No. 08-964      
Supreme Court of the United States 
On Writ of Certiorari to the  
United States Court of Appeals 
for the Federal Circuit 
1500 San Jacinto Center 
98 San Jacinto Boulevard 
Austin, Texas 78701-4078 
(512) 322-2500 
30 Rockefeller Center 
New York, NY  10112 
(212) 408-2500 
Counsel of Record 
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 

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. 

Questions Presented ................................................... 

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 ......... 

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 

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 

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 
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 

Robert C. Oh & David L. Brown, Vitamin 
B12 Deficiency, 67 Am. Fam. Physician 
979 (2003)............................................................. 16 

Supreme Court of the United States 
NO. 08-964 
On Writ of Certiorari 
to the United States Court of Appeals 
for the Federal Circuit 
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-

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 
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. 

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 
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 

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.” 

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.  
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).” 

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 

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.   
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 

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. 

§ 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 
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 

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 

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 

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-

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. 

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-
Recent advances in the biological sciences have also 
identified relationships between biomarkers and diseases 
that not only indicate an individual’s predisposition for a 

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 
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 

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: 

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 
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 

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). 

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 

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-

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-

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 

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. 

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. 

Respectfully submitted. 
1500 San Jacinto Center 
98 San Jacinto Boulevard 
Austin, Texas 78701-4078 
30 Rockefeller Center 
(512) 322-2500 
New York, NY  10112 
(212) 408-2500 
Counsel of Record 
1299 Pennsylvania Ave., NW 
Washington, D.C. 20004-2400 
(202) 639-7700 
Counsel for Amicus Curiae Novartis Corporation 
August 6, 2009 

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