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federal government, and public on the issue, largely THE USPTO, GENE PATENTS, AND ASSOCI-
due to the experiences of women patients with the ATION FOR MOLECULAR PATHOLOGY V.
patents. MYRIAD GENETICS
The second section examines a crucial strategy The USPTO first granted gene patents in the
of the advocacy: centering on the lives of women early 1980s. Notably, the first patents claimed genes
to assert the importance of the effects on patients themselves, including genes existing in the human
when evaluating gene patents and the scope of patent body (2). Over time, however, the USPTO’s practice
regulation. The lawsuit championed the standing evolved, such that it granted patents on “isolated”
of women, including patients and women’s health DNA, defined as a gene excised from a naturally
advocacy groups, in coalition with other professional occurring chromosome (3). “Isolated” DNA patents
organizations, clinicians, and researchers to chal- thus reached any DNA removed from a human cell,
lenge the patents at issue. Thus, unlike most patent regardless of the individual from whom it was taken
litigation, the Myriad suit was filed by many who or the purpose for which it was isolated. Along with
were harmed by the patents but who were not com- isolated DNA claims, the USPTO typically granted
petitors to the patentee. Connecting the experiences patent claims on any and all methods for comparing
of women patients, particularly women of lower eco- the claimed DNA—e.g., comparing a sequence from
nomic classes and women of color, with the effects of a patient with a reference sequence. Any differences
patents on clinical practice and research provided a would suggest genetic variations that could be cor-
rich context through which to understand the impli- related with medical conditions. These method claims
cations of gene patenting and the applicable legal usually did not involve the development of any new
standards. It called on the courts to recognize the processes or tools for genetic analysis; instead, they
larger public impact of patenting on women and their allowed the patentee to stop others from applying
families, medical practice, and scientific research. well-known and long-used methods of genetic anal-
The third section explores how feminist analyt- ysis to the patented gene. With this combination of
ical methods contributed to the lawsuit’s critique patent claims, the patentee could exclude all others
of the United States Patent Office (USPTO) policy from isolating the particular gene or from compar-
that led to the issuance of Myriad’s patents. The pol- ing a patient’s genetic sequence with the reference
icy generally stemmed from a deep skepticism of sequence. In short, the patentee controlled access to
longstanding exceptions to Section 101 of the Patent that portion of the genetic code.
Act. By asserting the vitality of the prohibition on Numerous and diverse individuals and groups
patenting products of nature, laws of nature, and opposed the USPTO practice. As early as 1992, Dr.
abstract ideas, the suit endorsed the importance of a James Watson, a co-discoverer of DNA’s helical struc-
contextual analysis of patent eligibility. Furthermore, ture, resigned his position as Human Genome Project
the litigation exposed how the USPTO’s definition director because he objected to the National Institutes
of “isolated” DNA relied on an understanding of the of Health’s (NIH) procurement of gene patents (4).
patented subject matter that did not reflect scien- By the late 1990s and early 2000s, the scientific and
tific consensus or account for the monopolization of patient communities began to organize concertedly
genetic information but, instead, prioritized ease of against the USPTO’s practice of issuing gene patents
approving patents on genes. Similarly, the issuance (5-9). The National Breast Cancer Coalition asserted
of patents on any method of comparing two genetic that “scientists should have free access to the raw
sequences resulted in maximal intellectual property fundamental data on the human genome” because
protection and restricted the ability of patients to such “unencumbered access would benefit the public
access genetic testing. by providing the greatest opportunity for scientific
The article concludes with observations regarding advancements against diseases” (10).
directions for the future of feminist engagement in Despite this widespread opposition, the USPTO
patent law arising from the Myriad litigation. formalized its policy of granting gene patents in a
2001 regulation. It explained, “an excised gene is