Patenting Nature

• Author: Rochelle C. Dreyfuss
• Position: 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...
• Pages: 8-65

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.