No. 08-964
IN THE
Supreme Court of the United States
————
BERNARD L. BILSKI AND RAND A. WARSAW,
Petitioners,
v.
JOHN J. DOLL, ACTING UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY AND
ACTING DIRECTOR OF THE UNITED STATES PATENT
AND TRADEMARK OFFICE,
Respondent.
————
On Writ of Certiorari to the
United States Court of Appeals
for the Federal Circuit
————
BRIEF OF AMICUS CURIAE NOVARTIS
CORPORATION SUPPORTING PETITIONERS
————
EVAN A. YOUNG
JENNIFER GORDON
BAKER BOTTS L.L.P.
SCOTT B. FAMILANT
1500 San Jacinto Center
STEVEN P. LENDARIS
98 San Jacinto Boulevard
JENNIFER COZEOLINO
Austin, Texas 78701-4078
BAKER BOTTS L.L.P.
(512) 322-2500
30 Rockefeller Center
New York, NY 10112
(212) 408-2500
JEFFREY A. LAMKEN
Counsel of Record
BAKER BOTTS L.L.P.
1299 Pennsylvania Ave., NW
Washington, D.C. 20004-2400
(202) 639-7700
Counsel for Amicus Curiae Novartis Corporation
WILSON-EPES PRINTING CO., INC. – (202) 789-0096 – WASHINGTON, D.C. 20002
QUESTIONS PRESENTED
1. Whether the Federal Circuit erred by holding that
a “process” must be tied to a particular machine or appa-
ratus, or transform a particular article into a different
state or thing (“machine-or-transformation” test), to be
eligible for patenting under 35 U.S.C. § 101, despite this
Court’s precedent declining to limit the broad statutory
grant of patent eligibility for “any” new and useful pro-
cess beyond excluding patents for “laws of nature, physi-
cal phenomena, and abstract ideas.”
2. Whether the Federal Circuit’s “machine-or-trans-
formation” test for patent eligibility, which effectively
forecloses meaningful patent protection to many business
methods, contradicts the clear Congressional intent that
patents protect “method[s] of doing or conducting busi-
ness.” 35 U.S.C. § 273.
(i)
TABLE OF CONTENTS
Page
Questions Presented ...................................................
i
Interest Of Amicus Curiae ........................................ 1
Summary Of Argument .............................................. 2
Argument...................................................................... 7
The Federal Circuit’s Machine-or-
Transformation Test Unduly Narrows The
Scope Of Patent-Eligibility For Process
Claims Under § 101 ............................................... 7
A. The Text and Structure of the Patent
Act Reflect § 101’s Broad Scope as
Well as the Counter-Balance Pro-
vided by Other Sections of the Act .........
8
B. Diagnostic-Process Claims Merit
Protection Under § 101 Because
They Are Applications of “Laws of
Nature” ....................................................... 13
1. The Ability to Detect or Measure
Biomarkers Makes Personalized
Medicine Possible................................ 14
2. The Claim at Issue in Lab. Corp.
Is Patent-Eligible Under § 101 ......... 16
3. The Rigidity of the Decision
Below Improperly Threatens
Diagnostic-Process Claims ................ 21
C. Regardless of How It Resolves the
Instant Appeal, This Court Should
Not Endorse the Machine-or-Trans-
formation Test as the Definitive
Means for Assessing the Patent-
Eligibility of Process Claims ................... 22
Conclusion..................................................................... 24
(iii)
iv
TABLE OF AUTHORITIES
Page
CASES
Aro Mfg. Co. v. Convertible Top
Replacement Co., 365 U.S. 336 (1961)............. 18
Bonito Boats, Inc. v. Thunder Craft
Boats, Inc., 489 U.S. 141 (1989)........................ 12
In re Cruciferous Sprout Litig., 301 F.3d
1343 (Fed. Cir. 2002).......................................... 11
Diamond v. Chakrabarty, 447 U.S. 303
(1980).................................................................... 10
Diamond v. Diehr, 450 U.S. 175
(1981).................................................... 10, 14, 18, 20
EMI Group N. Am., Inc. v. Cypress
Semiconductor Corp., 268 F.3d 1342
(Fed. Cir. 2001)................................................... 12
In re Fisher, 421 F.3d 1365 (Fed. Cir.
2005)..................................................................... 12
Funk Bros. Seed Co. v. Kalo Inoculant
Co., 333 U.S. 127 (1948) .................................. 10, 12
Gottschalk v. Benson, 409 U.S. 63 (1972) ......... 10, 19
In re Grimme, 274 F.2d 949 (C.C.PA.
1960)..................................................................... 20
J.E.M. Ag. Supply, Inc. v. Pioneer Hi-
Bred Int’l, Inc., 534 U.S. 124 (2001) .............. 4, 22
Jimenez v. Quarterman, 129 S. Ct. 681
(2009).................................................................... 8
KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398 (2007)............................................................. 12
Lab. Corp. of Am. Holdings v. Metabolite
Labs., Inc., 548 U.S. 124 (2006)................ passim
v
TABLE OF AUTHORITIES—Continued
Page
Mackay Radio & Telegraph Co. v.
Radio Corp. of Am., 306 U.S. 86
(1939).................................................................... 10
Metabolite Labs., Inc. v. Lab. Corp. of
Am. Holdings, 370 F.3d 1354 (Fed.
Cir. 2004) ................................................... 16, 17, 18
Muniauction, Inc. v. Thomson Corp., 532
F.3d 1318 (Fed. Cir. 2008) ................................ 17
In re O’Farrell, 853 F.2d 894 (Fed. Cir.
1988)..................................................................... 12
O’Reilly v. Morse, 56 U.S. (15 How.) 62
(1853).................................................................... 12
Para-Ordnance Mfg., Inc. v. SGS
Importers Int’l, Inc., 73 F.3d 1085
(Fed. Cir. 1995)................................................... 18
Regents of the Univ. of California v. Eli
Lilly & Co., 119 F.3d 1559 (Fed. Cir.
1997)..................................................................... 12
Schering Corp. v. Geneva Pharms., Inc.,
339 F.3d 1373 (Fed. Cir. 2003) ......................... 11
In re Swinehart, 439 F.2d 210 (C.C.P.A.
1971)..................................................................... 20
STATUTES
35 U.S.C. §100(b)..................................................... 8-9
35 U.S.C. §101 ................................................. passim
35 U.S.C. §102 ..................................... 5, 11, 12, 13, 20
35 U.S.C. §103 ........................................... 5, 11, 13, 20
35 U.S.C. §112 ..................................... 5, 11, 12, 13, 20
vi
TABLE OF AUTHORITIES—Continued
Page
MISCELLANEOUS
Robert C. Oh & David L. Brown, Vitamin
B12 Deficiency, 67 Am. Fam. Physician
979 (2003)............................................................. 16
IN THE
Supreme Court of the United States
————
NO. 08-964
————
BERNARD L. BILSKI AND RAND A. WARSAW,
Petitioners,
v.
JOHN J. DOLL, ACTING UNDER SECRETARY OF COMMERCE
FOR INTELLECTUAL PROPERTY AND
ACTING DIRECTOR OF THE UNITED STATES PATENT
AND TRADEMARK OFFICE,
Respondent.
————
On Writ of Certiorari
to the United States Court of Appeals
for the Federal Circuit
————
BRIEF OF AMICUS CURIAE
NOVARTIS CORPORATION
SUPPORTING PETITIONERS
————
INTEREST OF AMICUS CURIAE
Novartis Corporation, through its U.S. affiliates
(hereinafter collectively “Novartis”), provides healthcare
solutions that address the evolving needs of patients and
societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet patient and social
needs: innovative medicines, cost-saving generic pharma-
2
ceuticals, preventive vaccines, diagnostic tools, and con-
sumer health products. Novartis is the only company
that provides innovative benefits to patients in all of
these areas. Novartis relies on the patent system to pro-
tect its many innovations in patient care. Without the
promise of exclusive rights in validly patented subject
matter, the investment incentive for the research and
development needed to discover innovative pharma-
ceutical and diagnostic products is greatly diminished.
Novartis has great interest in this case because the
Federal Circuit’s rigid and putatively exclusive machine-
or-transformation test, as articulated in the decision
below, potentially threatens to remove from patent-
eligibility under 35 U.S.C. § 101 the types of inventive
processes in which Novartis has heavily invested and
continues to pursue at great cost, including innovations
relating to personalized medicine. Personalized medicine
not only provides for more effectively and economically
marshaled healthcare resources but also—and more
importantly—improves patients’ well-being and, indeed,
saves lives. Affirmance of the Federal Circuit’s approach
for determining process patent-eligibility could have an
immediate, negative impact on personalized health care,
an area of great importance to patients and to Novartis.1
SUMMARY OF ARGUMENT
This Court should reject the Federal Circuit’s one-
size-fits-all test for assessing the patent-eligibility of
process claims. That court held that § 101 of the Patent
1 Pursuant to this Court’s Rule 37.6, amicus affirm that no counsel
for a party authored this brief in whole or in part, that no such
counsel or party made a monetary contribution intended to fund the
preparation or submission of this brief, and that no person or per-
sons other than amicus and its counsel made such a monetary contri-
bution. Both parties have consented to the filing of this brief. The
parties’ letters so consenting have been filed with the Clerk’s office.
3
Act, 35 U.S.C. § 101, permits a process to be patented
only if “(1) it is tied to a particular machine or apparatus,
or (2) it transforms a particular article into a different
state or thing.” Pet. App. 12a. Although the decision
below evaluated a business-method claim, its machine-or-
transformation test appears intended to apply to any
process claim. Id. at 15a-16a. In that respect, the test
overreaches and unduly restricts § 101’s textually broad
scope.
The difficulty of reconciling the Federal Circuit’s test
with process claims arising in the context of the biological
sciences—a field that differs greatly from the transaction
hedging the Federal Circuit had before it—is strong evi-
dence that the Federal Circuit went too far. This Court
recently had an opportunity to consider the scope of pat-
ent-eligibility under §101 in a biological context in Lab.
Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S.
124 (2006). But the Court was unable to reach the merits
because the issue was not properly preserved for its re-
view. In his dissent, Justice Breyer (joined by Justices
Stevens and Souter) stated that he would have reached
the question presented and would have held that the pat-
ent claim at issue (a process claim for detecting a vitamin
deficiency) amounted to “an unpatentable ‘natural
phenomenon.’ ” Id. at 132-34, 138 (Breyer, J., dissenting
from dismissal of certiorari).
Although the decision below and the dissenting views
expressed in Lab. Corp. spring from legitimate concerns,
their proposed solutions, which are based on faulty prem-
ises, would unduly constrict the scope of § 101. Both
opinions unnecessarily raise uncertainties about the pat-
ent-eligibility of diagnostic methods that are based on the
detection or measuring of “biomarkers,” such as DNA se-
quences or other biological substances that are indicative
of a host having or being predisposed to a certain disease
4
or condition. This case provides an opportunity to ensure
that the scope of § 101 is properly calibrated.
A. The Lab. Corp. dissent and the machine-or-trans-
formation test as applied by the court below focus on
§ 101 without giving full effect to its text or how it fits into
the overall scheme of the Patent Act. Although § 101’s
scope is not boundless, this Court has recognized that it
is a “dynamic provision designed to encompass new and
unforeseen inventions.” See J.E.M. Ag. Supply, Inc. v.
Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 135 (2001).
There is no reason why process claims based on de-
tecting or measuring biomarkers should fall outside
§ 101’s scope. Section 101 guarantees that “[w]hoever in-
vents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent there-
for, subject to the conditions and requirements of this
title.” The only explicit limitation on that expansive stat-
utory language is the exclusion of processes that preempt
laws of nature, natural phenomena, or abstract ideas.2
Processes applying the foregoing, however, do not pre-
empt them, and hence are eligible for patent protection
under § 101.
Giving § 101 its ordinary and expansive meaning does
not minimize the legitimate and important concerns un-
derlying the Lab. Corp. dissent—that abusive or other-
wise meritless patent claims not be allowed to impede the
proper functioning of the patent system as a whole or to
deprive society of free access to knowledge that is not at-
tributable to an inventor. But this important policing
2 Although the “laws of nature” and “natural phenomena” exceptions
are technically separate, they are analytically indistinct for purposes
of this brief. When referring to the conceptual space occupied by
both the “laws of nature” and “natural phenomena” exceptions, this
brief will refer for convenience to “the laws of nature.”
5
function is ordinarily not the job of § 101; it is instead, as
§ 101 itself indicates, the work of other “conditions and
requirements” of the Patent Act. Sections 102, 103, and
112 are particularly potent statutory safeguards against
claims unworthy of protection, even if those claims fall
within the capacious scope of § 101.
B.
Diagnostic-process claims properly fall within
§ 101’s protection. They are integral and inseparable in-
gredients in the larger process of managing and treating
disease. Such claims are at the front-end of the healing
process. An extraordinary investment of intellectual and
financial resources allows scientists to identify biomark-
ers, which in turn have created a new era of “personal-
ized medicine,” i.e., individualized patient care tailored to
a patient’s unique biological profile, including his or her
genetic makeup. Innovations in personalized medicine
are thus largely based on the discovery of natural laws,
specifically that biomarkers are, for example, predictive
of disease or of responsiveness to specific drugs.
The dissent in Lab. Corp. expressed doubts about the
patent-eligibility of diagnostic-process claims that, with-
out reciting an underlying transformative event, appear
to cover data gathering and a natural correlation.3 The
dissent’s view that such claims are essentially and imper-
missibly directed to a law of nature itself is incorrect.
That error arose because the assaying step of the claim
at issue in Lab. Corp. was never fully analyzed below, if
at all, in the § 101 context. Claims such as those at issue
in Lab. Corp. are directed to a practical application of a
3 For instance, a diagnostic claim might be phrased “a method for
diagnosing disease X in a human patient comprising (a) detecting in
a sample taken from such patient the presence of sequence Y in gene
Z, wherein the presence of sequence Y in gene Z indicates the
likelihood of developing disease X; and (b) diagnosing whether the
patient will develop disease X based on the result of step (a).”
6
law of nature. They require the testing of a patient sam-
ple (an act of human intervention) for a particular bio-
marker, which, if present, signifies a corresponding dis-
ease or a predisposition to develop it in the future. Such
test results, in turn, open the door for that patient to be
treated in an individualized fashion. Consequently, diag-
nostic-process claims are directed to perhaps the most
“useful” endeavor of all—directly enhancing the quality
of, or even sustaining the very existence of, human life.
Importantly, such claims do not “preempt” the laws of
biology, physics, or chemistry as they manifest them-
selves in nature, as the Lab. Corp. dissent suggests. The
two steps of the claim (i.e., “assaying” and “correlating”)
must be practiced for there to be an act of infringement.
Hence, an individual who possesses a biomarker indic-
ative of a particular condition does not infringe such
claims by living and breathing. Neither do such claims
stop anyone, including a patient’s own physician, from
simply thinking about possible medical predispositions in
light of the presence or absence of a biomarker.
Similarly, the Federal Circuit’s approach in the deci-
sion below has the potential to deny protection to diag-
nostic-process claims to the extent they neither tie the
method of detecting a given biomarker to a particular
machine nor recite a series of transformative steps that
enable that detection. But the development of such diag-
nostic methods is the fruit of tremendous intellectual and
financial exertion, and the resulting methods provide
both increasing and extraordinary benefits to patients.
The factual and policy considerations surrounding the
patent-worthiness of claims to life-saving diagnostics are
simply too distinct and complex to foreclose their ability
to qualify for patent-eligibility on considerations other
than whether they implicate machines or transforma-
tions. If the machine-or-transformation test were to
deny such diagnostic methods the opportunity for patent
7
protection, the incentive for conducting such costly and
useful research would be dramatically diminished.
C. Because diagnostic-process claims are proper un-
der § 101, this Court should make clear that it is not en-
dorsing the machine-or-transformation test as the defini-
tive test for assessing the patent-eligibility of all process
claims. But even if the Court were to adopt the machine-
or-transformation test in some fashion, it should recog-
nize that diagnostic-process claims are entirely unlike the
business-method claims at issue in this case. A bare,
descriptive mathematical formula addressing commodity-
price hedging may be susceptible to the § 101 limitation
on patenting “abstractions.” But diagnostic-process
claims such as those involving biomarkers implicate the
very different limitation on claiming “laws of nature.”
Hence whatever merit there may be to using the
machine-or-transformation test as one means to assess a
process claim’s patent-eligibility, this Court should make
clear that it is not requiring satisfaction of that test as
the only test for a diagnostic-process claim to be patent-
eligible; that narrow question should at the very least be
reserved for a case that squarely involves such patent
claims and raises such issues.
ARGUMENT
THE FEDERAL CIRCUIT’S MACHINE-OR-TRANSFORMA-
TION TEST UNDULY NARROWS THE SCOPE OF PATENT-
ELIGIBILITY FOR PROCESS CLAIMS UNDER § 101
This case asks one of the most fundamental questions
in patent law: When is a “process” eligible for patent
protection under 35 U.S.C. § 101? In the opinion below,
the Federal Circuit ruled that any process claim is pat-
ent-eligible only if “(1) it is tied to a particular machine or
apparatus, or (2) it transforms a particular article into a
different state or thing.” Pet. App. 12a. Three years ago,
this Court considered a similar question in Lab. Corp. of
8
Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124
(2006). Because the Court ultimately concluded that the
question had not been properly preserved, it declined to
address it. In dissent, Justice Breyer (joined by Justices
Stevens and Souter) urged that the Court should have
answered the question, and opined that the patent claim
at issue—a process for detecting a vitamin deficiency—
was “an unpatentable ‘natural phenomenon.’ ” Id. at 138
(Breyer, J., dissenting from dismissal of certiorari).
The two opinions in those two cases chart different
courses and involve different types of process claims (a
business-method claim and a diagnostic-process claim).
But both endanger the ability of the pharmaceutical and
biotechnology industries, which are revolutionizing the
nature of health care, to patent diagnostic processes
emerging from intensive and costly research and devel-
opment. Denying patents for such claims would contra-
vene the text and purposes of the Patent Act. This case
provides the Court an opportunity to rectify the errone-
ous approaches suggested by the decision below and the
dissenting opinion in Lab. Corp.
A. The Text and Structure of the Patent Act
Reflect § 101’s Broad Scope as Well as the
Counter-Balance Provided by Other Sections of
the Act
Any consideration of the scope of § 101 must “begin[]
with the plain language of the statute.” Jimenez v.
Quarterman, 129 S. Ct. 681, 685 (2009). Section 101
provides that “[w]hoever invents or discovers any new
and useful process, machine, manufacture, or composition
of matter, or any new and useful improvement thereof,
may obtain a patent therefor, subject to the conditions
and requirements of this title.” 35 U.S.C. § 101 (emphasis
added). “Process” is defined as “process, art, or method,
and includes a new use of a known process, machine,
manufacture, composition of matter, or material.” Id.
9
§ 100(b). The Federal Circuit, by pronouncing that the
machine-or-transformation test is the sole prism through
which a process claim’s compliance with § 101 should be
judged, failed to respect the capacious statutory standard
established by § 101’s text.
Section 101 identifies four independent classes of
patent claims that are eligible for protection. So long as
it is “new and useful,” any “process,” “machine,” “manu-
facture,” or “composition of matter” can be the subject a
patent claim. The court below, by adopting the machine-
or-transformation test, adds a requirement that makes
qualifying a process claim under § 101, in comparison to
the other three recognized classes of patent claims, more
onerous. Nothing in the text of § 101, however, requires
that a process claim’s patent-eligibility should turn on its
having a nexus to a machine or transformation. To the
contrary, § 101 by its terms makes a new and useful
“process” or “machine” or “manufacture” or “composi-
tion of matter” potentially patentable subject matter;
nowhere does it limit patent-eligibility for processes to
those that are “tied” to a machine or transformation of
matter.
Moreover, imposing such a requirement is antithetical
to § 101’s intended reach. The machine-or-transforma-
tion test could, for instance, be one way of establishing
that a process is patent-eligible. The Federal Circuit was
therefore correct to observe that any “claimed process is
surely patent-eligible under § 101” if it satisfies that test.
Pet. App. 12a. But the court erred by making it the
exclusive test applicable to all types of process claims—a
sine qua non for process claims to be patentable subject
matter. See id. at 15a-16a. In doing so, that court failed
to give proper effect to, and unduly constricted, § 101.
This Court, by contrast, has repeatedly acknowledged
§ 101’s breadth. For example, the Court has held that it
was Congress’s intent that the Patent Act authorize the
10
patenting of “anything under the sun that is made by
man.” Diamond v. Diehr, 450 U.S. 175, 182 (1981)
(citation omitted). This broad perspective on § 101 has
been the underlying basis for this Court’s findings of
patent-eligibility for a diverse array of subject matter,
ranging from a directional antenna system in which the
wire arrangement was determined by the logical appli-
cation of a mathematical formula, see Mackay Radio &
Telegraph Co. v. Radio Corp. of Am., 306 U.S. 86 (1939),
to organisms genetically engineered to break down crude
oil, see Diamond v. Chakrabarty, 447 U.S. 303 (1980).
Such a perspective recognizes that the text of § 101 is
broadly inclusive. The only restrictions on that broad
understanding of § 101 are the prohibitions against claim-
ing “laws of nature, natural phenomena, and abstract
ideas.” Diehr, 450 U.S. at 185.
Even those exclusions have their limitations, as pro-
cess claims involving such laws, phenomena, or ideas are
patent-eligible if the process is a new and useful
application of those laws, phenomena, or ideas. Id. at
187. Other decisions by this Court make the same point:
“ ‘He who discovers a hitherto unknown phenomenon of
nature has no claim to a monopoly of it which the law
recognizes. If there is to be invention from such a discov-
ery, it must come from the application of the law of
nature to a new and useful end.’ ” Gottschalk v. Benson,
409 U.S. 63, 67 (1972) (quoting Funk Bros. Seed Co. v.
Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (emphasis
added)). This Court’s precedents thus establish a bright-
line test under which one may not preempt a law of
nature itself, but may patent an application of it for “new
and useful” ends. This should not be viewed as an
unusual balance to strike; virtually any useful patent
claim must ultimately rely on laws of nature to generate
worthwhile results. As articulated in more detail in
Section B, infra, diagnostic-process claims like the one at
11
issue in Lab. Corp. are not directed to a law of nature
itself, but to a practical application of a law, namely the
use of a natural correlation to make a diagnosis. Hence
they do not offend § 101.
This does not minimize or trivialize the legitimate and
important concerns expressed, in particular, in the Lab.
Corp. dissent. Those concerns underscore the necessity
of having proper safeguards to weed out abusive or
otherwise meritless patents. If “anything under the sun”
can be patented, that overabundance can create genuine
inefficiencies and unfairness. “[S]ometimes too much
patent protection can impede rather than ‘promote the
Progress of Science and useful Arts,’ the constitutional
objective of patent and copyright protection.” Lab.
Corp., 548 U.S. at 126-27 (Breyer, J., dissenting)
(emphasis in original). One can agree with this concern
while disputing how best to deal with it. Section 101 may
appear to be unduly embracive, but it bears emphasis
that it is, by its own terms, not the final hurdle a claim
must clear before it can be patented. Rather, patentabil-
ity ultimately turns on meeting “the conditions and re-
quirements of” the rest of the Patent Act. 35 U.S.C.
§ 101.
Those “conditions and requirements” appear princi-
pally in §§ 102, 103, and 112 of the Patent Act. For exam-
ple, §§ 102 and 103 preclude claims from covering subject
matter that is anticipated by or obvious in view of the art.
See, e.g., In re Cruciferous Sprout Litig., 301 F.3d 1343,
1345, 1352 (Fed. Cir. 2002) (claims to growing sprouts to
reduce the level of carcinogens and, in turn, the risk of
developing cancer in animals that consume them were
anticipated; the carcinogen-lowering potential of sprouts
are “inherent properties * * * put there by nature” such
that the patentee had “not claimed anything that is
new”); Schering Corp. v. Geneva Pharms., Inc., 339 F.3d
1373, 1382 (Fed. Cir. 2003) (method of treating hay-fever
12
with a metabolite of loratadine was inherently anticipated
because loratadine, a prior art therapy, inherently con-
verts to the metabolite upon ingestion); In re O’Farrell,
853 F.2d 894, 904 (Fed. Cir. 1988) (producing the claimed
genus of proteins would have been obvious in view of the
prior art). Indeed, § 102 provides an added level of pro-
tection against claims directed to a law of nature itself
because such a law would inherently be within the art
and hence anticipate such claims. See EMI Group N.
Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d
1342, 1351 (Fed. Cir. 2001) (citing Funk Bros. Seed, 333
U.S. at 130).
Section 112 provides further protection. It ensures
that claims are properly supported by a specification that
describes their subject matter in a sufficiently clear and
detailed fashion that they can be made and used. See,
e.g., Regents of the Univ. of California v. Eli Lilly & Co.,
119 F.3d 1559, 1567 (Fed. Cir. 1997) (disclosure of the
genetic sequence for rat insulin gene did not entitle the
patentee to generically claim mammalian or vertebrate
insulin genes or the human insulin gene); In re Fisher,
421 F.3d 1365, 1367 (Fed. Cir. 2005) (claims to purified
nucleic acid sequences that encode proteins and protein
fragments in maize plants were not enabled; “the claimed
invention lacks a specific and substantial utility and * * *
the * * * application does not enable one of ordinary skill
in the art to use the invention”).4
4 See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)
(expanding the circumstances under which claims can be deemed
obvious); Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S.
141, 151 (1989) (“Both the novelty and the nonobviousness require-
ments of federal patent law are grounded in the notion that concepts
within the public grasp, or those so obvious they readily could be, are
the tools of creation available to all.”); O’Reilly v. Morse, 56 U.S. (15
How.) 62, 119-20 (1853) (patent specification’s description did not
adequately support claims generically directed to using electro-
13
As the foregoing examples make clear, the Patent Act
strikes a balance that makes frequent recourse to § 101
unwarranted. Consequently, there was little reason for
the decision below to impose a restrictive construction on
that provision by requiring processes to have a relation-
ship to a machine or to the transformation of matter. To
the contrary, that requirement is incompatible with the
broad scope of § 101 that this Court has long recognized
and that its text commands. To the extent the Lab. Corp.
dissent can be construed as endorsing that test as the
only way to judge a diagnostic-process claim’s compliance
with § 101, see 548 U.S. at 136 (Breyer, J., dissenting), it
too suffers from the same fundamental defect.
To be sure, § 101 does provide a gate-keeping function
that would be triggered where the claim at issue at-
tempts to patent nothing more than a “natural phenome-
non.” See Lab. Corp., 548 U.S. at 137-38 (Breyer, J.,
dissenting). But as shown in Section B, infra, diagnostic-
process claims like the one in Lab. Corp. properly fall
within § 101’s scope.
B. Diagnostic-Process Claims Merit Protection
Under § 101 Because They Are Applications of
“Laws of Nature”
Viewing a claim to a diagnostic process as nothing
more than a claim to the discovery of a law of nature, as
the dissent did in Lab. Corp., is analytically flawed. That
view ignores expressly-recited claim steps and wholly
misunderstands the nature and import of such process
claims. As explained below, the nature of the subject-
matter covered by diagnostic-process claims makes clear
magnetism to print characters at a distance). There is no doubt that
the principles articulated in this Court’s patent law precedent, while
developed outside the biological context, are fully capable of appli-
cation in that context, and that diagnostic-process claims—like any
other claim—are subject to scrutiny under §§ 102, 103, and 112.
14
that such revolutionary, 21st century subject matter is
properly protected under § 101 and is not, as the Lab.
Corp. dissent asserted, excluded from protection as an
improper preemption of “laws of nature.”
1. The Ability to Detect or Measure Biomarkers
Makes Personalized Medicine Possible
Advancements in human genetic research have
exploded in the 28 years since this Court last considered
the scope of patent-eligibility for processes under § 101 in
Diehr. The Human Genome Project—the first complete
sequencing of the entire human genome—is perhaps the
most prominent example; it has captured the public’s
imagination in showing how far science has moved. By
providing researchers with a detailed map of the genes
on all 23 human chromosomes, the Human Genome
Project has accelerated the identification of relationships
between specific genes and diseases. Products encoded
by genes sequenced under the Human Genome Project
have complex interrelationships; teasing out those rela-
tionships, and identifying malfunctions in these gene
products, particularly those that cause diseases, has only
just begun to produce improved medical treatments.
Finding those relationships provides doctors with un-
precedented tools for the treatment and prevention of
disease. Indeed, the identification of those relationships
will allow our healthcare system to shift from reaction to
prevention. Simple genetic tests have the potential to
flag disease predisposition long before any symptoms oc-
cur, when steps can be taken to delay or even prevent
what otherwise would be inevitable. That shift to preven-
tion is widely recognized as having the potential to result
in unprecedented gains in patient outcome and cost con-
tainment.
Recent advances in the biological sciences have also
identified relationships between biomarkers and diseases
that not only indicate an individual’s predisposition for a
15
particular disease, but also how a patient may respond to
particular treatments for that disease. The identification
of biomarkers that help predict the efficacy of particular
therapies permits physicians to tailor a treatment regi-
men for a particular patient. Such tailoring, in turn,
lowers healthcare costs. That benefits not only individual
patients and public and private insurance companies. It
also benefits the federal government and state govern-
ments that now bear substantial healthcare funding obli-
gations. Personalized medicine achieves significant effi-
ciencies—and dramatic improvements in results and
quality of life—by identifying which therapeutics will
work for a particular patient, and which might be less
effective, without physicians having to engage in the ex-
pensive, time-consuming, and often empirical process of
determining whether a patient responds favorably to a
therapy, which has been the hallmark of traditional
medicine.
Novartis and many other healthcare companies are
expending hundreds of millions of dollars to identify new
biomarkers and apply their detection to new diagnostic
and therapeutic methods. Although driven by the desire
to improve healthcare, the prospect of patent protection
also provides an important incentive to expend the time,
effort, and dollars involved in making biomedical discov-
eries and translating them into new medical procedures
that help patients. The days of administering a drug to
all patients sharing a particular disease may soon be over
as healthcare companies identify the patient subpopula-
tions most likely to benefit from any one particular thera-
py. Thus, it is of paramount importance that appropriate
consideration be given to the patentability of the process
claims at the heart of personalized medicine.
The incentives afforded by the patent system, which
spur on these critical advancements, may be at risk if this
Court adopts the approach of the dissent in Lab. Corp. or
16
the Federal Circuit’s decision below. It is all too easy to
dismiss the relationships being identified in this new era
of personalized medicine as discoveries of the laws of
nature. After all, they reflect a correlation between a
biomarker and a patient’s predisposition to have a
disease or respond to a particular drug. But the discov-
ery of those relationships and their utility in treating dis-
eases can represent a critical advance in the important
art of making the unhealthy healthy, or providing the
individual who is prone to disease with immunity to its
effects. Where a new and useful process for identifying
those who are at risk for disease or most likely to benefit
from a particular treatment is discovered, it represents a
true advance in the art of medicine and technology. The
fact that the claimed invention is not tied to a particular
machine or transformation should not exclude it from
being patentable subject matter nor make it less worthy
of patent protection.
2. The Claim at Issue in Lab. Corp. Is Patent-
Eligible Under § 101
The invention at the core of the controversy in Lab.
Corp. was a method for detecting B vitamin (cobalamin
or folate) deficiencies. See Metabolite Labs., Inc. v. Lab.
Corp. of Am. Holdings, 370 F.3d 1354, 1358-59 (Fed. Cir.
2004). Deficiencies in cobalamin and folate are medically
significant. If left untreated, such deficiencies can lead to
serious complications including cardiovascular, neuro-
logic, and psychiatric pathologies, such as stroke, periph-
eral neuropathy, and depression. See, e.g., Robert C. Oh
& David L. Brown, Vitamin B12 Deficiency, 67 Am.
Fam. Physician 979, 979 (2003). Claim 13 of U.S. Patent
No. 4,940,648, the only claim at issue in Lab. Corp., reads
as follows:
13. A method for detecting a deficiency of cobala-
min or folate in warm-blooded animals comprising
the steps of:
17
assaying a body fluid for an elevated level of total
homocysteine; and
correlating an elevated level of total homocysteine
in said body fluid with a deficiency of cobalamin or
folate.
See 370 F.3d at 1358-59. The law of nature exploited in
the claimed method is the fact that cobalamin and folate
are used by the body as co-factors for enzymatic activity.
Much as an automobile engine cannot convert gasoline
into motive power in the absence of spark plugs, the en-
zyme that the body employs to convert homocysteine into
cysteine cannot effectively accomplish that conversion in
the absence of its co-factors cobalamin and folate. Thus,
an increase in homocysteine and a decrease in cysteine,
both of which would occur if the enzyme were not func-
tioning properly, may be indicative of a deficiency in one
or both of the co-factors. Claim 13 therefore represents a
particular application of the discovery that homocysteine
is converted to cysteine by an enzyme requiring cobala-
min or folate as a co-factor for optimal activity. Specifi-
cally, the claim is directed to measuring increased levels
of homocysteine (which occur because it is not being
enzymatically converted to cysteine) as a marker for a
cobalamin or folate deficiency.
The concerns raised by Justice Breyer in his dissent in
Lab. Corp. are significant and deserve a full and robust
debate. But the debate in Lab. Corp. was distorted by
the way in which that case had been litigated, and the
issues framed, in the lower courts. Under controlling
jurisprudence, patent-infringement liability attaches to a
method claim when a single party can be held
accountable for practicing all steps of the claim. See
Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318,
1328-30 (Fed. Cir. 2008) (a method claim is infringed only
when a single party can be found to have performed
every step of the claim, or where a party can be held
18
vicariously liable for others practicing those steps). In
Lab. Corp., the parties did not dispute before the Federal
Circuit whether the doctors performed one of the critical
steps, which was the assaying step. See Metabolite
Labs., 370 F.3d at 1364 n.1. Instead, the focus of the
parties’ arguments was the district court’s interpretation
of the correlating step of the claim and whether, as a
result of that construction, the doctors could be said to
have performed it. Because the assaying step was not in
dispute, the correlating step became determinative of
whether doctors infringed the claim.
The exclusive focus of the infringement inquiry on the
correlating step all but ensured that the import of the
assaying step would be conceptually disregarded as
merely “gather[ing] data” in the context of the dissent’s
§ 101 analysis. See Lab. Corp., 548 U.S. at 137 (Breyer,
J., dissenting). Without the benefit of a fully developed
record regarding the meaning and import of the assaying
step, the Lab. Corp. dissent appeared to construe claim
13 as embodying only the correlation between elevated
homocysteine levels and a deficiency in cobalamin or
folate, and, in turn, viewed the claim as impermissibly
directed to a law of nature, in violation of § 101.
The assaying step is an integral limitation of the claim
that cannot be disregarded when analyzing the claim’s
compliance with § 101. Indeed, were the correct analysis
applied, it would have been clear that the claim does not
attempt to monopolize a law of nature. It is a general
principle of patent law that “claims must be considered as
a whole.” Diehr, 450 U.S. at 176, 188; see also Aro Mfg.
Co. v. Convertible Top Replacement Co., 365 U.S. 336,
345 (1961) (applying this principle to analyzing infringe-
ment); Para-Ordnance Mfg., Inc. v. SGS Importers Int’l,
Inc., 73 F.3d 1085, 1088 (Fed. Cir. 1995) (applying the
principle to a determination of obviousness).
19
The assaying step of claim 13 serves a critical function.
Beyond providing a measurement needed to make the
correlation that the second step of the claim requires, the
assaying step enables a doctor to make a diagnosis with
respect to a particular patient and prescribe a therapy
for treating that patient. That is no trivial matter. By
according the assaying step its proper meaning, claim 13
is no longer directed to the law of nature itself, but to a
practical application of that law. Indeed, as a matter of
logic, the ability to make a diagnosis cannot be changed
from an application of a law of nature into the law of
nature itself, or vice versa, simply because the claim does
or does not explicitly refer to a machine or trans-
formative events.
As a result, the claim at issue in Lab. Corp. does not
preempt “ ‘basic tools of scientific and technological
work,’ ” Lab. Corp., 548 U.S. at 127 (Breyer, J., dis-
senting) (quoting Gottschalk, 409 U.S. at 67), that should
be free for anyone’s use. Significantly, the claim does not
encroach on the practice of medicine as envisioned in the
dissent. For example, the claim does not prevent doctors
from drawing conclusions based on test results they are
not accountable for generating. Similarly, the claim pre-
sents no bar to doctors mentally considering or applying
the correlation when it is not tied to a test result. Nor
does the claim cover the population of people whose bod-
ies inherently manifest the correlation because they are
deficient in cobalamin or folate. Rather, the claim is lim-
ited to only those situations where a single actor can be
held accountable for both: (a) assaying the amount of ho-
mocysteine present in a body fluid; and (b) correlating an
elevated amount with a cobalamin or folate deficiency.
In addition, the assaying step requires considerable
human intervention; a doctor cannot detect a deficiency
in cobalamin or folate through simple observation of a
patient. Such a diagnosis can only be reached following
20
testing of a sample. Such deliberative action is tanta-
mount to creating a machine that operates in accordance
with the law of nature or using the law to induce a trans-
formation. Hence, claim 13 falls comfortably within
Diehr’s pronouncement that patent-eligibility should be
extended to “anything under the sun that is made by
man.” Diehr, 450 U.S. at 182.
Furthermore, the patentee in Lab. Corp. was correct
in arguing to this Court that the assaying techniques
necessary to measure cobalamin and folate levels do
invariably implicate transformations of one form or
another. Hence, the claim at issue did not need to recite
a particular assaying means, as the dissent suggests, see
548 U.S. at 136 (Breyer, J., dissenting), for the patentee
to avail itself of such an argument; the claim language
should have sufficed. Moreover, there is nothing other-
wise inappropriate about using a term such as “assaying”
(or “detecting” or “measuring”) in the first step of a
diagnostic-process claim so long as such a term: (a) is
properly supported by the specification under § 112, see,
e.g., In re Swinehart, 439 F.2d 210, 213 (C.C.P.A. 1971);
In re Grimme, 274 F.2d 949, 952 (C.C.PA. 1960); and (b)
does not read on the prior art under §§ 102 and 103.
The points made above are equally applicable to virtu-
ally any diagnostic claim relating to personalized medi-
cine. At a minimum, such claims involve an assay or de-
tection step, such as a genetic test to determine the pres-
ence or absence of a particular DNA sequence, coupled to
a subsequent correlation of the presence or absence of
that sequence with a predisposition for either developing
a disease or receptiveness to a particular therapy. In
such contexts, the act of detecting the DNA sequence, or
some other biomarker, is a significant corporeal inter-
vention that invariably implicates transformative events.
Moreover, the detection step enables the law of nature to
be applied to facilitate a diagnosis or treatment. Such ap-
21
plications of the law of nature take the claim out of the
realm of monopolizing the law of nature itself. Again,
when not accountable for performing an assaying or
detection step, doctors do not infringe when they use the
results of such a step to counsel a patient. By embodying
so much more than mere naturally-occurring correla-
tions, diagnostic claims relating to personalized medicine
fall well within the scope of § 101, as defined by this
Court’s precedent.
3. The Rigidity of the Decision Below Improp-
erly Threatens Diagnostic-Process Claims
The Federal Circuit’s unreasonably rigid application
of the machine-or-transformation test also jeopardizes
the patent-eligibility of diagnostic-process claims. In
contrast to the test applied by the Federal Circuit, § 101
requires only that the “invent[ion] or discover[y]” for
which protection is sought be “new and useful.” As
shown above, diagnostic-process claims are based on
discoveries of previously-unknown relationships, without
which the benefits they unlock would remain hidden.
Additionally, they are indisputably “useful.” Personal-
ized medicine can be the difference between life and
death. It directly enhances the quality of, or even sus-
tains the very existence of, human life. It is hard to
imagine a more “useful” invention than a process apply-
ing newly discovered natural relationships to that end.
The Federal Circuit’s test is, of course, one way to
determine that a process is patent-eligible, but the
adoption of a strict rule, which extols consistency at the
expense of innovation, is in direct conflict with this
Court’s precedent. The diagnostic-process claims at the
heart of personalized medicine are the result of the same
kind of intellectual exertion and have the same utility as
machine-age processes, even though they are couched in
the language of molecular biology rather than that of
mechanics and electronics. Factual and policy considera-
22
tions in the 21st century show the wisdom of this Court’s
description of § 101 as a “dynamic provision designed to
encompass new and unforeseen inventions.” J.E.M. Ag.
Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124,
135 (2001). The machine-or-transformation test takes the
opposite approach, forcing all process claims into a mold
that decidedly looks backward in time. These considera-
tions cast considerable doubt on any approach that would
allow life-saving diagnostics to be patented only if they
can satisfy a rigid machine-or-transformation test.
* * *
The analysis suggested in the Lab. Corp. dissent and
the machine-or-transformation test articulated by the
decision below have the potential to deny patent pro-
tection to diagnostic-process claims that are no less
deserving of that protection than any other new and
useful discovery. They would do so, moreover, by writing
new requirements into the text of § 101 and by refusing
to acknowledge the full content of those claims. Nothing
in the text or history of § 101 suggests that patent protec-
tion ought not extend to the valuable fruits of the exact-
ing labor that must be invested to develop such important
new medical advances. Nor is there any basis for this
Court engrafting such an exclusion into the statute itself.
C. Regardless of How It Resolves the Instant
Appeal, This Court Should Not Endorse the
Machine-or-Transformation Test as the Defini-
tive Means for Assessing the Patent-Eligibility
of Process Claims
No doubt, petitioners and other amici will demon-
strate that the Federal Circuit simply misread this
Court’s cases when it interpreted them as imposing the
machine-or-transformation test as the definitive standard
for judging the patent-eligibility of a process claim. The
Court thus should reverse the decision below in light of
23
the Federal Circuit’s fundamental misreading of this
Court’s cases and the text of § 101.
If the Court endorses the machine-or-transformation
test in this context, nonetheless, it should make clear that
its decision does not make that test the dispositive stan-
dard against which all process claims’ compliance with
§ 101 must be judged. Novartis does not believe that
diagnostic-process claims necessarily fail to satisfy the
machine-or-transformation test as a general matter. But
the Court ought not attempt to create a one-size-fits-all
solution in the context of a case, like this one, which
provides no reason to rule that expansively. As the Lab.
Corp. dissent makes clear, a diagnostic-process claim
may implicate the “laws of nature” exception to § 101,
whereas business-method claims, like those at issue in
the present case, implicate the distinct “abstractions”
exception to § 101. The substantial differences between a
claim to diagnosing a pathology (as illustrated in Lab.
Corp.) and price hedging (as illustrated in this case), and
the likely legal consequences stemming from those differ-
ences, only further underscore the fact that this case is
not the proper vehicle for assessing whether a diagnostic-
process claim must or can meet a machine-or-trans-
formation test.
Accordingly, should this Court affirm the judgment
below, it should reserve for another day whether the
machine-or-transformation test should be the sole test
for judging the patent-eligibility of diagnostic-process
claims. Such a reservation will ensure that lower courts
and litigants do not attribute to this Court a “holding”
that extends inappropriately beyond the issues and
matters before it. Reserving the issue will facilitate this
Court’s ability to resolve that issue after a full record is
developed in an appropriate case squarely raising a
diagnostic-process claim’s compliance with § 101.
24
CONCLUSION
This Court’s precedents regarding patent-eligibility
under 35 U.S.C. § 101 have served the country well and, if
reaffirmed, will continue to do so. By contrast, the
Federal Circuit’s rigid implementation of the machine-or-
transformation test represents an unnecessary departure
from this Court’s precedents. And it has the potential to
jeopardize the benefits of many modern innovations,
including the innovations that will allow personalized
medicine to become a reality. Similarly, the Lab. Corp.
dissent too freely invokes the “law of nature” exception to
deprive a diagnostic-process claim of patent-eligibility
under § 101. This Court should therefore reaffirm its
broad interpretation of § 101 and reverse the Federal
Circuit’s pronouncement that the so-called machine-or-
transformation test is the sole test for judging the
patent-eligibility of all process claims.
25
Respectfully submitted.
JENNIFER GORDON
EVAN A. YOUNG
SCOTT B. FAMILANT
BAKER BOTTS L.L.P.
STEVEN P. LENDARIS
1500 San Jacinto Center
JENNIFER COZEOLINO
98 San Jacinto Boulevard
BAKER BOTTS L.L.P.
Austin, Texas 78701-4078
30 Rockefeller Center
(512) 322-2500
New York, NY 10112
(212) 408-2500
JEFFREY A. LAMKEN
Counsel of Record
BAKER BOTTS L.L.P.
1299 Pennsylvania Ave., NW
Washington, D.C. 20004-2400
(202) 639-7700
Counsel for Amicus Curiae Novartis Corporation
August 6, 2009
Document Outline
- DC01-#532707-v3-Novartis - Bilski -- Amicus Brief Cover Page.pdf
- DC01-#532708-v1-Novartis -- Bilski QP.pdf
- DC01-#532396-v1-TOC -- Novartis v_ Bilski amicus brief.pdf
- DC01-#532401-v3-Novartis v_ Bilski TOA.pdf
- DC01-#532791-v3-Bilski Amicus Brief.pdf