W.L. Gore & Associates, Inc. et al v. Medtronic, Inc. et al

Filing 123

OPINION AND ORDER - Gore's Motion to Dismiss Medtronic's Inequitable Conduct Counterclaim is DENIED. Signed by District Judge Mark S. Davis and filed on 2/3/12. (jcow, )

UNITED

STATES

DISTRICT

EASTERN DISTRICT

COURT

OF VIRGINIA

Norfolk Division
W.L.

GORE

& ASSOCIATES,

GORE

ENTERPRISE

INC.,

HOLDINGS,

and

INC.,

Plaintiffs,
v.

Civil Action No.

MEDTRONIC,

INC. ,

INC.,

2:10cv441

MEDTRONIC USA,

and MEDTRONIC VASCULAR,

INC. ,

Defendants.

OPINION AND

Plaintiffs
Holdings,

Inc.

W.L.

Gore

Medtronic,

Vascular,

Inc.

'870

in

patent"),

Conduct
12(b)(6),

has

Gore's

is

Medtronic

Gore's

U.S.

various

alleging

3,

Federal

before

2010,

patent

USA,

Inc.,

Dismiss

the

and

5,810,870

("the

Graft."

of

Court.

Medtronic
that

Medtronic,

defenses

Medtronic's

Rule

against

alleging

No.

Stent

Enterprise

action

affirmative

under

the motion will

September

Gore

this

Patent

"Intraluminal

FACTUAL AND

and

"Medtronic"),

to

presently

Inc.

filed

Motion

Counterclaim,

I.

Medtronic

upon

asserted

discussed below,

On

Inc.,

entitled

counterclaims.

"Gore")

(collectively

infringed

turn,

Associates,

(collectively

Defendants,

Medtronic

&

ORDER

Inequitable

Civil
For

and

Procedure

the

reasons

complaint

against

be DENIED.

PROCEDURAL

Gore

filed

infringement.

BACKGROUND

a

Gore

alleges

that

Medtronic's

Talent Thoracic

Stent

Grafts

infringe

which

are

graft

disclosed

filed

a

2011,

this

directed

Motion

in

to

Stent Graft

claims

12,

to

methods

the

patent.

Dismiss

16

of

and

and

19

making

a

Plaintiff's

has

asserted

non-infringement,

(2)

inequitable

Medtronic's
Civil

'870

tubular
19,

patent

intraluminal

2010,

Medtronic

On

April

Court denied the Defendant's Motion to Dismiss.

Medtronic

to

the

Complaint.

26,

filed an Answer and Counterclaim on May 10,

due

Talent Abdominal

of

On November

then filed an Amended Complaint on April

(1)

its

conduct

12(b)(6).

in

and

Gore

Medtronic's

and Medtronic

its

(3)

now

count

Gore

2011.

counts

invalidity,

conduct.

inequitable

Procedure

three

2011,

20,

counterclaim:

unenforceability

moves

under

to

dismiss

Federal

inequitable

Rule

conduct

of

count

can be broken into three allegations:
(1)

House

and

patent)

Myers

(the

intentionally

(specifically

U.S.

and 5,397,628

House

and

references

Myers
they

(specifically,
patent),
'507

patent),

patent)).

(the

Nos.

named

the

'870

material

prior

art

5,358,516

(the

'516

intentionally

Patent
(the

and German

in

l628 patent)).

disclosed

U.S.

5,107,852

withheld

Patent

patent)

(2)

inventors

to

Nos.

'852

mischaracterized

the

5,123,917

patent),

Patent

Patent

No.

Office

(the

'917

4,768,507

(the

3,918,736

(the'736

(3)

House

and

patent

office

(stating
and

Myers

a

signing

the

by

they

joint

submitted

believed

inventors")

they

false

affidavit

standard

were

required

the
to

to

inventor

"original,

be

the

filed

oath

first

with

the

patent application.
II.

Application
procedural

regional
1354,
to

a

procedural

claim

347

F.3d
"[t]o

935,

survive

to

relief

their

claims

Aziz

v.

Bell

Atlantic

above

across

Alcolac,

a

statements

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court

of

state a claim.

must

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Id.

to

relief

Prods.

can

to

Co

658

from

F.3d 388,

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accept

550

cases

granted

must

for
is

(same) .
pursuant

purely

on

regional

be

the

to

enough

Fourth

12(b)(6),

to

to

conclusions

F.3d

Thus,

In

conceivable

the material

the

Bridgestone/Firestone,

thereby

U.S.

a

failure

a

the

level,'

391

of

501

law.

of

is

law

dismiss

law

v.

the

Corp.,

patent

dismiss

speculative

line

be

2003)

allegations

legal

to
the

Cir.

a motion

the

v.

Nextel

("A motion

(Fed.

the

Inc.,

Spring

apply

Indus.

patent

governed by

pertaining

must]

*[f]actual

right

v.

which

937

in

therefore

2007)

not

Court

Polymer

plaintiffs'

Although

upon

question

circuit.");

is

Cir.

REVIEW

12(b)(6)

McZeal

{Fed.

[this

Circuit,

and

circuits.

state

Inc.,

Rule

question

1355-56

review

of

STANDARD OF

raise

a

%nudg[ing]

plausible.'"

(4th Cir.

2011){quoting

544,

570,

555,

facts

will

be

alleged

(2007)).
as

true,

insufficient

to

Although
with

most

unenforceability

particularity,

exception.
states

with

Rule

that:

9 (b)

"In

particularity
Malice,

person's

mind may

Ashcroft

intent

may

elements

of

statements,
been

not
is

do

129

not

law of

unique

Inc.,

to

575

Admixture
F.3d

F.3d

1347,

dismiss

1356

under

of

is

(Fed.

R.

what,

particularity
when/

omission
(emphasis

"intent"

where

committed
added).

may

be

1937,

how

before

it

Thus,

12(b)(6),

of

the

and
the

PTO."
under

generally,

Wal-Mart

a

of

the

has
law,

to

Cent.

482

a motion

R.

Civ.

9(b),

pleading

at

"knowledge"

of

P.

who,

misrepresentation

F.3d

to

conduct

specific

575

or

Stores,

P.C.,

inequitable

Exergen,
Rule

{although

Circuit

satisfy Fed.

a

9{b);

"pertains

the

of

conduct

survive

"identify

or

conclusory

Solutions,

to

material

P.

2009) (citing

an

defense must

Although

alleged

because

Cir.

2007)).

mere

Federal

(Fed.

state

fraud

recitals

of

an

Procedure

Civ.

inequitable

v.

is

must

(2009)

by

Corp.

P.

R.

"threadbare
supported

pled

conditions

Fed.

Advanced Cardiac

Civ.

party

other

be

conduct

Civil

1949-50

question

standard

and

and

Whether

1326

Cir.

a

not

constituting

Exergen

v.

of

mistake,

circuit,

law."

counterclaim or affirmative

9(b)'s

Ct.

a

regional

Servs.

Fed.

S.

action,

1312,

Pharm.

Rules

generally."

suffice").

patent

or

generally,

pleaded

the

Federal

knowledge,

alleged

need

inequitable

circumstances

intent,

cause

of

fraud

the

averred

a

the

be

adequately

the

of

Iqbal,

v.

be

defense

alleging

mistake.

see

the

defenses

or

1328
and

inequitable

conduct

must

include

"reasonably

infer

invalidating

withheld

that

a

1337,

1350

Farms

{Fed.

Co.

Cir.

facts

specific

that

was

with

information

Delano

a

v.

from

individual
withheld

specific

Cal.

Table

2011). *

which

a

both

from

intent

Grape

Court

of

PTO

and

deceive

Comm'n,

"A reasonable

knew

the

to

can

655

inference

the
F.3d

is

one

Charging inequitable conduct has become a common litigation

tactic

and

patent

cases

Becton,
In

that

information

PTO."

1

sufficient

an

recent

studies

included

Dickinson
attempt

recently

to

&

have

such

Co.,

F.3d

the

doctrine,

the

that

allegation.

649

control

tightened

estimated

an

1276,

standards

eighty percent

Therasense,

1289
the

for

(Fed.

inc.

Cir.

Federal

of
v.

2011).

Circuit

has

intent

finding

and

materiality.
Id.
at
1290.
Under Therasense,
"the accused
infringer must prove by clear and convincing evidence that the
applicant knew of the reference, knew that it was material, and
made a deliberate decision to withhold it."
Id.
Thus, a party
alleging inequitable conduct must now show "but-for materiality"
and that the intent to deceive is "the single
inference able to be drawn from the evidence."
(emphasis added).
Although

Therasense

inequitable

conduct

address

pleading

the

on

has

the

heightened

merits,

stage.

The

it

Court

most
Id.

the

does
is

reasonable
at 1290-91

standards

not

aware

for

specifically
that

at

least

one district
court
in
the Eastern District
of
Virginia has
concluded that the heightened standards of Therasense must be
incorporated
Inc.

v.

*57-58

and

Teva

(E.D.

Therasense,

"a

considered

Pharms.

Va.

USA,

Aug.

party

must

at

the

Inc.,

12,
make

pleading

2011

2011)
an

U.S.

stage.
Dist.

(concluding

initial

showing

See

Pfizer,

LEXIS

90021,

that

after

from which

it

may be plausibly inferred that:
(1) the individual knew of the
information not disclosed;
(2) the information not disclosed was
but-for material to the prosecution of the patent; and (3) the

intent to deceive
non-disclosure").

is the single most likely explanation for the
However, subsequent to the Pfizer opinion, in

a

opinion,

post-Therasense

the

Federal

Circuit

recently

stated

that
to
survive a motion to dismiss,
an inequitable conduct
counterclaim simply must recite "facts from which the court may
reasonably
infer
that
a
specific
individual
both
knew
of
invalidating
information
that was
withheld
from
the
PTO and
withheld that information with a specific intent to deceive the

that

is

plausible

alleged,

and

including

faith."

Exergen,

allegations
favorable

any

575

of material

to

the

that

in

flows

objective

F.3d

at

fact

nonmoving

Consumeraffairs.com,

(noting

that

ruling

indications

1329.

The

See

Nemet

F.3d

250,

a

motion

to

court must assume all well-pleaded facts
Thus,

with

the

assess Medtronic's

above

standards

the

candor
must

in

253

good

accept

all

the light most

(4th

dismiss,

to be

facts

and

Chevrolet,

in mind,

three theories of
III.

of

them

591

on

from

Court

and construe
party.

Inc.,

logically

Ltd.

Cir.

the

v.

2009)

district

true).
the

Court

will

now

inequitable conduct.

DISCUSSION

A. Undisclosed Prior Art

Medtronic
employee

and

Wayne

D.

the prosecuting attorney/agent

for

intentionally
patent)

and

specific

that

U.S.

x870

f

David J.

the

PTO."

alleges

withheld

to

45,

patent,

Delano

that

Patent

No.

a

No.

Gore

the

deceive

Farms,

655

F.3d

(the

and

at

1350

at

'516
f

(citing

at 1318,
1330; citing generally Therasense).
will
follow
the
Delano
court's
recitation
standard,

without

requirements,

as

any modification

it

for

the

is binding precedent

patent,

'516

patent)

with

listed

the

Gore

(the

Answer

similarly

the

(Id.

a

*870

(Def.'s

withheld
PTO.

the

'628

Medtronic

employee

the

House,

5,358,516

PTO.

69) .

intentionally

to

No.

5,397,628

deceive

Docket

Myers,

intent

U.S.

Patent

intent

Counterclaim

specific

first

and

alleges

inventor
patent

48) .

Exergen,

of

with

Medtronic

575

F.3d

Thus,
this Court
of
the
Exergen

heightened Therasense

on this Court.

argues

that
art

that

the

an

alleges

the

of

application

invention

covering

and

capability

of

Mr.

patented implantable medical
'628
Mr.

patents).
House

(Id.

and

Mr.

%516

argues

and

the

5

devices

references

*870

patent.

"628

patents

'870

patent.

were

are

describe

'516

solely

to

the

argues

different

patent

coated with a

insulation.

at

B,

material"

whose

cellular
Docket

V628

No.

69-3;

Ex.
patent

purpose

rubber wet

in

the

had

than
other

V516

argues

the

PTO

and
that
that

is

suits

X628

Docket

discloses

to

that

and

the

a

wire

col

the

and

the

than

the

carrying

thin layer of ePTFE

No.

69-2;

a

"rubber

"increase

that

of

%516

technologies

the

'516

1:54-57).

patent

body

wearing

and orthopedic braces."

patent

the

information

on

concerning

patentability

discloses

that is

The

less

than conclusory allegations

Gore

vastly

allegations

electrical current

1:37-43).

PTO,

already

Medtronic
to

prior

the

were

{specifically,

pled

"material"

Specifically,

(Id.

to

coverings

represented

Medtronic's

patent

The

such

PTO

Medtronic

Gore

that

Thus,

falsely

belief and contain nothing more
these

using

over

thick.

that

the

than 0.10mm did not exist in the prior art.

that

X628

aware

51-62).

Myers

ePTFE coverings less
Gore

at

0.10mm

coverings

already been

to

improvement

representation

were

ePTFE

represented

the

than

this

Myers

making

and had

and

less

notwithstanding

House

thick

patent

the

ePTFE

that,

Mr.

0.10mm

*870

"crux"

was

both

the

Gore

for

col

protection

comfort

(Id.

an

at

also

Ex.

of
C,

argues

that

it

is

the

clear

(516

and

from

the

patentability.
patent

refers

Gore

and

X628

itself.

to

patents

patents

Last,

that

Gore

are

'870

since

"eliminate

No.

argues

contradicted
the

is

by

patent

irrelevant

less

basis

is

the

of

the

'566

to

'870

patent)

than 0.10mm thick.2

for

alleging
by

the

the

of

prosecution

'516

patent

Medtronic's

history

instructed

marginally

that

material

(the

reasonableness
the

patent

be

contradicted

examiner

and

'870

not

3,953,566

film that

material

the

specification

Medtronic's

are

of

would

the

Patent

an ePTFE

allegations

to

'628

U.S.

argues

patent

specification

Specifically,

which discloses
Thus,

the

the

of

the

applicants

pertinent

cumulative

references."3
The

first

element

misrepresentation

of

stage,

must

claim

2

Medtronic
from

a

an

inequitable

material

merely

fact.

At

allege

reasonable

conduct

the

motion

a

plausible

could

jury

claim

infer

to

and

that

is

dismiss

specific
Mr.

House

The %566 patent was issued in 1976 and discloses a "process

for

producing

improper
not

for

the

need

porous

the

attached

Court

as

not

products."

Court
an

to

exhibit

address

Medtronic

consider
to

this

the

argues

'566

patent

Medtronic's

issue

because

it

Again,

Medtronic

consider

the

attached

as

the

patent

was

part

*214

attached

of

Docket
'214

an

'870

a
No.

to

joint

argues

exhibit

to

does

application

appendix.

it

is

is

(Pi.

Nevertheless,

application in ruling on

not

improper

for

as

part

claim

rely

Court

the motion.

The

on

of

the

was

record

construction
does

not

not

However,
brief

Claim Construction Brief,
the

is
was

the Court

it

counterclaim.

already

opening

it
it

the pleading.

prosecution history

Medtronic's

plaintiff's

66-3) .

that

patent's

that
since

counterclaim.

'566 patent in assessing the sufficiency of

3

to

which

a

of

rely

and
as

Ex.

3,

on

the

and Mr.

Myers

use

material,

was

knew

with

deceptive

has,

in

when,

a

of

the

and

decided

intent.

detailed

where,

575

examples

of prior art

omissions
infer

are

Mr.

at

of

1328.

to
655

disclose
F.3d

the

has

and

and

Mr.

not

were

1350.

Medtronic
"who,

what,

misrepresentation.

referred

cite,

cumulative,

Myers

the prior

information

specific

alleged

Medtronic

that

that

at

the

that Gore did not

material

House

not

appreciated

identified

how"

Exergen,

use,

Delano,

manner,

and

F.3d

prior

specific

detailed why
and

aware

to

of

how
the

one

those
could

undisclosed

patents and their potential materiality.
The
intent

second

to

element

deceive.

the

sufficient

deceive

could

conduct arguments

cited

by

Inc.

v.

Medtronic
Pergo,

2010)(noting
examiner
also

noting

of

cumulative

a

is

material

information

consider
that

other

it

and

material

inference

of

of

these

173,

material

important

in

is

not

information

already

determination will

require

intent

See

when

to

a
a

Alloc,

(Fed.

Cir.

reasonable
patent;
if

disclosed").
fuller

pled

the prior art

material

a

of

inequitable

176

issuing

is
art

benefit

also

non-cumulative.

is

"information

prior

has

on whether

Appx.

claim

significant

strength

Fed.

conduct

Medtronic

reasonable

The

366

of

the

ultimately hinge

Inc.,

that

would

cumulative
the

based.
will

exclusion

granted,

upon which

be

inequitable

applicant with

application

facts

an

Because

could provide a patent

having

of

it

but
is

However,

record and

is

not

a

proper

alleged

the

inquiry

at

in Medtronic's

Therasense

alleged

facts

requirements.

the

stage.

Although

counterclaim may not

elements
are

12 (b) (6)

by

clear

sufficient

Therefore,

and

to

this

be

enough

convincing

satisfy

the

to

satisfy

evidence,

Exergen's

inequitable

facts

conduct

the

pleading

claim

will

not be dismissed.
B. Mischaracterized Prior Art

Next,
conduct

Medtronic

by

materially

solution by
of

ePTFE"

patent,

use

of

Answer

the

when

the

thinner
and

and

the

covering

In

patent,

ePTFE

knew
and

by

alleging

patent

St

response,
over

than

as

describes

'736

"with

Docket

Myers

information
the

'870

thinner

the prior
Medtronic

stent

patent

Mr.

first

'917

patent

(Id.

argues
art

is

not

states.

graft

with

10

when

at f

that

69) .

Gore

(Def.

in

a

problem

knew
a

pattern

the

of

'516

thinner

ePTFE

'870 patent's

"sole

49) .

the

an

the

Similarly,

the

he
of

'852

intentionally

engaged

the use

the

devices."

solved

coverings

for

disclosed

also

and

problem

thinner covering

all

No.

inequitable

patent,

medical

already disclosed

Gore

a

the

46,

that

with

the

coverings

material

improvement"

patent

House

"with medical devices."

0.10mm

in

the

that

stent

'852

that

Mr.

alleges

a

engaged

"a stent with a

mischaracterized

creating

Gore

misrepresenting

Counterclaim,

deception

that

'870 patent was

'507

Medtronic

of

alleges

ePTFE
notes

various

covering of
that

features

the

such

less
'870

as

a

diametrically

adjustable

covering

on

exterior

surface

Medtronic
attribute

the

exterior

allegations

the

on

Mr.

concedes

that

each

during

the

patent

application)

before

the

issuing

argues

that

prior

of

and

mischaracterized

was

'214

these

to

{Pi.

and

Ex.

allegations

references

submitted

because Gore disclosed these very references
The

Court

finds

pleading standards
why

the

facts

has

identifying

by

Medtronic

the

misrepresentation

to

support

Taking

the

party,

Medtronic

involved

facts

with

prosecuting

a

reasonable

in

the

these

and

inference

of

that

House

they

li

prior

to
art

Gore

deliberately

make

sense

Rule

to

and

patents
were

pled

intent

favorable

thus

parent

Thus,

the

has

most

and

PTO

9 (b)

alleged misrepresentation,

material,

art

the

not

satisfied

light

prior

the

to the Examiner.

alleged

has

agents) ,

was

pled

application

they

do

one

Medtronic

*892

23680-88).

simply

of

to

(the

X214

that

that

and

that

initialed

1,

the

intentionally

out

actual

a

Medtronic's

conclusory

application

the

from

argues

that

Myers

are

0.10mm,

importance

argues

Mr.

patents

Gore

the

Gore

than

extending

surface.

and

considered

Medtronic's

seam

patents

the

the patent.

less

points

cites

examiner

a

Gore

these

prosecution

demonstrate

Second,

belief.
of

and

elevates

House

these

and

covering

luminal

improperly

that

information

the

others.

"mischaracterized"

a

surface,

through

therefore
over

stent,

aware

to

the

Myers

(as
that

sufficient

deceive.

non-moving
were

inventors
Gore

both
or

already

had

the

0.10mm
House
the

capability

thick.
and

Yet,

Myers

"thick

of

Medtronic

still

bulky

whether

and

made

with

not

just

pleading

to

intent

alleged
to

of

deceive

However,

has

this

satisfied

inequitable

or stricken at

this

that

the

with

'870

past

will

taking

the

coverings

stents.

facts

Medtronic

Rule

conduct

9 (b)

was

will

solving

ultimately

was

actual
the

material
evidence,

light

thorough

pleading

claim

as

To

in

than

knowledge,

patent

require

the

less

this

mischaracterization

the non-moving party,

and

Therefore

alleges

problem

this

argument.

ePTFE

characterized

wall"

determine

favorable

manufacturing

most

in

its

requirements.

not

be

dismissed

stage.

C. False Affidavit
In
accuse

Medtronic's
both

Mr.

House

false affidavit.
affidavit
the

he

knew

disclosed

medical

the

use
(Def.

69) .

Additionally,

filed

a

subject

matter

Mr.

alleges

joint

'628,

of

since

he

of

allegation,

intentionally

stating

inventor

of

'852,

House

the
knew

similarly
first
the

believed

the

subject
and

less

than

12

l

alleges

and
'516

filed a

'507,

coverings

joint
and

they

filing

he

and Counterclaim,

Medtronic
as

conduct

that Mr.

by

'917,

ePTFE

Answer

affidavit

Myers

inventor

and

'516,

the

false

and

alleged
first

devices.

inequitable

Medtronic

an

"original,

when

all

as

last

'736

he

was

matter"
patents

with

Docket No.

that

Mr.

inventor
the

false

0.10mm

47,

a

'852

Myers
of

the

patent

already

disclosed

medical

relying

has

is

use

of

(Id.

devices.

Gore

before

the

at I

50).

argued

that

something

submitting

the

Court

of

failure

a

accepts

the

that

Court

on

inventor

application.

disclose

ePTFE

declaration

Medtronic's

the

thinner

every

patent

to

a

would

which

is

every

trigger

with

Medtronic

required

Thus,

argument,

covering

Gore

to

is

sign

posits,

if

single

allegation

false

affidavit

a

allegation.
Because

conduct

allegations

allegation
Mr.

House

ePTFE
be

to

also
and

Mr.

to

disclose

reasonable

Myers

oath

the allegations

the

with

for

invalidating

withheld
Delano,

655

to

a

the

Court

information

F.3d at

1350.

prior

infer

false

was

with

a

Thus,

As

13

standards.

If

that

Mr.

specific
false

art

House

could
failed

it

is

and

Mr.

signing

above,

the

although

to win on the merits

the

the

disclosed

then

by

stated

facts

alleged

individuals

withheld

the

last

intentionally

that

standards,

that

this

art

affidavit

that

that

patents,

sufficient

find

inequitable

knew the prior

still

knowledge.

to

finds

those

also

heightened

information

that

of

and

two

pleading

0.10mm thick,

filed
that

Court

aware

patentability

Court

previous

9{b)'s

alone may not be

Therasense's

sufficient

than

the

Rule

were

the

mischaracterized

intentionally

inventors

under

less

or

for

Myers

the

found

sufficient,

satisfies

coverings

material

has

from

intent

the

to

affidavit

"knew
PTO

are
of
and

deceive."

inequitable

conduct
this

allegation

will

also

be

dismissed

or

stricken

at

time.
IV.

For

the

reasons

Medtronic's
The
Order

not

Inequitable Conduct

Clerk
to

It

is

counsel
is

discussed

so

REQUESTED
of

record

to

CONCLUSION

above,

Gore's

Counterclaim
send

for the

a

copy

Motion
is

to

Dismiss

DENIED.

of

this

Opinion

and

parties.

ORDERED.

/s/
Mark
UNITED

Norfolk,

Virginia

February 3 /

2012

14

S.

STATES

Davis
DISTRICT

JUDGE