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A feminist approach encourages us to ask not so “Isolation” of something from nature was sufficient
much where such intellectual property doctrines to create patentable subject matter even where there
require us to draw the line between creativity that was no further change to the naturally-occurring
is rewarded and creativity that is not, as it requires DNA. The policy of granting patents on isolated DNA
us to ask why such criteria was selected in the therefore reinforced the prevailing USPTO practice
first instance. The places where lines have been of permissively granting patents on natural prod-
drawn may tell us something about the reason ucts. It also provided a bright-line rule that could be
for the lines. (43) administered relatively simply by patent examiners,

This inquiry was of central importance in the reflecting the general preference for relying on formal
context of gene patents because the practice rested rules within patent law while ignoring the impact of
on an understanding of patent law and USPTO policy patents (47).
that had been in place for decades. Querying why the Second, the “isolation” rubric attempted to dis-
lines were drawn to permit patents on isolated DNA tance the patented DNA from the people from whom
and any method for analyzing sequences was central it came. Many defenders of the gene patent policy
to challenging them. reasoned that at least it did not allow patent claims
At the time the lawsuit was filed, the Section 101 to be asserted on genes in the body (48). Plaintiffs
doctrine prohibiting patents on products of nature, responded that claims on “isolated DNA” were a
laws of nature, and abstract ideas was largely dor- “lawyers’ trick” designed to get around the prohi-
mant. Many construed the Supreme Court’s decision bition on patenting the genes in the human body
in Diamond v. Chakrabarty to permit the patenting (49). Empowered by the USPTO, the patentee could
of “anything under the sun made by man,” an expan- prevent any person from obtaining his or her own
sive view of patentable subject matter (44). While genetic information and appropriate that informa-
in a 2006 dissenting opinion Justice Breyer raised tion by being the sole provider of genetic testing. As
concerns about whether a patent on a method of a result, Myriad exclusively amassed information
diagnosis violated Section 101, most patent lawyers about millions of people’s genomes (26). Today, the
did not see the Section 101 exceptions as meaningful struggle to control that data continues (50,51).
limitations on patents (45). They also did not view the Third, dubbing “isolation” of the gene as the point
exceptions as including “products of nature.” Myriad’s of invention underscored a more fundamental debate
attorneys explicitly argued that products of nature or about differing scientific understandings of DNA.
natural products are patent-eligible under Section The claims paradoxically defined DNA’s patent eli-
101 and should be distinguished from unpatentable gibility according to its chemical composition while
“laws of nature, natural phenomena, and abstract implicitly recognizing that isolated DNA was sig-
ideas” (46). nificant only because of the biological importance
This approach to patent eligibility set up a system of the genetic information encoded therein. At the
that allowed for the patenting of nearly anything time Myriad discovered the sequences of the BRCA1
that was extracted from nature. By operating on a and BRCA2 genes, the process of isolating DNA was
narrow definition of “nature,” while expanding the entirely routine and well-known. In light of the exten-
realm of potential “invention,” the patent system pri- sive research being performed on the human genome,
oritized the ability to claim property by minimizing there is no doubt that many researchers around the
what is in nature (43). In the case of the BRCA1 and world “isolated” portions of the BRCA1 and BRCA2
BRCA2 patents, this dynamic masked how the patents genes in the course of their studies before Myriad
asserted exclusive rights over genetic information applied for its patents (52). However, the sequencing
residing in women’s bodies. of the BRCA1 and BRCA2 genes was momentous.
The USPTO’s choice to draw the line at “isolated It gave geneticists and laboratory professionals the
DNA” had significant implications. First, the equa- ability to use the genetic sequence information to
tion of isolation with invention served to bypass the test patients for variants of the genes and determine
basic principle prohibiting patents on laws of nature. their connection to cancer risk. Because the sequence