r 

 

John E. Flaherty 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Errol B. Taylor 

Fredrick M. Zullow 

William J. McNamara 

MILBANK, TWEED, HADLEY & 

 & McCLOY LLP 

1 Chase Manhattan Plaza 

New York, New York 10005-1413 

(212) 530-5000 

Attorneys for Plaintiff Orexo AB 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

OREXO AB, 

 Plaintiff, 

 v. 

 

MYLAN PHARMACEUTICALS INC. and 

MYLAN INC., 

 Defendants. 

: 

: 

: 

: 

: 

: 

: 

: 

: 

: 

Honorable Freda L. Wolfson, U.S.D.J. 

Honorable Lois H. Goodman, U.S.M.J. 

Civil Action No. 3:11-cv-03788 (FLW)(LHG) 

OREXO AB’S MEMORANDUM IN OPPOSITION TO 

MYLAN PHARMACEUTICALS INC. AND MYLAN INC.’S 

MOTION TO SEAL PORTIONS OF THE JULY 6, 2012 LETTER 

AND EXHIBITS TO THE JULY 8, 2012 LETTER

Case 3:11-cv-03788-MAS-LHG Document 77 Filed 08/06/12 Page 1 of 10 PageID: 757
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TABLE OF CONTENTS 

Page(s) 

I. FACTS ............................................................................................................................... 1 

II. LEGAL STANDARD ........................................................................................................ 2 

III. ARGUMENT ..................................................................................................................... 3 

A. MYLAN HAS NOT SPECIFICALLY IDENTIFIED HOW THE 

INFORMATION IT SEEKS TO SEAL RELATES TO MYLAN 

CONFIDENTIAL INFORMATION. .................................................................... 3 

B. MYLAN’S PROPOSED CONSTRUCTIONS OF THE OREXO PATENT 

CLAIMS SHOULD NOT CONTAIN MYLAN CONFIDENTIAL 

INFORMATION.................................................................................................... 4 

C. MYLAN HAS IMPROPERLY IDENTIFIED ITS ANDA 

INFORMATION AS “HIGHLY CONFIDENTIAL” ........................................... 5 

IV. CONCLUSION .................................................................................................................. 6 

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TABLE OF AUTHORITIES 

Page(s) 

CASES

In re Cendant Corp., 

260 F.3d 183 (3d Cir. 2001).......................................................................................................2 

RULES

Fed. R. Civ. P. 26(c) ........................................................................................................................2 

N.J. Loc. Civ. R. 5.3(c)(2) ...............................................................................................................2 

N.J. Loc. Civ. R. 5.3(c)(2)(a) ...........................................................................................................3 

N.J. L. Pat. R. 4.2(a)-(c) ...................................................................................................................1 

N.J. L. Pat. R. 4.2(d) ........................................................................................................................1 

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Plaintiff Orexo AB opposes Defendants Mylan’s motion to seal non-confidential 

information in Mylan’s July 6, 2012 letter to the Court and in exhibits to Orexo’s July 8, 2012 

response (the “July 16 Motion to Seal”). Mylan previously sought to seal this same nonconfidential information in its July 13, 2012 Motion to Seal (the “July 13 Motion to Seal”), 

which has already been fully briefed by the parties (see Dkt. Nos. 66, 71, 74 and 75). Orexo 

opposes Mylan’s current Motion to Seal for the substantially same reasons set forth in its July 

23, 2012 Opposition (Dkt. No. 71) and July 31, 2012 Sur-reply (Dkt. No. 75), which are 

incorporated herein by reference. Accordingly, Mylan’s July 13 Motion to Seal and July 16 

Motion to Seal should stand or fall together. 

I. FACTS 

Mylan’s motion seeks to designate its claim constructions and supporting evidence as 

confidential. Contrary to Mylan’s argument, this information is not confidential. Rather, it 

concerns: (1) Mylan’s proposed claim constructions which should be based on publicly available 

information and would be part of the public record when the Court enters a claim construction 

ruling; (2) the publicly available patent-in-suit and publicly available file history; and (3) 

descriptions of expert testimony on the teachings of the publicly available patent and prior art. 

This information does not include even one citation to Mylan confidential information such as 

Mylan’s ANDA. 

Mylan did not designate this information as confidential when it exchanged its 

Preliminary or Responsive Claim Construction Charts pursuant to N.J. L. Pat. R. 4.2(a)-(c), when 

the parties conferred pursuant to N.J. L. Pat. R. 4.2(d); or when the parties exchanged Draft Joint 

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Claim Construction Statements.1 Counsel for Orexo has relied on Mylan’s previous disclosures 

as non-confidential and disclosed Mylan’s proposed constructions and support to Orexo. 

II. LEGAL STANDARD 

Mylan, as the party seeking to seal portions of its July 6, 2012 letter to the Court and the 

exhibits to Orexo’s July 8, 2012 response must show (1) “that the material is the kind of 

information that courts will protect”; and (2) “disclosure will work a clearly defined and serious 

injury to the party seeking closure.” See In re Cendant Corp., 260 F.3d 183, 192 (3d Cir. 2001) 

(holding that the district court abused its discretion by issuing confidentiality order sealing 

documents) (internal citations and quotations omitted). 

A party may properly shield its confidential or proprietary information from public view 

under certain, limited circumstances. See Fed. R. Civ. P. 26(c). Mylan must show (a) the nature 

of the materials are of the type that should be protected, (b) the legitimate private or public 

interests which warrant the relief sought, (c) the clearly defined and serious injury that would 

result if the relief sought is not granted, and (d) why a less restrictive alternative to the relief 

sought is not available. N.J. Loc. Civ. R. 5.3(c)(2); see also Orexo v. Mylan Discovery 

Confidentiality Order of March 26, 2012, at ¶ 12 (confirming burden in motion to seal remains 

on party claiming confidentiality). 

 

1

 In its Draft Joint Claim Construction Statement, Mylan indicated that two direct references to Mylan’s 

ANDA product were confidential, but failed to identify any other portion as confidential. These two 

references were subsequently removed before the Joint Statement was submitted to the Court and are not

at issue in this motion. 

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III. ARGUMENT 

Prior to this motion and despite being the subject of the parties’ exchanges under L. Pat. 

R. 4.2 and 4.3, Mylan did not designate its (or Orexo’s) proposed constructions or its (or 

Orexo’s) evidentiary support as “Confidential.” Counsel for Orexo has relied on this previous 

decision not to designate and disclosed Mylan’s claim construction positions to Orexo while 

discussing its own positions. Mylan should not be permitted to seal its proposed constructions 

and large portions of the support without meeting its burdens under the rules to specifically 

identify the confidential information and Mylan’s need to seal. 

A. MYLAN HAS NOT SPECIFICALLY IDENTIFIED HOW THE 

INFORMATION IT SEEKS TO SEAL RELATES TO MYLAN 

CONFIDENTIAL INFORMATION. 

Mylan does not meet its burden of demonstrating need. Nowhere does Mylan indicate 

how the information that relates only to construction of Orexo’s patent and claims could possibly 

reveal Mylan’s confidential information. Mylan only broadly alleges that Mylan’s and Orexo’s 

claim constructions and supporting evidence include information from the ANDA. But, Mylan’s 

constructions and supporting evidence do not cite its ANDA or describe its ANDA formulation 

in any manner. Mylan fails to connect the dots, by failing to identify the nature of the 

confidential material included in the letter and exhibits, see N.J. L. Civ. R. 5.3(c)(2)(a). Mylan’s 

support is insufficient to justify restricting public access to the proposed claim constructions; 

citations to the ‘910 Patent’s claims, specification, and file history in support of those claim 

constructions; and publicly-available extrinsic evidence. 

Orexo does not agree that Mylan’s proposed constructions or citations to publicly 

available evidence should be considered confidential. If there are specific portions of Mylan’s 

proposed constructions and supporting evidence that Mylan believes contains confidential 

Case 3:11-cv-03788-MAS-LHG Document 77 Filed 08/06/12 Page 6 of 10 PageID: 762
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information, it should identify these sections to this Court and to Orexo with an explanation 

concerning exactly how this information reveals Mylan’s confidential information so that the 

Parties can further consider this matter. 

B. MYLAN’S PROPOSED CONSTRUCTIONS OF THE OREXO 

PATENT CLAIMS SHOULD NOT CONTAIN MYLAN 

CONFIDENTIAL INFORMATION. 

In seeking to seal its proposed claim constructions, Mylan asks this Court to remove from 

public view these proposed constructions, which by definition address the meaning of the claims 

of the publicly available patent-in-suit. It is Orexo’s (not Mylan’s) patent and claims that are the 

subject of these construction proceedings. Thus, these proposed constructions cannot reasonably 

be considered confidential. If Mylan’s logic is accepted, this Court would be required to seal its 

rulings on the meaning of claim language in Orexo’s publicly available ‘910 patent – an odd 

result to say the least. 

Nor should Mylan’s supporting evidence contain Mylan’s confidential information. This 

evidence includes citations to, characterizations of, and proposed expert testimony regarding the 

patent specification, the prosecution history and prior art – all of which are publicly available. If 

Mylan believes that the public record supports its claim constructions, then its proposed claim 

constructions must likewise be non-confidential. 

Mylan seeks to redact references to a specific material (not identified here to avoid the 

need for further motions to seal) in its July 6, 2012 letter. In its July 30, 2012 Reply Brief in 

support of the July 13 Motion to Seal, Mylan admitted that the only reason it seeks to address 

this unnamed material in its construction is because it is present in Mylan’s ANDA product. 

That is plainly improper and highlights the weakness of the argument (as Orexo will address in 

claim construction briefing). But, Mylan previously and incongruously argued in its Joint Claim 

Construction Statement that the ‘910 patent specification and file history supported a claim 

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construction excluding this unnamed material. Given this position (that even Mylan now admits 

is wrong), Mylan cannot reasonably argue that the reference to the unnamed material should be 

sealed. By expressly naming the “unnamed material” in its construction, Mylan destroys any 

justification for sealing references to that unnamed material. 

C. MYLAN HAS IMPROPERLY IDENTIFIED ITS ANDA 

INFORMATION AS “HIGHLY CONFIDENTIAL” 

Mylan alleges that the exhibits to Orexo’s July 8, 2012 letter contain information relating 

to Mylan’s ANDA product, yet Mylan has incorrectly designated these as “Highly Confidential” 

(and not “Confidential”) under the Protective Order. The protective order entered in this case 

provides: 

“The designation ‘Confidential’ shall be limited to information that 

the Producing Party, Including a third party, in good faith believes 

to contain: (1) proprietary or commercial sensitive information 

concerning the formulation or composition of products ... For the 

avoidance of doubt, the following information shall be of the type 

considered ‘Confidential’ and not ‘Highly Confidential’ under this 

order: (1) All portions of ANDA 20-2657 ... (4) all documents 

relating to the composition, manufacture, specification, testing, 

analysis, makeup, content, ingredients, development and structure 

of Mylan’s ANDA products.” 

While Orexo disagrees that July 6 letter and exhibits to the July 8 letter contain ANDA 

information, to the extent Mylan believes certain disclosures reveal information about Mylan’s 

ANDA product and the court permits sealing, this information should be designated (or redesignated) pursuant to the court’s Protective Order as “Confidential” and not “Highly 

Confidential.” 

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IV. CONCLUSION 

For the reasons set forth above, Mylan’s Motion to Seal should be denied. 

Respectfully submitted 

Dated: August 6, 2012 By: s/John E. Flaherty 

 John E. Flaherty 

McCARTER & ENGLISH 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Errol B. Taylor 

Fredrick M. Zullow 

William J. McNamara 

MILBANK, TWEED, HADLEY & 

McCLOY LLP

1 Chase Manhattan Plaza 

New York, New York 10005-1413 

(212) 530-5000 

Attorneys for Plaintiff 

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CERTIFICATE OF SERVICE 

The undersigned hereby certifies that a true copy of OREXO AB’S MEMORANDUM IN 

OPPOSITION TO MYLAN PHARMACEUTICALS INC. AND MYLAN INC.’S MOTION TO 

SEAL PORTIONS OF THE JULY 6, 2012 LETTER AND EXHIBITS TO THE JULY 8, 2012 

LETTER were caused to be served on August 6, 2012, upon the following via e-mail and/or the 

CM-ECF system: 

Arnold B. Calmann (abc@saiber.com) 

Jeffrey Soos (js@saiber.com) 

Katherine A. Escanlar (kae@saiber.com) 

SAIBER LLC 

One Gateway Center, 10th Floor 

Newark, New Jersey 07102-5311 

973-622-3333 

Douglass C. Hochstetler (DHochstetler@KelleyDrye.com) 

Constantine Koutsoubas (CKoutsoubas@KelleyDrye.com)

KELLEY DRYE & WARREN LLP 

333 West Wacker Drive 

Chicago, IL 60606 

312-867-7070 

Beth D. Jacob (BJacob@KelleyDrye.com) 

Clifford Katz (CKatz@KelleyDrye.com) 

Sung Kim (SuKim@KelleyDrye.com) 

KELLEY DRYE & WARREN LLP 

101 Park Avenue 

New York, NY 10178 

212-808-7800 

s/John E. Flaherty 

John E. Flaherty 

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