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FEMINIST CHALLENGE TO GENE PATENTS 663

that also correlated with breast and ovarian cancer rearrangement testing while offering very limited
risk, designated as BRCA2. Starting in 1998, Myriad financial waivers (24). Myriad’s monopoly also barred
obtained a series of patents relating to the BRCA1 researchers from conducting genetic testing as part
and BRCA2 genes and sent cease-and-desist letters of studies and sharing subjects’ results with them,
to other laboratories that were conducting genetic usually at no or low cost (25). Thus, low-income
testing. Many labs complied, while others were sued. patients like Ceriani and Fortune could not access
Through the aggressive enforcement of its patent testing because other labs could not offer testing
rights, Myriad became in short order the only lab to them either commercially or through research
offering genetic sequencing of BRCA1 and BRCA2 to studies.
patients in the U.S., even though other labs were fully The patents notably affected research about
capable of providing testing using different methods hereditary risk. Myriad was able to amass the larg-
than those employed by Myriad. est database about BRCA1 and BRCA2 variants
Thus, the patents on the BRCA1 and BRCA2 genes in the world; moreover, they stopped sharing the
not only affected women because of the relation- information with the medical and scientific com-
ship of these genes with two cancers that women munities, in violation of professional standards set
disproportionately experience but also because the out by the American Medical Association (26,27).
government policy and Myriad’s exercise of its rights Thus, it became difficult for other researchers to study
limited women’s medical options. Myriad’s patent the significance and prevalence of many mutations.
enforcement illustrated how the USPTO’s practice This was especially problematic for women from
particularly harmed women. While some argued that minority groups. While genetic make-up is distinct
the USPTO practice was not problematic because from social constructions of race, racial minorities
many patentees chose not to enforce gene exclusivity, are less likely to obtain genetic testing in the U.S.,
Myriad’s conduct demonstrated that the public could and genetic variants that may appear more often in
not rely on patentees’ largesse. Indeed, a survey of these patients are less likely to be understood by the
laboratory directors in the U.S. showed that 25% medical community (28). Plaintiff Runi Limary, an
had stopped offering a genetic test they developed Asian-American patient, confronted this problem.
because of a gene patent and that 53% had decided She was diagnosed with breast cancer at only 27
not to develop or perform a genetic test in the first years old but could not afford to get BRCA genetic
place because of a gene patent (23). testing until two years later when she got new health
The lawsuit brought the impact of these patents insurance that offered coverage. She received the test
on women to the fore in a variety of ways. First, six result of “genetic variant of uncertain significance,”
women patients were plaintiffs. They sought access indicating that Myriad had identified a variant but
to testing that Myriad did not provide, and their did not know whether it was correlated with higher
experiences illustrated the wide-ranging harms for cancer risk (14). Because the patents barred others
patients. Lisbeth Ceriani and Patrice Fortune were from providing her with additional testing and gath-
both breast cancer patients with Medicaid insurance ering more information about the variant, she felt that
coverage who were advised by medical professionals she could not determine the best medical course for
to obtain BRCA genetic testing. They alleged that herself.
Myriad refused to accept their insurance coverage, The lack of competition also meant that Myriad
and, because they could not afford to pay out-of- had little incentive to improve on the accuracy of
pocket for testing and there were no alternative labs, its testing. For years, Myriad’s standard test did not
they did not obtain testing (14). While the cost of identify large genetic rearrangements known to the
performing genetic testing dropped dramatically scientific community, and Myriad refused to give
from 1998 to 2013, Myriad increased the price for permission to other labs to perform such testing.
its BRCA genetic testing substantially over that Consequently, a 2006 study found that approximately
time period, ultimately charging $3,340 for its stan- 12% of women from high-risk families had likely
dard BRACAnalysis test and an additional $700 for received false negative test results from Myriad (29).