Opposition Brief — Genentech, Inc. v. Novo Nordisk A/S

No. 97-337 | SEP 22 1997

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Supreme Court of the United States

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October Term, 1996

GENENTECH, INC.,

Petitioner,

vs.

NOVO NORDISK A/S, NOVO NORDISK OF NORTH AMERICA,

INC. and NOVO NORDISK PHARMACEUTICALS, INC.,

Respondenis.

On Petition for a Writ of Certiorari to the United States Court of

Appeals for the Federal Circuit

RESPONDENTS’ BRIEF IN OPPOSITION

JOHN C. VASSIL ALBERT L. JACOBS, JR.

KURT E. RICHTER Counsel of Record

KENNETH H. SONNENFELD JESSE D. REINGOLD

MORGAN & FINNEGAN LLP GRAHAM & JAMES LLP

345 Park Avenue 885 Third Avenue

New York, New York 10154 New York, New York 10022

(212) 788-4800 (212) 848-1000

Attorneys for Respondents

72056 gut

(800) 3 APPEAL « (800) 5 APPEAL « (800) BRIEF 21 A late ‘

ervices, inc.

QUESTIONS PRESENTED

Respondents object to the Questions Presented because they

incorrectly assert that the Federal Circuit disregarded settled

law and the text of 35 U.S.C. § 112 and adopted a new test for

enablement that the Federal Circuit did not in fact adopt.

Contrary to Question 1, the Federal Circuit did not rule that

“a patent specification must state what is already known in the

art.” Nor did the Federal Circuit, as is stated in Question 1a,

rule “that information well known in the art may be used only

to ‘supplement’ a patent specification with ‘minor details.’ ”

Since the Federal Circuit did not make these rulings, Question

1b, whether the decision below will “call into question the

validity of thousands of issued patents;” “lead to a substantial

increase in the length of patent specifications,” and “diminish

the ability of inventors to obtain meaningful patent coverage,”

is also objectionable, and improperly uses hyperbole to seek

this Court’s review of mere conjecture. It is based on the

incorrect premise that the Federal Circuit changed long-standing

precedent. :

Respondents also object to Petitioner’s formulation of

Question 2 because it wrongly assumes that the Federal Circuit’s

decision was premised on the resolution of “disputed issues of

fact,” rather than on a de novo determination of a controlling

issue of law.

ii

PARTIES TO THE PROCEEDING

The parent companies, subsidiaries (except wholly owned

subsidiaries), and affiliates, that have issued shares to the public,

of the Respondents are: Novo Nordisk A/S.

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TABLE OF CONTENTS

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Parties to the Proceeding ..... 2... 0.0... cc ccc cccss li

Table of Contents ..................eeccceeeecee: iti

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A. Having Twice Failed Before The Federal Circuit

To Enforce Improvidently Granted Preliminary

Injunctions Against Novo Nordisk, Genentech

Now Turns To This Court To Resolve This Private

ES re l

B. Although The Parent Application Of The ‘199

Patent Was Filed In 1979, Claims To Enzymatic

Cleavable Fusion Expression Of Human Growth

Hormone Were Not Presented Until 1989. .... 2

C. The Holding Of Lack Of Enablement Of The ‘199

Patent Was Foreshadowed In Novo ].......... 3

Reasons for Denying the Writ .................... 5

I. The Decision Correctly Stated And Applied Long-

Standing Precedent Concerning The Law Of

EES ey er 6

II.

Il.

IV.

VI.

VII.

iv

Contents

Despite The Broad Scope Of The Claim Of The

‘199 Patent, The Specification, As The Federal

Circuit Held, “Does Not Describe In Any Detail

Whatsoever How To Make hGH By Enzymatic

Cleavable Fusion Expression” And Hence, As A

Matter Of Law, The ‘199 Patent Is Invalid. ...

Unable To Deny That The Federal Circuit Applied

The Correct Rule Of Law, Genentech

Misrepresents The Decision And Tries To Show

That The Federal Circuit Established A New Rule

Sg CSET ee TCC ee eT re te rer

Genentech’s Unsupported Hyperbole Of Dire

Consequences To The Patent System Should Be

PE, bn bss cede caeKteubeNene cee en.

The Federal Circuit Was Correct In Adjudicating

And Dismissing Genentech’s Claims On The

Merits By Holding The ‘199 Patent Invalid After

Two Lengthy Preliminary Injunction Hearings.

“eevee eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee

Contrary To Genentech’s Assertions, The Federal

Circuit Acted Upon A Complete Record When It

Held The ‘199 Patent To Be Invalid. .........

The Federal Circuit Had Authority Under 28

U.S.C. § 2106 To Enter Judgment Against

Genentech After The Extensive Preliminary

8 Re re rr reer

Page

10

16

17

18

21

Contents

Page

VIII. Genentech’s Arguments Are Not Supported By

Fee Re TO GA nce vcceeneds sueencees 23

| PPT eT ee Te TOT OTT Tee 29

TABLE OF CITATIONS

Cases Cited:

Amgen, Inc. v. Chugai Pharm, Co., 927 F.2d 1200, 18

USPQ2d 1016 (Fed. Cir. 1991) ......ccccccccces 6,7

Brown & Williamson Tobacco Corp. v. FTC, 710 F.2d 1165

(6th Cir. 1983), cert. denied, 465 U.S. 1100 (1984)

OPT PETE Ee eT rE OT TP ery 24

CES Publishing Corp. v. St. Regis Publications, Inc., 531

we Bie fs 2 erry rr rere rrr TT 24

Chicago Observer, Inc. v. City of Chicago, 929 F.2d 325

(7 CAs. TDDT) 2 ccc eccccncceccccccsccccsccess ple

Dennison Mfg. Co. v. Panduit Corp., 475 U.S. 809 (1986)

per kbe en ede dates obs ke ee ae ee eee 24

Diginet, Inc. v. Western Union ATS, Inc., 958 F.2d 1388

Ce te SOD 6 0-0-4: 5.0:2 465055045 aS Oe 23

Doe v. Sundquist, 106 F.3d 702 (6th Cir. 1997) ....... 23

Gellman v. State of Maryland, 538 F.2d 603 (4th Cir. 1976)

vi

Contents

Page

Genentech, Inc. v. Novo Nordisk, A/S et al., 108 F.3d 1361

0 Sin Sk yn Sa ee Se ens eee ke l

Glasgow, Inc. v. Federal Highway Administration, 843

ce eee ee 22

Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d

1367 (Fed. Cir. 1986), cert denied, 480 U.S. 947 (1987)

PONE tren hahha teks bt te eile Naa acai Gk A 10

In re Buchner, 929 F.2d 660 (Fed. Cir. 1991) ........ 12

In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)

Sette Ble Ok i ai be end eee ae eral lee cae 6, 7,8

In re Glass, 492 F.2d 1228 (CCPA 1974) ........... 2

In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993) ....... 6, 7

In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991) .......... 6, 8,9

In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir.

CE ee eT ane we EA ee 6,7

Joy Tech., Inc. v. Flakt, Inc., 6 F.3d 770 (Fed. Cir. 1993)

RU en edad vid ekeckes Oud eeee ce eae eee 1]

Lawther y. Hamilton, 124 U.S. 1 (1888) ............ 12

Layne & Bowler Corporation v. Western Well Works, 261

ED x 9.5.40 4004 hake eh wee eee Me

vil

Contents

Page

Libertarian Party of Indiana v. Packard, 741 F.2d 981 (7th

RT Pre re rere Tr or en en ee 24, 25

Meccano, Ltd. v. John Wanamaker, 253 U.S. 136 (1920)

Ee ee Ee ee Ce ee E RTT Pee Tee eee 24

Minerals Separation v. Hyde, 242 U.S. 261 (1916) ... 12

Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261

(Fed. Cir. 1986), cert. denied, 479 U.S. 1030 (1987)

Ee ee eee TE OCCT TOES eRe Te ae 6, 20, 27

Moses H. Cone Memorial Hospital v. Mercury Const.

Sg UU MU BE NIIED vince cues ueescnasen den 25, 26

National Ass'n of Farmworkers Org. v. Marshall, 628 F.2d

i OU 5 cs dc n'ss neaweadaleneeekae cs 22

Newell Co., Inc. v. Kenney Mfg. Co., 864 F.2d 757 (Fed.

Cir. 1988), cert. denied, 493 U.S. 814 (1989) ...... 27

Novo Nordisk of North America, Inc. v. Genentech, Inc..,

77 F360 1966 (Ped. Cir. 1996) 2... ccc ccscccnccs 1,4

Susquehanna Corp. v. Pan American Sulphur Co., 423 F.2d

eee AS TOD vaca cedadesecvienkivcsteats 18, 22

University of Texas v. Camenisch, 451 U.S. 390 (1981)

RECTU eC LSC CTE CT ETT eT te) | A Pee 23, 24

vill |

Contents

Page |

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Statutes Cited: |

po gh Eso 5) re 5, 17, 20, 21, 22, 23, 26, 28, 29 ;

MUSE 6. has oki eee 10, 13

Pe MPa OE Ahab bb 4a ek dk esdeR eRe 10, 13 ;

CUS 408 2h i, 1, 2, 4, 5, 6, 7, 8, 20

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Be ea Ob Oe % ik 6-4 04% RSS Re Ree 2

Rules Cited:

Federal Rules of Civil Procedure Me Veo ne vu wheues 24

Federal Rules of Civil Procedure 65(a) ............. 28

aE ee

Respondents (hereinafter collectively “Novo Nordisk”),

respectfully oppose the prayer of Petitioner (hereinafter

“Genentech”) that a writ of certiorari issue to review the

Judgment and Opinion of the United States Court of Appeals

for the Federal Circuit, dated March 13, 1997 (Appendix A).

STATEMENT OF THE CASE

A. Having Twice Failed Before The Federal Circuit To

Enforce Improvidently Granted Preliminary Injunctions

Against Novo Nordisk, Genentech Now Turns To This Court

To Resolve This Private Dispute.

The dispute between Novo Nordisk and Genentech before

the United States District Court for the Southern District of New

York resulted in two successive preliminary injunctions against

Novo Nordisk. Both preliminary injunctions were vacated by

the Federal Circuit. The Petition seeks review of the Federal

Circuit’s vacatur of the second injunction.

The first preliminary injunction (issued on June 28, 1995),

based on Genentech’s U.S. Patent 4,601,980 (the “ ‘980 patent”),

was vacated by the Federal Circuit on February 26, 1996. Novo

Nordisk of North America, Inc. v. Genentech, Inc., 77 F.3d 1364

(Fed. Cir. 1996) (“Novo I’). The second preliminary injunction

(issued on June 27, 1996), based on Genentech’s related

U.S. Patent 5,424,199 (the “ ‘199 patent”), was vacated by the

Federal Circuit on March 13, 1997. Genentech, Inc. v. Novo

Nordisk, A/S et al., 108 F.3d 1361 (Fed. Cir. 1997) (“Novo IT’)

(“Decision”) (Appendix A). Novo J did not reach the issue of

the validity of the ‘980 patent. Novo I] held that the ‘199 patent

was invalid for failing to meet the enablement requirement of

35 U.S.C. § 112,47 1.

2

B. Although The Parent Application Of The ‘199 Patent Was

Filed In 1979, Claims To Enzymatic Cleavable Fusion

Expression Of Human Growth Hormone Were Not Presented

Until 1989.

The ‘199 patent issued from the last of a series of continuing

patent applications that began with the filing by Genentech of a

“parent” patent application in 1979. According to 35 U.S.C.

§ 112, ] 2, a patent applicant must assert “claims” for the subject

matter “which the applicant regards as his invention.” However,

it was not until 1989, ten years after the filing of the 1979 parent

application, that claims were first presented to enzymatic

cleavable fusion expression of hGH.' The undisputed record is

that Genentech never made hGH by enzymatic cleavable fusion

expression prior to the filing of the parent application in July

1979. The Decision clearly recognized that the ‘199 patent is

nothing more than a means by which Genentech impermissibly

seeks to bootstrap a claim to an invention which it neither made

nor has any rights therein:

[T]he specification for the ‘199 patent, which

is the same as the specification for the ‘980

patent, does not provide a specific enabling

disclosure concerning what the new claim

recites, viz, obtaining hGH by cleaving an

hGH-containing protein. That was the

problem avoided by the invention claimed in

the ‘980 patent. The present specification

contains no more disclosure than the ‘980

specification, but this patent now purports to

claim the unresolved problem that the ‘980

1. The enablement requirement must be fulfilled for the ‘199 patent as

of the 1979 filing date of the parent application. /n re Glass, 492 F.2d 1228,

1232 (CCPA 1974). See also 35 U.S.C. § 120.

7

patent overcame. Genentech is attempting to

bootstrap a vague statement of a problem into

an enabling disclosure sufficient to dominate

someone else’s solution of the problem. This

it cannot do.

(Appendix A at 9) (emphasis added).

C. The Holding Of Lack Of Enablement Of The ‘199 Patent

Was Foreshadowed In Novo I.

The holding in Novo II that the ‘199 patent specification

did not enable the enzymatic cleavable fusion expression of hGH

was foreshadowed in Novo I. The issue whether the ‘980 patent

specification, which is identical to that of the ‘199 patent

specification, enabled enzymatic cleavable fusion expression

was raised in Novo I, but was unnecessary to decide because

the Federal Circuit determined that the patent did not claim

cleavable fusion expression. However, in Novo I, the Federal

Circuit did express its doubt as to whether Genentech could

assert a claim to the production of hGH by enzymatic cleavable

fusion expression, because the ‘980 patent specification

“contained little, if any, specific disclosure” as to the production

of hGH by that process:

Genentech consistently argued during

prosecution that the patentable invention was

a method of directly expressing human

growth hormone; it never argued that the

invention included cleavable fusion

expression.

As a practical matter, Genentech’s retreat

during prosecution from its reference to

4

cleavable fusion expression is unsurprising,

given the numerous PTO revections of the

claims as unpatentable over known fusion

protein processes, and the fact that the ‘980

specification contains little, if any, specific

disclosure of how to obtain the expression

product by cleavable fusion expression. It

appears that Genentech wrote a broader

disclosure, but settled for patent protection

for its preferred embodiment.

77 F.3d at 1370, n.8 (citations omitted) (emphasis added).

Unimpressed by the Federal Circuit’s statement that the ‘980

specification, and hence the identical ‘199 specification,

contained “little, if any, specific disclosure” regarding claim to

cleavable fusion expression, Genentech moved quickly, after the

Novo I preliminary injunction was vacated, for another

preliminary injunction based on the alleged infringement of the

‘199 patent. The second preliminary injunction was granted by

the district court. On appeal to the Federal Circuit, the Novo I/

court vacated the second preliminary injunction, and held the

‘199 patent invalid under 35 U.S.C. § 112, J 1, as a matter of

law, because its specification failed to enable those skilled in

the art how to make and use the full scope of the claimed

enzymatic cleavable fusion expression invention without undue

experimentation. (Appendix A at 6).

Having been told twice by the Federal Circuit that the ‘199/

"980 patent specification does not satisfy the enablement

requirement of 35 U.S.C. § 112, J 1, Genentech now turns to

this Court for assistance in its baseless quest to enjoin Novo

Nordisk from selling hGH in the United States. As detailed

below, there is no cause for this Court’s review of this

controversy. ;

5

REASONS FOR DENYING THE WRIT

The Petition must be denied because if fails to raise

questions of patent law that are important to persons other than

the parties, or that impact other patents. Layne & Bowler

Corporation v. Western Well Works, 261 U.S. 387, 393 (1923).

Moreover, the decision of the Federal Circuit in Novo I] was

correct.

Enablement is a question of law that is reviewed

independently by the court of appeals. Applying properly stated,

long-standing rules of patent law, and after a careful review

of the complete factual record, the Federal Circuit vacated the

preliminary injunction in Novo I] because the ‘199 patent

specification contained no details whatsoever concerning how

to carry out the claimed invention, and thus failed to enable one

skilled in the art to make and use the full scope of the claimed

invention without undue experimentation. Accordingly, the

Federal Circuit held, as a matter of law, that the ‘199 patent was

invalid. (Appendix A at 5-6).

The Petition also fails to raise an important question

concerning the Federal Circuit’s determination of invalidity of

the ‘199 patent under 35 U.S.C. § 112, { 1, on the merits,

pursuant to 28 U.S.C. § 2106. After a twelve-day evidentiary

hearing before the district court, during which many witnesses

testified for each side on the enablement issue, the factual record

was “full and complete,” and the issues “thoroughly ventilated.”

Novo Nordisk represented to the Federal Circuit, during oral

argument, that it would not introduce new evidence on the issue

of enablement and Genentech represented to the Federal Circuit,

also during oral argument, that it would introduce new evidence

“only in response to new arguments and new defenses raised by

Novo.” The issue of enablement was therefore ready for final

decision. (Appendix A at 12-13).

6

THE DECISION CORRECTLY STATED AND

APPLIED LONG-STANDING PRECEDENT CONCERNING

THE LAW OF ENABLEMENT.

No cause exists for this Court’s review of the Decision

holding that the ‘199 patent failed to satisfy the requirements

of 35 U.S.C. § 112, J 1. It is beyond debate that the correct

standard of law was applied by the Federal Circuit in invalidating

the ‘199 patent.

Whether a patent disclosure is enabling pursuant to

35 U.S.C. § 112, J 1, is a legal issue that is reviewed by the

Federal Circuit de novo. See Moleculon Research Corp. v. CBS,

Inc., 793 F.2d 1261, 1268 (Fed. Cir. 1986), cert. denied, 479

U.S. 1030 (1987); see also In re Goodman, 11 F.3d 1046, 1049-

1050 (Fed. Cir. 1993) (“Whether Goodman’s specification

satisfies 35 U.S.C. § 112’s enablement requirement is a question

of law which this court reviews independently.”). Factual issues

underlying the legal issue whether a claimed invention is enabled

are reviewed by the court of appeals for clear error. Jn re Vaeck,

947 F.2d 488, 495 (Fed. Cir. 1991). Citing its own precedents,

the Federal Circuit properly stated the correct rule of law

concerning enablement:

[T]o be enabling, the specification of a patent

must teach those skilled in the art how to

make and use the full scope of the claimed

invention without ‘undue experimentation.’ In

re Wright, 999 F.2d 1557, 1561, 27 USPQ2d

1510, 1513 (Fed. Cir. 1993); see also Amgen

Inc. v. Chugai Pharm, Co., 927 F.2d 1200,

1212, 18 USPQ2d 1016, 1026 (Fed. Cir.

1991); In re Fisher, 427 F.2d 833, 839, 166

7

USPQ 18, 24 (CCPA 1970) (“/TJhe scope of

the claims must bear a reasonable

correlation to the scope of enablement

provided by the specification to persons of

ordinary skill in the art.”).

(Appendix A at 6) (emphasis added).

Il.

DESPITE THE BROAD SCOPE OF THE CLAIM OF

THE‘199 PATENT, THE SPECIFICATION, AS THE

FEDERAL CIRCUIT HELD, “DOES NOT DESCRIBE IN

ANY DETAIL WHATSOEVER HOW TO MAKE hGH BY

ENZYMATIC CLEAVABLE FUSION EXPRESSION” AND

HENCE, AS A MATTER OF LAW, THE ‘199 PATENT IS

INVALID.

Claim 1 of the ‘199 patent is of extremely broad scope. On

its face, it seeks to encompass the expression of any fusion or

conjugate protein comprising hGH fused to any amino acid

sequence, and the use of any enzyme that will cleave the amino

acid sequence from the conjugate protein to provide 1-191 amino

acid hGH. (Appendix A at 2-3). It has long been the law that a

patent claim with such broad scope must be supported by a patent

specification with a commensurate degree of disclosure to meet

the enablement requirement under 35 U.S.C. § 112, | 1. See

Amgen, Inc., 927 F.2d at 1212 (“The essential question here is

whether the scope of enablement of claim 7 is as broad as the

scope of the claim.”); Jn re Wright, 999 F.2d at 1561 (citing Jn

re Fisher, 427 F.2d at 839 (“the first paragraph of section 112

requires that the scope of protection sought in a claim bear a

reasonable correlation to the scope of enablement provided

by the specification.”)). Both Amgen and Wright were cited in

the Decision for this very same principle. (Appendix A at 6).

See also In re Goodman, 11 F.3d at 1050 (“Naturally, the

8

specification must teach those of skill in the art how to make

and how to use the invention as broadly as it is claimed.”); Jn re

Vaeck, 947 F.2d at 495-496 (“There is no reasonable correlation

between the narrow disclosure in appellants’ specification and

the broad scope of protection sought in the claims encompassing

gene expression in any and all cyanobacteria . . . . Accordingly,

we affirm the § 112 rejection as to those claims.”).

Claim | also broadly claims “the application of an

unpredictable technology in the early stages of development.”

(Appendix A at 12). Patents that claim subject matter in

undeveloped or unpredictable fields, such as biotechnology and

pharmaceuticals, are held to a well-established higher

enablement standard under 35 U.S.C. § 112, | 1. In re Vaeck,

947 F.2d at 496 (limited disclosure found not enabling for an

unpredictable art); Jn re Fisher, 427 F.2d at 839 (“In cases

involving unpredictable factors, such as most chemical reactions

and physiological activity, the scope of enablement varies

inversely with the degree of unpredictability of the factors

involved.”). The court in Vaeck thus explained:

It is well settled that patent applicants are

not required to disclose every species

encompassed by their claims, even in an

unpredictable art. [citation omitted].

However, there must be sufficient disclosure,

either through illustrative examples or

terminology, to teach those of ordinary skill

how to make and how to use the invention as

broadly as it is claimed. This means that the

disclosure must adequately guide the art

worker to determine, without undue

experimentation, which species among all

those encompassed by the claimed genus

possess the disclosed utility. Where, as here,

9

a claimed genus represents a diverse and

relatively poorly understood group of

microorganisms, the required level of

disclosure will be greater than, for example,

the disclosure of an invention involving a

“predictable” factor such as a mechanical or

electrical element.

947 F.2d at 496 (emphasis added).

Notwithstanding its broad claim to an unpredictable and

undeveloped biotechnology, the ‘199 patent specification

contains no details whatsoever to guide the art worker to practice

the enzymatic cleavable fusion expression of hGH. The Federal

Circuit thus held as a matter of law:

There is no dispute that the portion of the

specification chiefly relied upon by

Genentech and by the district court, column

7, lines 29-59, does not describe in any detail

whatsoever how to make hGH using

cleavable fusion expression. For example, no

reaction conditions for the steps needed to

produce hGH are provided; no description of

any cleavable conjugate protein appears.

(Appendix A at 6-7) (emphasis added). Consequently, the

Federal Circuit also held, as a matter of law, that:

[R]easonable detail must be provided in order

to enable members of the public to

understand and carry out the invention. That

requirement has not been met in this

10

specification with respect to the cleavable

fusion expression of hGH.

(Appendix A at 8) (emphasis added).

Ill.

UNABLE TO DENY THAT THE FEDERAL CIRCUIT

APPLIED THE CORRECT RULE OF LAW, GENENTECH

MISREPRESENTS THE DECISION AND TRIES TO

SHOW THAT THE FEDERAL CIRCUIT ESTABLISHED

A NEW RULE OF LAW.

Genentech concedes that the ‘199 patent specification does

not describe in any detail whatsoever how to make hGH using

enzymatic cleavable fusion expression. (Appendix A at 6). It

argues in response, however, that the Federal Circuit departed

from the rule that a specification need not disclose what is well-

known in the art. (Petition at 5-7). However, the Federal Circuit

took full cognizance in its Decision of the rule that “a

specification need not disclose what is well known in the art,”

properly citing that rule and its precedent, Hybritech Inc. v.

Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385 (Fed. Cir.

1986), cert denied, 480 U.S. 947 (1987). (Appendix A at 8).

Genentech thus misrepresents the Decision by using “[citations

omitted]” in its quotation taken from the Decision, thereby

misleadingly suggesting that the Federal Circuit failed to apply

established precedent in judging Genentech’s specification.

(Petition at 7).

In addition, Genentech fails to come to grips with the fact

that enzymatic cleavable fusion expression of hGH was not well-

known in the art in 1979.? After reviewing the record developed

in the district court, the Federal Circuit concluded that

2. Indeed, if the cleavable fusion expression of hGH had been known

to others within the art, the process claimed in the ‘199 patent would not

have been patentable to Genentech under 35 U.S.C. §§ 102 and/or 103.

EEE VCO

1]

This failure of skilled scientists, who were

supplied with the teachings that Genentech

asserts were sufficient and who were clearly

motivated to produce human proteins,

indicates that producing hGH via cleavable

fusion expression was not then within the

skill of the art.

(Appendix A at 10-11).

As the specification of the ‘199 patent did “not describe in

any detail whatsoever how to make hGH using cleavable fusion

expression,” (Appendix A at 6), the Federal Circuit was then

correct in holding, as a matter of law, that the patent was not

enabled.* Because the ‘199 patent specification “does not

describe in any detail whatsoever how to make hGH using

[enzymatic] cleavable fusion expression,” (Appendix A at 6)

(emphasis added), the Federal Circuit was further correct in

holding, as a matter of law, that the gross inadequacies of the

specification could not be remedied through the wholesale

substitution of an expert’s retrospective and hypothetical creation

of the claimed process. (Appendix A at 10). Accordingly, since

as a matter of law the specification of the ‘199 patent is

inadequate to provide an enabling disclosure for the full scope

of claim 1, conclusory expert testimony on the ultimate issue of

3. The Federal Circuit also held that the district court’s findings on

enablement were not supported by the record. For example, the record of the

preliminary injunction hearing did not support the district court’s finding

that hGH could be produced in useful form, and instead indicated that

determination of how to obtain hGH by cleavable fusion expression “required

further undue experimentation.” (Appendix A at 11). Thus, the preliminary

injunction was property vacated because of the district court’s clear error of

judgment in weighing relevant factors, or its clearly erroneous factual findings.

Joy Tech., Inc. v. Flakt, Inc., 6 F.3d 770, 772 (Fed. Cir. 1993). (Appendix A at

4).

12

enablement is irrelevant. (Appendix A at 11, citing Jn re Buchner,

929 F.2d 660, 661 (Fed. Cir. 1991)).

In each of this Court’s precedents cited by Genentech,

(Petition at 5), the patent-in-suit did contain a detailed

description of the claimed invention. None involved, as here, a

patent that contained no details whatsoever regarding the claimed

invention. Hence, these cases do not aid Genentech.

Thus, Lawther v. Hamilton, 124 U.S. 1, 9 (1888), involved

a three-step process, where “[e]very step of this process was

already understood, although not connected in the manner

pointed out in the patent.” 124 U.S. at 9. In Webster Loom

Company v. Higgins, 105 U.S. 580 (1881), the patent contained

a detailed description of the invention, and the defendants even

acknowledged that the elements of the claimed machine were

well known. 105 U.S. at 587. Hence, the patent was clearly

enabled. In Minerals Separation v. Hyde, 242 U.S. 261 (1916),

the patent specification described in detail a process for treating

ores with oil, but did not specify the precise treatment required

for each ore. 242 U.S. at 271. The Court explained that it was

acceptable to leave “something to the skill of persons applying

the invention.” Jd. at 271. In each of these cases, only minor

details were omitted from the specification, details that were

well-known to the skilled worker.

The Federal Circuit did not depart from this Court’s or its

own precedents, by explaining that while “well-known”

information need not be disclosed in the specification, this is

merely “a rule of supplementation,” allowing a patent application

to omit minor details. While this rule permits the application to

leave “something to the skill of persons applying the invention,”

Minerals Separation, 242 U.S. at 271 (emphasis added), it cannot

be “a substitute for basic enabling disclosure.” (Appendix A at

8). Thus, where as here, the specification utterly lacks an

13

enabling disclosure, the patent must fail, because “the

specification, not the knowledge of one skilled in the art...

must supply the novel aspects of an invention in order to

constitute adequate enablement.” (Appendix A at 8-9).

Indeed, it simply makes sense to say that the “novel aspects”

of an invention cannot be “well-known information” to those of

ordinary skill at the time of a purportedly new invention. To say

the opposite, as Genentech’s urges, is to say that the “novel

aspects” of a claimed new invention can at the same time be

“well-known information,” which stands the logic of patent law

on its head. See 35 U.S.C. §§ 102, 103. The Federal Circuit's

reference to “novel aspects” was therefore not a formulation of

a new rule of enablement. Rather, it was the court’s expression

of a common sense rejection of Genentech’s argument that it

could substitute for the lack of “any detail whatsoever [of] how

to make hGH by cleavable fusion expression,” (Appendix A at

6), the conjectures of an expert trial witness (speaking with the

benefit of nearly 20 years’ hindsight), that enzymatic cleavable

fusion expression of hGH, a technology Genentech claims to

have invented in 1979, could have been developed by others in

1979.

After setting up the strawman that the Federal Circuit

promulgated a “point of novelty” test for enablement, Genentech

refers to a number of Federal Circuit precedents that have

rejected the “point of novelty” test as the standard of non-

obviousness under 35 U.S.C. § 103, and says that, by force of

analogy, the purported “novel aspects” test should be rejected

here. (Petition at 8). This argument is too facile to work. By

referring to the “novel aspects” of the ‘199 specification, the

Federal Circuit was not adopting a “point of novelty” test, but

was merely explaining why the absence in the specification of

any details whatsoever of how to make hGH by enzymatic

cleavable fusion expression was a fatal defect that could not be

cured by expert testimony.

14

Having held that the specification of the ‘199 patent contains

no disclosure to instruct the art worker how to practice the

enzymatic cleavable fusion expression of hGH, the Federal

Circuit provided several examples of what was missing from

the ‘199 patent:

* no description of reaction conditions for the steps needed

to enzymatically cleave a conjugate protein (Appendix A at 8,

10);

* no description of any specific cleavable protein from

which hGH could be obtained (Appendix A at 8, 10);

* no suggestion of “a single amino acid sequence, out of

the virtually infinite possibilities that would yield hGH in a

useful form” (Appendix A at 8); and

* no actual or prophetic example in the patent specification

(Appendix A at 11).

These illustrations of what is missing from the specification

are not new requirements for an enabling disclosure, as

Genentech stridently asserts, (Petition at 8-9), but rather reflect

the Federal Circuit’s determination that, in an unpredictable and

underdeveloped science,

[W]hen there is no disclosure of any specific

Starting material or of any of the conditions

under which a process can be carried out,

undue experimentation is required ....

(Appendix A at 8).

Genentech further argues that the Federal Circuit applied a

subjective test for enablement by ruling that the ‘199 patent

15

should have disclosed standard reaction conditions for known

enzymes. (Petition at 9). The court made no such ruling.* The

reaction conditions necessary for the enzymatic cleavable fusion

expression of hGH were not well known. The record merely

indicated that while general routine methods for the digestion

of proteins (i.e., breaking proteins into pieces or fragments) were

disclosed in a textbook reference, that text did not teach how to

specifically and precisely cleave conjugate proteins to yield

intact, useful proteins. (Appendix A at 7-8). In addition, the

British patent relied upon by Genentech to supplement its

disclosure indicated that the only disclosed enzyme that might

be used, trypsin, would not be useful for the cleavable fusion

expression of proteins such as hGH. The Federal Circuit

correctly observed:

This specification [of the British patent] is

so lacking with respect to the limitation of

paragraph (b) of claim 1 that providing

testimony regarding the skill of the art has

been an exercise in futility.

(Appendix A at 11). Further, neither the ‘199 patent nor

Genentech’s extrinsic references even suggested “a single amino

acid sequence, out of the virtually infinite range of possibilities,

that would yield hGH in a useful form when cleaved from the

conjugate protein.” (Appendix A at 7-8).

4. The Petition states that the “Decision states definitively and without

qualification that a failure to disclose a starting material or process condition

... leads to the unwavering conclusion that the patent is not enabled ... .”

(Petition at 9, n.2) (emphasis added). Here, Genentech has again

misrepresented the language of the Decision. The quote from the Decision is

properly: “when there is no disclosure of any specific starting material or of

any of the conditions under which a process can be carried out, undue

experimentation is required; there is a failure to meet the enablement

requirement that cannot be rectified by asserting that all the disclosure related

to the process is within the skill of the art.” (Appendix A at 8) (emphafSis

added).

16

IV.

GENENTECH’S UNSUPPORTED HYPERBOLE OF

DIRE CONSEQUENCES TO THE PATENT SYSTEM

SHOULD BE DISREGARDED.

Genentech predicts that the Decision will cause

“irreparabl[e] harm . . . by promoting inconsistent district court

decisions and unreliable PTO actions,” and that patent

specifications will now be of “enormous length” because

inventors are now allegedly required to repeat the prior art.

(Petition at 9-10).

Genentech’s prediction is wholly unsupported by the record

and reason. Nothing in the Decision requires patent applicants,

past or present, to “repeat the prior art” in their applications.

The Decision holds that Genentech failed to meet the enablement

requirement by failing to disclose in the specification “any detail

whatsoever how to make hGH by cleavable fusion expression.”

(Appendix A at 6). In fact, according to the standard practice of

patent attorneys noted by the Federal Circuit, if Genentech knew

how to produce hGH by enzymatic cleavable fusion expression,

such a process would have been disclosed, not omitted, from

the specification:

[I]t stands to reason that if the disclosure of

a useful conjugate protein and the method

for its cleavage were so clearly within the

skill of the art, it would have been expressly

disclosed in the specification, and in the usual

detail. Patent draftsmen are not loath to

provide actual or constructive examples, with

details, concerning how to make what they

wish to claim.

17

(Appendix A at 11). The fault with the ‘199 patent lies in

Genentech’s failure to describe “in any detail whatsoever how

to make hGH using cleavable fusion expression.” (Appendix A

at 6).

Ve

THE FEDERAL CIRCUIT WAS CORRECT IN

ADJUDICATING AND DISMISSING GENENTECH’S

CLAIMS ON THE MERITS BY HOLDING THE

‘199 PATENT INVALID AFTER TWO LENGTHY

PRELIMINARY INJUNCTION HEARINGS.

In a baseless attempt to manufacture a question of great

public importance in a dispute that presents none, Genentech

argues that the Federal Circuit’s decision vacating the

preliminary injunction and holding the ‘199 patent invalid for

failing to meet the enablement requirement “changed the

function of an appellate court.” (Petition at 10). Genentech

further asserts that the court “conducted a trial at the appellate

level,” deprived it of “due process,” and denied “its opportunity

to present a complete trial record.” (Jd.). Genentech is simply

wrong on the facts and the !aw, however, because the Federal

Circuit — deciding an issue of law on a record that Genentech’s

counsel conceded was complete as to that issue — properly

exercised its authority under 28 U.S.C. § 2106 in vacating the

preliminary injunction and determining that Genentech’s patent

was invalid as a matter of law.

18

VI.

CONTRARY TO GENENTECH’S ASSERTIONS,

THE FEDERAL CIRCUIT ACTED UPON A COMPLETE

RECORD WHEN IT HELD THE ‘199 PATENT TO BE

INVALID.

The Federal Circuit had the power to make a final

determination on the defense of invalidity because it had a full

and complete record before it. See Susquehanna Corp. v. Pan

American Sulphur Co., 423 F.2d 1075, 1086 (Sth Cir. 1970). In

the Petition, Genentech misleadingly omits the following

representations of counsel made in response to Judge Bryson’s

questions concerning the record below on enablement during

the oral hearing of this appeal before the Federal Circuit:

Mr. Jacobs [counsel for Novo Nordisk

responding to Judge Bryson]:

This court has a very full and complete

record before it. It’s hard to imagine

any significant additional evidence

being adduced at the full trial on the

merits. So this court really has the

benefit of everything it really needs

to have.

Judge Bryson: [to Ms. Ben-Ami]

I don’t want to bind you to a

concession, but you started out by

saying that you thought Novo would

like to produce different evidence,

would like to re-try the case I think

19

that was your characterization. Is there

anything you would introduce at trial

other than what you have introduced

during the twelve days of preliminary

injunction here?

Ms. Ben-Ami [counsel for Genentech]:

Yes. As to the issues that weren't

raised below that they are trying to

raise on appeal.

Judge Bryson:

I see, but the ones that are before us,

for example, written description,

enablement.

Ms. Ben-Ami [counsel for Genentech]:

There might be. There might be.

Because, while we have had discovery

from a prior ITC proceeding, when

you're plaintiff in a patent case you

really need to look at what the

defendant’s defenses are and then plan

accordingly. We were given you know,

a limited number of defenses that

Novo was going to raise and if they

were to change their positions or add

to their positions, which is something

they could do, we would have to have

that ability at some point to put in

other evidence.

(Audio tape of oral argument before the Federal Circuit, dated

December 5, 1996 (emphasis added)).

20

Based on the above representations, the Federal Circuit was

correct to note that “Genentech stated that it would introduce

new evidence at a full trial only in response to new arguments

and new defenses raised by Novo.” (Appendix A at 12, n.5).

After a twelve-day preliminary injunction hearing in Novo II,

and a prior thirteen-day evidentiary hearing in Novo / on the

identical patent specification, the Federal Circuit was also

correct in concluding that “the parties agreed at oral argument

that the issue had been thoroughly ventilated,” and that it was

therefore “appropriate to rule on Novo’s defense of invalidity”

pursuant to 28 U.S.C. § 2106. (Appendix A at 12). The

preliminary injunctions in both Novo / and Novo II were issued

after lengthy hearings at which expert and fact witnesses testified

for several days, hundreds of exhibits were introduced, and

extensive arguments were presented by counsel for the parties

— all of which amounted to twenty-five (25) days of evidentiary

hearings on the identical ‘199 and ‘980 patent specifications.

Importantly, the Federal Circuit held that the district court

“abused its discretion by granting the preliminary injunction

based upon an error of law.” (Appendix A at 13) (emphasis

added). As a matter of law, and after its de novo review, the

court held the ‘199 patent invalid for failure to meet the

enablement requirement of 35 U.S.C. § 112. See Moleculon

Research Corp., 793 F.2d at 1268. Genentech knew the legal

standard of review on this issue when it briefed and argued the

appeal, and when it agreed that it would present evidence at

trial “only as to new arguments and new defenses raised by

Novo,” Genentech permitted the Federal Circuit to decide the

enablement issue on the merits. After twenty-five (25) trial days,

both parties agreed that there was not much left to say about

enablement. That the ultimate decision was unfavorable to

Genentech would seem to be the only motivation for Genentech

to now Say the record is “incomplete.”

21

Genentech also asserts that the Federal Circuit made and

substituted its own fact findings for those of the district court.

(Petition at 11-13). It did not. After a thorough review of the

record, the Federal Circuit held that the established facts

concerning the knowledge of one skilled in the art at the time of

the effective date of the ‘199 application, July 1979, did not

Support the conclusion that enzymatic cleavable fusion

expression, an emerging technology, was well known in 1979,

and that, as a matter of law, the ‘199 specification did not enable

the claim to cleavable fusion production of hGH. The Federal

Circuit correctly held that the specification did “not describe in

any detail whatsoever how to make hGH using cleavable fusion

expression.” (Appendix A at 6-7).

All of these facts were in the record of the district court

and were reviewed, not “found” or “resolved,” by the Federal

Circuit. Because the ‘199 patent was devoid of any details

whatsoever concerning the claimed process, the Federal Circuit

held, as a matter of law, that the ‘199 patent specification lacked

an enabling disclosure such that the hindsight expert testimony

offered by Genentech could not save it. Genentech’s

disagreement with the Federal Circuit’s review of the record is

not cause for review by this Court.

VII.

THE FEDERAL CIRCUIT HAD AUTHORITY UNDER

28 U.S.C. § 2106 TO ENTER JUDGMENT AGAINST

GENENTECH AFTER THE EXTENSIVE PRELIMINARY

INJUNCTION HEARING.

The Federal Circuit properly adjudicated Novo Nordisk’s

defense of invalidity on the merits under the statutory authority

of 28 U.S.C. § 2106, which provides, in pertinent part:

22

The Supreme Court or any other court of

appellate jurisdiction may . . . direct the entry

of such appropriate judgment, decree, or

order, or require such further proceedings to

be had as may be just under the

circumstances.

28 U.S.C. § 2106 (emphasis added). Section 2106 grants

appellate courts broad discretion in the disposition of a case on

appeal. See Susquehanna Corp., 423 F.2d at 1086. Indeed, when

an appellate court determines that it has a complete record before

it, the court has the power to make final determinations. Jd. That

the Federal Circuit had the power to rule on the merits of Novo

Nordisk’s defense of lack of enablement in the context of a

preliminary injunction is beyond controversy.

Numerous appellate courts, acting within the purview of

Section 2106, have entered judgment on the merits after a

preliminary injunction hearing. See Chicago Observer, Inc. v.

City of Chicago, 929 F.2d 325, 329 (7th Cir. 1991) (reversing

preliminary injunction and instructing lower court to enter

judgment in defendant’s favor because the plaintiff “has not

suggested that it holds more evidence it could offer at trial and

we cannot imagine what additional evidence could aid its

cause.”); Glasgow, Inc. v. Federal Highway Administration, 843

F.2d 130, 139 (3d Cir. 1988) (appellate court reversed district

court’s order granting permanent injunction and directed that

the action be dismissed where district court’s finding was error

as a matter of law); National Ass’n of Farmworkers Org. v.

Marshall, 628 F.2d 604, 622 (D.C. Cir. 1980) (appellate court

decided case on review of district court’s denial of a preliminary

injunction because “the merits [we]re ready for review.”);

Susquehanna, 423 F.2d at 1086 (complaint dismissed where the

record on a lengthy seven-day preliminary injunction hearing

in the district court was complete).

23

Other appellate courts have reached similar results without

specifically relying on Section 2106. See Doe v. Sundquist, 106

F.3d 702 (6th Cir. 1997); Diginet, Inc. v. Western Union ATS,

Inc., 958 F.2d 1388, 1395 (7th Cir. 1992) (court denied a

permanent injunction on review of a preliminary injunction,

reasoning that “[w]hen the appeal from a preliminary injunction

brings up dispositive issues of law that can be decided without

a trial, the sensible course is to convert the preliminary-

injunction proceeding into a permanent-injunction proceeding

and go directly to the merits”).

VIII.

GENENTECH’S ARGUMENTS ARE NOT

SUPPORTED BY THE CASES THEY CITE.

Genentech misplaces its reliance on University of Texas v.

Camenisch, 451 U.S. 390 (1981), for its assertion that it was

inappropriate for the Federal Circuit to reach the merits at the

preliminary injunction stage, given the limited nature of the

record. (Petition at 11). Whereas Genentech agreed that there

was no need for additional evidentiary proceedings, including a

trial, on the enablement issue, such was not the case in

Camenisch, where this Court noted:

The proceedings here bear the marks of the

haste characteristic of a request for a

preliminary injunction: the parties have

relied on a short stipulation of facts, and even

the legal theories on which the University has

relied have seemed to change from one level

of the proceedings to another.

451 U.S. at 398.

24

In the present case, the proceedings were lengthy and

complete and the legal theories fully developed. Camenisch

simply does not aid Genentech. Dennison Mfg. Co. v. Panduit

Corp., 475 U.S. 809 (1986), is similarly inapposite. In Dennison,

this Court found that the Federal Circuit did not explicitly apply

a clearly erroneous standard to the district court’s findings on

obviousness, a question of fact, under Federal Rule of Civil

Procedure 52(a). 475 U.S. at 811. In this case, however, the

Federal Circuit made it clear that the ‘199 patent was not valid

because it did not meet the statutory requirement of enablement.

Its ruling was made as a matter of law on an issue of law on a

complete record. (Appendix A at 1, 12-13).

Genentech’s other citations also fail to serve its cause. In

Brown & Williamson Tobacco Corp. v. FTC, 710 F.2d 1165 (6th

Cir. 1983), cert. denied, 465 U.S. 1100 (1984), the district court

refused to rule on the merits because it erroneously held that it

lacked jurisdiction. However, the Sixth Circuit held that, like

here, the record was sufficiently developed for it to reach the

merits. 710 F.2d at 1172-1173. In CES Publishing Corp. v. St.

Regis Publications, Inc., 531 F.2d 11 (2d Cir. 1975), the Second

Circuit held, on review of a preliminary injunction, that since

the main Lanham Act claim was dismissible upon motion, the

state law claims for trademark infringement should also be

dismissed. In addition, even though the court did not have

jurisdiction over the cross appeal, the court could dismiss it on

the merits because, under this Court’s precedents, “on appeal

from a mere interlocutory order, the Circuit Court of Appeals

might direct the bill to be dismissed if it appeared that the

complainant was not entitled to maintain its suit.” 531 F.2d at

15 (citing Meccano, Ltd. v. John Wanamaker, 253 U.S. 136, 140-

141 (1920)). Libertarian Party of Indiana v. Packard, 741 F.2d

981 (7th Cir. 1984), is also similar to the present case. There,

the Seventh Circuit held that “since the plaintiffs’ claims largely

involve questions of law, and since both parties have argued the

7

I aia

25

merits of these claims on appeal,” the appellate court deemed it

“appropriate ... to consider the merits of the plaintiffs’

constitutional claims.” 741 F.2d at 986.

Genentech is wrong in contending that Judge Easterbrook’s

decision in Chicago Observer, 929 F.2d at 329, “adds nothing

to the court’s authority” because the parties there agreed to

submit that controversy on papers. (Petition at 12, n.3). In fact,

however, the Seventh Circuit in Chicago Observer, like the

Federal Circuit here, in fact found that it could decide the case

on the merits because the parties had no further evidence to

offer at trial:

The preliminary injunction must be reversed

because the Observer has no chance of

success on the merits. Indeed, the City is

entitled to judgment without further ado. The

Observer has not suggested that it holds more

evidence it could offer at a trial, and we

cannot imagine what additional evidence

could aid its cause . . . Once it becomes clear

that additional proceedings are pointless, the

court should bring the case to a close.

929 F.2d at 329 (emphasis added).

Genentech’s reliance on then Justice Rehnquist’s dissent in

Moses H. Cone Memorial Hospital v. Mercury Const. Corp.,

460 U.S. 1, 35 (1983) (Petition at 12-13), depends upon a

misleading cropping of the passage therefrom. The sentence

omitted from Genentech’s quotation, but which directly follows

and completes the paragraph, reads:

The Court of Appeals did have before it the

memoranda filed in the District Court but,

26

contrary to the Court’s intimation, ante, at

29, this issue was not argued in the Court of

Appeals. See 656 F.2d 933, 948, n.1 (Hall J.

dissenting) (“No one argued that this court

should decide that issue”).

460 U.S. at 36 (emphasis added). Thus, a proper quote from

then Justice Rehnquist’s dissenting opinion in Moses H. Cone

would have revealed that the dissent was concerned that the issue

decided by this Court was not argued below, a situation very

different than this case. Here, the issue of enablement was

“thoroughly ventilated” at the district court level, with multiple

days of hearing, and was fully briefed and completely argued at

the court of appeals level. Moreover, the majority opinion in

Moses H. Cone, not cited by Genentech, held that because the

court of appeals had full briefs and submissions on the issue

before it, it was justified in issuing an order on the merits under

28 U.S.C. § 2106:

Title 28 U.S.C. § 2106 gives a court of

appeals some latitude in entering an order to

achieve justice in the circumstances. . . . The

Court of Appeals had in the record full briefs

and evidentiary submissions from both

parties on the merits of arbitrability, and held

that there were no disputed issues of fact

requiring a jury trial before a § 4 order could

issue. Under these circumstances, the court

acted within its authority in deciding the legal

issues presented in order to facilitate the

prompt arbitration that Congress envisaged.

460 U.S. at 29. Plainly, then, Moses H. Cone fully supports the

Federal Circuit’s reliance on Section 2106.

27

Genentech also argues that it has been deprived of a right

to a jury trial on the enablement issue, relying on the dissent in

Newell Co., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 775 (Fed.

Cir. 1988), cert. denied, 493 U.S. 814 (1989).5 (Petition at 13).

The Newell case concerned the standards for JNOV in deciding

the obviousness issue, a mixed issue of law and fact. The Newell

majority held that where a general jury demand is made, the

demanding party:

[H]as a right to a jury trial in an action at

law, not a right to a jury verdict. A jury

verdict need not be obtained and may be set

aside under the common law principles

incorporated into the Constitution where

there is no fact issue ... to decide. The

authority of the judge to rule on issues of law

during the course of proceedings is an

essential element of a jury trial.

864 F.2d at 763. The Newell majority also held, that a mixed

law/fact question, such as obviousness, “is ultimately a question

of law decidable by the court in response to a motion for JNOV,”

and is “subject to independent plenary review by” the Federal

Circuit. 864 F.2d at 764. So, too, is the issue of enablement. See

Moleculon Research Corp., supra.

Genentech’s alternative arguments are equally unpersuasive.

First, Genentech claims that the Federal Circuit’s decision

deprived it of due process, citing Gellman v. State of Maryland,

538 F.2d 603, 606 (4th Cir. 1976). (Petition at 11). In Gellman,

the “perilously close ... violation of due process” occurred

because the defendants had not filed a responsive pleading nor

5. The text of the Petition fails to state that Genentech is in fact relying

on the dissent, and not the majority opinion, in Newell.

28

even filed, prior to the hearing, a motion to dismiss. 538 F.2d at

606. Hence, the facts of Gellman bear no resemblance to the

present case whatsoever.

Finally, Genentech’s reliance upon the notice requirement

contained in Rule 65(a) of the Federal Rules of Civil Procedure

is misplaced because Rule 65(a) only applies to consolidation

by trial courts, not appellate courts. As Rule 65(a) does not

apply, and Section 2106 has no statutory or common law notice

requirement, whether or not Genentech had notice of the Federal

Circuit’s intention to make a determination of the legal issue of

enablement is wholly irrelevant.

29

CONCLUSION

The enablement issued decided by the court below is not

an exceptional issue requiring review by this Court. The Federal

Circuit decided the issue as a matter of existing law and

precedent and did not create new tests or standards. There is

nothing in the Decision or record to indicate that the Decision

will have an impact beyond the dispute between the parties.

Moreover, the Federal Circuit correctly exercised its authority

pursuant to 28 U.S.C. § 2106, after two comprehensive hearings

on the enablement issue, to render a decision on the merits.

Respectfully submitted,

ALBERT L. JACOBS, JR.

Counsel of Record

JESSE D. REINGOLD

GRAHAM & JAMES LLP

885 Third Avenue

New York, New York 10022

(212) 848-1000

JOHN C. VASSIL

KURT E. RICHTER

KENNETH H. SONNENFELD

MORGAN & FINNEGAN LLP

345 Park Avenue

New York, New York 10154

(212) 788-4800

Attorneys for Respondents