App

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELA W ARE

THE MEDICINES COMPANY )
)
Plaintiff, )
v.
) C.A. No. 09-750-ER
) ( Consolidated)
TEV A PARENTERAL MEDICINES, )
INC., et al. ) (DM 10)
)
Defendants. )
)
ORDER
This matter is presently before the Special Master on defendants APP Pharmaceuticals,
LLC's and APP Pharmaceuticals, Inc. 's ("APP") Motion to Compel De-Designation of Non-
Confidential Information (D.I. 346) (DM 10) ("Redactions Motion") with respect to "two
categories of documents: (1) filings regarding APP's Motion for Leave to [File First Amended
Answers and Counterclaims Under Federal Rule of Civil Procedure 15(a) (D.!. 181) ("Motion
for Leave")] (D.l. 181-182, 191, 237, 266) and (2) [plaintiff The Medicines Company's
("MedCo")] April 1th Letter regarding this dispute." (See D.l. 346 at 1.)
Having read and considered the briefs submitted by the parties, and having heard the
parties' oral arguments during the telephonic hearing on June 13,2011 ("June 13 Hearing") and
during the monthly status conference on June 16, 2011 ("June 16 Status Conference"), for the
reasons stated below, APP's Motion is GRANTED.
WMIA 1003222v3 06/30111
Case 1:09-cv-00750-ER Document 455 Filed 06/30/11 Page 1 of 24 PageID #: 4449
Accordingly, MedCo is HEREBY ORDERED to: (1) dedesignate all of the Disputed
Redactions! and the April 12, 2011 letter within 2 days of the date this Order becomes final in a
manner consistent with the direction provided in this Order; (2) electronically file revised public
versions of D.l. 191 and D.l. 266 within 1 day of dedesignating them; (3) meet and confer with
APP within 5 days of the date this Order becomes fmal regarding what redactions should be
made to the Amended Report and Recommendation (D.!. 444) in light of this Order for the
purpose of docketing a public version of the Amended Report and Recommendation;
(4) forthwith after the meet-and-confer, submit an electronic copy of the Amended Report and
Recommendation with the agreed-upon redactions to the Special Master for docketing; and
(5) refrain from designating any information such as the Disputed Redactions as "Highly
Confidential-Outside Counsel Only" or "Confidential" in the future, whether in filings,
discovery, or correspondence between the parties.
In addition, APP may file revised public versions of D.l. 181 (including the Exhibits
thereto), D.L 182 and D.l. 237 within 1 day of receiving dedesignated versions of those
documents from MedCo.
I. BACKGROUND
A. Final Protective Order
The stipulated Final Protective Order in this action (D.l. 82) was entered by the Court on
August l3, 2010. Pursuant to the Final Protective Order, a producing party may, when
appropriate, designate information produced in the case, as well as "[a]ny memoranda, pleadings,
affidavits or other papers served or filed with the Court," as "Confidential" or "Highly
Confidential-Outside Counsel Only" ("Highly Confidential").
1 Defined infra at 6.
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i. Highly Confidential Information
"Highly Confidential" information is defined in paragraph 2 of the Final Protective
Order as follows:
"Highly Confidential-Outside Counsel Only" shall mean and
presumptively include a Producing Party's commercial information
(including, for example, business plans, business strategies,
negotiations, and license agreements), financial information
(including, for example, budgeting, accounting, sales figures and
advertising expenditures), business relationship information
(including, for example, information pertaining to potential and/or
existing customers, competitors, suppliers, distributors, affiliates,
subsidiaries, and parents), personnel information (including, for
example, compensation, evaluations and other employment
information), technical and research and deveLopment
information (including, for example, laboratory notebooks,
development reports, testing records, research plans, patent
prosecution documents, market and demographic research, and
product and advertising development), non-public information
concerning drug applications, and non-public communications
with the United States Food and Drug Administration ( " F D A ' ~
or other reguLatory agencies, any Product Samples, and all
documents referring or relating to such Product Samples, or any
other material within the meaning of Federal Rule of Civil
Procedure 26(c)(1)(G). Designated Material that is designated
Highly Confidential-Outside Counsel Only may be disclosed to
any of the individuals identified in Paragraph 5(b). HighLy
Confidential-Outside CounseL OnLy information includes
communications concerning HighLy Confidential-Outside
CounseL Only information and any information or data derived
from Highly Confidential-Outside Counsel OnLy information.
(0.1. 82 ~ 2) (emphasis added).
The Final Protective Order provides that "[a]ccess to any party's information marked
'HIGHLY CONFDIENTIAL-OUTSIDE COUNSEL ONLY' shall be limited to," inter alia,
"outside counsel of record" in this case "and their employees whose duties and responsibilities
require access to such materials." (See OJ. 82 ~ ~ 5(b)(i).)
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ii. Confidential Information
"Confidential information" is defined in paragraph 3 of the Final Protective Order as
follows:
"Confidential Information" shall mean and include other material
of a Producing Party that is not publicly known and which the
Producing Party would not normally reveal to third parties or, if
disclosed, would require such third parties to maintain in
confidence. Designated Material that is designated Confidential
Information may be disclosed to any of the individuals identified in
Paragraph S(c).
(D.l. 82,-] 3.)
In contrast to "Highly Confidential" information, "Confidential" information is accessible
to, inter alia, "[t]wo in-house counsel for each Party" in addition to "outside counsel of
record...." (See D.l. 82 , - ] ~ 5(b)(i) and 5(c)(i)-(ii).)
iii. Challenge to designation
Pursuant to paragraph 8 of the Final Protective Order, "[a)ny party may at any time
challenge the designation of any discovery materials as Highly Confidential-Outside Counsel
Only or Confidential Information and may request permission to use or disclose information with
the Highly Confidential-Outside Counsel Only or Confidential Information designation other
than as permitted ...." (See D.l. 82 ~ 8(b).)
The party requesting disclosure must serve a written request upon counsel for the
producing party which "specifically identif[ies] the [information] sought to be disclosed and the
name, title and function of the person(s) to whom such disclosure is desired to be made." (See
id.) "The Producing Party shall thereafter respond to the request in writing within seven (7)
business days after receipt of' the written request. (See id. ~ 8(c).) "If, where consent has been
withheld, the parties are subsequently able to agree on the terms and conditions of the requested
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disclosure, the matter may be submitted to the Court for resolution by the party seeking
disclosure." (See id.)
B. APP's Motion for Leave (DM 2)
On February 25,2011, APP filed its Motion for Leave, and an Opening Brief in support
thereof (D.1. 182), to assert: (1) unenforceability defenses and declaratory judgment
counterclaims based on MedCo's and named inventors Gary Musso's ("Musso") and Gopal
Krishna's ("Krishna") alleged inequitable conduct before the United States Patent and
Trademark Office ("PTO"); and (2) unenforceability defenses and declaratory judgment
counterclaims based on MedCo' s alleged unclean hands before the United States Food and Drug
Administration ("FDA") and in filing suit against APP. (See D.l. 182 at 1.)
APP attached as Exhibits A and C to the Motion for Leave its proposed amended answers
and counterclaims in, respectively, the '727 patent action (C.A. No. 09-752-ER) and the '343
patent action (10-476-ER) (consolidated for pretrial purposes in C.A. No. 09-750-ER).
MedCo filed a brief in Opposition to APP's Motion for Leave (D.I. 191) on March 14,
2011, and APP filed a Reply Brief in support of its Motion for Leave (D.I. 237) on March 24,
2011. At the direction of the Special Master, the parties submitted supplemental briefs relating
to APP's unclean hands allegations on April 14, 2011 (D.I. 266 ("MedCo's unclean hands
submittal"); D.1. 267 ("APP's unclean hands submittal").)
APP's Motion for Leave, Exhibits A and C thereto, and the parties' briefing in
connection with the Motion for Leave were filed under seal. In accordance with Section G of the
Administrative Procedures Governing Filing and Service by Electronic Means, APP and MedCo
each filed public versions of the documents originally filed under seal by that party.
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The Special Master issued a Report and Recommendation granting APP's Motion for
Leave on April 26, 2011 (D.!. 298) and an Amended Report and Recommendation granting
APP's Motion for Leave (D.l. 444) on June 23, 2011. MedCo filed objections to the Amended
Report and Recommendation on June 28, 2011. (D.l. 45l.) As of the date of this Order, the
Court has not ruled on MedCo's objections to the Amended Report and Recommendation. Thus,
APP's inequitable conduct and unclean hands claims are not presently in the case.
C. APP's Redactions Motion (DM 10)
The parties corresponded regarding the instant matter pursuant to paragraph 8 of the Final
Protective Order. (See D.l. 348, Ex. A-D.) Following the parties' unsuccessful attempts to
resolve this matter without involving the Court, APP filed its Redactions Motion on May 10,
2011. In the Redactions Motion, APP "seeks [the Special Master's] assistance to resolve the
parties' dispute regarding MedCo's practice of redacting infonnation that does not qualify as
'Confidential' or 'Highly Confidential-Outside Counsel Only' Information as defined by [the]
Final Protective Order and the relevant case law [hereinafter "Disputed Redactions"]''' (D.l. 346
at 1.)
The Redactions Motion "centers on MedCo's redaction of allegedly 'Highly
Confidential-Outside Counsel Only' information from two categories of documents" (D.l. 346
at 1):
(1) filings regarding APP's Motion for Leave:
APP's Motion for Leave (D.l. 181); (redacted public version is D.l. 186)
Proposed Amended Answer and Counterclaims in the '727 patent action (D.l.
181, Ex. A); (redacted public version is D.l. 186-1)
Proposed Amended Answer and Counterclaims in the '343 patent action (D.l.
181, Ex. C); (redacted public version is D.l. 186-2)
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APP's Opening Brief in Support of Motion for Leave (D.l. 182); (redacted
public version is D.l. 187)
MedCo's Brief in Opposition to APP's Motion for Leave (D.l. 191); (redacted
APP's Reply Brief in Support of Motion for Leave (D.l. 237); (redacted
MedCo' s unclean hands submittal CD.!. 266): (redacted public version IS
D.l. 283)2
(2) MedCo' s April 12, 2011 letter regarding this dispute.
(See D.l. 346 at 1 and D.l. 348, Ex. A-D). APP identifies in its Redactions Motion seven distinct
categories of Disputed Redactions in the foregoing documents which it asserts were improperly
designated as "Highly Confidential" by MedCo:
The facts of this lawsuit
The trade name Angiomax or the phrase "prior art Angiomax"
Communications between MedCo and the PTO during the prosecution of the patents-
in-suit
References to Paragraphs 103 or 104 of the proposed Amended Answer
The fact that MedCo communicated with the FDA
Conclusions drawn from the publicly-available patent prosecution documents
APP's general allegations regarding inequitable conduct and unclean hands
(See D.l. 346 at 2.)
According to APP, "[nJone of the statements at issue relates to MedCo' s commercial,
financial, business relationship, personnel, technical and research and development information
or otherwise non-public information submitted to any U.S. agency, as defined by the Final
Protective Order." (D.!. 346 at 2.) APP further argues that "[eJven if the information really is
2 APP provided the Special Master with color-coded copies of the foregoing documents. (See D.l. 348,
Ex. A and D). The words highlighted in blue and yellow in these documents represent all of the
infonnation that Medeo designated for redaction as "Highly Confidential." The Disputed Redactions are
highlighted in blue in Exhibit A and in yellow in Exhibit D; the words highlighted in yellow in Exhibit A
represent redactions that APP does not dispute.
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confidential (which it is not), MedCo fails to explain why it did not use the less restrictive
designation of 'Confidential' under the Final Protective Order." (ld. at 3.) Finally, APP's
outside counsel asserts in the Redactions Motion that "[t]hese disputes [regarding MedCo's
redactions] must be resolved in order to inform [our] client APP of the general contours of the
litigation."3 (See id.)
Accordingly, "APP seeks an order requiring MedCo to: (1) dedesignate all the [Disputed
Redactions] and (2) prohibit MedCo from designating any such information as 'Highly
Confidential-Outside Counsel Only' or 'Confidential' in the future, whether in mings,
discovery, or correspondence between the parties." (See id.)
On May 18,2011, MedCo filed a brief in opposition to APP's Redactions Motion (D.l.
373) ("Opposition"), asserting that the Redactions Motion should be denied given that:
(i) it involves serious and unproven allegations of inequitable
conduct and unclean hands and will cause embarrassment and
harm the reputations of those accused; and (ii) the motion is moot
as MedCo has already agreed to provide APP its requested relief
and permit APP's litigation counsel to discuss such claims with
APP's designated in-house counsel.
(D.l. 373 at 1) (emphasis in original).
MedCo explains in its Opposition that "[ dJuring the course of briefing APP's [Motion for
Leave], MedCo designated for redaction in all papers, including the proposed pleadings, the
underlying factual assertions that APP derived from MedCo's Highly Confidential Information
produced in discovery." (See id. at 1.) Further, MedCo asserts that "given the seriousness of
APP's allegations, MedCo designated any other information that, in the context of the motion
papers and/or the proposed amended pleading, suggests or infers the existence of facts that are
3 To this end, APP states that "(a]t a minimum, we wish to disclose the information above to in-house
counsel at APP so that APP is apprised of APP's inequitable conduct and unclean hands defenses and
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Highly Confidential." (fd at 2.) MedCo further explains that "[i]n particular, MedCo redacted
the identities of the accused, and information that identifies or implies the bases for APP's
allegations, which all stem from Highly Confidential Information produced during this action."
(ld.)
MedCo advances three principal arguments in support of its position that the Disputed
Redactions are proper. Two of MedCo's arguments relate to the issue of whether the Disputed
Redactions are protected under the existing Final Protective Order. First, MedCo asserts that the
Redactions Motion is moot because "MedCo has already agreed to provide APP its requested
relief. ..." (See id at 1.) Second, MedCo asserts that it properly designated the Disputed
Redactions as "Highly Confidential" under the Final Protective Order. (See id. at 2.)
In addition, MedCo advances a third argument that is unrelated to the provisions of the
Final Protective Order: MedCo "seeks to preclude disclosure of [the Disputed Redactions]" on
the grounds that their disclosure to the public "would result in embarrassment and potentially
disparage reputations." (See id. at 3.) Although MedCo has not moved for a protective order in
connection with the instant matter, MedCo's request to keep the Disputed Redactions sealed to
avoid embarrassment is best treated as a motion for an order of protection under Fed. R. Civ. P.
26(c).
II. ANALYSIS
A. APP's Redactions Motion is Not Moot
According to APP, during a between APP's counsel and MedCo's
counsel on May 3, 2011, APP's counsel "said [she] would need [1] a written proposal from
MedCo that specifically the [D]isputed [Redactions] so that [she] could provide
counterclaims." (D.I. 346 at 3.)
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the properly-redacted briefs and draft pleadings to [her] client" and "[2] assurance from MedCo
that it would change its previous practice regarding designations under the Protective Order."
(See Declaration of Emily A. Evans in Support of APP Pharmaceuticals, LLC and APP
Pharmaceuticals, lnc.'s Reply to The Medicines Company's Opposition to APP's Motion to
Compel De-designation of Non-Confidential Information (D.l. 386), ~ 5.)
On May 6, 2011, MedCo sent a letter to APP stating that: (1) "we do not object to you
discussing with your client's designated in-house counsel APP's [Motion for Leave] (DM 2),
including any information that we have designated as confidential"; and (2) "[w]e are willing to
discuss a proposal wherein the parties discuss with designated in-house counsel Highly
Confidential filings for purposes of advising their clients pursuant to paragraph 1 0 of the
Protective order." (D.L 386 ~ 7) ("MedCo's May 6 proposal").
APP informed MedCo later that day that MedCo's May 6 proposal was unacceptable, and
APP accordingly filed the Redactions Motion. (See D.l. 374, Ex. B.)
APP states in its Redactions Motion that "[a]t a minimum, we wish to disclose the
information above to in-house counsel at APP so that APP is apprised of APP's inequitable
conduct and unclean hands defenses and counterclaims." CD.I. 346 at 3.)
According to MedCo, APP's Redactions Motion "should be denied as moot" because
"MedCo has already given APP the relief it seeks and agreed that APP's outside counsel can
discuss with its in-house counsel APP's proposed allegations." (See D.l. 373 at 4.)
APP clarifies in its Reply Brief that "APP's counsel seeks to provide the amended,
redacted pleadings and related papers to its client redacted only for the [Highly Confidential]
material that is not presently in dispute," and that "MedCo's offer precludes APP from receiving
those materials." CD.!. 385 at 2.) APP further states that "[g]iven MedCo's refusal to
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dedesignate the disputed information, it is unclear what information APP' s counsel could
disclose without violating the Protective Order." (ld. at 2.)
It is clear to the Special Master that MedCo's May 6 proposal did not "give[J APP the
relief it seeks." As written, MedCo's May 6 proposal would not permit APP's outside counsel to
physically show to APP's in-house counsel the Disputed Redactions in APP's proposed
pleadings and associated briefing. Nor does MedCo's May 6 proposal address whether MedCo
will refrain from designating material in a similar fashion in the future. Thus, MedCo's May 6
proposal did not moot APP's Redactions Motion.
B. The Disputed Redactions Do Not Constitute "Highly Confidential"
Information Under the Final Protective Order
Upon review of the Disputed Redactions, the Special Master concludes that they do not
constitute "Highly Confidential" information under the Final Protective Order.
In response to APP's Redactions Motion, MedCo contends that it "properly designated its
Highly Confidential Information in the motion papers and briefing with respect to OM 2." (0.1.
373 at 2.) Pointing out that "[uJnder the Protective Order, 'Highly Confidential-Outside
Counsel Only' information includes technical and research and development information as well
as non-public communications with the FDA or other regulatory agencies" (0.1. 373 at 1, citing
O.I. 82 at 3-4), Medeo asserts that "APP's inequitable conduct and unclean hands allegations
were developed based on a review of MedCo's Highly Confidential internal manufacturing,
product development and regulatory documents." (O.l. 373 at 2.) According to MedCo, it
follows that "direct references to facts contained in those documents, and contextual
surroundings that may infer or suggest those facts, are properly redacted." (ld.) MedCo's
arguments are unavailing.
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The only two categories of "Highly Confidential" infonnation listed in the Final
Protective Order that MedCo asserts apply to the Disputed Redactions are "technical and
research and development infonnation" and "non-public communications with the FDA or other
regulatory agencies." (See D.I. 373 at 1, citing 0.1. 82 at 3-4). The Special Master is mindful
that infonnation falling within these two categories, as well as "communications concerning
(such] infonnation and any information or data derived from [itJ"4 (0.1. 82 ~ 2), constitutes
"Highly Confidential" infonnation under the Final Protective Order.
It is clear that the Disputed Redactions do not constitute "technical and research and
development infonnation" or "non-public communications with the (FDA] or other regulatory
agencies" under the Final Protective Order, and MedCo does not assert as much. Rather, MedCo
asserts that the Disputed Redactions constitute "infonnation or data derived from Highly
Confidential-Outside Counsel Only infonnation" (D.!. 82 ~ 2) under the Final Protective Order.
(See OJ. 373 at 1-2) (referring to the Disputed Redactions as "underlying factual assertions that
APP derived from MedCo' s Highly Confidential lnfonnation produced in discovery";
"information that ... suggests or infers the existence of facts that are Highly Confidential"; and
"information that identifies or implies the bases for APP's allegations" and "which ... stem(s]
from Highly Confidential Infonnation produced during this action").
While the clause "infonnation or data derived from Highly Confidential infonnation"
would certainly encompass a direct quote (or a paraphrase of a direct quote) from a "Highly
Confidential" document which revealed non-public technical research and development
infonnation or non-public communications with the FDA, a plain reading of that clause dictates
4 APP's statement that "[rJedactions must be limited to information that is itself [Highly Confidential]
material" is incorrect. (See D.l. 385 at 1.)
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that the protection does not extend to general allegations, legal arguments, and factual assertions
that do not in any way reveal any such information.
MedCo attempts to expand the reach of the clause, "information or data derived from
Highly Confidential information" (0.1. 82 ~ 2 (emphasis added)) to encompass "information
that ... suggests or infers the existence of facts that are Highly Confidential" and "information
that identifies or implies the bases for APP's allegations." (See OJ. 373 at 2) (emphasis added).
In the Special Master's view, this overly broad construction of the "derived from" clause would
invite a slippery slope wherein any information relating in any way to "Highly Confidential"
information would be cloaked with "Highly Confidential" protection, thereby shielding
otherwise public information from the other parties' in-house counsel and the public. The
Special Master's conclusions below underscore this point. To condone such a result would be to
contravene the "common law right of public access to court proceedings," see In re Violation of
Rule 28(d), Slip Op. 976,2011 U.S. App. LEXIS 6312, *8 (Fed. Cir. Mar. 29, 20] 1), as well as
the requirement that a party establish "good cause" for a protective order under Fed. R. Civ. P.
26(c).
Using APP's categorization of the Disputed Redactions as a guide (see D.L 346 at 2-3)5,
for the following reasons, the Special Master concludes that none of the Disputed Redactions
reveal any "technical and research and development information" or "non-public
communications with the [FDA] or other regulatory agencies," and, thus, Medeo improperly
designated the following information as "Highly Confidential":
Information regarding the procedural posture of this lawsuit, including when APP first
raised the issue of amending its answer (D.l. 191 at 5) and what motions APP had to file
5 The Special Master takes APP's characterizations of Medeo's designations as accurate. Indeed,
Medea does not dispute the accuracy of APP's characterizations of the Disputed Redactions in its
Opposoition.
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to obtain discovery from MedCo (D.1. 237 at 3-4) are not "Highly Confidential"
information and do not reveal any "Highly Confidential" information. Likewise, cases
cited by the parties (D.1. 191 generally; D.l. 237 at 9; D.L 266) do not fall under the
definition of "Highly Confidential" information in the Protective Order.
The trade name Angiomax and the phrases "prior art Angiomax" and "claimed
Angiomax" do not disclose any information that could be considered MedCo's "Highly
Confidential" information.
oSee D.l. 181, Ex. A6 at 90, 92, 95, 99,103,104,106,107
oSee D.L 182 at Table of Contents, 3, 4,9,10.
Communications between MedCo and the PTO during the prosecution of the patents-in
suit are public.
oSee D.l. 181, Ex. A 44, 49,50, 116, 132
oSee D.l. 182 at 1, 8, 9,10,11
oSee D.l. 191 at4; D.I. 237 at 1,6,7.
None of the references to Paragraphs 103 or 104 of the proposed Amended Answer can
be considered MedCo's "Highly Confidential" information because the quoted material is
already public, not having been redacted in Paragraphs 103 or 104.
o 111, 118, 119, 122
oSee D.1. 182 at 8.
The fact qua fact that MedCo communicated with the FDA does not reveal any "non
public information concerning drug applications [ or] non-public communications with
the [FDA]" and consequently is not "Highly Confidential" information.
oSee D.l. 181 at 2-3
oSee D.l. 181, Ex. A at, 135, Counterclaim Count Five, 26
oSee D.l. 182 at 1.
Conclusions drawn from the publicly-available patent prosecution documents are not
"Highly Confidential."
oSee D.l. 181, Ex. A at 45, 49, 50,102,110,116,121,122,124,125
oSee D.I.182 at 11,12
oSee D.l. 237 at 6, 7.
APP's general allegations of inequitable conduct and unclean hands, and legal arguments
in the parties' briefs, do not disclose the specific underlying "Highly Confidential" facts.
oSee D.l. 181, Ex. A at " 45, 110, 116, 117, 122, 125, 126, 130, 131, 133, and
section headings
oSee D.l. 182 at Table of Contents, 7, 8, 9,10,11,12,13
6 As APP points out, "MedCo has also designated identical infonnation as 'Highly Confidential
Outside Counsel Only' in Ex. C to D.!. 181." (D.!. 346 at 2 n.2.) The Special Master's conclusions with
respect to D.l. 181 Exhibit A apply equally to the corresponding paragraphs in D.L 181 Exhibit c.
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oSee D.l. 191 at Table of Contents, 2, 3, 7, 9,10,11,12,13,14,15
oSee D.l. 237 at 1,5,6, 7,8,9
oSee D.l. 266 at 1-2.
For the self same reasons, the Special Master concludes that MedCo's April 12, 2011
letter to APP regarding the instant matter is devoid of "Highly Confidential" information.
C. The Disputed Redactions Do Not Constitute "Confidential" Information
Under the Final Protective Order
"Confidential Information" is defined in the Final Protective Order as "other material of
a Producing Party that is not publicly known and which the Producing Party would not normally
reveal to third parties or, if disclosed, would require such third parties to maintain in
confidence." (D.l. 82 ~ 3.)
APP asserts in its motion that "[e]ven if the information really is confidential (which it is
not), MedCo fails to explain why it did not use the less restrictive designation of 'Confidential'
under the Final Protective Order." (D.l. 346 at 3.) MedCo did not address APP's assertion in
this regard in its Opposition.
The applicability of the "Confidential Information" clause has not been developed in any
respect on the record before the Special Master-i.e., it has not been litigated. In any event, for
the reasons stated in Section II.B. above, the Special Master concludes that neither the Disputed
Redactions nor MedCo's April 12,2011 letter contain any "Confidential" information.
D. MedCo Has Not Demonstrated That Public Disclosure of the Disputed
Redactions Will Cause Embarrassment
MedCo asserts that the Disputed Redactions "should be withheld from the public"
because APP's "allegations [of inequitable conduct and unclean hands] embarrass and attack the
reputations of the individual inventors and MedCo and risk harm to their reputations." (D.l. 373
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at 3.) For the reasons discussed below, the Special Master concludes that MedCo has not
satisfied its burden in this regard.
In assessing MedCo's assertion that the Disputed Redactions "should be withheld from
the public" because their disclosure would be embarrassing, it is important to note that "[t]here is
a strong presumption in favor of a common law right of public access to court proceedings." In
re Violation of Rule 28(d), Slip Op. 976,2011 U.S. App. LEXIS 6312, *8 (citing Nixon v.
Warner Commc 'ns, Inc., 435 U.S. 589, 597-99 (1978).) Further, "while 'the common law right
of access creates a strong presumption in favor of public access ... , this presumption should not
apply to materials properly submitted to the court under seal.'" Id. (quoting United States v.
Corbitt, 879 F.2d 224, 228 (7th Cir. 1989).) Finally, "[i]n determining whether to restrict the
public's access to court documents, the court must 'weigh[] the interests advanced by the parties
in light ofthe public interest and the duty of the courts.'" Id. (quoting Nixon, 435 U.S. at 602).
Against this backdrop, Fed. R. Civ. P. 26(c) permits "[a] party or any person from whom
discovery is sought [to] move for a protective order in the court where the action is
pending.... The court may, for good cause, issue an order to protect a party or person from
annoyance, embarrassment, oppression, or undue burden or expense ...." FED. R. Cr\'. P. 26(c).
Fed. R. Civ. P. 26( c) "places the burden of persuasion on the party seeking the protective order."
See Cipollone v. Liggett Group, Inc., 785 F.2d 1108, 1121 (3d Cir. 1986) (Cipollone I). "To
overcome the presumption, the party seeking the protective order must show good cause by
demonstrating a particular need for protection." Id. "Broad allegations of harm, unsubstantiated
by specific examples or articulated reasoning, do not satisfy the Rule 26(c) test." Id.
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i. MedCo Has Not Demonstrated That Public Disclosure of the Disputed
Redactions Will Embarrass MedCo
MedCo argues that "publicly accusing MedCo-a publicly traded company-of having
made misrepresentations to the FDA will embarrass MedCo and may cause harm to its reputation
and negatively impact MedCo's business, e.g., affecting its stock price, hampering its ability to
obtain investors, and/or affecting its relationships with collaborators and customers." (ld.)
In the Special Master's view, MedCo has not met its burden to show that it will suffer
"particularly serious embarrassment" if the Disputed Redactions are disclosed to the public. See
Cipollone I, 785 F.2d at 1121 ("[B]ecause release of information not intended by the writer for
public consumption will almost always have some tendency to embarrass, an applicant for a
protective order whose chief concern is embarrassment must demonstrate that the embarrassment
will be particularly serious.").
In Cipollone I, the court noted the "especially difficult" burden of establishing
embarrassment: "As embarrassment is usually thought of as a nonmonetizable harm to
individuals, it may be especially difficult for a business enterprise, whose primary measure of
well-being is presumably monetizable, to argue for a protective order on this ground." Id. "[T]o
succeed, a business will have to show with some specificity that the embarrassment resulting
from dissemination of the information would cause a significant harm to its competitive and
financial position." Id; see also Crum & Crum Enterprises, Inc. v. NDC ofCalifornia, L.P., 2011
WL 886356, *4 (D. Del. Mar. 10,2011) (same).
In Cipollone v. Liggett Group, Inc., 822 F.2d 335 (3d Cir. 1987) (Cipollone 11), the Third
Circuit elucidated the standard for establishing "financial embarrassment" articulated in
Cipollone I. In upholding the district court's denial of the defendant corporations' motion for a
protective order, the court in Cipollone II noted that the corporations had "made only broad
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allegations of harm" and "fail[ed] to provide the district court with a single document as a
concrete example of the type of harm they would suffer." Id. Notably, the court observed that
the district court had rej ected the corporations' arguments after "ma[king] a careful analysis of
[their] submissions concerning potential financial harm," which included "a market analysis
distributed by the investment firm of Drexel Burnham Lambert which referred to the 'obvious
volatility' of tobacco stocks in relation to events arising out of the smoking and health litigation"
and "evidence that the firm of E.F. Hutton has noted that the viability of tobacco stocks was
'directly related' to product liability litigation." Id.
The court then contrasted its ruling with that in Tavoulareas v. Washington Post Co., III
F.R.D. 653 (D.D.C. 1986), in which "Mobil Oil Co. reviewed specific documents and provided
the court with concrete examples of how their disclosure would harm its business operations."
See id. n.6. In Tavoulareas, unlike in Cipollone 11, the corporation seeking a protective order
(Mobil) had submitted an attorney statement which "demonstrate[d] the reasons why Mobil
currently believes disclosure would be harmful." Tavoulareas, III F.R.D. at 659.
MedCo's conclusory arguments-which are not supported by affidavit or concrete
examples-fall far short of demonstrating "financial embarrassment" under Cipollone.
ii. MedCo Has Not Demonstrated That Public Disclosure of the Disputed
Redactions Will Embarrass Musso and Krishna
MedCo further argues that public disclosure of the Disputed Redactions relating to APP' s
allegations of inequitable conduct would result in "particularly serious" embarrassment to named
inventors Musso and Krishna, especially "if the allegations do not ultimately come into the
case." (See D.1. 373 at 3.)
With respect to Musso, MedCo asserts the following: "[O]ne of the inventors, Gary
Musso, is an independent consultant who works with several pharmaceutical companies.
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Publicly accusing Dr. Musso of committing fraud will embarrass him, and may cause harm to his
professional reputation and his ability to maintain and obtain his consulting clients, thereby
affecting his livelihood." (ld.)
With respect to Krishna, MedCo asserts the following: "[P]ublicly accusing the other
inventor, Gopal Krishna, of committing fraud will embarrass him and may cause harm to his
professional reputation in his current position as a MedCo employee, as well as in any future
attempts to seek employment." (ld.)
Given the syntax of MedCo's argument-i.e., that public disclosure "will embarrass
[Musso and Krishna] and may cause harm to [their] professional reputation[s]" (see id.)
(emphasis added)-the Special Master understands MedCo to be advancing two distinct
arguments with respect to the named inventors: (1) public disclosure will embarrass them; and
(2) public disclosure may cause harm to their professional reputations. For the sake of
simplicity, the Special Master will address these issues in reverse order.
First, MedCo contends that the Disputed Redactions should remam sealed because
publicly disclosing them will harm Musso's and Krishna's professional reputations, thereby
affecting their livelihoods. This argument is unavailing. The Third Circuit has made clear that
"embarrassment is usually thought of as a nonmonetizable harm to individuals." See Cipollone
1, 785 F.2d at 1121 (emphasis added); see also Crum & Crum Enterprises, 2011 WL 886356, at
*4. MedCo's assertions ignore this bedrock principle.
Second, MedCo argues that "publicly accusing [Musso and Krishna] of committing fraud
will embarrass [them]." (ld.) The Special Master concludes that MedCo has failed to
demonstrate that Musso and Krishna would suffer "particularly serious" embarrassment if the
Disputed Redactions were publicly disclosed.
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Beyond the oft quoted Third Circuit principle that "embarrassment is usually thought of
as a nonmonetizable harm to individuals," see Cipollone 1, 785 F.2d at 1121, the Special Master
is not aware of any authority which precisely defines the term "embarrassment" with respect to
an individual in the context of Fed. R. Civ. P. 26(c), and the parties brought no such authority to
the Special Master's attention. According to Merriam-Webster's Online Dictionary, to
"embarrass" means, inter alia, "to cause to experience a state of self-conscious distress."7
To establish that good cause exists to protect an individual from embarrassment, the party
seeking protection must demonstrate with specificity that the embarrassment will be "particularly
serious." See Constand v. Cosby, 229 F.R.D. 472, 480 (E.D. Pa. 2005) (Robreno, J.) (quoting
Cipollone 1,785 F.2d at 1121); see also Wilcock v. Equidev Capital LLC, 2001 WL 913957, *1
(S.D.N.Y. Aug. 14, 2001) ("Defendant Coleman speculates that Plaintiffs contacts with the
clients would be embarrassing or would result in loss of those clients or, perhaps, litigation by
those clients. Such conclusory statements fall short of the specificity required to establish[] good
cause for a protective order.") (citing Cipollone 1, 785 F.2d at 1121).
In addition, the party seeking protection must establish "a nexus between the potential for
serious embarrassment and the particular information sought to be kept confidential." See
Constand, 229 F.R.D. at 480. In setting forth this standard for establishing nexus, the court in
Constand acknowledged that allegations of bad conduct "may cause ... serious embarrassment."
1d. The court explained, however, that "[e]mbarrassment alone, ... even if serious, does not
justify the cloak of confidentiality over all discovery." 1d. Rather, "the party seeking
protection[] must show a nexus between the potential for serious embarrassment and the
particular information sought to be kept confidential." It is clear that under Constand, a party's
7 See http://www.merriam-webster.com/dictionary/embarrasses.
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assertion that an allegation of wrongdoing is embarrassing in and of itself will not satisfy the
nexus requirement. Rather, the party seeking protection must connect the "particular information
sought to be kept confidential" to "the potential for serious embarrassment." See id. It follows
that the "particular information" must be embarrassing in and of itself in order to satisfy the
nexus requirement set forth in Constand.
In the Special Master's view, none of the particular information contained in the Disputed
Redactions listed on pages 13-15 below is embarrassing in and of itself. The following examples
underscore this observation:
The trade name "Angiomax" and the phrases "prior art Angiomax" and
"claimed Angiomax" (D.I. 181, Ex. A ~ ~ 90, 92) are not embarrassing in and
of themselves.
The fact that "Example ) In the '727 Patent was the only experimental
evidence submitted to the PTO purporting to show that Applicants possessed
the claimed invention" (D.L 181, Ex. A ~ 102) is not embarrassing in and of
itself.
The fact that the Patent Examiner "repeatedly rejected the claims of the '727
Patent based on a finding that claimed Angiomax was not different from prior
art bivalirudin products" (D.l. 181, Ex. A ~ 116) is not embarrassing in and of
itself.
The fact that certain experimental results were not submitted to the PTO (D.l.
181, Ex. A ~ 121) is not embarrassing in and of itself.
The fact that the PTO advised the named inventors of their "obligation under
37 [C.F.R.] 1.56 to point out the inventor and invention dates of each claim
that was not commonly owned at the time a later invention was made in order
for the examiner to consider the applicability of 35 U.S.c. 103(c) and
potential 35 U.S.C. 102(e), (f), or (g) prior art under 35 U.S.C. 103(a)"
(D.I. 181, Ex. A ~ 132) is not embarrassing in and of itself.
Given that the particular information in the Disputed Redactions is not itself
embarrassing, in the Special Master's view, logic dictates that there cannot be a nexus between:
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(1) "the potential for serious embarrassment"; and (2) "the particular information sought to be
kept confidential." See Constand, 229 F.R.D. at 480 (emphasis added).
Indeed, MedCo makes no attempt to establish that any of the information in the Disputed
Redactions is itself embarrassing. Instead, it is the allegations of inequitable conduct that
MedCo asserts are embarrassing. Rather than attempting to connect "the particular information
sought to be kept confidential" to "the potential for serious embarrassment" as is required under
Constand to establish nexus, MedCo instead attempts to draw a link between APP's allegations
of inequitable conduct and "the potential for serious embarrassment." (See D.l. 373 at 3) ("such
allegations embarrass and attack the reputations of the individual inventors"; "Publicly accusing
Dr. Musso of committing fraud will embarrass him ...."; "publicly accusing the other inventor,
Gopal Krishna, of committing fraud will embarrass him ...."). That is not the correct standard
for establishing nexus under Constand.
Moreover, MedCo has failed to demonstrate with specificity that disclosure of the
Disputed Redactions will cause "particularly serious" embarrassment to Musso and Krishna.
Offering no affidavits or concrete examples whatsoever in support of its position, MedCo's bald
assertion that public disclosure will "embarrass" the named inventors does not suffice. See, e.g.,
Cipollone I, 785 F.2d at 1121; Constand, 229 F.R.D. at 480; Wilcock, 2001 WL 913957, at *1.
III. CONCLUSION
In sum, the Special Master concludes that the Disputed Redactions do not constitute
"Highly Confidential" or "Confidential" information under the Final Protective Order. In
addition, MedCo has not met its burden to establish that the Disputed Redactions should remain
sealed because their disclosure to the public would result in particularly serious embarrassment
to MedCo and named inventors Musso and Krishna. Finally, it follows that MedCo has not
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overcome the "strong presumption in favor of a common law right of public access to court
proceedings" with respect to the Disputed Redactions. In re Violation of Rule 28(d), 2011 U.S.
App. LEXIS 6312, at *8.
Accordingly, APP's Redactions Motion is GRANTED. MedCo is HEREBY ORDERED
to:
1) dedesignate all of the Disputed Redactions and the April 12, 2011 letter
within 2 days of the date this Order becomes final in a manner consistent
with the direction provided in this Order;
2) electronically file revised public versions of D.L 191 and D.l. 266 within 1
day of dedesignating them;
3) meet and confer with APP within 5 days of the date this Order becomes
final regarding what redactions should be made to the Amended Report
and Recommendation CD.I. 444) in light of this Order for the purpose of
docketing a public version of the Amended Report and Recommendation;
4) forthwith after the meet and confer, submit an electronic copy of the
Amended Report and Recommendation with the agreed-upon redactions to
the Special Master for docketing; and
5) refrain from designating any information such as the Disputed Redactions
as "Highly Confidential-Outside Counsel Only" or "Confidential" in the
future, whether in filings, discovery, or correspondence between the
parties.
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In addition, APP may file revised public versions of D.I. 181 (including the Exhibits
thereto), D.I. 182 and D.l. 237 within 1 day of receiving dedesignated versions of those
documents from MedCo.
THE SPECIAL MASTER'S ORDER WILL BECOME A FINAL ORDER OF THE
COURT UNLESS OBJECTION IS TAKEN IN ACCORDANCE WITH THE
ACCOMPANYING ORDER WHICH SHORTENS THE TIME WITHIN WHICH AN
APPLICATION MAY BE FILED PURSUANT TO FED. R. CIV. P. 53(f)(2).
SO ORDERED this 30
th
day of June, 20 .
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