month. She expects that the Court will decide by spring of 2012 whether or not it will hear the case.
Although the Supreme Court refuses to hear most of the appeals that are brought before it, many are hopeful that the Myriad case will be granted its fifteen minutes on the Hill. University of Utah visiting professor of law Kenneth Chahine predicts that the snowballing national profile of the gene patenting issue, along with the fact that the Court recently accepted a related case, may help the ACLU's chances of acquiring a hearing. Chahine also speculates, optimistically so, about the possibility of a ruling that swings back into the plaintiffs' favor:
"I would say the ACLU probably has a better chance at the Supreme Court than they do at the Federal Circuit…It's not unusual for the Supreme Court to disagree, or at least partially disagree, with the Federal Circuit."
Noting the broad array of public interests, the gravity of the issue itself, and pattern of judicial discord at the District and Federal Appeals levels, one would naturally assume that the Myriad case fits the bill for the Supremes. Deciding big issues is their job after all.
The rising notoriety of the Myriad case brings into stark relief the complexity and consequence of research science as a public interest issue. While many proponents of gene patents see it simply as an issue of incentivizing innovation (which many, however, have argued that gene patenting does not do), larger questions related to public good, health and morality are undoubtedly at play. Ellen Matloff, a genetic counselor at Yale for 15 years and plaintiff in the Myriad case, notes the implications of private ownership of human genes for family health: "It is going to impact them [patients], their children, their siblings their grandchildren, their nieces and nephews, and from a clinician's standpoint it is horrifying." Furthermore, public discomfort with patenting and commercializing human tissues for profit only seems to be growing, both at home and abroad.
Much is bound to happen between now and a Supreme Court hearing for the Myriad case (if it is indeed accepted for appeal). What we can hope for in the meantime, perhaps, is that big biotech's prerogative to "occupy" the human genome will be likened in the public eye to other "profit-first people-second"' corporate practices with which the current generation seems to be so disillusioned.
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Posted in Biotech & Pharma, Doug Pet's Blog Posts, Patents & Other IP, Reproductive Justice, Health & Rights, Sequencing & Genomics, US Federal
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