CORNERSTONE THERAPEUTICS, INC. et al v. SANDOZ INC.

Filing 178

MEMORANDUM OPINION AND ORDER: ORDERED that Defendant's informal application for the issuance of a patent prosecution bar [Doc. Nos. 40, 42, 51, 76] shall be, and hereby is, DENIED WITHOUT PREJUDICE; and it is further ORDERED that the discovery confidentiality order appended to Plaintiffs' March 4, 2014 submission [Doc. No. 47-1] shall be entered in this action. Signed by Magistrate Judge Ann Marie Donio on 8/21/2014. (tf, )

[Doc. Nos. 40, 41, 42, 47, 51, 76, 77, 78]
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
CAMDEN VICINAGE

CHIESI USA, INC., CORNERSTONE
BIOPHARMA, INC., and EKR
THERAPEUTICS, LLC,
Plaintiffs,

Civil No. 13-5723 (NLH/AMD)

v.
SANDOZ INC., SANDOZ AG, and
ACS Dobfar Info SA,
Defendants.
MEMORANDUM OPINION AND ORDER
In this patent infringement action, Plaintiffs Chiesi
USA, Inc., Cornerstone Biopharma, Inc., and EKR Therapeutics,
LLC (collectively, “Plaintiffs”) generally allege that Defendant
Sandoz
market,

Inc.’s
and/or

nicardipine

(hereinafter,
distribute

injection

“Defendant”)
a

generic

infringes

four

of

attempt

to

produce,

ready-to-use

premixed

Plaintiffs’

patents.

Presently before the Court are the parties’ various submissions
concerning

the

entry

(hereinafter, “DCO”).

of

a

discovery

confidentiality

The parties agree to the entry of a DCO,

but dispute the inclusion of a patent prosecution bar. 1

1

order

For the

The Court conducted an in-person conference on April 16, 2014
concerning the issue of a patent prosecution bar, at which time
the Court directed the parties to submit a revised proposed form

reasons set forth herein, the Court finds that Defendant has
failed to demonstrate good cause sufficient for the imposition
of

a

patent

prosecution

bar

and,

therefore,

denies

without

prejudice Defendant’s informal application.
The Court’s Order dated August 15, 2014 sets forth the
background of this patent infringement action, and shall not be
reiterated herein.
15, 2014.)
Court

(See generally Order [Doc. No. 168], Aug.

Rather, with respect to the pending submissions, the

notes

that

Defendant

asserts

that

Plaintiffs’

active

prosecution of patent applications related to the patents-insuit warrants the inclusion of a patent prosecution bar in any
DCO entered in this action.
Defendant

specifically

(See Letter [Doc. No. 42], 1.)

asserts

that

the

breadth

of

potential

disclosures in this action will require Defendant to disclose
non-public information concerning “the precise ingredients,” the
“method

of

manufacture,”

the

container

“composition”

“design” of Defendant’s generic nicardipine product.
see also Letter [Doc. No. 51].)
that

it

“faces

confidential

the

risk

information

that
will

and

(Id. at 5;

Defendant therefore asserts
knowledge
improperly

of

its

highly

affect

[the]

recipient[’s] advice and guidance[,]” and that Plaintiffs and/or

of a patent prosecution bar without prejudice to the parties’
positions with respect to the entry of a patent prosecution bar.
(See Order on Informal Application [Doc. No. 72], Apr. 16, 2014,
1-2.)
2

counsel for Plaintiffs may inadvertently and/or subconsciously
misuse this information in connection with (and for the benefit
of) Plaintiffs’ active prosecution of patents related to the
patents

at

issue

in

this

litigation.

regarding DCO [Doc. No. 76], 2.)

(Letter

from

Defendant

Defendant therefore asserts

that the DCO must include a patent prosecution bar precluding
counsel

involved

in

the

discovery

in

this

litigation

from

drafting new patent claims and/or amendments, in addition to
drafting

claim

specifications

and/or

rendering

advice

“on

arguments to be made to the [Patent and Trademark Office] that
may

likewise

affect

claim

scope.”

(Id.)

Defendant

further

asserts that the bar must “appropriate[ly]” reflect the subject
matter

of

the

patents-in-suit,

by

barring

patent

prosecution

activities concerning nicardipine parenteral formulations, the
storage container, and the various methods for production and
use of nicardipine formulations.

(Id. at 3; see also Letter

from Defendant Sandoz Inc. – Response to Plaintiffs’ May 9, 2014
Submission [Doc. No. 86], 3 (asserting that Defendant’s “product
is a complex product with a particular active ingredient, in a
certain

formulation,

in

a

certain

container;

[and

that]

the

patents in suit likewise contain elements relating to each of
these areas[,]” thereby creating “a grave and recognized risk of

3

misuse”).)

For those reasons, Defendant specifically moves for

the inclusion in the DCO of the following provision: 2
Any
person
that
receives
Attorneys’
Eyes
Only
technical or regulatory information from another party
may not, during the pendency of this action and for
one year thereafter, participate in, assist in, or
advise regarding the drafting of patent claims, claim
amendments, and patent specifications, or regarding
arguments to be made in any proceeding before the U.S.
Patent and Trademark Office (or equivalent foreign
agency), relating to patents or patent applications
owned or controlled by the person, their employer or
clients, or the receiving party concerning the subject
matter of the patents in suit, i.e., pre-mixed
nicardipine parenteral formulations, their containers,
active ingredients, methods of manufacture and methods
of treatment.
2

Defendant initially proposed the following patent prosecution
bar:
All persons having access to Confidential Material or
Attorneys’ Eyes Only material received from another
party must not currently be and for the duration of
one year after the conclusion of the litigation
(including
appeals)
be
involved
formally
or
informally, directly or indirectly, in the prosecution
of patents or patent applications (including but not
limited to patent office proceedings that may lead to
the procurement of new or amended claims) relating in
any way to nicardipine or nicardipine formulations
(including but not limited to methods of using,
manufacturing,
or
preparing
such
compounds,
compositions, or formulations), where such patents or
applications are owned or controlled by the person,
their employer or clients, or the receiving party.
(See [Proposed] Discovery Confidentiality Order [Doc. No. 40-1],
¶ 6; Exhibit A [Doc. No. 42-1], ¶ 6.) On the record on April 16,
2014, the Court reserved decision with respect to the inclusion
of a patent prosecution bar. At that time, however, the Court
found
the
scope
of
Defendant’s
initial
prosecution
bar
inappropriate, and directed Defendant to meet and confer with
Plaintiffs and to submit a revised version to the Court.
(See
generally Order on Informal Application [Doc. No. 72], Apr. 16,
2014.)
4

(See [Proposed] Discovery Confidentiality Order [Doc. No. 761], ¶ 6.)
Plaintiffs generally assert that Defendant has failed
to

demonstrate

injury’”

“‘a

sufficient

prosecution bar. 3

clearly
to

defined,

support

the

specific

imposition

and
of

serious
a

patent

(Letter from Michael Griffinger [Doc. No. 83],

3 (citation omitted) (emphasis in original).)

3

Plaintiffs assert

Plaintiffs initially opposed the entry of Defendant’s proposed
patent prosecution bar in part because neither party had
“specifically designated any individuals to receive confidential
information under the DCO.” (Letter from Michael R. Griffinger
to the Honorable Ann Marie Donio, U.S.M.J. [Doc. No. 47], 1.)
Plaintiffs asserted at that time that, prior to the imposition
of a patent prosecution bar, binding Federal Circuit case law
requires Defendant to first identify specific DCO designees that
pose “an actual risk of inadvertent disclosure or competitive
decisionmaking” in light of the specific individual’s “job
function or patent prosecution responsibilities.” (Id. at 2, 4.)
During the in-person conference on April 16, 2014, the Court
directed the parties to identify and exchange lists of
individuals to be designated as recipients of the parties’
confidential information. (See Order on Informal Application
[Doc. No. 72], Apr. 16, 2014, 1-2.) Having exchanged the
relevant designations, Plaintiffs assert that their “designation
of two in-house attorneys” moots the pending request, in light
of the fact that these designees perform only “‘high altitude’”
oversight of patent prosecution activities, and are not
otherwise involved in “any competitive decision[]making” or
patent prosecution. (Letter from Michael R. Griffinger [Doc. No.
93], 1 (citation omitted); Letter from Michael R. Griffinger
[Doc. No. 83], 2-3.) Defendant, however, dispute Plaintiffs’
characterization of the strategic involvement of their designees
and counsel in this action, particularly given the “small size”
of Plaintiffs’ legal department, and because even such high
level oversight “necessarily involves advising regarding the
scope of future patent claims that Plaintiffs hope to obtain and
assert against [Defendant].” (Letter from Defendant, Inc. –
Response to Plaintiffs’ May 9, 2014 Submission [Doc. No. 86], 23.)
5

that Defendant instead predicates its assertions concerning the
necessity

of

a

patent

prosecution

bar

upon

“‘mere

general

allegations’” of harm, without identifying “‘specific facts’” to
demonstrate

an

entitlement

to

such

a

bar.

(Id.

at

3-4.)

Moreover, Plaintiffs assert that Defendant “cannot demonstrate
that

its

misuse,

requested

bar

particularly

reasonably

in

light

of

reflects
the

fact

any

‘risk’”

that

of

Defendant’s

proposed generic nicardipine product constitutes “a qualitative
and

quantitative

product.

copy”

of

Plaintiffs’

brand

name

nicardipine

(Id. at 4; see also Letter from Michael R. Griffinger

[Doc. No. 93], 1 (“although [Defendant] admits that its generic
product ‘mirrors’ Plaintiffs’ patented drug product, it still
vaguely

maintains—without

specifying

any

particular

harm—that

information relating to its generic copy could somehow be used
‘to

craft

claims

[Defendant’s]

that

[Plaintiffs]

product”).)

would

Plaintiffs

also

know

would

assert

cover

that

the

unlimited scope of Defendant’s proposed prosecution bar renders
the proposed provision unworkably vague and overbroad, because
the

“proposed

advice

with

strategies.”

bar

broadly

respect

to

prohibits
patent

oversight,
prosecution

direction,
or

or

patenting

(See Letter from Michael Griffinger [Doc. No. 83],

5-6; see also Letter from Michael R. Griffinger to the Honorable
Ann

Marie

Donio,

U.S.M.J.

[Doc.

No.

41],

4-5.)

Plaintiffs

therefore assert that the scope of any prosecution bar should be
6

implemented in accordance with Lifescan Scotland, Ltd. v. Shasta
Techs., LLC, No. 11-4494, 2013 WL 5935005 (N.D. Cal. Nov. 4,
2013), in which the Northern District of California found the
defendants

“suitably

protected

by

an

order”

barring

the

“specified individuals from using the defendants’ confidential
information in any proceedings in the PTO” and which barred the
specified individuals “from any involvement in drafting any new
claims or claim amendments.” Id. at *6 (emphasis added). (See
also

Letter

from

Michael

Griffinger

[Doc.

No.

83],

5.)

Plaintiffs further assert that Defendant’s proposed bar “extends
well

beyond

the

encapsulating
associated

patent

with

compositionally
Michael

subject

matter

work

Griffinger

[Doc.

the

concerning

Plaintiffs’
identical

of

brand

proposed
No.

83],

patents

the

suit”

by

active

ingredients

(and

Defendant’s

product
generic).
5-6;

in

see

(Letter
also

from

Letter

from

Michael R. Griffinger to the Honorable Ann Marie Donio, U.S.M.J.
[Doc.

No.

41],

5

(citation

omitted).)

Consequently,

while

contending that Defendant’s present proffer fails to demonstrate
the propriety of a patent prosecution bar, 4 Plaintiffs assert
that any prosecution bar should be limited as follows:

4

In lieu of an express
propose the entry of a
provision:

patent prosecution bar, Plaintiffs
DCO which includes the following

A party may not disclose Confidential or Attorneys’
Eyes Only information to an in-house attorney or in7

Any
person
that
receives
Attorneys’
Eyes
Only
technical or regulatory material from another party
may not, during the pendency of this action (including
appeals),
participate
in,
assist
in,
or
advise
regarding the drafting of new patent claims or claim
amendments in any proceeding before the U.S. Patent
and Trademark Office (or equivalent foreign agency)
relating to patents or patent applications concerning
the subject matter of the patents in suit, i.e., premixed nicardipine parenteral formulations.
(Letter from Michael Griffinger [Doc. No. 78], 1.)
Resolution

of

the

pending

application

turns

on

the

evaluation of Federal Circuit case law concerning the entry of a
house advisor pursuant to paragraph 4(c) or paragraph
5 of this Order until after the in-house attorney or
in-house advisor has signed an undertaking in the form
of Exhibit A to this Order and provided a description
of the in-house attorney’s or in-house advisor’s
patent prosecution activities on behalf of any party
to this action. At least ten (10) business days before
the first disclosure of Confidential or Attorneys’
Eyes Only information to an in-house attorney or inhouse advisor, the party obtaining the undertaking
must serve it via email on all other parties. If the
producing party has good cause to object to the
disclosure, it must serve the party proposing to make
the disclosure with a written objection within ten
(10)
business
days
after
service
of
the
identification. Unless the parties resolve the dispute
within ten (10) business days after service of the
objection, or a longer period if the parties so agree,
the producing party must move the Court promptly for a
ruling, and the Confidential or Attorneys’ Eyes Only
information may not be disclosed to the in-house
attorney or in-house advisor without the Court’s
approval. An in-house attorney or in-house advisor
granted access to Confidential or Attorneys’ Eyes Only
information under this paragraph shall provide an
updated description of his/her patent prosecution
activities if his/her patent prosecution [activities]
on behalf of any party to this action change.
(Exhibit A [Doc. No. 47-1], ¶ 6.)
8

discovery confidentiality order.

See In re Deutsche Bank Trust

Co. Ams., 605 F.3d 1373 (Fed. Cir. 2010) (setting forth the
consideration

relevant

to

the

entry

of

a

patent

prosecution

bar). The Court therefore turns to In re Deutsche Bank Trust
Company Americas, 605 F.3d 1373 (Fed. Cir. 2010) (hereinafter,
“Deutsche”)—the interpretation of which both parties rely upon
in their pending submissions. 5

(See, e.g., Letter from Michael

5

The parties dispute the manner in which Deutsche applies to the
consideration of a patent prosecution bar.
Plaintiffs allege
that
Deutsche
requires
a
counsel-by-counsel
inquiry
in
determining the existence of a risk of inadvertent disclosure
and in balancing the potential harm to the non-moving party.
(See Letter from Michael R. Griffinger to the Honorable Ann
Marie Donio, U.S.M.J. [Doc. No. 47], 2.)
Defendant, by
contrast, generally asserts that Deutsche presumes imposition of
a patent prosecution bar, and only requires a counsel-by-counsel
determination with respect to a request for an exemption from
the bar. (See Letter [Doc. No. 51], 2.) The Court, however,
finds
Defendant’s
view
overly
narrow.
Deutsche
clearly
contemplates an examination of the parties’ respective positions
prior to the imposition of a patent prosecution bar.
See
Deutsche, 605 F.3d at 1380-82. Moreover, the automatic entry of
a prosecution bar, particularly when opposed, would effectively
preclude the opposing party from presenting its arguments
concerning the risk of inadvertent disclosure—one of the
considerations set forth in the Deutsche framework. See NeXedge,
LLC v. Freescale Semiconductor, Inc., 820 F. Supp. 2d 1040, 1043
(D. Ariz. 2010) (following a two-step inquiry, which first
requires the moving party to show, on a counsel-by-counsel
basis, “that there is an ‘unacceptable’ risk of inadvertent
disclosure of confidential information,” and then, balancing
that risk against the potential harm to the non-movant)
(citations omitted); Iconfind, Inc. v. Google, Inc., No. 110319, 2011 WL 3501348, *5 (E.D. Cal. Aug. 9, 2011) (“Because
Google has not met its initial burden of showing that there
exists a risk of inadvertent disclosure (i.e., that Iconfind's
counsel participate in ‘competitive decisionmaking’) the court
does not find that a prosecution bar is necessary.”); Kraft
Foods Global, Inc. v. Dairilean, Inc., No. 10–8006, 2011 WL
9

R. Griffinger to the Honorable Ann Marie Donio, U.S.M.J. [Doc.
No. 41], 3; Letter [Doc. No. 42], 3.)
In Deutsche, the Federal Circuit set forth a multipart framework applicable to the determination of whether the
circumstances in a particular action warrant the inclusion in a
DCO of a patent prosecution bar.

Id.

In that regard, the Court

first rejects Defendant’s assertion that Deutsche presumes the
imposition of a patent prosecution bar without requiring any
counsel-specific inquiry.
4.)

Indeed, the Deutsche court expressly indicated that, “[i]n

evaluating
first

(See, e.g., Letter [Doc. No. 42], 3-

whether

instance,

information

a

that

to

grant

court
will

a

must

patent
be

trigger

prosecution

satisfied
the

bar”

that

bar
the

relates

in
kind

“to

the
of
the

preparation and prosecution of patent applications” before the
Patent and Trademark Office.
Court

finds

that

such

Id. at 1381 (emphasis added).

“first

instance”

analysis

The

clearly

contemplates an individualized and fact-sensitive inquiry with
respect to specific individuals.

See generally id.

Moreover,

any per se imposition of a patent prosecution bar without an

1557881 (N.D. Ill. Apr. 25, 2011) (“Kraft has not cited any
evidence to demonstrate that Dairilean's outside counsel is
involved in competitive decisionmaking with respect to Dairilean
or any of its other clients who might compete with Kraft.”);
contra Eon Corp. IP Holdings, LLC v. AT&T Mobility LLC, 881 F.
Supp.
2d
254,
257-58
(D.P.R.
2012)
(determining
the
reasonableness of a prosecution bar, rather than applying the
two-step inquiry).
10

individualized

inquiry

requirement

Federal

of

would
Rule

eviscerate
of

Civil

the

“good

Procedure

cause”

26(c).

See

generally Fed. R. Civ. P. 26(c); see also Supernus Pharmas.,
Inc. v. Actavis, Inc., No. 13-4740, 2014 WL 654594, at *1-*2
(D.N.J. Feb. 20, 2014) (affirming the magistrate judge’s order
denying
patent

without

prejudice

prosecution

bar

in

defendants’
the

DCO

request

to

include

for

failure

to

make

notes

that

the

a
the

requisite showing).
Consequently,

the

Court

Deutsche

framework first considers “the risk of inadvertent disclosure or
competitive
specific

in

attorneys’

prosecution.
the

use”

light

the

involvements,

Id. at 1380.

attorneys’

of

nature
if

and

at

extent

all,

in

of

patent

In evaluating the risk in light of

involvements,

the

Deutsche

court

delineated

certain guideposts applicable to this risk inquiry as follows:
1.

2.

3.

the

Minimal attorney engagement in patent prosecution
(by, for example, “reporting office actions or
filing ancillary paperwork”) gives rise to a limited
risk of inadvertent disclosure;
“Substantial[]”engagement in patent prosecution (by,
for example, “investigating prior art” or “making
strategic decisions on the type and scope of patent
protection”) involves a high risk of inadvertent
disclosure; and
A middle “range of patent prosecution activities”
(involving,
for
example,
only
an
occasional
opportunity “to shape the content of a patent
application”) that “may pose a closer question”
concerning the propriety of a patent prosecution
bar, but nonetheless require an individualized
inquiry.

11

Id. at 1379-80.

With respect to the classification of attorney

involvement in patent prosecution activities, Deutsche expressly
cautioned, however, that “[t]he facts, not the category must
inform the result.” Id. at 1379; see also id. at 1381 (noting
that,

“[f]or

business

example,

information,

financial

even

if

data

deemed

and

other

confidential,

sensitive
would

not

normally be relevant to a patent application and thus would not
normally be expected to trigger a patent prosecution bar”).

The

risk presented by the specific level of attorney engagement in
patent prosecution activities must then be balanced against “the
potential harm to the opposing party from restrictions imposed
on that party’s right to have the benefit of counsel of its
choice.”

Id.

In balancing these “conflicting interests[,]”

Deutsche sets forth the following factors to be considered:
1.
2.
3.

“[T]he extent and duration of counsel’s past history
in representing the client before the PTO,
[T]he degree of the client’s reliance and dependence
on that past history, and
[T]he potential difficulty the client might face if
forced to rely on other counsel for the pending
litigation or engage other counsel to represent it
before the PTO.”

Id. at 1381 (citation omitted). After conducting the requisite
balancing, courts must then ascertain whether the movant has
sufficiently

demonstrated

that

information

“that

will

trigger

the bar” relates “to the preparation and prosecution of patent

12

applications

before

the

PTO.”

Id.

at

1381.

Courts

must

accordingly consider:
1.
2.
3.
Id.

“[T]he scope of activities prohibited by the bar,
[T]he duration of the bar, and
[T]he subject matter covered by the bar[.]”

Subsequent to the issuance of a patent prosecution bar, a

party

may,

notwithstanding

a

finding

that

a

bar

should

be

issued, request that a particular individual be exempted from
the

preclusion

effects

of

the

bar,

by

demonstrating,

on

a

counsel-by-counsel basis, that:
1.

2.

“[C]ounsel’s representation of the client in matters
before the PTO does not and is not likely to
implicate competitive decisionmaking related to the
subject matter of the litigation so as to give rise
to a risk of inadvertent use of confidential
information learned in litigation”; and
“[T]he potential injury to the moving party from
restrictions imposed on its choice of litigation and
prosecution counsel outweighs the potential injury
to the opposing party caused by such inadvertent
use.”

Id.
The

party

seeking

the

inclusion

of

a

patent

prosecution bar bears the burden of demonstrating good cause
sufficient for issuance of such a bar.

Id. at 1378 (“A party

seeking a protective order carries the burden of showing good
cause for its issuance.”) (citation omitted); see also FED. R.
CIV. P. 26(c)(1)(B), (G) (noting that the Court “may, for good
cause,

issue

annoyance,

an

order

to

embarrassment,

protect

a

oppression,
13

party
or

or
undue

person
burden

from
or

expense, including[:]” “specifying terms” for the disclosure or
discovery

and/or

confidential

“requiring

research,

that

a

development,

trade

or

secret

commercial

or

other

information

not be revealed or be revealed only in a specified way”).
party

requesting

the

bar

must

therefore

demonstrate

The
“that

‘specific prejudice or harm will result’” in the absence of a
protective order. In re Violation of Rule 28(D), 635 F.3d 1352,
1358 (Fed. Cir. 2011) (citations omitted) (generally considering
the

requisite

showing

pursuant

to

Federal

Rule

of

Civil

Procedure 26(c)).
Here, the Court concludes that Defendant has failed to
set forth facts sufficient to demonstrate a risk of inadvertent
disclosure. (See generally Declaration of Josephine Liu, J.D.,
PH.D in Support of Discovery Confidentiality Order [Doc. No. 762], ¶¶ 15-27.) Rather, Defendant asserts that there exists a
strong, substantiated risk of inadvertent disclosure in light of
Plaintiffs’

ongoing

prosecution

of

“additional

applications related to the patents-in-suit.”

patent

(Id. at ¶ 16; see

also Letter from Sandoz Inc. regarding Discovery Confidentiality
Order [Doc. No. 40]; Letter [Doc. No. 42]; Letter [Doc. No.
51].)
the

Defendant asserts that this active prosecution requires

issuance

prosecution
claims

that

of

a

process

patent
will

[Plaintiffs]

prosecution
enable
draft
14

bar

Plaintiffs
or

amend

because
“to
now,

the

patent

contend
directed

that
to

nicardipine products,” relate back to the initial filing date of
the “related” applications. (Declaration of Josephine Liu, J.D.,
PH.D in Support of Discovery Confidentiality Order [Doc. No. 762],

¶¶

16-18

(emphasis

in

original).)

Defendant,

however,

proffers no specific facts concerning the nature and extent of
the specific

attorneys’

(and/or

designees)

alleged

with respect to patent prosecution activities.
605

F.3d

necessary

at
to

1378-80

(setting

demonstrate

a

risk

forth
of

the

engagement

See Deutsche,

specific

inadvertent

showing

disclosure).

Rather, Defendant argues that counsel for Plaintiffs and/or the
designees

cannot

compartmentalize

and

appropriately

segregate

any confidential information obtained in the context of this
litigation.

(See, e.g., Letter from Defendant Sandoz Inc. -

Response to Plaintiffs' May 9, 2014 Submission [Doc. No. 86], 3
(asserting that Deutsche Bank recognized that “the human mind
cannot compartmentalize information”).)

See also Deutsche Bank,

605 F.3d at 1378 (recognizing that, in certain situations, “even
the most rigorous efforts of the recipient of such information
to preserve confidentiality in compliance with the provisions of
such

a

protective

compromise”).

Here,

order

may

however,

not

prevent

Plaintiffs

have

inadvertent
repeatedly

asserted that its outside counsel, Frommer Lawrence & Haug LLP,
neither prosecutes patents on Plaintiffs’ behalf, nor assists
Plaintiffs in competitive decision making.
15

(See, e.g., Letter

from Michael R. Griffinger to the Honorable Ann Marie Donio,
U.S.M.J. [Doc. No. 41], 3; (Letter from Michael R. Griffinger
[Doc.

No.

83],

3

(asserting

that

counsel

for

Plaintiffs

has

limited

to

counseling

[Plaintiffs]

Defendant’s

confidential

in

any

“indirect

patent

involvement”

prosecution

on

information,

e.g.,

be

unrelated

issues

“would

to

the

scope

and

content of prior art references and other validity issues”).)
Plaintiffs

similarly

assert

that

the

nature

of

the

DCO

designees’ oversight of patent activities does not include “any
competitive

decision[]making”

or

active

patent

prosecution.

(Letter from Michael R. Griffinger [Doc. No. 93], 1 (citation
omitted); Letter from Michael R. Griffinger [Doc. No. 83], 2-3.)
Defendant

disagrees

concerning

the

activities

(and

segregate

nature

with
and

counsels’

confidential

Plaintiffs’

extent
and

of

the

information

the

characterizations
patent

designees’
between

prosecution

abilities

various

to

patent

actions), but fails to demonstrate any specific facts to support
Defendant’s assertion concerning these individuals.

(See, e.g.,

Letter from Sandoz Inc. – Response to Plaintiffs’ May 9, 2014
Submission [Doc. No. 86], 2-3 (asserting, without support, that
any advice by counsel for Plaintiffs concerning patent validity
issues

“necessarily

involves

advising

regarding

the

scope

of

future patent claims that [Cornerstone] hope[s] to obtain and
assert

against

Sandoz”);

Declaration
16

of

Josephine

Liu,

J.D.,

PH.D in Support of Discovery Confidentiality Order [Doc. No. 762], ¶¶ 15-27.)

In light of Plaintiffs’ assertions concerning

the patent prosecution involvement of the specific attorneys in
this

litigation,

concerning

the

the
risk

Court
of

finds

Defendant’s

inadvertent

assertions

disclosure

lack

the

appropriate foundation, and therefore insufficient at this time
to

impose

a

patent

prosecution

standard set forth in Deutsche.

bar

in

accordance

with

the

See Warner Chilcott Labs. Ir.

Ltd. v. Impax Labs., Inc., Nos. 08-6304, 09-0228, 09-0469, 091233, 09-2073, 2009 WL 3627947, at *3 (D.N.J. Oct. 29, 2009)
(denying defendant’s request for a patent prosecution bar where
defendant failed to allege “any specifics showing that anyone
serving

as

[p]laintiffs’

counsel

[would]

intentionally

or

unintentionally disclose or utilize confidential information in
their future activities”).

The Court accordingly denies without

prejudice Defendant’s application for a patent prosecution bar
in

the

form

set

forth

in

paragraph

six

(6)

of

Defendant’s

initially-proposed DCO (see Exhibit A [Doc. No. 42-1], ¶ 6) and
its

revised-proposed

DCO.

(See

[Proposed]

Confidentiality Order [Doc. No. 76-1], ¶ 6.)

Discovery

Rather, the Court

concludes at this time that Plaintiffs’ proposed paragraph six
(6) provides an appropriate mechanism for both parties to timely
object to the disclosure of specific confidential information to
the DCO designees.

(See generally Exhibit A [Doc. No. 47-1], ¶
17

6.) Consequently, for the reasons set forth herein, and for good
cause shown:
IT IS on this 21st day of August 2014,
ORDERED that Defendant’s informal application for the
issuance of a patent prosecution bar [Doc. Nos. 40, 42, 51, 76]
shall be, and hereby is, DENIED WITHOUT PREJUDICE; and it is
further
ORDERED

that

the

discovery

confidentiality

order

appended to Plaintiffs’ March 4, 2014 submission [Doc. No. 47-1]
shall be entered in this action.

s/ Ann Marie Donio
ANN MARIE DONIO
UNITED STATES MAGISTRATE JUDGE
cc:

Hon. Noel L. Hillman

18