Georgia Biotechnology Organization provides three reasons in addition, and in support of, to the reasons provided in the Petition filed on ### by ### in the matter ###: 1) the machine or transformation test contradicts previous Supreme Court findings in

No. 08-964
1fn tlCbt
~upreme ~ourt of  tbe  Wniteb  ~tate£s
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 GEORGIA BIOMEDICAL
PARTNERSHIP, INC.
AS AMICUS CURIAE IN SUPPORT OF
PETITIONERS
William H. Kitchens
Counsel of Record
Robert A.  Hodges, PhD
David E. Huizenga, PhD
Scott E. Taylor
Heather Smith Michael
ARNALL GOLDEN GREGORY LLP
171  17th Street, NW
Suite 2100
Atlanta, Georgia  30363
(404) 873-8500
Counsel for Amicus Curiae Georgia Biomedical
Partnership,  Inc.  d / b / a  Georgia Bio
LANTAGNE  LEGAL  PRINTING
801  East  Main  Street Suite  100  Richmond,  Virginia  23219  (800)  847-0477

ii
D.
The Federal Circuit’s
“Machine-Or-
Transformation” Test
Conflicts With The Supreme
Court’s Interpretation Of The
Patent Statute.............................12
II.
THE FEDERAL CIRCUIT’S
“MACHINE-OR-
TRANSFORMATION” TEST
CONFLICTS WITH THE PROPER
CONTRUCTION OF FEDERAL
LAW .......................................................14
A.
Supreme Court Principles Of
Statutory Construction
Require Harmony Between
Different Sections Of The
Same Statute...............................15
B.
Section 287(c) Of The Patent
Code Contemplates As
Patent Eligible Biomedical
Inventions That Are At Risk
Of Exclusion By Bilski’s
“Machine-Or-
Transformation” Test..................16
C.
Section 100(b) Of The Patent
Code Defines As Patent
Eligible Inventions That Are
At Risk Of Exclusion By
Bilski’s “Machine-Or-
Transformation” Test..................22
CONCLUSION............................................................25

iii
TABLE OF CITED AUTHORITIES

CASES PAGES
Classen Immunotherapies, Inc. v. Biogen Idec, 304
Fed. Appx. 866, 2008 WL 5273107
(Fed.
Cir. 2008) ..................................................19, 24
Classen Immunotherapies, Inc. v. Biogen Idec, Civil
No. WDQ-04-2607, 2006 WL 6161856
(D. Md. Aug. 16, 2006).............................................20
Cochrane v. Deener, 94 U.S. 780 (1876).....................10
Corning v. Burden, 56 U.S. 252 (1853) ......................10
Diamond v. Chakrabarty, 447 U.S. 303 (1980)..........13

Diamond v. Diehr, 450 U.S. 175 (1981).............. passim

Dolbear v. American Bell Tel. Co., 126 U.S. 1
(1888) .......................................................................10
Expanded Metal Co. v. Bradford, 214 U.S. 366
(1909) .......................................................................10

Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S.
127 (1948).................................................................10
Gottschalk v. Benson, 409 U.S. 63 (1972)...........passim
In re Bilski, 545 F.3d 943 (Fed. Cir. 2008).........passim

Le Roy v. Tatham, 55 U.S. 156 (1852)........................11

iv
Mackay Radio & Tel. Co. v. Radio Corp. of Am.,
306 U.S. 86 (1939) ...................................................10
Mastro Plastics Corp. v. National Labor Relations
Bd., 350 U.S. 270 (1956)..........................................15
O'Reilly v. Morse, 56 U.S. 62 (1853)...........................10
Parker v. Flook, 437 U.S. 584 (1978)............7, 8, 11, 13
Peck v. Jenness, 48 U.S. 612 (1849)............................15
Richards v. U.S., 369 U.S. 1 (1962)............................15
Rubber-Tip Pencil Co. v. Howard, 87 U.S. 498
(1874) .......................................................................10
Tilghman v. Proctor, 102 U.S. 707 (1880)..................10
Waxham v. Smith, 294 U.S. 20 (1935) .......................10

STATUTES
35 U.S.C. § 100(b)................................................passim
35 U.S.C. § 101....................................................passim
35 U.S.C. § 287(c)................................................passim

OTHER AUTHORITIES
H.R. Rep. No. 104-863 (1996) .........................18, 19, 21
U.S. Const. art. I, § 8, cl. 8............................................5
U.S. Pat. No. 5,723,283, claim 1...........................20, 24
142 Cong. Rec. H8275-79 (daily ed. July 24, 1996) ...18

1
STATEMENT OF INTEREST OF THE AMICUS
CURIAE
Georgia Biomedical Partnership, Inc. d/b/a
Georgia Bio (“GaBio”) is a non-profit, membership-
based organization that promotes the interests and
growth of the life sciences industry in Georgia.
Members include companies, universities, research
institutions, government groups and other industry
associations involved in the discovery and
application of life sciences products and related
services that improve the health and well-being of
people throughout the world. GaBio is the Georgia
state affiliate of the Washington, D.C.-based
Biotechnology Industry Organization (BIO).1
GaBio has an interest in this matter. GaBio
submits that the Federal Circuit’s decision in In re
Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), will
reduce the value of patents held by members of
GaBio, as well as others in the biotechnology
industry. GaBio further states that a broad reading
of “patent-eligible subject matter” benefits the
biotechnology industry because the limited monopoly
provided by patent protection is often necessary to
compensate for the large investment needed to bring

1 Petitioners have consented to the filing of all amicus curiae
briefs in support of either or neither party. Respondent has
consented to the filing of this amicus curiae brief on behalf
of GaBio. Pursuant to Rule 37.6, the amicus states that no
counsel for a party authored this brief in whole or in part,
and no counsel or party made a monetary contribution
intended to fund the preparation or submission of this brief.
No person other than the amicus, its members, or its counsel
made a monetary contribution to the preparation or
submission of this brief.

2
biotechnology inventions to the public. Without the
incentive of patent protection, many biotechnology
inventions would not be developed for public use.
SUMMARY OF THE ARGUMENT
GaBio submits this amicus brief in support of
Petitioners because this case is of special importance
to the biotechnology and pharmaceutical industries.
As Petitioners note, this case involves the most basic
question in patent law: what is patentable? The
Patent Code and this Court’s decisions on this
question support a broad view of what is patent
eligible, with only limited exceptions. The Federal
Circuit’s decision in this case cuts off significant
technologies from patent protection.
Although Petitioners’ invention is a method of
hedging financial risk (a so-called “business method
patent”), the test adopted by the Federal Circuit to
determine what is patent eligible can be, and already
has been, applied to strike down a broad class of
biotechnology and medical inventions, as pointed out
by Petitioners. These types of biotechnology and
medical inventions have long been patented, have
been specifically considered by Congress and
affirmatively included in the Patent Code, have
considerable value to the public, and require patent
protection to ensure their development. Without the
limited monopoly provided by patent protection, the
biotechnology and pharmaceutical industries cannot
and will not make the large investments needed to
commercialize these inventions for the benefit of the
public. For this reason, this case has significance far
beyond Petitioners’ invention or even Petitioners’
industry.

3
The Patent Code defines what can be
patented. Included within this defined patent-
eligible subject matter are processes. At the core of
this case is the determination of the meaning and
scope of “process.” As defined in the Patent Code, a
process includes a new use of a known process,
machine, manufacture, composition of matter, or
material. 35 U.S.C. § 100(b). Although the scope of
a “process” as defined by the Patent Code is broad,
this Court has determined that some limited subject
matter is not patent eligible. In particular, this
Court has held that “laws of nature, natural
phenomena, and abstract ideas” are not patent
eligible. Diamond v. Diehr, 450 U.S. 175, 185 (1981).
In a misguided attempt to provide a definitive rule
for determining what is patent eligible, the Federal
Circuit adopted a mandatory test (referred to as the
“machine-or-transformation” test) that, while
purporting to define this Court’s limited exceptions
to patent-eligible subject matter, actually excludes
far more inventions than those amounting to laws of
nature, natural phenomena, and abstract ideas.
GaBio joins Petitioners’ arguments and
further submits that: (1) the Federal Circuit’s
“machine-or-transformation” test conflicts with
Supreme Court precedent declining to adopt a rigid
test for determining patent-eligible subject matter;
and (2) the “machine-or-transformation” test
conflicts with the proper construction of federal law
defining what is a patent-eligible process.
The Federal Circuit held that its test was the
only applicable test and required that the U.S.
Patent & Trademark Office and lower courts apply
this test when determining what is patent eligible.
Bilski, 545 F.3d at 954, 964. Such a requirement

4
clearly contradicts this Court’s precedent, which has
been careful not to establish a single test or formula
for determining patent eligibility, recognizing that
one size does not fit all inventions.
The Federal Circuit formulated its test as a
“gateway” test for patent eligibility. An invention is
patent eligible only if it meets the test. In other
words, the Federal Circuit’s test determines whether
an invention is patent eligible. This too contradicts
this Court’s precedent, which consistently seeks to
determine if the invention at hand is not patent
eligible. This Court’s jurisprudence aligns more
closely with a “culling” test than a “gateway” test.
This Court carefully “culls” subject matter that is not
patent eligible rather than applying a one-size-fits-
all test of patent-eligible subject matter.
In addition, the Federal Circuit’s mandatory
test excludes from the definition of “process” in one
section of the Patent Code processes that are
specifically contemplated as patent eligible in other
sections of the Patent Code. This is contrary to the
Patent Code and to the rules of statutory
construction.
Accordingly, this Court should reverse the
Federal Circuit’s decision and correct the Federal
Circuit’s improper adoption of the inappropriately
narrow and rigid “machine-or-transformation” test.

5
ARGUMENT
I. THE FEDERAL CIRCUIT’S “MACHINE-
OR-TRANSFORMATION” TEST
CONFLICTS WITH SUPREME COURT
PRECEDENT DECLINING TO ADOPT A
RIGID TEST FOR DETERMINING
PATENT-ELIGIBLE SUBJECT MATTER
The Framers of the United States
Constitution recognized the importance of patents
when they empowered the U.S. Congress “[t]o
promote the progress of science and the useful arts,
by securing for limited times to authors and
inventors the exclusive right to their respective
writings and discoveries.” U.S. Const. art. I, § 8, cl.
8. Based on this authority, Congress established a
patent system early in our country’s history.

Congress codified this broad and open-ended power
to promote the progress of science and the useful
arts in what is now Title 35 of the United States
Code. Section 101 of Title 35 defines what qualifies
for patent protection:
Whoever 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.

6
A. The Federal Circuit’s “Machine-Or-
Transformation” Test Is Too Rigid
And Categorical
In In re Bilski, 545 F.3d 943, 954 (Fed. Cir.
2008) (en banc), the Federal Circuit adopted a single
test, the so-called “machine-or-transformation” test,
as the exclusive and mandatory test for determining
patent-eligible subject matter. In doing so, it
incorrectly characterized Supreme Court precedent
as follows: “The Supreme Court … has enunciated a
definitive test to determine whether a process claim
is tailored narrowly enough to encompass only a
particular application of a fundamental principle
rather than pre-empt the principle itself.” Id.
(emphasis added). The Federal Circuit went on to
determine that the “machine-or-transformation” test
was the exclusive test for patent-eligible subject
matter:
Neither the PTO nor the courts
may pay short shrift to the
“machine-or-transformation” test
by using purported equivalents or
shortcuts such as a “technological
arts” requirement. Rather, the
“machine-or-transformation” test
is the only applicable test and
must be applied, in light of the
guidance provided by the Supreme
Court and this court, when
evaluating the patent-eligibility of
process claims.
Id. at 964 (emphasis added).
With the Federal Circuit’s mandate in Bilski
that the “machine-or-transformation” test is the only

7
test for determining patent-eligible subject matter,
the Federal Circuit contradicts this Court’s
precedent applying § 101 of the Patent Code, as well
as this Court’s avoidance of rigid and categorical
rules for determining fact dependent inquiries in the
complex area of patent law. For at least this reason,
this Court should reverse.
B. Supreme Court Precedent On Patent
Eligibility Is Flexible And Permissive
In adopting the “machine-or-transformation”
test as the exclusive test for determining patent-
eligible subject matter, the Federal Circuit cited
Diamond v. Diehr, 450 U.S. 175 (1981), Gottschalk v.
Benson, 409 U.S. 63 (1972), and Parker v. Flook, 437
U.S. 584 (1978). However, Diehr, Benson, and Flook
do not mandate any exclusive, rigid test for
determining patent-eligible subject matter, much
less the “machine-or-transformation” test. Indeed,
this Court has found that no collection of tests is
even sufficient to define patent-eligible subject
matter.
In Benson, this Court held that a particular
algorithm for converting numerals in binary coded
decimal form to numerals in binary form was not
patent-eligible subject matter under § 101. 409 U.S.
at 71-72. After reviewing the Court’s prior cases on
patent-eligible subject matter, the Court specifically
declined to hold that “a process patent must either
be tied to a particular machine or apparatus or must
operate to change articles to a ‘different state or
thing.’” Id. In fact, the Court went further, stating
that “[w]e do not hold that no process patent could
ever qualify if it did not meet the requirements of
our prior precedents,” id. at 71, thus signaling that

8
no prior holding or combination of holdings on patent
eligibility affirmatively defines the limits of patent-
eligible subject matter. Hence, the Court rejected a
single, categorical test—or even a combination of
tests—for patent-eligible subject matter.
In Flook, this Court solidified Benson’s
rejection of the notion that any of the Court’s
previous tests could be dispositive, stating: “[a]s in
Benson, we assume that a valid process patent may
issue even if it does not meet one of these
qualifications of our earlier precedents.” 437 U.S. at
588 n.9. This language was selectively quoted in
Bilski, but was editorially changed. Specifically, the
Federal Circuit replaced “one of these qualifications
of our earlier precedents” with “[the machine-or-
transformation test],” thus obscuring Flook’s
conclusion that even the totality of this Court’s
precedents cannot be applied as a litmus test. Id.;
Bilski, 545 F.3d at 956.
Diehr merely identified the “machine-or-
transformation” test as one way of determining
patentability. The Diehr Court held that a process
for curing synthetic rubber that included the use of a
mathematical formula was patent-eligible subject
matter under § 101. 450 U.S. at 192-93. In
analyzing the claimed process, the Court noted that
“a physical and chemical process for molding
precision synthetic rubber products falls within the §
101 categories of possibly patent-eligible subject
matter. That respondents’ claims involve the
transformation of an article, in this case raw,
uncured synthetic rubber, into a different state or
thing cannot be disputed.” Id. at 184 (emphasis
added).

9
Thus, Diehr involved a process in which a
transformation of an article took place. Because the
“machine-or-transformation” test is permissive, as
indicated in the prior cases of this Court, and
because the process in Diehr involved a
transformation, this Court appropriately applied it
there. However, that such a process fell within the
subset of the Court’s cases involving the
transformation and reduction of an article to a
different state or thing does not establish that such
was the only test intended by this Court, or the only
basis on which a process can qualify as patent-
eligible subject matter under § 101. Rather, the
Federal Circuit misinterpreted this Court’s
precedent, which is merely consistent with the
inclusion of the “machine-or-transformation” test as
one way of determining patent eligibility, as
mandating the “machine-or-transformation” test.
C. The Federal Circuit’s “Machine-Or-
Transformation” Test Conflicts With
The Supreme Court’s Approach To
Patent Eligibility
As set forth above, GaBio agrees with
Petitioners that the rigid application of the
“machine-or-transformation” test conflicts with this
Court’s previous patent-eligible subject matter
holdings. In addition, the very manner in which the
Federal Circuit framed the question of what is
patent-eligible subject matter as a rigid exclusionary
test flatly contradicts prior direction from this Court
on this issue. The Federal Circuit seeks to take
many tests and many ways of determining how to
identify what is patent eligible from its own
jurisprudence and condense them to a single test.
However, prior jurisprudence from this Court

10
indicates that each test, and each way of
determining patent-eligible subject matter, is
permissive and that they are to be used as tools to
verify that a claimed process is not disqualified as “a
‘process’ within the meaning of the Patent Act.”
Benson, 409 U.S. at 64; see also Funk Bros. Seed Co.
v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)
(product not patent eligible because the qualities of
the product are manifestations of laws of nature);
Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306
U.S. 86, 94 (1939) (product created by applying a
scientific truth is patent eligible); Waxham v. Smith,
294 U.S. 20, 21-22 (1935) (method that achieves a
function is not unpatentable as an attempt to patent
the function performed or a natural law); Expanded
Metal Co. v. Bradford, 214 U.S. 366, 385-86 (1909)
(method involving mechanical operations but not
chemical transformation is patent eligible); Dolbear
v. American Bell Tel. Co., 126 U.S. 1, 534-35 (1888)
(method using altered electrical current to transmit
speech is patent eligible); Tilghman v. Proctor, 102
U.S. 707, 729 (1880) (process of chemical
transformation not limited to a particular means or
apparatus is patent eligible); Cochrane v. Deener, 94
U.S. 780, 787-88 (1876) (process to achieve a result is
patent eligible regardless of what instrument or
machine is used to effect that result); Rubber-Tip
Pencil Co. v. Howard, 87 U.S. 498, 507 (1874) (device
embodying and applying an idea is patent eligible);
Corning v. Burden, 56 U.S. 252, 268 (1853) (use of a
machine to continuously process iron is not a patent-
eligible method because it represents the function of
the machine); O'Reilly v. Morse, 56 U.S. 62, 112-13
(1853) (method of using electromagnetism is not
patent eligible as an attempt to protect a power of

11
nature);  Le Roy v. Tatham, 55 U.S. 156, 175 (1852)
(process applying a principle is patent eligible).
This Court has consistently held that there
are many ways to define patent-eligible subject
matter and that the use of precedents should be
inclusive rather than exclusive. This comports with
the broad notion of patent-eligible subject matter
starting with the U.S. Constitution and continuing
through each iteration of the Patent Code, especially
the broad definition of patent-eligible subject matter
in § 101. It is much more logical and sensible to
determine whether a particular process before an
examiner or a court is not patent eligible than to try
to define—for all time, in all circumstances, and in
one test—what is patent eligible. Determining what
is not patent eligible is precisely how this Court has
consistently handled the question. A condensation of
Diehr,  Benson, and Flook, as well as other prior
cases, reveals that this Court has chosen to provide
relatively clear direction as to what is not patent
eligible (indicating that laws of nature, natural
phenomena, and abstract ideas cannot be patented
per se), as opposed to what is patent eligible.
Indeed,  Diehr, far from validating Bilski’s
“machine-or-transformation” test, confirms and
distinguishes the application of different principles
for determining patent-eligible subject matter.

Diehr actually recites with favor a more general test
of patent-eligible subject matter: “It is now
commonplace that an application of a law of nature
or mathematical formula to a known structure or
process may well be deserving of patent protection.”
450 U.S. at 188 (emphasis in original). The broad
test set forth in Diehr in effect limits the exclusion of
subject matter from patent eligibility. Even though

12
Diehr involved a process that transformed an article,
the holding in Diehr was not based on the “machine-
or-transformation” dichotomy of Bilski:
On the other hand, when a claim
containing a mathematical
formula  implements or applies
that formula in a structure or
process which, when considered as
a whole, is performing a function
which the patent laws were
designed to protect (e.g.,
transforming or reducing an
article to a different state or
thing), then the claim satisfies the
requirements of § 101.
Id. at 192 (emphasis added).  Thus, contrary to the
reasoning in Bilski,  Diehr does not establish or
support the “machine-or-transformation” test as the
only test for determining patent-eligible subject
matter. Instead, the rigid “machine-or-
transformation” test of Bilski conflicts with this
Court’s precedent.
D. The Federal Circuit’s “Machine-Or-
Transformation” Test Conflicts With
The Supreme Court’s Interpretation
Of The Patent Statute
The Federal Circuit in Bilski also failed to
give sufficient weight to the constitutional and
statutory source of patent-eligible subject matter.
The Constitution grants Congress broad power to
promote the progress of science and the useful arts.
Under this broad power, Congress has enacted a
broad definition of patent-eligible subject matter. As
this Court has repeatedly noted, the definition and

13
scope of patent-eligible subject matter provided in §
101 is broad and without specific limits. See Diehr,
450 U.S. at 188; Diamond v. Chakrabarty, 447 U.S.
303, 309-10 (1980) (statutory subject matter
intended to include “anything under the sun that is
made by man”) (citations omitted); Flook, 437 U.S. at
588 n.9 (“As in Benson, we assume that a valid
process patent may issue even if it does not meet one
of these qualifications of our earlier precedents”);
Benson, 409 U.S. at 71 (“We do not hold that no
process patent could ever qualify if it did not meet
the requirements of our prior precedents”).
It is in this context that this Court has found
careful, limited exceptions to the statutory mandate
of broad patent-eligible subject matter. The Patent
Code does not provide any exceptions and so,
appropriately, this Court has made them of the most
limited scope. The exceptions are rooted in the
principle that only “[p]henomena of nature, though
just discovered, mental processes, and abstract
intellectual concepts are not patentable, as they are
the basic tools of scientific and technological work.”
Benson, 409 U.S. at 67. The Federal Circuit
apparently lost sight of this limited basis for
exceptions and misread Supreme Court precedent to
produce an unwarranted and unsupported extension
and expansion of this Court’s limited exceptions to
patent-eligible subject matter. Neither the Patent
Code nor the exception for laws of nature, natural
phenomena, and abstract ideas support the effect of
the Federal Circuit’s “machine-or-transformation”
test, which is to exclude from patent protection
inventions that meet the requirements of the
Constitution and the Patent Code.

14
This Court’s framework of finding limited
exceptions to patent eligibility is akin to a “culling”
of subject matter that is not patent eligible. In
contrast, the Federal Circuit’s categorical “machine-
or-transformation” test is more like a “gateway,”
through which no invention can pass unless it has
the particular attributes of patent-eligible subject
matter set forth in Bilski. Many sound inventions
that should never be culled will be blocked at the
Federal Circuit’s “machine-or-transformation” gate.
II. THE FEDERAL CIRCUIT’S “MACHINE-
OR-TRANSFORMATION” TEST
CONFLICTS WITH THE PROPER
CONTRUCTION OF FEDERAL LAW
At issue in Bilski was the meaning of
“process,” as used in § 101 of the Patent Code. The §
101 definition of “process” established in Bilski
contradicts the construction and clear meaning of
“process” in other parts of the Patent Code. Because
such a conflict between different sections of the same
statute cannot stand under clear Supreme Court
precedent, Bilski’s § 101 definition of “process,” and
the “machine-or-transformation” test that depends
on this definition, are inconsistent with federal law.
For this reason as well, this Court should reverse.
The area of conflict between the Bilski
decision and the statute discussed here by GaBio is
different from the statutory conflict identified by
Petitioners. In this discussion, GaBio demonstrates
a broader Congressional intent not to limit patent-
eligible subject matter and shows that the Patent
Code contemplates and authorizes patent protection
for biomedical and biotechnological inventions that

15
would be excluded from patent eligibility by Bilski’s
“machine-or-transformation” test.
A.
Supreme Court Principles Of
Statutory Construction Require
Harmony Between Different Sections
Of The Same Statute
It is a fundamental principle of statutory
construction that provisions in the same act are to be
construed in harmony. See Peck v. Jenness, 48 U.S.
612, 623 (1849). Moreover, an act is to be read as a
whole, with an eye to its underlying context, object,
and policy. Richards v. U.S., 369 U.S. 1, 11 (1962).
“[E]very section, provision, and clause of a statute
shall be expounded by a reference to every other; and
if possible, every clause and provision shall avail,
and have the effect contemplated by the legislature.”
Peck, 48 U.S. at 623. In effecting Congressional
intent, courts must “give full effect to all the
provisions of the act.” Id. at 623; see also Richards,
369 U.S. at 11 (adopting the construction that is
most “consistent with the Act considered as a
whole”); Mastro Plastics Corp. v. National Labor
Relations Bd., 350 U.S. 270, 286-87 (1956) (rejecting
proposed construction of statute because of
incongruous effect that would undermine the
underlying purpose of the act).
Thus, statutes should be construed with due
regard for their counterparts. No interpretation
should undermine a neighboring provision without
express direction from Congress. Cf. Peck, 48 U.S. at
623. In Bilski, the Federal Circuit interpreted
“process” under § 101 so as to exclude some patent-
eligible “uses of compositions” and “biotechnology
processes” contemplated under § 287(c) of the Patent

16
Code, even though the express statutory language
does not support or provide for that limitation.
Furthermore, the Bilski definition of “process”
conflicts with the clear meaning of “a new use of a
known process” in § 100(b) of the Patent Code. The
Bilski decision therefore creates disharmony
between different sections of the Patent Code (§§
100(b), 101, and 287(c)) where none need exist and,
indeed, where principles of statutory construction
provide that it shall not exist. It is possible to
interpret “process” so as to give full effect to all
patent-eligible processes contemplated by the
express terms of §§ 100(b) and 287(c). Section 101’s
reach should comport with the purposes and
expansive intent behind the Patent Code,
considering that provision not in isolation, but in
harmony with the remainder of the Code.
B. Section 287(c) Of The Patent Code
Contemplates As Patent Eligible
Biomedical Inventions That Are At
Risk Of Exclusion By Bilski’s
“Machine-Or-Transformation” Test
Section 287(c) of the Patent Code
contemplates patent protection for biomedical and
biotechnological processes excluded by Bilski’s
“machine-or-transformation” test. Because, as set
forth above, statutes in the same act are to be
construed in harmony and statutes should be
construed with due regard to their counterparts, the
processes contemplated by § 287(c) must fall within
the definition of “process” in § 101 of the Patent
Code. Nevertheless, the Bilski test impermissibly
excludes at least some of the processes contemplated
by § 287(c).

17
Section 287(c) of the Patent Code exempts
medical practitioners from patent infringement
liability when their performance of a “medical
activity” infringes a patent. 35 U.S.C. § 287(c)(1).
This exemption is itself limited by the exclusion of
three enumerated activities from the definition of
“medical activity.” Id. at § 287(c)(2)(A). Specifically,
§ 287(c) does not exempt medical practitioners from
infringement liability if the activity they perform is
“(i) the use of a patented machine, manufacture, or
composition of matter in violation of [the] patent, (ii)
the practice of a patented use of a composition of
matter in violation of [the] patent, or (iii) the
practice of a process in violation of a biotechnology
patent.” Id.
As explained below, “use of a composition of
matter” and “a process in violation of a biotechnology
patent” encompass more processes than just those
that transform an article or use a particular
machine, as required by the Bilski test.2 35 U.S.C. §
287(c)(2)(A). Thus, Bilski’s “machine-or-
transformation” test excludes from patent eligibility
some processes clearly considered patent eligible in
another section of the same statute.
The legislative history of § 287(c) makes the
scope of processes contemplated in that section
especially clear and highlights the discord between
the processes contemplated there and the limited
scope of patent-eligible subject matter allowed under
Bilski. The amendment that became § 287(c)
initially proposed barring patents on medical

2 GaBio notes that the Patent Code defines a “process” as
including “use of a composition of matter.”  35 U.S.C. §
100(b).

18
activities. 142 Cong. Rec. H8275-79 (daily ed. July
24, 1996). Over strenuous objection to the breadth of
the amendment—but not to the intent of insulating
doctors from certain types of infringement—the
Senate version was altered to exempt doctors from
infringement liability, but not to bar the patenting of
medical activities. Id. In a discussion of the
definition ultimately adopted in § 287(c), the
Committee stated:
‘Uses of compositions of matter’
include, without limitation, novel
uses of drugs, novel uses of
chemical or biological reagents for
diagnostic purposes, novel
methods for scheduling or timing
administration of drugs, novel
methods for combining drug
therapies, and novel methods for
providing genetic or other
biological materials to a patient
(including gene therapies.) [sic] A
particular example would be a
claim that recites only the novel
use of a drug for the treatment of
diabetes that involves the
administration of a drug at a
particular time of day and/or at a
specified dose and/or with a
specified concomitant medicinal
therapy could not be construed as
a ‘medical activity.’
H.R. Rep. No. 104-863, at 854 (1996) (Conf. Rep.).
Thus, Congress intended to exclude “uses of
chemical or biological reagents for diagnostic

19
purposes” and “methods for scheduling or timing
administration of drugs” from § 287(c)’s definition of
“medical activity.” Id. Congress contemplated these
activities as the subject of patents and thus as
patent-eligible subject matter. Yet, many such “uses
of chemical or biological reagents for diagnostic
purposes” and “methods for scheduling or timing
administration of drugs,” id., may not involve the
“transformation of an article” or the use of a
“particular machine,” as required in Bilski’s
“machine-or-transformation” test. Bilski, 545 F.3d
at 954. An example of this is discussed below. Thus,
the Bilski test excludes from patent eligibility some
processes considered patent eligible in another
section of the same statute.
GaBio sees special urgency for the present
case to correct this conflict with § 287(c) of the
Patent Code because the Federal Circuit has already
used the Bilski test to invalidate a claim that both
uses a “chemical or biological reagent[] for diagnostic
purposes” and is a “method[] for scheduling or timing
administration of drugs.” H.R. Rep. No. 104-863, at
854 (1996) (Conf. Rep.). In Classen
Immunotherapies, Inc. v. Biogen Idec, 304 Fed. Appx.
866, 2008 WL 5273107, at *1 (Fed. Cir. 2008), in a
one paragraph opinion, the Federal Circuit held that
a claim to a method of determining whether an
immunization schedule affects the incidence or
severity of a chronic immune-mediated disorder
failed the Bilski “machine-or-transformation” test.
Thus, although the Classen claim arguably fell
within the meaning of § 287(c)(2)(A), the Federal

20
Circuit held that it fell outside the definition of a
process in § 101.3
The claim at issue in Classen reads:
A method of determining whether
an immunization schedule affects
the incidence or severity of a
chronic immune-mediated disorder
in a treatment group of mammals,
relative to a control group of
mammals, which comprises
immunizing mammals in the
treatment group of mammals with
one or more doses of one or more
immunogens, according to said
immunization schedule, and
comparing the incidence,
prevalence, frequency or severity
of said chronic immune-mediated
disorder or the level of a marker of
such a disorder, in the treatment
group, with that in the control
group.
U.S. Pat. No. 5,723,283, claim 1 (emphasis added);
see also Classen Immunotherapies, Inc. v. Biogen
Idec, Civil No. WDQ-04-2607, 2006 WL 6161856, at
*5 (D. Md. Aug. 16, 2006), aff’d, 304 Fed. Appx. 866
(Fed. Cir. 2008).

3 Notably, 35 U.S.C. § 287(c) was not at issue in Classen.
However, the claim in Classen is an example of the type of
invention that § 287(c) may have contemplated as patent
eligible, and the Federal Circuit’s invalidation of that claim
using
Bilski’s “machine-or-transformation” test is
inconsistent with the scope of patent-eligible biomedical
processes, as established in § 287(c) of the Patent Code.

21
Without commenting on whether the claim at
issue in Classen should or should not fall within the
§ 287(c) exemption, one cannot doubt that Congress
understood that § 101 encompassed the type of
activity embodied by the Classen claim when it
amended the Patent Code by adding § 287(c)
precisely to address such activities by doctors. The
Bilski “machine-or-transformation” test thus unduly
restricts Congressional intent regarding what can be
a patent-eligible process.
One can also analyze the Classen claim from
the perspective of § 287(c)’s “process in violation of a
biotechnology patent.” 35 U.S.C. § 287(c)(2)(A).
While the Patent Code itself does not define
“biotechnology patent,” during the legislative
process, Congress stated that a biotechnology patent
is “… a process of making or using biological
materials, including treatment using those
materials, where those materials have been
manipulated ex vivo at the cellular or molecular
level.” H.R. Rep. No. 104-863, at 854 (1996) (Conf.
Rep.). Congress went on to state:
Biological materials which may be
manipulated ex vivo at the cellular
or molecular level include a
variety of cellular, intracellular,
extracellular, and acellular
substances. Cellular substances
include (but are not limited to)
cultured microbial and
mammalian cells. Intracellular
substances include (but are not
limited to) genetic materials, such
as DNA and RNA that is obtained
from within the cell. Extracellular

22
substances include (but are not
limited to) proteins and other
molecules that are secreted or
excreted by cells. Acellular
substances include (but are not
limited to) viruses and other
vectors for transmitting genetic
material. Ex vivo manipulation
includes propagation, expansion,
selection, purification,
pharmaceutical treatment, or
alteration of the biological
characteristics of these substances
outside of a human body.
Id.
The “immunogen” of the Classen claim can be
considered a “biological material” because
immunogens commonly include “proteins and other
molecules that are secreted or excreted by cells,”
which are mentioned in the Congressional Report.
Id. Thus, the Classen claim can be considered a
“biotechnology process.” Because Congress, in
enacting § 287(c), contemplated that such claims are
patent eligible, and because Bilski’s “machine-or-
transformation” test excluded the Classen claim
from patent eligibility, Bilski conflicts with the
proper interpretation of the Patent Code as a whole.
C. Section 100(b) Of The Patent Code
Defines As Patent Eligible Inventions
That Are At Risk Of Exclusion By
Bilski’s “Machine-Or-Transformation”
Test
The Bilski “machine-or-transformation” test
also conflicts with § 100(b) of the Patent Code, which

23
provides definitions for the Patent Code, including §
101. Section 100(b) reads: “The term ‘process’ means
process, art, or method, and includes a new use of a
known process, machine, manufacture, composition
of matter, or material.”  35 U.S.C. § 100(b). Thus,
patent-eligible subject matter under § 101 includes a
new use of, for example, a composition, such as a
drug. Many uses of compositions are not tied to a
particular machine and might be considered not to
involve a transformation to a new state or thing. For
example, a known chemical compound may be
discovered to be useful to treat a particular disease.
This would be a “new use of a known … composition
of matter.” Id. If the compound is administered
using known and conventional techniques, this use
arguably would not be tied to a “particular machine”
and might be considered not to involve “a
transformation to a new state or thing” as required
under the Bilski “machine-or-transformation” test.4
The result would be to exclude from patent eligibility
an invention falling within the definition of “process”
in § 100(b). Thus, it is clear that Bilski’s rigid
“machine-or-transformation” test excludes from
patentability some processes plainly contemplated in
§ 100(b).
Indeed, the Classen claim could be considered
a new use of a composition of matter. The
immunogen in the Classen claim is a composition of

4 GaBio does not take a position for the purpose of this
amicus curiae brief regarding whether a compound
administered to a patient does or does not involve “a
transformation to a new state or thing” so as to satisfy the
Bilski “machine-or-transformation” test. Rather, GaBio
points out the error and harm that result when no such
transformation is found.

24
matter, and the claim includes a method of using the
immunogen—“immunizing mammals in the
treatment group of mammals with one or more doses
of one or more immunogens.” U.S. Pat. No.
5,723,283, claim 1. Thus, the Classen claim falls
within the definition of a patent-eligible process in §
100(b). However, the Federal Circuit has already
applied the Bilski test to the Classen claim and held
it not to be patent eligible. Because such a result
conflicts with § 100(b) of the Patent Code, the rigid
Bilski “machine-or-transformation” test, which has
the effect of pitting one section of the Patent Code
against another, is contrary to established tenets of
statutory construction.
In short, Bilski’s definition of “process” will
exclude from patent eligibility many claims that are
patent eligible according to settled expectations, and
at worst will carve out entire areas of subject matter
from patent eligibility because they do not transform
an article. See, e.g., Classen, 304 Fed. Appx. at 866.
Bilski’s “machine-or-transformation” test is so broad
that it undermines clear Congressional intent and
proper statutory construction as to what “processes”
are patent eligible under § 101.
Although Washington and Jefferson could not
have envisioned such a method as the one in Classen
when the first U.S. patent for a “process” of making
potash (U.S. Patent X000001) was issued, GaBio
submits that the Framers would have intended, and
Congress has so determined, that Article I, section 8
of the Constitution covers this modern day process
and many others like it. The conflict between the
test articulated in Bilski and other sections of the
Patent Code, as well as the violation of this Court’s
statutory construction precedent by the Bilski court,

25
require that the Supreme Court reverse the Federal
Circuit’s decision in Bilski and its adoption of a
mandatory “machine-or-transformation” test.
CONCLUSION
The Federal Circuit’s “machine-or-
transformation” test conflicts with this Court’s
precedent declining to adopt a rigid test for
determining patent-eligible subject matter, as well
as with the proper construction of federal law
defining what is a patent-eligible process.
The Federal Circuit’s test is formulated as a
“gateway” test of what is patent eligible. This is
contrary to this Court’s precedent, which
consistently seeks to determine if the invention at
hand is not patent eligible, in keeping with this
Court’s limited exceptions to patent-eligible subject
matter. Only if an invention is clearly not patent
eligible under these limited exceptions has this
Court excluded the invention from patent protection.
In addition, the Federal Circuit’s mandatory
test excludes from the definition of “process” in one
section of the Patent Code—and thus excludes from
patent protection—biotechnology and medical
processes that are specifically contemplated as
patent eligible in other sections of the Patent Code.
This conflict between sections of the Patent Code is
contrary to the rules of statutory construction.
Accordingly, the Court should reverse the
Federal Circuit’s improper adoption of the
inappropriately narrow and rigid “machine-or-
transformation” test.

26
Respectfully Submitted,

William H. Kitchens

Counsel of Record
Robert A. Hodges, PhD
David E. Huizenga, PhD
Scott E. Taylor
Heather Smith Michael
ARNALL GOLDEN GREGORY LLP
171 17th Street, NW
Suite 2100
Atlanta, Georgia 30363
(404) 873-8500
Counsel for Amicus Curiae
Georgia Biomedical Partnership, Inc
d/b/a Georgia Bio

August 5, 2009