No. 08-964 
1fn tlCbt 
~upreme ~ourt of  tbe  Wniteb  ~tate£s 
On Writ of Certiorari to the 
United States Court of Appeals 
for the Federal Circuit 
William H. Kitchens 
Counsel of Record 
Robert A.  Hodges, PhD 
David E. Huizenga, PhD 
Scott E. Taylor 
Heather Smith Michael 
171  17th Street, NW 
Suite 2100 
Atlanta, Georgia  30363 
(404) 873-8500 
Counsel for Amicus Curiae Georgia Biomedical 
Partnership,  Inc.  d a  Georgia Bio 
801  East  Main  Street Suite  100  Richmond,  Virginia  23219  (800)  847-0477 

AMICUS CURIAE ........................................................1 
SUMMARY OF THE ARGUMENT..............................2 
ARGUMENT .................................................................5 
MATTER ..................................................5 
The Federal Circuit’s 
Transformation” Test Is Too 
Rigid And Categorical...................6 
Supreme Court Precedent On 
Patent Eligibility Is Flexible 
And Permissive .............................7 
The Federal Circuit’s 
Transformation” Test 
Conflicts With The Supreme 
Court’s Approach To Patent 

The Federal Circuit’s 
Transformation” Test 
Conflicts With The Supreme 
Court’s Interpretation Of The 
Patent Statute.............................12 
LAW .......................................................14 
Supreme Court Principles Of 
Statutory Construction 
Require Harmony Between 
Different Sections Of The 
Same Statute...............................15 
Section 287(c) Of The Patent 
Code Contemplates As 
Patent Eligible Biomedical 
Inventions That Are At Risk 
Of Exclusion By Bilski’s 
Transformation” Test..................16 
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 

 Classen Immunotherapies, Inc. v. Biogen Idec, 304 
Fed. Appx. 866, 2008 WL 5273107 
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 

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

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).
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. 

biotechnology inventions to the public.  Without the 
incentive of patent protection, many biotechnology 
inventions would not be developed for public use. 
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’ 

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 

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 
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. 

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. 

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 
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 

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, DiehrBenson, 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 
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 

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 

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 

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 Corpof 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 

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 

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 

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. 

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. 
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 

would be excluded from patent eligibility by Bilski’s 
“machine-or-transformation” test. 
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 

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). 

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. § 

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 

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 

Circuit held that it fell outside the definition of a 
process in § 101.
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 
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 
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. 

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 

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. 
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” 
The  Bilski “machine-or-transformation” test 
also conflicts with § 100(b) of the Patent Code, which 

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. 

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, 

require that the Supreme Court reverse the Federal 
Circuit’s decision in Bilski  and its adoption of a 
mandatory “machine-or-transformation” test. 
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. 

Respectfully Submitted, 
 William H. Kitchens 
Counsel of Record 
Robert A. Hodges, PhD  
David E. Huizenga, PhD 
Scott E. Taylor 
Heather Smith Michael 
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