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

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 1997
- **Citation:** 522 U.S. 963

## Text

No. 97-337 | SEP 22 1997
aii a
Supreme Court of the United States
>—

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

Page
ee i
Parties to the Proceeding ..... 2... 0.0... cc ccc cccss li
Table of Contents ..................eeccceeeecee: iti
ee kk teu kbnwnceees V
IT nn aku enanccsacaccesacs l
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 |

|

|

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

|

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386013_1289%3A2. Public record. Not legal advice.