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660 PARK FEMINIST CHALLENGE TO GENE PATENTS 661

federal government, and public on the issue, largely THE USPTO, GENE PATENTS, AND ASSOCI- eligible for a patent as a composition of matter or as nature, laws of nature, and abstract ideas in viola-
due to the experiences of women patients with the ATION FOR MOLECULAR PATHOLOGY V. an article of manufacture because that DNA mole- tion of Section 101 of the Patent Act, which defines
patents. MYRIAD GENETICS cule does not occur in that isolated form in nature” patentable subject matter; second, they contended
The second section examines a crucial strategy The USPTO first granted gene patents in the (3). The USPTO did not address how patents on that the patents violated the First Amendment and
of the advocacy: centering on the lives of women early 1980s. Notably, the first patents claimed genes isolated DNA effectively locked up that portion of the Progress Clause of the Constitution by claiming
to assert the importance of the effects on patients themselves, including genes existing in the human the human genome from future research, as isolation thought and knowledge.
when evaluating gene patents and the scope of patent body (2). Over time, however, the USPTO’s practice is a prerequisite step for any substantial examination Each court that reviewed the case approached the
regulation. The lawsuit championed the standing evolved, such that it granted patents on “isolated” or testing of a person’s gene. legal issues differently. As a preliminary matter, U.S.
of women, including patients and women’s health DNA, defined as a gene excised from a naturally By the mid-2000s, the USPTO had granted District Judge Robert Sweet determined that all plain-
advocacy groups, in coalition with other professional occurring chromosome (3). “Isolated” DNA patents thousands of patents on different human genes to tiffs had legal standing to challenge the patents (15).
organizations, clinicians, and researchers to chal- thus reached any DNA removed from a human cell, companies and universities pursuant to its policy This was a major ruling affirming the importance
lenge the patents at issue. Thus, unlike most patent regardless of the individual from whom it was taken (11). The courts regularly heard lawsuits involving of the plaintiffs’ claims, as traditionally the parties
litigation, the Myriad suit was filed by many who or the purpose for which it was isolated. Along with gene patents, but they were not asked to rule on the to a patent suit are entities whose patents are being
were harmed by the patents but who were not com- isolated DNA claims, the USPTO typically granted basic question of whether genes are patentable subject infringed or entities that are threatened with suit for
petitors to the patentee. Connecting the experiences patent claims on any and all methods for comparing matter under the Patent Act (12). infringing on a patent. By recognizing the standing of
of women patients, particularly women of lower eco- the claimed DNA—e.g., comparing a sequence from The filing of the Myriad litigation in 2009 was an all the plaintiffs, Judge Sweet acknowledged that many
nomic classes and women of color, with the effects of a patient with a reference sequence. Any differences explicit challenge to this status quo, a case brought others have a stake in challenging patents, includ-
patents on clinical practice and research provided a would suggest genetic variations that could be cor- in order to further the public interest (13). The case ing patients and women’s health advocacy groups.
rich context through which to understand the impli- related with medical conditions. These method claims was originally filed in the U.S. District Court of the In 2010, in a decision that shocked many, he then
cations of gene patenting and the applicable legal usually did not involve the development of any new Southern District of New York on behalf of twenty granted summary judgment to the plaintiffs, find-
standards. It called on the courts to recognize the processes or tools for genetic analysis; instead, they plaintiffs, including four organizations represent- ing that none of the patent claims survived Section
larger public impact of patenting on women and their allowed the patentee to stop others from applying ing pathologists and geneticists, six geneticists, two 101 of the Patent Act (16). He concluded that the
families, medical practice, and scientific research. well-known and long-used methods of genetic anal- genetic counselors, a women’s health advocacy group, isolated DNA claims covered products and laws of
The third section explores how feminist analyt- ysis to the patented gene. With this combination of a breast cancer patients advocacy group, and six nature because isolated DNA embodies the same
ical methods contributed to the lawsuit’s critique patent claims, the patentee could exclude all others women patients against the USPTO, Myriad Genetics, genetic code as DNA in the body. He also deter-
of the United States Patent Office (USPTO) policy from isolating the particular gene or from compar- and the University of Utah, which co-owned the mined that the method claims were invalid because
that led to the issuance of Myriad’s patents. The pol- ing a patient’s genetic sequence with the reference patents (14). The case challenged claims on “iso- they covered any method for comparing two genetic
icy generally stemmed from a deep skepticism of sequence. In short, the patentee controlled access to lated” DNA, covering DNA coding for the BRCA1 sequences—including mental comparison—and
longstanding exceptions to Section 101 of the Patent that portion of the genetic code. and BRCA2 proteins, DNA with as few as 15 of the because the similarity or differences between two
Act. By asserting the vitality of the prohibition on Numerous and diverse individuals and groups nucleotides of the BRCA1 gene, DNA coding for genetic sequences is a law of nature and not some-
patenting products of nature, laws of nature, and opposed the USPTO practice. As early as 1992, Dr. naturally-occurring mutated forms of the BRCA2 thing invented by Myriad. Because he invalidated the
abstract ideas, the suit endorsed the importance of a James Watson, a co-discoverer of DNA’s helical struc- protein, and DNA with specified, naturally-oc- claims under Section 101, he dismissed without prej-
contextual analysis of patent eligibility. Furthermore, ture, resigned his position as Human Genome Project curring mutations. For example, claim 6 of Patent udice the constitutional claims against the USPTO.
the litigation exposed how the USPTO’s definition director because he objected to the National Institutes 5,837,492 covered all mutated forms of the BRCA2 Myriad appealed the ruling, and, in July 2011, the
of “isolated” DNA relied on an understanding of the of Health’s (NIH) procurement of gene patents (4). gene associated with cancer risk without specifying U.S. Court of Appeals for the Federal Circuit issued a
patented subject matter that did not reflect scien- By the late 1990s and early 2000s, the scientific and the mutations or the types of associated cancers: split decision, reversing in part Judge Sweet’s opinion
tific consensus or account for the monopolization of patient communities began to organize concertedly “An isolated DNA coding for a mutated form of (17). The panel concluded that only one plaintiff,
genetic information but, instead, prioritized ease of against the USPTO’s practice of issuing gene patents the BRCA2 polypeptide set forth in SEQ ID No.2, Dr. Harry Ostrer, had standing. Judges Lourie and
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 wherein said mutated form of the BRCA2 polypeptide Moore then wrote separately to uphold the patents
sequences resulted in maximal intellectual property fundamental data on the human genome” because is associated with a susceptibility to cancer.” The case on isolated DNA. Judge Lourie zeroed in on chemical
protection and restricted the ability of patients to such “unencumbered access would benefit the public also challenged method claims where the purported differences between isolated DNA and DNA in the
access genetic testing. by providing the greatest opportunity for scientific method included any way of comparing or analyz- body, namely that covalent bonds are broken when
The article concludes with observations regarding advancements against diseases” (10). ing two genetic sequences (e.g., a BRCA1 sequence DNA is isolated. While Judge Moore expressed doubt
directions for the future of feminist engagement in Despite this widespread opposition, the USPTO from a patient against the reference sequence) for about whether full-length genes could be patented,
patent law arising from the Myriad litigation. formalized its policy of granting gene patents in a the purpose of determining whether a mutation she concluded that the patents were valid because
2001 regulation. It explained, “an excised gene is exists. Plaintiffs raised two legal arguments: First, industry had relied on USPTO policy for years. Judge
they argued that the patents claimed products of Bryson dissented, noting that Myriad’s claims on