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664 PARK FEMINIST CHALLENGE TO GENE PATENTS 665

Eventually, Myriad decided to offer testing for large genetic counselor plaintiffs, Breast Cancer Action, crucial to some patients’ medical and personal constitutional argument raised by plaintiffs: the fail-
rearrangements but decided to market the test as and the Boston Women’s Health Book Collective decision-making. Myriad’s “isolated DNA” patents ure of the patents to promote the progress of science
a separate test (“BRCA Analysis Rearrangement stated that their practice and activities were restricted reached the DNA of every person in the United States. and the useful arts, as mandated by Article I. Unlike
Testing,” or BART), charging most patients an addi- because they could not offer patients information For women with family histories of cancer, isolated Europe, the U.S. patent system does not generally
tional $700. Myriad continued to treat BART as an about options other than Myriad for genetic testing, DNA was not just a chemical created in a lab. It was allow for consideration of ethical concerns or the
add-on test despite guidelines from the National which they would do once the monopoly ended (14). the blueprint for how their cells and bodies would public interest in making decisions about whether
Comprehensive Cancer Network recommending That these different stakeholders joined together to function and could disclose whether they, their chil- to grant patents (33). The patent system is basically
that all patients who are advised to obtain genetic bring suit showed that this patent dispute was not dren, and their relatives faced a much higher risk set up to presume that approved patents promote
testing receive large rearrangement testing unless just between a patentee and potential competitors of cancer in their lifetimes. This understanding of progress (34). But “just as the act of invention can-
they already know of a specific familial mutation but implicated broader issues of access to healthcare, “isolated DNA” was key to the product of nature not stand apart from the community that integrally
(30). Plaintiffs Vicky Thomason and Kathleen Raker barriers to scientific inquiry and research, and the argument ultimately accepted by the government fosters and supports the act of inventions, neither
were both patients who obtained Myriad’s standard ethical provision of medicine. and the Court. The government, through the Solicitor can deployment of the invention occur without con-
“Comprehensive BRACAnalysis” testing and received As plaintiffs, the patients asserted their right to General, ultimately came to support the invalidation sideration of the impact that invention may have on
negative results. They were advised to obtain the challenge patents that interfered with their ability to of patents on isolated DNA, in direct contradiction of the wider community”—including women patients
BART test but could not afford the extra cost, and obtain crucial information about their own genomes. the USPTO’s position. Acting Solicitor General Neal (35). The plaintiffs challenged an abstract analysis of
thus they, like many other patients, did not obtain Women’s experiences with gene patents had not been Katyal deployed a test for patentable subject matter progress by voicing their personal and collective nar-
the fuller picture of their inherited risk (14). considered in approving them. Bringing suit, there- that emphasized the patient’s connection to this DNA ratives, demanding that their experiences be counted
The patents also prohibited patients from obtain- fore, was a formal mechanism through which they and the information it contained. He argued that if in defining what counts as progress under Article I (36).
ing testing through another laboratory that could could contest the patents, arguing that their experi- one could use a “magic microscope” and zero in on Women’s experiences with the patents were magni-
confirm results they obtained from Myriad. Plaintiff ences were central to understanding the validity of and view a particular segment of the chromosome in fied through the amicus briefing as well as the media
Genae Girard obtained genetic testing shortly after gene patents. the body, the sequence would be the same upon iso- advocacy that accompanied the litigation. Nearly
her breast cancer diagnosis at 36 years old and tested This approach was met with mixed results in the lation and thus should be understood as a product of every brief filed in support of petitioners documented
positive for a BRCA2 mutation (14). She wanted courts. In an early ruling, the district court con- nature (31). The “magic microscope” test reinforced the numerous detrimental consequences of these
confirmatory testing of that result from another lab cluded that the patients, like the other plaintiffs, had the notion that Myriad’s patents perversely claimed patents for women’s health (37-40). Likewise, the
before making major medical decisions, including legal standing to bring the suit because they were what existed in the human body. media attention on the case primarily explained the
about whether she should undergo a prophylactic meaningfully prepared to engage in contributory Likewise, the Supreme Court dismissed the court issue through the experiences of the patients (41,42).
oophorectomy and mastectomy. She learned that, infringement by taking advantage of alternatives to of appeals’ decision because it saw the patents as Asking the woman question about gene patents both
due to the patents, Myriad was the only facility in Myriad’s BRCA testing (15). However, the U.S. Court claiming portions of a patient’s genome. Judge Lourie influenced the legal proceedings and raised the vis-
the U.S. that could provide full genetic sequencing of Appeals for the Federal Circuit eventually rejected of the Federal Circuit was the only judge who con- ibility of a highly technical legal and scientific issue
because other labs were forbidden from doing so. this argument, concluding that the only plaintiff with sidered the case to completely adopt the view that with the public. Ultimately, women’s lived experiences
All of these patients’ stakes in the case were closely standing was Dr. Harry Ostrer, a geneticist who had isolated DNA should be patentable because chemical with the patents shaped the government’s position,
tied to the interests of the four medical associations, directly received a threat from Myriad and who was bonds are broken in the process of isolation. He said, the courts’ views, and the public’s concern about gene
six geneticists, two genetic counselors, and two wom- capable of and would immediately begin performing “the claimed isolated DNA molecules are distinct patenting.
en’s health and breast cancer advocacy groups—Breast BRCA genetic testing but for the patents (31). The from their natural existence as portions of larger
Cancer Action and the Boston Women’s Health Book U.S. Supreme Court did not take up the standing entities, and their informational content is irrelevant APPLYING FEMINIST ANALYTICAL METHODS
Collective, the publisher of Our Bodies, Ourselves— question beyond agreeing that Dr. Ostrer had stand- to that fact” (31). The Supreme Court rejected this TO GENE PATENTS
that were also plaintiffs. United as plaintiffs, they ing (1). view, stating that “Myriad’s claims are simply not In addition to centering on women’s experiences
revealed the problematic operations of the patents Despite the later denial of their standing in the suit, expressed in terms of chemical composition, nor do with gene patents, the litigation drew from feminist
from their different vantage points. The geneticists the patients’ experiences informed the debate beyond they rely in any way on the chemical changes that perspectives in developing its critique of gene patents.
stated that they were fully capable of and meaning- their status as plaintiffs. As feminist scholars have result from the isolation of a particular section of I discuss here how feminist approaches contributed
fully prepared to infringe the patents by performing observed about scientific study, picturing the object DNA” (1). Isolated DNA could not have “markedly to the analysis by illuminating the ideologies that
BRCA genetic testing, including for the patient plain- of knowledge as an actor and agent itself transforms different characteristics from any found in nature” were at the root of the gene patent policy.
tiffs (15). Likewise, the associations of pathologists the entire project of producing social theory; here, when the entire purpose of Myriad’s testing was to Feminists have exposed how seemingly neutral
and geneticists stated that they opposed the patents stressing the agency of the patients influenced how inform a patient about whether she had inherited rules and procedures can mask the ideologies of the
because of how they interfered with patient care, and the legal arguments were crafted and received (32). certain genetic mutations. decision-makers and reinforce the power of those in
their members attested that they too were meaning- First, their presence in the suit ensured a spotlight Second, the patents’ damaging effects on wom- dominant positions. Applied to intellectual property
fully prepared to engage in infringing activity. The on DNA as the embodiment of genetic information, en’s lives became a major component of a novel law, Dan Burk has observed: