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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. 

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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) 

CERTIFICATION IN SUPPORT OF 

STIPULATED DISCOVERY CONFIDENTIALITY ORDER 

John E. Flaherty, under penalty of perjury, declares as follows: 

1. I am a member of the firm of McCarter & English, LLP and counsel for 

plaintiff Orexo AB (“Plaintiff” or “Orexo”), the plaintiff in the above-captioned actions. I 

submit this Attorney Certification in support of a request for entry of a Stipulated Discovery 

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Confidentiality Order (“Confidentiality Order” or “Order”) made by all parties to the abovecaptioned actions. 

2. These cases arise out of Plaintiff’s assertions of patent infringement under 

the Hatch-Waxman Act and Defendants’ defenses thereto. Orexo holds an approved New Drug 

Application from the United States Food and Drug Administration (“FDA”) for a zolpidem 

tartrate sublingual product sold under the brand name Edluar®. By letter dated, May 19, 2011, 

Mylan notified Orexo that it had filed Abbreviated New Drug Application No. 20-2657 seeking 

FDA approval to commercially market a generic zolpidem tartrate sublingual product. Given the 

nature of the claims and the defenses asserted by the parties, discovery will likely include several 

areas of a sensitive nature, such as the parties’ research and development efforts and confidential 

information. It is my understanding that the documents concerning these subjects contain trade 

secrets or other confidential research, development, or commercial information, and it is 

anticipated that other information and materials produced or created during the course of 

discovery, such as deposition transcripts, may also contain confidential information. 

3. The parties in these cases assert that disclosure of this information without 

the entry of the Confidentiality Order would, among other things, result in harm to all parties and 

non-parties stemming from disclosure of trade secrets or other confidential research, 

development, or commercial information within the meaning of Fed. R. Civ. P. 26(c). Because 

the disclosure of such materials poses a substantial risk of causing harm to the parties, the parties 

developed and reached agreement upon a protocol for controlling disclosure of such information 

produced in discovery. The agreed-upon protocol is embodied in the proposed Confidentiality 

Order. 

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4. The parties respectfully submit that good cause exists for the entry of the 

proposed Order. See Fed. R. Civ. P. 26(c); Pansy v. Borough of Stroudsburg, 23 F.3d 772, 786 

(3d Cir. 1994). The nature of these cases requires the parties to seek and produce documents and 

information and elicit deposition testimony, the disclosure of which poses a substantial risk of 

harm to the producing party’s legitimate proprietary and financial interests. The proposed 

Confidentiality Order provides reasonable restrictions on the disclosure of such sensitive 

materials. To streamline the discovery process and minimize the need for the Court’s 

intervention, the proposed Order adopts an approach that allows the producing party to designate 

certain materials being produced or deposition testimony as confidential. See Order, ¶ 1. 

Disclosure of such materials or deposition testimony designated as “Confidential” or “Highly 

Confidential” is limited to specific classes of persons as defined in the Order. Id., ¶¶ 4-5. 

Moreover, the proposed Order requires the parties to seek permission to file confidential 

documents with the Court under seal, if such documents need to be filed as part of motion 

practice or other proceeding. Id., ¶ 11. 

5. The proposed Order also provides that the party requesting production of 

the information may challenge a producing party’s confidential designation before the Court, 

thereby minimizing the likelihood that non-sensitive documents will be unnecessarily designated 

as confidential. Id., ¶ 13. Orders of this type have been approved by the United States Court of 

Appeals for the Third Circuit. See Pansy, 23 F.3d at 787 n.17; Cipollone v. Liggett Group Inc., 

785 F.2d 1108, 1122 (3d Cir. 1986), cert. denied, 484 U.S. 976 (1987). These actions do not 

involve any government entity or official, but rather involve private litigants. Furthermore, the 

information at issue would not otherwise be available under a freedom of information law. 

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These factors further weigh in favor of entering the proposed Confidentiality Order. Pansy, 23 

F.3d at 786, 791. 

6. Nothing herein is a waiver by Plaintiff of any objection to any discovery 

request by any other party, nor an admission of the existence or relevance of such documents or 

information. 

I declare under penalty of perjury that the foregoing is true and correct. 

Executed on March 8, 2012. 

 By: s/ John E. Flaherty 

 John E. Flaherty 

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