UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

OREXO AB, 

Plaintiff, 

v. 

MYLAN PHARMACEUTICALS INC. and 

MYLAN INC., 

Defendants. 

Civil Action No. 3:11–cv–3788–FLW–LHG 

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

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

 Document Filed Electronically 

 

DEFENDANTS’ PROPOSED FINDINGS OF 

FACT AND CONCLUSIONS OF LAW IN FURTHER 

SUPPORT OF PLAINTIFF’S MOTION TO SEAL (ECF NO. 124) 

 

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 

973-286-2465 (facsimile) 

Douglass C. Hochstetler 

(DHochstetler@KelleyDrye.com) 

Constantine Koutsoubas 

(CKoutsoubas@KelleyDrye.com) 

KELLEY DRYE & WARREN LLP

333 West Wacker Drive 

26th Floor 

Chicago, IL 60606 

312-857-7070 

312-857-7095 (facsimile) 

Beth D. Jacob (BJacob@KelleyDrye.com) 

Clifford Katz (CKatz@KelleyDrye.com) 

Sung W. Kim (SuKim@KelleyDrye.com) 

KELLEY DRYE & WARREN LLP 

101 Park Avenue 

Suite 1700 

New York, NY 10178 

212-808-7800 

212-808-7897 (facsimile) 

Attorneys for Defendants/Counterclaim 

Plaintiffs Mylan Pharmaceuticals Inc. and 

Mylan Inc. 

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 1 of 8 PageID: 2918
1 

INTRODUCTION 

Pursuant to Local Civil Rule 5.3(c), Defendants/Counterclaim-Plaintiffs Mylan 

Laboratories Limited and Mylan Inc. (collectively, “Mylan”) hereby submit Proposed Findings 

of Fact and Conclusions of Law in further support of Plaintiff Orexo AB’s Motion to Seal (ECF 

No. 124). Local Civil Rule 5.3(c) places the burden of proof on the moving party as to why a 

motion to seal or otherwise restrict public access should be granted. Specifically, it requires a 

showing of: 

(1) the nature of the materials or proceedings at issue; 

(2) the legitimate private or public interest which warrants the relief sought; 

(3) the clearly defined and serious injury that would result if the relief sought 

is not granted; and 

(4) why a less restrictive alternative to the relief sought is not available. 

Orexo and Mylan seek to seal the following documents Orexo electronically filed in 

connection with its Motion for the Issuance of a Letter of Request to the Central Authority of 

India for the Testimony from Subash Chandra Mohanta and P. Kurali Krishna: 

• Orexo AB’s Memorandum of Law in Support of Plaintiff Memorandum of Law in 

Support of Plaintiff Orexo AB’s Motion for the Issuance of a Letter of Request to 

the Central Authority of India for Testimony from Subash Chandra Mohanta and 

P. Murali Krishna (ECF No. 123) (“Orexo’s Brief”) at page 4, line 11 to page 5, 

line 2 between the words “Misters Mohanta and Krishna” and “Mylan’s ANDA 

Products”; 

• Orexo’s Brief at page 6, lines 6–17 between the words “Mr. Mohanta” and 

“Mylan’s ANDA Products)”; 

• Orexo’s Brief at page 10, lines 4–7 between the words “Specifically” and 

“discoverable evidence”; 

• Orexo’s Brief at page 11, lines 7–14 between the words “The two” and “observed 

and evaluated;” and 

• Exhibits A, C, D, E, F. 

Set forth below are the findings of fact and conclusions of law addressing each of the 

elements of Local Civil Rule 5.3(c). These findings of fact and conclusions of law support the 

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 2 of 8 PageID: 2919
2 

granting of Orexo’s Motion to Seal, as further supplemented by Mylan, the Confidential 

Documents identified herein. 

DISCUSSION 

I. THE NATURE OF THE MATERIALS OR PROCEEDINGS AT ISSUE 

A. Findings of Fact 

1.) The Confidential Documents contain and/or reflect information contained in or 

derived from Mylan’s Abbreviated New Drug Applications (“ANDA’’) and confidential 

manufacturing, formulation, and research and development information. (See Declaration of 

Constantine Koutsoubas, filed herewith (“Koutsoubas Decl.”) at ¶ 8.) Some of the Confidential 

documents contain sensitive personal information of the third party witnesses that are the subject 

of Orexo’s underlying motion. (Id.) The Confidential Documents reflect information that is 

presently confidential and unavailable to the public. (Id.) 

B. Conclusions of Law 

2.) There exists in civil cases a common law public right of access to judicial 

proceedings and records. In re Cendant Corp., 260 F.3d 183, 192 (3d Cir. 2001) (citing Littlejohn 

v. BIC Com., 851 F.2d 673, 677–78 (3d Cir. 1988)). The party seeking to seal any part of a 

judicial record bears the burden of demonstrating that “the material is the kind of information 

that courts will protect.” Miller v. Indiana Hosp., 16 F.3d 549, 551 (3d Cir. 1994) (quoting 

Publicker Indus., Inc. v. Cohen, 733 F.2d 1059, 1071 (3d Cir. 1984)). 

3.) This Court has the power to seal where confidential information may be disclosed 

to the public. Fed. R. Civ. P. 26(c)(l)(G) allows the court to protect materials containing “trade 

secret[s] or other confidential research, development, or commercial information[,]” upon 

motion by a party, to prevent harm to a litigant’s competitive standing in the marketplace. See 

Zenith Radio Com. v. Matsushita Elec. Indus. Co., Ltd., 529 F. Supp. 866, 889–91 (E.D. Pa. 

1981). 

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 3 of 8 PageID: 2920
3 

4.) This Court must also seal sensitive personal information of individuals pursuant 

to L. Civ. R. 5.2 ¶ 17. 

II. THE LEGITIMATE PRIVATE OR PUBLIC INTEREST WHICH 

WARRANTS THE RELIEF SOUGHT 

A. Findings of Fact 

5.) The Confidential Documents sought to be sealed contain information that was 

designated as confidential and proprietary under the Discovery Confidentiality Order, entered by 

this Court on March 26, 2012 (ECF No. 47) that presently governs the instant action. 

(Koutsoubas Decl., ¶ 8.) It also contains sensitive personal information of the third party 

witnesses that are the subject of Orexo’s motion. (Id.) 

6.) Counsel for Mylan has submitted a Declaration stating that Mylan has an interest 

in not publicly disclosing this information, has not publicly disclosed this information, and, in 

the case of some of the information, relies on such information to gain a competitive advantage 

in the pharmaceutical industry. (See Declaration of Constantine Koutsoubas, filed herewith 

(“Koutsoubas Decl.”).) 

7.) Commercially sensitive and proprietary information, such as non-public 

information related to Mylan’s ANDA, from which competitors could identify Mylan’s 

commercial interests embodies content which, if disclosed, might (and likely would) harm 

Mylan’s competitive standing. (Koutsoubas Decl. ¶ 9.) 

8.) Personal sensitive information of the third party witnesses that are the subject of 

the Orexo’s underlying motion should be redacted as a matter of course pursuant to Local Civil 

Rule 5.2 ¶ 17. 

9.) Orexo and Mylan—private parties—are in a patent dispute. Mylan has a 

legitimate interest in ensuring that its confidential and proprietary non-public information remain 

undisclosed. (Koutsoubas Decl. ¶¶ 8–9.) If this information were to become publicly available, 

then Mylan’s competitors could potentially (and likely would) use that information in the highly 

competitive pharmaceutical product marketplace. (Id. at ¶ 9.) 

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 4 of 8 PageID: 2921
4 

B. Conclusions of Law 

10.) The presumption of public access is not absolute and may be rebutted. Republic of 

the Philippines v. Westinghouse Elec. Corp., 949 F.2d 653, 662 (3d Cir. 1991). “Every court has 

supervisory power over its own records and files, and access has been denied where court files 

might have become a vehicle for improper purposes.” Littlejohn, 851 F.2d at 678 (quoting Nixon 

v. Warner Commc’ns, Inc., 435 U.S. 589, 598 (1978)). 

11.) Courts may deny access to and seal a document when it encompasses business 

information that might harm a litigant’s competitive standing. See Littlejohn, 851 F.2d at 678 

(citations omitted). 

12.) Courts should restrict access to personal sensitive information of individuals. L. 

Civ. R. 5.2 ¶ 17. 

13.) The District of New Jersey has held that the inclusion of trade secrets and other 

confidential information in documents warrant the sealing of such documents. “A well-settled 

exception to the right of access is the ‘protection of a party’s interest in confidential commercial 

information, such as a trade secret, where there is a sufficient threat of irreparable harm.’” In re 

Gabapentin Patent Litig., 312 F. Supp. 2d 653, 664 (D.N.J. 2004) (citation omitted). “The 

presence of trade secrets or other confidential information weighs against public access and, 

accordingly, documents containing such information may be protected from disclosure.” Id.

(citations omitted). 

14.) Information included in an ANDA often consists of trade secrets, and federal law 

requires such information to remain confidential. See id. at 667 n.7 (citing 21 C.F.R. 

§ 314.430(b)-(d)). As such, a party’s confidential processes, chemical formulas and 

specifications, and research information should be sealed. Gabapentin, 312 F. Supp. 2d at 667–

68. 

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 5 of 8 PageID: 2922
5 

III. THE CLEARLY DEFINED AND SERIOUS INJURY THAT WOULD 

RESULT IF THE RELIEF SOUGHT IS NOT GRANTED 

A. Findings of Fact 

15.) In light of its reference to, and disclosure of, non-public business information that 

is otherwise unavailable to third parties, the public disclosure of the Confidential Documents 

identified above poses a substantial risk of harm to Mylan’s legitimate proprietary interests and 

competitive position. (Koutsoubas Decl., ¶ 9) 

16.) Disclosure of specific information related to Mylan’s business practices would 

permit competitors to develop business strategies to duplicate, undercut, or otherwise counter 

Mylan’s commercial performance. (Id.) 

17.) Competitors would improperly benefit from the disclosure of Mylan’s non-public 

business information and would likely use the confidential information to enhance their market 

or negotiation positions. 

B. Conclusions of Law 

18.) This Court has discretion to balance the factors for and against access to court 

documents. See Pansy v. Borough of Stroudsburg, 23 F.3d 772, 781 (3d Cir. 1994). 

19.) Protection of a party’s interest in confidential commercial information, such as a 

trade secret, is a sufficient threat of irreparable harm, and is clearly defined as a serious injury. 

See Publicker, 733 F.2d at 1071. 

20.) The public’s interest in having access to the specific information presented in the 

Confidential Documents does not outweigh the competitive harms, which Mylan likely would 

sustain if the information were disclosed. 

IV. A LESS RESTRICTIVE ALTERNATIVE TO THE RELIEF SOUGHT IS 

NOT AVAILABLE 

A. Findings of Fact 

21.) Moreover, Mylan’s request to seal the Confidential Documents is narrowly 

tailored to restrict access only to confidential and proprietary information concerning the 

products that are the subject of Mylan’s ANDA. 

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 6 of 8 PageID: 2923
6 

22.) The disclosure of this confidential, proprietary information would pose a financial 

and competitive risk to Mylan. The only way to protect Mylan’s confidential interests is to seal 

the identified documents. 

B. Conclusions of Law 

23.) Under Local Civil Rule 5.3(c)(2), a party seeking to seal documents must meet 

the fourth prong that a no less restrictive alternative to the relief sought is available. See 

Securimetrics, Inc. v. Iridian Techs., Inc., No. 03-cv-04394, 2006 WL 827889, at *2 (D.N.J. 

Mar 30, 2006). 

24.) The sealing of confidential documents and information is an accepted practice in 

the District of New Jersey. Gabapentin, 312 F. Supp. 2d 653, passim. 

25.) For all of the above reasons, and because Mylan’s interests in the confidential 

information identified herein outweigh the minimal, if any, public interest in its disclosure, there 

is good cause to grant Plaintiff’s Motion to Seal, as further supplemented by Mylan, the 

Confidential Documents identified herein. 

Dated: May 9, 2013 Respectfully submitted, 

By: s/ Arnold B. Calmann________

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 

973-286-2465 (facsimile) 

Douglass C. Hochstetler 

(DHochstetler@KelleyDrye.com) 

Constantine Koutsoubas 

(CKoutsoubas@KelleyDrye.com) 

KELLEY DRYE & WARREN LLP

333 West Wacker Drive 

26th Floor 

Chicago, IL 60606 

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 7 of 8 PageID: 2924
7 

312-857-7070 

312-857-7095 (facsimile) 

Beth D. Jacob (BJacob@KelleyDrye.com) 

Clifford Katz (CKatz@KelleyDrye.com) 

Sung W. Kim (SuKim@KelleyDrye.com) 

KELLEY DRYE & WARREN LLP

101 Park Avenue 

Suite 1700 

New York, NY 10178 

212-808-7800 

212-808-7897 (facsimile) 

Attorneys for Defendants/Counterclaim Plaintiffs 

Mylan Pharmaceuticals Inc. and Mylan Inc.

Case 3:11-cv-03788-FLW-LHG Document 127-2 Filed 05/09/13 Page 8 of 8 PageID: 2925