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

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| 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

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

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

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

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,

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.

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

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.

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).

(“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

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, ~

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

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

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.

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.

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

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

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)).

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).

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).

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.

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

'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).

(“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.

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)”).

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

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).

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.

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).

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.

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.

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).

“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.

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,