Amicus Curiae Brief — Warner-Jenkinson Co. v. Hilton Davis Chemical Co.

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BEST AVAILABLE COPY

opie Supreme Court, U.S,

ets FILED

____No. 95-728 ——_| ___ war 18 19%

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

BRIEF OF AMICUS CURIAE

CHIRON CORPORATION IN SUPPORT OF

RESPONDENT

DONALD S. CHISUM

Counsel of Record

RACHEL KREVANS

Sue C. HANSEN

Emeryville, California 94608 § STEPHEN B. THAU

(510) 655-8730 MORRISON & FOERSTER LLP

345 California Street

: San Francisco, California 94104

(415) 677-7000

Counsel for Amicus Curiae

Chiron Corporation

Bowne of San Francisco, Inc., Law Printers (415) 362-2300 E Ii

iv

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TABLE OF CONTENTS

I. THE BIOTECHNOLOGY INDUSTRY

DEPENDS ON A HEALTHY DOCTRINE

OP TRPUVALGIOTS «once cc ccccccs.

A. Industries and Inventors Rely on the Doc-

trine: Abolition or Limitation Would Be a

Drastic Change in Patent Law that

Should Be Made, If at All, by Congress

B. Loss of the Doctrine Would Be a Step

Backwards in the Movement to Provide

Effective International Patent Protection

C. The Doctrine of Equivalents Is Integral to

United States Patent Law and Is Compat-

ible with Particular and Distinct Claiming

D. The Public Interest in Biotechnology

Development Would Be Impaired If the

Doctrine Were Eliminated or Cut Back

E. Equivalents Must Include Later-Discov-

ered Equivalents.....................

F. Absolute Certainty in Claim Interpre-

tation Is an Unattainable Goal.........

10

1]

li

TABLE OF CONTENTS

Page

Il. DETERMINATION OF INFRINGEMENT

UNDER THE DOCTRINE OF EQUIV-

ALENTS IS A QUESTION OF FACT,

BASED ON OBJECTIVE CRITERIA,

THAT MUST BE TRIED TO THE JURY 2!

A. Infringement Is a Question for the Jury 21

B. The Existence of Infringement by

Equivalents Should Be Based on Objec-

dct nccewhaesebeeeccescsece 24

Ill. AS MOST APPLICATIONS ARE

AMENDED, ADOPTING PETITIONER'S

POSITION ON PROSECUTION HIST-

ORY ESTOPPEL WOULD RESULT IN A

DE FACTO ELIMINATION OF THE

DOCTRINE OF EQUIVALENTS........ 26

SEE CAG FG obn be d6ecasesviosdescewes 30

EE OE OT Teer eer Tree ee la

iil

TABLE OF AUTHORITIES

CASES

Page(s)

Amgen, Inc. v. Chugai Pharmaceutical Co.,

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

eS ecg etiecocces 15, 16-17

Autogiro Co. of Am. v. United States,

ee, GE Me ccecccescoscccccs 20

Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve,

Inc., 796 F.2d 443 (Fed. Cir. 1986), cert. denied,

| 8

Bischoff v. Wethered,

76 U.S. (9 Wall.) 812 (1870) ................ 23

Brothers v. United States,

ned cadnbccseeeeeedex 19

Burr v. Duryee,

68 US. (1 Wall.) S31 (1063) .........0eeeee: 21

Chiron Corp. v. Abbott Labs., Inc.,

902 F. Supp. 1103 (N.D. Cal. 1995) ......... 2,9n.2

Continental Paper Bag Co. v. Eastern Paper Bag

in 6.5 see edensecesens 5-6, 19

Credle v. Bond,

25 F.3d 1566 (Fed. Cir. 1994) ................ 13

Eibel Process Co. v. Minnesota & Ontario Paper

OED onccccedeceseccoceees 8,13

Exhibit Supply Co. v. Ace Patents Corp.,

TN eid h ot cekndscnseees 27

Fiers v. Revel,

984 F.2d 1164 (Fed. Cir. 1993) ............... 15

Graver Tank & Mfg. Co. v. Linde Air Prods. Co.,

CR a re 28

Graver Tank & Mfg. Co. v. Linde Air Prod. Co.,

Be Gs EY CED a hoses ccscceces 5, 21, 25 n.11, 28

iv

TABLE OF AUTHORITIES

CASES

Page(s)

Haynes Int'l, Inc. v. Jessop Steel Co.,

8 F.3d 1573 (Fed. Cir. 1993), on rehg,

15 F.3d 1076 (Fed. Cir. 1994) .............. 26 n.12

Hilton Davis Chems. Co. v. Warner-Jenkinson Co.,

62 F.3d 1512 (Fed. Cir. 1995) ...... 23 n.8, 23 n.9, 25

Hoechst Celanese Corp. v. BP Chem. Lid.,

78 F.3d 1575 (Fed. Cir. 1996) .............05- 19, 20

Hoganas AB v. Dresser Indus., Inc.,

9 F.3d 948 (Fed. Cir. 1993) ...........0555. 26 n.12

Hughes Aircraft Co. v. United States,

717 F.2d 1351 (Fed. Cir. 1983) ..............- 9, 27

1.T.S. Rubber Co. v. Essex Rubber Co.,

SD Bs Ge SE Gc evbbuccecccetccoouagss 27

In re Angstadt,

$37 F.2d 498 (C.C.P.A. 1976) ............555. 7,9

In re Bell,

991 F.2d 781 (Fed. Cir. 1993) .............055. 2, 16

In re Brana,

$1 F.3d 1860 (Fed. Cir. 1995) ............54.- 9n.2

In re Deuel,

Be fF Fe eee 2

In re Ochiai,

71 F.3d 1565 (Fed. Cir. 1995) ..............4.. 9 n.2

In re Wands,

858 F.2d 731 (Fed. Cir. 1968) ................ 17

Kewanee Oil Co. v. Bicron Corp.,

Ge Te ee eh bedicncncccsedstictodns 9

Machine Co. v. Murphy,

AOS fo Seen 21, 22

Vv

TABLE OF AUTHORITIES

CASES

Page(s)

Markman v. Westview Instruments, Inc.,

64 U.S.L.W. 4263 (U.S. Apr. 23, 1996) ...... 6, 21, 23

Miles Labs., Inc. v. Shandon, Inc.,

997 F.2d 870 (Fed. Cir. 1993), cert. denied,

EE ie dive cdanansasesec< 13,19

Musher Found., Inc. v. Alba Trading Co.,

150 F.2d 885 (2d Cir.), cert. denied,

dee carat eeseweee ce 27-28

North Am. Vaccine, Inc. v. American Cyanamid

Co., 7 F.3d 1571 (Fed. Cir. 1993), cert. denied,

en OEN cee vedivesses 13

Pall Corp. v. Micron Separations, Inc.,

Fs br Re | Tere 27

Royal Typewriter Co. v. Remington Rand, Inc.,

168 F.2d 691 (2d Cir.), cert. denied,

eS oa co eck eeckeaceees 12-13

Royer v. Schultz Belting Co.,

i 22

Sanitary Refrigerator Co. v. Winters,

EY 6, 21

Smith v. Magic City Kennel Club, Inc.,

Ee Pe ows cc oweccene 27

TSC Indus., Inc. v. Northway, Inc.,

OE ee 7

Texas Instruments, Inc. v. United States Int'l Trade

Comm'n, 805 F.2d 1558 (Fed. Cir. 1986) ...... 19

Tilghman v. Proctor,

EE in oc ede tendeetsecesesve 18

Transmatic, Inc. v. Gulton Indus., Inc.,

53 F.3d 1270 (Fed. Cir. 1995) ................ 7

vi

TABLE OF AUTHORITIES

CASES

Page(s)

Tucker v. Spalding,

80 U.S. (13 Wall.) 453 (1872) ............... 23-24

Tyler v. Boston,

74 US. (7 Wal.) 327 (IGGB) .. wc ccccccesess 22

Winans v. Denmead,

56 U.S. (15 How.) 330 (1853) ............... passim

CONSTITUTIONS, STATUTES AND REGULATIONS

Se i Es UR indcncecescecesses set 11

ST TT eee 8

TT TT ee 8

Be Cee non pecans ccvecscasibe 8, 12 n.5, 13, 28-29

FP ee ED chi cecssdeccdesctbevenan 12 n.5, 24

BP Ce chee cdicecntcvectede ste 25 n.10

Be Cy RR i dune vee édcbiebebdeseneceeal 25 n.10

37 C.F.R. $§ 1.821 et seq. (1995) ............... 16 n.7

Pub. L. No. 103-465, tit. V, § 532(a)(1), 1994

U.S.C.C.A.N. (108 Stat.) 4809 (1994) ........ 8

MISCELLANEOUS

141 Cong. Rec. S7300-01 (daily ed. May 24, 1995) .. 14

141 Cong. Rec. S15221 (daily ed. Oct. 17, 1995) .. 14

2 D. Chisum, Patents (rev. ed. 1995)......... 8, 29 n.13

K. Drlica, Understanding DNA and Gene Cloning:

A Guide for the Curious (2d ed. 1992) ........ 141.6

T. Takenaka, New Policy in Interpreting Japanese

POD c vcdectbucdscancosveauachenemadsen 10, 16

vii

TABLE OF AUTHORITIES

U.S. Department of Commerce, Patent &

Trademark Office, Manual of Patent Examining

Procedure (rev. ed. Sept. 1995)............... 16 n.7

U.S. General Accounting Office, /ntellectual

Property Rights: U.S. Companies’ Patent

Experiences in Japan, GAO/GGD-93-126

SLED Sn cud bec tdnecusese cs 7, 8,9, 10 & n.4, 26

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

BRIEF OF AMICUS CURIAE

CHIRON CORPORATION IN SUPPORT OF

RESPONDENT

STATEMENT OF INTEREST

Founded in 1981 by scientists at the University of Califor-

nia, Chiron Corporation (“Chiron”), with more than seven

thousand employees, is the world’s largest biotechnology

company. Chiron applies biotechnology and other tech-

niques of modern biology to develop products intended to

lower the overall cost of healthcare and improve the quality

of life by diagnosing, preventing, and treating disease. To

carry out this mission, Chiron invests heavily in biological

2

research. Last year, Chiron spent over $300 million on

research and development; in the past five years, Chiron’s

research and development expenditures averaged nearly

40 percent of its annual revenues. Chiron’s inventions in-

clude the first genetically engineered vaccine for hepatitis B,

the first drug to treat multiple sclerosis, blood tests used

worldwide to screen donated blood for HIV (the virus that

causes AIDS) and hepatitis C virus, drugs to treat cancer,

and a genetically engineered form of the whooping cough

vaccine which eliminates the risks to children of the tradi-

tional vaccine.

As do other biotechnology companies, Chiron depends on

patent protection to achieve adequate returns on its research

outlay to encourage stockholder investment. Chiron now

owns over two thousand United States and foreign patents.

Chiron has also taken a lead role in litigating issues related

to biotechnology patent protection, including both infringe-

ment actions against companies that seek to use its patented

technologies without a license and appeals from Patent and

Trademark Office (“PTO”) decisions related to issues of

patentability for biotechnology inventions. See, e.g., Jn re

Bell, 991 F.2d 781 (Fed. Cir. 1993); Chiron Corp. v. Abbott

Labs., Inc., 902 F. Supp. 1103 (N.D. Cal. 1995); cf In re

Deuel, 51 F.3d 1552 (Fed. Cir. 1995) (appearing on behalf

of Amici). From its vantage point on the cutting edge of

biotechnology law, Chiron has a unique perspective on the

necessity of the doctrine of equivalents to ensure adequate

protection for biotechnology inventions.

SUMMARY OF ARGUMENT

The doctrine of equivalents fills a critical role in United

States patent law. Since at least 1853, inventors, industries,

‘Written consent to the filing of this brief has been obtained from

Petitioner and Respondent, and is lodged herewith.

3

and their patent counsel have benefited from the application

of the doctrine to “temper the unsparing logic” of literal

infringement. By deterring infringement through insubstan-

tial alterations to a patented invention, the doctrine has

protected inventors’ intellectual property rights and ensured

fair returns on their investments in innovation, without

creating uncertainty about the scope of patents.

The biotechnology industry and the consumers of the

industry’s medical innovations benefit from a healthy appli-

cation of the doctrine of equivalents. Patent protection for

biotechnological inventions has attracted investment capital

to the industry, making possible the research necessary to

discover and develop life-saving and life-improving medical

treatments at a time when public funding for research is on

the decline. Because of peculiar features of biotechnology

inventions, and because of the law that the Federal Circuit

has developed to deal with those inventions, the doctrine of

equivalents is crucial to protect biotechnology inventions

adequately. Without such patents, however, the industry

would be unable to attract investment, and could not con-

tinue the research necessary to develop new treatments and

save lives.

Biotechnology patents also illustrate the need for the

doctrine of equivalents to protect patentees’ property rights

against loss from alterations found to be equivalent after a

patent is filed. Biotechnology presents two such problems.

First are modifications that have no effect on an invention,

such as certain substitutions of one amino acid for another

in a_ large protein molecule. Allowing _later-

discovered modifications such as these to avoid infringement

could obliterate the value of an inventor’s patent grant.

Second are improvements that build upon an invention,

adding additional features or properties. In the case of

improvements, the improvement itself may be patentable.

4

That fact, however, should not limit the rights of the

inventor whose basic invention is being exploited.

The loss of the doctrine of equivalents, or a substantial

reduction in its scope, would be a serious blow to the

biotechnology industry’s viability. It would not, however,

provide the certainty in claim interpretation that Petitioner

seeks. Inherent limits in the ability of language to describe

“the heart of an invention” preclude absolute certainty

regarding the scope of patent claims, even in cases of literal

infringement. Without the doctrine of equivalents, patent

attorneys would attempt to protect against insubstantial

alterations to an invention by blurring the borders of their

claims, making literal infringement determinations even

more difficult. Moreover, if patent attorneys could no longer

rely on the doctrine of equivalents, the number of claims per

patent would rise, as would the complexity of each claim.

Parties seeking to determine whether they infringe a patent

would be buried in an avalanche of information, and would

have more difficulty drawing conclusions about infringement

than they do today.

As the brief of the Solicitor General notes, it is the policy

of the United States government to encourage other coun-

tries to adopt a doctrine of equivalents as healthy as our

own. A very recent decision by the High Court in Osaka,

Japan shows that Japanese courts are turning to our view. In

light of the changes occurring internationally, and en-

couraged by the United States, it would be ironic for this

Court now to limit dramatically a doctrine which is recog-

nized as a cornerstone of United States industrial policy.

Anyone who chooses to practice an invention on the

borders of its claims takes a risk. The doctrine of

equivalents, which states only that insubstantial alterations

to an invention will not eliminate infringement, does little to

increase that risk or make it less predictable. Nor does

application of the doctrine by juries. Infringement is, and

5

has always been, a question for the jury. In addition,

application of the doctrine should not depend on equitable

factors. A rule that allowed only “good” plaintiffs to sue

“bad” defendants under the doctrine would promote, rather

than lessen, uncertainty.

Petitioner asks this Court to extend the application of

prosecution history estoppel, a long-established limit on the

doctrine of equivalents, beyond its proper circumstances.

Prosecution history estoppel prevents a patentee from using

the doctrine of equivalents to recapture subject matter that

would not have been patentable over prior art. Petitioner,

however, would find an estoppel whenever there was an

amendment, regardless of its purpose. As most patent appli-

cations are amended, Petitioner’s proposal would amount to

a de facto elimination of the doctrine of equivalents. Such a

rule has no basis in this Court’s decisions and would serve no

useful purpose.

ARGUMENT

I. THE BIOTECHNOLOGY INDUSTRY DEPENDS

ON A HEALTHY DOCTRINE OF EQUIVALENTS.

A. Industries and Inventors Rely on the Doctrine: Abo-

lition or Limitation Would Be a Drastic Change in

Patent Law that Should Be Made, If at All, by

Congress.

The doctrine of equivalents has been an integral part of

the United States patent system for nearly a century-and-a-

half, since this Court decided Winans v. Denmead, 56 U.S.

(15 How.) 330 (1853). In subsequent years, this Court’s

decisions repeatedly affirmed the vitality of the doctrine and

rejected efforts to limit its scope. See, e.g., Graver Tank &

Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608-09

(1950) (collecting cases); Continental Paper Bag Co. v.

Eastern Paper Bag Co., 210 U.S. 405, 415 (1908) (refusing

6

to limit the doctrine’s applicability to “pioneer” inventions).

Just last month, in Markman v. Westview Instruments, Inc.,

64 U.S.L.W. 4263 (U.S. Apr. 23, 1996), this Court again

reiterated the importance of the doctrine, noting that a

patent claim “functions to forbid not only exact copies of an

invention, but products that go to ‘the heart of the invention

but avoid the literal language of the claim by making a

noncritical change.’” Jd. at 4264 (quoting H. Schwartz,

Patent Law and Practice 82 (2d ed. 1995)).

The long-established pedigree of the doctrine of

equivalents puts individuals on notice that “to copy the

principle or mode of operation [described in a patent], is an

infringement, although such copy should be totally unlike

the original in form or proportions.” Winans, 56 U.S. at 342;

see also Sanitary Refrigerator Co. v. Winters, 280 U.S. 30,

42 (1929) (finding infringement “by a device in which there

is no substantial departure from the description in the

patent”). Patentees and accused infringers alike anticipate

that the doctrine will be used to determine questions of

infringement. Patentees rely on the doctrine when drafting

their claims. Patent attorneys, who interpret patent claims

according to familiar rules of patent interpretation, which

include a doctrine of equivalents, apply this law every day to

ascertain properly the scope of a claimed invention. Poten-

tial infringers also must consider the doctrine when evaluat-

ing whether to engage in conduct that may infringe a patent.

The decision to practice a patented invention near the

borders of its claims is a calculated risk, requiring no more

care than in analogous areas of the law. Application of the

“substantial differences” test used by the majority of the

court below in this case is no less certain, for example, than

application of a “reasonableness” test found in ordinary tort

law. Parties must make judgment calls, and patent attor-

neys, schooled in claim interpretation and familiar with the

technology involved in the patent, are eminently able to

7

make such determinations. That they may sometimes be

wrong is no reason to eliminate or severely limit the doc-

trine. They are also sometimes wrong in opining on literal

infringement. See, e.g., Transmatic, Inc. veGulton Indus.,

Inc., 53 F.3d 1270, 1278-79 (Fed. Cir. 1995).

Elimination or limitation of the doctrine of equivalents

would result in a number of predictable adverse conse-

quences. First, patentees, unable to rely on the doctrine of

equivalents, would claim a greater number of variants of

their inventions to attempt to gain protection against insub-

stantial changes. Such additional disclosures could cause an

explosion in the verbiage a patent contains. The Court of

Customs and Patent Appeals noted that “[t]o require such

a complete disclosure would apparently necessitate a patent

application or applications with ‘thousands’ of examples...

along with information as to whether each exhibits [the

property of the invention].” Jn re Angstadt, 537 F.2d 498,

502 (C.C.P.A. 1976). Because the additional information

disclosed would consist of insubstantial variations, there

would be little corresponding public benefit from this disclo-

sure, if any. Instead of reasonable notice of the scope of

claims (including equivalents), competitors would be buried

in “an avalanche of trivial information—a result that is

hardly conducive to informed decisionmaking.” TSC Indus.,

Inc. v. Northway, Inc., 426 U.S. 438, 448-49 (1976) (find-

ing that financial disclosure in too much detail provides

investors less useful information).

Practices in Japan, where patents traditionally have been

subject to narrow literal interpretations, substantiate this

fear. See U.S. General Accounting Office, /ntellectual Prop-

erty Rights: U.S. Companies’ Patent Experiences in Japan,

GAO/GGD-93-126, at 28 (July 1993) (“Under Japanese

patent practice, patent claims are construed as narrowly as

possible.””). Whenever a patent of value is published, com-

petitors of the patentee will file “excessive numbers” of

8

patents claiming minor variations, a practice known as

“patent flooding.” Jd. at 18. Without a doctrine of

equivalents, competitors would do the same in the United

States, to hem in important inventions and extort a cross-

license at an unfair price.

Second, loss of the doctrine of equivalents would provide

added incentive for patentees to blur the boundaries of their

inventions with broadening terms and imprecise adjectives.

See, e.g., Eibel Process Co. v. Minnesota & Ontario Paper

Co., 261 U.S. 45, 66 (1923) (using “substantial” and

“high” to describe a patentable improvement to a

papermaking machine); Bausch & Lomb, Inc. v. Barnes-

Hind/Hydrocurve, Inc., 796 F.2d 443, 450 (Fed. Cir. 1986)

(claiming a “smooth” contact lens), cert. denied, 484 U.S.

823 (1987). See generally 2 D. Chisum, Patents

§ 8.03[3][c] (rev. ed. 1995) (discussing words of degree

and relational terms). Literal infringement analyses, already

difficult, would become more so.

Third, abolition of the doctrine of equivalents would

increase the number of claims per patent, increasing the

burden on an already overworked PTO. During examination,

a patent examiner must evaluate whether each claim is

definite, enabled by the specification, and supported by a

written description. 35 U.S.C. § 112. In addition, the exam-

iner must compare each claim to the prior art to determine

whether the art anticipated or rendered obvious the claim.

35 U.S.C. §§ 102, 103. The additional work created by

vastly greater numbers of claims per patent would increase

the time from the filing of a patent application to issuance of

a patent. The impact on inventors would be exacerbated by

the recent change in the term of patent protection, formerly

seventeen years from the date the patent issues, now twenty

years from the date of filing. Pub. L. No. 103-465, tit. V,

§ 532(a)(1), 1994 U.S.C.C.A.N. (108 Stat.) 4809, 4983-

4984 (1994) (codified as amended at 35 U.S.C. § 154).

9

Biotechnology patents, which now may take eight or ten

years to issue,’ could well take fifteen years instead, leaving

the patentee with only a few years of protection.

If this Court were to limit the doctrine of equivalents,

patents obtained in reliance on the doctrine would become

valueless. Indeed, very few patents are granted with claims

as originally filed. General Accounting Office, supra, at 17;

Hughes Aircraft Co. v. United States, 717 F.2d 1351, 1363

(Fed. Cir. 1983). Many patentees have accepted claim

language amendments suggested by the PTO because cur-

rent law provides adequate coverage and does not create an

estoppel. If any change in the law is appropriate, it should be

made by Congress, which can adopt appropriate

grandfathering legislation.

Lastly, and contrary to the patent law's objective of

encouraging the public disclosure of useful inventions, the

loss of the doctrine of equivalents would inevitably cause

companies to rely more heavily on trade-secret protection

for their inventions. “The interest of the public is that the

bargain of 17 years of exclusive use in return for disclosure

be accepted.” Kewanee Oil Co. v. Bicron Corp., 416

U.S. 470, 489 (1974). Faced with uncertainty that their

patents may be rendered “hollow and useless” by only strict

literal reading, or that prosecution history estoppel would

nullify the doctrine, inventors will be forced to limit disclo-

sure of certain inventions, especially in unpredictable arts

such as biotechnology. See Angstadt, 537 F.2d at 503. The

public interest would suffer from the delay in industry's

ability to build on patented inventions.

*See, eg. In re Ochiai, 71 F.3d 1565, 1566 (Fed. Cir. 1995)

(seventeen years from filing to final rejection by the PTO and three

more years for appeal, which allowed the patent to issue); /n re Brana,

51 F.3d 1560, 1562 & n.2 (Fed. Cir. 1995) (eight years from application

to appeals court decision reversing PTO rejection); Chiron Corp., 902 F.

Supp. at 1108 (eight years from filing to issuance).

10

B. Loss of the Doctrine Would Be a Step Backwards in

the Movement to Provide Effective International

Patent Protection.

It would be ironic for this Court now to cut back the

doctrine of equivalents. As the brief of the Solicitor General

notes, it has been the policy of the United States govern-

ment to encourage other countries to adopt an effective

doctrine of equivalents like our own. Just recently, a deci-

sion by the High Court in Osaka, Japan shows that Japanese

courts are turning to our view. See T. Takenaka, New Policy

in Interpreting Japanese Patents (in press, submitted in the

appendix to this brief).’ Genentech, a large United States

biotechnology company, sued a Japanese pharmaceutical

company for infringing Genentech’s Japanese patents for a

protein called t-PA, which is comprised of a chain of four

hundred thirty-nine amino acids. The Japanese company’s

product differed from Genentech’s claimed invention . by

only one amino acid and functioned almost identically.

Applying traditional Japanese law of infringement, which

focuses exclusively on literal claim language, see Takenaka,

supra, General Accounting Office, supra, at 28, the Japa-

nese trial court found no infringement. In an opinion that

reflects fundamental changes in Japanese patent law, the

Osaka High Court reversed, based on reasoning largely

similar to that of the majority of the Federal Circuit in the

decision below in this case. See Takenaka, supra. That the

rest of the world is adopting policies this Court has long

affirmed emphasizes the soundness of U.S. law.‘

*Dr. Takenaka’s remarks, including her translation of the Japanese

High Court decision that she discusses, will be published in Volume 3,

Issue 2, of the CASRIP Newsletter (Summer 1996).

“In its 1993 study of patent practice in the United States, Europe, and

Japan, the General Accounting Office surveyed over three hundred

companies, including top patent holders in the chemical, semiconductor,

and biotechnology industries. General Accounting Office, supra, at 19.

C. The Doctrine of Equivalents Is Integral to United

States Patent Law and Is Compatible with Particu-

lar and Distinct Claiming.

Since 1853, when this Court decided Winans, the doc-

trine of equivalents has been a necessary and integral part of

United States patent law. In Winans, Justice Curtis, a

former patent practitioner, found the doctrine necessary to

carry out Congress’ constitutional mandate “To Promote the

erty of Science and Useful Arts.” U.S. Const., art. I,

§ 8, cl. 8.

The exclusive right to the thing patented is not

secured, if the public are at liberty to make sub-

stantial copies of it, varying its form or proportions.

And, therefore, the patentee, having described his

invention, and shown its principles, and claimed it

in that form which most perfectly embodies it, is,

in contemplation of law, deemed to claim every

form in which his invention may be copied, unless

he manifests an intention to disclaim some of

those forms.

Winans, 56 U.S. at 343. The Winans majority endorsed the

application of the doctrine in the face of the identical

arguments now raised by Petitioner and several Amici, that

the doctrine of equivalents is inimical to the policy of

providing notice about the scope of patent claims. See id. at

347 (Campbell, J., dissenting).

When aches to commas dieu Ge petent putection Gey mode to

Japan, 41 percent reported significant problems with the narrow scope

given these patents. Only 5 percent, however, criticized the scope of

Lasted States patent protection, which includes the doctrine of

equivalents. /d at 28. Efforts to harmonize the patent laws of the United

States, Europe, and Japan call for Japan to adopt a United States-like

doctrine of equivalents, not vice-versa. Jd at 73 tbl. 6.2.

12

Although the doctrine has never been expressly part of

any of this nation’s Patent Acts,° it plays a fundamental role

in United States patent laws. As Judge Learned Hand

explained:

[A] boundary [in patent claims] cannot be drawn

with precision; and the draftsman of claims is

always in something of a dilemma—the dilemma

which has led to the very “doctrine of equivalents”

itself. ...On the one hand, if he confines himself

rigidly to those elements as they appear in the

specifications, he deprives the patent of any practi-

cal value, because it is always, or almost always,

possible to change the form of these as they

appear, and yet cull the full advantage of the

discovery. On the other hand, if he too much

abandons the elements as they are disclosed, he

will not “particularly point out * * * the part * * *

or combination which he claims”: i.e. he will have

so far generalized the disclosure, that the combi-

nation of any elements which will effect the same

result will be covered. The patent will then pro

tanto stifle progress in the art and be invalid. It is

impossible in practice to emerge from this embar-

rassment without some measure of compromise;

the elements as they appear in the claims must be

clearly enough identified with elements as they

appear in the manifold to be “substantially” lim-

ited by their description, verbal and pictorial. Yet

*The Patent Acts have never expressly proscribed “literal” infringe-

ment either. The relevant section of the current Act says only that

“whoever without authority makes, uses, offers to sell or sells any

patented invention . . . infringes the patent.” 35 U.S.C. § 271(a). The

Act defines “invention” through section 112, which states that an

applicant must claim “the subject matter which the applicant regards as

his invention.” 35 U.S.C. § 112.

13

the claims must be given enough scope to cover

“substantially similar” variants.

Royal Typewriter Co. v. Remington Rand, Inc., 168 F.2d

691, 693-94 (2d Cir.), cert. denied, 335 U.S. 825 (1948).

Petitioner argues that the doctrine of equivalents is in-

compatible with the current Patent Act, particularly with

35 U.S.C. section 112, which requires that a patentee

“particularly point[ ] out and distinctly claim[ ]” his inven-

tion. There is no incompatibility. As the Federal Circuit,

which has special expertise in this area, has explained, a

patentee can only draft claims that are “as precise as the

subject matter permits.” See, e.g, North Am. Vaccine, Inc.

v. American Cyanamid Co., 7 F.3d 1571, 1580 (Fed. Cir.

1993), cert. denied, 114 S. Ct. 1645 (1994); see also Eibel

Process, 261 U.S. at 65-66. It may not be possible to

describe the inventor’s technical concept with absolute pre-

cision, and a patent’s claims will be allowed if they ““reason-

ably apprise those skilled in the art of the scope of the

invention.” Credle v. Bond, 25 F.3d 1566, 1576 (Fed. Cir.

1994) (quoting Miles Labs., Inc. v. Shandon, Inc., 997 F.2d

870, 875 (Fed. Cir. 1993)).

Section 112, then, establishes only a “reasonableness”

standard for claim precision, one that must be evaluated

according to the facts and circumstances of each case. This

“reasonableness” standard would be inconsistent with a

legal regime that did not allow for infringement by

equivalents. No purpose would be served by a requirement

for “reasonable” precision in the description of an invention

if the law also required absolute identity between the claims

and the accused device for a finding of infringement.

14

D. The Public Interest in Biotechnology Development

Would Be Impaired If the Doctrine Were Elimi-

nated or Cut Back.

“The biotechnology industry has been one of the success

stories in U.S. industry, creating new jobs and pioneering

exciting breakthroughs that improve our way of life.” 141

Cong. Rec. $15221 (daily ed. Oct. 17, 1995) (statement of

Sen. Hatch). “In 1994, sales of biotechnology products totaled

close to $8 billion, and the Department of Commerce esti-

mates that biotechnology will be a $50 billion industry by the

year 2000.” 141 Cong. Rec. S7300-01 (daily ed. May 24,

1995) (statement of Sen. Harkin). Biotechnology products

include insulin to treat diabetes, drugs to treat AIDS and

cancer, human growth hormone to treat dwarfism, and diag-

nostic tests to ensure the safety of the world’s blood supply

against viruses such as those causing hepatitis and AIDS.

“The biotechnology industry relies heavily on patent protec-

tion in recouping the costs of bringing new drugs to the

market. Furthermore, adequate patent protection is vital in

persuading investors to provide the necessary capital to the

industry.” 141 Cong. Rec. S15221 (daily ed. Oct. 17, 1995)

(statement of Sen. Hatch). Cutting back the doctrine of

equivalents would devastate the biotechnology industry's ca-

pacity to protect the value of its inventions. Any such change

would dramatically inhibit the industry's ability to conduct the

extensive research and development required to deliver new

life-saving products to the public.

To understand the importance of the doctrine of equivalents

to biotechnology patents, a modicum of background in biology

is helpful. All living organisms contain genetic material,

usually made of DNA (deoxyribonucleic acid). Smaller mole-

cules, called nucleotides, are arranged in a DNA molecule like

*For addiuonal background, see K. Drlica, Understanding DNA and

Gene Cloning: A Guide for the Curious 27-37 (2d ed. 1992).

15

beads on a string. Only four nucleotides, typically labeled A,

T, C, and G, comprise DNA, but a single strand of DNA may

have thousands or millions of nucleotides.

DNA contains encoded information that living cells use

to build proteins. Proteins are molecules that help to per-

form a wide variety of functions in living organisms, from

digesting food to forming muscles to helping the immune

system combat infections. Like DNA, proteins can be

described as linear (chain-like) molecules. All protein

chains are made from combinations of twenty smaller mole-

cules, called amino acids. The sequence of nucleotides in

DNA “encodes” the sequence of amino acids in a protein.

Each group of three nucleotides in a DNA sequence

“codes” for one amino acid. In this way, a long molecule of

DNA describes a long protein molecule. Living cells have a

complex machinery that “reads” a molecule of DNA, taking

the sequence information from the DNA molecule and

building the corresponding protein. A “gene” is simply a

sequence of DNA that encodes for a particular protein.

The doctrine of equivalents is essential for biotechnology

patents claiming particular genes or proteins. In biotech-

nology patent cases, the Federal Circuit has developed a rule

that an inventor cannot claim a gene without disclosing its

sequence. Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir.

1993); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d

1200, 1206 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).

Thus, under the law that the PTO applies during biotechnol-

Ogy patent examinations, it is impossible to write a valid

claim for “a DNA sequence encoding protein X” unless the

specification to the patent discloses that the sequence

AGGTTAAATCAC etc. encodes protein X. Therein lies

the rub. Because there are sixty-four combinations of three

nucleotides (recall that three nucleotides encode one amino

acid) and only twenty amino acids, several different combi-

nations of nucleotides are known to encode for the same

16

amino acid. For example, nucleotides AGG and CGA both

code for the same amino acid. Thus, two very different

strands of DNA can encode the same amino acid sequence:

AGG TTA AAT CAC ACT GAA Nucieotides

a 4 eee ee 8 ee ee Tee

| | |

Arg Leu Asn His Thr Glu Amino Acids

| ) | J |

i" eer: Oe be ae) Se

CGA CTT AAC CAT ACC GAG

Equivalent

Nucleotides

So, too, for proteins: certain individual amino acids are

interchangeable without effect on some functions of a pro-

tein. See Takenaka, supra.

Without a doctrine of equivalents, a gene patent would be

valueless unless it claimed every equivalent sequence of

nucleotides — competitors could infringe at will simply by

substituting nucleotides with others known to be inter-

changeable. The mathematics alone, however, make

describing every possible variant impractical. See Jn re Bell,

991 F.2d 781, 784 (Fed. Cir. 1993) (noting that 10°

nucleotide sequences encode a protein called IGF). While

no doubt a computer could be programmed to print out

every analog, the resulting patent claims would be a stack of

paper many miles high, and would overwhelm the PTO, as

well as those who track patents, with their sheer bulk.’

Protein patents present a similar problem. As the Federal

Circuit noted in analyzing a patent claim to the protein

erythropoietin, “over 3,600 different [protein] analogs can

be made by substituting at only a single amino acid position,

and over a million different analogs can be made by substi-

"The difficulties of examining DNA and protein patents have already

forced the PTO to adopt special rules in this area. 37 C.F.R. §§ 1.821 et

seq. (1995); U.S. Department of Commerce, Patent & Trademark

Office, Manual of Patent Examining Procedure §§ 2420 et seq. (rev. ed.

Sept. 1995).

17

tuting three amino acids.”” Amgen, 927 F.2d at 1213. Many

analogs are functionally indistinguishable, and no purpose

would be served by requiring their disclosure.

Biotechnology also needs a doctrine of equivalents to allay

unpredictability in application of the law concerning the

breadth of claims allowable under section 112. An applicant

who isolates a particular protein may, for example, claim

that protein. In addition, he or she may identify particularly

useful protein fragments, and claim those as well. The

patentee may then attempt to claim all similar protein

fragments generally. Whether the PTO or courts will allow

such a claim depends on an eight-factor test, described by

the Federal Circuit in Jn re Wands, 858 F.2d 731 (Fed. Cir.

1988). The factors include:

(1) the quantity of experimentation necessary [to

make the claimed invention], (2) the amount of

direction or guidance presented [in the specifica-

tion], (3) the presence or absence of working

examples, (4) the nature of the invention, (5) the

state of the prior art, (6) the relative skill of those

in the art, (7) the predictability or unpredictability

of the art, and (8) the breadth of the claims.

Id. at 737. Stating the test emphasizes the difficulty an

inventor faces at the time of application in predicting whether

the claims will be allowed based on the patent’s specification.

See Amgen, 927 F.2d at 1212-14. As a result, section 112

alone, without any prior art, can severely limit claims.

Without a doctrine of equivalents to temper this unpre-

dictability, decisions in the PTO based on the Wands test

could cut of} legitimate rights to claim an invention and its

substantial equivalents. An inventor’s only protection against

these losses would be to make and test each potentially

useful variant and to describe each in his specification. The

extra work would slow down patent applications and would

18

divert the industry's resources from developing the best

commercial embodiments of its inventions.

E. Equivalents Must Include Later-Discovered

Equivalents.

The special problems in biotechnology highlight the need

for a doctrine of equivalents that includes equivalents dis-

covered after a patent is filed. The example described in the

appendix to this brief illustrates this point. Genentech ob-

tained a patent for t-PA, which is made up of four hundred

thirty-nine amino acids. One of Genentech’s competitors

later discovered that substituting the amino acid methionine

for the amino acid valine as the protein’s two hundred and

forty-fifth amino acid created a protein with functionally

identical biological properties. Without a doctrine of

equivalents, the value of Genentech’s patent would have

been lost, even though the substitution of methionine for

valine creates a molecule which is, for all known relevant

biological purposes, the “same” protein.

Later-discovered improvements also should not preclude

a finding of infringement by equivalents. Additional research

on t-PA could show, for example, that all but the last fifty of

the molecule’s four hundred thirty-nine amino acids make

up the part of the molecule with therapeutic uses, and that

cutting off the last fifty amino acids lowers the molecule’s

cost of manufacture by making the molecule more soluble.

That discovery may itself be patentable. See Tilghman v.

Proctor, 102 U.S. 707, 724-25 (1880). Nevertheless, one

using t-PA without its last fifty amino acids is still using

t-PA and still exploiting the basic discovery of t-PA.

Later-discovered equivalents and improvements in bio-

technology are most likely for pioneer patents, which open

up new avenues of research. Loss of the doctrine of

equivalents in such cases would lead to the ironic result that

pioneer patents would receive less protection than merely

19

incremental inventions, instead of the full protection to

which they are entitled. See Brothers v. United States, 250

U.S. 88, 89 (1919) (noting that pioneer patents are “enti-

tled...to a liberal application of the doctrine of

equivalents”); Continental Paper Bag, 210 U.S. at 415.

A doctrine of equivalents that established a per se rule

based on distinctions between noninfringing improvements

and infringing equivalent alterations would unfairly elimi-

nate patentees’ property rights. It would also be arbitrary.

The distinction between these concepts inevitably turns on

facts unique to each case. Compare Miles Labs., 997 F.2d

at 877 with Texas Instruments, Inc. v. United States Int'l

Trade Comm'n, 805 F.2d 1558, 1571 (Fed. Cir. 1986). Any

attempt by this Court to fashion a rigid rule based on an

improvement/alteration distinction would only exacerbate

the uncertainty already inherent in infringement analysis.

F. Absolute Certainty in Claim Interpretation Is an

Unattainable Goal.

Petitioner and several Amici argue that by eliminating the

doctrine of equivalents this Court would return certainty to

questions of infringement. They also suggest that the doc-

trine of equivalents is unnecessary, or can be drastically

limited, because patentees could protect themselves against

too narrow literal infringement findings simply by claiming

their inventions with more care.

These arguments imply that there is little or no uncer-

tainty in a literal infringement analysis. This is demonstrably

wrong. The inherent limits in the ability of language to

describe inventions create an inevitable amount of uncer-

tainty at the borders of patent claims, whether the infringe-

ment asserted is literal or equivalent. In Hoechst Celanese

Corp. v. BP Chems. Ltd., 78 F.3d 1575 (Fed. Cir. 1996), the

patent-at-issue claimed a method for reducing iodide con-

tamination in an organic medium. The method requires a

20

“stable” resin. Jd. at 1578. The specification of the patent

defined “stable” to mean “that the resin will not chemically

decompose, or change more than about 50 percent of its dry

physical dimension upon being exposed to the organic me-

dium. ...” Jd. at 1578-79.

Despite the detail in this definition, Hoechst and BP, both

sophisticated parties, hotly disputed the literal meaning of

“stable.” The particulars of the dispute are unimportant to

this discussion. What matters is that these two large chemi-

cal companies, and their patent counsel, each felt that a

literal reading of “stable” led to a literal infringement

finding in its favor.

Disputes such as these are inevitable, especially when

words in a document are used to describe new technology.

An invention exists most importantly as a tangible

structure or a series of drawings. A verbal portrayal is

usually an afterthought written to satisfy the require-

ments of patent law. This conversion of machine to

words allows for unintended gaps which cannot be

satisfactorily filled. Often the invention is novel and

words do not exist to describe it.

Autogiro Co. of Am. v. United States, 384 F.2d 391, 396-97

(Ct. Cl. 1967). Loss of the doctrine of equivalents would

give patent attorneys added incentive to blur the borders of

their claims with broadening terms and imprecise adjectives.

Infringement evaluations would become more uncertain, not

less.

21

Il. DETERMINATION OF INFRINGEMENT UNDER

THE DOCTRINE OF EQUIVALENTS IS A QUES-

TION OF FACT, BASED ON OBJECTIVE CRITE-

RIA, THAT MUST BE TRIED TO THE JURY.

A. Infringement Is a Question for the Jury.

Determination of infringement by equivalents is a ques-

tion of fact, historically left to juries. Some have argued that

the application of the doctrine of equivalents is an equitable

“remedy,” granted by the court under certain circum-

stances, or a matter of claim construction, also for the court.

Those arguments, based on a misconception of the doctrine,

are incorrect.

The doctrine of equivalents recognizes that, in patent law,

if two devices do the same work in substantially the same

way, and accomplish substantially the same result, they are

the same, even though they differ in name, form, or shape.”

Graver Tank, 339 U.S. at 608 (quoting Machine Co. v.

Murphy, 97 U.S. 120, 125 (1877)); see also Sanitary

Refrigerator, 280 U.S. at 41-42 (“There is a substantial

identity, constituting infringement,” where a device copies a

claimed device, without variations or with such variations

‘““as are consistent with its being in substance the same

thing.””) (quoting Burr v. Duryee, 68 U.S (1 Wall.) 531,

573 (1863)). Therefore, a device or product which does not

literally infringe a claim may be an infringement nonethe-

less, because a claim “functions to forbid not only exact

copies of an invention, but products that go to ‘the heart of

the invention but avoid the literal language of the claim by

making a noncritical change.’” Markman, 64 U.S.L.W. at

4264 (quoting Schwartz, supra, at 82).

A cause of action of infringement by equivalents is not an

equitable remedy, nor any sort of “remedy” at all. Nor is it,

as some have argued, analogous to contract reformation.

Application of the doctrine does not require a search for

22

errors made in drafting the claim, so that the claim can be

reformed. Instead, it allows for the inherent limitations of

language by recognizing that “the substantial equivalent of a

thing, in the sense of the patent law, is the same as the thing

itself... .” Machine Co., 97 U.S. at 125. No matter how

carefully drafted, words can never describe a claim so

completely and precisely that it encompasses all possible

variations. Therefore, it is fair and just to provide protection

not only to the exact language of the claim, but also to its

substantial equivalents. That is the only sense in which the

doctrine of equivalents is equitable.

Arguments made by Petitioner and Amici suggest that

the doctrine of equivalents requires two different construc-

tions of the claim. Such arguments are wrong. Application

of the doctrine of equivalents arises after the court construes

the claim, during the comparison of the claim as construed

with the accused device or process. Consideration of that

evidence is part of the factual determination of whether or

not infringement occurred. If the evidence shows that the

accused device is identical to a device literally described by

the claim, literal infringement is established, and the com-

parison is finished. If the accused device is not identical, the

fact-finder considers the evidence to determine the substan-

tiality of the differences between the accused device and one

that would be literally infringing. If the differences are

insubstantial, infringement by equivalents is established.

Both of these determinations are questions of fact.

This Court has held consistently for nearly one hundred

and fifty years that determinaticn of infringement by

equivalents is a factual question for the jury. See Royer v.

Schultz Belting Co., 135 U.S. 319, 325 (1890); Tyler v.

Boston, 74 U.S. (7 Wall.) 327, 330-31 (1868); Winans, 56

U.S. at 344, Less than a month ago, this Court explained

again that issues of product identification, that is, “‘ques-

tions of identity and diversity of inventions,” are properly

23

reserved for the jury. Markman, 64 U.S.L.W. at 4268

(quoting Bischoff v. Wethered, 76 U.S. (9 Wall.) 812, 816

(1870) ). Allowing the court to make an “initial” determina-

tion that the diversity between the claim and the accused

product or process is insubstantial, as has been suggested,"

would completely usurp the role of the jury. Once the judge

has considered the evidence and decided as a matter of fact

that the differences are insubstantial, nothing is left for the

jury to do. Just as it would be improper (as it was in

Bischoff) for the court to compare the claim and the

accused device or process to determine whether as a matter

of fact there are any differences, it would be improper for

the court to compare them to determine whether as a matter

of fact any differences are insubstantial. That sort of disposi-

tive role for the court is precisely what this Court warned in

Markman “would improperly eliminate the jury’s function

in answering the ultimate question of infringement.”

Markman, 64 U.S.L.W. at 4267.

Some of those who argue for the elimination of the jury

seem to be motivated by a belief that patent infringement

cases are too complicated for juries. That is not a new

complaint. One hundred twenty-four years ago, in Tucker v.

Spalding, 80 U.S. (13 Wall.) 453 (1872), this Court held

*This proposition was made in one of the dissenting opinions in the

lower court, which recognized that the assessment made by the judge

would overlap “in considerable degree” with the analysis to be applied

by the jury. Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d

1512, 1544 (Fed. Cir. 1995) (Plager, J., dissenting).

* Affirming that the judge must not make the factual determinations

about the substantiality of differences does not mean that every case

where infringement by equivalents is alleged will get to the jury. To the

contrary, as the Federal Circuit clearly has established, the patentee

must offer admissible objective evidence of infringement. See, ez.

Hilton Davis, 62 F.3d at 1519. If the evidence is lacking, such that a

reasonable jury could not find infringement by equivalents, summary

judgment is appropriate.

24

““[w]hatever may be our personal opinions of the fitness of

the jury as a tribunal to determine the diversity or identity in

principle of two mechanical instruments, it cannot be ques-

tioned that .. . that question must be submitted to the jury,

if there is so much resemblance as raises the question at

all.” Jd. at 455. Patent cases may be complicated. Other

types of cases are complicated, too, but we do not take them

from the jury for that reason. The solution to complexity is

not to eliminate the jury, but to present the evidence in such

a way that the jury can understand it.

B. The Existence of Infringement by Equivalents

Should Be Based on Objective Criteria.

Those who would misconstrue the doctrine of equivalents

as an equitable remedy would have courts condition the

applicability of the doctrine on subjective criteria such as

the good behavior of the patentee or the ill intent of the

alleged infringer. That argument is inconsistent with the

strict liability aspect of patent law, which does not make

liability for infringement dependent on intent to infringe.

35 U.S.C. § 271(a). The law places the responsibility to

determine if an existing patent is being infringed on those

who are developing devices or products in a particular field.

Patents are publicly available so that anyone can determine

if a particular device or process has been patented. Liability

for infringement is avoided by taking care to avoid it, not by

ignoring the possibility of infringement. Liability should -

change just because a particular “innocent” infringer w

fortunate enough inadvertently to avoid literal olla

by having made insubstantial changes. Such a result would

be inconsistent with the policy of providing uniform protec-

tion for patents.

The argument that only deliberate copiers should be liable

for infringement by equivalents is also contrary to the

purpose of the doctrine itself. The doctrine protects “the

25

heart of the invention” from infringement through insub-

stantial changes. It guards against infringement by one who

is either clever or lucky enough to include an element that

uses the patented idea but avoids the exact words of

the claim. The doctrine is concerned with protecting the

ay cee eS eee not with punishing infring-

ers. The protection given through application of the doc-

trine would be severely diminished if it were applied only to

those who intentionally infringed.''

Evidence of deliberate copying versus independent devel-

opment is not irrelevant to infringement by equivalents.

Evidence that an alleged infringer studied the patent and

then made only the changes necessary to avoid the literal

scope of the patent could allow the fact-finder to draw an

inference that the differences are insubstantial. Evidence

that the alleged infringer undertook significant independent

research and development could allow the contrary infer-

ence. Neither type of evidence would be conclusive, how-

ever, as under the rules established by the expert judges of

the Federal Circuit, the determination of infringement by

equivalents depends on the objective differences between

the claim and the accused device or process. Hilton Davis,

62 F.3d at 1519.

°Punishment of infringers is found elsewhere in patent law. Under 35

U.S.C. sections 284 and 285, the court may award a patentee enhanced

damages and attorney fees if the infringer is shown to have acted in bad

faith. Those sections do not distinguish between literal and equivalent

infringers, but apply to both.

‘The Court's reference in Graver Tank to an “unscrupulous copyist”

was not a restriction on the application of the doctrine, but only a

recognition that the need for application of the doctrine is particularly

apparent where such infringers appear. Graver Tank, 339 U.S. at 607,

612.

26

lil. AS MOST APPLICATIONS ARE AMENDED,

ADOPTING PETITIONER’S POSITION ON

PROSECUTION HISTORY ESTOPPEL WOULD

RESULT IN A DE FACTO ELIMINATION OF

THE DOCTRINE OF EQUIVALENTS.

Prosecution history estoppel is a well-established limita-

tion on the scope of permissible equivalents to a patent

claim. In applying principles of prosecution history estoppel

established by this Court, the Federal Circuit, which reviews

dozens of prosecution histories each year, has established an

appropriate balance between the property interests of the

patentee and the reliance interests of accused infringers.'?

This case presents no reason to rewrite this law.

Petitioner essentially asks this Court to expand the appli-

cation of prosecution history estoppel to preclude a paten-

tee’s resort to the doctrine of equivalents whenever claims

are amended during prosecution. Although Petitioner

couches its argument in terms of “deliberate surrenders,” as

a practical matter, any narrowing amendment could be

characterized in later litigation as a surrender. Were the

Court to adopt Petitioner’s “surrender” approach to prose-

cution history estoppel, any patentee who amended his

claims would be unable to rely on the doctrine of

equivalents. Since most patent applications are amended

after filing, General Accounting Office, supra, at 17, Peti-

tioner is, in fact, seeking a de facto elimination of the

doctrine of equivalents. This result is not compelled either

by this Court’s precedents or by the policies behind prosecu-

tion history estoppel.

'? See Hoganas AB v. Dresser Indus., Inc., 9 F.3d 948, 952 (Fed. Cir.

1993) (measuring estoppel “from the vantage point of what a competi-

tor was reasonably entitled to conclude, from the prosecution history,

that the applicant gave up to procure issuance of the patent”); see also

Haynes Int'l. Inc. v. Jessop Steel Co.. 8 F.3d 1573, 1578 (Fed. Cir.

1993), on reh'g, 15 F.3d 1076 (Fed. Cir. 1994) (same).

27

This Court’s precedents have made clear that when, as in

Hilton Davis, a patent applicant surrenders subject matter

during patent examination to overcome an objection based

on prior art, the patentee cannot use the doctrine of

equivalents to recapture subject matter that was not patent-

able in the first instance. Exhibit Supply Co. v. Ace Patents

Corp., 315 U.S. 126, 136 (1942) (prosecution history estop-

pel applies when an applicant alters his claims “in order to

meet objections in the Patent Office, based on references to

the prior art”); Smith v. Magic City Kennel Club, Inc., 282

U.S. 784, 789 (1931) (“where an applicant for a patent to

cover a new combination is compelled by the rejection of his

application by the Patent Office to narrow his claim by the

introduction of a new element, he cannot after the issue of

the patent broaden his claim by dropping the element’’);

I.T.S. Rubber Co. v. Essex Rubber Co., 272 U.S. 429, 443

(1926) (same). A more expansive view of the doctrine is

not warranted.

As the Federal Circuit has noted, “in the course of patent

examination claims are often amended and rewritten and

added and subtracted.” Pall Corp. v. Micron Separations,

Inc., 66 F.3d 1211, 1219 (Fed. Cir. 1995). “No reason or

warrant exists for limiting application of the doctrine of

equivalents to those comparatively few claims allowed ex-

actly as originally filed and never amended.” Hughes Air-

craft Co. v. United States, 717 F.2d 1351, 1363 (Fed. Cir.

1983). Application of the Wands test, for example, often

results in limiting amendments. For this reason, “[a] non-

substantive change or a change that did not in fact deter-

mine patentability does not create an estoppel.” Pall Corp.,

66 F.3d at 1219; see also Musher Found., Inc. v. Alba

Trading Co., 150 F.2d 885, 888 (2d Cir.) (L. Hand, J.)

(when a patentee’s amendment is not to overcome prior art

“it becomes an open question which must be proved,

whether he intends to surrender the disclosure in such sense

—s

28

that he abandons any equivalents of the elements of those

claims which he keeps”), cert. denied, 326 U.S. 770 (1945).

Petitioner's position on prosecution history estoppel ig-

nores its purpose, and would apply prosecution history

estoppel in even those cases in which an amendment was not

required to overcome prior art. Graver Tank itself suggests

circumstances in which this could occur. The patent-at-

issue in Graver Tank originally contained broad claims that

read literally on the defendant’s infringing process as well as

narrow claims that did not. Graver Tank, 339 U.S. at 616

(Black, J., dissenting). The broad claims were found unpat-

entable because they covered inoperable ermbodiments. See

Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 336 U.S.

271, 276-77 (1949). Nevertheless, in finding infringement

of the narrow claims under the doctrine of equivalents, the

majority of this Court acknowledged a zone of patent

coverage that was broader than the literal language of the

claims, but which was not unpatentable over the prior art,

and could therefore be infringed. The same situation could

arise through an amendment during patent prosecution.

Single

inoperative

Original Embodiment

Claim

Limits

Limits of

Allowable No

Claims Based Prior

on section An

112/Wands

Equivalent

Invention

As this diagram illustrates, a patentee may be forced to

limit his claims under the enablement requirement of sec-

tion 112 to only a portion of the full scope of his invention.

This could occur, as in Graver Tank, if the original claims

29

contained inoperative embodiments. If the next broadest

claim the applicant files consistent with the requirements of

section 112 is substantially narrower than the original claiin,

the claims will be limited to a narrow scope, even though a

broader invention scope is allowable over the prior art.'?

Petitioner would have this Court adopt a rule allowing

anyone to commercialize “B” without any liability to the

patentee, depriving the patentee of the benefits of his inven-

tion and chilling patent law’s incentives for research.

Petitioner’s prosecution history estoppel position creates

odd justice. An applicant who filed narrow claims, and

received no rejections, would be entitled to the full range of

equivalents. An applicant who submitted broad claims, and

narrowed them during examination, would get no protection

against equivalents, even though the narrower claims are the

same as would have been allowed in the first instance.

Rigid application of prosecution history estoppel would

also flood the courts with PTO appeals. Applicants, reluc-

tant to risk the estoppel effect of narrowing amendments,

would have newfound incentive to litigate examiner’s deci-

sions. The result would be increased administrative expense

for the entire patent system, from the examiners through the

Board of Patent Appeals and into the courts. Patent attor-

neys well understand the application of prosecution history

estoppel, which this Court and the Federal Circuit have

clearly described. No new rules are needed.

A patentee is not free to amend claims in any manner he or she

desires. Section 112 requires support in the application as filed for each

claim limitation. For example, if a patentee has claimed a process with a

temperature range from 25° to 75°, the patentee may not limit that

claim to a range of 30° to 60° unless the application as filed also

disclosed the latter specific range. Merely being within the originally

disclosed range is not sufficient to satisfy section 112. See 2 Chisum.

supra, at § 7.04[2].

30

CONCLUSION

The doctrine of equivalents plays an important role in

patent law, and is particularly crucial for the biotechnology

industry. The loss or limitation of the doctrine would harm

the industry without adding any certainty to claim interpre-

tation. The decision of the court below should be affirmed.

Respectfully submitted,

DONALD S. CHISUM

Counsel of Record

RACHEL KREVANS

Sue C. HANSEN

STEPHEN B. THAU

MORRISON & FOERSTER LLP

345 California Street

San Francisco, California 94104

(415) 677-7000

CHIRON CORPORATION

ROBERT P. BLACKBURN

KENNETH M. GOLDMAN

4560 Horton Street

Emeryville, California 94608

(510) 655-8730

Counsel for Amicus Curiae

Chiron Corporation

.

ee ee ee ee

———— ee

APPENDIX

New Policy in Interpreting Japanese Patents:

Osaka High Court Affirming Infringement of

Genentech’s t-PA Patents under the Doctrine of

Equivalents

Toshiko Takenaka*

On March 29, 1996, Osaka High Court reversed Osaka

District Court’s decision and found that Sumitomo’s t-PA

infringes Genentech’s pioneer patents for human t-PA

under the doctrine of equivalents. Since this case may

change Japanese case law on patent claim interpretation | 80

degrees to merge with German and U.S. case law, I have

included a summary of the case as well as my comments in

comparative law aspects.

Decision of Osaka High Court (Osaka Koto Saibansho)

March 29, 1996-Case No. Heisei 6 (ne) 3292

Background

The plaintiff-appellant, who owns two patents for a

human tissue plasminogen activator (t-PA), sued the defen-

dant, who was preparing to manufacture and sell a human

tissue plasminogen activator, in order to prevent defendant

*Assistant Director, Center for Advanced Study and Re-

search on Intellectual Property (“CASRIP’’), University

of Washington School of Law. Ph.D. and LL.M., Univer-

sity of Washington School of Law (1990, 1992); B.A.,

Seikei University (1981).

es ||

2a

from engaging such manufacture and sale. Claims of Patent

A issued to the plaintiff read:

1. A recombinant human tissue plasminogen activator

resulting from a non-human host cell, having no other

human protein, which activator is characterized by

(1) a function to convert plasminogen to plasmin;

(2) an ability to provide an affinity for fibrin;

(3) an ability to immunoprecipitate with antibody

against human tissue plasminogen activator

originating from Bowes melanoma cell line;

(4) an amino acid sequence providing a kringle region

and serine protease region; and

(5) either single or multiple amino acid; and

comprises a segment of 89th to 527th amino acid as indi-

cated in the appendix 1.

2. A method for manufacturing a recombinant human

tissue plasminogen activator having no other human protein,

comprising steps of culturing non-human host cell trans-

formed with a DNA sequence encodinghuman tissue plas-

minogen under conditions to enable said host cell to express

said DNA; whereby providing a recombinant human tissue

plasminogen activator characterized by

(1) a function to convert plasminogen to plasmin;

(2) an ability to provide an affinity for fibrin;

(3) an ability to immunoprecipitate with antibody

against human tissue plasminogen activator

originating from Bowes melanoma cell line;

(4) an amino acid sequence providing a kringle region

and serine protease region; and

(5) either single or multiple amino acid; and

3a

comprises a segment of 89th to 527th amino acid as indi-

cated in the appendix 1; arid recovering said recombinant

human tissue plasminogen activator.

3. A medicine for the treatment of thrombosis compris-

ing an amount of recombinant human tissue plasminogen

activator resulting from a non-human host cell, having no

other human protein, which amount is sufficient for such

treatment and mixed with a carrier permissible as a

medicine, which activator is characterized by

(1) a function to convert plasminogen to plasmin;

(2) an ability to provide an affinity for fibrin;

(3) an ability to immunoprecipitate with antibody

against human tissue plasminogen activator

originating from Bowes melanoma cell line;

(4) an amino acid sequence providing a kringle region

and serine protease region; and

(5) either single or multiple amino acid; and

comprises a segment of 89th to 527th amino acid indicated

in the attached appendix |.

The only claim of Patent B read:

A microorganism, yeast, and mammal cell transformed

by a recombinant expression vector containing a DNA

sequence encoding human tissue plasminogen activa-

tor, having a sequence of Ist to 527th amino acids listed

in the attached appendix 1.

The defendant requested a trial of nullity on both patents

but the request was rejected by the Japanese Patent Office.

Plaintiff sued another Japanese pharmaceutical company for

infringement of the same patents. The Osaka District Court

found for plaintiff because that company’s t-PA included a

sequence of amino acids as they are listed in the claims

although the sequence also included some insignificant

4a

amino acids. In contrast, the same court found no infringe-

ment for this case since one amino acid was different from

the claimed sequence. The court rejected to look at sources

other than the claims, stating that it is not necessary to

make reference to other sources when the invention is clear

from the claim language. Since one amino acid is missing

from defendant's t-PA, the court did not find literal infringe-

ment. It also rejected plaintiff's request to apply the doctrine

. of equivalents, emphasizing on the third parties’ interests,

relying on the claims. The plaintiff appealed, arguing that

the defendant’s product was substantially the same or

equivalent to the patented invention.

In determining equivalency, the parties’ arguments fo-

cused on the obviousness of replacing valine with methio-

nine, because the replacement is the only structural

difference between the patented inventions and the defen-

dant’s product. The plaintiff emphasized that the patented

inventions are pioneer inventions. To establish non-

equivalency, the defendant argued that its t-PA was devel-

oped independently from the patented inventions.

Opinion

The contested decision is set aside and the defendant-

appellee is sustained from engaging in infringing activities.

The plaintiff-appellant’s appeal is admissible.

I. Infringement by Equivalents

As arguments by the parties indicate, it is not automati-

cally clear whether the invention including met-t-PA is

substantially the same as the invention including val-t-PA.

Since an invention is defined as a highly advanced creation

of technical idea using a law of nature, courts must put

weight on experts’ (those skilled in the art) opinions and

views in deciding whether an accused embodiment falls

within the technical scope provided in Article 70. Unless the

Sa

experts can understand the technical scope of the patented

invention with no uncertainty on the basis of the claim,

claim language is not the only resort for determining the

technical scope of a patented invention. Although an inven-

tion, which is the subject matter of a patent, ic., an

industrial property right, is described in a claim, the content

described in claims is simply the gist of the invention. Since

an invention is intangible, its structure must be described in

terms of words. It should be noted that although Article 70

provides a means with which to decide the technical scope

of the invention on basis of claim language, but does not

limit the scope to only cover the literal scope of the claim.

Because it is impossible to fully describe the structure of an

intangible subject in terms of words, Article 70 provides

courts with the flexibility to decide the scope in granting an

injunction based on a patent, on the basis of the claim

language. The question of whether an accused embodiment

falls within the technical scope of a patented invention is a

step to define the outermost boundary of the technical scope

and is solved by the court which decides infringement.

If an accused embodiment corresponds to the claimed

invention and thus is clearly found by one skilled in the art

to fall within the technical scope, patent law requires a

method for determining the technical scope of a patented

invention. This enables courts to find such embodiment

being equivalent to the patented invention, even if the

embodiment neither literally infringes the claim, nor meets

every element of the claim.

In affirming infringement by an embodiment which is not

literally the same as the structure of patented invention,

courts must pay attention to third parties’ interests which

rely on the technical scope based on the claim language in

balance with the patentee’s interest. It is necessary to

establish a standard to balance both interests. In scholarly

opinions, two elements of interchangeability and obvi-

6a

ousness of interchangeability are proposed as requirements

to find equivalency to establish such a standard. Therefore,

the parties’ dispute in this case centers on whether the

accused product meets the two elements. These two cle-

ments are positive requirements to affirm equivalency. On

the other hand, there are other elements in particular cases,

such as some facts in patent prosecution which may prevent

courts from finding equivalency. In determining whether the

defendant's t-PA including met-t-PA is equivalent to Pat-

ented Invention A or B including val-t-PA, courts must

affirm equivalency by examining every positive and negative

element, while confirming that finding of equivalency would

not upset the balance between interests of third parties, who

rely on the description of the claims, and those of patentees.

Il. Evaluation With Respect To Positive Elements for

Equivalents

1. Interchangeability

It is not disputed that all amino acid sequence in patented

t-PA and defendants’ t-PA are exactly the same, except that

the 245th amino acid in Patented Inventions A and B is

valine, whereas the corresponding acid in the defendants

t-PA is methionine. The defendant also does not dispute

that its t-PA has the characteristics cited in the claims of

Patents A and B. Accordingly, the defendant’s t-PA pro-

vides the same function as the patented t-PA, and thus

satisfies the interchangeability element.

2. Obviousness of Interchangeability

(Courts listed 11 expert opinions obtained from distin-

guished professors in molecular biology.)

7a

Expert Opinions

In summary, the experts’ opinions on whether one skilled

in the art would have readily obtained the defendant's

thrombolytic agents by replacing valine with methionine is

as follows:

(1) Valine and methionine behave similarly in struc-

turing three dimensional protein structure.

(2) Transformation from valine to methionine in pro-

tein amino acid sequences occurs relatively frequently.

This transformation does not affect the function of the

protein (trivial transformation).

(3) t-PA’s 245th position is buried in the hydrophobic

region of the three dimensional structure of the protein

and has no significant role in relation to biological activity.

(4) If a sequence of amino acids is identified, one

skilled in the art could have manufactured a t-PA varia-

tion wherein some amino acid residues are replaced,

deleted or added by manufacturing t-PA’s cDNA and

changing a segment of the canonical amino acid sequence

in the t-PA.

(5) The significance of Patented Inventions A and B is

to express a t-PA cDNA encoding a recombinant t-PA

which provides a biological activity.

(6) In scientists’ view, the significance of the first

successful cloning of a t-PA c-DNA and producing a

recombinant t-PA is vastly greater than subsequently

repeating the cloning of t-PA by making reference to the

disclosure of the first cloning procedure.

(7) Production of a different form of t-PA by making

reference to amino acid sequence of t-PA has no practical

use, unless the different form of t-PA provides improved

characteristics.

(8) Cloning errors occur very frequently. In most

cases, such errors result from replacements of insignifi-

cant amino acid residues with similar amino acid residues

which do not affect the function of the protein. When a

protein resulting from a cloning error has the same

function as that of the original protein, the error results

from a replacement of insignificant amino acids with

similar amino acids. Therefore, one skilled in the art

could have known that the protein in a different form

resulting from the error would have the same function as

the original protein.

Technical Objective of Patented Inventions A and B

On the priority date of Patented Inventions A and B,

natural t-PA was only produced by isolating from human

cells, and the quantity produced by this isolation was very

small. Although production of useful proteins through Te-

combinant DNA technology was about to become a reality,

the production of t-PA through recombinant DNA technol-

ogy was very difficult, because an only very small quantity of

natural t-PA is available, the concentration of t-PA mRNA

is extremely low; and t-PA mRNA consists of a very long

sequence. Based on the state of art as discussed, the objec-

tive of Inventions A and B is to produce a sufficient quantity

of t-PA through a recombinant DNA and to develop t-PA

thrombolytic agents. Inventions A and B achieved the

objective by determining the sequence of a full-length t-PA

clone, which is essential to produce t-PA through recombi-

nant DNA technology. This results in information disclosure

which enables one skilled in the art to produce a sufficient

quantity of t-PA which is capable of replacing natural t-PA,

a sufficient quantity of t-PA to conduct animal and clinical

experiments for governmental approvals to commercialize

t-PA as medicine.

9a

Significance of Inventions

With respect to the objective, the significance of Inven-

tions A and B relies on a form of t-PA, i.e., an invention of a

product, obtained through a recombinant DNA technology.

The list of amino acids in the claims indicates that the

invention identified t-PA and discovered all amino acids in

t-PA. The t-PA claimed as Inventions A and B is defined as

a t-PA obtained through a recombinant DNA technology.

The disclosure of Inventions A and B enabled one skilled

in the art to understand the manufacturing method of t-PA

with the disclosed characteristics through a recombinant

DNA technology. One skilled with his or her general knowl-

edge in the art would have been able to produce a sufficient

quantity of t-PA, which was not possible by conventional

methods.

As the findings from the expert opinions indicate, if the

amino acid sequence of t-PA is identified, t-PA in various

forms could be produced. This is also discussed in the

specification. These findings support the view that one

skilled in the art, with the general knowledge available on

the priority date of Inventions A and B, could have readily

made t-PA in various forms by replacing a portion of the

amino acid sequence recited in the claims, so as to obtain a

form of t-PA with improved characteristics. In the Scien-

tists’ view, unless a t-PA in a different form reveals charac-

teristics superior to that of the original t-PA, the modified

t-PA does not have any practical significance above that of

the original t-PA.

Because the 245th position is not in a significant region,

the replacement of valine with methionine does not affect

the function of the protein, and a t-PA in a different form

would have been readily made; it was highly possible or

expected on the priority date, for one skilled in the art, to

replace valine in the 245th position with methionine in the

10a

t-PA protein so as tc ~htain a T-PA in a different form with

a function comparable to that of the original T-PA. The

defendant’s witness’s statement that the defendant’s T-PA

resulted from a cloning error also supported that it was well

expected for one skilled in the art to obtain a t-PA in a

different form resulting from a cloning error.

(The court rejected defendant's arguments that a replace-

ment of valine with methionine would change the character-

istics of the protein, relying on the expert opinions that the

characteristics of defendant’s t-PAs are indistinguishable

from those of the patented t-PA.)

III. Negative Element: Prosecution History

1. Prosecution History of Patented Inventions A and B

The original application for Invention A_ included

16 claims, including a claim which reads: “a DNA human

tissue plasminogen activator, having substantially no other

human protein.” During the examination of the opposition

against the application, the JPO examiner upheld the oy »o-

sition and rejected on the basis of lack of enablement. [he

examiner agreed with the opponent that the claim was too

broad compared with the disclosure. The published claims

covered any t-PA having characteristics cited in the claims,

which are comparable to the characteristics of natural t-PA.

The application, however, did not include any disclosure on

variations where amino acid residues in positions 69 through

527 were replaced. Since the characteristics of t-PA in a

different form were unknown, the claim scope including

these unknown variations was not permitted. In the trial

against the decision of refusal, the plaintiff gave up and

limited the claims to include a list of amino acids in

positions 69 to 527.

Similarly, the original application of Invention B did not

include a list of amino acids, and was rejected for lack of

enablement, on the ground that the claims were too broad

compared with the disclosure in the specification. To over-

come this rejection, the plaintiff introduced the list of amino

acids in positions | to 527 positions. In its argument accom-

panying the amendment, the plaintiff emphasized that the

introduction of the limitation on the specific sequence of

amino acids should not be interpreted to exclude t-PA in

different forms, which would be obvious to one skilled in the

art from the amino acid sequence cited in the amended

claims. This amendment did not satisfy the JPO examiner.

The defendant again amended the claim and deleted the

words “allelic variations” and “derivatives,” these words

were pointed out by the examiner as being not fully sup-

ported by the disclosure in the application.

Although the claims were amended to recite only the

particular amino acid sequence, the specification of Patent

Invention A described possible variation resulting from

single or multiple amino acid substitutions, deletions, addi-

tions or replacements, and made clear that the scope of this

invention comprised these variations, as long as they main-

tained the characteristics of human tissue plasminogen acti-

vator. The specification of Patent B also maintained a

description that the term “a DNA sequence encoding

human tissue plasminogen activator” included all DNA

encoding all allelic variations and modifications resulting in

derivatives of human tissue plasminogen activator.

These facts in the patent prosecution indicate that the

limitation of amino acid sequence was introduced to meet

the requirement provided in Article 36, because variations

included in the original claims were not supported by the

disclosure in the specification. When a claim is amended to

overcome the rejection for lack of novelty or inventive step,

the invention is not patentable if its scope is interpreted

beyond the literal claim scope. Thus, the interpretation is

not permissible. In comparison, when a claim is amended to

clarify the description of an invention, the interpretation

l2a

beyond the literal claim scope would not result in lack of

novelty or inventive step and thus should be permissible.

Communications from the examiner do not indicate that all

variations were excluded from the technical scope of pat-

ented t-PA. Thus, no fact in the patent prosecution history

gives rise to an element to prevent the court from finding

equivalency. No plaintiff's argument gives rise to the appli-

cation of estoppel.

IV. Argument of Independent Development

A product or method infringes a patent as long as it

falls within the technical scope of the patented invention

regardless of its independent development from the patented

invention. Evidence of the defendant’s copying of the pat-

ented invention is indirectly relevant to suggest that the

interchangeability and obviousness of interchangeability ele-

ments are met in affirming equivalency. An argument of

independent development is relevant to refute the plaintiff's

contention that the accused product meets the two elements

of interchangeability and obviousness of the interchangea-

bility, because the defendant copied the patented invention.

Because a finding of infringement does not rest on the

subjective awareness of the defendant, argument of indepen-

dent development is not directly relevant to establish none-

quivalency by the defendant.

In this case, the plaintiff did not introduce the evidence of

the defendant's copying of the patented t-PA. Thus, the

defendant’s argument was not relevant in determining

equivalency.

(Despite the irrelevancy of the evidence on independent

development, the court examined evidence on the defen-

dant’s process of developing its t-PA and rejected the

argument that the defendant independently developed the

t-PA.)

l3a

V. Conclusion

In summary, no fact which prevents a finding of

equivalency was found, and a finding of equivalency between

the patented inventions and defendant’s t-PA does not upset

third parties’ reliance on the patent claims. Accordingly, the

defendant's t-PA is equivalent to the patented t-PA. The

defendant’s t-PA, its manufacturing method and

thrombolytic agents fall within the technical scope of the

patented invention.

It is established that the defendant is preparing to culture

the accused cell and manufacture and sell the accused

thrombolytic agents by using the accused method. Since

these activities constitute infringement of the plaintiff's

patents, the plaintiff's request to enjoin the activities, and

destroy the accused products, is lawful.

Comments

This case is very important not only because it may

completely change case law direction on Japanese claim

interpretation, but also because it involves pioneer inven-

tions owned by U.S. biotech company, the significance of

the invention is great not only to that company but also to

US. industry. The Osaka District Court’s denial of finding

infringement almost resulted in trade disputes between U.S.

and Japanese government. Interestingly, infringement suit

was also brought against the defendant’s licensor in the

United States on the basis of the U.S. patents corresponding

to Japanese patents in this case (although U.S. patent

claims did not include the limitation of amino acid se-

quence). In appeal from the trial court’s finding of infringe-

ment, the defendant of the U.S. case did not appeal on the

issue of infringement concerning the form of t-PA disputed

ae Inc. v. Welcome Foundation Lid., 29 F3d 1555 (Fed. Cir.

l4a

in Japanese case. Regarding the U.S. defendant's FEIX

protein, a different product from the Japanese defendant’s

product, Federal Circuit found no infringement.

Japanese patent law has been extensively criticized for its

narrow claim interpretation and its reluctance to find in-

fringement under the doctrine of equivalents.’ As typically

shown by the first instance decision of this case, when the

disputed claim does not literally cover the accused embodi-

ment, Japanese courts find no infringement and reject pat-

entee’s request to apply the doctrine of equivalents, giving

weight on third parties’ interests and legal certainty. When

parties dispute a claim term whether the claim includes the

accused device, courts find that the claim does not clearly

specify the invention, and limits the scope to the scope

explicitly or implicitly disclosed in the specification.’ The

recent cases, however, indicate a new tendency in Japanese

courts which favors the patentee’s interests although even in

a most progressive case Tokyo High Court carefully avoided

using a term “equivalency or equivalents” as the reason to

extend the protection beyond the claim literal scope.* The

Osaka High Court’s determination to change the case law

and affirm the doctrine of equivalents is clear from its

discussion of patent law policy. In civil law countries,

*For a general discussion of Japanese patent claim interpretation in

comparison with United States and German patent claim interpretation,

see Takenaka, /nterpreting Patent Claims: The United States, Germany

and Japan (1996).

*Fujitsu v. TI, Judgment of Tokyo District Court August 31, 1994,

reported in Hanrei Jiho (No. 1510) 35 (1995); Hanrei Taimuzu

(No. 862) 108 (1995). (In this case, the Tokyo Trial Court rejected the

literal coverage of a pioneer invention for manufacturing integrated

circuits including the modifications resulting from the later technologi-

cal development, stating that no suggestion of the modification is found

in the disclosure. )

“Takenaka, Case Comment “Ball Spline Bearing” 26 11C 683 (1995).

lSa

particularly Japan, courts’ opinions do not include an exten-

sive discussion on legal theory and policy since their power

is limited to solve disputes involved in a particular case. This

court opinion begins with an extensive discussion of needs

for extending the protection beyond the literal claim scope

because the nature of words makes impossible to fully

describe an invention, a technical idea, without any ambigu-

ity. The patent policy discussed by the Osaka High Court

closely parallels to the United States Patent Policy to make

reference to sources other than claims and find infringement

under the doctrine of equivalents.’

An important rule that the Osaka High Court emphasized

was that patent claims must be interpreted as if one skilled

in the art would have read the claim. Claims should be read

by making reference to the specification, drawings and

general knowledge of one skilled in the art. In other words,

the protection scope of Japanese patents includes not only

disclosed embodiments but also those obvious to one skilled

in the art. From now on, expert testimony may take a

significant role in Japanese patent infringement cases deal-

ing with high technology such as biotechnology.

A strong U.S. influence is also shown by the test adopted

by Osaka High Court. The court’s crag test, neaaiine

(1) whether the amino acid recited in the claims is inter-

changeable with the amino acid in the defendant’s t-PA and

(2) whether one skilled in the art would have known or

conceived the replacement of such amino acids clearly

parallels to the interchangeability and known interchangea-

bility tests in determining an insubstantial difference

adopted by Federal Circuit in Hilton Davis Chemical Com-

“Autogiro Company of America v. the United S

tates, 384 F.

(Ct. Cl. 1967). oe

l6a

pany Inc. v. Warner-Jenkinson Co.° Similarly, Osaka High

Court’s reasoning to reject the defendant’s argument of

independent development parallels to that of Federal Circuit

in Hilton Davis, stating that the argument is relevant only if

patentee argued that the accused embodiments are copied to

establish the interchangeability and known interchangeabil-

ity between the claimed invention and accused embodiment

for finding equivalency. Finally, the Osaka Court followed

Federal Circuit in limiting the application of prosecution

history estoppelonly when limitations are introduced to

overcome a rejection for lack of novelty and inventive step.’

In short, this t-PA case moved Japanese patent claim

interpretation merged with the United States patent claim

interpretation. Since Hilton Davis has moved United States

patent claim interpretation to German counterpart,® patent

claim interpretation in three major jurisdictions is now in

line. Giving the pending disposition before the Supreme

Court of Hilton Davis, the test and limitation for the

doctrine of equivalents the Osaka High Court is premature

in the United States at this time. For the sake of harmoniza-

tion, I cannot help hoping that the Supreme Court would

affirm the substantial difference test adopted in Hilton

Davis.

‘Hilton Davis Chemical Company Inc. v. Warner-Jenkinson Co., 62

F.3d 1512, USPQ2d 1641 (Fed. Cir. 1995).

"Id., at 1525.

*Takenaka, Doctrine of Equivalents After Hilton Davis: Comparative

Law Analysis, Rutgers Technology and Computer Law Journal (forth-

coming 1996 May).