Patenting Nature

AuthorRochelle C. Dreyfuss
PositionRochelle C. Dreyfuss is the Pauline Newman Professor of Law at New York University School of Law and codirector of its Engelberg Center on Innovation Law & Policy. She is currently the Arthur Goodhart Visiting Professor of Legal Science at the University of Cambridge in the United Kingdom. She teaches and writes in the areas of patent law and...
Pages8-65
Published in Landslide® magazine, Volume 12, Number 2, a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ©2019 by the American Bar Association. Reproduced with permission. All rights reserved.
This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.
Patenting
Nature
By Rochelle C. Dreyfuss
Published in Landslide® magazine, Volume 12, Number 2, a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ©2019 by the American Bar Association. Reproduced with permission. All rights reserved.
This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.
Patenting
Nature
In May 2019, Senators Thom Tillis and Chis Coons proposed legisla-
tion that would overturn judicially created exceptions to § 101 of the
Patent Act for laws of nature, natural phenomena, and abstract ideas.1
Although nonstatutory, these exceptions to patentable subject matter
have deep roots in U.S. law and have long required courts to engage
in the difcult task of distinguishing between an insight about nature
and a “valuable application of it to the arts.”2 The problem is episodic in
that it arises whenever science makes a signicant advance.3 However, in
recent years the issue has surfaced in a particularly virulent form. The cur-
rent batch of exciting discoveries are in the life sciences and personalized
medicine, where the desire for advancement is acute, the cost of bringing
products to market is high, and the public’s interest in access is particularly
urgent. In addition, now that universities have entered the patent business,
the pressure to patent upstream inventions—fundamental science discov-
ered in academia—has increased, as has the frustration of many scientists.4
These factors converged in two U.S. Supreme Court cases. The rst,
Mayo Collaborative Services v. Prometheus Laboratories, Inc.,5 invali-
dated a patent on a diagnostic for identifying the appropriate treatment
of certain autoimmune diseases. The second, Association for Molecular
Pathology v. Myriad Genetics, Inc.,6 held that isolated, naturally occur-
ring DNA associated with early-onset breast cancer was not eligible for
patent protection. Both cases involved areas where research institutions
were especially active: the result in Mayo allowed the Mayo Clinic to
engage in work to improve the diagnostic; the patents at issue in Myriad
were based on discoveries made at the University of California, and, as
in Mayo, the Court’s decision allowed university researchers to continue
to pursue that line of research. However, when these cases are coupled
with two contemporaneous Supreme Court cases on abstract ideas,7 the
concern is growing that the breadth of these judicially created exceptions
presents a signicant threat to the incentive system supporting innova-
tion—hence the proposal to eliminate them.
This article discusses the rationales underlying the judicial decisions
to create and expand exceptions to patent eligibility and then describes
the problems produced by the current case law. It ends with a critique
of the Tillis-Coons proposal.8
Rochelle C. Dreyfuss is the Pauline Newman Professor of Law at New York
University School of Law and codirector of its Engelberg Center on Innovation
Law & Policy. She is currently the Arthur Goodhart Visiting Professor of Legal
Science at the University of Cambridge in the United Kingdom. She teaches and
writes in the areas of patent law and international intellectual property law. She
can be reached at rochelle.dreyfuss@nyu.edu.
Image: GettyImages
Published in Landslide® magazine, Volume 12, Number 2, a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ©2019 by the American Bar Association. Reproduced with permission. All rights reserved.
This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.
recommendations.13 In Myriad, the Court stressed the infor-
mational content of DNA sequences.14 It then held that
naturally occurring DNA was not patentable, but nonetheless
decided that complementary DNA (cDNA) synthesized to
exclude noncoding material was patent eligible.15
Conrming the conclusions of the SACGHS, immedi-
ately after the decisions, new laboratories announced they
would enter the diagnostics eld and provide cheaper and
more comprehensive tests.16 Dr. Francis Collins, director of
the National Institutes of Health, claimed the Myriad decision
“represent[ed] a victory for all those eagerly awaiting more
individualized, gene-based approaches to medical care.”17
The Problems
The aftermath of the Supreme Court cases has not been as
rosy as Dr. Collins predicted. Although the Supreme Court
created law on what is not patentable, it neglected to explain
how to determine what is patentable. Indeed, both cases cre-
ated considerable confusion. Because synthetic DNA contains
the same information as natural DNA, the distinction drawn
in Myriad did not assuage concerns about preemption. Many
advances in the life sciences rely on slight alterations of natural
substances,18 yet the Court never stated how different mate-
rial had to be in order to constitute patentable subject matter.
The metabolite in Mayo depended on the administration of a
foreign substance, making it hard to see how the correlation
constituted a natural phenomenon. Moreover, the patent cov-
ered only the therapeutic window identied by the patentee, a
claim the Court acknowledged was drawn to a “narrow law[]
that may have limited applications.”19 But if that is enough to
destroy eligibility, many patents would appear vulnerable.
Unsurprisingly, the U.S. Patent and Trademark Ofce
(USPTO) and the courts have had a difcult time implement-
ing these decisions. The Federal Circuit began by taking a
dim view of all diagnostics. For example, in Ariosa Diagnos-
tics, Inc. v. Sequenom, Inc.,20 the inventors had discovered
that paternally inherited cell-free fetal DNA (cffDNA) circu-
lates in a pregnant woman’s blood. They found ways to detect
it and to use it to determine fetal characteristics. Although
this was a major breakthrough in prenatal care, and reduced
the need to rely on amniocentesis, which poses signicant
risks, the court held that the diagnostic was based on a law
of nature and was not patentable.21 The Federal Circuit is
currently distinguishing between claims to diagnostics and
claims to methods of treatment,22 but it remains to be seen
whether adding a fairly straightforward application step will
alter a diagnostic claim’s patentability.23 Meanwhile, the
USPTO keeps rening its guidelines on when a product is
markedly different from nature, what constitutes adding sig-
nicantly more, and how unconventional a step must be to
escape the exceptions.24 However, its decisions can be highly
unpredictable.25 As a result, some investors may be shy-
ing away from funding life sciences research.26 There is also
increasing reliance on trade secrecy, which can be even more
detrimental to progress than patents.27
Complicating matters, foreign countries have not followed
in the footsteps of the U.S. Supreme Court. Australia comes
the closest in that it had its Myriad moment and invalidated
The Rationales
It is easy to understand why judges might seek to prevent anyone
from patenting laws and phenomena of nature. Nature furnishes
the essential building blocks on which every technological inno-
vation rests. Since it cannot be invented around and because it is
unlikely that the rst to make a discovery will have the techni-
cal capacity and resources to fully exploit it, patents on nature
risk preempting further innovation. As Justice Breyer put it,
“sometimes too much patent protection can impede rather than
‘promote the Progress of Science and useful Arts.’”9
Experience suggests that preemption concerns are not mis-
placed. During the period prior to Myriad and Mayo, when
gene and diagnostic patents were common, right holders
sometimes cleared research markets and prevented scientists
from engaging in follow-on work.10 Moreover, enforcement
activity severely impinged on health care. Studies by the
Health and Human Services Secretary’s Advisory Commit-
tee on Genetics, Health, and Society (SACGHS) found that
centralizing genetic testing led to breakdowns with insurance
companies and eliminated access to second opinions.11 Exclu-
sivity also reduced the incentive to improve tests to keep
them current with advances in science and made it impossi-
ble to monitor quality through interlaboratory comparisons.
Exclusive rights in truths about the world (and individuals)
also raised issues with constitutional overtones sounding in
due process and First Amendment values.12
Mayo and Myriad responded to these concerns. Mayo
invalidated a patent on a method for determining whether the
dosage of a pharmaceutical was within a specied therapeu-
tic window by measuring blood levels of one of the drug’s
metabolites. The Court reasoned that the relationship between
dose and effect is a natural law to which nothing more than
“well-understood, routine, conventional activity previously
engaged in by researchers in the eld” had been added, and
concluded that the patent would block more rened treatment
Nature furnishes
the essential build-
ing blocks on which
every technological
innovation rests.
Patents on nature
risk preempting
further innovation.

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