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
THE UNIVERSITY OF SOUTH FLORIDA
IN SUPPORT OF PETITIONERS
————
Jeff Lloyd
Counsel of Record
Saliwanchik, Lloyd & Saliwanchik
A Professional Association
P.O. Box 142950
Gainesville, FL 32614-2950
(352) 375-8100
Attorney for Amicus Curiae
The University of South Florida
i
TABLE OF CONTENTS
Table of Contents........................................................i
Table of Cited Authorities ......................................... ii
Interest of Amicus Curiae.......................................... 1
Summary of the Argument ........................................ 3
Argument.................................................................... 4
I.
The Federal Circuit’s new test is overly restrictive. ..4
II. The Framers of the Constitution intended to promote
advances in medical diagnosis and treatment. ...................6
III. Congress intended advances in medical diagnosis and
treatment to be patentable subject matter.........................12
Conclusion ................................................................ 16
ii
TABLE OF CITED AUTHORITIES
CASES
Classen Immunotherapies, Inc. v. Biogen IDEC, 304
F.App’x 866 (Fed. Cir. 2008) ........................... 2, 4-5
Classen Immunotherapies, Inc. v. Biogen IDEC, Civil
No. WDQ-04-2607, 2006 WL 6161856 (D. Md. Aug.
16, 2006).................................................................. 5
Diamond v. Chakrabarty, 447 U.S. 303 (1980).. 12-14
Diamond v. Diehr, 450 U.S. 175 (1981)................... 15
Gottschalk v. Benson, 409 U.S. 63 (1972).................. 4
Graham v. John Deere, 383 U.S. 1 (1966).............. 6-7
In re Bilski, 545 F.3d 943 (Fed. Cir. 2008).......passim
Parker v. Flook, 437 U.S. 584 (1978)......................... 4
United States v. Dubilier Condenser Corp., 289 U.S.
178 (1933)......................................................... 14-15
STATUTES
35 U.S.C. § 101 (2006).............................................. 13
35 U.S.C. § 287 (2006).............................................. 14
Omnibus Consolidated Appropriations Act, 1997,
Pub. L. No. 104-208, 110 Stat. 3009-67 ............... 14
U.S. CONST. art. I, § 8, cl. 8........................................ 6
OTHER AUTHORITIES
1 WILLIAM CULLEN, FIRST LINES OF THE PRACTICE OF
PHYSIC (New York, L. Nichols 1801).................... 11
3 A SOC’Y OF GENTLEMEN IN SCOT., ENCYCLOPÆDIA
BRITANNICA (1st ed. 1771) ........................... 7, 10-11
HIPPOCRATES, THE OATH AND LAW OF HIPPOCRATES,
reprinted in 38 HARVARD CLASSICS, pt. 1 (Charles
W. Eliot ed., P.F. Collier & Son 1910) (1909) ........ 6
THOMAS JEFFERSON, WRITINGS (Merrill D. Peterson
ed., Library of America 1984)............................ 8-10
1
INTEREST OF AMICUS CURIAE1
The University of South Florida (hereinafter,
“USF”) is the nation’s ninth largest public university
and a leading research institution. Founded in 1956,
USF has over 46,000 students and more than 13,000
faculty and staff members, with an annual operating
budget in excess of $1.8 billion dollars. USF’s
mission includes research and scientific discovery for
the generation, dissemination, and translation of
new knowledge across disciplines; to strengthen the
economy; to promote civic culture and the arts; and
to design and build sustainable, healthy
communities. Fueled by its research efforts, USF
has a substantial economic impact on its region
estimated at over $3.2 billion dollars annually.
USF medical researchers strive to expand the
frontiers of medicine, searching for improved
methods of diagnosing, prognosing, and treating
diseases such as cancer, HIV, diabetes, and
neurological disorders such as Alzheimer’s and
Parkinson’s diseases. USF is one of the top 50
1 In accordance with Supreme Court Rule 37, amicus curiae
states that this brief was not authored in whole or in part by
counsel for any party, and that no monetary contribution to the
preparation or submission of this brief was made by any person
or entity other than amicus curiae or its counsel. Counsel of
record for all parties were timely notified 10 days prior to the
filing of this brief. Petitioners have consented to the filing of all
amicus curiae briefs in support of either or neither party, and
respondent has consented to the filing of this brief via a
separate letter of consent dated July 14, 2009. A copy of this
letter has been filed with the Clerk of the Court.
2
medical schools receiving funding from the National
Institutes of Health, and USF’s Pediatric
Epidemiology Center has received over $300 million
dollars in NIH funding to direct global efforts in
juvenile diabetes research. For the 2007/2008 fiscal
year alone, USF was awarded more than $360
million dollars in research contracts and grants.
USF’s hospital partners, Tampa General Hospital
and the H. Lee Moffitt Cancer Center and Research
Institute, have been ranked among the nation’s top
50 hospitals by U.S. News & World Report; and USF
is classified by the Carnegie Foundation as a top tier
research university.
USF has a diverse portfolio of patents and
pending patent applications across a wide range of
medical technologies, which through USF’s licensing
efforts generate additional funding to support
further research. The new patent eligibility
standards adopted by the Court of Appeals for the
Federal Circuit in In re Bilski, 545 F.3d 943 (Fed.
Cir. 2008), and as applied by the Federal Circuit in
Classen Immunotherapies, Inc. v. Biogen IDEC, 304
F.App’x 866 (Fed. Cir. 2008), if allowed to stand and
proceed unchecked may have an adverse affect on
USF’s research programs.
Amicus curiae therefore submits this brief to
present argument in support of an affirmative
response to the first question presented. Amicus
curiae presents no argument here on the second
question presented.
3
SUMMARY OF THE ARGUMENT
The Federal Circuit’s “machine-or-
transformation” test is more restrictive than any
Supreme Court precedent, excluding from patent
eligibility certain processes that Congress intended
to be patent eligible. The test has been applied to
invalidate issued claims directed to certain medical
methods. There is no legislative basis for such a
restriction. Methods that promote the progress of
medicine, diagnosis and treatment in particular,
were clearly contemplated by the Framers of the
Constitution as well as members of Congress to be
patent eligible. Courts should not read into the
patent laws limitations and conditions which
Congress has not expressed. Despite this, the
Federal Circuit adopted the “machine-or-
transformation” test as the sole test for patent
eligibility of a process, thereby excluding from patent
eligibility subject matter that Congress clearly
considered patent eligible. This was error. The first
question presented should be answered in the
affirmative, and the Federal Circuit’s error should be
reversed.
4
ARGUMENT
I.
The Federal Circuit’s new test is overly
restrictive.
The Federal Circuit’s holding that a process
claim that “neither recites a particular machine or
apparatus, nor transforms any article into a
different state or thing, is not drawn to patent-
eligible subject matter” unnecessarily, unwisely, and
improperly excludes from patent protection
technologies that Congress clearly intended to be
patentable. In re Bilski, 545 F.3d 943, 961 (Fed. Cir.
2008). This “machine-or-transformation” test is
useful as a starting point for determining whether
process claims are directed to patent eligible subject
matter. This Court has held that the “machine-or-
transformation” test is sufficient to qualify a process
claim as patent eligible, but the Court has declined
to state that passing this test is a necessary
requirement for the patent eligibility of a process
claim. See Parker v. Flook, 437 U.S. 584, 588 n.9
(1978); Gottschalk v. Benson, 409 U.S. 63, 71 (1972).
Excluding from patent eligibility certain processes
involving medical diagnosis and treatment merely
because they do not recite a particular machine or
apparatus or transform an article into a different
state or thing is improper, as such processes are
unquestionably within the realm of patent eligible
subject matter. Yet this is exactly what the Federal
Circuit’s “machine-or-transformation” test has done.
The Federal Circuit first applied its new
“machine-or-transformation” test in a single-
paragraph, nonprecedential opinion in Classen
5
Immunotherapies, Inc. v. Biogen IDEC, affirming a
district court judgment invalidating claims to
methods of immunizing a mammalian subject.2 304
F.App’x 866 (Fed. Cir. Dec. 19, 2008), reh’g denied en
banc reh’g denied (Feb. 9, 2009). While the claims at
issue might well have been found invalid on other
grounds (for example, as obvious or anticipated), as
discussed below, they are certainly within the realm
of subject matter contemplated as patent eligible by
the Framers of the Constitution and Congress. Thus,
applying the “machine-or-transformation” test as the
2 The district court had summarized the Classen claims as
requiring “1) comparing the incidence of immune mediated
disorders in treatment groups with different vaccination
schedules; and 2) immunizing patients on a schedule identified
as low risk.” Classen Immunotherapies, Inc. v. Biogen IDEC,
Civil No. WDQ-04-2607, 2006 WL 6161856, at *5 (D. Md. Aug.
16, 2006). Rather than properly construing the claims as “a
method for reducing the incidence of chronic immune mediated
disorders” and recognizing that an improved process of
vaccination is a human invention, the district court held that
the claims describe a natural correlation. Id. Characterizing
the correlation between vaccination schedules and incidents of
immune mediated disorders as a natural phenomenon, the
court held the claims invalid as an attempt to patent a natural
phenomenon. Id. The district court’s reasoning was faulty: the
existence of an immune response in mammals is a natural
phenomenon. Human experimentation, manipulation, and
optimization of the immune response to achieve beneficial
results is not a natural phenomenon. On appeal, the Federal
Circuit did not discuss whether the claims describe a natural
phenomenon. Instead, the panel applied the new test without
analysis, declaring “Dr. Classen’s claims are neither ‘tied to a
particular machine or apparatus’ nor do they ‘transform[ ] a
particular article into a different state or thing.’ Therefore we
affirm.” Classen, 304 F.App’x at 867 (quoting In re Bilski, 545
F.3d. at 954) (alteration in original).
6
only test for patent eligibility is clearly improper.
II.
The Framers of the Constitution
intended to promote advances in medical
diagnosis and treatment.
The Constitution grants Congress broad power
to legislate to “promote the Progress of Science and
useful Arts, by securing for limited Times to . . .
Inventors the exclusive Right to their . . .
Discoveries.” U.S. CONST. art. I, § 8, cl. 8. At the
time the Constitution was drafted, medicine had for
more than two thousand years been known as one of
the “useful Arts.” The Oath of Hippocrates refers to
medicine as “the art,” “this art,” or “my art” on five
occasions. HIPPOCRATES, THE OATH AND LAW OF
HIPPOCRATES, reprinted in 38 HARVARD CLASSICS, pt.
1 (Charles W. Eliot ed., P.F. Collier & Son 1910)
(1909). The first sentence of The Law of Hippocrates
states “Medicine is of all the Arts the most noble; but
owing to the ignorance of the ones who practice
it, . . . it is at present far behind all the other arts.”
Id. In the late 18th century, those who were
educated in classical learning included Thomas
Jefferson, and they were well aware that medicine
was one of the “useful Arts.”
In Graham v. John Deere, this Court discussed
the legislative history of patent law at length,
including analysis of the influence of Thomas
Jefferson on the development of our patent system,
noting “[b]ecause of his active interest and influence
in the early development of the patent system,
Jefferson’s views on the general nature of the limited
patent monopoly under the Constitution, as well as
7
his conclusions as to conditions for patentability
under the statutory scheme, are worthy of note.”
383 U.S. 1, 7 (1966). As illustrated below,
Jefferson’s writings and other writings of his time
indicate that medicine, including methods of
treatment and diagnosis, would have been included
in the Framers’ definition of “useful Arts.”
In Jefferson’s time and in Jefferson’s mind,
medicine was clearly understood to be one of the
“useful Arts.” The first edition of the Encyclopædia
Britannica states:
Medicine is generally defined to be, The art
of preserving health when present and of
restoring it when lost . . . . Most arts require
the experience of ages before they can arrive
at a high degree of perfection. Medicine is
unquestionably one of the most ancient; and
consequently, the improvement of it might be
expected to bear some proportion to its
antiquity but, whilst philosophy, in all its
branches, has been cultivated and improved
to a great extent; medicine, not withstanding
the collateral advantages it has of late
derived from anatomy and other sciences
still continues to be buried in rubbish and
obscurity.
3 A SOC’Y OF GENTLEMEN IN SCOT., ENCYCLOPÆDIA
BRITANNICA 58 (1st ed. 1771) [hereinafter
ENCYCLOPÆDIA BRITANNICA] (emphasis added).
Jefferson’s letters make clear that he considered
medicine to be one of the “useful Arts” in need of
8
advancement through both observation and
innovation. For example, in his letter on “Freedom
of Mind” to William Green Munford dated June 18,
1799, Jefferson states:
Surgery is well advanced; but prodigiously
short of what may be. The state of medecine
[sic] is worse than that of total ignorance . . . .
We have a few medecines, as the bark, opium,
mercury, which in a few well defined
diseases are of unquestionable virtue: but
the residuary list of the materia medica, long
as it is, contains but the charlataneries of
the art; and of the diseases of doubtful form,
physicians have ever had a false knowledge,
worse than ignorance. Yet surely the list of
unequivocal diseases & remedies is capable
of enlargement; and it is still more certain
that in the other branches of science, great
fields are yet to be explored to which our
faculties are equal, & that to an extent of
which we cannot fix the limits. I join you
therefore in branding as cowardly the idea
that the human mind is incapable of further
advances.
THOMAS JEFFERSON, WRITINGS 1065 (Merrill D.
Peterson ed., Library of America 1984) (emphasis
added). Similar evidence is found in Jefferson’s
letter entitled “Unlearned Views of Medicine” to Dr.
Caspar, dated June 21, 1807. In this letter,
Jefferson provides his opinions on the state of
medicine and medical education:
. . . [F]ulness of the stomach we can relieve
9
by emetics; diseases of the bowels, by
purgatives; inflammatory cases, by bleeding;
intermittents [fevers], by the Peruvian bark;
syphilis, by mercury; watchfulness, by
opium; etc. So far, I bow to the utility of
medicine. It goes to the well-defined forms
of disease, & happily, to those the most
frequent. But the disorders of the animal
body . . . are as various as the elements of
which the body is composed . . . . To an
unknown disease, there cannot be a known
remedy. Here then, the judicious, the moral,
the humane physician should stop . . . . But
the adventurous physician goes on, &
substitutes presumption for knolege [sic] . . . .
It is in this part of medicine that I wish to
see a reform, an abandonment of hypothesis
for sober facts, the first degree of value set
on clinical observation, and the lowest on
visionary theories . . . . I would wish the
young practitioner . . . to have deeply
impressed on his mind, the real limits of his
art.
Id. at 1181-1185 (emphasis added). Yet another
example can be found in Jefferson’s letter “The
Value of Classical Learning” to John Brazier dated
August 24, 1819. Jefferson advocated studying the
Classics in their original Greek and Latin and was
thoroughly familiar with the writings of Hippocrates.
In discussing the benefits of classical learning and in
particular its utility to various members of society,
Jefferson notes that the Greek and Roman texts
have given to physicians:
10
as good a code of his art as has been given
us to this day. Theories and systems of
medicine, indeed, have been in perpetual
change from the days of the good
Hippocrates to the days of the good Rush,
but which of them is the true one? The
present, to be sure, as long as it is the
present, but to yield its place in turn to the
next novelty, which is then to become the
true system, and is to mark the vast advance
of medicine since the days of Hippocrates.
Our situation is certainly benefited by
the discovery of some new and very valuable
medicines; and substituting those for some of
his with the treasure of facts, and of sound
observations recorded by him (mixed to be
sure with anilities of his day) and we shall
have nearly the present sum of the healing
art.
Id. at 1424 (emphasis added). Thus, substantial
evidence exists that Jefferson and others of his time
considered the term “useful Arts” to encompass
medicine. Moreover, these letters indicate that
Jefferson considered medicine, including medical
diagnosis and treatment, to be a field in which great
progress was both possible and needed for the
benefit of society.
The 1771 edition of Encyclopædia Britannica
again echoes Jefferson’s sentiments regarding the
need for progress in the “art” of medicine:
In every art which is not founded on known
facts and established principles, new projects
11
are eagerly grasped at; and though they lead
to error and false reasoning, it is long before
the professors of that art can be induced to
give over the pursuit. This observation is
particularly applicable to medicine. The
theories of diseases, as well as the mode of
prescription, are as variable as the fashion of
a lady’s headdress. No other argument is
necessary to shew the crude state of the art
and the boundless field for improvement.
3 ENCYCLOPÆDIA BRITANNICA, supra, at 60 (emphasis
added).
Finally, one of the foremost medical experts of
the 18th Century, Dr. William Cullen wrote in the
first lines of the introduction of his two-volume
treatise First Lines of the Practice of Physic:
1.] In teaching the Practice of Physic, we
endeavor to give instruction for discerning,
distinguishing, preventing, and curing
diseases, as they occur in particular persons.
2.] The art of DISCERNING and
DISTINGUISHING diseases . . . .
1 WILLIAM CULLEN, FIRST LINES OF THE PRACTICE OF
PHYSIC 25 (New York, L. Nichols 1801) (Introduction
written in 1789) (second emphasis added). Thus,
authorities in the field of medicine also viewed
various aspects of the field as an “art.”
From the foregoing it is clear that the field of
medicine was considered by the Framers to be one of
12
the “useful Arts.” It is also clear that procedures for
diagnosis and treatment of diseases were considered
arts within the more general art of medicine.
Moreover, Jefferson and his contemporaries
repeatedly voiced an acute need for progress in the
art of medicine. The Constitution was thus drafted
with an understanding of medicine as a “useful Art”
in which “progress” was greatly desired.
III. Congress intended advances in medical
diagnosis and treatment to be patent
eligible subject matter.
From the first Patent Act, Congress has broadly
described the class of inventions eligible to be
considered for Patents. Later acts of Congress made
clear that medicine, including methods of diagnosis
and treatment, were meant to be included in that
description. As further discussed below, reading the
Patent Act in a manner which excludes methods of
diagnosis and treatment from the class of patent
eligible inventions is contrary to the legislative
history as interpreted by this Court.
This Court has repeatedly recognized that the
legislative history of the Patent Act supports a broad
construction of patent eligible subject matter. In
Diamond v. Chakrabarty, this Court noted that:
The Patent Act of 1793, authored by Thomas
Jefferson, defined statutory subject matter
as “any new and useful art, machine,
manufacture, or composition of matter, or
any new or useful improvement [thereof].”
Act of Feb. 21, 1793, § 1, 1 Stat. 319. The
13
Act embodied Jefferson's philosophy that
“ingenuity should receive a liberal
encouragement.” 5 Writings of Thomas
Jefferson 75-76 (Washington ed. 1871). See
Graham v. John Deere Co., 383 U.S. 1, 7-10,
86 S.Ct. 684, 688-690, 15 L.Ed.2d 545 (1966).
Subsequent patent statutes in 1836, 1870,
and 1874 employed this same broad
language. In 1952, when the patent laws
were recodified, Congress replaced the word
“art” with “process,” but otherwise left
Jefferson's language intact. The Committee
Reports accompanying the 1952 Act inform
us that Congress intended statutory subject
matter to “include anything under the sun
that is made by man.” S.Rep.No.1979, 82d
Cong., 2d Sess., 5 (1952); H.R.Rep.No.1923,
82d Cong., 2d Sess., 6 (1952).
447 U.S. 303, 308-309 (1980). Though Congress
replaced the word “art” with “process,” in the 1952
act, the act also defined “process” as “a process, art,
or method.” 35 U.S.C. § 101(b) (2006). Thus, the
term “process” was defined as including that which it
replaced. Accordingly, “any new and useful art . . .
or any new or useful improvement [thereof]” which
was patent eligible before enactment of the 1952
Patent Act remained patent eligible subject matter
under the 1952 act.
In Chakrabarty, this Court went on to discuss
the reasons behind a broad construction of the
patent eligible subject matter provisions of the
Patent Act. The Court recognized that “[t]he subject
14
matter provisions of the patent law have been cast in
broad terms to fulfill the constitutional and
statutory goal of promoting ‘the Progress of Science
and the useful Arts’ with all that means for the
social and economic benefits envisioned by
Jefferson.” Chakrabarty, 447 U.S. at 315. As
discussed above, advances in medicine, particularly
methods of diagnosis and treatment, were social
benefits that Jefferson hoped for and envisioned.
The current act provides further evidence that
Congress intended processes of diagnosis and
treatment to be patent eligible subject matter. In
1996, the act was amended to explicitly exclude
medical practitioners from liability for infringing a
patent by the performance of a medical or surgical
procedure on a body (including a human body, organ,
or cadaver, or a non-human animal). Omnibus
Consolidated Appropriations Act, 1997, Pub. L. No.
104-208, 110 Stat. 3009-67 (codified as amended at
35 U.S.C. § 287(c) (2006)). Significantly, § 287
excludes from its application the practice of patented
biotechnology processes and certain pharmacy and
clinical laboratory services, for which medical
practitioners remain liable for patent infringement.
35 U.S.C. § 287(c) (2006). The fact that Congress felt
the need to create such exclusions makes clear that
they intended new and useful medical processes such
as methods of diagnosis or treatment to be patent
eligible subject matter.
In United States v. Dubilier Condenser Corp.,
this Court cautioned: “We should not read into the
patent laws limitations and conditions which the
15
Legislature has not expressed.” 289 U.S. 178, 199
(1933). The Federal Circuit’s “machine-or-
transformation” test as set forth in In re Bilski is
more restrictive than required by this Court’s
precedent and finds no support in any legislation. In
practice, it has already been applied to strike down
patents directed to methods of immunizing patients
with improved efficacy and safety thereby casting a
cloud on the validity of a great many process patents
in the medical and biotechnological fields.
The “machine-or-transformation” test is a useful
starting point for analysis of patent eligibility of
process claims. However, if a process claim is not
tied to a particular machine or does not recite
transformation of an article into a different state or
thing, the inquiry should not stop there, as the
process may still be patent eligible as long as it does
not attempt to claim “laws of nature, natural
phenomena, [or] abstract ideas.” Diamond v. Diehr,
450 U.S. 175, 185 (1981). The inquiry should
carefully analyze whether the claimed process is
truly claiming a phenomenon of nature, ever mindful
of the difference between phenomena that are
entirely products of nature and inventions that are
the result of how nature reacts to the purposeful
activity of man. Where the activities of man cause a
useful, tangible, concrete result that did not exist
before, the process should be considered patent
eligible.
16
CONCLUSION
The Federal Circuit’s holding that a “process”
must be tied to a particular machine or apparatus, or
transform a particular article into a different state
or thing, to be patent eligible is too restrictive. The
holding excludes subject matter that Congress
clearly intended to be patent eligible. Therefore,
amicus curiae respectfully requests that the Court
reverse the decision of the Federal Circuit and
answer the first question presented in the
affirmative.
Respectfully submitted,
Jeff Lloyd
Counsel of Record
Saliwanchik, Lloyd & Saliwanchik
A Professional Association
P.O. Box 142950
Gainesville, FL 32614-2950
(352) 375-8100
Attorney for Amicus Curiae
The University of South Florida