Main Biotechnology Law Report {BLR 1292} ALZA - Ciba-Geigy - Cygnus Therapeutic Systems - Elan -Nicotine - Drug Delivery Systems

{BLR 1292} ALZA - Ciba-Geigy - Cygnus Therapeutic Systems - Elan -Nicotine - Drug Delivery Systems

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Volume:
11
Language:
english
Journal:
Biotechnology Law Report
DOI:
10.1089/blr.1992.11.136a
Date:
March, 1992
File:
PDF, 7.89 MB
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Language:
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File:
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11

Biotechnology Law Report

136

(Number 2, March-April 1992)

LITIGATION
{BLR 1291} Xoma

Centocor Monoclonal Antibodies
-

-

-

Infringement.

XOMA ENTITLED TO PAYMENT AND
REPORTS ON CENTOCOR SALES
—Decision Follows Xoma's Victory in Patent Infringement Suit
over Anti-Sepsis Monoclonal Antibody
SAN FRANCISCO, CAL. 12/10/91-Xoma Corp. is entitled to receive
payments as well as use and sales reports from Centocor (Malvern, Perm.) as a
result of Xoma's October 1991 victory in a patent infringement suit concerning
the two companies' monoclonal antibodies used to treat septic shock (see <BLR

1239, vol. 10, no. 6, 1991). The order was issued by Judge Robert H.
Schnacke of the District Court for the Northern District of California (see below
in this issue at <BLR 1300>). The jury had found that Centocor's Centoxin
infringed Xoma's patent for monoclonal antibodies directed against
lipopolysaccharide from gram-negative bacteria (for technical information, see
<BLR 1034>, vol. 9, no. 2, 1990).

Although neither firm has received marketing approval for its product from
the U.S. Food and Drug Administration, such approval for Centoxin has been
recommended by an FDA advisory panel. Centocor is selling the product in
Europe (see <BLR 1211>, vol. 10, no. 5, 1991).
Xoma has said that it intends to ask the U.S. District Court to set the amount
of payment. In the future, it may also ask the court to issue an injunction
prohibiting the U.S. sale of Centoxin. In response to the order, Centocor said
that it is pleased that the court denied Xoma's request for an injunction at this
time. The Pennsylvania company has asked for a reconsideration of the jury
verdict or a new trial, and arguments were scheduled for the end of January.
#

#

{BLR 1292} ALZA Ciba-Geigy Cygnus Therapeutic Systems
Delivery Systems.
-

-

#
Elan -Nicotine
-

-

Drug

ALZA, CIBA-GEIGY, CYGNUS, ELAN
AND PARTNERS SQUARE OFF OVER
CONTROL OF RIGHTS TO
NICOTINE DELIVERY PATCH
—Product is Quit-Smoking Aid

NEWARK, NJ 12/20/91-Complex s; kin patches that release nicotine slowly
into the blood of smokers trying to quit have become the focus of a patent battle
involving four companies and their marketing partners. At stake is a market that
may be worth $400 million by 1995.
The U.S. Food and Drug Administration (FDA) approved the nicotine skin
patch called Nicoderm®, made by the ALZA Corp., on November 10, 1991.

11

137

Biotechnology Law Report

(Number 2, March-April 1992)

The Palo Alto (Calif.) company has formed a marketing partnership for the
Nicoderm patch with Marion Merrell Dow, Inc., (MMD) of Kansas City, Mo.

On November 27, the FDA

approved the Habitrol® patch produced by Ciba-

Geigy (Research Triangle Park, NC) under a license from the patent holder, the

University of California. Approval of a third patch, made by Cygnus
Therapeutic Systems of Foster City, Calif, and marketed in partnership with
Warner-Lambert of Morris Plains, NJ, was expected in February. The patch
will be Cygnus' first product. A fourth patch is on the horizon, although FDA
approval is not expected before the end of the year. This patch, Protstep, is
made by the Elan Corporation of Athlone, Ireland, which holds a broad patent
on transdermal delivery of nicotine and is in partnership with American
Cyanamid of Wayne, NJ.
Elan-American

Cyanamid

Seek to Block Sales of ALZA Patch

On November 21, 1991, Elan and American Cyanamid filed suit in U.S.
District Court for the Northern District of California asking for a preliminary
injunction and temporary restraining order against ALZA and MMD to prevent
sales of Nicoderm. In Elan and American Cyanamid's view, the ALZA patch
infringes U.S. patent 4,943,435 (" '435") (see below in this issue at <BLR
1031> for memorandum in support of the motion). A temporary restraining
order was issued.
ALZA and MMD responded on December 2 (see below at <BLR 1302>).
The two firms pointed to ALZA's leading role in the development of drug
delivery systems and MMD's work with therapeutic nicotine products to aid
smoking withdrawal. They also stated that Elan had offered to license its
product to MMD in 1987 and been turned down and that Warner-Lambert had
terminated a collaboration with Elan after a year. The companies filed a
supplemental memorandum three days later (see below at <BLR 1303>; see
also declaration of Dr. James Hunt at <BLR 1034>). ALZA and MMD noted
that the plaintiffs had said they would be irreparably harmed by sales of
Nicoderm, as such sales would prevent Prostep from being the first transdermal
nicotine patch on the market, whereas the defendants showed that Ciba-Geigy
was planning to introduce Habitrol. Thus, even if the ALZA-MMD patch were
not on the market, Elan's patch would not be the first. ALZA and MMD also
asserted that Elan and American Cyanamid had not clearly established the
validity of the '435 patent.
The plaintiffs' reply was filed on December 6, which began "[defendants'
voluminous submission is long on words but short on substance. Defendants
have not undermined in any way plaintiffs' showing that they are likely to
succeed on the merits of their claim have not refuted plaintiffs' showing that
they will be irreparably harmed if defendants are permitted to recommence their
infringement... [and] have not shown that the balance of hardships tips in their
favor" (see below at <BLR 1035>).
...

An answer and counterclaims

1306>).

were

filed

on

January 3,

1992

(see at <BLR

Attorneys for the plaintiffs are Harold A. Stone and Francis M. McKeown
of Gudmundson, Siggins, Stone & Skinner of San Francisco. Of counsel are
John O. Tramontine, Ron E. Shulman, and Mark H. Bloomberg of Fish &

11

Biotechnology Law Report

138

(Number 2, March-April 1992)

Neave of New York. Attorneys for the defendants are John F. Young of
Cooley, Godward (San Francisco) and Thomas V. Heyman, Theresa M. Gillis,
and James P. Jeffry of Jones, Day, Reavis & Pogue of New York.

Ciba Seeks to Block Sales of Both ALZA and Elan Patches
On November 27, Ciba-Geigy filed suit against ALZA and MMD in the
U.S. District Court for the District of New Jersey, alleging infringement of
U.S. patent 5,016,652 (" '652"), assigned to the Regents of the University of
California and licensed exclusively to Ciba. The suit asked for preliminary and
permanent injunctions, as well as damages and costs (see below at <BLR

1307>).

ALZA and MMD's memorandum in opposition was filed on December 13.
In it, they asserted, among other things, that Ciba-Geigy had failed to establish
its standing to bring suit and had not tried to explain how the patent it had
licensed was valid over prior art. This document also outlined the history of
what it called the "Nicotine Patch Wars" (see below at <BLR 1308>).
A

reply memorandum was filed on December 18 (see below at <BLR

1309>). In it, Ciba-Geigy said that "[defendants

...

assert[

...

] that Ciba-

Geigy has brought this motion only to throw a road block in defendants'
inexorable march to the marketplace. Defendants assert that as the 'first team' it
is their destiny to be in the marketplace, even going so far as to accuse CibaGeigy of deliberately trying to lead this Court into reversible error just to delay
defendants' entry into the market."

Acting for the plaintiff is Robert J. Fettweis of Sills Cummis Zuckerman of

Newark, NJ. Of counsel are Hugh A. Chapin, Arthur D. Gray, James
Galbraith, and Thomas J. Meloro of Kenyon & Kenyon (New York) and CibaGeigy attorneys Michael W. Glynn and Jennifer K. Benenson. Acting for
ALZA and MMD are George J. Kenny of Connell, Foley & Geiser of
Roseland, NJ, and Heyman, Gillis, Jeffrey, and Claire Ann Koegler of Jones,

Day.

Adding to the complexity of this litigation, Ciba-Geigy filed suit against Elan
and American Cyanamid on December 2 (see below at <BLR 1310>).
Plaintiffs Rebuffed

On December 13, the California court denied the Elan-American Cyanamid

application for a preliminary injunction and lifted the temporary restraining
order. District Judge J. P. Vukasin, Jr., wrote that the plaintiffs had failed to
satisfy the burden of showing a probable success on the merits (see below at
<BLR 1311>).

The response by the court in New Jersey came on December 20 in a bench
memorandum and order by District Judge Alfred M. Wolin, marked "Not for
Publication," denying the Ciba-Geigy application. Judge Wolin noted that there
is "voluminous prior art in the area of transdermal patches for administration of
drugs, including nicotine, which have not been considered by a federal court in
an adversarial setting" and wrote that Ciba-Geigy had been persuasive in
showing a likelihood of success on the merits. Wolin also stated that the
infringement and noninfringement arguments are "hypertechnical," such that a

11

Biotechnology Law Report

139

(Number 2, March-April 1992)

final decision will require a "thorough reading of the claims, specifications and
file histories" and probably "expert testimony subect to cross examination." He
ordered the case to proceed (see below at <BLR 1312>).
#

#

#

REGULATORY
{BLR 1293} FDA Disclosure John D. Dingell.
-

-

KUZAK ROCK FINDS NUMEROUS DEFECTS IN FDA
INFORMATION DISCLOSURE POLICY
—Law Firm Unable to Complete Study Because of Fears about
Access to Agency Secrets

WASHINGTON, DC-Kuzak Rock & Campbell has submitted a report to
Commissioner David Kessler of the U.S. Food and Drug Adminstration (FDA)
criticizing the agency's policies (or perhaps lack thereof) on disclosing
information.
Dr. Kessler had instituted the review by the Washington, DC, law firm as
part of his Integrity Initiative. However, Kuzak Rock had been unable to
complete its investigation because John D. Dingell (D, MI), Chair of the House
Subcommittee on Oversight and Investigations, suggested that the firm's access
to agency secrets was itself improper.

Nevertheless, from what it did learn, Kuzak Rock produced a report of more
than 200 pages, "FDA Safeguards against Improper Disclosure of Financially
Sensitive Information," which describes the agency's present policies as vague
and inconsistent. The firm also noted that various parts of the FDA apply the
policies in different ways. It pointed out in a footnote that even though the
scientific staff is very closemouthed, Kessler himself recently revealed the
pending approval of an AIDS drug on a national television broadcast.
The report makes several recommendations.

Among them, the agency:
(1) Should "modify its existing regulations and practices so that it may
publish notice of and otherwise permit its staff to disclose publically the
existence of all pre-rriâfket approval applications and petitions and completion of
certain 'milesones' in the product approval process."
...

The report recommends dissemination of this information on an electronic
bulletin board and by monthly publication in Drug & Device Product Approval
Listing. It also suggests weekly publication of a list of the scheduled meetings
of drug advisory committees. At present, the FDA has tried to prevent such
notice in order to thwart Wall Street analysts.

HAROLD A. STONE

TABLE Of AUTHO»TTTIg

GUDMUND80N, SI5CINS, STONE
One Embarcadero

i SKINNER

£asa

Cantar, Suite 1350

San Francisco, California 94111
Tal.i (415) 391-4200

CUM
efclM

JOHN O. TRAMOHTINE
RON E. SHULKAN

Powd«r go.

Auqat.

NARK H. BLOOKBIRO
FISH t NEAVE
875 Third Avenue
New York, New York 10022-6250
Tel.: (212) 715-0600

Inc.

642

(Fad.Cir. 19»5)

m.
.

John HtttiHnom t..peint«.

v.

506

r.Supp.

(N.D.N.Ï. 19*6)

.

Johnaton

v.

SttT.C.

v.

776 F.2d 320

H.H.

(Fad.Cir. 1989)
Robartaon. Co. v. United Stttl Dtcfc. Inc.
820 F.2d 384 (Fad.Cir. 1987)

BESTRATNTNC

ALZA CORPORATION and
MARION MERRELL DOW INC.
:

DATE:
TIME:
COURT:

.

.

Hugh«« Alret-»ft Co.

717 F.2d 1351

MEMORANDUM IM
SUPPORT OP MOTION
FOR PRELIMINARY
INJUNCTION WITH
TEMPORARY

9

tvac com.

Hvbrltech Inc.

Plaintiff«,

.

.

Civil Action NO.
C-91-4108-JPV

ELAN CORPORATION PLC, and
AMERICAN CYANAMID COMPANY,

10

Trie..

(Fad.Cir. 19«5)

885 F.2d 1574

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
SAN FRANCISCO DIVISION

14

v.

Dataacopa Corp.

ELAN CORPORATION PLC
AMERICAN CYANAMID COMPANY

11

Tnr...

Starllaht Archarv and Pro Lina Inc..
804 F.2d 135 (Fad.Cir. 1916) .

Carella

Attorney« for Plaintiff«

Dafendenta.

Ir.co Chaule«]

v.

773 F.2d 1230

v.

849 T.2d 1446

v.

united 8»at«i,

(Fad.Cir. 19»3)

Abbott

.

5
10

10,11

Tjilnirit^ri.i.

(Fad.Cir. 1988)

.

9,11,

13,15

Inc. V. Hugh»« Tool Go.
Bajth Tntirn.
718 F.2d 1573 (Fad.Cir. 1983) .

11

Wind.urflno mum. Tna. v. AUF, me,,
782 F.2d 995 (Fad.Cir. 1986) .

15

.

.

ORDER

I 282

.

9

35 D.S.C. i 283

.

1,»

35 U.S. C.

x

RUla 65, F.R.Civ.P.

"Devana, 1
paragraph in,

_,

Ex.

_"

1

refera to tha lndieatad

and tha indicated exhibit attachad to, th«

Affidavit Of John s. Devane, aubaittad herewith.

(Table

of Contents omitted)

«DouQan, 1

paragraph in, and

_,

Ex.

_"

rafara to tha indicated

th« indicated exhibit attachad to, tha

Affidavit Of Robart A. Douaan, aubaittad haravith.

PLAINTIFFS' MEM. IN SUPPORT
MOTION FOR A PRELIMINARY INJ.

"Fritiky, \ _"

rafara to tha indlcatad paragraph

in tha Affidavit Of Edward V. Frittfcy, aubaittad haravith.

"McVay, 1 _* rafara to tha indicatad paragraph
tha Affidavit Of Kenneth w. McVey, aubaittad herewith.

in

issues to a» nrcingp

I.

INTRODUCTION

Plaintiffs Elan Corporation pic ("Elan") and
American Cyanaaid Company ("Cyanaaid")
antar a

move

preliminary injunction, pursuant

the Patent Laws

(Title

35

Rule« Of Civil Prooedure,

U.S.C.) and
enjoining

to

("tha

to

'435

that tha

infringe

Have

1.

likelihood of

defendants
th«

'435

United Statea Patent No. 4,943,435

plaintiffs demonstrated
on

not

plaintiff«

plaintiff»

be

4.

by
a

»kin of

from

or

provide

to

Ex.

they

nicotina

denying thia motion?

an

extended

by

period

associated with cassation of

patch product

within tha last few days,
of

approval

known

begun

aa

to market a

plaintiff«

11 4-5), and that defendant«

pharmacies

arc

or

«

435 patent (Devane, «,«. 16-26).

enjoined
i«

so

harmed if defendants

continuing

to

because

plaintiffs

have

dermal nicotine

patch product

(Dougan,

or

about tha

4).

plainly infringe»

the

Plaintiffs will be
are not

infringe

from

begin,

to make Nicodara

for retail eala in

Defendant»' Nicoderm product

irreparably

(Devane,

is about to

to wholesalers

«asking

.

informed that

war«

to manufacture Nicoderm

EX. C), that defendant MMD ha« begun,

available in

transdernal

"Nicodara" (Dougan, J 3)

first weak of December 1991 (Dougan,

PLAINTIFFS' MEM. IN SUPPORT
MOTION FOR A PRELIMINARY INJ.

of tine for tha

A).

«hipping and/or sailing Nicodara
be served

a

patented product ia

The

controlled relea«« of nicotina to the

had obtained FDA

defendant Alza ha«

public interest

of the '435 patent.

Within tha past two weeks, defendants announced

infringing

of defendant«?

'435

'435 patent ia directed to

alleviating symptoms

smoking (Devane,

haraed if

herdahip« tip in favor

patch.

for

pati«nt

a

purpose of

reaaonabla

of the

the exclu«ive license« under the '435

Tha invention of the

that

irreparably

preliainarily enjoined

will th«

Cyanaaid ia

infringement
owner

patent.

the merit« of their claia that

Doea the balance of

or

Plaintiff Elan i« the

daaigned

tha Court:

action for

an

tranaderaal nicotine

patent?
3.

granting

("MMD")

fro»

infringed the '435 patent?
Mill

are

of

défendante Alza Corpora-

four ieeue« be conaldered

eucceas

defendant« have
2.

Plaintiff

283

Resolution of thie motion requires

patent").

following

patent.

Section

Rule 65 of the Federal

tion ("Alia") and Marlon Merrall Dow Inc.

continuing

Thi« i«

thia Court to

the

preliminarily
'435 patent.

developed their
known

as

own

"Prostep",

Thi»

trans-

for which

plaintiffe anticipate receiving
plaintiffe

this year, and which

early

1992

permitted
before

infringe

patch la adainistared

begin marketing by

expect to

If defendant«

are

market, plaintiffs will

suffer an

difficult, if

quantify (Fritzky, 1

referred to

above.

will be

significant

suffer any

Niooderm

public

The

of this «otion.

secured

maintained by

consuming public.
an

by patents:

Tha

the

right

th«

will

«tatutory

to exclude others froa

on

granted.

patient'a

Ex.

depot, and (3)

(2)
a

a

depot

of nicotine to maintain

quantity

or nora,

(l)

patch
a

a

for a total time
to cover

backing layer

rate-controlling

the flux of nicotine froa the

meana

for

patch (Devane,

A).

Nicodara Product

Infringing

Défendante'

B.

of

receipt

approval

fron the TDA to market Nicoderm (Dougan,

shortly thereafter, plaintiff« l««rn«d that defendant

1 3).
Alza

was

manufacturing Nicodara

about to

or wa«

and that defendant MMD wa«,

begin, shipping and/or selling

Alza to wholeaalar«

(Devana,

Ex. C; Dougan,

Nicoderm made

«,J 4-5).

Plaintiffs also hav« l«arn«d that Nicoderm ia acheduled to
be

in

ning

pharmaciee
in

and available to be «old at retail

or about the

firat week of December

begin-

(Dougan, J4).

Plaintiff« have received coplea of MMD literature

'435 Patent

a

controlling

by

plaintiffs respectfully request

The transdermal nicotine

placad

three elements:

1 and 11

Within the last two week«, defendant« announced

STATEMENT OF FACTS

A.

the nicotine

The

generally

patch is

patch claimed in claims

comprises

sufficient

of 12 hours

injunction.

preliminary injunction

a

through tha patient's skin.

uaaful flux of nicotine from the

Th«

th« patent.

that their aotion be

i«

«at forth

interest also will be served by grant

Entry of

of the '435 patent

period

nicotina

as

the flux (Devana, Ex. A).

The tranadaraal

a

time

Nicoderm is not yet available,

For these reasons,

II.

as

defendants will not

public interest in «nforcing

tha

infringing

harmed

Defendant»' efforts to market

to th«

yet been «old,

statu» quo would be

right«

granted,

hern.

just beginning.

are

and has not

promote

irreparably

If thi« motion i«

If thia notion ia

défendante.

as

ovar

The released nicotine enters

rate of release of nicotine froa the

containing

hardships tips decidedly in favor

preliminarily «njoining

denied, plaintiff

impossible,

to

6; McVey, 1 10).

The balance of
of

not

blood«traan

patient'a

irrecoverable loss of salaa, market share and other danag«,
the extent of which will be

patient

to the

ia released froa the patch.
the

marketing Nicoderm

th« '435 patent by

antera th«

Prostep

approval by the end of

3; McVey, 16).

(Fritzky, f
to

FDA

»kin.

patch

of the '435

patent

Nicotine contained in the

which, thay understand, describes
the performance of the

the Nicoderm

product

product (Devane, \\ 6-15,

Ex.

and

B).

Plaintiffe' technical expert, Dr. John G. Devane, has
studied thi« literature and th« '435 patent
Deven« aleo has

compared

(Id.).

product

the Nicoderm

as

tiff» hav« not yet received approval from the FDA due

Dr.

admini»tr»tiv« delays within that agency (McVey, H 4-6).

described

in the MMD literature with each of claia« 1 and 11 of the
4 35
the

Nicoderm product literally contains each and every

element recited

in claiae l end 11

Johnston

IVAC Corp.

v.

Nicoderm,

(Id.).

885 F.2d

1574,

1577

new

Plaintiffs' Prosteo Product
A«

told that the

developed their

own

transdermd nicotina

designed

and

patch product,

(McVey, î lOd).

And,

Elan also ha« Invested mor« than

$5

million to develop and build facilities necessary to manufacture

Prostap (Id.).

This

greater than $13 million

$10.4 million (Id.).

first to market in

patch product.
vu

Th« N«w

a

be

the

tran«d«rmal nicotina

Drug Appliootion ("NDA")

on

Pro«tep

filed with the FDA in June 19»», almost two years before

d«f«nd«nta filed their NDA

H 4, 9).

on

Despite thi» n«arly

Nicoderm in March 1991 (McVey,
two

than

filing

ita NDA in 1989,

the FDA to fil« the NDA

The

one

new

a

group failed to act

At that

year.

with

point, Elan

on

was

group had redefined the necessary clinical

requiring Elan

to

design

Th«»« tests were

«nd carry out

new

completed and the data

th« NDA

wa«

flr«t submitted (McV«y, 11 3-6).

requirement«

a

effect,

midstream
wae

Thus,

even

though

new

defen-

later, they sailed through th« approval

apparently
Elan

group had established their

for clinical teat«.

dants filed much

process,

new

because

they did not suffer any delay

change of protocol,

penelised

for

a«

did Elan.

having filed

In

year» before

defendants.

Plaintiff« also have mad« great effort« to
th« United state«

after

by

Defendants did not file their NDA until March

from

investment exceeds Elan'* total earning» in th« last fiscal
year, which totalled about

new

1991, long after the

than Í8 million to design and develop Prostap

(McVey, «, 9;

submitted to the FDA in June 1991, almost two year» to th«

day aft«r

Elan, alone, ha«

ment in Proetap ha« been substantial.
»ore

have

By any a«»»ur«, plaintiff«' invest-

Proetap (McVey, 12).

invested

thus

more

clinical teat«.

previously noted, plaintiffs

told

wae

group within the agency.

trials,
C.

particular,

In

Elan

Elan'a NDA for

(Fed.Cir. 1989).

months

Dougan, 13).

plaintiff

claim» 1 and 11 of the '435 patent.

therefore, infringes

approval in eight

Defendants received

Dr. Devana ha« concluded that

patent (Id., JJ 17-26).

to

year headetart,

plain-

Notwithstanding

tha

delay« encountered in

plaintiff» anticipate receiving approval

for

th« FDA,

Proatep by th«

•nd of thi» y««r, and th«t marketing of Prostap will b«gin
in January 1992

(Fritzky, 1

3; MoVay,

1 6).

The Market For Nicotine Patch Producta

D.

There ara

State«,

United

approximately

million of whom would like

38

ing (Fritzky, 1 5).

the m«rk«t

Thu«,

patch product« in th« United
aid, which

h»s th« exclusivo

to

potential

right«

$140 nillion in tha first year

—

in th«

for nicotine

Cyana-

them,

aera

sale« of approximately

provided, however,

to

the

(Fritzky, 1 6b).

infringe

If defendants «re

product

that

the

permitted to

Prostap is available, first year Prostep sale«

product

to

drop

from $140 million to $55 million

B«ing

th« number of smokers i« great,

ia temporary.

patch product

on

patch

product.

th« first available

skeptical,

and would b«

markat.

advantage is

Although

reasons.

their presence in th« markat

Those who fail to

unlikely

to return to th«

become

cu»to««rs for

other

market ehara.

prescription products,

the

a

patch product

on the

market
—

great advantage

prescribe the patch

market (Fritzky, 1 6c).

which currently represents

—

obtaining exclusiva

»ales

relationship«

share even after others enter the markat.

Later «ntrant«

can

regain lost

«mar«

the market leader in

expenditure would

only by substantially

promotion.
ultimately prove unprofit-

advertising

and

because the second «ntrant will be »addled

profit margins (Fritzky, 1 6c).

Indeed, plaintiff Elan projecta that if Proatap is the
is

Thia

in the managed health

where the first entrant stands

with lower volume« and lower

becauaa unlike moat

nicotine

.

greater market

able, however,

commanding

a

be expected to

particularly pronounced

Suoh « levai of

enjoy

patch

bout 40% of the market

outspending

1 «»)•
so

(Fritzky, 1 6c)

brand is requested, the

no

Th« flr»t «ntrant will continue to enjoy it»

the second entrent in the market is diminished (Fritzky,

Thia is

the market ia

(Fritzky, 1 6d).

nlootin«

The first entrant in tha markat alao will

can

segment of th«

stop after

patch product likely will

Thu«, the number of potential

oar«

when

on

prescribed before, which in all likelihood

th« beet chance of

th« markat will have no further need for

the next available

using

patch

«top smoking after using th« first

Thos« who

have

will be the first

th« fir»t entrant in th« nicotine

market 1« of critical importance for many

physicians

that they

(Id.).

The firat product

the market will have

on

Conau-

familiarity with

achieved through formal advertiaing and

Moreover even

becauaa

result of

a

a«

that will be the best known

first product

expected

are

name

amoking

for, and have prescribed

brand of nlootin« patch product.

informal word of mouth.

patent and to market Nicoderm before

the '435

«pacific

a

will «elect that brand

Prostep is the first transdermal nicotine patch to reach th«
market

smoker» will ask

well known,

are

Consumers have no need for medical

becauaa the health risks associated with

diagnosis

atop emok-

Prostap in the

to market

driven product.

consumer

smokers

states 1« tremendous.

anticipate« Prostep

United States,

million

50

a

second

product

on

the market,

it will fail to recoup the

substantial investment it has made in its

facilities (McVey,

validity-challenger

aanufacturing

has 'so carried his burden

1 10b).

The Federal Circuit also ha» mad«
III. ARGUMENT

The patent owner's

infringing

right

activities is set forth in 35 U.S.C.

patent

injunction

must establish its

owner

in

Abbott Laboratories.

849 F.2d 1446,

"(1) reasonable likelihood of
(2) irreparable harm; (3) tha
tipping in its favor; and (4)
on

tha

public

success on

balance of hardships
the impact of the

I 282.
SMBC.

th«

Inc..

776 F.2d 320,

323

United State«. 717 F.2d 1351,

1361

on

ment to

statutory presumption

motion for
an

a

injunction

presumptions

of

o

validity is applicbecau»» entitle-

preliminary injunction

"i» d«t«rain«d in th« contaxt of the

and burden« that would inhere at trial

H.H.

merits."

'435 Patent la Valid

Robert-son.

388

Co.

v.

on

pat«nt

a

infringed?

Aa to

35 U.S.C.

fData«cope

Corn,

success

tha

^

There, the Federal

?0

on the

change the "immutable allocation

proving invalidity" by

burden of

marit«, that

to the

(Fed.Cir. 1985)):

Ths presumption that the
"'Patents are born valid.
patent is valid, 35 U.S.C. 5 282, continues until the

477 U.S.

242

r«»ponding

(1986)).

to this

v.

»

the

Q\

convincing

^~.

LlbtrtY Lobby. Inc.,

Thus, if defendant« here, in

preliminary injunction motion, fail

adduca evidence eufficient to show that

they

are

"^

does not

challenger of

claar and

evidence (Id., referring to Anderson
v.

o
O

United Steel Deck, Inc..

(Fed.Cir. 1987).

strut« likelihood of

to b« valid.

A« th« Federal Circuit has held

preponderance

only

of the evidence.

Circuit explained that although tha moving party must demon-

basic liability issue« in

patent is presumed

The

1.

820 F.2d 3S4,

There I« A Strong Likelihood
That Plaintiff« Mill Succeed
at, The Merit« of Thmlr Claim

validity,

a

need

(Fed.Cir. 1983).

able

intar««t.

is th« patent valid and ha« it been

oh:

v.

the clear and

satisfy

invalidity, plaintiffs

burden to prove

The

requested."

«re two

defendant« must

Huches Aircraft Co.

the merits;

"These factor», takan individually, ar« not
rather, th« district court must weigh and
measure eech factor againet the other factor« and
against tha form and magnitud« of th« relief

There

convincing

(Fed.Cir. 1986).

infringeaent by

establish

clear and

v.

dispositive;

B.

convincing

(Fed.Cir. 1988)):

1451

138

no

Starlight Archery and Pro Line Inc..

v.

Although

preliminary

a

of four factora (Hvbrltech Inc.

light

injunction

right

to

135,

804 F.2d

5 283:

"The several courts having jurisdiction of case«
under thi« title may grant injunctions in accordance
with the principias of equity to prevent the violation
of any right secured by patent, on such terms as the
court deems reasonable."

The

CftrsUa

evidence.

injunction against

to an

to

plain that defendants have

proving invalidity by

the burden of

The Applicable Legal Authorities

A.

as

persuaded the d«ci«ionaak«r that the patent can
longer be accepted aa valid'" (citation« omitted).

have

likely

z
=

3

<T
to
to

^j

5£

I
I

clearly and convincingly, that

prov«,

invalid, then plaintiffa

the '43 5

will have demonstrated

of suco««« on the issue of

patent i«
a

"It is well-««ttl«d that, because th« principal
valu« of a patent is its statutory right to exclude,
th« natur« of th« patent grant weigh« «gainst holding
that monetary damage» will always suffice to maka the
patentee whole."

likelihood

validity.

Plaintiff«
Defendant» Infringe The '435 Patent

2.

dante'

infringement by

Hughes Aircraft Co.

Where,

th« likelihood of

quite strong.

773 F.2d

Chamícela.

717 F.2d at 1361.

product,

the accused Nicoderm
is

prapondarance of the evidence.

success

See Atlas Powder Co.

v.

succeeding

of

on

permitted

on

Ireco

1230, 1233 (Fed.Cir. 1985).

As

harm

party

a

the merits of its
fSmlth intern.

moving

strong likelihood that it will succeed

claim, irreparable

Inc.

v.

Hughes

harm will ba

Tool Co.

,

718 F.2d

on

presumed

manufacturing
cepacity

1456-57:

PLAINTIFFS' MEM. IN SUPPORT
MOTION FOR A PRELIMINARY INJ.

supra.

849 F.2d at

a

are

permit-

in the United States
In that

Elan also stands to lose
revenue

event, Elan'«

new

recovar

it« investment

markat before

Prostap (McVey, 1 10c).

represents approximately

approximately

i« fir«t

on

four yeara,

profit»

approximately $30

million

in the first year alone if Nicoderm enter« th«
This

projected

4 5* of Elan's total revenu«

lose

Inc.

product

and Elan will be unable to

U1BXM, 773 F.2d at 1233):

Hybrltech

they

facilities for Prostep will operate below

th« lest fiscal year (Id.).

"If monetary raliaf were the »ole relief afforded by
the patent statute then injunctiona would be
unnecessary and infrlngers could become compulsory
licensees for as long a» the litigation lasts."

compelling

will suffer if defendants

enters the market.

Th« Federal Circuit also ha» noted that (Atla» Powder Co..

effect is

have adduced

need not

in tho«e facilitle« (McVey, 1 10b).

in

"The very n«ture of the patent right i« the right to
To hold otherwise would be conexclude others....
trary to th« public policy underlying th« patent law«."

»ana

Plaintiffs, however,

IUCX4, PP• 7-8, there will be

explained,

Prostap

1573, 1581

(Fed.Cir. 1983)):

To th«

atrong likelihood

substantial and irrecoverable reduction in plaintiffs' sales

before

The Federal Circuit haa held that where the

of

their infringement.

to continue

ted to sell their Nicoderm

has shown

a

of, and markat ahara for, Proatap if defendants

Plaintiffa Will Be Irreparably Harmed

C.

presumption

they have shown

the merits.

irreparable

avidance of
are

on

presumption because they

rest on the

Dr.

as

here, the asserted claim« literally read

Devane has shown

infringement

a

supra,

harm because

Irreparable

Plaintiff» must establish the likelihood of défen-

entitled to a

are

Similarly, cyanamid

loss

during

stands to

$85 million in the fir»t y«ar if Nicoderm

th« markat

(Tritzky, 1 6b).

Cyanamid anticipate»

if Prostep is sscond

on

a

And,

over the next

$205 million reduction in

the market

(Id.).

explained

A»

Elan's goodwill reata

in the
on

McVey Affidavit, H

lta demonatrated

ability

10e and

f,

develop

to

provided

therefore
tion.

innovative drug delivery system products ahead of the

competition,
products

and to license the exclusive

rights

lsrger pharmaceutical corporations,

to

are

then able to

markat ahead of the

competition.

Cyanamid, which

bring

If défendante

are

mitted to market Nicoderm before Prostap, Elan's

Cyanamid, will

have been

markat with the niootine

immeasurable
the

damage
of

essence

prevented

from

being

reputation

plaintiffs' right

to

above.

per-

suffer

licenaee,

first

and

goodwill.

under the

'435

decidedly in

overturning

the

on

tha

And,

patent

plaintiffs. If this motion
irreparably harmed aa explained

favor of

plaintiff will be

Elan will suffer

patch product.

to its

as

products

those

for

injunc-

Here, however, the balance of hardships tips

to those

such

grounds

no

Id. at 1458.

If defendants are

harm.

significant

Nicoderm

are

and has not

yet

been

A

sold,

little,

denied,

at

length

will not

efforts to market

Defendt-.its'

just beginning.

dants will suffer
business.

enjoined, however, they

is

Nicodsrm is not yet available,

to the

if any,

consuming public.

disruption

preliminary injunction will

Defen-

of thsir

maintain the status

quo.
—

the

to exclude others from

right

all

producta

covered

making) using

or

sailing

will have been irrep-

by the patent
—

arably

diminished.

But even if defendants could show substantial

shut down

The Balance Of Hardship»
Tin« Tn Plaintiffs' Fsvcr
The Federal

to

Circuit haa held that it is

unneces-

sary for tha movant to demonstrate that the balanoe of

hardships tips

in its favor invlii-<t-«nh

Tnn.

jutmxa,,

849 F.2d

"[W]e never have required, aa a prerequiaite to
awarding preliminary injunctiva relief, that tha
district court expressly find the existence of this
factor."

The trial court's determination in that

party

has

infringe

a

clear

advantage'"

on

the

case

question

that "'neither

of

hardship

the

simply
'435

is thus

experience

to the

observed in Auoat.
642

point

of

having

patent.

no more

Inc

F.Supp. 506,

to

a

the result of their conscious choice

Any hardship defendants might

than the foreseeable result of

their choice of business alternatives.

InCju,

at 1457):

even

part of their business, such hardship is, in

fundamental way,
D.

business,

of their

disruption

v.

509

As tha Court

John Maizallnoua Associates.

(N.D.N.Y. 198«):

"Defendant has no legal right to continue to profit
from sales which appear at this stage in the liti-

gation

to infringe plaintiff's patent....
extent the preliminary Injunction poses a

To the

hardship to
excessively dependent

defendant because it has become
on sales of its coaxial connector this poses

no

bar to

injunction where it appears that
those salas infringe plaintiff's patent rights....
Rather, halting defendant's unauthorized use of plaintiff's patent is consistent with the Federal Circuit's
the issuance of an

view that

trespasses should

(Citations omitted.)

be halted

'cold

turkey.'"

See also Windsurfing Intern.

Inc.

AMF.

v.

Inc..

782 F.2d

995, 1003 n.12 (Fed.Cir. 1986):
build a business on a product found
infringe cannot be heard to complain if an injunction against continuing infringement destroys the
"On* who elects to

to

busin«««

elected."

«o

The Public Interest
Favors An Injunction

E.

The

public

has

a

compalllng

patents against infringers

to

right conveyed by patents:

the

appropriating

the invention.

in Hvbrltech Ino.

intarest in enforcing

give life

right

COOLEY GODWARD CASTRO
HUDDLESON & TATUM
JOHN F. YOUNG
One Maritime P!aza-20th Floor
San Francisco, C A 94111
Tel: (415) 981-5252

JONES, DAY, REAVIS & POGUE
THOMAS V. HEYMAN
THERESA M. GILLIS
JAMES P. JEFFRY
599 Lexington Avenue
New York, NY 10022
Tel: (212) 326-3939

Attorneys

to the essential

to exclude othera from

for Defendants
MARION MERRELL DOW INC.
and ALZA CORPORATION

Ae the Federal Circuit noted

UNITED STATES DISTRICT COURT

supra, 849 F.2d at 145«:

NORTHERN DISTRICT OF CALIFORNIA

respect to
proceeding,
that tha public interest in «nforcing valid patent«
outweighed any othar public interest considerations."

"Here, the district court found, with
most of Abbott's products involved in this

i«

There

no

countervailing public

défendent« to continue

permit

continuad

pecuniary

infringing

Interest in

intereats of tha

permitting

the '435 patent.

infringement would only

infringing

serve

ELAN CORPORATION PLC, and
AMERICAN CYANAMID COMPANY,

th«

Plaintiffs,

To

v.

privat«,

défendante.

ALZA CORPORATION, and MARION
MERRELL DOW INC.,

Civ. No.

C-91-4108-JPV
Date:
Time:
Courtroom:

December 2, 1991
10:00 a.m.
2

Defendants.
IV.

CONCLUSION
For all of the

raapectfully r«quest
their

foregoing

reasons,

that their motion be

proposed Preliminary Injunction

plaintiffs

granted,

be entered

and that

DEFENDANTS' MEMORANDUM IN OPPOSITION TO
MOTION FOR PRELIMINARY INJUNCTION

by the

Court.

Respectfully submitted.
(Table
GUDNUNDSON, SIGGINS, STONE

t

SKINNER

Dated: November

21,

1991

^^.ro^A^^nT ¿/"WL

of Contents

omitted)

See also Windsurfing Intern.

Inc.

AMF.

v.

Inc..

782 F.2d

995, 1003 n.12 (Fed.Cir. 1986):
build a business on a product found
infringe cannot be heard to complain if an injunction against continuing infringement destroys the
"On* who elects to

to

busin«««

elected."

«o

The Public Interest
Favors An Injunction

E.

The

public

has

a

compalllng

patents against infringers

to

right conveyed by patents:

the

appropriating

the invention.

in Hvbrltech Ino.

intarest in enforcing

give life

right

COOLEY GODWARD CASTRO
HUDDLESON & TATUM
JOHN F. YOUNG
One Maritime P!aza-20th Floor
San Francisco, C A 94111
Tel: (415) 981-5252

JONES, DAY, REAVIS & POGUE
THOMAS V. HEYMAN
THERESA M. GILLIS
JAMES P. JEFFRY
599 Lexington Avenue
New York, NY 10022
Tel: (212) 326-3939

Attorneys

to the essential

to exclude othera from

for Defendants
MARION MERRELL DOW INC.
and ALZA CORPORATION

Ae the Federal Circuit noted

UNITED STATES DISTRICT COURT

supra, 849 F.2d at 145«:

NORTHERN DISTRICT OF CALIFORNIA

respect to
proceeding,
that tha public interest in «nforcing valid patent«
outweighed any othar public interest considerations."

"Here, the district court found, with
most of Abbott's products involved in this

i«

There

no

countervailing public

défendent« to continue

permit

continuad

pecuniary

infringing

Interest in

intereats of tha

permitting

the '435 patent.

infringement would only

infringing

serve

ELAN CORPORATION PLC, and
AMERICAN CYANAMID COMPANY,

th«

Plaintiffs,

To

v.

privat«,

défendante.

ALZA CORPORATION, and MARION
MERRELL DOW INC.,

Civ. No.

C-91-4108-JPV
Date:
Time:
Courtroom:

December 2, 1991
10:00 a.m.
2

Defendants.
IV.

CONCLUSION
For all of the

raapectfully r«quest
their

foregoing

reasons,

that their motion be

proposed Preliminary Injunction

plaintiffs

granted,

be entered

and that

DEFENDANTS' MEMORANDUM IN OPPOSITION TO
MOTION FOR PRELIMINARY INJUNCTION

by the

Court.

Respectfully submitted.
(Table
GUDNUNDSON, SIGGINS, STONE

t

SKINNER

Dated: November

21,

1991

^^.ro^A^^nT ¿/"WL

of Contents

omitted)

TABLE OF AUTHORITIES

Cases
A.B. Dick Co.
798 F.2d 1392

Pape
Burroughs Corp..
(Fed. Cir. 1986) .12
v.

Amoco Corp. v. Exxon Chem. Co..
7 U.S.P.Q.2d 1453 (N.D. Ga. 1987).

9, 17, 19

Ampex Corp. v. Abekas Video Sys. Inc..
15 U.S.P.Q.2d 1219 (N.D. Cal. 1990). 9
Black & Decker. Inc. v. Hoover Serv. Center.
765 F. Supp. 1129 (D. Conn. 1991).9

Lemelson v. United States.
752 F.2d 1538 (Fed. Cir. 1985) .13, 14
Lund Indus.. Inc. v. GO Indus.. Inc..
938 F.2d 1273 (Fed. Cir. 1991) .7
Martin v. Mayer.
823 F.2d 500 (Fed. Cir.

1987).10

Nutrition 21 v. United States.
930 F.2d 867 (Fed. Cir. 1991).7,

8, 9, 13, 16

Oaklev. Inc. v. International Tropic-Cal. Inc..
923 F.2d 167 (Fed. Cir. 1991).7

Pump. Inc..
1987).8

Roche Prods.. Inc. v. Bolar Pharmaceutical Co.. Inc..
733 F.2d 858 (Fed. Cir.),
cert, denied. 469 U.S. 856 (1984).19

Chrysler Motors Corp. v. Auto Body Panels of Ohio. Inc..
908 F.2d 951 (Fed. Cir. 1990). 7

Rohm & Haas Co. v. Mobil Oil Corp..
525 F. Supp. 1298 (D. Del. 1981). 17, 19

Crucible Materials Corp. v. Sumitomo Special Metals Co..
719 F. Supp. 14 (D.D.C. 1989) .9

Scripps

Datascope Corp. Kontron Inc..
611 F. Supp 889 (D. Mass. 1985),
affd, 786 F.2d 398 (Fed. Cir. 1986).8, 19

SRI Int'l v. Matsushita Elec. Corp. of Am..
775 F.2d 1107 (Fed. Cir. 1985) .15

Chemlawn Servs. Corp.
823 F.2d 515 (Fed. Cir.

GNC

v.

v.

Eltech Sys. Corp. v. PPG Indus.. Inc..
903 F.2d 805 (Fed. Cir. 1990).13

Fields v. Conover.
443 F.2d 1386 (C.C.P.A.

1971).10

Graver Tank & Mfp, Co.. Inc. v. Linde Air Prods. Co..
339 U.S. 605 (1950) .14

Hybritech

Inc. v. Abbott Labs..
849 F.2d 1446 (Fed. Cir. 1988) .19

Illinois Tool Works. Inc.
906 F.2d 679 (Fed. Cir.
Ahlbrecht.
435 F.2d 908 (C.C.P.A.
In

18

re

re Wilder.
736 F.2d 1516 (Fed. Cir.

In

Grip-Pak. Inc..
1990).7, 9, 16,
v.

1971).10

1984)

.10

J.P. Stevens & Co.. Inc. v. Lex Tex Ltd.. Inc..
747 F.2d 1553 (Fed. Cir. 1984),
cert, denied. 474 U.S. 822 (1985).12

Laitram Corp. v. Rexnord. Inc..
939 F.2d 1533 (Fed.Cir. 1991).14, 15

666 F.

Clinic & Research Found, v. Genentech. Inc..
1379 (N.D. Cal. 1987)

Supp.

.

16, 19

Standard Oil Co. v. American Cyanamid Co..
774 F.2d 448 (Fed. Cir. 1985).15
T.J. Smith & Nephew Ltd. v. Consol. Medical Equip.. Inc..
821 F.2d 646 (Fed. Cir. 1987).7,

8, 16

Tandon Corp. v. International Trade Comm'n.
831 F.2d 1017 (Fed. Cir. 1987) .14
Union Carbide Corp. v. Dow Chem. Co..
619 F. Supp. 1036 (D. Del. 1985).12

Uniroval. Inc. v. Dalv-Herring Co..
294 F. Supp. 754 (E.D.N.C. 1968).20

Upiohn
641 F.

Co.

v.

Riahom

Supp. 1209 (D.

Corp..
Del. 1986).17

ZMI Corp. v. Cardiac Resuscitator Corp..
844 F.2d 1576 (Fed. Cir. 1988) .14
Statutes

35 U.S.C.

§ 102.11

35 U.S.C. § 112.15
35 U.S.C. §

120.10

35 U.S.C. § 132.14

INTRODUCTION
this motion,

By

Nicoderm
for

product,

smoking

seek

prevent the launch of the defendants'

plaintiffs
only U.S. government-approved
to

the

withdrawal. Plaintiff Elan's

Prostep

nicotine

Prostep

to the

and

patch

own

efforts to

have been unsuccessful.

market, Elan seeks

to

delay

Having

defendants'

nicotine skin
secure

nicotine

patch product

approval

to

as a

bring

product introduction by

prescription product using
smoking withdrawal symptoms.

market

therapeutic
1

product, Nicorette, a chewing

Moore Decl.

approved

to

agent for the treatment of

approximately

of its

failed in its efforts

Drug Administration ("FDA") approval
2. That

a

gum, has annual sales of

$100 million, and until this month it remained the

nicotine

antismoking product.

On November

Robinson Decl.

1 19;

only

FDA-

Moore Decl.

1

2.

7, 1991 MMD, in collaboration with Alza, became the first

infringing patent-a patent purchased by Elan five
weeks ago and which is not based on the technology of its Prostep patch.
In its moving papers Elan has (i) not attempted to establish validity of the
patent in suit, (ii) has ignored an essential element of the patent in its infringement
analysis, and (iii) has made no showing of irreparable injury during the pendency of
this suit. Entry of the requested injunction on this flimsy showing would not only
violate the legal standard for entry of a preliminary injunction, but also would

entity to complete the arduous process of obtaining final FDA approval to market
their new product, Nicoderm. Moore Decl. 1 2. Nicoderm is a skin patch which

impose irreparable harm on defendants. It would also deprive physicians and their
patients of a new and effective treatment option for the number one public health
problem: cigarette smoking. Under these circumstances, plaintiffs' motion for

rate.

preliminary injunction

available for the first time

alleging

that defendants

are

a

should be denied.

FACTS

technologies

for controlled administration of

patents and has approximately 1,000 foreign

systems and

technologies,

and its patent

drugs.

leader in

Nicoderm is

area

of

distributor of health

care

products, including

medical conditions. MMD is
to aid withdrawal

a

from

in

pioneer
smoking.

ethical

drug delivery

for

pharmaceuticals
development of therapeutic
In

1984,

a

and

variety

nicotine

MMD secured the first Food

wearer

proven in

patches covered by
then

anti-smoking

drops

to

a

that patent,

lower

delivery

But for the

treatment.

temporary restraining order, it would have made transdermal nicotine therapy

Decl.

11 3-4;

to

physicians

Glover Decl.

whose

patients

need to stop

11 2, 3, 8; Robinson

development of Nicoderm by
excess

Decl.

smoking.

11 9,

20.

the MMD/Alza collaboration took 4 years,

of $26 million and has received

an

reception from the medical and public health communities. Hoffman
Decl. 1 3; Blessing Decl. 1 4; Glover Decl. 1 8. The product has also received
strong favorable response from the marketplace, with strong advance orders. Heatley
Decl. 1 5; Robinson Decl. 11 17, 19. MMD projects that the market for its
enthusiastic

dominate the patent literature in the

("MMD") is a major manufacturer

clinically

has to date cost the two firms in

Alza holds 450 United States

patents in the

filings

developing

drug delivery field. Hoffmann Decl. 11 3-4.
Defendant Marion Merrell Dow Inc.

initially delivers a burst of nicotine and
Heslin Decl. 1 25; Enscore Decl. 1 10.

Nicoderm

The

industry

the bloodstream of the

'610 Patent). Enscore Decl. 1 4. Like all of the

Heatley

Defendant Alza, based in Palo Alto, is the

to

transdermally (i.e., through the skin), over an extended period. Robinson Decl.
1 7. Nicoderm is made by Alza according to Alza's U.S. Patent No. 5,004,610 (the

Defendants' Nicoderm Product.

A.

products

delivers controlled amounts of nicotine

Nicoderm
of

Decl.

1

product will

18.

exceed $85 million in its first year

on

the market. Robinson

Bringing

B.
A

new

Nicoderm to Market

prescription drug

developer establishes

to the

effective for its intended
established in

a

performance of a

not be

Safety

and

and difficult

for

efficacy

a

series of human clinical studies under

by

drug is

its

both safe and

pharmaceutical product are
rigorous

scientific

protocols,

FDA medical and other technical experts

significant amount of these launch expenses are "perishable," in the sense
delay in an underway launch-as has already occurred as a result of the
restraining order now in effect-requires that many of these expenses must be reincurred to re-start the process. Robinson Decl 11 17, 24. MMD and Alza estimate
that

regulatory

process is

considerable

regulatory

a

15.

complex,

expertise.

Shepherding

time

a new

consuming

that the present
December

Obtaining regulatory approval

to

market

a

logistical effort of major complexity,

market the

new

informational materials

pharmacies

aware

Completing
enormous

has

must
must

of the

be

11 11-13.

For

must also undertake

example,

be booked and distributed to make

are

the sales force to

physicians

and

product's availability.

the tasks essential to

resulted in

of the

a

successful

expenditures

well in

In the
excess

interruption

case

of

launch

requires

Nicoderm, this process

of $5 million. Robinson Decl.

continue for

MMD in 1987. Moore Decl.

technology

(estimated

at more than

year. Robinson Decl. 1 18.

a

and

1

drug delivery technology

with another

proposed product configuration,

currently

produced by Cygnus.
had its

1 8.

Elan thereafter formed

the

marketing

to

to

a

a

collaboration

develop product using

arm

of

a

competing nicotine patch

patch technology

only

with
own

with

to be

1 9.

Moore Decl.

Exh. C. As admitted in its

important party:

patch

a

rejected by prospective development

twice

partners (MMD and Warner-Lambert), Elan shopped its patch

had difficulties not

nicotine

Warner-Lambert terminated its collaboration with Elan earlier

technology.

Having

a

MMD declined to join in

pharmaceutical firm, Warner-Lambert,

this year, and is

for

7. After evaluation of the technical merits of Elan's

collaboration with Elan. Moore Decl.

Elan's

revenues

scheduled for

Plaintiff Elan's Nicotine Patch

entering a development deal
product

ongoing launch, originally

could cost millions in lost sales

Elan first offered to license its

recruited, hired and trained.1 Advertising and

effort, coordination and expense.

already

developer

one

in which many interrelated activities

Robinson Decl.

product

3 years in the

drug product is only

many hurdles in the commercialization process. The

ongoing simultaneously.

expended

product. Rolf Decl. 1 5; Wissel Decl. 11 5-6.

1991,

C.

of the

interruption

$85 million) should the

the FDA

expensive process, requiring

and

The MMD/Alza collaboration

process for the Nicoderm

drug through

A

a

determine whether the data is consistent with the claims made. Wissel Decl.

11 4-6; Rolf Decl. 11 12, 13,

a

consumption until

review process, which involves the

regulatory

and intensive review of the clinical data
to

1 24.

sold for human

satisfaction of the FDA that the

use.

complex

may

once

co-plaintiff American Cyanamid.
declarations

on

file in this

development partners,

the FDA. As admitted in its

more, this time

Moore Decl.

action, Elan's patch has

but also with

an even more

declarations, Elan's product has

had

mixed, and mostly negative, results in several years of its regulatory approval
1
MMD has recruited and hired an additional 135 new sales representatives,
dedicated to the sale of Nicoderm to augment its existing sales force. The direct salary
cost alone of this additional sales force, now idled by the restraining order, exceeds
$800 thousand per month. Robinson Decl. 1 17(c). The indirect costs of hiring this
force included recruitment personnel, training personnel, moving expenses, and the
like. Should the specially recruited sales force for Nicoderm be idled by court order,
MMD must either bear their payroll costs or explore other, equally unpleasant,
alternatives.

process.

McVey

Decl.

qualifying
for approval (Wissel
many

of its

11 4-6. Given

nicotine substitute
Decl.

product, Prostep,

product safety

are

concern, or

1 4),

the FDA's announced intention to put as

products on

the

delays

the market

in Elan's

indicative of either

an

as soon as

they

are

ready

obtaining regulatory approval
patch, an unaddressed

ineffective

insufficiently performed

or

documented clinical studies.

Wissel Decl.

1 8.

Prostep patch

will be available if at all.

It is

There is

important

a

singular absence of evidence indicating

that the Court be

previously unsuccessfully shopped

Elan-developed
Elan bought the patent
the "Pharmetrix
Exh. D, and

to MMD

patch, which

4,946,853 (the '853 Patent)

Thus, it should be clear

efforts,

bogged down
The

to

began

alleged

Pharmetrix Patent- is

purposes of

a mere

the

subject of an

delaying

or

five weeks ago, Moore Decl.

development of its

product.

own

has been twice jilted and

currently

Elan's

portfolio
competitors

investment

by Elan, acquired solely

who have succeeded in

securing

from Pharmetrix five weeks ago. Elan

motion,

purportedly distinguishes

patch is first applied.

claims of the patent

require,

large nicotine loads,

for the

FDA

in vitro, and

more

described

on

there has been

was not

the Pharmetrix Patent.

no

product developed

The Pharmetrix Patent

involved in the

Indeed, based

purchased by

it may not be

preferably

patch

possible

should

the record

Elan

on

transdermal

a

mg/cm2h

should

not

exceed 1

burst of

and the

exceed 2

some

mg/cm2.hr.

initial burst

maximum of 2
in vitro.

mg/cm2h and

minimizing

"

mg/cm2h

'435 Patent,

not exceed a

mg/cm2h."

effect,

maximum

'435 Patent, col.

when it

was

argued

the burst effect of

this

patch

that "this

was

again emphasized during

application recognizes

the

importance of

nicotine; ..." Heslin Decl. 1 19, Exh. F.
ARGUMENT

Plaintiffs bear the burden of clearly

marketing
to a

avoid

of 2

preferably

a

repeatedly teaches,

13, lines 44-49. "Any initial flux from the patch should
more

in the

is the absence of

12, lines 4-7.

under this patent.

(Heslin Decl. Exh. A) is directed

to

to

S_ee Claim 1 of

use.

never

a

for

means

patch described

exceed

not

should not exceed 1

development of the
on

air,

and

during

patches

The patent

backing

occlusive

col.

prosecution,
was

an

that the nicotine flux4 must

but this first burst flux from the
case.

the

This avoidance of an initial burst of nicotine

Based upon reports in the press, the Pharmetrix Patent

Patent has three elements:

the release rate of the nicotine to the skin

nicotine when the

"With

is

The Pharmetrix '435 Patent

technology

'435 Patent Abstract, and col. 5,

prior to use,

Pharmetrix Patent from other nicotine release

approval.
D.

prolonged periods.'

over

patch covered by the Pharmetrix

the '435 Patent. What

4,943,435 ('435 Patent

requested preliminary injunction-the so-called

a mere

nicotine

reservoir in which the nicotine is retained

controlling

issue in this case.2

in the FDA review process, but is otherwise not involved in this

vehicle for the

delivering

prevent release of the nicotine from the reservoir to the

the Court that the fruit of Elan's own inventive

Elan-developed Prostep patch,

the

not at

it has put at issue in this case, No.

four years after Elan

Elan has

and Warner-Lambert and which has

Patent") in October of 1991,

over

for

lines 12-14. The
that the nicotine

aware

been under submission before the FDA for these many years, is the

patent No.

when the

of Nicoderm. However, the evidence

plaintiffs have no
suit is invalid

infringe

showing

likelihood of

on at least two

prevailing

entitlement to

on

preliminarily enjoin

this motion establishes that the

because: (1) The Pharmetrix Patent in

separate grounds; (2) the Nicoderm product does

the Pharmetrix Patent;

not

(3) Preliminarily enjoining the marketing of

3
2

Elan has sued Cygnus, Warner-Lambert's partner, under the Elan '853 Patent.
Moore Decl. Exh. E. It is clear that Elan intends to block by any means possible
access to the market for any nicotine patch product further along in the FDA approval
process than its own Prostep.

The Pharmetrix Patent was not the first patent to describe sustained release of
nicotine. Three columns of the patent are dedicated to describing prior art controlled
release devices.
4

Flux is a
is the average

of the rate of release at a given instant in time.
of release over a period of time. See Enscore Decl.

measure

rate

Average
1 8.

flux

Nicoderm would
have

suffered)

harm MMD and Alza who will suffer

irreparably

losses for which the law

interest is ill-served

by an injunction

provides

which

physicians

awaited treatment alternative for

no

recourse; and

removes a

new,

to offer their

failed to carry its burden, and its request for

(indeed, already
(4) the public

On the other

safe, effective and long

smoking patients.

preliminary injunctive

Elan has

relief should be

denied.
I.

Applicable Legal

The standard

Standard

governing a

motion for

a

preliminary injunction

in

a

patent

case

that

plaintiffs have

only

if the movant carries the

failed

discretion, committed

to

a preliminary injunction in a patent case pursuant to 35 U.S.C.
party must establish a right thereto in light of four factors, (1) a
reasonable likelihood of succeeding on the merits, (2) irreparable harm if

heavy burden
of law

or

preliminary injunction

on

of

if it finds

any issue and will be reversed

showing

that the court abused its

seriously misjudged

647; Datascope Corp.

II.

Plaintiffs Are Unlikely

to

v.

the evidence. T.J.

Kontron Inc.. 786 F.2d

398,

Succeed On The Merits.

governing the

whether the Pharmetrix Patent is valid

infringes

injunction is not granted, (3) balance of hardships tipping in the
petitioner's favor, and (4) the injunction not harming the public interest.

Oakley.

Inc.

1991).5

None of the factors may be

v.

International

"likelihood of success" in this

case are

and, if so, whether the Nicoderm patch

Tropic-Cai.

ignored

in

determining whether,

on

Equip..

Inc.. 821 F.2d 646 (Fed. Cir.

Inc..

invalidity by

1987).

by

930 F.2d

review

findings

by

1991);

by

the

alleged infringer to

the Federal Circuit of the district court's

see

reasoning.

allow

a

See

168-69; Nutrition 21

v.

United States. 930 F.2d

alse Lund Indus.. Inc.

v.

GO Indus.. Inc.. 938 F.2d 1273

Oaklev. supra. 923 F.2d at

869 (Fed. Cir.

the issues raised

they

are

entitled

to a

presumption

clear and

convincing evidence

if

they

are to

validity

of

establishing

defeat this motion.

plaintiffs neglected to tell the court was that the
Federal Circuit has recently expressly rejected that very proposition. If there ever
was any doubt, it is now clear that the burden of proof on a motion for preliminary
injunction

on

that

Plaintiffs' Memo at 9-11. What

Nonetheless, the grant of a preliminary injunction will be reversed if not supported
sufficient factual

court

of the Pharmetrix Patent, and that defendants bear the burden of

balance,

inequitable. Illinois Tool Works. Inc. v. Grip-Pak.
1990).
The issuance of a preliminary injunction is discretionary. T.J. Smith &
Consol. Medical

Plaintiffs Burden Of Proof

Plaintiffs have told the

906 F.2d 679, 681-82 (Fed. Cir.

v.

it.

A.

Inc.. 923 F.2d 167, 168 (Fed. Cir.

grant of injunctive relief is

meaningful

the

a

the

Ltd.

deny

carry their burden

an error

The central issues

To obtain

§ 283,

court can

399 (Fed. Cir. 1986).

is well established:

5

hand, this

Smith, supra. 821 F.2d at

The

Nephew

(Fed. Cir. 1991).'

867,

Because this is an action arising under the patent laws (i.e. Title 35 of the United
States Code) any appeal will be to the Court of Appeals for the Federal Circuit
("Federal Circuit") and the precedent of that court, not the Ninth Circuit, governs the
decision on this motion. See Chrysler Motors Corp. v. Auto Body Panels of Ohio.
Inc.. 908 F.2d 951, 952-53 (Fed. Cir. 1990).

rests on the
at

patentee,

not

on

the

alleged infringer. Nutrition 21.

supra.

869-70.

The presumption of validity of a patent is a procedural device that places
the burden of going forward and the ultimate burden of persuasion aj.
trial on one attacking the validity of a patent, gee 35 U.S.C. § 282
(1988); Roper Corp. v. Litton Systems. Inc.. 757 F.2d 1266, 1270, 225
USPQ 345, 347 (Fed. Cir. 1985). However, at the preliminary
injunction stage, because of the extraordinary nature of the relief, the
patentee carries the burden of showing likelihood of success on the merits
with respect to the patent's validity, enforceability, and infringement.
1
The required findings must be entered before granting the preliminary injunction.
See Chemlawn Servs. Corp. v. GNC Pump. Inc.. 823 F.2d 515, 517 (Fed. Cir. 1987)
("The District Court's actions in this case are flawed in two respects. First, the court
failed to issue findings of fact and conclusions of law with its preliminary injunction as
required by Rule 52(a).").

However, the burden

persuasive showing of validity at
.

Id.

at

869-70

.

.

(emphasis added).

was on Nutrition 21 to make
this stage.

Indeed the court chided the

2!~which like plaintiffs7-had misled the district

[the alleged infringer]

to the

F.

Nutrition

patent will fail. Amoco Corp.

1987)";

v.

demonstrating

Exxon Chem. Co.. 7

Black & Decker. Inc.

v.

The Pharmetrix Patent issued based

Cal.

challenges

U.S.P.Q.2d 1453,

v.

Abekas Video Svs. Inc.. 15

1990).

are aware

of

no

patent. Ç_f. Illinois Tool, supra. 906 F.2d

at

682; Datascope. supra, 786 F.2d

at

Metals Co.. 719 F.

Supp. 14,
Special
17 (D.D.C. 1989) ("[M]ost of the cases supporting injunctions in patent cases have
come after an adjudication of the validity of the patent.").

400; Crucible Materials Corp.

There has been

Moreover,

as

validity

on

such

Sumitomo

prior adjudication of the Pharmetrix

discussed below, defendants have raised serious

patent's validity.
of

no

v.

Under the circumstances,

contained material

28, 1988 is the

on a

continuation-in-part application

28, 1988. Heslin Decl. 1 5, Exh. A. To the

filed October

application

Showing of Validity

unsupported

relevant date for

Ses 35 U.S.C. § 120; In

in the earlier parent

extent the CIP

application,

October

evaluating patentability of the patent over the prior

re

Ahlbrecht. 435 F.2d

an

application only

908, 910-11 (C.C.P.A.

1971).'
Material is

supported

in

if there is

(1)

a

"full, clear concise

description of the invention and (2) a disclosure which enables one to
make and use the invention. Id. (finding no support for a range of 2 to 12 based
a disclosure of 3 to 12); Fields v. Conover. 443 F.2d 1386, 1391-92 (C.C.P.A.

and exact"

published decision of the Federal Circuit upholding
the grant of a preliminary injunction absent a prior adjudication of the validity of the
Defendants

("CIP")

art.

Hoover Serv. Center. 765

Supp. 1129, 1134 (D. Conn. 1991); Ampex Corp.

U.S.P.Q.2d 1219, 1220-21 (N.D.

that defendants'

Clear

References Before October 1988 Are Prior Art.

a.

"the court that

proving invalidity by clear and convincing
Contrary to plaintiffs' suggestion, on this motion, it is

bear the burden of clearly

1456 (N.D. Ga.

by advising

a

The Pharmetrix Patent Is Invalid Over The Prior Art.

1.

plaintiff in

had the burden of

evidence." Id. at 871 n.2.

plaintiffs which

court

Plaintiffs Cannot Make

B.

a

plaintiffs cannot

Patent.

challenges

make

a

clear

1971) (mere suggestion of invention does not satisfy description requirement). See
also Martin v. Mayer. 823 F.2d 500, 504-05 (Fed. Cir. 1987) (description must
make it clear that the inventor made the

Plaintiffs' purpose on this motion is clear-to delay the launch of Nicoderm while
plaintiffs complete their own botched FDA clearance for Prostep. Plaintiffs do not care
if they lead this Court to commit reversible error. They simply need to buy time. And
the grant of the injunction-even if later vacated by the Federal Circuit-will buy them
the necessary time.

of the

In this case, the

re

Wilder.

and other

key

filing date).

flux and time limitations of the claims of the Pharmetrix

unsupported until the CIP was filed. Specifically, the parent
application contained no suggestion or disclosure of the limitations in the claims of
the Pharmetrix Patent which refer to maintaining the "useful flux of nicotine" for a
total time "period of 12 hours or more" and maintaining a flux less than "2 mg/cm2"
Patent

7

as

("objects" of the invention

In

application found insufficient to show possession of the

statements in

claimed invention

showing

this motion.

specific claimed invention);

736 F.2d 1516, 1520-21 (Fed. Cir. 1984)

general
to the

on

were

all

and "between 20 and 800

entitled

only to

^g/cm2h".

Heslin Decl.

the benefit of the CIP's

1 9.

The claims therefore

are

October 28, 1988.

filing date
-

'

Plaintiffs' counsel

successfully propounded

are

undoubtedly aware of the appropriate

that standard

on

standard since
behalf of Exxon in this decision.

they
The C.C.P.A. (i.e., the Court of Customs and Patent
Circuit's predecessor.

9

Appeals)

is the Federal

Prior Art Alza Patents Invalidate The Pharmetrix Patent.

b.

4,781,924'° (the

Alza's U.S. Patent No.
of nicotine from

delivery
A is

showing

claim chart

a

"'924 Patent") describes transdermal

the

correspondence

10 of the Alza '924 Patent demonstrate

mg/cm2h

for

an

was

"designed

a

initial

for the remainder of the twelve hours.
disclosed devices
facilitate

breaking

Fig.

10

sustain

1 18;

plainly
a

period

with

Example I in

between 20 and 800
a

flux of 20

a

to

Fig.

or more

and

800

2.

transdermally
.

one

patch

1

more

7.

than 20

Fig.

/ig/cm2h

/¡g/cm2h

shown in

over

of the

administered

The release rate of

Fig.

10 of the patent.

12 hours. Heslin Decl.

10 also shows that the release

for well

over

rate

of nicotine is

that controls nicotine release within the

rates

claimed in the

Patent which

B hereto is

a

claim chart

correspond to Claims

detailing

the disclosures of the '610

1 and 11 of the Pharmetrix Patent."

German Patent DE 3629304 also discloses all of the claimed elements of the

patch

by
Decl. 111.

covered

Enscore

the Pharmetrix '435 Patent. See Heslin Decl.

11 24, 35-40;

10

35 U.S.C. § 102(e) makes applications for United States patents filed before an
invention is made available as references as of their filing date. Thus, the '924 Patent
is prior art as of its November 9, 1987 filing date.
"

cert,

v.

to the Patent

Office, with

denied. 474 U.S. 822 (1985).

application

whether to allow the

or

intent to mislead. J.P.

1553, 1559 (Fed. Cir. 1984),

false information

or

issue

to

information,

exists if a reasonable examiner

Materiality

would have considered the omitted reference

deciding

an

Lex Tex Ltd.. Inc.. 747 F.2d

existence of fraudulent intent may be

misrepresentation,

The activities of Alza's inventors of the '610 and '924 Patents are also prior art
to the Pharmetrix Patent under 35 U.S.C. § 102(g). See Heslin Decl. 1 30, Exh. K.

presumed

see, e.g.. Union Carbide

patent."

as a

"important

in

Id. at 1562. The

upon proof of (i)

Corp.

v.

a

knowing

Dow Chem. Co.. 619

Supp. 1036, 1052 (D. Del. 1985); or (ii) failure to disclose a reference that the
applicant or his attorney knew or should have known was material. A.B. Dick Co.
F.

v.

Burroughs Corp.. 798 F.2d 1392, 1398 (Fed.
Both Baker,

an

of Alza's U.S. Patent No.

Indeed, they jointly
Decl.

11 32, 33,

1986).

Cir.

inventor of the Pharmetrix Patent, and his attorney

4,781,924 (the '924 Patent) which-like

'435 Patent—describes transdermal

Alza's '610 Patent discloses every claim limitation of the Pharmetrix

Similarly
Appendix

Stevens & Co.. Inc.

12 hours. Thus, the '924 patent

Pharmetrix Patent.

Patent.

A patent is invalid if the patentee fails to disclose material

.

10, lines 25-28.

for

these

The Pharmetrix Patent is Invalid For Fraud

submits false information,
a

ug/cm2h

the patent states that

to deliver nicotine

patch of Example I is

I and

over

references.

Appendix

shows that this device had "sufficient" nicotine in the reservoir to

release rate of

Enscore Decl.

discloses

as

particular, Example

flux of nicotine for 12 hours

the tobacco habit." Col.

nicotine from the transdermal

7. Attached

between the device of the '924 Patent

.

to

1

Exh. C; Enscore Decl.

and the device claimed in the Pharmetrix Patent. In

flux of less than 2

and/or the German Patent. The Pharmetrix Patent is therefore invalid

device which meets every limitation of the Pharmetrix

a

11 14, 15,

Patent. Heslin Decl.

Nothing in the Pharmetrix Patent was new or unobvious over Alza's patents

wrote an

delivery of nicotine

article

Exh. L. Yet

they

describing
chose

to

from

a

were aware

the Pharmetrix

polymeric

matrix.

the Alza patent in 1989. See Heslin

disclose

only

less relevant references

during prosecution of the Pharmetrix Patent. Surely there can
no doubt that the patent examiner would have been interested in a reference,

the patent examiner
be

which like the Pharmetrix

transdermally

over

Patent, disclosed

12 hours without

patentees had represented

to

an

a

patch

initial nicotine burst

the examiner that

Pharmetrix Patent, col. 5, lines 5-9. The

no

inequitable

particularly

when the

such references existed.

patentee's failure

patent renders the Pharmetrix Patent invalid for
The

for release of nicotine

to

disclose the Alza

inequitable conduct.

conduct did not end with issuance of the Pharmetrix patent,

to

but continued

during reexaminaron.'2 According to Pharmetrix

Patent Office,

one

could not determine whether

a

cited German reference disclosed

"useful flux" because the data disclosed in the reference
the

supposed deficiency

in the data did not

was too

actually exist,

11 36-40;

to have known that the

Patent. Heslin Decl.

Enscore Decl.

reference data

1 39;

Pharmetrix Patent is invalid

was

Enscore Decl.
or

Plaintiffs bear the burden of

Cir.

1990). Infringement

proving

v.

only

The claims of the Pharmetrix Patent which
are

a

patch infringes

the

the accused device with

1538, 1549 (Fed. Cir.

patent define the

the claims that

can

be

Claims 1 and 11. Claim 1 is directed to

a

A nicotine

distal

infringed.

depot layer containing

nicotine to maintain

12

a

a

side and

sufficient

patch

a

skin-

quantity

useful flux of nicotine from said

13

of

patch for

In 1990, Pharmetrix sought reexamination of its patent for the putative
bringing a pertinent German reference to the patent examiner's attention.

purpose

Unless this Court concludes that a defense of inequitable conduct is "entirely
in substance", the preliminary injunction should be denied. See Nutrition 21.
supra. 930 F.2d at 870-71 (In reversing the grant of the preliminary injunction the
Federal Circuit noted "It is not plain to us, on the basis of the record, that Thome's
inequitable conduct defense is entirely lacking in substance.").

lacking

a

but less than 5 hours, then

800

ug/cm2h

for

a

of nicotine from

first flux of greater than

any hour for

A claim is

/ig/cm2h

for

a

second time

period

literally infringed only

accused device. See ZMI

Corp.

v.

first time

zero

period

but less

of greater than

second flux between 20 and

at a

period

of 7 hours

or more,

of 12 hours

function in

equivalents, only
substantially

the

(1950).

flux of

or more.

if every element of the claim is found in the

1582 (Fed. Cir. 1988); Lemelson. supra. 752 F.2d

same

merely specifies a

Cardiac Resuscitator
at

Corp..

v.

way

to

844 F.2d

1549. A claim is

if the accused device

same

result. Graver Tank & Mfg. Co.. Inc.

in this

transdermal nicotine

depot layer, having a skin-facing

side, said

between 20 and 800

the

having:
(a)

controlling diffusion

zero

under the doctrine of

exact

plaintiffs have asserted

mg/cm2 in

a

said

side; and

Claim 11 is identical except that the third element

PPG Indus.. Inc.. 903 F.2d 805, 809

This is necessary because the "claims" in

side at

covering

(emphasis added)14

inequitable conduct.13

by comparing

for

means

or more:

in contact with and

said skin-distal

on

skin-facing

than 2

to that in the Pharmetrix

United States. 752 F.2d

v.

boundaries of the invention, and it is

of

said

of limited

sort

of 12 hours

backing layer

rate-controlling

(c)

the examiner would like

that the Nicoderm

is determined

the claims in suit. See Lemelson

motion

same

occlusive

depot layer

11. For this reason, too, the

is unenforceable for

Pharmetrix Patent. See Eltech Sys. Corp.

1985).

1

an

limited. In fact,

The Nicoderm Product Does Not Infringe The Pharmetrix Patent.

C.

(Fed.

111. Clearly

comparable

(b)

a

period

total time

a

and Pharmetrix knew it

did not exist because the Pharmetrix Patent itself contained the
data. Heslin Decl.

submissions to the

obtain

1576,

infringed

performs substantially

substantially

the

same

Linde Air Prods. Co.. 339 U.S. 605, 608

"To work 'in

substantially the same way,' all of the limitations of the claim
must be satisfied at least equivalently." Laitram Corp. v. Rexnord. Inc.. 939 F.2d
1533, 1539 (Fed.Cir. 1991). The claims of the Pharmetrix Patent are means plus

The underlined portions contain the limitations directed to controlling nicotine flux
avoid an initial burst of nicotine. As discussed in the Heslin Declaration
(Heslin Decl. 11 27-28), this claim limitation was amended during prosecution. The
purpose of the amendment is unclear. However, if the claim is interpreted to mean
anything other than the prevention of a burst of nicotine (i.e. a flux at any time
exceeding 2 mg/cm2h), it is invalid because no other interpretation is supported by the
application and introduction of unsupported material (i.e.. "new matter") by amendment
invalidates a patent claim. 35 U.S.C. § 132; See also Tandon Corp. v. International
Trade Comm'n. 831 F.2d 1017, 1023 (Fed. Cir. 1987) (A phrase added to a claim
during prosecution "can not enlarge the scope of the claims beyond that supported in
the specification, and can not change the disclosure in a way contrary to its substance
as filed"). The substance of the Pharmetrix Patent is clear
to prevent a burst of
nicotine greater than 2 mg/cm2!!. See discussion supra, p. 6.
14

so as to

-

function claims; that is, each claim is directed
fi.e..

controlling

§ 112 16. Means plus function claims

performs

the function

Claims

interpreted

a

nicotine). S.SS

burst of

infringed

are not

performing

a

function

35 U.S.C.

unless the accused device

the claims. Laitram. supra. 939 F.2d at 1536.

based
the language of the claim, other claims, the
prosecution history, and the prior art. SRI Int'l v. Matsushita
Corp. of Am.. 775 F.2d 1107, 1118 (Fed. Cir. 1985) (in banc). The
are

specification,
Elec.

required by

for

to a means

the flux of nicotine to prevent

on

order to obtain claim allowance." Standard Oil Co.
774 F.2d 448, 452 (Fed. Cir.

v.

emphasized as a key
flux of nicotine

Contrary
there be
an

no

initial flux in

initial burst of

excess

nicotine,

1 10.

the Nicoderm

patch

of 2

mg/cm2h.

requirement

in which the

prevent

exceeding 2 mg/cm2h,

mg/cm2h.

to meet a

infringe

Irreparably

was

only achieved

court

if the

required by

Scripps

Clinic & Research Found,

single limitation [of a claim]

Laitram. supra. 939 F.2d

By

at

is

1535,

Of

Irreparable

showing"

merits would entitle them

only a "strong" showing of likelihood
to a

presumption

of

irreparable

of

issues

as to

Supp. 1379,

1401

success;15

presumption

of

irreparable

Plaintiffs attempt
that

(i)

(iv) after a trial
it will be the

Decl.

on

patch

as a

to

sales of

he won't later try the

McVey

of

presumption of validity to show
validity is not a substitute for the "clear

entitled to

a

presumption

Showing

Of

sustain their burden of

Prostep

support the

will

of

irreparable

Irreparable

Harm

proving irreparable

drop during pendency

harm.

of this

harm

by

litigation

if the

granted; (ii)

if a smoker tries the Nicoderm

patch first,

Prostep patch; (iii)

Elan will lose its investment in

Prostep;

is not

the merits, doctors will continue to
with which

developer

11

to

harm. See Nutrition 21. supra. 930 F.2d at 871.

are not

Plaintiffs Have Made No

B.

arguing

presumption

that

validity).

the

on

that the Pharmetrix Patent is valid, which is necessary

they

are

of innovative

most

prescribe

Nicoderm because

familiar; and (v) Elan will lose its

drug delivery products. Memo

at

12-13;

4-5.

Harm.
15

Plaintiffs admit that

invalidity defenses.

Genentech. Inc.. 666 F.

v.

Here, plaintiffs have relied solely
likelihood of

reputation

A Denial Of The Motion.

Presumption

genuine

raised

preliminary injunction

11 25, 26;

the Pharmetrix Patent.

Harmed

Plaintiffs Are Not Entitled To A

an

nor meet an

its

(N.D. Cal. 1987) (no presumption of irreparable harm because evidence offered by

product produces

product gives

on

concluded:

Plainly, plaintiffs

Patent claims. Heslin Decl.

infringement of the claim,"
cannot be held to

Cf.

means

burst of nicotine

this limitation

the Nicoderm

Because the Nicoderm

"Since the failure

a

succeed

Nutrition 21 has not established facts entitling it to a
presumption of irreparable harm, because the validity of
the '927 patent has never been tested in litigation, and the
district court made no finding that Nutrition 21 had made a
'clear showing' that the '927 patent is valid.

of the claims of the Pharmetrix Patent that

it does not fulfill the function

Plaintiffs Will Not Be
A.

controlling

a rate

not

Illinois Tool, supra. 906 F.2d at 682. See. also Nutrition 21. supra. 930 F.2d at 871

Enscore Decl. 11 5, 6.

of, the Pharmetrix '435

sufficient to negate

III.

exceeds 2

the express

essential limitation

so as to

feature of the invention. This function is

never

to

American Cyanamid Co..

during prosecution

As discussed supra,

burst of nicotine

Enscore Decl.

(ii) the accused infringer probably would

alleged infringer

In the Pharmetrix Patent, all of the claims include

period.

in

1985).

which functions to control the rate of diffusion
first

requisite "strong" showing has been found lacking even where the court
(i) there was a "reasonable probability" of proving infringement and

has concluded

the

prosecution history "limits the interpretation of claims so as to exclude any
interpretation that may have been disclaimed or disavowed during prosecution

during a

11. The

success on

the

harm. Plaintiffs' Memo at

The fact that the Pharmetrix Patent has been the subject of a second examination
does not strengthen the presumption of validity. Cf. T.J. Smith.
supra. 821 F.2d at 648 (presumption of validity not strengthened by second
examination, i.e. reissue, of patent).

(i.e. reexamination)

Plaintiffs' first argument is the antithesis of
sales

during

not

irreparable. Likewise, plaintiffs'

quantifiable loss of sales.16

defendants' sales would be
supra. 7

a

If plaintiffs

direct

measure

U.S.P.Q.2d at 1460 (market

but of harm

lost

litigation are quantifiable (indeed plaintiffs have quantified them)

by definition,

and thus,

reflects

this

irreparable harm—plaintiffs'

compensable

of

were to

the

on

Already

merits,

millions

irreparable harm,

damages). The third argument is equally

first

plaintiffs'

product-in

market after the

merits and

are

succeed at

a

to

this

prescribe.

case

the Nicoderm

litigation

product-can

ends is if defendants succeed at the trial

trial

on

the

Cf. Rohm & Haas Co.

v.

reason). Surely plaintiffs
rather than

are

switching

suggesting

not
to

Patent

short time ago. There is

purportedly covered by

that

as
a

Supp. 1298,

F.

flawed for the

doctor would

irreparable

technology,

harm is

specious.

supra at 5. It

between defendants'

no nexus

the Pharmetrix Patent

1307

foregoing

irreparable injury.

See

Upiohn

no

Co.

product on

v.

Riahom

merely bought
of

and Elan's

a

the patent

a

product

reputation

for

the market cannot -establish

Corp..

641 F.

complain

Supp. 1209,

1221

(D.

16
Not surprisingly plaintiffs do not suggest that Nicoderm sales would have an
adverse impact on the goodwill of nicotine patches. That argument would fly in the
face of the fact that clinicians familiar with both Nicoderm and Prostep prefer
Nicoderm. See Glover Decl. 1 8.

is entered is clear.

damages during the period of the
Fairbank Decl. 11 3, 8; Robinson Decl. 1 17. Many

if they succeed

on

(and

will suffer

the

have

delayed. Unlike plaintiffs,

merits, defendants

suffered)

Windsurfing17 as authority

about

hardships

This citation

can

case

suffered in

only

reprimanded
dealing

merits. The Federal Circuit

if

they

without

are

are

enjoined

who

recourse

until

they

for the

shutting

proposition
down an

that defendants

allegedly infringing

be intended to mislead the court. In Illnois Tool,

the movant for
with

a

a

for

preliminary injunction

permanent injunction after

a

trial

on

relying

the

summarily rejected the notion that Windsurfing stood
a preliminary injunction. Illinois Tool, supra. 906

relevant to

proposition

F.2d at 684.

preliminary injunction will destroy the value of years of
development by MMD and Alza, the pioneers in the nicotine therapy and drug
delivery fields, respectively. Fairbank Decl. 1 9; Robinson Decl 1 17(d); Hoffmann
Decl. 1 14. Plaintiffs, on the other hand, will lose nothing more than the cost of
In this case,

Elan did not

preliminary injunction

the merits.

Windsurfing-a

for any

innovation.
Plaintiffs have not-and with

damages

Plaintiffs cite

on

If the Motion is Granted.

will be lost if the launch is further

the Federal Circuit

forego prescribing

marketing

technology

on

operation.

the

on

were to

the Prostep brand of patch!

Plaintiffs' final argument of

develop the Pharmetrix

Corp.. 525

Mobil Oil

succeed

cannot

merits, Nicoderm simply wouldn't be available for doctors

(D. Del. 1981) (court dismissed similar argument

anything

continue to erode

allowed to continue to market Nicoderm. If plaintiffs

more

damages they

for the

order.

restraining

can recover

quantifiable—the amount invested by Elan and not recouped
easily be calculated.
The suggestion in the fourth argument that the first product on the market will
forever erode that market unless stopped preliminarily is logically flawed. The only
a

Irreparably Injured

defendants have suffered millions in

temporary

can

way

Defendants Will Be

The harm to defendants if the

lost sales. £fi Amoco.

share loss not evidence of

with money

1986).

IV.

second argument

succeed

plaintiffs'

Del.

acquiring

a

the Pharmetrix Patent. A

damages award in the unlikely

compensate plaintiffs fully. Both defendants

successful

can

responding

in

balance of

hardships tip decidedly

damages.

Windsurfing

Mehrer Decl.

Int'l. Inc.

v.

are

11 4, 6; Hoffman Decl.

event

their suit is

capable of
1

2. Thus, the

in defendants' favor.

AMF. Inc.. 782, F.2d 995

(Fed.

Cir.

1986)

V.

The Public Interest

"[TJhe
litigation,

standards of the

measure

cert,

granted

1 7.

the

requirements of private

injunctive

propriety and

Bolar Pharmaceutical Co.. Inc.. 733 F.2d

need for

relier' in patent

physicians prefer"
Moreover, it

cases.

only

FDA

approved nicotine patch

will be unavailable. Robinson Decl.

since there

public interest, especially
of the product. Heatley Decl. 11 7, 8; Glover Decl. 19.
not

that all FDA

in the

patients

are

approved antismoking products

be available

in

is the

medically beneficial product,

courts

motions. See Hvbritech Inc.

v.

at

1401

only

have

of

source

(although

for

immediately.

There is

court

and

concluded there

alleged infringer's defenses, preliminary injunction
would suffer if product development were delayed);

preliminary injunction

bale wrap to

(finding

industry); Roh m

it would be

against

allegedly infringing insecticide
containing

the

growth of weeds

public
and to

deprive

at

a

U.S.P.Q.2d at

developed

the market for

public interest

with respect to

sales of

issue).

pioneered development of transdermal

under the Pharmetrix Patent and which the

Co.. 294 F.

in

allowing patentee
a

Supp. 754,

to use

1 5; Heatley

his patent to

Decl.

gain

1

5.

an

unrelated to his patent. See Uniroval. Inc.

will be withheld when it has been

v.

1968) (A preliminary

760 (E.D.N.C.

sought for

the purpose of

obtaining an

advantage.).

Because

plaintiffs

equities strongly

have not carried their burden

favor denial of the

American farmers of any herbicide

patch they strongly prefer over any other patch now being developed, including
Prostep. Heatley Decl. 1 8; Robinson Decl. 1 22; Pinney Decl. 1 7. Cf.
Datascope. 611 F. Supp 889, 895 (D. Mass. 1985), affd, 786 F.2d 398 (Fed. Cir.

this motion and because the

this motion should be

denied.

Respectfully submitted,
COOLEY GODWARD CASTRO
HUDDLESON & TATUM

By.
a

on

preliminary injunction,

successful weapon in

addition, the injunction would deprive doctors of the best patch available;

some

plaintiffs an injunction would allow
their patch-a patch using inferior technology

technology

Dated: November 27, 1991

of cotton

containing alleged infringing herbicide's active ingredient).
In

[if]

CONCLUSION

1309 (D. Del. 1981)

preliminarily enjoin

was not

supra.

hemophiliacs

disrupt supply

Supp.

which had proven to be

undue

infringement and rejected

Amoco, supra. 7

& Haas, supra. 525 F.

the

kits); Scripps.

denied because

where effect would be to

interest to

test

was

was

1461 (no

no

injunction

1446, 1458 (Fed. Cir.

hepatitis

Alza-not Elan-who

...

far declined to approve. To grant

Daly-Herring

a

uniformly denied preliminary injunction

cancer

at

by an injunction

outside the scope of the Pharmetrix Patent. Glover Decl.

Steinfeld,

product, particularly

a

Abbott Labs.. 849 F.2d

1988) (no preliminary injunction
666 F. Supp.

so

advantage

alleged infringer

surgical instrument

was

which

plaintiffs to protect

Steinfeld Decl. 1 6.
Where the

patch-a patch
FDA has

In his

General of the United States, Dr. Jesse

Surgeon

the

"the public will be harmed

drug delivery devices. Hoffman Decl. 1 3. In contrast, the Pharmetrix Patent was
purchased five weeks ago by Elan as leverage to protect the market for its own

858, 865-66 (Fed.

denied. 469 U.S. 856 (1984). In the instant case, if the motion is

declaration the former

urged

the

not

v.

That result is

dire need

public interest,

the

Roche Prods.. Inc.

Cir.),

1986) (recognizing that

Requires Denial Of The Motion

J4
John F.

IJourlg

Attorneys for Defendants
MARION MERRELL DOW INC.
and ALZA CORPORATION

Biotechnology Law Report

11

176 (Number 2,

COOLEY GODWARD CASTRO

HUDDLESON & TATUM
JOHN F. YOUNG
One Maritime Plaza, 20th Floor
San Francisco, CA 94111-3580
Telephone: (415) 981-5252

FILED
! DEC 0 5 1991j

Elan cannot be first to market.
The effect of the temporary

18 and

Memo., p.

(212) 326-3939

has not

Attorneys for Defendants
MARION MERRELL DOW INC.
and ALZA CORPORATION
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA

a

will simply

serve

any harm to

plaintiffs.

defendants

Defendants

bearing

advise the court of

to

the

on

changed

question

to

circumstances

hardships

materially

court with the

provide the

to

a

new

no

prior

for

by asserting

invention date;

Opp.

showing
because the

and reduced

the effective dates of the references

On this new issue

plaintiffs

from the '435 Patent's

case,

art

supposedly conceived

was

Def.

obvious.

(i.e.,

1987).2

the reference dates in

avoid invalidation of the '435 Patent

to

or

to refute that

sought

have

once

When

proof.

a

again failed

to inform

patent

attempts

to carry his date of invention back behind his

evaluating plaintiffs' efforts (made for the first time in their

reply papers)

to

October 1,

to

anticipated

the references are not

the court of the standard of

legal standard

proper

practice prior

prior

in this

action;

(ii)

cause

detailed how various references rendered

invention of the '435 Patent

of the balance of

preventing

of NICODERM will

by quantifiable damages for which

Plaintiffs have

solely by arguing that

Memorandum is submitted:

Supplemental

the

on

respond.

able to

carefully

Memo., pp. 10-13.

INTRODUCTION

(i)

fully

be first

to

preliminary injunction

a

Allowing launch

the invention of the '435 Patent

Defendants.

This

The order could not and

defendants without

injure

Opp.

PLAINTIFFS HAVE NOT CLEARLY ESTABLISHED
VALIDITY OF THE '435 PATENT

SUPPLEMENTAL MEMORANDUM OF
DEFENDANTS IN OPPOSITION TO
PRELIMINARY INJUNCTION

MERRELL DOW INC.,

to further

to

See Def.

Marion.

on

Similarly,

cannot be remedied

are

Civil Action No.
C-91-4108-JPV

ALZA CORPORATION and MARION

harm

declarations.

nicotine patch.

market with

AMERICAN CYANAMID COMPANY,

Plaintiffs,

supporting

lawsuit,

restraining order has been

irreparable

protected plaintiffs' supposed right

damage which

PLC, and

ELAN CORPORATION

For reasons unrelated to this

demonstrated to be wrong.

visit substantial and

conclusively

is thus

plaintiffs' irreparable injury argument

ORIGINAL

JONES, DAY, REAVIS & POGUE
THOMAS V. HEYMAN
599 Lexington Avenue
New York, New York 10022

Telephone:

March-April 1992)

filing

filing

date of October

carries

1987), he

owner

a

very

date

(in this

28, 1988 behind

heavy

burden of

Many years ago. Judge Learned Hand characterized this

proof.
burden:

(iii)

plaintiffs'

to correct

mischaracterizations of
When

an inventor's date is to be carried back
beyond his
application, courts regard the effort with great jealousy, and
be persuaded with a certainty which is seldom demanded
elsewhere; quite as absolute as in a criminal case, in
It makes no difference
practice perhaps even more so
how the question arises; whether the patentee is carrying back
his own invention, or a supposed infringer is carrying back
his; the burden is the same as the proof necessary to
establish a prior use.

technical information before the court; and

must

(iv)

plaintiffs'
NICODERM

art in response to

provide additional prior

to

argument that the '435 Patent is broad
if NICODERM delivers

even

an

enough

to cover

PLAINTIFFS' ARGUMENTS OF IRREPARABLE
HARM ARE REFUTED BY NEW EVIDENCE
When the temporary

action, the
would be

led

court was

irreparably

would

not

to

United Shoe Mach.

immediate

264

requested in this

believe that

(2d

plaintiffs

nicotine

and, ergo, plaintiffs

continues to

recently

tilinq

patch

Mendenhall

would be

enjoin launch

of NICODERM,

has yet to even receive FDA

not this

plaintiffs

approval

cannot

«

the

a

nicotine

patch.

have

whose

As shown in attached Exhibit A

already

has

publicly

announced that it will

launched its nicotine

patch by

the time of the

in this action
1 Because

on

December 6,

1991.1

The entire factual

Ciba-Geigy expects plaintiffs

here to

again try

hearing

premise
to

of

assert the '435 Patent, Ciba-Geigy has sought a
declaration of invalidity of the '435 Patent in New Jersey. See
Exhibit B. Ciba-Geigy has asserted one of its patents against
defendants' NICODERM product, but the District Court of New Jersey
has declined to enter a temporary restraining order in that action.

improperly

v.

263,

applies today:

....

Astee

even

requirement

invention.

(Emphasis added)

Industries Inc.,
887 F.2d 1094

13 U.S.P.Q.2d

(Fed.

the cases upon which

that evidence of

Cir.

1913, 1923 (E.D.

1989).

plaintiffs rely

set

prior invention be clear

forth
and

2 in
response to defendants' fraud challenge, plaintiffs attempt to
the failure to cite defendants' '924 Patent to the Patent
Office by stating that the '924 Patent was not believed to be
relevant because (i) the form of nicotine and (ii) the means for
controlling delivery of the nicotine which were described in the
'924 Patent are not the same as in the '435 Patent.
Baker Decl. u
3-8; Castro Decl. ïï 4-9. Plaintiffs do not explain how the
differences referred to by Castro and Baker would make the '924
Patent irrelevant to patentability of the '435 Patent claims, which
refer generally to nicotine (without any reference to a specific
form of nicotine) and to "means for controlling diffusion of
nicotine" at specified rates.
Indeed, plaintiffs' failure to argue
that the '435 Patent is in any way patentably distinct over the
'924 Patent suggests that the Castro and Baker differences are
merely post hoc creations to avoid the fraud challenge.
excuse

hereto, Ciba-Geigy Corporation

77 F.2d

be first in

—

the market with

Brooklyn Wood Heel Corp.,

reduced to practice
The uncorroborated
an inventor is insufficient to establish a
pre-

dare of

1988), aff'd,

Tenn.

or

v.

That standard still

testimony of

Indeed,
confirmed that whether

Corp.

1935).

diligently

injunction against launch of

patch, plaintiffs' Prostep

Cir.

.

To succeed in establishing an earlier invention date, the
inventor must prove by clear and convincing evidence that the
invention was conceived before the filing date and thereafter

Plaintiffs

harmed.

Defendants have
court

an

be first in the market

irreparably

product

by plaintiffs

was

harmed absent immediate relief.

theorized that without

defendants' Nicoderm

order

restraining

...

initial burst of nicotine.

Biotechnology

11
See, e.g., Freeman

unequivocal.

the invention

proving, by

clear and

American Standard, Inc.

application date");

'4 35 PATENT ARE BROAD ENOUGH
TO COVER NICODERM, THE PATENT IS INVALID

IF THE CLAIMS OF THE

1988) ("A patentee

unequivocal evidence, that

both conceived and reduced to

was

practice before the
Pfizer Inc., 722

v.

present

plaintiffs' proof falls far short of

case,

It consists

convincing.

one

solely

the '435 Patent

contains

no

conceived

dates

satisfies the

If the claims, in fact,

limited to

not

or

See

Reply Memo., pp.

nicotine

patches which satisfy the

at

practice because it

establishing

4,758,434, which

by

patch

Thus,

invention

required by

on

April 3,

'435 Patent

the

if the claims of the

NICODERM, the claims

cover

U.S. Patent No.

clear and

establishing

convincing

Because

are

U.S.

during

(more than

1986

filed),

was

describes

memorandum (pp.

12-13)

Hunt Decl.

'435 Patent.

'4 35 Patent are broad

during

of the
Date:

anticipated by

plaintiffs

have failed to carry their burden, denial

preliminary injunction
December 5,

is

required.

1991

Respectfully submitted,
HUBDLESON

&

TATUM

in Dr. Enscore's

from in vivo nicotine

plasma

must

skin when

applied

the

a

plasma.

the fact that in vitro flux

patch

is

Both the

Suppl.

into the

before it

permeability

can

plasma

do

Decl. ïî 4 and 5.

into and

initially diffuse

Rather, the nicotine

evidence of the in

through the skin

See Enscore

correlate.

as

(or flux) from the Nicoderm Product.

deliberately ignored

from Nicoderm and in vivo flux

necessarily

as

transdermal nicotine fluxes derived
concentrations

vitro rate of nicotine release

not

Attorneys

However,

Supplemental Declaration, plaintiffs

to in vivo

misleadingly point

Plaintiffs have

plaintiffs

necessarily disclosed adequate data.4

German reference

explained

misrepresented

In response,

wrong in his conclusion that the

was

begin

to

through the
diffuse into

of the skin and the

concentration of nicotine in the skin will affect the rate of
appearance of nicotine in the
on

evidence

concerning

avail.

plasma.

transdermal flux based

reliance

on

Clearly, plaintiffs'
plasma

levels to refute

in vitro release rate from the

The German Patent contained

adequate

data

product

is to

concerning

no

in

vitro flux.

///

///
3 if plaintiffs continue to press the argument that they can
antedate the cited references, defendants will also establish at
trial that the work upon which plaintiffs rely is neither a
conception nor a reduction to practice the alleged invention of the
'435 Patent.
4 The Devane declaration upon which

plaintiffs rely

to

support

their position contains numerous additional technical
As shown in the Enscore Supplemental Declaration,
misstatements.
the very technical authorities relied upon by Devane refute
Devane's

positions.

to

and are invalid over

COOLEY GODWARD CASTRO

and the

of the data in German Patent DE 3629304 was

reexamination of the '435 Patent.

contend that Dr. Enscore

m 3-10.

enough

Declaration of Dr. David J. Enscore î 11 established that the

adequacy

a

twelve-hour period

a

4,758,434.

an

evidence.

PLAINTIFFS HAVE AGAIN MADE MISREPRESENTATIONS
IN AN EFFORT TO AVOID THE GERMAN REFERENCE

opposing

initial

no

art.

CONCLUSION

uncorroborated evidence meets their burden of
earlier invention date

filed

was

which releases nicotine

the flux rates

contend that their undated and

cannot

have

patches which

some

of when the invention of

reduced to

,

anticipated by additional prior

references.3

surely

Defendants'

are

(i.e

two and a half years before the

is made up of selected pages of

let alone any dates

to the cited

Plaintiffs

are

9)

Memo., p.

—

Patent No.

—

prior

and

of the inventors, Richard W.

entirely non-probative

was

they

burst)

self-serving/

of the

and Exhibit B to Baker's declaration.

of report, is

sort

that broad

the '435 Patent

during "[a]ny

which

--

Indeed, Exhibit B, which

3-4.

infringes

patch

a

period" (Pi. Reply

low flux rates of the claims

uncorroborated statements of

Baker,

consecutive 12-hour

are

from Freeman).

clear and

Plaintiffs argue that NICODERM
because the '435 Patent covers

low flux rates set forth in the claims.

F.Supp. 86, 109 (D. Del. 1989) (setting forth the foregoing quote
In the

(Number 2, March-April 1992)

177

Report

Minnesota Mining &

v.

Manufacturing Co., 693 F.Supp. 134, 145 (D. Del.
has the burden of

Law

fojr

Defendants

MARION MERRELL DOW INC.
and ALZA CORPORATION

11

Biotechnology Law Report

(Number 2, March-April 1992)

178

{BLR 1304}

Formulation E by

COOLEY GODWARD CASTRO
HUDDLESTON & TATUM
JOHN F. YOUNG
One Maritime Plaza-20th Floor
San Francisco, CA 94111
Tel:

with stirring at

981-5252

(415)

i

599 Lexington Avenue
New York, NY 10022

Tel:

(212)

formulations

so

prepared

achieved.

was

by depositing the nicotine depot

release liner formed of 3 mils of

on a

fluorocarbon diacrylate coated polyethylene terephthalate film in a mold
and overlayed the depot formulation with an impermeable backing formed

DEC 0 S 1991

R|Ch«.-<- v\;'.

prepared nicotine patches

I

5.

ORIGINAL

JONES, DAY, REAVIS & POGUE
THOMAS V. HEYMAN
THERESA M. GILLIS
JAMES P. JEFFRY

temperature until uniformity

room

appropriate
powder slowly,

mixture to the 6338 PVC

adding the

and then

proportions

the nicotine and ADMEX in the

premixing

„' "

,

from 1 mil

326-3939

in the mold for 60 seconds at 290*F to a

pressed

Attorneys for Defendants
MARION MERRELL DOW INC.

The 44 mil thickness

mils.

The materials

film.

polyethylene terephthalate
produced

a

depot

nicotine depot

as

UNITED STATES DISTRICT COURT

described at column 8, line 47-51 of

patches

NORTHERN DISTRICT OF CALIFORNIA

then

were

punched

melt

layer having

weight corresponding to the coating weight of about 36

And ALZA CORPORATION

were

thickness of 44

ounces

a

yard

per

Two 10 cm2 circular

Kydonieus.

from each of the Formulation A, B, C, D and E

laminates.

)
)

Plaintiffs,

removal of the release liner,

C-91-4108-JPV

MERRELL DOW INC.,

Defendants.

were

on a

Teflon® disk which, after

reciprocated vertically

receptor solution of 100 gm of distilled water

December 6, 1991
) Date:
10:00 a.m.
) Time:
Courtroom:
2
)
)
) DECLARATION OF JAMES
) HUNT IN OPPOSITION TO
) ORDER TO SHOW CAUSE RE:
_) PRELIMINARY INJUNCTION

ALZA CORPORATION, and MARION

samples

I mounted each of the

6.

) Civ. No.
)

ELAN CORPORATION PLC, and
AMERICAN CYANAMID COMPANY,

releasing surfaces of the device exposed

into

a

at 30'C with the nicotine

receptor solution.

to the

The

amount of nicotine released into the receptor at the time intervals
shown in Exhibits B and C

length of 260

nm on

obtained for the

determined by UV absorption

precalibrated spectrophotometer.

a

two

was

of each formulations

samples

were

at

a wave

The measurements

numerically

averaged.
performing the experiment, nicotine was released into the
well as
receptor solution through the 10 cm2 face of each test sample as
Cumulative
of
the
sample.
through the 44 mil thick circumferential edge
In

7.

DECLARATION OF
JAMES HUNT

release data based

I, JAMES HUNT, declare

as

follows:

knowledge

are true

8.
a

Kansas and have been

PhD in Chemical

employed

Engineering from

University of

the

at ALZA Corporation for

over

3.

corresponding in

9.

and have determined,

D and E in

Example

a)

as

With

room

to Formulations

sealed jar

on a

proportions

was

Example

obtained.

compositions overnight

at room

temperature in

The viscosity of the ADMEX/6338 mixture in the

set forth in Formulation E was too

stirring

at room

temperature.

I

proportions to the ADMEX/6338

rotary mixer;

b)

all

samples
11.

seen

high

to

Accordingly,

permit easy
I

produced

converted

from the 1 hour data in Exhibit B, the

As can be seen from Exhibit D and
was in the range of 20-800

Further declarant saith

I declare under

A, B, C and D, 6338 PVC

temperature until uniformity

added nicotine base in the appropriate
mixture and mixed the

As can be

penalty

correct, that this declaration

added to the ADMEX® 760 in the proportions shown in

was

while stirring at

mixing

Formulations A, B, C,

follows:

respect

was

a

December 4, 1991.
3

were

less than 2

in the first hour.
10.

3 of

depot formulations

or

mg/cm2

Kydonieus.
I fabricated two 10 cm2 patches from each of the nicotine

4.

powder

as

time data

cumulative nicotine release from Formulations D and £

vitro flux from nicotine

patches having the depot compositions described

vs

vs

midinterval time and the flux data

clarity.

by the procedures set forth below, the in vitro cumulative release of
nicotine at 30*C, and the

is set

in Exhibits 0 and E.
corresponding to Exhibits 8 and C is set forth
scales
the
data,
same
being varied for
Exhibits 0 and E reflect the

I have reviewed US. Patent 4,758,434, attached hereto as
{hereafter, "Kydonieus") with particular reference to the

transdermal nicotine patches described in Example 3

The cumulative nicotine release

to in vitro nicotine flux

three years.

My present position is Research Scientist.

Exhibit A,

area

nicotine release out to about 70 hours.

be true.
I have

releasing surface

Exhibit B shows the cumulative nicotine

release for the initial 4 hours and Exhibit C shows the cumulative

and all statements made herein on information and belief are believed to

2.

the total nicotine

forth in Exhibits B and C.

That all statements made herein of my own

1.

on

of

iig/cm2-h

for

more

vitro flux from

than 40 hours.

not.

perjury that

was

E, the in

the

foregoing is

true and

executed in Palo Alto, California

on

(415)

Atlas Powder Co. v. Ireco Chemicals.
773 F.2d 1230 (Fed.Cir. 1985) .

391-4200

Auoat.

JOHN O. TRAMONTINE
RON E. SHULMAN
MARK H. BLOOMBERG

Attorneys

v.

Carella

v.

v.

.

(Fed.Cir. 1986)

.

E.I, du Pont de Nemours v. Polaroid Graphics.
706 F.Supp. 1135 (D.Del. 1989), aff'd

for Plaintiffs

without op. 887 F.2d 1095

Freeman v. Minnesota Min,

(Fed.Cir. 1989)

H.H.

Civil Action No.
C-91-4108-JPV

(1990)

_U.S.

Halliburton Co. v. Schlumberger Technology Corp..
925 F.2d 1435 (Fed.Cir. 1991) .
754

F.Supp. 1280 (N.D.111. 1991), affirmed
(Fed.Cir. 1991)

DECEMBER
10:00 AM

6, 1991

Hvbritech Inc.

(Fed.Cir. 1988)

849 F.2d 1446

863 F.2d 867

(Fed.Cir. 1990)
v.

v.

808 F.2d 1471

page
Intern. Trade Com'n.