Reply Brief — Warner-Jenkinson Co. v. Hilton Davis Chemical Co.

Supreme Court brief1997

Ask Donna

What actually matters in this document.

Text

Y Supreme Court, U.S. 7

n FILE

0 D

JUN 13 1995

No. 95-728

In THE

Supreme Court of the United States

OCTOBER TERM, 1995

WARNER-JENKINSON COMPANY, INC.,

Petitioner,

Vv.

HILTON Davis CHEMICAL Co..

Respondent.

On Writ of Certiorari to the

United States Court of Appeals

for the Federal! Circuit

REPLY BRIEF FOR PETITIONER

H. BARTOW FArR, III

(Counsel of Record)

RICHARD G. TARANTO

FARR & TARANTO

2445 M Street, NW

Washington, DC 20037

(202) 775-0184

J. ROBERT CHAMBERS

KuRT L. GROSSMAN

Woop, HERRON & EVANS

2700 Carew Tower

Cincinnati, OH 45202

WILSON - Eras Printing Co., Inc. - 789-0096 - WASHINGTON, D.C. 20001

TABLE OF CONTENTS

Page

ee Se oi ii

Re RE TE A ee Bk Rl, 4

2. The Agency-Approved Patentee’s Own Descrip-

tion of the Invention as Defining Patent Scope.. 5

PIB MD: BASING at OPE A BG RGN ll

> SPM Witsincsicbisitesustcuulisenchacliiattibitlletenitihiaiaiitia: iittala ahi 14

a asin 20

FI TIIET assiindpnscrcnntcbinsstindeashoonennniiaeanasaniamaaindmmeasibedion 20

TABLE OF AUTHORITIES

Cases Page

Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd.,

927 F.2d 1200 (Fed. Cir.), cert. denied, 502 U.S.

a ceemipeesemmemnnnecnss 18

Aro Mfg. Co., Inc. v. Convertible Top Replacement

Co., Inc., 365 U.S. 336 (1961) .. 4

Asgrow Seed Co. v. Winterboer, 115 s. Ct. 7188

Ea Se 17

Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489

a reeeemenieseneremes 2,9

Claude Neon Lights, Inc. v. E. Machlett & Son, 36

F.2d 574 (2d Cir. 1929), cert. denied, 281 U.S.

741 (1930) ... i Vr

Exhibit Supply Co. 1 v. . Ace Patents ‘Corp., B15 U.S.

126 (1942) . 10

Genentech, Ine. v. », Wellcome Fada. Ltd., 29 F.3d 1555

(Fed. Cir. 1994) ... 18

Graver Tank & Mfg. Co. ' v. », Linde Air Products Co., “

EE passim

1.7.S. Rubber Co. v. Essex Rubber Co., 272 U.S.

EE 11

In re Bell, 991 F.2d 781 (Fed. Cir. 1998) i ia 18

In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995) ........... 18

Keystone Bridge Co. v. Phoenix Iron Co., 95 U.S.

ET 7

Laitram Corp. v. NEC Corp., 62 F.3d 1388 (Fed.

Se 12

Markman v. Westview Instruments, Inc., 116 8. Ct.

EE passim

Markman v. Westview Instruments, Inc., 52 F.3d

967 (Fed. Cir. -— aff'd, 116 8S. Ct. 1384

(1996) .. 6

PPG Industries, ‘Ine. v. ». Guardian Industries Corp.

75 F.8d 1558 (Fed. Cir. 1996) ............................... 12

Scripps Clinic & Research Fdn. v. Genentech, Inc.,

927 F.2d 1565 (Fed. Cir. 1991) ............................ 17

Smith v. Magic City Kennel Club, 282 U.S. 784

IE 11

Sutter v. Robinson, 119 U.S. 580 (1886) —.............. 10

Transmatic, Inc. v. Gulton Industries, Inc., 53 F.3d

I eeiennmennns 12

iii

TABLE OF AUTHORITIES—Continued

Page

U.S. Industrial Chemicals, Inc. v. Carbide & Car-

bon Chemicals Corp., 315 U.S. 668 (1942) 7,8,9,10

Constitution and Statutes

U.S. Const., Art. I, § 8, cl. 8 0 9

Biotechnological Process Patents, Pub. L. No. 104-

41, 109 Stat. 351 (1995) 00. 17

Patent Act of 1952, 35 U.S.C. _

| ETE Te Ses eee SSE EE 18

AS seidaanseneiatiaiien 9

| RT ee ee ee i)

EE ee eee 1, 14, 16

§ 154(b) 19

Ee ee ee 19

ee eee 17

ES ee ee ae eee 17

ee eee 7

$271 (a) 1

TERE en ee ee 17

Plant Variety Protection Act, 7 U.S. C. § 2321 et

SS iiiceiersecretetestiiininniacideiiecieniasieaaaraeeiiaei aanaalaalaieas 17

Rev. Stat. § 4916 abies ee ae I 7

Administrative Materials

TET ae a eee 17

PTO, Manual of Patent Examining Procedure (6th

ed. 1995)

i 18

§ 2420 . 17

§ 2421 et seq. saideaidahdenicladaaieineideeadeelanmmidas nae 17, 18

PTO, Setting the Course for Our Future (Fiscal

Year 1995 Review)... 18

FTC, Anticipating the 21st Century: Competition

Policy in the New High-Tech, Global Market-

SD WI TIE cccsssiisscenttescstetendeaennieuteceeisteenitiesc etna 15, 16

REPLY BRIEF FOR PETITIONER

TABLE OF AUTHORITIES—Continued

when _ The Patent Act’s cause of action for infringement pro-

W. Soa, os 4 aim = tects against unauthorized use of the patentee’s “inven-

D. Chisum, Patents (1995) tion.” 35 U.S.C. § 271(a). The question in this case is

II cscs snnccsnccneccconncsenencensenencencnnennennenconecs 17 how the scope of the “invention” is to be determined.

A) ne seseeesnenenssnecsasennesnceees 11 | Our position is that the invention protected by the fed-

0 i | eral patent monopoly cannot go beyond what the patentee

sey) : has told the PTO (and hence the public) its invention is.

Jasna. eee ° Whether limited to the claim portion of the patent (fairly

R. Ellis, Patent Claims (1949) en 14 | read in full context), or permitted to point to the whole

Hantman, Doctrine of Equivalents, 70 J. Pat. & - patent and its documented history for clearly disclosed

Trademark Off. Soc’y 511 (1988) .. equivalents of claim elements, the patentee may not in an

Ko, An Economic a arte Dicteshnclegy Po 17.18 infringement suit invoke as its invention something not

naan festa of Patent ~ FRD. 43 ; asserted as the invention before the PTO. This view

estates le Berea eee Ayers: Sean 13 reflects the statute’s central principles that it is up to the

Merges & Nelson, On the Complex Economics of | patentee, in its disclosures made to and approved by the

Patent Scope, 90 Colum. L. Rev. 839 (1990)........ 15 expert agency, to define the invention for which the fed-

Seide & Szanto, Drafting Claims for Biotechnology eral monopoly is granted '; that the public is entitled to

Inventions, in Fifth Annual Patent Prosecution rely on a reading of those disclosures, and not undertake

Workshop: Advanced Claim and Amendment independent scientific experiments, to understand clearly

Writing (1995) ........ ye 17 the scope of the monopoly *; and that the basic “bargain

hei Patenting Gene Sequences, ‘ |

: Trademark Off. Soc’y 121 (1996) ee 18 1 See, e.g., 85 U.S.C. $112 (patent applicant must “distinctly

Slutsker & Churbuck, Whose Invention Is It Any- claim[]” what he “regards as his invention”); id. § 131 (if “the

way? Forbes (Aug. 19, 1991) —........... 16 alleged new invention” meets statutory requirements, the PTO must

Swanson, A Discussion of the Application of the See & Se ee en &

an hy hae gy tty + ag v. Linde 13 | that an applicant must claim ‘the subject matter which the applicant

regards as his invention.’” (emphasis added) ).

2 See Pet. Br. 16-23; Markman v. Westview Instruments, Inc.,

116 S. Ct. 1384, 1396 (1996): “As we noted in General Elec. Co.

Vv. Wabash Appliance Corp., 304 U.S. 364, 369 (1938), ‘[t]he

limits of a patent must be known for the protection of the patentee,

the encouragement of the inventive genius of others and the assur-

ance that the subject of the patent will be dedicated ultimately to

the public.’ Otherwise, a ‘zone of uncertainty which enterprise and

experimentation may enter only at the risk of infringement claims

would discourage invention only a little less than unequivocal fore-

closure of the field,” United Carbon Co. v. Binney & Smith Co.,

317 U.S. 228, 236 (1942), and ‘[t)he public [would] be deprived of

rights supposed to belong to it, without being clearly told what it

held out by the federal patent system [is] disclosure in

exchange for exclusive use.” Bonito Boats, Inc. v. Thun-

der Craft Boats, Inc., 489 U.S. 141, 159 (1989); id. at

149-51. Under this standard, determining the scope of

the patent is a matter of reading and interpreting docu-

ments to discern what the patentee has asserted and what

it has surrendered, a task that, when performed in in-

fringement litigation, is well within the traditional func-

tion of judges. See Markman, 116 S. Ct. at 1395.

The Federal Circuit, in fundamental disagreement, held

that the scope of the protected “invention” is not deter-

mined by interpreting the patentee’s own statement of its

invention. After such interpretation is exhausted, the

inquiry—first undertaken by other inventors and market

participants trying to avoid infringement, later under-

iaken by a finder of fact in adjudicating infringement—

then proceeds to an independent assessment of the scien-

tific facts to determine what changes from the patentee’s

asserted invention would make a “substantial difference.”

Under this standard, the invention awarded to the pa-

tentee is not limited to what the patentee has defined

through the statutory PTO processes for issuing (or re-

issuing) patents, but instead is defined in court through

factual determinations, even allowing recapture of cov-

erage the patentee dropped in the PTO to obtain the

patent, all based on a reassessment in the infringement

action of what the patentee could have claimed. In the

present case, the Federal Circuit applied its standard to

hold that a patentee who has throughout its patent dis-

closed a chemical process with clearly stated limits (e.g.,

a pH of approximately 6.0 or more), and included those

limits at the unchallenged insistence of the PTO, never-

theless was entitled to a monopoly on a process that con-

cededly falls outside any fair interpretation of those stated

limits, even though the patent nowhere suggests that the

repeatedly stated limits were unimportant to the process.

is that limits these rights.’ Merrill v. Yeomans, 94 U.S. 568, 573

(1877).”

The Federal Circuit's view shou!d be rejected in favor

of confining patent scope to what the patentee has said

its invention is. The Federal Circuit's view does not fol-

low from this Court’s decision in Graver Tank & Mfg.

Co. v. Linde Air Products Co., 339 U.S. 605 (1950), or

other precedents. It cannot be reconciled with the stat-

ute’s fundamental requirement that patentees circumscribe

their patent monopolies by the disclosures made to and

approved by the PTO, so that other inventors, market

competitors, and the public can understand with clarity

and without costly independent experimentation where

each such monopoly ends. And it would largely undo

this Court’s recent decision in Markman, where the Court

insisted that the job of interpreting claim language be

carried out so that “‘[t}he limits of a patent [are]

known,’ so that there is no “ ‘zone of uncertainty which

enterprise and experimentation may enter only at the

risk of infringement,’ so that the public is “ ‘clearly told

what it is that limits’” its rights. 116 S. Ct. at 1396.

Those objectives would immediately be defeated by hold-

ing that the actual “ ‘limits of a patent’” protected in an

infringement action extend beyond the interpretation of

the patent’s claims to an invention nowhere disclosed by

the patentee but defined in litigation under an inherently

uncertain “substantial differences” standard.*

* Although Hilton Davis suggests otherwise (Resp. Br. 11), we

do not understand this Court in Markman to have decided the

issue presented in this case (which was already accepted for review,

but not yet argued or fully briefed) by its passing quotation from

a Federal Judicial Center publication that sketches the outlines

of the lower court case law under review here. 116 S. Ct. at 1388

(“ “the heart of the invention’”). That reference formed no part

of the rationale of Markman, which in fact strongly points the

other way in its reaffirmation of the patent statute’s condemnation

of uncertainty about patent scope. Moreover, as Hilton Davis

recognizes (Resp. Br. 24 n.24), this Court has broadly rejected the

“heart of the invention” notion, specifically in the context of “com-

bination” claims like the example cited by this Court (116 S. Ct.

at 1388 n.1): “there is no legally recognizable or protected ‘essen-

tial’ element, ‘gist’ or ‘heart’ of the invention in a combination

|. Facts. Notwithstanding Hilton Davis’s several at-

tempts to relitigate the facts and to walk away from its

earlier correct concession of no literal infringement (Resp.

Br. 2-5 & n.4, 31 n.30), the facts of the case as it comes

to this Court—found by the jury, amply supported by

the evidence, and accepted by the courts below—are not

properly in dispute. “Warner-Jenkinson’s process operated

at... a pH of 5.” Pet. App. 4a.* Hilton Davis’s patent

claims expressly require a pH of at least “approximately

6.0.” J.A. 36-37. Hilton Davis conceded below that the

meaning of its claim words does not encompass Warner-

Jenkinson’s process: e.g., the pH levels differ by a factor

of 10, with the different acidity levels made possible by

different chemical compositions of the dye solutions being

filtered. The jury was not even presented with an issue

of literal infringement. See Pet. Br. 4-5.

Hilton Davis added the pH limit to the originally sub-

mitted patent claims by amendment, at the specific behest

of the PTO, so as to secure issuance of the patent. See

Pet. Br. 3-4. And no lower pH level is asserted to be

within the invention anywhere else in the lengthy descrip-

tion of the invention in the patent, which contains nu-

merous references to pH levels, all at least 6. See Pet.

Br. 5 n.6. Moreover, Hilton Davis’s patentee gave testi-

mony showing that this limit was no accident: when the

claimed filtering process was applied to industrial-size

volumes of the dye solution, lower pH levels would cause

patent.” Aro Mfg. Co., Inc. v. Convertible Top Replacement Co., Inc.,

365 U.S. 336, 345 (1961). In any event, Markman says nothing

about the sources for determining the scope of the invention: what

the patentee has disclosed and what it has surrendered; or inde-

pendent factual inquiry.

*Hilton Davis relies for a contrary assertion entirely on the

testimony of a witness who said that, on a visit to Warner-

Jenkinson’s plant, he saw four filtering machines, one of which was

not in operation, and one of the machines had a pH reading of 6.

See Resp. Br. 4-5 n.4, ultimately relying on J.A. 121. The same wit-

ness, however, when asked if it was the machine that was shut down

for cleaning (filled with cleaning solution rather than dye) that had

a pH of 6, acknowledged: “Could have been.” J.A. 122.

“tremendous foaming problems in the plant.” J.A. 111.

In short, the “invention” awarded to Hilton Davis in this

suit—with infringement found without questioning Warner-

Jenkinson’s independent development of its process—was

concededly one not asserted as the invention anywhere

in the patent, and, indeed, one deliberately dropped dur-

ing the application process in order to obtain the patent.°

2. The Agency-Approved Patentee’s Own Description

of the Invention as Defining Patent Scope. In our open-

ing brief, we argued that the “invention” protected against

infringement should reach no farther than what the pat-

entee asserted as its invention through the prescribed

PTO-approval processes, i.e., no farther than the fair

meaning of the patent claims plus substantive equivalents

disclosed as such in the remainder of the patent (and its

documented history). See Pet. Br. 38-41; see also Pet.

Br. 34-37 (surrender as part of disclosure standard). We

also argued that, if the Court were to reach the question

whether patent scope should ever extend beyond the

fair meaning of the patent claims (which it need not),

the Patent Act would be best construed to preclude

such an extension. Pet. Br. 41-49. In either event, we

argued, the Federal Circuit’s standard was deeply incom-

patible with the statutorily prescribed role of precise

“claiming” of the boundary of the protected invention

through prescribed agency processes. Pet. Br. 13-31.

a. Hilton Davis seeks to deny this basic incompat-

ibility. Resp. Br. 18-19. But its denial is devoid of any

explanation, relying instead only on its overreading of

Graver. Ibid. The inconsistency, moreover, has been

widely and repeatedly recognized precisely to the extent

that, as Hilton Davis must positively insist, the Federal

Circuit’s doctrine of equivalents extends patent scope

5 The jury rejected Hilton Davis’s charge of willful infringement

(J.A. 69), and the court of appeals accepted “Warner-Jenkinson’s

lack of intent” and “evidence of independent development” (Pet.

App. 20a).

beyond where the claim’s meaning leaves off. Resp. Br.

42-43.°

As a correct caution against crabbed construction of

patentees’ language, there is no such incompatibility. See

4 D. Chisum, Patents § 18.04[1][a][i], at 18-74 (1995)

(“Viewed as an aid to claim construction, as a prescrip-

tion against sterile literalism in construction and applica-

tion of claim language, the doctrine of equivalents is fully

consistent with the notion that the claim measures the

scope of the patent monopoly.”), quoted in part at Litton

Br. 11. But once the doctrine is not “so limited,” once

the meaning of words is left behind for expansion of

patent scope beyond those meanings, it is well recognized

that “a tension exists between the doctrine and the funda-

mental notion that the claim measures the scope of the

patent monopoly” (id. at 18-78). See also id. § 18.04,

at 18-73 (doctrine is “contrary to the general principle

that the claims measure the scope of the patent monop-

oly”); Pet. Br. 20-21, 43-45 (quoting numerous sources);

Claude Neon Lights, Inc. v. E. Machlett & Son, 36 F.2d

574, 575 (2d Cir. 1929), cert. denied, 281 U.S. 741

(1930) (doctrine “anomalous” for this reason). And a

similar tension obviously exists between a standard re-

quiring independent experimentation and factual inquiry

in court to determine the scope of the protected “inven-

tion” and the basic decision of the federal patent law,

made toward the end of the Ninteenth Century, to shift

onto the Patent Office and the patentee, and away from

the courts and the public, the duty to define the protected

* Here, it was correctly conceded by Hilton Davis, and accepted

below, that a pH of “approximately 6.0” cannot, as a matter of

English-language and scientific meaning, encompass a pH of 5

(which is ten times as acidic). The en banc Federal Circuit, having

reaffirmed in the Markman case that claims are to be given a fair

construction in their full documentary context and held that this

task was one for judges (Markman v. Westview Instruments, Inc.,

52 F.3d 967, 979-81 (1995), aff'd, 116 S. Ct. 1884 (1996) ), held in

this case that the determination of equivalents is—precisely be-

cause it involves going beyond the meaning of the words of claims—

a quite different task, requiring a factual determination by juries.

invention. Keystone Bridge Co. v. Phoenix Iron Co., 95

U.S. (5 Otto) 274, 278-79 (1877); see Pet. Br. 17.

b. Contrary to Hilton Davis’s unelaborated assertion

(Resp. Br. 21; see also U.S. Br. 27), the Federal Cir-

cuit’s decision effectively circumvents the careful limits

set by Congress in granting the PTO authority to reissue

a patent with broadened claim language—authority re-

stricted to making the new claim language reflect “the

invention disclosed in the original patent” (35 U.S.C.

§ 251). This Court recognized in Keystone that expan-

sion of patent scope beyond claim language was in reality

a substitute for the reissue process. 95 U.S. at 278 (“If

the patentees have not claimed the whole of their inven-

tion, and the omission has been the result of inadvertence,

they should have sought to correct the error by a sur-

render of their patent and an application for a reissue.” ).

Moreover, this Court’s leading modern precedent on re-

issue confirms that the “invention” is limited to what the

Original patent asserted and is not to be determined by a

later independent inquiry into whether scientific facts

make the original disclosure unduly narrow.

In U.S. Industrial Chemicals, Inc. v. Carbide & Carbon

Chemicals Corp., 315 U.S. 668 (1942) (cited at Resp.

Br. 45), this Court held that a reissued patent was in-

valid because it was not “for the same invention” (Rev.

Stat. § 4916, predecessor of 35 U.S.C. § 251) as the

original patent. The original patent claims and specifica-

tion described a process in which the introduction of

water was required, whereas the reissued claims treated

the introduction of water as noncritical. 315 U.S. at 671-

75. The Court held that the claims were not “for the

same invention,” based on its “comparison of the dis-

closures of the two instruments.” 315 U.S. at 675, 671

(emphasis added). The Court explained that it was not

enough that, as a matter of scientific fact, the change made

no difference in substance: the “invention” was limited to

what the initial patent clearly disclosed. /d. at 676-80.

The Court explained that the invention of the original

patent was only what was “intended or sought to be

covered or secured by the original patent” and that “[t}he

required intention does not appear if the additional matter

covered by the claims of the reissue is not disclosed in

the original patent.” /d. at 676 (footnotes omitted).

That the patentee knew more than it said was irrelevant:

If there be failure of disclosure in the original patent

of matter claimed in the reissue, it will not aid the

patentee that the new matter covered by the reissue

was within his knowledge when he applied for his

original patent. And it is not enough that an inven-

tion might have been claimed in the original patent

because it was suggested or indicated in the specifica-

tion. It must appear from the face of the instrument

that what is covered by the reissue was intended to

have been covered and secured by the original.

Ibid. (footnotes omitted). Nor was it relevant that both

lower courts, based on expert testimony, had found that

the change in the process (omission of water) was “im-

material” (id. at 677), “not essential to the technological

success of the process” (id. at 679), and that the patentee

knew this “when he applied for his original patent.” /d.

at 677. “The inquiry at once arises, if this were so, why

did he not say so.” /bid. The disclosure, rather than in-

court scientific evidence, determines the “invention” pro-

tected by the patent: “It is inadmissible to enlarge the

scope of the original patent by recourse to expert testimony

to the effect that a process described and claimed in the

reissue, different from that described and claimed in the

Original patent, is, because equally efficacious, in substance

that claimed originally.” /d. at 678 (footnote omitted).

The Federal Circuit’s holding that the protected inven-

tion is to be scientifically defined in court cannot com-

fortably co-exist with U.S. Industrial Chemicals. That

decision established—before the 1952 Act—that the “in-

vention” protected by a patent claim is limited to what

the patent on its face discloses as the invention, and the

scientific immateriality of an element asserted to be part

of the invention throughout the specification, even if that

immateriality was known to the patentee, does not change

the protected invention to more than what was clearly dis-

closed. If courts are to look beyond the meaning of the

patent claims, U.S. Industrial Chemicals makes clear that

they may look no further than the full patent for what

the patentee said its invention was.

c. Not surprisingly, Hilton Davis’s efforts to point to

supposedly contrary precedent fail. See Resp. Br. 30

n.29; see also Litton Br. 13. None of the cited precedents

repudiates the central importance of disclosure, as recog-

nized in U.S. Industrial Chemicals. Nor do any of the

cited decisions contradict the necessarily implied require-

ment—which this Court has repeatedly stated—that any

newly asserted equivalent must have been known to be

so when the patent issued. See 4 D. Chisum, Patents

§ 18.04[3], at 18-17 to 18-125 (surveying Court’s prece-

dents stating this requirement; contrary rulings by the

Federal Circuit, not this Court); Pet. App. 126-130a.

Limiting non-literal infringement to what is disclosed

by the patentee serves fundamental patent policies. The

core principle that patentees gain protection only for

“their . . . Discoveries” (U.S. Const., Art. I, § 8, cl. 8)—

for what they figured out that was “novel” and “non-

obvious” (35 U.S.C. §§ 102, 103)—makes it difficult to

encompass within the protected “invention” anything ex-

cept what the patentee knew was equivalent to its claim.

And the basic statutory bargain of “disclosure in ex-

change for exclusive use” (Bonito Boats, 489 U.S. at

159), together with the long-recognized compelling need

for clear public notice of the scope of patents (see note

2, supra), justifies limiting the patentee’s protected “in-

vention” to what it disclosed as part of the invention,

so that other inventors need not conduct independent ex-

periments even to figure out the scope of the patentee’s

menopoly. Here, without such experiments, no one could

have known whether, when industrial volumes of dye were

used (cf. Resp. Br. 5 n.5, 34 n.24), the filtering process

would function equivalently with a pH of less than ap-

proximately 6.0. In the absence of the rules that, in

Graver, restricted patentees’ ability to write sufficiently

protective claims (see Pet. Br. 33 n.26), patentees today

are broadly able to make clear disclosures of their inven-

tions. In these circumstances, if a patentee later asserts

that the invention “really” encompasses more than was

stated, “(t]he inquiry at once arises, if this were so, why

did he not say so.” U.S. Industrial Chemicals, 315 U.S.

at 677.

d. One aspect of the principle that the patentee’s pro-

tection is limited to what it asserted as its invention be-

fore the PTO is the long-recognized principle that a

patentee may not recapture through the doctrine of

equivalents what it provably dropped from its asserted

coverage by narrowing amendments made at the insist-

ence of the PTO, because such amendments constitute

a surrender of coverage that makes clear what was not

part of the asserted (and approved) invention. See Pet.

Br. 34-37. The Federal Circuit rejected this limit, hold-

ing instead that a court in an infringement suit must

independently reevaluate the reason for the documented

surrender to decide whether the patentee actually could

have secured approval for the patent without the drop-

ping of coverage—even though the patentee did not

pursue appeals from any rejections of coverage it believed

erroneous. Hilton Davis briefly defends that ruling, but

its defense plainly fails. Resp. Br. 33-34.

Hilton Davis relies entirely on two decisions of this

Court as support for the Federal Circuit’s rule (Resp.

Br. 33, citing Sutter v. Robinson, 119 U.S. 530, 541

(1886), and Exhibit Supply Co. v. Ace Patents Corp.,

315 U.S. 126, 136-37 (1942)), but neither of the two

decisions, nor any other decision of which we are aware,

anywhere says that a documented dropping of coverage

at the behest of the PTO is to be subjected to a judicial

reevaluation in an infringement suit, so that such surren-

ders may be reversed if they were not after all legally re-

quired. This Court has in fact rejected such a judicial

reexamination, stating that a patentee who is “dissatisfied

with the rejection [of a broader claim by the PTO]...

should pursue his remedy by appeal; and where, in order

to get his patent, he accepts one with a narrower claim,

he is bound by it. Whether the examiner was right or

wrong in rejecting the original claim, the court is not to

inquire.” 1.7.8. Rubber Co. v. Essex Rubber Co., 272

U.S. 429, 443 (1926) (citations omitted); Smith v.

Magic City Kennel Club, 282 U.S. 784, 789-90 (1931).

Core patent policies powerfully support this simple rule

of surrender: the public must be able to rely on the docu-

mented record, and the patentee has ample means of self-

protection, including rights of administrative and judicial

appeal from improper rejections.’

. 3. Graver. Hilton Davis, like the Federal Circuit, re-

lies heavily on the notion that the 1952 Patent Act in-

corporated a broad doctrine of equivalents based on

Graver. Resp. Br. 11-15. But it has no convincing an-

swer to our showing that Graver itself is consistent with

the much narrower doctrine, based on a strict disclosure-

* The discussion of the issue by the United States, which omits

any reference to this Court’s precedents (U.S. 20-23), illustrates

how uncertain patent boundaries would be if judicial reexamination

of the reasons for undisputed, documented surrenders were per-

mitted. The United States states initially that this doctrine of

prosecution history estoppel “prevents a patentee from obtaining,

through the doctrine of equivalents, protection that he could not

have obtained, or that he refrained from obtaining, from the PTO

at the time the patent was issued.” U.S. Br. 20 (emphasis added).

It then suggests, however, that a court in an infringement suit

may allow equivalents protection for what a patentee demonstrably

refrained from obtaining” depending on the reason for the drop-

ping of coverage before the PTO. But while the United States

indicates that avoidance of prior art counts as a good enough rea-

son to preclude equivalents protection, it is unclear about when

an inadequate specification is a good enough reason. U.S. Br. 22-23

(“should not necessarily estop”) (emphasis added). The United

States does not seem to speak to the problem of inoperativeness

of the “equivalent” process as a reason—a very different “enable-

ment” problem from the problem of merely insufficient explanation.

See : D. Chisum, Patents §§ 7.03[6], [7] (c) (1995). The evidence

in this case was that pH levels below 6.0 caused “tremendous foam-

ing” problems that, as far as Hilton Davis was aware, made the

filtration process unworkable for its industrial purposes.

in-the-patent standard, that we have suggested. Pet. Br.

31-34. For that reason, and because Graver must be

read in light of the long line of decisions of this Court

on the role of claims and what the “invention” is, includ-

ing those noted above, Graver cannot support the conclu-

sion that the 1952 Congress codified a doctrine of equiva-

lents like that adopted by the Federal Circuit.”

Unsurprisingly, the other precedents to which Hilton

Davis points are equally unsupportive of a broad, gener-

ally available doctrine expanding patent scope beyond

claim language that is required to give clear public no-

tice. See Resp. Br. 11, 22, 25; Litton Br. 9-10. The

earlier decisions come from an era when, as this Court

has recognized, the role of claims—and hence their draft-

ing and interpretation—was critically different: they were

not understood to define with precision the outer reaches

of patent scope. See Markman, 116 S. Ct. at 1390.° The

8 Although Graver stated memorably that “[o]utright and forth-

right duplication is a dull and very rare type of infringement”

(339 U.S. at 607), we do not understand how the statement sup-

ports a broader standard of nonliteral infringement: a high rate

of violation is usually not viewed as an indication of the success

or appropriateness of a legal standard. In any event, today literal

infringement cases are not rare—or, as far as we know, rarer than

nonliteral infringement cases. Among the most recent cases see,

e.g., PPG Industries, Inc. v. Guardian Industries Corp., 75 F.3d

1558 (Fed. Cir. 1996) ; Laitram Corp. v. NEC Corp., 62 F.3d 1388

(Fed. Cir. 1995); and Transmatic, Inc. v. Gulton Industries, Inc.,

58 F.3d 1270 (Fed. Cir. 1995). Appellate judges would seem likely

to see a disproportionately small share of cases of “outright and

forthright” infringement, which are most likely not to be pursued

to that advanced stage of litigation.

® The Court in Markman noted the evolving importance of patent

“claims” in the Nineteenth Century: “Although, as one historian

has observed, as early as 1850 ‘judges were . . . beginning to express

more frequently the idea that in seeking to ascertain the invention

“claimed” in a patent the inquiry should be limited to interpreting

the summary, or “claim,”’ ‘[t}he idea that the claim is just as

important if not more important than the description and drawings

did not develop until the Act of 1870 or thereabouts.’” 116 S. Ct.

at 1390 (citations omitted). That change in role for claims makes

a -

more recent decisions, including all those from the 20th

Century, rejected infringement findings for the very rea-

sons we have urged, or involved the question whether to

restrict potentially broad claim language that often used

phrases like “substantially as described” to refer to the

narrower description found in the specification. In the

latter cases, rather than invalidate the patent claim as

insufficiently supported by the specification, this Court,

as a matter of construction or otherwise, narrowed the

patent’s coverage based on the specification. See, e.g.,

Koykka, Infringement of Patents, 42 F.R.D. 43, 59-63

(1967); Hantman, Doctrine of Equivalents, 70 J. Pat.

& Trademark Off. Soc’y 511, 521-40 (1988); id. at 539

(discussing Sanitary Refrigerator specifically and noting

breadth of claim language). That approach, whatever its

current validity (Pet. Br. 45 n.31), preserves rather than

defeats the ability of the public to rely on claim language

as the clear outer boundary of forbidden territory and

reinforces the central principle that patent scope is lim-

ited to the patentee’s disclosures in the patent. In short,

by the time of Graver, there was no modern precedent of

the Court that would have demanded overruling in order

for the Court finally to announce, based on the Court’s

numerous precedents on the monopoly-defining role of

patent claims, that patent scope could not be expanded

beyond the meaning of the claims. See Pet. Br. 43-45

(quoting articles from period). Graver is the only sig-

nificant precedent, and it is consistent with our proposed

disclosure standard."

inapposite earlier authorities calling for in-court definition of

inventions without restriction to a fair interpretation of the lan-

guage of claims—language that was, in any event, comparatively

uninformative until the latter 1800s. See Pet. Br. 15-16, 43-46.

In the absence of any such express repudiation by this Court,

there were of course some lower court precedents invoking the

doctrine of equivalents to expand claims, but even those decisions

were comparatively few in number and—unlike the Federal! Circuit

decision here—treated the doctrine as exceptional, not routinely

available to go beyond claim language. See Swanson, A Discussion

Even if this Court were to consider whether patent

scope should ever exceed the fair meaning of valid patent

claims, as Graver held permissible, Graver is not suffi-

cient to compel an affirmative answer. The statute en-

acted by the 1952 Congress textually and structurally

implies a commitment to agency-approved claims as the

outer limits of the protected invention; pertinent legisla-

tive history reflects no endorsement of Graver but sug-

gests a deliberately narrow use of “equivalents,” in a

context of interpreting certain “functional” claim language

(35 U.S.C. § 112 (paragraph 6)); and Graver was well

understood to be anomalous in light of a long line of this

Court's decisions on claims as the limit of protection.

See Pet. Br. 13-31, 42-45. But even if the 1952 Act is

not read as repudiating Graver’s recognition of patent-

scope expansion beyond claim language, it certainly can-

not be understood as codifying such a doctrine: at most,

it left this judicially created doctrine in the hands of this

Court for continued consideration of its coherence in the

overall patent regime. Nothing about what Congress did

in 1952, or since, deprives this Court of the freedom to

abandon the doctrine if it turns out, as the Federal Cir-

cuit has now held, that the doctrine cannot be narrowly

cabined so as to preserve the basic role of agency-

approved disclosures in furnishing clear public notice of

the scope of patent monopolies."

4. Policy. The basic policy issue in this case is

whether it is possible to institutionalize the sort of flexi-

of the Application of the Doctrine of Equivalents in the Graver v.

Linde Case, 33 J. Pat. Off. Soc’y, 19, 31 (1951); R. Ellis, Patent

Claims 11-12, 41-42, 59-60 (1949).

™ Our opening brief noted some of the post-1952 enactments by

Congress that reaffirm the need for clear public notice of what

territory is covered by valid patents. Pet. Br. 23-24. Hilton Davis

cites some post-1952 amendments to the Patent Act, including the

addition of “offers to sell” to the infringement provision (Resp.

Br. 15), but there is no suggestion—and we know of no evidence—

that Congress ever considered what the protected “invention” is

when enacting any such provisions.

bility as to patent scope adopted by the Federal Circuit

to deal with individual instances of inadequate claim

drafting—a “substantial differences” standard applied in

litigation—without systemic undermining of the statutory

recognition of the public’s need for clear notice of patent

boundaries, supplied through agency-approved, patentee-

drafted disclosures. Hilton Davis has not remotely shown

how to accomplish such a feat, much less how to do so

consistent with the intrinsic need to ensure that patent

protection does not stifle innovation.” Any such showing

is all the less likely under the disclosure standard we

have set forth, which looks beyond the language of claims

themselves to see whether the patentee has clearly asserted

equivalents of the claimed invention in the more expan-

sive and less constraining sections of the patent. Ulti-

mately, the systemic statutory commitment to known

patent boundaries simply cannot survive any standard

that would allow a pH of 5 to be found part of a patent

that was deliberately limited throughout to pH levels of

approximately 6.0 or more (for reasons that could not be

determined without independent experimentation ).

12 The recently issued FTC Report, summarizing considerable

literature and extensive public hearings, reiterated that overbroad

patent scope can be the enemy of both competition and innovation

and that there is no reasonable consensus on how much protection is

too much, which may, in fact, vary from field to field. FTC, Antici-

pating the 2ist Century: Competition Policy in the New High-Tech,

Global Marketplace ch. 6, ch. 8 at 12-17 (May 1996). “ “We often

talk about how important patents are to promote innovation, because

without patents, people don’t appropriate the returns to their

innovation activity ....On the other hand, some people jump from

that to the conclusion that the broader the patent rights are, the

better it is for innovation, and that isn’t always correct, because

we have an innovation system in which one innovation builds on

another. If you get monopoly rights down at the bottom, you may

stifle competition that uses those patents later on, and so .. . the

breadth and utilization of patent rights can be used not only to

stifle competition, but also have adverse effects in the long run

on innovation. We have to strike a balance.” Jd. Ch. 6, at 6

(quoting Joseph Stiglitz, chairman of Council of Economic Ad-

visers). See also Merges & Nelson, On the Compler Economics

of Patent Scope, 90 Colum. L. Rev. 839 (1990).

Two amicus briefs defend the Federal Circuit’s stand-

ard of nonliteral infringement by arguing that the stand-

ard is needed to ensure “proper” protection for biotech-

nology inventions. Chiron Br. 14-18; Biotech. Ind. Org.

Br. 7-10. But it is hardly possible in this case to decide

whether the asserted problem is even a legitimate prob-

lem, i.e., whether biotechnology patents are narrower than

they should be (so as to reward true invention that would

not otherwise have been forthcoming, without stifling sub-

sequent improvements that may be just as important);

and whether biotechnology inventors who can describe

their inventions well enough to say what is new and to

“enable” others to make them in their full asserted scope

(35 U.S.C. § 112 (paragraph 1)) nevertheless are unable

to “claim” what they have invented to capture that scope.”

18 There is considerable debate over the proper scope of patent

protection in biotechnology: some commentators have suggested

that overprotection has stifled important improvements. See, e.g.,

FTC, Anticipating the 21st Century, ch. 6 at 3-4, ch. 8 at 13-14

(FTC Staff Report, May 1966); Slutsker & Churbuck, Whose

Invention Is It Anyway?, Forbes, Aug. 19, 1991, at 114 (“Overly

broad patents discourage innovation by making it hard for inventors

to come along and make an idea even more useful. .. . In case

after case, latecomers to the protein research lose their court chal-

lenges and walk away from their research.”); Ko, An Economic

Analysis of Biotechnology Patent Protection, 102 Yale L.J. 777,

779, 790 n.98 (1992) (research dropped and deterred).

The examples offered by amici raise obvious questions about

whether a genuine problem exists, and suggest the importance of

carefully attending to just what the patentee has discovered or

invented when analyzing the asserted inadequacies of “claiming”

practice. If the patentee’s invention is an isolated protein, with

the patentee having discovered the amino acid sequence, then the

claim may state the amino acid sequence; and it is irrelevant that

there is “redundancy” in the genetic code. See BIO Br. 8-9; Chiron

Br. 15-16. If what the patentee has done is to identify and isolate

a “particular gene,” i.e., one special “sequence of DNA that encodes

for a particular protein” (Chiron Br. 15), then it is unclear why

the patentee’s monopoly should extend beyond that sequence. Simi-

larly, it is not clear why a patent claim for one protein should be

protected against a different protein—‘“later discovered” by some-

one else—simply because, unbeknownst to the patentee, it had “func-

tionally identical biological properties” (Chiron Br. 18). See Ko,

What is possible to decide here is that, if the problems

in this particular field are real, their solution lies else-

where—other than in a generally applicable, broad doc-

trine of equivalents that undermines the need for clear

notice of patent scope in all fields.

If distinctive statutory rules for biotechnology inven-

tions are needed, Congress has shown itself more than

able to write them, having repeatedly written special rules

for piants (35 U.S.C. § 162 (softening Section 112 dis-

closure requirement); see also Plant Variety Protection

Act, 7 U.S.C. § 2321 et seq.; Asgrow Seed Co. v. Winter-

boer, 115 S. Ct. 788 (1995)) as well as for modern bio-

technology inventions (e.g., 35 U.S.C. §§ 156(a)(5)(B)

and 271(e); Biotechnological Process Patents, Pub. L.

No. 104-41, 109 Stat. 351 (Nov. 1, 1995)). In any

event, the scope of patentable inventions, the proper

means of drafting patent claims, and other potentially

distinctive problems in biotechnology are the subjects of

continuing and active administrative and judicial atten-

tion; and flexibility of claiming in this area is anything

but foreclosed. See, e.g., 37 C.F.R. § 1.821 et seq.;

PTO, Manual of Patent Examining Procedure (MPEP)

§$ 2420 et seq. (6th ed. 1995); Seide & Szanto, Drafting

Claims for Biotechnology Inventions, in Fifth Annual

Patent Prosecution Workshop: Advanced Claim and

Amendment Writing 357-492 (1995).% It is through

supra, at 785 (“[A) single amino acid change at a critica! locus can

dramatically alter the shape of the protein, nullifying the protein's

original function or creating an entirely new function. Because this

relationship between structure and function remains unpredictable,

creating an improved second generation protein may be as daunting

a task as producing the first generation recombinant protein.) ; 2

D. Chisum, Patents § 5.04[6], at 5-429, 5-430 & n.5.1 (1955) (“Be-

cause of the unpredictable nature of chemical reactions, a newly-

synthesized compound may be very similar in structure to known

and existing compounds and yet exhibit very different properties.” ;

“Similar problems concerning the impact of unpredictability are

encountered in the field of biotechnology.” ).

%# An extensive review of biotechnology patent claims is con-

tained in Seide & Szanto, supra, at 438-56. See also Scripps Clinic

continuation of that focused process—rather than an

across-the-board doctrine of equivalents that may be par-

ticularly unsuited to biotechnology (see Ko, supra, at

791)—that issues about further flexibility or breadth in

the definition of particular protected inventions should be

resolved. The expert agency (and the courts on review)

can thereby address the problems of the particular sub-

ject, judging with respect to any unique problems of

biotechnology and for particular types of inventions (e.g.,

a protein, an isolated gene sequence, a process) what

language will simultaneously capture the patentee’s con-

tribution to technology and provide sufficient notice to

other researchers of the scope of the territory monopolized

by the patentee. Such targeted clarifications, moreover,

establish settled and reliable understandings about how

particular inventions may be patented. Those subject-

specific, expert-based, and stabilizing means of defining

“proper” patent protection in this area make reliance on

any special problems in biotechnology insufficient to

& Research Fdn. v. Genentech, Inc., 927 F.2d 1565, 1572 (Fed.

Cir. 1991) (“Open-ended claims are not inherently improper... .

They may be supported if there is an inherent . . . upper limit

and the specification enables one of skill in the art to approach that

limit.”); Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927

F.2d 1200, 1214 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991)

(court “dofes] not intend to imply that generic claims to genetic

sequences cannot be valid where they are of a scope appropriate

to the invention disclosed by an applicant”); Jn re Dewel, 01 F.3d

1552 (Fed. Cir. 1995); In re Bell, 991 F.2d 781 (Fed. Cir. 1993) ;

Genentech, Inc. v. Wellcome Fdn. Ltd., 29 F.3d 1555 (Fed. Cir.

1994); Sheiness, Patenting Gene Sequences, 78 J. Pat. & Trade-

mark Off. Soc’y, 121, 123, 124 (1996) (“many patents have issued

containing broad claims that encompassed variants and alleles’).

The PTO has required standardized computerized submissions

for biotechnology patents (37 C.F.R. § 1.821; MPEP § 2421 et seq.),

for the same reason that it has made significant (statutorily man-

dated) efforts to ensure ease of access to patents through computer-

ized and other search mechanisms (see 35 U.S.C. § 41(i); MPEP

§ 902 et seq.; PTO, Setting the Course for Our Future 26-27 (Fiscal

Year 1995 Review) ): recognition of the need of inventors and busi-

nesses to be able to determine with clarity the boundaries of forbid-

den territory before they expend potentially vast resources in their

own efforts to innovate and to compete in the marketplace.

justify a universally available, inherently uncertain stand-

ard for in-court definition of all inventions through a

broad doctrine of equivalents."

The inescapable addition of substantial systemic uncer-

tainty as to patent boundaries (cf. Chiron Br. 19-20

(noting claim construction not perfectly precise) ) is not

the only problem with Hilton Davis’s policy argument for

departing from the meaning of the patent disclosure,

which rests ultimately on an appeal to fairness and

the basic patent-law policy of providing an adequate

reward for the patentee’s contribution to knowledge. See

Resp. Br. 27, 35. The argument also is one-sided and

misstates the patent statute’s policy. The patent scheme’s

fundamental judgment to accept present monopoly returns

in exchange for promoting innovations that would not

otherwise occur has no direct application in a case of

independent (and simultaneous) development. W. Bow-

man, Patents and Antitrust Law 17 (1973) (if “a patent

monopoly were granted for a product which would have

been forthcoming anyway, then the restricted output

caused by the patent monopoly leads to a net social loss

to the community”). And Hilton Davis cannot simul-

taneously insist on a uniform patent scope and on de-

partures from the patent disclosures based on fairness to

patentees “who have failed to express their complete

% Amici appear to suggest that requiring care in claiming may

overburden the PTO and delay issuance of biotechnology patents.

Chiron Br. 8; BIO Br. 9-10. But the alternative is to impose on

the marketplace and then the courts the burdens of clarifying the

scope of patents issued with less care—patents that, in the mean-

time, also deter economically beneficial competition and improve-

ments within the zone of uncertainty. As for concern about the

application process eating up substantial portions of the new 20-

year-from-filing term of patents (replacing the former 17-years-

from-issuance term), most biotechnology patents seem to be issued

only slightly more slowly than other patents, and in under three

years, see Sheiness, supra, at 136-37); the term may be extended

to account for successful appeals from adverse PTO decisions (35

U.S.C. § 154(b)); and special extensions are prescribed for certain

biotechnology inventions (id. § 156). Of course, problems in term

length can be addressed again, if necessary, by Congress.

meaning” (Claude Neon Lights, 36 F.2d at 576), for

any invocation of fairness requires consideration of the

defendant's equities as well: here, substantial investment

to arrive independently at the process the plaintiff seeks

to monopolize despite its omission from the patent. A

uniform, known patent scope demands adherence to the

patent’s disclosures as the definition of the patent

monopoly.

5. Judge or Jury. Hilton Davis's final argument is

that juries rather than judges should apply the doctrine of

equivalents. Resp. Br. 36-50. This argument, however,

is completely dependent on this Court’s accepting the gen-

erally applicable “substantial differences” standard of the

Federal Circuit, which calls for what the patentee in-

vented to be defined by scientific testimony about what

was technologically important or unimportant to the in-

vention. A standard that, in contrast, limits the “inven-

tion” to what the patentee disclosed is plainly a matter

for application by judges, as the interpretation of patent

documents is at the core of judges’ traditional role and

expertise. See Markman, 116 S. Ct. at 1395.

CONCLUSION

The judgment of the court of appeals should be

reversed.

Respectfully submitted,

H. BARTOW Fark, III