Amicus Curiae Brief — KSR Intern. Co. v. Teleflex Inc.

gnp f FILED

Ho) OCT 16 2006

x OFFICE OF THE CLcRK

No. 04-1350 | SUPREME COURT. U.S._|

IN THE

Supreme Court of the United States

KSR INTERNATIONAL Co.,

Petitioner,

Vv.

TELEFLEX INC. AND TECHNOLOGY HOLDING Co.,

Respondents.

On Writ of Certiorari to the

United States Court of Appeals for the Federal Circuit

BRIEF OF AMICUS CURIAE PHARMACEUTICAL

RESEARCH AND MANUFACTURERS OF AMERICA

IN SUPPORT OF RESPONDENTS

DAVID E. KORN ALLEN M. SOKAL

Of Counsel Counsel of Record

PHARMACEUTICAL RESEARCH ROBERT A. MATTHEWS, JR.

AND MANUFACTURERS FINNEGAN, HENDERSON, FARABOW,

OF AMERICA GARRETT & DUNNER, L.L.P.

950 F Street, NW 901 New York Avenue, NW

Washington, DC 20004 Washington, DC 20001-4413

(202) 835-3400 (202) 408-4000

October 16, 2006

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QUESTION PRESENTED

Whether the Federal Circuit has erred in holding that

a claimed invention cannot be held “obvious,” and thus

unpatentable under 35 U.S.C. § 103(a), in the absence of

some proven “teaching, suggestion, or motivation’ that

would have led a person of ordinary skill in the art to

combine the relevant prior art teachings in the manner

claimed."

TABLE OF CONTENTS

INTEREST OF AMICUS CURIAE .............:csceeseseseseeees 1

SUMMARY OF THE ARGUMENT...............ccccccscseceeseees 3

EES ticinatciastceutnsinintnancnnieantoneuanguisiciommnnemsats 5

I. The “Motivation-Suggestion-Teaching” Test

Should Remain a Requirement of an Obviousness

ee eviesihsicteinicttcticenniseniibitinipiinipineiaidttaieitaienietinarie 5

A.

By Enacting § 103, Congress Sought to Inject

Predictability, Uniformity, and Objectivity

into Patentability Analysis ......................:0000+ 5

The “Motivation-Suggestion-Teaching” Test

Serves Four Important Purposes in

Evaluating the Question of Obviousness

Under the Framework of Graham................... 8

This Court’s Precedents Support the

“Motivation-Suggestion-Teaching” Test ........ 12

The “Motivation-Suggestion-Teaching”

Test Is Workable and Does Not Impose

Undue Evidentiary Burdens.......................++. 15

Without the “Motivation-Suggestion-

Teaching” Test There Are No Meaningful

Guidelines for Objectively Analyzing

Petitioner’s Anecdotal Evidence Does Not

Show that the “Motivation-Suggestion-

Teaching” Test Is a Failed Experiment......... 22

- iii -

fl. THE STANDARD FOR DETERMINING

OBVIOUSNESS SHOULD NOT BE MERE

CAPABILITY OF COMBINING TEACHINGS

ar Fe cctecectcupccnseentnesersscesenseosnmecterags

lil. SYNERGY SHOULD NOT BE THE TEST

FOR HOLDING A COMBINATION PATENT

B. A Synergy Requirement Is Contrary to the

Legislative Purpose of § 103 .............ccccccceeeeees

CONCLUSION

-iv-

TABLE OF AUTHORITIES

FEDERAL CASES

AK Steel Corp. v. Sollac,

344 F.3d 1234 (Fed. Cir. 2003) .00.........:.cccceseeseseeeeeeees 11

Abbott Laboratories v. Andrx Pharmaceuticals, Inc.,

452 F.3d 1331 (Fed. Cir. 2006) .............................s00000 16

Adams v. Bellaire Stamping Co.,

BG TR, Ge or cencctacsntctncscicnsntisisstiisisialiiiapainniapiinamamil 11

Adamson v. Gi'liland,

BES Be, FeO CIGD cccccccsscscscnssscssscssenniocsenmnssvenciinminne 20

Alza Corp. v. Mylan Laboratories, Inc.,

__ F.3d __, 2006 WL 2556356

(Fed. Cir. Sept. 6, 2006) ..0...........:sccceeceeereresens 15, 16, 17

Anderson's-Black Rock, Inc. v. Pavement

Salvage Co.,

ee ee Oe Cc ctcasticatcnstidadntantnetinaniidiiians 14, 26, 29

Aro Manufacturing Co. v. Convertible Top

Replacement Co.,

ks FL) | een 9

Athletic Alternatives, Inc. v. Benetton

Trading USA, Inc.,

74 Fed. Appx. 571, 2006 WL 870806

(Fed. Cir. Mar. 31, 2006), cert. denied,

2006 U.S. LEXIS 7222 (U.S. Oct. 2, 2006) ............... 19

Atlantic Const. Fabrics, Inc. v. Dandy Prod., Inc.,

64 Fed. Appx. 757, 2003 WL 1949582

(Fed. Cir. Apr. 23, 20038) ........-....-csserssssseerersneeneneneesenns 19

Avia Group International, Inc. v. L.A. Gear

Cal., Inc.,

853 F.2d 1557 (Fed. Cir. 1988) ............cccccccccsseeeeeseees 20

Barbed Wire Patent,

nn 25

Barnhart v. Sigmon Coal Co.,

ee 27, 28

In re Beattie,

974 F.2d 1309 (Fed. Cir. 1992) ............ccccccceceecceseseneees 18

Biotec Biologische Naturverpackungen GmbH

& Co. KG v. Biocorp, Inc.,

249 F.3d 1341 (Fed. Cir. 2001) .................ccccccceeeeceseees 19

Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,

i 6

Bradley v. Richmond School Board,

ES 28

Brand Mgt., Inc. v. Menard, Inc.,

135 F.3d 776, 1998 WL 15241

in cnceecerreermnenmnneiseiensin 19

C. & A. Potts & Co. v. Creager,

SE 5, 24, 25

Cantrell v. Wallick,

ESE TE 23

Chiuminatta Concrete Concepts, Inc. v.

Cardinal Indus.,

145 F.3d 1303 (Fed. Cir. 1998) ..............ccccccccsceceseeeeees 19

Chore-Time Equipment, Inc. v. Cumberland Corp.,

713 F.2d 774 (Fed. Cir. 1963) .................cc.ccceeccceceeeees 19

Colvin v. National Automobile Parts Association,

168 F.3d 1321, 1998 WL 536885

I 19

Comfort Silkie Co. v. Seifert,

215 F.3d 1344, 1999 WL 507166

re ee 19

Connell v. Sears, Roebuck & Co.,

722 F.2d 1542 (Fed. Cir. 1983) ............ccccccccccecseees 11, 23

Cross Medical Products, Inc. v.

Medtronic Sofamor Danek, Inc.,

424 F.3d 1293 (Fed. Cir. 2005) ...............cc.eccccceseseeeees 17

Crown Operations International, Ltd. v. Solutia, Inc.,

289 F.3d 1367 (Fed. Cir. 2002) ................-.cesccccccceceeees 19

Custom Accessories, Inc. v. Jeffrey-Allan Indus.,

807 F.2d 955 (Fed. Cir. 1986) ...............cccccececeeeeeseeeeeees )

In re Dance,

160 F.3d 1339 (Fed. Cir. 1998) .............ccccccccceesesseeeeees 16

Day v. Fair Haven & Westville Railway Co.,

I icin tenia scnaiasialeniaiaalliiih intern dinasieatiis 13

Diamond Rubber Co. v.Consolidated Rubber Tire Co.,

Ee 25

Diamond v. Diehr,

NTT ini nrstsetasninicrenstntieniantsiinhintinnesinseaiiiaidis 28

In re Donaldson Co.,

16 F.3d 1189 (Fed. Cir. 1994) ............cccccceseseeseeseeeeennees 6

- Vii -

DyStar Textilfarben GmbH & Co. Deutschland KG v.

C.H. Patrick Co., __ F.3d __, 2006 WL 2806466

(Fed. Cir. Oct. 3, 2006).............cecececeseseseees 17, 18, 25, 26

Ecolochem, Inc. v. S. Cal. Edison Co.,

91 F.3d 169, 1996 WL 297601

(Ped. Cir. Jume &, 1906) ..............0cc0c.cccesccseseccsececcesseees 19

Expanded Metal Co. v. Bradford,

eee 11,12

Fountain v. Filson,

| RE Eee ee eee 18

Fromson v. Advance Offset Plate, Inc.,

755 F.2d 1549 (Fed. Cir. 1985) ...........cccccccccecceecceceoeeee 23

In re Fulton,

391 F.3d 1195 (Fed. Cir, 2004) o.........cccccccccccceceeeee 16, 18

Gabrielidis v. Prince Sports Group, Inc.,

243 F.3d 565, 2000 WL 1648134

ES ee 19

Gillette Co. v. S.C. Johnson & Son, Inc.,

919 F.2d 720 (Fed. Cir, 1990) 0.0.0... cccccccecccecccceseceeeeee 23

Gould v. Rees,

|, EERO 23

Graham v. John Deere Co.,

- Vill -

Graver Tank & Manufacturing Co. v.

Linde Air Prod. Co.,

ee) ee ertepietintnneonntnisbtomneensecenmemeunnssil 27

Great Atlantic & Pacific Tea Co. v.

Supermarket Equipment Corp.,

Se Ca aI inicrnicnsisitienniintentipienetteesbuptnesenssiai 28. 29

Hobbs v. Beach,

ee SN ncnpsscsepnenenenssenpitentinncescatemasmseentines 25

Hollister v. Benedict & Burnham Manufacturing Co.,

es TEI ictinictieriutatstintntiainpietmmseniguerpanmanennuii 13

Imhaeuser v. Buerk,

ES ana e 23

In re Inland Steel Co.,

265 F.3d 1354 (Fed. Cir. 2001) ............cccccecesseeeseeernees 17

Iron Grip Barbell Co. v. USA Sports, Inc.,

392 F.3d 1317 (Fed. Cir. 2004) .............:ccccsceseeeeeeeeeees 19

In re Johnston,

435 F.3d 1381 (Fed. Cir. 2006) ...................cccesceseeeeeees 16

Jungersen v. Ostby & Barton Co.,

ee itecinenisinisinteteiniansumaveencnrcsntnenenigtt 22

In re Kahn,

441 F.3d 977 (Fed. Cir. 2006) ...............cccccccceceeeees 16, 17

Kegel Co. v. AMF Bowling, Inc.,

127 F.3d 1420 (Fed. Cir. 1997) ...........c.eccescsseceseesseesssees 19

Leeds & Catlin Co. v. Victor Talking Machine Co.,

213 U.S. 325 (1909), overruled on other grounds sub

nom. Mercoid Corp. v. Mid-Continent Inv. Co.,

| RRR I Eh Te i)

Loom Co. v. Higgins,

ii a 25

Mast, Foos & Co. v. Stover Manufacturing Co.,

— , ERR A Ron ee RS 13

Mazzari v. Rogan,

323 F.3d 1000 (Fed. Cir. 2008) 00.0... ..ccccccccecceeceeee 17, 19

McNeil-PPC, Inc. v. L. Perrigo Co.,

337 F.3d 1362 (Fed. Cir. 2003) .0..........ccccccccocecceoceeceees 20

Mumm v. Jacob Decker & Sons,

I i 20

National Steel Car, Ltd. v. Canadian

Pacific Railway, Ltd,

357 F.3d 1319 (Fed. Cir. 2004) oo... occccccccceccceceeeeeeee 17

Norian Corp. v. Stryker Corp.,

363 F.3d 1321 (Fed. Cir. 2004) oo......cccccccccccocecceeceeeeees 16

Novo Nordisk A/S v. Becton Dickinson and Co.,

304 F.3d 1216 (Fed. Cir. 2002) .o.....occccccccececceccoceeeeeees 17

Old Town Canoe Co. v. Confluence Holdings Corp.,

448 F.3d 1309 (Fed. Cir. 2006) ooo... ccccccccccccocesseceeeeee 17

Ormco Corp. v. Align Technology, Inc.,

__ F.3d __, 2006 WL 2493245

Otto v. Koppers Co.,

246 F.2d 789 (4th Cir. 1957)...........-:c0c0cscesssesessesersseees 20

Pandrol USA, LP v. Airboss Railway Products, Inc.,

424 F.3d 1161 (Fed. Cir. 2005) .............:ccccccecereeeseeseeee 11

Panduit Corp. v. Dennison Manufacturing Co.,

810 F.2d 1561 (Fed. Cir. 1987) ................000006. 12, 23, 25

Park 'N Fly, Inc. v. Dollar Park & Fly, Inc.,

a Ie hsierrhescsienscenitibanieteanenatetutnmaescantiansiitels 28

Parks v. Booth,

a iin icctrrnicciiinidinniesiiniaiiencisbittiaatimpigsititll 23

Paulik v. Rizkalla,

760 F.2d 1270 (Fed. Cir. 1985) .0..........:cccccccceseeeeeeeeeeeees 6

Permutit Co. v. Graver Corp.,

ey Hee iccindsnicnnsiisiascepninatncticnsapectatanistinienaiisianins 11

Peters v. Active Manufacturing Co.,

ED CE icenernsepntstdnssesiceneccecnteitmnimentataieaniil 27

Peters v. Hanson,

SS Oe EE tcrnnctcnnsassieineneninsiantenstontitiamaninintants 13

Petersen Manufacturing Co. v. Central

Purchasing, Inc.,

740 F.2d 1541 (Fed. Cir. 1984) .0...........cccccccscceceeeeeeees 19

Princeton Biochemicals, Inc. v. Beckman

Coulter, Inc.,

411 F.3d 1332 (Fed. Cir. 2005) ..........:..c:cccccsererseeseeeee 17

Radio Corp. of America v..Radio Engineering Labs.,

Inc.,

Ee Be ee cesteccrsncnsengnenimensennitinsaededosinimneemnaninet 20

-Xi-

Richardson-Vicks Inc. v. Upjohn Co.,

122 F.3d 1476 (Fed. Cir. 1997) ..........ccccceseseseseseseeseees 20

Rogers v. Desa International Inc.,

No. 02-1247, 2006 WL 1965660

(Fed. Cir. July 13, 2006) .0..........c.ccccceccceccessesseeecsereesees 19

Ruiz v. A.B. Chance Co.,

357 F.3d 1270 (Fed. Cir. 2004) .........ccccccccecccescecsceeenees 17

Sakraida v. Ag Pro, Inc.,

EES ET EE nene meen 14, 26

Sandt Technology, Ltd. v. Resco Metal &

Plastics Corp.,

264 F.3d 1344 (Fed. Cir. 2001) ..........cccceessseseseseseecerere 19

Select Engineered System, Inc. v. Sentex System, Inc.,

194 F.3d 1331, 1999 WL 129637

(Fed. Cir. Mar. 10, 1999) .0..0......cccccccccccsseccececeseeesesevsene 19

Semmler v. Honda Motor Co.,

178 F.3d 1308, 1998 WL 791718

(Ped. Cir. Nov. 12, 1998) ..........c..cccccccccccececscecsceceeseees 19

Seymour v. Osborne,

i 23

Shultz v. Moore,

I cia ie 11

Smith v. Hall,

a ae CT 20

Thomson Spot Welder Co. v. Ford Motor Co.,

co ee 13, 16,18

- Xii -

Topliff v. Topliff,

gE eR Cy eee Seren 12

Tucker v. Spalding,

I ica ssciisciiieiastaeaiacnihlidaiidadiaiaal 11, 13

UV Coatings, Inc. v. Sico, Inc.,

250 F.3d 763, 2000 WL 986965

Ss ey GI SIE aiicinssecsttetctnssceniccniasitidumnismessasens 19

Union Carbide Corp. v. America Can Co.,

724 F.2d 1567 (Fed. Cir. 1964) ........cccccccccscsssssessoveseoes 19

United States v. Adams,

ee ee ci ninnrtincinncetneniticcneshdaiehiettiabiotaladitiistniaieahiia 14

Weber Electric Co. v. E.H. Freeman Electric Co.,

8 RUE ea eee reer 27

Wood v. Underhill,

A, Be i ineitiicnieniieticatanntnntinsiiciintatiainesialaadipitiaiissliaiaiiiel 11

FEDERAL STATUTES

gk eee Se en 28

Sy es UP tiiieicticrisniastnssstenieittnseniiiiepidinanbaclainiatonts beinbeissbiaintionnta 6

a ae ti cereitnciccnssitabitaneinianemnsiiniaignianseabins passim

By Oe I sociccntncceiansnsecindaniniiatanteaiimanladl 2,6, 8, 27

ey ee A aseniscnssiisicesiilteteasiccielnasasnengiaianiientinaiauniba 11

BP Ty III dciinsscscentteissnnnccanennatindtibtaniideasmaentmniiaiel i)

BD RII, B iB ccescevaccoccvcssssocsesncesoneseesocensesosessoonosenensnecns 20

- Xiii -

EERE ae re ene Ce ee nae eT 21

B5 U.S.C. §§ 305 & 314(C) ..ccseccsssesesssesssssecesseceesneeesnecesse 21

OTHER

P.J. Federico, "COMMENTARY ON THE NEW PATENT ACT,"

35 U.S.C.A. (1954), reprinted in 75 J. PAT. &

TRADEMARK OFF. SOC’Y 160 (1993)...............4. 6, 7, 8, 27

S. Rep. No. 82-1979 (1952), reprinted in

Re i Gi tn cicrrssccnnncnsirccsccovecetenectatvaseennees 5

Revision Notes to § 103 of Title 35,

NE eee 15

Giles S. Rich, Laying the Ghost of the Invention

Requirement,

1 APLA Q.J. 26 (1972), reprinted in

14 Fed. Cir. B.J. 163 (2004) .................... 4, 5, 6, 28, 30

Howard T. Markey, J., Why Not the Statute,

65 J. Pat. Off. Soc'y 331 (1983) ............::cccsesessecesseeeees 23

P.J. Federico, Origins of Section 103,

Rn CT I si isciirrtinntenesnepetninincenttornans 29

John Milton, Paradise Lost, Part V1 ..........ccccccceceeeeeeeees 23

American Intellectual Property Law Association

(AIPLA), "Guide to Model Patent Jury Instructions,"

Feb. 2006

(available at http://www.aipla.org/Content/

ContentGroups/Publications1/Publications_

available_for_viewing]1/MPJ_021006.pdf).................. 11

INTEREST OF AMICUS CURIAE'

The Pharmaceutical Research and Manufacturers of

America (“PhRMA”) is a voluntary, nonprofit association

representing the nation’s leading research-based

pharmaceutical and biotechnology companies. Member

companies are in the business of developing new drugs—a

complex process involving huge expenditures of time and

money. In 2005 alone, PhRMA members invested an

estimated $39.4 billion toward the discovery and

development of new medicines. Collectively, PhRMA

members are responsible for a huge portion of the

innovative medicines approved for use in the United

States in the past several decades.

Pharmaceutical companies spend many years working

to develop each new drug that appears on the market, as

well as many that will never earn approval. The process

typically begins with creating a new compound or

screening hundreds of thousands of existing compounds.

The most promising compounds are then modified to

optimize their properties, thus producing a candidate

drug. At that point, both compounds and their potential

uses are often separately patented. Selected compounds

are then tested in the lab and in animals to determine

whether they might effectively and safely treat a disease.

That is followed by clinical trials in normal human

volunteers and a series of studies in a relatively small

number of patients. The next stage of development is a

series of large clinical trials testing the effectiveness as

well as the safety of a drug in patients. Those clinical

trials, which typically take six to eight years, precede the

‘ Counsel for both parties have consented to the filing of this brief,

and the parties’ letters of consent have been filed with the Clerk of

Court. No counsel for any party authored this brief in whole or in part,

and no person or entity, other than PARMA or its members,

contributed monetarily to the preparation or submission of this brief.

A complete listing of PhRMA’s members is available online at

http//www.phrma.org/member_company_list/.

sf,

process of seeking approval from the Food and Drug

Administration (“FDA”). Altogether, the entire drug

development process might last upwards of fifteen years.

Moreover, a critical part of the research process is

discovering how to deliver a drug substance to a patient

in a safe and effective manner. That often involves

creating appropriate dosage forms for delivery of the drug

to a particular part of the body with certain specifications.

Those dosage forms can be optimized with particular

ingredients or coatings, and can involve combinations of

ingredients or *schnologies designed to provide particular

benefit to patients, exactly the kinds of innovations that

could be affected by the outcome of this case. Such

innovations can be significant for patient health.

Given the time and expense necessary to develop new

drugs, intellectual property principles, especially those

involving patent rights, are critical to PhRMA members

and their research and development efforts. PhRMA has

a strong interest in seeing the law continue to protect

those patent rights essential to ensuring future

innovation and the timely development of new medicines.

As practitioners in an industry where research and

development are expensive and competition is fierce,

PhRMA’s members need strong patent protection to be

able to recoup the costs of their investments.

PhRMA submits that to show that a combination of

prior art references renders a claimed invention obvious,

within the meaning of 35 U.S.C. § 103(a), a challenger

should have to provide evidence of either an express or an

implicit motivation, suggestion, or teaching to combine

the teachings of the references in the manner alleged to

render the claimed invention as a whole obvious.

Rejecting the requirement that the prior art show a

motivation, suggestion, or teaching before finding a

patent claim invalid under § 103 will make validity

challenges unpredictable. The focus will shift from an

objective analysis of what the prior art teaches to a

person having ordinary skill in the art to a subjective

analysis by the judicial officer considering the patent of

a.

whether the claimed invention has sufficient merit to

warrant a patent. Such an undesirable change in the law

will significantly undermine the confidence of innovators

such as PhRMA members in their ability to enforce

patents against free-riding infringers who use the fruits of

research and clinical-testing efforts of PhRMA members

without incurring the costly expenses associated with

developing, testing, and obtaining approval of new drug

products. Hence, PhRMA members have a strong interest

in preserving an obviousness standard that promotes

predictability and uniformity in the obviousness analysis,

to preserve the patent system as a strong economic

driving force for highly beneficial, yet expensive, research

and development efforts.

SUMMARY OF THE ARGUMENT

Through change in analytical perspective resulting

from the enactment of § 103, patentability analysis now

requires objective evidence that one of skill in the art

would readily deduce a claimed combination from the

prior art. Subjective assessment by the judiciary of

whether the claimed subject matter meets the indefinable

definition of “invention” has been repealed. It should not

be effectively resurrected by permitting subjective

conclusions or conclusory allegations of how one skilled in

the art would use the prior art to govern an obviousness

analysis concerning a claimed combination. Rather, the

law should continue to demand that objective evidence be

used in the analysis to show that, before the applicant’s

invention, one of ordinary skill in the art would have

recognized that the prior art teachings could be combined

as claimed in the patent. A lesser standard would lose

sight of the congressional directive to consider the

invention “as a whole.” The evidence can be direct or

circumstantial, i.e., an express or implicit motivation to

combine the prior art teachings, but there must be

evidence. That is what the “motivation-suggestion-

teaching” ("MST") test does. It requires evidence to

+s

support the contention that where all the components of a

claimed invention are found individually in the prior art,

one of skill in the art would find the claimed combination,

when viewed “as a whole,” obvious. There is no good

reason to reject that test in favor of an unspecified

standard that focuses the analysis on the differences

between individual components of the claimed

combination without demanding any objective evidence to

ascertain whether the combination when considered as a

whole would have been obvious as the statute explicitly

requires. As Judge Rich explained, “what must have been

obvious is ‘the subject matter as a whole. .. . If, for

example, a combination is claimed, Section 103 requires

that to invalidate the claim, it must be shown that the

combination was obvious, not merely its components.”

Giles S. Rich, Laying the Ghost of the Invention

Requirement, 1 APLA Q.J. 26, 34 (1972), reprinted in 14

Fed. Cir. BJ. 163, 70 (2004) [hereinafter “Ghost”].

Rejecting the MST test will reintroduce subjectivity,

hindsight, and uncertainty into patentability analysis,

defeating the whole patent system and casting a cloud

over many meritorious combination patents.

The arguments by the petitioner and its supporting

amici—that the MST test requires an express teaching,

precludes summary judgment, has no basis in this Court’s

precedents, and ill serves the patent law—do not

withstand scrutiny. To the contrary, the test permits a

wide variety of evidence, including implicit teachings and

expert testimony, permits summary judgment when

circumstances warrant, has support in this Court’s pre-

and post-§ 103 enactment precedents, and has beneficially

served the patent law and advanced technology.

Petitioner’s contention that the Court should reject the

MST test in favor of a standard that merely requires

technical capability to combine the teachings of the prior

art should not be adopted. It sets the bar too low, for it

ignores the principle that a patentable invention can

come from merely recognizing that a never-before-made

combination can be made even if the combination is

yo

upheld. Neither should petitioner’s suggestion that the

Court resurrect a “synergy” requirement be adopted, since

Congress overruled such a requirement with the

enactment of § 103.

L. The “Motivation-Suggestion-Teaching” Test

Should Remain a Requirement of an

Obviousness Analysis

A. By Enacting § 103, Congress Sought to Inject

Predictability, Uniformity, and Objectivity

into Patentability Analysis

Determining whether a claimed invention comprised

of components found in the prior art is patentable

presents a question that “has taxed the ingenuity of

courts ever since the passage of the patent acts.” C. & A.

Potts & Co. v. Creager, 155 U.S. 597, 606 (1895). To

answer that question before the enactment of the 1952

Patent Act, courts examined the claimed subject matter to

see whether it showed “invention” er the mere work of an

ordinary mechanic. Focusing the analysis on whether the

claimed subject matter showed sufficient “invention”

proved unsatisfactory, as the answer often turned on the

subjective views of the judicial officer considering the

patent. That in turn led to inconsistency and

unpredictability concerning whether a patent would be

upheld or found invalid for lack of invention. See Rich,

Ghost, 1 APLA Q.J.at 28-31, reprinted in 14 Fed. Cir. B.J.

at 165-70.

To eliminate the subjectivity of the analysis and

provide for uniformity in the application of the law,

Congress enacted § 103 of the 1952 Patent Act.” Section

103 changed the focus of the analysis from whether the

2

S. Rep. No. 82-1979, at 6 (1952), reprinted in 1952 US.C.CAN.

2394, 2400.

_,

claimed subject matter showed a sufficient level of

“invention” to whether the “differences between the

subject matter sought to be patented and the prior art are

such that the subject matter as a whole would have been

obvious at the time the invention was made to a person

having ordinary skill in the art to which said subject

matter pertains.” 35 U.S.C. § 103(a) (emphasis added).

Graham v. John Deere Co., 383 U.S. 1, 14 (1966). In other

words, instead of judging whether the subject matter

claimed in the patent rose to the dignity of “invention,” a

concept difficult to define, the analysis focuses on whether

the claimed subject matter, when viewed as a whole,

would have been “obvious” from the prior art to a person

having ordinary skill in the art. See Bonito Boats, Inc. v.

Thunder Craft Boats, Inc., 489 U.S. 141, 150 (1989) (“The

nonobviousness requirement extends the field of

unpatentable material beyond that which is known to the

public under § 102, to include that which could readily be

deduced from publicly available material by a person of

ordinary skill in the pertinent field of endeavor.”).

The late Judge Giles S. Rich, a principal drafter of

§ 103, instructed that the section was a legislative

directive for a new approach to considering patentability.

Rich, Ghost, 1 APLA Q.J. at 34, reprinted in 14 Fed. Cir.

B.J. at 170 (“As compared to finding or not finding

“invention,” Section 103 was a whole new way of thinking

and a clear directive to the courts to think that way.

Some courts and some lawyers do not yet seem to realize

that.”).

Mr. P.J. Federico,’ the other principal drafter of § 103,

* Mr. Federico has been identified as the “primary author of the

Patent Act of 1952” 75 J. Pat. & TRADEMARK Orr. Soc’y 160, 160

(1993). See also Paulik v. Rizkalla, 760 F.2d 1270, 1277 (Fed. Cir.

1985) (Rich, J., concurring). Hence, although not definitive evidence of

Congress's intent, see In re Donaldson Co., 16 F.3d 1189, 1193 2.3

(Fed. Cir. 1994) (en banc) (Rich, J), his commentary provides useful

There has been some discussion as to whether

section 103 modifies the so-called standard of

invention (which itself is an unmeasurable

quantity having different meanings for different

persons) in the courts and it may be correct to

state that the printed record does not show an

explicit positive command to the courts. While it is

not believed that Congress intended any radical

change in the level of invention or patentable

novelty, nevertheless, it is believed that some

modification was intended in the direction of

moderating the extreme degrees of strictness

exhibited by a number of judicial opinions over the

past dozen or more years; that is, that some

change of attitude more favorable to patents was

hoped for. This is indicated by the language used

in section 103 as well as by the general tenor of

remarks of Committees in the reports and

particular comments. Weight should be given to

the terms used in the section since a variety of

expressions used in decisions were available,

including some stated with an extreme degree of

strictness, which could have been used as the

model for the phraseology to be adopted, but the

language selected was of the more moderate

variety. The Committee Report, in the general

part, states that the section “should have a

stabilizing effect and minimize great departures

information in understanding the policies the drafters sought to

advance with the 1952 Act.

what the report indicates should be minimized.

P.J. FEDERICO, “COMMENTARY ON THE NEW PATENT ACT,”

35 U.S.C.A. at pp. 22-23 (1954), reprinted in 75 J. PAT. &

TRADEMARK OFF. SOC’Y 160, 183-84 (1993) (emphasis

added). Mr. Federico also noted that after its enactment

there were concerns that “new section 103 may not have

the influence on the courts which was anticipated by its

enactment.” Id. at 23, reprinted in 75 J. Pat. &

Trademark Soc'y at 184. That concern seems justified by

the current positions urged by the petitioner and the

amici supporting the petitioner.

B. The “Motivation-Suggestion-Teaching” Test

Serves Four Important Purposes in

Evaluating the Question of Obviousness

Under the Framework of Graham

Section 103 of the Patent Act dictates that the main

inquiry in considering the possible obviousness of a

claimed invention is whether “the differences between the

subject matter sought to be patented and the prior art are

such that the subject matter as a whole would have been

obvious at the time the invention was made to a person

having ordinary skill in the art to which said subject

matter pertains.” 35 U.S.C. § 103(a) (emphasis added).

As guidance for conducting that analvsis, this Court, in

Graham, set forth the now familiar legal principle that

Under § 103, the scope and content of the prior art

are to be determined; differences between the prior

art and the claims at issue are to be ascertained;

and the level of ordinary skill in the pertinent art

resolved. Against this background, the

obviousness or nonobviousness of the subject

matter is determined.

-9-

Graham, 383 U.S. at 17-18. While providing a starting

point, the Graham instruction fails to provide explicit

guidance on how one should apply the distinct evidentiary

factors (a/k/a “the Graham factors”) in determining

obviousness. The MST standard provides an analytical

framework, and perhaps the only possible analytical

framework, for applying the Graham factors.

At least four important purposes in assessing the

Graham factors are served by the MST test. First, by

requiring evidence that one of skill in the art would have

a motivation to combine the teachings of the prior art in a

manner that yields the claimed invention, the standard

ensures that the obviousness analysis gives due credence

to the statutory requirement that the claimed invention

be viewed “as a whole.” Permitting the analysis to be

based on the mere presence in various items of prior art of

the elements of a claimed invention without requiring any

showing that one of skill in the art would have been

motivated to combine the teachings of those items of prior

art risks transforming the analysis into a consideration of

only the individual elements. But the statute demands

that the invention be considered “as a whole.™ Indeed,

how can it accurately be proven that a claimed

combination “as a whole” would have been obvious to a

person having ordinary skill in the art without a showing

that something would have taught, suggested, or

* Custom Accessories, Inc. v. Jeffrey-Allan Indus., 807 F.2d 955, 959

(Fed. Cir. 1986); see also Grain Processing Corp. v. Am. Maize-Prods.,

Co., 840 F.2d 902, 907-08 (Fed. Cir. 1988). Cf. Aro Mfg. Co. v.

Convertible Top Replacement Co., 365 U.S. 336, 344-45 (1961) (“the

combination patent covers only the totality of the elements in the

claim"); Leeds & Catlin Co. v. Victor Talking Machine Co., 213 US.

325, 333 (1909) (“A combination is a composition of elements, some of

which may be old and others new, or al! old or al! new. It is, however,

the combination that is the invention, and is as much a unit in

contemplation of law as a single or noncomposite instrument.”),

overruled on other grounds sub nom. Mercoid Corp. v. Mid-Continent

Inv. Co., 320 U.S. 661 (1944), superceded by statute 35 U.S.C. § 271(d).

-10-

motivated that person to combine the teachings of the

prior art in a manner to make the claimed combination?

Second, evidence of whether or not one of skill in the

art would have had a motivation to combine the teachings

of the prior art provides a way to evaluate the significance

of the differences between the prior art and the claimed

invention. Differences that may seem insignificant but

would not have occurred to one of skill in the art likely

deserve patent protection. Significant differences may

not deserve patent protection if they would easily occur to

one of skill in the art. Evidence showing the presence or

absence of a motivation to combine the teachings of the

prior art provides guidance for evaluating whether the

differences between the claimed invention and prior art

show that the invention would or would not have been

obvious

Third, requiring evidence that one of skill would be

motivated to combine the teachings of the prior art to

arrive at the claimed invention ensures that the fact-

finder bases the obviousness determination on objective

evidence of how one of skill in the art could view and use

the prior art. Without that standard, fact-finders will rely

on their own subjective perceptions of how one of skill in

the art could use the prior art teachings. Reliance on

subjective perceptions, rather than objective evidence,

will lead to uncertainty in obviousness determinations,

which in turn will create instability in the law.

Fourth, the MST test also serves “to guard against

slipping into use of hindsight and to resist the temptation

to read into the prior art the teachings of the invention in

issue.” Graham, 383 U.S. at 36. Although the petitioner

and several amici try to downplay the importance of

* See also Grain Processing Corp., 840 F.2d at 907 (“Care must be

taken to avoid hindsight reconstruction by using ‘the patent in suit as

a guide through the maze of prior art references, combining the right

references in the right way so as to achieve the result of the claims in

suit.™).

-ll-

guarding against hindsight, the need for that protection is

especially important when a jury will determine the issue

of obviousness.° Jurors on patent cases must often deal

with new and complex technology that they have never

encountered before. Over the course of a trial, which

generally will last for at least several days, they are

presented with testimony regarding the patent, the story

of how the inventor created the invention, testimony on

the prior art, a host of instructions on patent-law

principles’ and claim constructions to apply to the facts,

demonstrative exhibits, usually conflicting testimony of

highly qualified expert witnesses, and more. Given the

overload of information, it is not realistic to expect a lay

juror when determining the issue of obviousness to ignore

the teachings of the patent specification when he or she

must look to those teachings to understand and evaluate

the invention for other purposes.’ Requiring proof of a

motivation to combine the teachings of the prior art to

* Although obviousness presents a question of law, it is an issue

typically given to the jury. Adams v. Bellaire Stamping Co., 141 US.

539, 542 (1891); Tucker v. Spalding, 80 U.S. 453, 455 (1871); Connell v.

Sears, Roebuck & Co., 722 F.2d 1542, 1547 (Fed. Cir. 1983); but see

Shultz v. Moore, 419 U.S. 930, 931-32 (1974) (Douglas, J., dissenting)

(entending Gast validity questions cheuls ast gp to 0 Jury).

" See, e.g., American Intellectual Property Law Association (AIPLA),

“GUIDE TO MODEL PATENT JURY INSTRUCTIONS,” Feb. 2006 (available at

http//www.aipla.org/ Content/ ContentGroups/ Publications 1/Public-

ations_available for _viewingl/ MPJ_021006 pdf) (providing 37 pages,

in single-spaced type, of model jury instructions for use in a typical

patent infringement case).

* For example, if a challenger to the patent asserts that the patent

fails to enable a person of ordinary skill in the art to practice the

invention or fails to provide an adequate written description of the

claimed invention (both defenses arising under 35 U.S.C. § 112, para.

1), the juror must specifically consider the teachings of the patent

specification. See Permutit Co. v. Graver Corp., 284 U.S. 52, 59-60

(1931); Expanded Metal Co. v. Bradford, 214 U.S. 366, 380-81 (1909);

Wood v. Underhill, 46 U.S.. 1, 4-5 (1847); Pandrol USA, LP v. Airboss

Ry. Prods., Inc., 424 F.3d 1161, 1165 (Fed. Cir. 2005); AK Steel Corp. v.

Sollac, 344 F.3d 1234, 1244 (Fed. Cir. 2003).

°-12-

arrive at the claimed invention helps to ensure that the

jury does not impermissibly use the inventor’s teachings

in determining the obviousness or unobviousness of a

claimed invention.

By achieving those four purposes, the MST standard

realizes the congressional intent of stabilizing the patent

law. The tesi provides an analytical framework that can

be uniformly applied to all patent disputes. Furthermore,

since it focuses on objective evidence of how one of skill in

the art can use the teachings of the prior art, it avoids the

unfairness and uncertainty of determinations based on

subjective perceptions of the lay fact-finder. It also

prevents the lay fact-finder from injecting into the

obviousness analysis his or her perception of the worth of

the patent.’ And most importantly, it requires that the

fact-finder consider only objective evidence, direct or

circumstantial, of how one of skill could use the prior art

teachings.

C. This Court’s Precedents Support the

“Motivation-Suggestion-Teaching” Test

The MST test has roots in the precedents of this

Court. In determining patentability before the passage of

the 1952 Patent Act, this Court often considered whether

the prior art “suggested” the modification that yielded the

claimed invention. For example, in Topliff v. Topliff, 145

U.S. 156, 161 (1892), the Court refused to find that a prior

art patent, via a modification to its teachings, could

invalidate an asserted patent where there was not

“anything in [the prior art] patent which would have

suggested [the modification] to a mechanic of ordinary

intelligence, unless he were examining it for that

purpose.” The Court upheld the validity of a claim

directed to an improved process for making expanded

* Worth of patent is not, and should not be, the test for obviousness.

Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1573 (Fed. Cir.

1987).

o 13.

sheet metal in Expanded Metal Co. v. Bradford, 214 U.S.

366, 381 (1909), because “the prior art does not suggest

the combination of operations which is the merit of

Golding’s invention.” In Thomson Spot Welder Co. v. Ford

Motor Co., 265 U.S. 445, 451, 453-54 (1924), the Court

found “no error in law” in a lower court’s analysis holding

claims to a spot-welding process invalid for lack of

invention where all the individual elements were known

in the prior art and the combination was “naturally

enough suggested by the prior art.” Other case examples

from the Court show that the notion that something other

than the challenged patent must explicitly or implicitly

suggest the claimed combination to a mechanic of

ordinary skill has firmly been part of the patent law for

well over a hundred twenty-five years.” Contrary to the

contention of the petitioner and its supporting amici, the

foregoing shows that this Court in the past has required

the finding of an explicit or implicit suggestion in the

prior art to combine the teachings of the prior art to yield

the claimed combination before invalidating a

combination claim.

” E.g., Mast, Foos & Co. v. Stover Mfg. Co., 177 U.S. 485, 493-94

(1900) (claim to windmill gearing was held invalid because, in view of

the state of the prior art, the claimed combination “would have been

suggested to an intelligent mechanic, who had before him the patents

to which we have called attontion.”); Day v. Fair Haven & Westville Ry.

Co., 132 U.S. 98, 102 (1889) (claim invalid where invention “would

naturally suggest itself to any mechanic, and its use in that way is

within the range of common knowledge and experience”); Hollister v.

Benedict & Burnham Mfg. Co., 113 U.S. 59, 72 (1885) (claim to a

stamp device invalid since it was “the suggestion of that common

experience, which arose spontaneously and by a necessity of human

reasoning, in the minds of those who had become acquainted with the

circumstances with which they had to deal”); Tucker, 80 U.S. at 455-56

(prior art reference should have been admitted if it “suggested to the

mind of an ordinarily skilful mechanic” the claimed invention); see also

Peters v. Hanson, 129 U.S. 541, 552-53 (1889) (noting expert testimony

that an ordinary mechanic would be motivated to apply prior art

ae of using slots to provide adjustable attachments to invalidate

aim).

- 14.

This Court’s § 103 precedents considering the validity

of a claim in view of the combined teachings of prior art -

references show a continuing of the requirement that a

challenger present evidence of an explicit or implicit

motivation for one of skill in the art to combine those

teachings in a manner that yields the claimed invention.

For example, in United States v. Adams, 383 U.S. 39

(1966), the Court held the invention unobvious, in part,

because the prior art “deter[red] any investigation into

such a combination as is used by Adams.” Jd. at 52. In

other words, the Court sustained validity because the

prior art failed to show a motivation to combine the prior

art teachings in a manner that yielded the claimed

invention.

In Calmar, Inc. v. Cook Chemical Co., the companion

case to Graham, this Court effectively found an implicit

motivation to combine teachings of prior art references

where the references were directed to solving the same

type of mechanical closure problem. 383 U.S. at 35.

Similarly, Anderson’s-Black Rock, Inc. v. Pavement

Salvage Co., 396 U.S. 57 (1969), shows another situation

where the nature of the problem to be solved—in that

case, preventing the formation of cold joints in paving

operations—implicitly provided the necessary motivation

to combine a radiant heat burner, known to be useful in

eliminating cold joints, with a paving apparatus to yield

the claimed invention.

Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976), provides

an example where all the elements of the claimed

combination were found in several prior art references

directed to the same narrow field of the invention—

systems using flowing water to clean animal wastes from

barn floors. Hence, the narrow field of the invention

provided the implicit motivation to combine the teachings

of the references in a manner that yielded the claimed

invention.

,

As shown in Section I(D), infra, all of those factors—

the presence or absence of a suggestion in the prior art,

nature of the problem to be solved, and narrow field of the

invention—are factors the Federal Circuit considers as

evidence that can be used to show a motivation for

combining the teachings of the prior art.

D. The “Motivation-Suggestion-Teaching” Test

Is Workable and Does Not Impose Undue

Evidentiary Burdens

When Congress enacted §103, it realized that

additional criteria beyond the main standard in the

statute would likely be needed to achieve the goal of

providing a patentability analysis based on objective

evidence and achieving greater uniformity in its

conclusions. The MST test is one of those “worked out”

criteria.

In essence, the test requires merely that a conclusion

of obviousness be based on objective evidence, and not a

subjective judgment or conclusory assertions. The

Federal Circuit made that clear in Alza Corp. v. Mylan

Laboratories, Inc., __ F.3d _, No. 06-1019, 2006 WL

2556356 (Fed. Cir. Sept. 6, 2006), where it explained:

At its core, our anti-hindsight jurisprudence is

a test that rests on the unremarkable premise that

legal determinations of obviousness, as with such

determinations generally, should be based on

evidence rather than on mere speculation or

conjecture... .

... [R]ejections on obviousness grounds cannot be

sustained by mere conclusory statements; instead,

there must be some articulated reasoning with

" Revision Notes to § 103 of Title 35, 1952 U.S.C.C_A.N. 2403, 2411

(“This paragraph [§ 103] is added with the view that an explicit

statement in the statute may have some stabilizing effect, and also to

serve as a basis for the addition at a later time of some criteria which

may be worked out.”) (emphasis added).)

-16-

some rational underpinning to support the legal

conclusion of obviousness. This requirement is as

much rooted in the Administrative Procedure Act

{for our review of Board determinations], which

ensures due process and _ non-arbitrary

decisionmaking, as it is in § 103.

Alza Corp., slip op. at 5-6, _. F.3d at _, 2006 WL

2556356, at *3-*4 (quoting In re Kahn, 441 F.3d 977, 989-

90 (Fed. Cir. 2006)) (citations omitted).

This Court itself has noted that conclusory analysis

and assertions are not sufficient for a patentability

analysis. Thomson Spot Welder, 265 U.S. at 453

(rejecting invalidity analysis by one court that contained

“only general allusions to the prior art and no analysis of

the prior patents” while accepting invalidity analysis of a

second court supported by factual findings).

The United States Patent and Trademark Offfice

(“PTO”) and those challenging the validity of a patent in

court have a wide variety of evidence they can use to show

that the prior art would motivate one of ordinary skill in

the art to combine aspects of the prior art in a way that

may render a claimed invention obvious. At one end of

the spectrum, evidence that the prior art expressly

discloses that the combination can be made will meet the

standard.” At the other end of the spectrum, an implicit

motivation to combine can also suffice. Under Federal

Circuit precedent, an implicit motivation to combine can

be found where the prior art references are in the same

" Eg., In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004); Norian

Corp. v. Stryker Corp., 363 F.3d 1321, 1328 (Fed. Cir. 2004).

* Alza Corp., slip op. at 6,__ F.3d at __, 2006 WL 2556356, *4 (“There

is flexibility in our obviousness jurisprudence because a motivation

may be found implicitly in the prior art. We do not have a rigid test

that requires an actual teaching to combine before concluding that one

of ordinary skill in the art would know to combine references.”); e.g.,

Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1341 (Fed. Cir.

2006) (implicit disclosure of interchangeability provided motivation).

-17-

field of invention.’ The nature of the problem solved may

also provide evidence of an implicit motivation where the

prior art references address the same problem.”

Nonconclusory expert testimony may also show that one

of skill in the art would have been motivated to make the

claimed combination.” Contrary to the contention of the

petitioner and several amici, inherent knowledge of one of

skill in the art (where that knowledge is articulated and

placed in the record) can show the necessary motivation.”

In fact, evidence used to show the motivation to combine

does not even have to be publicly available.”

* E.g., In re Johnston, 435 F.3d 1381, 1384-85 (Fed. Cir. 2006); In re

Dance, 160 F.3d 1339, 1343 (Fed. Cir. 1998).

* E.g., Old Town Canoe Co. v. Confluence Holdings Corp., 448 F.3d

1309, 1319 (Fed. Cir. 2006); Cross Med. Prods., Inc. v. Medtronic

Sofamor Danek, Inc., 424 F.3d 1293, 1322-23 (Fed. Cir. 2005);

Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 411 F.3d 1332,

1339 (Fed. Cir. 2005); Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276-77

(Fed. Cir. 2004); In re Inland Steel Co., 265 F.3d 1354, 1362 (Fed. Cir.

2001).

“ E.g., Alza Corp., slip op. at 11-15, _ F.3d at _, 2006 WL 2556356,

*6-*8; Princeton Biochemicals, Inc., 411 F.3d at 1337-40; Mazzari v.

Rogan, 323 F.3d 1000, 1005 (Fed. Cir. 2003).

" DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick

Co., slip op. at 20,__ F.3d __, __, No. 06-1088, 2006 WL 2806466, *11

(Fed. Cir. Oct. 3, 2006) (“Our suggestion test is in actuality quite

flexible and not only permits, but requires, consideration of common

knowledge and common sense.”). E.g., Ormco Corp. v. Align

Technology, Inc., slip op. at 16, _ F.3d __, __, No. 05-1426, 2006 WL

2493245, *7 (Fed. Cir. Aug. 30, 2006) (relying on “well-known practice

of packaging items in the manner most convenient to the purchaser”);

Novo Nordisk A/S v. Becton Dickinson and Co., 304 F.3d 1216, 1219

(Fed. Cir. 2002); see also In re Kahn, 441 F.3d at 989-90.

* Alza Corp., slip op. at 12, __ F.3d at __, 2006 WL 2556356, *7; e.g.,

Cross Med. Prods., 424 F.3d at 1322-23 (non-prior art material showed

recognition of the problem to supply necessary motivation to combine

or modify prior art teachings); Nat'l Steel Car, Ltd. v. Canadian Pac.

Ry., Ltd, 357 F.3d 1319, 1337-39 (Fed. Cir. 2004) (motivation found

from unpublished drawing made by an engineer and a private

ee a eeray Sage ae Sane ae Sp SO

Additionally, under the Federal Circuit’s precedents,

evidence of a motivation to combine does not have to

match the reasons contemplated by the inventor.” Given

the wide variety of evidence, direct or circumstantial, that

can be used to show a motivation, suggestion, or teaching

to combine teachings of prior art references, the MST test

does not place an undue burden on challengers or the

PTO to substantiate a claim of obviousness with some

form of objective evidence.”

Petitioner and several of the amici contend that the

MST test virtually precludes summary judgment. That

contention does not withstand scrutiny. The obviousness

inquiry requires resolution of “factual inquires” before

arriving at the ultimate legal conclusion on obviousness.

Graham, 383 U.S. at 17. But cf. Thomson Spot Welder,

265 U.S. at 446 (“The question whether an improvement

requires mere mechanical skill or the exercise of the

faculty of invention, is one of fact.”). Hence, where

genuine issues of material fact exist regarding whether

some form of objective evidence shows a motivation to

combine teachings of references, it comes as no surprise

that a district court may not grant summary judgment.

Fountain v. Filson, 336 U.S. 681, 682-83 (1949). But

” E.g., In re Fulton, 391 F.3d at 1202; In re Beattie, 974 F.2d 1309,

1312 (Fed. Cir. 1992).

* The breadth of evidence that can be used to show an explicit or

implicit motivation to combine teachings of the prior art refutes the

characterization by some of the amici that the MST standard is

nothing more than a “generalized novelty requirement.” See DyStar,

slip op. at 15-23, _ F.3d at __, 2006 WL 2806466, at *8-*12 (stating

that commentators have distorted the “motivation-suggestion-

teaching” test and illustrating cases showing the broad flexibility

inherent in the test). The MST test also permits giving effect to the

“ability to combine and modify prior art references that is consistent

with the creativity and problem-solving skills that in fact are

characteristics of those having ordinary skil] in the art” as urged by

other amici. See id., slip op. at 26, 2006 WL 2806466, at *13. What

the test does not permit, however, is conclisory assertions of a

motivation to combine prior art teachings.

-19-

where the circumstances show no genuine issue of

material fact on the question of obviousness, including

whether a motivation exists to combine or modify prior

art teachings, the Federal Circuit has affirmed invalidity

rulings under § 103 on summary judgment.” Where

proper the Federal Circuit has also affirmed summary

judgments dismissing obviousness challenges.”

" E.g., Rogers v. Desa Int'l Inc., No. 02-1247, 2006 WL. 1965660 (Fed.

Cir. July 13, 2006) (nonprecedential), Athletic Alternatives, Inc. v.

Benetton Trading USA, Inc., 74 Fed. Appx. 571, 574, No. 05-1378, 2006

WL 870806, *3 (Fed. Cir. Mar. 31, 2006) (nonprecedential), cert. denied,

2006 U.S. LEXIS 7222 (U.S. Oct. 2, 2006)); Iron Grip Barbell Co.

v.USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004); Mazzari, 323

F.3d at 1005 (affirming summary judgment for PTO in a § 145 action),

Atl. Const. Fabrics, Inc. v. Dandy Prod., Inc., 64 Fed. Appx. 757, 762,

No. 02-1451, 2003 WL 1949582, *4 (Fed. Cir. Apr. 23, 2003)

(nonprecedential); Sandt Tech., Lid. v. Resco Metal & Plastics Corp.,

264 F.3d 1344, 1355 (Fed. Cir. 2001); Gebdrielidis v. Prince Sports

Group, Inc., 243 F.3d 565, No. 99-1469, 99-1490, 2000 WL 1648134, *8-

*11 (Fed. Cir. Nov. 1, 2000) (nonprecedential); UV Coatings, Inc. v.

Sico, Inc., 250 F.3d 763, No. 99-1336, 2000 WL 986965, *4-*5 (Fed. Cir.

July 18, 2000) (nonprecedential); Comfort Silkie Co. v. Seifert, 215 F.3d

1344, No. 98-1476, 1999 WL 507166, *2 (Fed. Cir. July 16, 1999)

(nonprecedential); Select Engineered Sys., Inc. v. Sentex Sys., Inc., 194

F.3d 1331, No. 98-1166, 1999 WL 129637, *1 (Fed. Cir. Mar. 10, 1999)

(nonprecedential), Semmiler v. Honda Motor Co. 178 F.3d 1308, No. 97-

1390, 1998 WL 791718, *%4-°5 (Fed. Cir. Nov. 12, 1998)

(nonprecedential), Colvin v. Nat'l Auto. Parts Ass'n, 168 F.3d 1321, No.,

98-1104, 1998 WL 536885, *1 (Fed. Cir. Aug 18, 1998)

(nonprecedential), Brand Mgt., Inc. v. Menard, Inc., 135 F.3d 776, No.

97-1329, 1998 WL 15241, *11 (Fed. Cir. Jan. 14, 1998)

(nonprecedential), Ecolochem, Inc. v. S. Cal. Edison Co., 91 F.3d 169,

No. 95-1320, 1996 WL 297601, *3-*4 (Fed. Cir. June 5, 1996)

(nonprecedential); Petersen Mfg. Co. v. Cent. Purchasing, Inc., 740 F.2d

1541 (Fed. Cir. 1984); Union Carbide Corp. v. Am. Can Co., 724 F.2d

1567, 1577 (Fed. Cir. 1984); Chore-Time Equip., Inc. v. Cumberland

Corp., 713 F.2d 774, 778 (Fed. Cir. 1983).

" E.g., Crown Operations Int'l, Lid. v. Solutia, Inc., 289 F.3d 1367,

1378 (Fed. Cir. 2002); Biotec Biolagische Naturverpackungen GmbH &

Co. KG v. Biocorp, Inc., 249 F.3d 1341, 1355 (Fed. Cir. 2001);

Chiuminatta Concrete Concepts, Inc. v. Cardinal Indus., 145 F.3d

1303, 1312-13 (Fed. Cir. 1998); Kegel Co. v. AMF Bowling, Inc., 127

- 20 -

One of the amici supporting the petitioner suggests

that the MST test unfairly prevents generic drug

manufacturers from introducing generic forms of patented

drug combinations. PhRMA submits that that

observation does not withstand scrutiny either, for the

Federal Circuit has invalidated drug-combination patents

where the claimed drug combination was shown to be

obvious under the MST test.”

Sound patent policy fostering predictability,

uniformity, and stability in the patent law should not be

sacrificed just so accused infringers or disenchanted

licensees can summarily invalidate a patent. Hard-

earned government rights, subject to a statutory

presumption of validity,“ should not be so easily cast

F.3d 1420, 1430-31 (Fed. Cir. 1997); Avia Group Int'l, Inc. v. LA. Gear

Cal., Inc., 853 F.2d 1557, 1564 (Fed. Cir. 1988).

” Eg., McNeil-PPC, Inc. v. L. Perrigo Co., 337 F.3d 1362, 1370-71

(Fed. Cir. 2003); Richardson-Vicks Inc. v. Upjohu Co., 122 F.3d 1476,

1484 (Fed. Cir. 1997).

“ 35 USC. § 282. This Court has held thet one who seeks to

Sons,

301 US. 168, 171 (1937); Radio Corp. of Am. v. Radio Eng’g Labs.,

Inc., 293 US. 1, 7-8 (1934); Adamson v. Gilliland, 242

(1917). Petitioner and one of the amici contend that a

art not considered by the PTO, neither considers the scenario of when

that art is merely cumulative to art considered by the PTO. See Otto v.

Koppers Co., 246 F.2d 789, 801 (4th Cir. 1957) (“Astute and

enterprising attorneys can always find (prior art] references not of

~ 24 -

down.”

E. Without the “Motivation-Suggestion-

Teaching” Test There Are No Meaningful

Guidelines for Objectively Analyzing

Obviousness

It is notable that while criticizing the MST test,

neither petitioner nor its supporting amici have offered

alternative guidelines that permit an evaluation of

obviousness based on objective evidence to show what one

of skill in the art could or could not readily deduce from

the prior art. Several amici suggest that the Court should

reject the MST test and return to the Graham standard.

But those amici have not offered any guidelines on how

the differences between the claimed invention and the

prior art should be assessed in view of the level of skill in

the art to answer the statute’s question: “Would the

invention have been obvious?” The “no standard”

approach amounts to an amorphous standard that will

not achieve the congressional purposes of bringing

stability and uniformity to the patent law. Furthermore,

the parties urging the “return to Graham” fail to see that

the MST test is nothing more than a rule of evidence for

implementing the Graham standard. Others offer tests

that effectively presume that anything that consists of a

combination of items found in the prior art can be readily

deduced by one of ordinary skill in the art. This Court

has long rejected that premise, see Section II, infra, nor

does that premise provide meaningful guidance for

evaluating the Graham factors.

™ Parties seeking to challenge a patent have alternatives to litigation.

Where a substantia! new question of patentability exists, they can seek

either an ex parte or an inter partes reexamination in the PTO. 35

U.S.C. § 301 et seg. Those proceedings are conducted within the PTO

“with special dispatch.” 35 U.S.C. $§ 305 & 314(c).

Re

F. Petitioner’s Anecdotal Evidence Does Not

Show that the “Motivation-Suggestion-

Teaching” Test Is a Failed Experiment

Members of this Court have wisely cautioned against

imposing by judicia) fiat overly strict patentability

standards in reaction to random instances of patents of

dubious validity. Jungersen v. Ostby & Barton Co., 335

U.S. 560, 572 (1949) (Jackson, J., dissenting). Petitioners

and amici have offered several examples of anecdotal

evidence purportedly showing patents of questionable

validity upheld under a suspect application of the MST

test, and sentiments of dissatisfaction with the current

state of the patent system. That anecdotal evidence and

self-interested promotion, however, fails to show that

under the totality of the circumstances, the MST test has

harmed or fails to beneficially advance the patent system.

To the contrary, having the MST test has provided a

robust patent system where obviousness challenges must

be proven with objective evidence of how one skilled in the

art would understand and use the teachings of the prior

art rather than a subjective assessment by a judge or jury

of whether the differences between the claimed invention

and the prior art, considered individually, show the

claimed invention would have been obvious. The MST

test works especially well with complicated inventions.

Concerns about possible mis-application of the test when

applied to simple inventions do not lessen the need for the

test or justify rejecting it. One cannot seriously question

the rapid strides technology has made during the last

twenty-four years under the carefully balanced incentive

provided by the patent system's promise of limited

exclusive rights. Upsetting that balance as the petitioner

proposes risks crippling the pace of technology's advance.

Il. THE STANDARD FOR DETERMINING

OBVIOUSNESS SHOULD NOT BE MERE

CAPABILITY OF COMBINING TEACHINGS OF

REFERENCES

Petitioner suggests that instead of requiring evidence

-%3-

of a motivation, suggestion, or teaching to combine the

teachings of the prior art, the test should require only

that one of skill in the art have the capability to make the

combination. That test sets the bar too low.

As the late Chief Judge Markey stated, “Only God

works from nothing. Men must work with old elements.”

Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549,

1556 n.3 (Fed. Cir. 1985) (quoting Markey, J.. Why Not

the Statute, 65 J. Pat. Off. Soc'y 331, 334 (1983)).

Accordingly, patentability is not, and never has been,

denied merely because all elements of a combination are

individually known in the prior art.” As this Court noted,

if the rule were otherwise for combination patents “not

one patent of the kind in a thousand of modern date could

be held valid.” Parks v. Booth, 102 U.S. 96, 104 (1880).”

Merely requiring that one of skill in the art have the

capability to combine the teachings of the prior art

references fails to give any consideration to whether one

of skill in the art would, without the patent, know to do

so. The merits of an invention can lie in just recognizing

that the claimed combination can be made even though in

hindsight the invention was simple and its making well

within the capability of one of skill in the art.”

* Cantrell v. Wallick, 117 U.S. 689, 694 (1886) (rejecting “theory that

a patent cannot be valid unless it is new in all its elements as well as

in the combination, if it is for a combination” because “no patent for an

improvement on a known contrivance or process could be valid” under

that theory (citations omitted)); Parks, 102 U.S. at 102; Gould v. Rees,

82 U.S. 187, 189 (1872); Seymour v. Osborne, 78 U.S. 516, 542 (1870);

see also Imhaeuser v. Buerk, 101 U.S. 647, 660 (1879).

” Accord Panduit Corp., 810 F.2d at 1575 (“The notion ... that

combination claims can be declared invalid merely upon finding

similar elements in separate prior patents would necessarily destroy

virtually all patents and cannot be the law under the statute, § 103.”);

Connell, 722 F.2d at 1549.

* The poet Milton described that phenomenon over three centuries

ago: “The invention al] admired, and each how he To be the inventor

missed; 80 easy it seemed, Once found, which yet unfound most would

have thought, Impossible!” Paradise Lost, Part VI, L. 478-501 (quoted

-24-

Acknowledging that, and the consequent need to consider

whether the combination would have occurred to one of

skill in the art, this Court has explained:

[I]t often requires as acute a perception of the

relation between cause and effect, and as much of

the peculiar intuitive genius which is a

characteristic of great inventors, to grasp the idea

that a device used in one art may be made

available in another, as would be necessary to

create the device de novo. And this is not the less

true if, after the thing has been done, it appears to

the ordinary mind so simple as to excite wonder

that it was not thought of before. The apparent

simplicity of a new device often leads an

inexperienced person to think that it would have

occurred to any one familiar with the subject; but

the decisive answer is that with dozens and

perhaps hundreds of others laboring in the same

field, it had never occurred to any one before. The

practiced eye of an ordinary mechanic may be

safely trusted to see what ought to be apparent to

As a result of the authorities upon this subject,

it may be said that, if the new use be so nearly

analogous to the former one that the applicability

of the device to its new use would occur to a person

of ordinary mechanical skill, it is only a case of

double use; but if the relations between them be

remote, and especially if the use of the old device

produce a new result, it may at least involve an

exercise of the inventive faculty.

in Gillette Co. v. S.C. Johnson & Son, Inc., 919 F.2d 720, 726 (Fed. Cir.

1990)).

-25-

C. & A. Potts & Co., 155 U.S. at 607-08.”

Petitioner's suggested test of merely determining

whether one of skill in the art would have the capability

to make the claimed combination—without considering

whether there is any evidence to show that one of skill

would have had the motivation to make the

combination—fails to consider the standard pronounced

in C. & A. Potts of whether the combination “would occur

to a person of ordinary mechanical skill.” It also fails to

heed the statute’s command that the invention must be

viewed as a “whole.” A necessary component of the

“whole” is knowing that elements can be combined to

create the “whole.” The capability of physically combining

items or teachings in the prior art does not show that one

of skill in the art would have recognized that the “whole”

could even have veen made from the prior art.”

The alternative test suggested by one of the amici of _

applying a rebuttable presumption that one of skill in the

art would be motivated to combine the teachings of the

prior art where the references are analogous art also fails

to consider whether the thought of the combination would

occur to one of skill in the art. It erroneously presumes

that the thought would be there. Accordingly, it suffers

the same deficiencies as the petitioner’s proposed test and

should not be adopted.

The Federal Circuit recently suggested in DyStar that

* See also Diamond Rubber Co. v. Consolidated Rubber Tire Co., 220

U.S. 428, 434-35 (1911); Barbed Wire Patent, 143 U.S. 275, 282-83

(1892).

” E.g., Hobbs v. Beach, 180 U.S. 383, 393 (1901) (“the mere change in

shape of the dies was a minor part of the work ... the invention

consisting rather in the idea that such change could be made, than in

making the necessary mechanical alterations”) (emphasis added),

Loom Co. v. Higgins, 105 U.S. 580, 591 (1881) (“Now that [the

inventor) has succeeded, it may seem very plain to any one that he

could have done it as well. This is often the case with inventions of the

greatest merit.”); see also Panduit Corp., 810 F.2d at 1572 (“The

statute requires utility, novelty and nonobviousness, not complexity.”).

=o

the capability of one of ordinary skill to combine teachings

of prior art references occasionally may supply the

requisite motivation to combine. DyStar, slip op. at 21, __

F.3d at _, 2006 WL 2806466, at *11. Importantly,

however, the court qualified its statement with a

companion requirement for a presence of a technology-

independent economic driving force motivating one of skill

in the art to seek a product or process that could be

“stronger, cheaper, cleaner, faster, lighter, smaller, more

durable, or more efficient.” Jd. In that context—economic

motivation for a product or process having certain

improved advantages plus technical capability to modify

the technology to achieve the advantage—it can, in many

circumstances, make sense to find an implicit motivation

to combine teachings of prior art references in a way that

will obviously realize the sought after advantage. Absent

the economic driving force, it would not make sense to

presume that just because one of skill in the art had the

technical capability to combine the teachings of the prior

art, he or she would have thought to do so. Hence, the

Federal Circuit’s statement in DyStar should not be

viewed as endorsing the petitioner’s suggested test that

mere capability, even in the absence of a technology-

independent economic driving force, suffices to prove that

it would have been obvious to combine teachings of prior

art references.

Ill. SYNERGY SHOULD NOT BE THE TEST FOR

HOLDING A COMBINATION PATENT VALID

The petitioner and some of the amici supporting the

petitioner suggest that statements in Sakraida, 425 U.S.

at 282, and Anderson’s-Black Rock, Inc., 396 U.S. at 61,

noting the absence of a “synergistic effect” in the claimed

invention, should apply as a special definitive test for

determining validity of combination patents. Imposing a

requirement of synergy is not warranted and would

virtually destroy the patent system.

-27-

A. The Text of § 103 Does Not Support a Synergy

Requirement

The plain language of § 103 shows that an analysis for

obviousness must focus on the “differences between the

subject matter sought to be patented and the prior art” to

determine whether “the subject matter as a whole would

have been obvious at the time the invention was made to a

person having ordinary skill in the art to which said

subject matter pertains.” 35 U.S.C. § 103(a) (emphasis

added). Notably, the statute does not say that the

“differences” between the subject matter sought to be

patented and the prior art must include a new result

produced by the claimed invention. Nor does it state that

to be unobvious the subject matter must produce a new

result. Accordingly, the deliberate” absence of a “new

result” requirement in the text of § 103 strongly suggests

that one should not be read into the statute.” Barnhart v.

Sigmon Coal Co., 534 U.S. 438, 454 (2002) (refusing to

* One of the principal drafters of § 103 stated: “Weight should be given

to the terms used in the section since a variety of expressions used in

decisions were available, including some stated with an extreme

degree of strictness, which could have been used as the model for the

phraseology to be adopted, but the language selected was of the more

moderate variety.” FEDERICO, “COMMENTARY ON THE NEW PATENT Act”

at 23, reprinted in 75 J. PAT. & TRADEMARK OFF. Soc’y at 183.

” Many things can be unobviously different, but produce the same

result. Indeed, this is why in analyzing infringement under the

doctrine of equivalents this Court has required a showing that the

same function is performed in the same way to achieve the same result,

and rejected contentions that infringement should be found where only

the same result is achieved. Graver Tank & Mfg. Co. v. Linde Air

Prod. Co., 339 U.S. 605, 608 (1950); Weber Elec. Co. v. E.H. Freeman

Elec. Co., 256 U.S. 668, 675 (1921). Given the relationship between

validity and infringement as exemplified by the maxim “that which

[literally] infringes if later, anticipates if earlier,” Peters v. Active Mfg.

Co., 129 U.S. 530, 557 (1889), a principle that infringement cannot be

found merely because the same result is achieved suggests that

invalidity should not be found merely because the same result is

achieved.

- 28 -

read into statute provisions that Congress could have

“clearly and explicitly” included but did not); Bradley v.

Richmond Sch. Bd., 416 U.S. 696, 716 n. 23 (1974) (“We

are reluctant to read into the statute the very ...

limitation that Congress eliminated.”); see also Park 'N

Fly, Inc. v. Dollar Park & Fly, Inc., 469 U.S. 189, 194

(1985) (“Statutory construction must begin with the

language employed by Congress and the assumption that

the ordinary meaning of that language accurately

expresses the legislative purpose.”).

Furthermore, the Patent Act requires a “new and

useful” criterion as a condition for patentability under

only the utility requirement of 35 U.S.C. § 101,” a

patentability requirement separate and distinct from

unobviousness under § 103. Diamond v. Diehr, 450 U.S.

175, 191 (1981). Under traditional rules of statutory

construction, where Congress has included a requirement

in one statutory provision and omitted it in another, it is

to be presumed that the omission was intentional.

Barnhart, 534 U.S. at 452. Hence, the presence of a “new

and useful” requirement in §101 counsels against

construing §103 to include a requirement that a

combination patent must provide a synergistic effect.

B. A Synergy Requirement Is Contrary to the

Legislative Purpose of § 103

The legislative history of § 103 does not expressly

state that the changes made by the statute legislatively

overruled a synergy requirement. But one of the principal

authors of the statute has stated that that was the intent

of § 103. Addressing how the reasoning of the majority

and concurring opinions in Great Atlantic & Pacific Tea

Co. v. Supermarket Equipment Corp., 340 U.S. 147 (1950),

prompted the drafting committee to develop a new

* 35 U.S.C. § 101 limits patentable subject matter to a “new and

useful process, machine, manufacture, or composition of matter, or any

new and useful improvement thereof .. .”

- 29 -

standard for determining patentability to replace the

“invention” standard, Judge Rich commented that “what

was said in the opinions [was] typical of all that was

wrong with the patent law’s ‘invention’ requirement.”

Rich, Ghost,, 1 APLA Q.J. at 32, reprinted in 14 Fed. Cir.

B.J. at 168-69.

Judge Rich explained that the new patentability

standard provided in § 103 overruled Great A & P to the

extent that case required that special rules, such as

synergy, apply to combination patents.“ With § 103, the

drafters intended to establish a uniform standard

applicable to all classes of invention without requiring

synergy. Id. at 32-33, reprinted in 14 Fed. Cir. B.J. at

169-70.

Addressing the apparent resurgence of a synergy

requirement based on dictum in Anderson’s-Black Rock,

Inc., 396 U.S. 57, Judge Rich again noted that synergy is

“an impossible test, so Section 103 was enacted to replace

it.” He stated:

Now what was the dictum in Black Rock that

bugs people? Well, it was the very idea expressed

in A & P which stimulated the enactment of

Section 103 to supplant it, but which, unhappily, is

still current dogma in some courts, namely, that

inventions which are a combination of old elements

must be tested for patentability (formerly for

“invention” now for unobviousness) by an extra

severe test—more severe than the test for

inventions of other kinds. A & P spoke of the

“difficulty and improbability of finding invention in

an assembly of old elements" and said the whole

must in some way exceed the sum of its parts to

produce unusual or surprising consequences. That

“ See also P.J. Federico, Origins of Section 103, 5 APLA Q.J. 87, 95

(1977) (the Great A&P case “served to stimulate” the committee

meetings that resulted in the new patentability standard of § 103).

- 30 -

is the “severe test.” It was indeed severe—it was

an impossible test, so Section 103 was enacted to

replace it.

Congress in Section 103 threw down the gauntlet

to these notions by substituting a different test—

the obviousness test—applicable to all inventions

alike. Since then no justification can be found for

treating one kind of invention differently from

another.

... 1 doubt that any trial lawyer, ever, is going to

be able to meet the “strict test” implicit in the

following two unfortunate sentences of the Black

Rock dictum:

A combination of elements may result in an

effect greater than the sum of the several

effects taken separately. No such

synergistic result is argued here.

The laws of physics and chemistry in accordance

with which all inventions perform do not permit of

the judicially imagined magic according to which 2

+ 2=5. Wherever such a spurious test prevails all

patents are invalid. And there are those who

think that is heaven.

Rich, Ghost, 1 APLA Q.J. at 43-44, reprinted in 14 Fed.

Cir. B.J. at 177-78.

Given that a synergy requirement presents an almost

impossible requirement to meet, has no basis in the text

of § 103, and was intended to be eliminated by the

enactment of § 103, it should not be adopted.

CONCLUSION

For al] the above reasons, the use of the MST test

should be upheld.

DAVID E. KORN

Of Counsel

PHARMACEUTICAL

RESEARCH AND

MANUFACTURERS

OF AMERICA,

950 F Street, NW

Washington, DC

20004

(202) 835-3509

Respectfully submitted,

ALLEN M. SOKAL

Counsel of Record

ROBERT A. MATTHEWS, JR.

FINNEGAN, HENDERSON,

FARABOW, GARRETT &

DUNNER, L.L.P.

901 New York Ave., N.W.

Washington, DC 20001

(202) 408-4000

Attorneys for Amicus Curiae

Pharmaceutical Research and

Manufacturers of America