# Amicus Curiae Brief — Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2006
- **Citation:** 548 U.S. 124

## Text

| FILED
fy) FEB 6 ~ 2006

OFFICE OF THE CLERK

U.S.
No. 04-607 PREME COURT

IN THE
Supreme Court of the Anited States

LABORATORY CORPORATION OF AMERICA HOLDINGS,
D/B/A LABCORP,

Petitioner,
Vv.

METABOLITE LABORATORIES, INC. AND
COMPETITIVE TECHNOLOGIES, INC.,

Respondents.

ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT

BRIEF AMICUS CURIAE
FRANKLIN PIERCE LAW CENTER _
IN SUPPORT OF THE RESPONDENTS

CRAIG STEVEN JEPSON
Professor of Law
Counsel of Record

FRANKLIN PIERCE
LAW CENTER
2 White Street
Concord, NH 03301
(603) 228-1541

Amicus Curiae

EEE PTS
Wit SON-EPES PRINTING CO. INC. — (202) 789-0096 -— WasHinGron.D C. 20001

TABLE OF CONTENTS

Page
TABLE OF AUTHORITIES .................c.cccssessesseveees iil
INTEREST OF AMICUS CURIAE ...0...........cccc000 1
SETI Tec siucisiiceidlendespetiidctabinsicniesaneninnpaciateuidemiitgidsidin 2
SUMMARY OF ARGUMENT. .................cccccseesseenees 3
IEE <eipnnnctaneientinibcicinndipcitiaiapuimiintstitogiineiie 4

I. THIS COURT HAS NEVER INVALIDATED
A PATENT CLAIM FOR CLAIMING A LAW
SEF IPI seciceseciceninisimncisatoneninimnanectgboumiatin 6

A. Birth of the Prohibition: The First Patent
Claims to Laws of Nature Were Upheld. . 6

B. Many Decisions Purporting to Invalidate
Patent Claims to Laws of Nature Do So
Only by Importing Conditions of
Patentability from Statutory Provisions.. 9

II. SOUND POLICY SUPPORTS ISSUANCE
OF CLAIMS DIRECTED TO LAWS OF

SUITE: iccianiibleritstniiidstatinatediteedaiiaislaianpinbitiinedoes 12
A. Reinvigorating Our Patent System
Reinvigorated Our Economy................... 13

B. Expanding the Scope of Subject Matter
Protectable by Patent-like Incentives
Te mace seaee 17

III. THIS CASE IS THE APPROPRIATE
VEHICLE FOR BUILDING ON
CHAKRABARTY AND DIEAR. .................. 21

il
A. The Prohibition is Arbitrary and Has
Always Been Difficult to Apply. ............. 22

B. This Court and Congress Consistently
Have Moved Away from Arbitrary Line
Drawing Regarding Patentable Subject
See bcnnidipechinicunsiseiininincinonpdaniidnieiienbtoneiinnaiais 27

eA iceciicnninnitntetisinchoninnsigeivntenpiatoniniiiien 30

il

TABLE OF AUTHORITIES

Cases Page
Am. Fruit Growers, Inc. v. Brogdex Co.,

I ile 27
Brenner v. Manson,

SIL Te Te Soe tee aN 14
Cohens v. Va.,

ak © 4 kT, | REESE e penne 8
Dawson Chem. Co. v. Rohm & Haas Co.,

A 16, 17
De Forest Radio Co. v. Gen. Elec. Co.,

EE ey ae ee er Newnan Reneonnnen 7
Diamond v. Chakrabarty,

A i 4, 6, 16, 27
Diamond v. Diehr,

ES SUITE sieshisciicinciseihierntsiasideantcdjuesapcnatsnietiadl passim
Dolbear v. Bell, ‘

I 22
Eibel Process Co. v. Minn. & Ont. Paper Co.,

I A a 11-
Funk Bros. Seed Co. v. Kalo Inoculant Co.,

I 6, 10, 27
Gottschalk v. Benson,

ESA CC RD ret ee em 6, 27
Graham v. John Deere Co.,

Ia 14
Househill Coal & Tron Co. v. Neilson,

1 Webs. Pat. Cas. 673 (S.C.(H.L.) 1843) .00......0000.00000.. 8

lv

Cases—Cont'd | Page
In re Breslow,

FA TT Dek FS ——_ oer 21
In re Gulack,

708 F.2d 1381 (Ped. Cir. 1963) .......ccccccccccccccssccccosesees 28
In re Miller,

GID Fe BE Gee a: Ne ccctcncecstscianiindnsannataniaia 28
In re Schrader,

ae ) f Be i — ERED me ee 29
In re Tarczy-Hornoch,

Se Fe ee ee Rs i cecettintcictiinnsttiavinnaimseniaian 28
In re Walter,

TEAR Pet YG = =— a ee 11
Jungerson v. Ostby & Barton Co.,

Be ek ee ee ceenciccctnsncttininsntencssestnnctsnmenmpeamneiiings 13
Katz v. Horni Signal Mfg. Corp.,

FP es . Eft | ere 11
Le Roy v. Tatham,

55 U.S. (14 How.) 156 (1853) .................cccseeceeees 6, 7, 22
Le Roy v. Tatham,

ge BF RG er 8
Neilson v. Harford,

151 Eng. Rep. 1266 (Exch. 1841)...........:cccccccceesereeeseees 8
O'Reilly v. Morse,

56 U.S. (15 How.) 62 (18653)............csccccccsrsroccseeees passim
Parker v. Flook,

GS TE G8 Cae ccsertcincetenctsininsiniarsstmmesiiiians 6, 9, 14

Pres. & Fellows of Harvard Coll. v. Can. (Comm’r of
Patents),
SRBBEE 6: FC. GIB ceccccccccccesccscssesesttcsantsevesnsnsoienitatessnnes 26

Cases—Cont'd Page
Reiner v. I. Leon Co.,
a 13
Republic Indus., Inc. v. Schlage Lock Co.,
eS 14
Risdon Iron & Locomotive Works v. Medart,
RE 28
Sakraida v. Ag Pro, Inc.,
TT 14
Smith v. Downing,
22 F. Cas. 511 (C.C.D. Mass. 1850)...................c000008. 23
SmithKline Beecham Corp. v. Apotex Corp.,
403 F.3d 1331 (Fed. Cir. 2005) ........... steitiiesibspendiadiiianatitninis 26
State St. Bank & Trust Co. v. Signature Fin. Group,
Inc., 149 F.3d 1368 (Fed. Cir. 1998)................ 5, 10, 29
Tilghman v. Proctor,
EE 22, 24, 25, 26
Statutes
Rs 20
TE ee 2
Ee 2
A 2
a ae 2

ey Ob a reccinncinssttscnntenenssossnnennemsnvemnvemnammnene 3

Legislative Materials Page

American Patent System: Hearings on S. Res. 92 Before
the Subcomm. On Patents, Trademarks, & Copyrights
of the Comm. on the Judiciary, 84th Cong. (1955) ... 12

Bayh-Dole Act of 1980,

Pub. L. No. 96-517, 94 Stat. 3015 (1980) .................. 15
Econ. Recovery Tax Act of 1981,

Pub. L. No. 97-34, 95 Stat. 172 (1981) ...................... 15
Fed. Courts Improvement Act of 1982,

Pub. L. No. 97-164, 96 Stat. 25 (1982) ...................... 15
Fed. Tech. Transfer Act of 1986,

Pub. L. No. 99-502, 100 Stat. 1785 (1986) ................ 15
Food & Drug Admin. Modernization Act of 1997,

Pub. L. No. 105-115, 111 Stat. 2296 (1997).............. 20
I Ee 4
Orphan Drug Act of 1983,

Pub. L. No. 97-414, 96 Stat. 2049 (1983) .................. 18
Patent Law Amendments Act of 1984,

Pub. L. No. 98-622, 98 Stat. 3383 (1984)........... 15, 16

Patent Law Codification & Revision: Hearings on H.R.
3760 Before Subcomm. No. 3 of the House Comm. on

the Judiciary, 82d Cong. (195 1)..............ccccccccceeceeeeeeees 4
Patent Misuse Reform Act of 1988,

Pub. L. No. 100-703, 102 Stat. 4674 (1988) .............. 16
Process Patent Amendments Act of 1988,

Pub. L. No. 100-418, 102 Stat. 1107 (1988) .............. 16
BD, SR, SE, GS I Cc rccsccencnsceccszsenscncessssemsenscsanensees 4
Stevenson-Wydler Technology Innovation Act of 1980,

Pub. L. No. 96-480, 94 Stat. 2311 (1980) .................. 15

————————————

vil
Legislative Materials—Cont'd Page
The Pediatric Exclusivity Provision: U.S. Food & Drug
Admin. Jan. 2001 Status Report to Congress (2001) 20
Other Materials

Anand, B. & T. Khanna,
The Structure of Licensing Contracts,

48 J. Indus. Econ. 103 (2000) ....0......0....cccccceeceeeceeeeees 15
Arora, A., et al.,
_ Markets for Technology: Economics of Innovation and
Corporate Strategy (MIT Press 2001)....................00+. 14
Beyond Borders: Global Biotechnology Report 2005
Sy SONNEI sas tindensecitilisninetesiniinigtaehtenineiinaiiingsien 19
Beyond Borders: The Global Biotechnology Report 2002
gE acer ee 18
Biological Sciences,
14 Encyclopedia Britannica 1069 (15th ed. 2005).... 23
Carr, Geoffrey,
A Survey of the Pharmaceutical Industry: The
Alchemists, Economist, Feb. 21, 1998 ...................006. 17
Chevreul, M. E.,
De la Loi du Contraste Simultané des Couleurs et de
l‘assortiment des Object Colorés (Paris 1839)........... 25
Chisum, Donald S.,
TT | 14, 16

Duffy, John F.,
The Festo Decision and the Return of the Supreme
Court to the Bar of Patents,
2002 Sup. Ct. Rev. 273 (2002) ...0...........ccccccceseceeeeeeees 13

Electricity and Magnetism,
18 Encyclopedia Britannica 15S (15th ed. 2005)...... 23

vin

Other Materials—Cont'd Page
Geriak, James W..,
Synergism—How Long Will the Malady Linger On?
FS ne ee 14

Lichtenberg, Frank R. & Joel Waldfogel,
Does Misery Love Company? Evidence from
pharmaceutical markets before and after the Orphan
Drug Act,

NBER Working Paper No. 9750 (June 2003) ........... 18
Manual of Patent Examining Procedure

Sa, NEL, Is TEI ccccunndnrpincessicetsepinceedenemenntonete 21
Milne, Christopher-Paul

Exploring the Frontiers of Law and Science: FDAMA's

Pediatric Studies Incentive,

57 Food & Drug LJ. 491 i
Nat'l Research Council of the Nat'l Acads.,

A Patent System for the 21st Century (Stephen A.
Merrill, et al., eds. 2004).....................ccceeeeees 14, 15, 17

Note, FDA Reform and the European Medicines
Evaluation Agency,
108 Harv. L. Rev. 2008 (1995) ...............0....0.0-sseeeceee 18

Park, W. & J. Ginarte,
Intellectual Property Rights and Economic Growth,
15 Contemp. Econ. Pol’y 51 (1997) .............:ccccceeeeeees 16

Shapiro, Gilbert,
A Skeleton in the Darkroom: Stories of Serendipity in
Science (HarperCollins 1986) ...................cccececeeeeeeees 23

Story, J.,
On the Patent Laws,
16 U.S. (3 Wheat.) app. n. (ii) (1818)......................... 11

ix
Other Materials—Cont'd Page

U.S. Food & Drug Admin. Ctr. for Drug Evaluation &
Research, Pediatric Drug Development,
http://www.f la.gov/cder/pediatric/
(last visited Jan. 31, 2006).................. cilia iiaiietieaia 21

U.S. Food & Drug Admin.,
List of Orphan Designations & Approvals,
http://www.fda.gov/orphan/designat/list.htm

CS eee 18
as Uy Ba ee 25
I 26

Webster, Daniel,
12 Encyclopedia Britannica 549 (15th ed. 2005)........ 6

IN THE

Supreme Court of the Anited States

No. 04-607

LABORATORY CORPORATION OF AMERICA HOLDINGS,
D/B/A LABCORP,

Petitioner,
v.

METABOLITE LABORATORIES, INC. AND
COMPETITIVE TECHNOLOGIES, INC.,

Respondents.

ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT

BRIEF AMICUS CURIAE
FRANKLIN PIERCE LAW CENTER
IN SUPPORT OF THE RESPONDENTS

INTEREST OF AMICUS CURIAE '

Amicus curiae Franklin Pierce Law Center
(hereafter “Pierce Law”) is an accredited law school
located in Concord, New Hampshire. From its

' Both parties have consented to the filing of this brief amicus
curiae. The letters of consent have been filed with the Clerk of the
Court. This brief was not authored, in whole or in part, by counsel to
a party, and no monetary contribution to the preparation or
submission of this brief was made by any person or entity other than
the amicus curiae. Amicus Curiae gratefully acknowledges the
assistance of law students C. Gideon Korrell and Sean Tassi.

2

founding in 1973, a principal mission of Pierce Law
has been the teaching of patent law and practice.
The sole interest of Amicus Curiae in this case is
the proper development and application of patent
law to promote innovation and economic progress.

DISCUSSION

A number of provisions in the Patent Laws limit
the scope of an inventor’s patent rights. The
invention must be patentable subject matter, i.e.
“any new and useful process, machine,
manufacture, or composition of matter, or any new
and useful improvement thereof.” 35 U.S.C. § 101
(2000); see also Diamond v. Diehr, 450 U.S. 175,
182 (1981) (“Congress intended statutory subject
matter to ‘include anything under the sun that is
made by man.” (expanding patentable processes to
include computer-program related inventions). The
invention must have demonstrable utility; the
invention must be novel and-nonobvious. 35 U.S.C.
§§ 101-103 (2000).

In addition, the inventor must comply with
certain formal requirements. The specification
must include a written description of the invention
sufficient to enable a person having ordinary skill
in the art (hereafter “POSA”) to which the patent is
most closely related to make and use the invention.
In addition, the inventor must disclose her best
mode of practicing the invention, and must
distinctly claim the subject matter of her invention.
35 U.S.C. § 112, ¥4 1, 2 (2000). Only after meeting
these requirements does an inventor qualify for her

3

patent rights, and then only for a limited time.
35 U.S.C. § 154(a)(2) (2000).

While the question this Court presented for
review does not facially challenge the standards for
patentable subject matter, the invitation of this
Court to the Solicitor General indicates an interest
in considering whether the patent-in-suit claims
patentable subject matter. The Solicitor General
counseled denial of the petition for writ of certiorari
and endorsed as correct the application by the PTO
of this Court’s standards articulated in Diehr.

Pierce Law agrees that the PTO correctly
applied the standards for patentable subject matter
set forth in Diehr. Pierce Law urges, however, that
this case is the appropriate vehicle for building
upon Diehr by discarding the judicially-created
prohibition against patent claims directed to so-
called laws of nature.

SUMMARY OF ARGUMENT

This Court should discard the prohibition
against patent claims directed to so-called laws of
nature. The prohibition arose from dicta contained
in old, English, common law decisions. It has no
statutory support in our law. It is unnecessary and
nearly impossible to apply because it is error-prone,
redundant, and obsolete.

This Court has never invalidated a patent claim
for claiming a law of nature. This Court has,
instead, correctly relied only on statutory authority
mandated by Congress in 1952 under 35 U.S.C.

§§ 102, 103, and 112.

dq

Recent experience in the United States shows
that when this Court, the Legislature, or the
Executive has rejuvenated a component of our
patent system, that action has rejuvenated a
component of our economy.

. The prohibition against claims directed to laws
of nature is a relic, an arbitrary bar to
patentability, such as Congress and this Court
consistently have acted to eliminate.

ARGUMENT

Congress never intended patentability to turn
on whether what is claimed might be considered a
law of nature. Congress intended patentability to
turn only on whether what is claimed, when viewed
as a whole, meets the requirements of patentability
as set forth in 35 U.S.C. §§ 101, 102, and 103.2 The
Committee Reports accompanying the 1952 Patent
‘Act reveal that Congress intended statutory subject
matter to “include anything under the sun that is
made by man.”® S. Rep. No. 82-1979, at 5 (1952);
H.R. Rep. No. 82-1923, at 6 (1952). See also
Diamond vy. Chakrabarty, 447 U.S. 303, 315 (1880)

2 “The repetitive use of the expansive term ‘any’ in § 101 shows
Congress’s intent not to place any restrictions on the subject matter
for which a patent may be obtained beyond those specifically recited
in § 101.” State St. Bank & Trust Co. v. Signature Fin. Group, Inc.,
149 F.3d 1368, 1373 (Fed. Cir. 1998) (Rich, J.).

3 P. J. Frederico, a principal draftsman of the 1952 Patent Act, also
employed this expansive language in his testimony regarding that
legislation: “[U]nder section 101 a person may have invented a
machine or a manufacture, which may include anything under the
sun that is made by man * * * .” Patent Law Codification &
Revision: Hearings on H.R. 3760 Before Subcomm. No. 3 of the House
Comm. on the Judiciary, 82d Cong. 37 (1951).

5

(“Congress, not the courts, must define the limits of
patentability”); State St. Bank & Trust Co., 149
F.3d at 1374-75 (Rich, J.) (explaining that under
the 1952 Patent Act, many once-held exclusions are
no longer applicable).

This mandate reflects the role of the
Constitution in protecting the rights of Citizens:

The law acknowledges the existence of the right
of an inventor to his invention as property, and
the Constitution is remarkably exact in the
language in which it speaks of this important
subject. The Constitution does nct attempt to
give an inventor a right to his invention * * * .
No such thing. But the Constitution recognizes
an original, pre-existing, inherent right of
property in the invention, and authorizes
Congress to secure to inventors the enjoyment of
that right. But the right existed before the
Constitution and above the Constitution, and is,
as a natural right, more clear than that which a
man can assert in almost any other kind of
property. * * * Invention, as a right of property,
stands higher than inheritance or devise,
because it is personal earning.

Argument by Daniel Webster for Charles Goodyear
in the patent case Charles Goodyear v. Horace H.
Day, United States Circuit Court for the District of
New Jersey, March, 1852. (emphasis in original).*

4 Daniel Webster was born in Salisbury, N.H., January 18, 1782,
attended Phillips Exeter Academy, Exeter, N.H., and in 1801
graduated from Dartmouth College, Hanover, N.H. The citizens of
New Hampshire elected him as a Federalist to the Thirteenth and

6

1. THIS COURT HAS NEVER INVALIDATED
A PATENT CLAIM FOR CLAIMING A LAW
OF NATURE.

Because this Court has never invalidated a
patent claim for being directed to a so-called law of
nature, this Court should affirmatively discard the
prohibition. Absent such direction, the lower courts
will fail to embrace the broadest scope for
patentable subject matter, as was mandated by
Congress. Instead, courts will mistakenly continue
to follow obiter dicta imported from English
common law. That dicta has given rise to a false
notion: That so-called laws of nature are
unpatentable.

A. Birth of the Prohibition: The First
Patent Claims to Laws of Nature Were
Upheld.

This Court dates the prohibition against
claiming laws of nature to Le Roy v. Tatham (Le
Roy I), 55 U.S. (14 How.) 156 (1853). See Diehr,
450 U.S. at 185 (relying on Le Roy); Chakrabarty,
447 U.S. at 309 (relying on Le Roy); Parker v.
Flook, 437 U.S. 584, 588-89 (1978) (relying on Le
Roy); Gottschalk v. Benson, 409 U.S. 63, 67 (1972)
(relying on Le Roy); Funk Bros, Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127, 130 (1948) (relying on
Le Roy); De Forest Radio Co. v. Gen. Elec. Co., 283
U.S. 664, 685 (1931) (relying on Le Roy for the

Fourteenth Congresses (March 4, 1813-March 3, 1817). He
represented Dartmouth College before this Court in The Dartmouth
College Case, 17 U.S. (4 Wheat.) 518 (1819). Webster, Daniel, 12
Encyclopedia Britannica 549 (15th ed. 2005).

notion that scientific methods, not explanations,
are patentable); O'Reilly v. Morse, 56 U.S. (15
How.) 62, 114-18 (1853) (citing Le Roy and English
common law)..

Tatham was the assignee of the Hanson patent
for an improved method of manufacturing by
extruding pipes from soft metals such as lead.

Le Roy I, 55 U.S. at 172. The Hanson patent
embodied the mechanics of an earlier invention
patented in 1820. Hanson’s invention, however,
used a newly-discovered property in metals (that
they may be recombined and strengthened when
placed under extreme pressure) which resulted in a
marked improvement in pipe manufacturing—
wrought pipe rather than cast pipe. /d. at 174.
This Court wrote that while natural “processes
used to extract, modify, and concentrate natural
agencies” are inventive, tiie patentable “invention
is not in discovering them, but in applying them to
useful objects.” Id. at 175 (“A new property
discovered in matter, when practically applied, in
the construction of a useful article of commerce or
manufacture, is patentable’).

That discussion, however, was obiter dictum, as
this Court wrote: “The question whether the newly
developed property of lead * * * might have been
patented, if claimed as developed * * * was not in
the case.” Jd. at 177. Indeed, this Court ultimately
upheld Hanson’s patent while acknowledging that
it was on a law of nature:

‘A patent will be good, though the subject of the
patent consists in the discovery of a great, ~

8

general and most comprehensive principle in
science or law of nature, if that principle is, by
the specification, applied to any special purpose,
so as thereby to effectuate a practical result and
benefit not previously attained.’

Le Roy v. Tatham (Le Roy ID), 63 U.S. (22 How.)
132, 135-36 (1860) (quoting Househill Coal & Iron
Co. v. Neilson, 1 Webs. Pat. Cas. 673, 683
(S.C.(H.L.) 1843) (also upholding a patent directed
to a law of nature)).

In Neilson, James Beaumont Neilson’s invention
was the pre-heating of air before sending it into a
blast furnace. Use of the invention increased the
temperature of the fire in the blast furnace and the
efficiency of iron smelting. Neilson v. Harford, 151
Eng. Rep. 1266 [1 Webs. Pat. Cas. 328] (Exch.
1841). No device was claimed, which raised the
question of whether Neilson claimed a mere
principle or instead a patentable process. The
English court upheld the patent as directed to a
patentable process. Jd. at 1274. Thus, the
foundation for the judicially created prohibition
against patent claims directed to so-called laws of
nature is at best obiter dictum.

A dictum that has not acquired a gloss in reason
-should not be followed. In Cohens v. Va., 19 U.S. (6
Wheat.) 264 (1821), Chief Justice Marshall

disapproved reliance on dicta:

It is a maxim not to be disregarded, that
general expressions, in every opinion, are to be
taken in connection with the case in which those
expressions are used. If they go beyond the

9

case, they may be respected, but ought not to
control the judgment in a subsequent suit when
the very point is presented for decision. The _
reason of this maxim is obvious. The question
actually before the Court is investigated with
care and considered in its full extent. Other
principles which may serve to illustrate it, are
considered in their relation to the case decided,
but their possible bearing on all other cases is
seldom completely investigated.

Id. at 399-400.

Because the dictum from Le Roy “ought not to
{have controlled] the judgment in [the] subsequent”
cases, those cases on this point are entitled to little
weight.

B. Many Decisions Purporting to
Invalidate Patent Claims to Laws of
Nature Do So Only by Importing
Conditions of Patentability from
Statutory Provisions.

Many decisions seen as turning on unpatentable
subject matter have, on closer reading, turned on
statutory criteria imported from 35 U.S.C. §§ 102,
103, or 112. See Flook, 437 U.S. at 600 (Stewart, J.,
dissenting). In these decisions, reliance on one or
more of §§ 102, 103, or 112 to invalidate the patent
claims would have been appropriate, but the
reliance on unpatentable subject matter was
misplaced.

An example is Funk Bros. Seed Co., 333 U.S. at
127 (denying patentability as “natural

10

phenomenon” to man-made mixture of six isolated
bacterium recombined in respective quantities so as
to be noninhibitive of each other), which actually
was decided on the basis of what would soon
thereafter become known as 35 U.S.C. § 103
obviousness:

There is, of course, an advantage in the
combination. The farmer need not buy six
different packages for six different crops. He
can buy one package and use it for any or all of
his crops of leguminous plants. And, as
respondent says, the packages of mixed
inoculants also hold advantages for the dealers
and manufacturers * * *. But a product must
be more than new and useful to be patented; it
must also satisfy the requirements of invention
or discovery.

Id. at 131.

Likewise, Judge Rich explicated in State St.
Bank & Trust Co., 149 F.3d at 1376, that all the
decisions that had been thought to hold that
business methods were not patentable subject
matter were, on closer reading, based on statutory
grounds (35 U.S.C. § 102 (novelty) or § 103
(obviousness)). The courts had blurred the subject
matter requirement with those statutory
requirements.

The blurring is understandable because in one
sense, the prohibition against patent claims
directed to so-called laws of nature is but an
undeniable truism: At some level of abstraction the
statutory requirements for patentability cannot be

met. See In re Walter, 618 F.2d 758, 769 (C.C.P.A.
1980) (Rich, J.) (“One could as easily say that the
inclined paper-making wire in Eibel Process Co. [v.
Minn. & Ont. Paper Co., 261 U.S. 45 (1923)] was on
a fundamental level, mathematical in nature
because it operated according to the law of gravity
*** ”): Katz v. Horni Signal Mfg. Corp., 145 F.2d
961, 961 (2d Cir. 1944) (J. Frarik, J., A. Hand, & T.
Swan, JJ.) (“Epoch-making ‘discoveries’ of ‘mere’
general scientific ‘laws,’ without more, cannot be
_patented.”). Justice Story explained:

A patent cannot be for a mere principle,
properly so called; that is, for an elementary
truth. But the word principle is often used in a
more lax sense, to signify constituent parts,
peculiar structure, or process; and in
specifications, it is generally used in this latter
sense; and in this view, it may well be the
subject of a patent.

J. Story, On the Patent Laws, 16 U.S. (3 Wheat.)
app. n. (ii) at 15-16 (1818). Thus, where courts
have not clearly seen that claims should be rejected
as not being novel and nonobvious, courts have
resorted, mistakenly, to subject matter.

Therefore, the prohibition against claims
directed to so-called laws of nature—in addition to
being judicially created and founded in dicta—is
unnecessary. The prohibition is also unworkable
and contrary to sound economic policy.

12

i. SOUND POLICY SUPPORTS ISSUANCE
OF CLAIMS DIRECTED TO LAWS OF
NATURE.

We have learned much since 1955 when Judge
Learned Hand testified on the American Patent
System:

You can find—I have been at the job nearly 50
years—there are two schools and the one school
beats the air and says without the patent
system the whole of American industry would
never have developed. It is the stimulus which
has brought us to the top, and the other says it
is nothing but a beastly method * * * .

No one really knows. Each side is beating
the air.

American Patent System: Hearings on S. Res. 92
Before the Subcomm. On Patents, Trademarks, &
Copyrights of the Comm. on the Judiciary, 84th
Cong. 116 (1955).

We are beating the air no longer. Recent
changes in laws related to patents prove that
expanding the scope of subject matter protected by
patents, rather than contracting it, fosters growth
and innovation.

13

A. Reinvigorating Our Patent System
Reinvigorated Our Economy.

The United States patent system was robust
until the early part of the last century when the
judiciary slowly soured on it:5

There can be no doubt that the Act of 1952 [was]
meant to change [that] slow but steady drift of
judicial decision that had been hostile to patents
which made it possible for Mr. Justice Jackson
in dissent to speak of the ‘strong passion in this
Court for striking them’ (patents) ‘down so that
the only patent that is valid is one which this
Court has not been able tc get its hands on.’

Reiner v. I. Leon Co., 285 F.2d 501, 503 (2d Cir.
1960) (L. Hand, J.) (quoting Jungerson v. Ostby &
Barton Co., 335 U.S. 560, 572 (1949)).
Unfortunately, the anti-patent hostility of the
courts continued.®

5 “The importance of federal patent law during the nineteenth
century can be measured not only in terms of the lawyers attracted
to the field, but also in the treatment that the subject received at the
Court.” John F. Duffy, The Festo Decision and the Return of the
Supreme Court to the Bar of Patents, 2002 Sup. Ct. Rev. 273, 274-75
(2002). In upholding Alexander Graham Bell's patents in the
Telephone Cases, this Court consolidated five matters, heard oral
argument over twelve days, and filed a report filling an entire
volume of the U.S. Reports. /d. at 275. Particularly interested in
patent law, Justice Story wrote a number of seminal opinions and
articles that are still referred to today. Id. “And, even when the
Court was drowning in appeals toward the end of the century,
retiring Justice William Strong supported a congressional proposal!
that would have limited the Court’s mandatory appellate jurisdiction
except in patent and copyright cases.” Id.

® See James W. Geriak, Synergism - How Long Will the Malady
Linger On? 1980 Pat. L. Ann. 51 (1980) (discussing various

14

As our patent system weakened, our economy
weakened. “[In] the 1970s, when productivity
growth rates fell sharply” and in the 1980s, “when
Japanese competition fostered the notion that U.S.
manufacturing industries were on the decline,” the
bar, industry, and government mobilized. Nat’l
Research Council of the Nat'l Acads., A Patent
System for the 21st Century at 18 (Stephen A.
Merrill, et al., eds. 2004). Consequently, “[t]he
1980s saw [an] upward surge in the role and
importance of the patent system.” 1 Donald S.
Chisum, Chisum on Patents § 7 (2005). “Beginning
in 1980 a series of legislative actions, judicial
decisions, executive branch initiatives, and
international agreements * * * strengthened the
rights of intellectual property owners [by extending
rights] into new areas of technology.” A Patent
System for the 21st Century at 21-22.7

reincarnations of tests for patentability which have “clouded the !
minds of the courts”); see also Flook, 437 U.S. at 584 (1978) (claimed |
process lost status as patentable subject matter simply because one
step in the process would not be patentable subject matter if
considered in isolation.); Sakraida v. Ag Pro, Inc., 425 U.S. 273
(1976) (disparaging patents to so-called “co ibinations”); Brenner v.
Manson, 383 U.S. 519 (1966) (inventor must disclose in application a
specific practical utility); Republic Indus., Inc. v. Schlage Lock Co.,
592 F.2d 963, 964-65 (7th Cir. 1979) (“Increasingly, the district
courts in this circuit * * * have taken the view that synergism and
not the criteria articulated in Graham v. John Deere Co., 383 U.S. 1
(1966), is the controlling test in combination patent claims.”).

7 “The ‘pro-patent’ era is unquestionably associated with a rapid
growth in the markets for new knowledge. On the basis of secondary
data, Arora and colleagues [Arora, A., A. Fosfuri, and A.
Gambardella, Markets for Technology: Economics of Innovation and
Corporate Strategy (MIT Press 2001)] roughly estimate that the
value of technology licensing in the United States increased from $24
billien in 1990 to $44 billion in 1995 in constant dollars, and the

15

Congress began the movement by enacting
important, pro-patent legislation.’ In 1982,
Congress created the United States Court of
Appeals for the Federal Circuit and gave it
exclusive appellate jurisdiction over cases that
arise under the patent laws. Federal Courts
Improvement Act of 1982, Pub. L. No. 97-164, 96
Stat. 25 (codified as amended 28 U.S.C. § 1295(a)(1)
(1995)). In 1984, Congress passed the Patent Law
Amendments Act amending 35 U.S.C. §§ 103, 116,
and 120, which changed the “complex body of case
law [that discouraged] communication among
members of research teams working in
corporations, universities or other organizations.”
Patent Law Amendments Act of 1984, Pub. No. L.
98-622, § 104, 98 Stat. 3383 (codified as amended in
scattered sections of 35 U.S.C. (1988)). Congress
also amended the infringement statute at 35 U.S.C.
§ 271(f) to make an infringing act the exportation of

number of deals increased from more than 200 to well over 2,100.”
Id. at 37. In addition, “Anand and Khanna [Anand, B. & T. Khanna,
The Structure of Licensing Contracts, 48 J. Indus. Econ. 103, 135
(2000)} support the hypothesis of a direct relationship by showing
that licensing is more frequent in industries where patents are also
prevalent.” Jd.

* Important legislation facilitated moving university research to
production lines and encouraged the commercial! exploitation of
federally funded research. See Fed. Tech. Transfer Act of 1986, Pub.
L. No. 99-502, 100 Stat. 1785 (1986) (codified as amended at 15
U.S.C. § 3701 et seq. (1988)); Econ. Recovery Tax Act of 1981, Pub. L.
No. 97-34, 95 Stat. 172, 241 (1981) (codified as amended at scatterea
sections of 26 U.S.C. (1984)); Bayh-Dole Act, Pub. L. No. 96-517, 94
Stat. 3015, 3019-28 (1980) (codified as amended at 35 U.S.C. §§ 200.
~ 212 (1984)); Stevenson-Wydler Technology Innovation Act of 1980,
Pub. L. No. 96-480, 94 Stat. 2311 (1980) (codified as amended at 15
U.S.C. § 3701 et seq. (1984)).

16

components of a patented combination. Patent Law
Amendments Act of 1984, Pub. L. No. 98-622, 98
Stat. 3383 (codified as amended in scattered
sections of 35 U.S.C. (1988)). In 1988, Congress
passed the Patent Misuse Reform Act, Pub. L. No.
100-703, 102 Stat. 4674, 4676 (codified as amended
at 35 U.S.C. § 271(d) (1994)), restricting application
of the misuse doctrine to certain patent licensing
and sales practices. The same year, it enacted the
Process Patent Amendments Act, Pub. L. No. 100-
418, 102 Stat. 1107, 1563 (codified as amended at
35 U.S.C, § 271(g) (1994)), extending to owners of
patents with claims directed to processes the right
to exclude unauthorized importation of unpatented
products made abroad by use of the claimed
processes. 1 Chisum on Patents § 7 (enumerating
important legislation that reinvigorated the
economy).

This Court followed Congress’s lead, also
expanding the subject matter protectable by
patents. Chakrabarty, 447 U.S. at 318, upheld the
patentability of genetically-altered living
microorganisms. Dawson Chem. Co. v. Rohm &
Haas Co., 448 U.S. 176, 201 (1980), applied 35
U.S.C. § 271(d) to hold that the owner of a patent
claiming a process of using an unpatented (and

® Empirical research from 60 countries for the period 1960-1990
shows that the strength of patent protection is positively and
significantly correlated with investment in research and
development in modern economies. See Park, W. & J. Ginarte,
Intellectual Property Rights and Economic Growth, 15 Contemp.
Econ. Pol’y 51 (1997) (indexing the strength of patent protection in
60 countries to determine the role of intellectual property rights in
economic growth).

17

unpatentable) herbicide had not misused the
patent when he sold the herbicide but refused to
license the process to competing manufacturers of
the herbicide. This Court held that because the
herbicide was not a staple suited for uses other
than in the patented process, the patent owner was
not unlawfully extending the scope of the patent
claims. Jd. at 201, 214 (“the provisions of § 271(d)
effectively confer upon the patentee, as a lawful
adjunct of his patent rights, a limited power to ~
exclude others from competition in nonstaple
goods.”). Thus, this Court extended the subject
matter protectable by patents.

Reinvigorating the patent system worked. “[By]
the mid-1990s the [United States] economy was
again exhibiting high productivity growth.” A
Patent System for the 21st Century at 18.

B. Expanding the Scope of Subiect Matter
Protectable by Patent-like Incentives
Fosters Innovation.

By the early 1980s, twenty-five million
Americans suffered from one or more of six
thousand diseases so rare that they presented little
economic incentive to drug innovators.'° Therefore,
to “provide [patent-like] incentives for drug
companies to develop and manufacture products for
rare diseases that would otherwise produce

10 [’rug companies will not decide, ex ante, to risk capital on drug
development unless there is a reasonable prospect of a substantial
return. See Geoffrey Carr, A Survey of the Pharmaceutical Industry:
The Alchemists, Economist, Feb. 21, 1998, at 4 of insert (reporting
estimate of 13 years and 300 million dollars to develop a new drug).

18

insufficient patient demand to support drug
development, Congress in 1983 enacted the Orphan
Drug Act. See 21 U.S.C. 360aa-ee (1988).” Note,
FDA Reform and the European Medicines
Evaluation Agency, 108 Harv. L. Rev. 2009, 2013
n.24 (1995).'! These patent-like incentives, which
expanded the subject matter eligible for protection,
fostered drug development.

In the ten years prior to enactment of the
Orphan Drug Act (“ODA”), the FDA reports, only
ten products for rare diseases were developed and
approved for marketing without federal funding.!2
Since the passage of the ODA, however, the FDA
has approved for market 283 orphan drugs and
biologics. U.S. Food & Drug Admin., List of
Orphan Designations & Approvals,
http://www.fda.gov/orphan/designat/list.htm (last
visited Jan. 31, 2006). The FDA also reports that
more than 1,544 orphan designated products are in
development. Jd. Our enlightened expansion of the
scope of protectable subject matter blazed a path
for the rest of the developed world. See Beyond
Borders: The Global Biotechnology Report 2002, at
107 (Ernst & Young 2002) (“Since introduction of

'! These provisions “allow tax credits for money spent on clinical
testing of drugs for a ‘rare disease or condition,’ defined as one that
affects fewer than 200,000 persons,” as well as “drugs that are
expected to cost more than they will earn on the market.” Jd. In
addition, “the Act provides manufacturers with seven years of post-
approval market exclusivity for any unpatentable orphan drug.” Id.
'2 Frank R. Lichtenberg & Joel Waldfogel, Does Misery Love
Company? Evidence from pharmaceutical markets before and after
the Orphan Drug Act, NBER Working Paper No. 9750 (June 2003)
available at http://papers.nber.org/papers/w9750.

19

the orphan drug rules by the EC in 2000, there
have been over 150 applications submitted.
Fourteen products achieved orphan drug status in
2000 and many more companies followed suit in
meee? OL

Pharmaceutical innovation also lagged in the
field of neonatal and pediatric medicine until
Congress put in place patent-like incentives that
expanded the scope of protectable subject matter.
Drugs cannot be used on children merely because
they have been FDA appreved for adults. Dosages
and responses are not linear; the metabolism and
the absorption rates for the body of a child are
different than those of an adult. Despite the urgent
need for pediatric applications, the lack of
profitability for that small market precluded
development of new drugs. As a result, the
majority of all drugs approved for adult populations
had not been approved, or adequately tested, for
pediatric populations. Christopher-Pau] Milne,
Exploring the Frontiers of Law and Science:
FDAMA's Pediatric Studies Incentive, 57 Food &
Drug L.J. 491, 491-94 (2002).

In response to these realities, Congress decided
to provide patent-like incentives to previously
unpatentable subject matter in the Food & Drug
Administration Modernization Act of 1997

am

'S “In the United States, the Bayh-Dole Act is credited with
encouraging the creation of a whole generation of innovative
startups from university research. It may be no coincidence that
Japan’s recent changes to its university system are designed to
achieve precisely the same result.” Beyond Borders: Global
Biotechnology Report 2005, at 68 (Ernst & Young 2005).

20

(“FDAMA’”), Pub. L. No. 105-115, 111 Stat. 2296,
2305 (codified as amended at 21 U.S.C. § 355a
(Supp. 1997)). FDAMA encourages pediatric
testing by providing six months of market
exclusivity for innovator drug sponsors who
perform clinical studies on specific drugs for
pediatric patients. See 21 U.S.C. § 355a(a) (2000).

The expansion of protectable subject matter
succeeded. Prior to the enactment of the patent-
like pediatric exclusivity provisions, only eleven of
the seventy-one pediatric studies requested by the
FDA were completed. The Pediatric Exclusivity
Provision: U.S. Food & Drug Admin. Jan. 2001
Status Report to Congress at 8 (2001).'4 Over a six-
year period between 1991 and 1996, drug sponsors
agreed to complete seventy-one post-marketing
pediatric studies, but then only eleven were
actually completed. Jd. All this changed with
incentives.

The FDA reports that the “pediatric exclusivity
provision has been highly effective for many drugs.
In general, the industry’s response has been
vigorous and the public health benefits have been
extensive.” Id. Statistics from the FDA’s website
show that the patent-like incentives have
significantly increased the number of drugs tested
on pediatric patients. The FDA reports that drug
sponsors had submitted 715 proposed study
requests and the FDA had issued 311 written
requests for studies as of December 2005. U.S.
Food & Drug Admin. Ctr. for Drug Evaluation &

'4 Available at http://www .fda.gov/cder/pediatric/reportcong0 | .pdf.

21

Research, Pediatric Drug Development,
http://www.fda.gov/cder/pediatric/ (last visited Jan.
31, 2006). Additionally, 115 grants of pediatric
market exclusivity had been obtained as of
December 2005. /d.

Thus, recent history shows that changes to
patent-related laws expanding the scope of subject
matter eligible for patent protection and patent-like
exclusivity have resulted in economic growth and a
pouring forth of significant innovations.

il. THIS CASE IS THE APPROPRIATE
VEHICLE FOR BUILDING ON
CHAKRABARTY AND DIEHR.

The distinction between patentable subject
matter, on the one hand, and a law of nature, on
the other hand, has never shimmered with
lucidity.!5 Consequently, the prohibition is difficult
to apply, and such application leads to arbitrary
and artificial line drawing and patent claim
drafting gamesmanship. This Court should use the
present case to build on Chakrabarty and Diehr by
discarding the arbitrary and unworkable
prohibition.

'5 For example, electro-magnetic signals, when properly claimed, are
patentable subject matter. See Manual of Patent Examining
Procedure § 2106(B)(1)(c) (8th ed., Rev. Aug. 2005) (“However, a
signa] claim directed to a practical application of electromagnetic
energy is statutory regardless of its transitory nature. See O'Reilly,
56 U.S. at 114-19; In re Breslow, 616 F.2d 516, 519-21, 205 USPQ
221, 225-26 (CCPA 1980)”).

22

A. The Prohibition is Arbitrary and Has
Always Been Difficult to Apply.

There is no bright line separating a patentable
process from an unpatentable principle. Both are
“[conceptions] of the mind, seen only by [their]
effects when being executed or performed. Either
may be the means of producing a useful result.”
Tilghman v. Proctor, 102 U.S. 707, 728 (1881); see
also Diehr, 450 U.S. at 189 (“To accept t..e analysis
proffered by the petitioner would, if carried to its
extreme, make all inventions unpatentable because
all inventions can be reduced to underlying
principles of nature * * * .”); Le Roy J, 55 U.S. at
174 (“The word principle is used * * * with such
want of precision in its application, as to mislead.”).

This Court early on encountered the elusive
distinction between a patentable new method and
unpatentable known principles in two cases
involving similar technology. Dolbear v. Bell, 126
U.S. 1 (1888), concerned only the scope of claims of
the Bell patent of March 7, 1876:

5. The method of, and apparatus for,
transmitting vocal or other sounds
telegraphically, as herein described, by causing
electrical undulations * * * .

Id. at 13-14. Yet, thirty-four years earlier, in
Morse, 56 U.S. at 62, this Court seemed to have
little trouble finding unpatentable subject matter
in a similar claim in an application to Morse:

{8.| * * * [T]he use of the motive power of
~ electric or galvanic current * * * for making or

23

printing intelligible characters, signs, or letters,
at any distances * ** .

Id. at 107.

The distinction that made the Bell decision
difficult, and the Morse decision less so, was not in
any distinction between the similar subject
matters, nor in the choice of claim language, but
rather the scientific context. Galvanic current had
been stored and discharged as early as 1790.16
Experiments showed that such current could be
transmitted by wire and that it could be used for
communication. By 1819 or 1820, Hans Christian
Oersted, a Danish philosopher, had discovered that
a magnetic needle at a distance could be deflected
by a galvanic current, and thus mark information.!7
In 1820, André Marie Ampére expressly stated that
such a deflective needle could be used for
telegraphing. Smith v. Downing, 22 F. Cas. 511,
512-13 (C.C.D. Mass. 1850). Indeed, “very soon
after the discovery made by Oersted, it was
believed by men of science that this newly-
discovered power might be used to communicate
intelligence to distant places.” Morse, 56 U.S. at
94. Thus, this Court, in effect, resolved the Bell

'6 In 1746, the Abbé Jean Antoine Nollet, who became professor of
experimental physics at Navarre, “used wire made of iron to connect
a row of Carthusian monks more than a kilometre long”; when he
discharged a Leyden jar through the wire, “the white-robed monks
reportedly leapt simultaneously into the air.” See Biological
Sciences, 14 Encyclopedia Britannica 1069, 1096 (15th ed. 2005);
Electricity and Magnetism, 18 Encyclopedia Britannica 159, 189
(15th ed. 2005).

'7 Gilbert Shapiro, A Skeleton in the Darkroom: Stories of
Serendipity in Science, pp. 37-38 (HarperCollins 1986).

24

and the Morse decisions not on the basis of claiming
or not claiming a law of nature, but rather on the
basis that what Bell claimed was novel, and that
what Morse claimed was obvious. As explained by
Justice Grier in dissent, as a practical matter,
dodging a decision based on whether what was
claimed was a law of nature was unavoidable;
attempting to draw a distinction based on subject
matter is often impossible and usually
unnecessary. !®

This court again struggled with the elusive
distinction between a patentable process and an
unpatentable principle in Tilghman, 102 U.S. at
707. The sole claim of Tilghman’s patent was
directed to “the manufacturing of fat acids and
glycerin from fatty bodies by the action of water at
a high temperature and pressure.” I/d. at 709
(quoting U.S. Pat. No. 11,766 (Oct. 3, 1854)). The
issue salient there was whether Tilghman was
entitled to a claim on his process generally (viewed
from a high degree of abstraction), or whether he
was entitled to only a subset process limited by “the
particular device mentioned” in the patent
specification. Jd. at 718. That claimed process
might have included limitations on the time,
temperature, and pressure of each step, the

'® Justice Grier reviewed the stated policy rationales for prohibiting
time-limited patent claims to laws of nature, and found those
rationales lacking. He expressed concern that the line between
patentable processes as opposed to unpatentable laws of nature was
difficult to discern, and was better viewed as a prohibition on that
which was known. In his view, the laws of England and the United
States, in effect, permitted claims to laws of nature in general and
would have allowed Morse’s claim in particular. /d. at 130-35.

25

arrangement of tubing, and the composition of the
reaction vessel, because all such parameters were
nicely described in the specification. /d. at 721; see
also U.S. Pat. No. 11,766 at page 2, Ist col. (issued
Oct. 3, 1854). The more structural limitations and
process parameters in the claim, the more the
claim looks like a patentable process; the fewer
structural limitations and process parameters, the
more the claim looks like an unpatentable law of
nature

But again, the distinction was found not in the
choice of claim language, but rather primarily the
scientific context. Michel Eugéne Chevreul’’ as
early as 1813 had published his discovery of the
law of nature that tallow consisted of a base of
glycerin and fatty acids, specifically, stearic,
margaric, and oleic acids. Chevreul in 1825 also
patented a parficular process using sulfuric acid to
separate the glycerin from the fatty acids. Id. at
711. That process did not require preventing water
under pressure from becoming steam. Analogously,
this Court held that Tilghman too had discovered a
law of nature, that the elements of neutral fats can
be separated from each other by water. But this
Court also held, while asserting that the line was
difficult to draw, that Tilghman was entitled to
claim as a process the practical application of
performing that separation by “the action of water
at a high temperature and pressure.” /d. at 718,
730.

'* Chevreul also invented the red, orange, yellow, green, purple,
blue-color wheel. M. E. Chevreu!, De la Loi du Contraste Simultané
des Couleurs et de l'assortiment des Object Colorés (Paris 1839).

26

Without knowing the backdrop of the
developments from 1813 to 1853, it is unlikely that
Tilghman’s process could have been seen to be a
process rather than a law of nature. Patentability
should not be based on serendipity.

The line between a law of nature and patentable
subject matter shimmers with no greater clarity
today. “Paroxetine hemihydrate is not the first
invention to blur the line between [the workings of
a] natural process and [its result,| a synthetic
product * * * .” SmithKline Beecham Corp. v.
Apotex Corp., 403 F.3d 1331, 1360 (Fed. Cir. 2005)
(Gajarsa, J., concurring); see also Pres. & Fellows of
Harvard Coll. v. Can. (Comm’r of Patents), {2000] 4
F.C. 528 (struggling “to distinguish between
human intervention and the laws of nature,” and
dismissing appeal from decision of Comm’r of
Patents denying an application for a transgenic
mouse) (nonpatentability was affirmed by the
Supreme Ct. of Can. at Pres. & Fellows of Harvard
Coll. v. Can. (Comm'r of Patents), [2002] 4 S.C.R.
45). Yet, the Harvard mouse is patentable subject
matter under U.S. law. See United States Patent
No. 4,736,866 to Leder, Philip, and Stuart, Timothy
A., for “Transgenic Non-Human Mammals” issued
April 12, 1988 assigned to President & Fellows of
Harvard College, Cambridge, Mass.

This arbitrary, error-prone, and unworkable
prohibition should be discarded.

27

B. This Court and Congress Consistently
Have Moved Away from Arbitrary Line
Drawing Regarding Patentable Subject
Matter.

Prior to Diehr, the line with respect to the
patentability of proto-software inventions was
drawn by whether the patent claim included a
mathematical algorithm. If it did, then it did not
claim patentable subject matter. Gottschalk, 409
U.S. at 71-72 (“The mathematical formula involved
here has no substantial practical application except
in connection with a digital computer [so] the
patent would wholly pre-empt the mathematical
formula and in practical effect would be a patent on
the algorithm itself.”). This Court in Diehr erased
that arbitrarily drawn line. 450 U.S. at 187 (“a
claim * * * does not become nonstatutory simply
because it uses a mathematical formula”).

Likewise, in Chakrabarty, 447 U.S. at 303, this
Court rejected drawing a line at “living inventions”
even though some argued that that line had been
clearly drawn by Funk Bros. Seed Co., 333 U.S. at
131 (denying patentability to man-made mixture of
six isolated bacterium recombined in respective
quantities so as to be noninhibitive of each other)
and Am. Fruit Growers, Inc. v. Brogdex Co., 283
U.S. 1, 12 (1931) (denying patentability to man-
made fungus-resistant citrus because: “It remains
a fresh orange, fit only for the same beneficial uses
as theretofore.”).

Congress also eliminated certain arbitrary lines
in the 1952 recodification of the Patent Law.

28

Risdon Iron & Locomotive Works v. Medart, 158
U.S. 68 (1895), had come to stand for a prohibition
on claims directed to functions of a machine. This
Court there held unpatentable a process for
manufacturing belt pulleys, holding that no patent
could “be obtained for a process which involves
nothing more than the operation of a piece of
mechanism, or, in other words, for the function of a
machine;” /d. at 77. Congress effectively erased
that arbitrary distinction in the 1952 Patent Act by
the broad inclusive language of § 101. See In re
Tarczy-Hornoch, 397 F.2d 856, 867 (C.C.P.A. 1968)
(Rich, J.) (“Exceptional treatment for this narrow
class of processes is, pro tanto, inconsistent with
the broad goal of the patent system * * * .”).2°

It was once believed that patentable weight
could be given to printed materials only when a
novel relationship was established between that
printed material and the remaining structure of the
claimed device or prevess. See In re Miller, 418
F.2d 1392, 1395 (C.C.P.A. 1969) (drawing line
between patentable and nonpatentable subject
matter). The Federal Circuit has since held that
there is no support in 35 U.S.C. § 101 of the 1952
Patent Act for any such prohibition. Jn re Gulack,
703 F.2d 1381, 1384 (Fed. Cir. 1983) (“we do not
interpret the board as holding that the printed
matter can be ignored because it, by itself, is non-
statutory subject matter”; if there is a basis for a

* Decisions of the Court of Customs and Patent Appeals are binding
as precedent on the United States Court of Appeals for the Federal
Circuit. South Corp. v. U.S., 690 F. 2d 1368, 1371 (Fed. Cir. 1982).

29

“printed matter” rejection, it is obviousness under
§ 103).

Most recently, the courts have recognized that
Congress intended by § 101 that no arbitrary line
may be drawn to prohibit claims to methods of
doing business. In the seminal decision, Judge
Rich quoted the rationale from a dissent by Judge
Newman in Jn re Schrader, 22 F.3d 290, 298 (Fed.
Cir. 1994):

‘(The business method exception] is * * * an
unwarranted encumbrance to the definition of
statutory subject matter in section 101, that
[should] be discarded as error-prone, redundant,
and obsolete. It merits retirement from the
glossary of section 101. * * * All of the ‘doing
business’ cases could have been decided using
the clearer concepts of Title 35 [meaning §§ 102,
103, and 112]}.’

State St. Bank & Trust Co., 149 F.3d at 1375.

Because the arbitrary prohibition against
patent claims directed to so-called laws of nature
was borne of dicta, is contrary to the expansive
language of § 101, and likewise is error-prone,
redundant, and obsolete, it should be discarded.

30

CONCLUSION

For the reasons presented above, this Court
should either affirm without reaching the issue of
patentable subject matter, or, in the alternative,
hold the arbitrary prohibition hgainst the
patentability of so-called laws of nature overruled.

~

Respectfully submitted,

CRAIG STEVEN JEPSON
Professor of Law
Counsel of Record

FRANKLIN PIERCE
LAW CENTER
2 White Street
Concord, NH 03301
(603) 228-1541

Amicus Curiae

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0050%3A25. Public record. Not legal advice.