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-MAS-LHG 

Hon. Michael A. Shipp, U.S.D.J. 

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

Motion Return Date: August 6, 2012 

Document Filed Electronically 

 

REPLY BRIEF IN SUPPORT OF MYLAN PHARMACEUTICALS INC. 

AND MYLAN INC.’S MOTION TO SEAL PORTIONS OF THE JOINT CLAIM 

CONSTRUCTION AND PREHEARING STATEMENT AND EXHIBITS THERETO 

 

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, Illinois 60606 

312-867-7070 

312-867-7096 (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, New York 10178 

212-808-7800 

212-808-7897 (facsimile) 

Attorneys for Defendants/Counterclaim Plaintiffs 

Mylan Pharmaceuticals Inc. and Mylan Inc 

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TABLE OF CONTENTS

PAGE

I. THE CLAIM CONSTRUCTIONS IN DISPUTE REVEAL PORTIONS OF 

MYLAN’S CONFIDENTIAL FORMULATION..................................................................1

II. MYLAN HAS NOT WAIVED THE CONFIDENTIALITY OF THE 

DESIGNATED INFORMATION. .........................................................................................3 

III. MYLAN HAS NOT SOUGHT TO SEAL PUBLIC INFORMATION.................................4 

CONCLUSION................................................................................................................................5 

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TABLE OF AUTHORITIES

Page(s) 

FEDERAL CASES

O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 

521 F.3d 1351 (Fed. Cir. 2008)..................................................................................................2 

U.S. Surgical Corp. v. Ethicon, Inc., 

103 F.3d 1554 (Fed. Cir. 1997)..................................................................................................2 

RULES

Civ. R. 5.3(c)(2)...............................................................................................................................1 

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“Orexo does not dispute that portions of Mylan’s ANDA are confidential.” (Orexo’s 

Opp’n Br. at 3.) Orexo recognizes Mylan’s ability to seal “confidential or proprietary 

information from public view.” (Orexo Opp’n Br. at 2.) Nevertheless, in an opposition that 

lacks specifics, Orexo opposes Mylan’s motion to seal those portions of the joint claim 

construction statement that reveal Mylan’s confidential formulation of Mylan’s zolpidem 

product—as disclosed in Mylan’s confidential ANDA. Orexo apparently opposes Mylan’s 

motion because Orexo simply does not agree that Mylan’s proposed claim constructions reveal 

Mylan’s confidential formulation and Orexo contends that Mylan is seeking to seal public 

information. The Court should reject Orexo’s argument because, as set forth below, Orexo is 

wrong on both counts and relies on incorrect factual predicates. 

I. THE CLAIM CONSTRUCTIONS IN DISPUTE REVEAL 

PORTIONS OF MYLAN’S CONFIDENTIAL FORMULATION

Orexo argues that Mylan’s motion should be denied because claim constructions are not 

to be based on the product at issue and are based on “publicly available evidence.” It further 

argues that Mylan failed to “connect the dots” by identifying the confidential information 

included in the joint claim construction statement. (Orexo Opp’n Br. at 3.) 

Evidently, Orexo would prefer that Mylan reveal its highly confidential information in its 

motion to seal papers, even though such motions are publicly available under L. Civ. R. 

5.3(c)(2). To follow Orexo’s approach would eviscerate Mylan’s claim of confidentiality with 

respect to its formulation—the very information that Mylan is trying to protect. Without 

prejudice to Mylan, we respectfully submit that a general discussion of the issue demonstrates 

that the proposed claim constructions reveal Mylan’s confidential information. 

With respect to the “bioadhesion and/or mucoadhesion promoting agent” portion of the 

“ordered mixture...” limitation, Orexo has taken the position that Mylan’s use of a certain 

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ingredient satisfies the claim’s requirement for a “bioadhesion and/or mucoadhesion promoting 

agent.” As shown in a redacted excerpt of Mylan’s proposed claim construction below, Mylan 

proposes that the term “bioadhesion and/or mucoadhesion promoting agent,” as properly 

construed in Orexo’s patent and based on the intrinsic evidence, explicitly excludes that 

ingredient: 

Bioadhesion and/or mucoadhesion promoting agent

A substance that is effective in making the active agent adhere to 

the oral mucosa. 

For the ‘910 patent, neither [Ingredient A] nor [Ingredient B] is 

such an agent. 

(Joint Claim Construction and Prehearing Statement (ECF No. 63) at p. 26, Att. 3, Col. 2.) 

Both parties agree that this term (as well as the other construction that Mylan seeks to 

seal) are “central to Mylan’s primary non-infringement allegations.” (See Joint Claim 

Construction and Prehearing Statement (ECF No. 63) at 13-14.) It is no wonder, then, that the 

proposed constructions of these terms reveal aspects of Mylan’s confidential formulation for 

Mylan’s zolpidem tartrate sublingual tablets. The parties, of course, would ask the Court to 

construe only claim terms that are relevant to the issues in the case. See, e.g., O2 Micro Int’l Ltd. 

v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008) (“[C]laim construction is 

a matter of resolution of disputed meanings and technical scope, to clarify and when necessary to 

explain what the patentee covered by the claims, for use in the determination of infringement.” 

(quoting U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997)).) Mylan 

crafted its proposed construction, which is based on the intrinsic evidence of Orexo’s patent, to 

highlight a key infringement dispute before the Court. As such, one need not be a formulation 

scientist to make the appropriate inference that Mylan’s product incorporates one or both of 

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Ingredients A and B. Mylan’s proposed construction relevant to this dispute undeniably reveals 

that portion of Mylan’s highly confidential formulation. 

Mylan’s generic competitors could use that information to develop competing zolpidem 

tartrate products that—like Mylan’s product—are bioequivalent to Orexo’s product but do not 

infringe Orexo’s patent. Accordingly, in order to protect Mylan’s highly confidential and 

proprietary information, Mylan’s claim constructions should not be disclosed or otherwise 

available on the public docket. 

II. MYLAN HAS NOT WAIVED THE CONFIDENTIALITY OF THE 

DESIGNATED INFORMATION 

Orexo argues that Mylan’s motion should be denied because Mylan failed to designate 

this information as highly confidential in the parties’ exchanges of information during the meetand-confer process. (See, e.g., Orexo Opp’n Br. at 2.) Mylan, however, has now corrected its 

inadvertent failure to designate the constructions as Confidential and served versions of those 

disclosures with the appropriate confidentiality designation on July 30, 2012 pursuant to the 

Discovery Confidentiality Order. Under paragraph 10(b) of the Court’s Discovery 

Confidentiality Order, a party does not waive the right to designate information as confidential if 

it inadvertently failed to designate the information as confidential. 

Orexo next contends that it already has discussed Mylan’s confidential information with 

“Orexo,” but its papers notably do not claim that this included anyone at Orexo who is not 

permitted access to Mylan confidential information under the Discovery Confidentiality Order.1

(Orexo Opp’n Br. at 2.) In any event, the fact that Mylan may have been injured by disclosure to 

 

1

 A number of Orexo personnel are permitted access to the ANDA and other confidential 

information under the Discovery Confidentiality Order; these are the people who, according to 

Orexo, are able to analyze Mylan’s product in light of Orexo’s patent. (See Discovery 

Confidentiality Order (ECF No. 47) at ¶ 4(b)(1)(b).)

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unidentified people at Orexo is not support for compounding that injury by publicly disclosing 

this information about Mylan’s formulation to Mylan’s competitors. 

Orexo next suggests that its ability to litigate the case will be hampered if Mylan’s 

confidential information is filed under seal (Orexo Opp’n Br. at 3-4), but that is always the case 

when a litigation involves confidential information. The Discovery Confidentiality Order 

contemplates that counsel will not be able to share all relevant information with their clients. 

(Discovery Confidentiality Order (ECF No. 47) at ¶ 4.) This is not a reason to deny Mylan’s 

motion to seal portions of the record. 

III. MYLAN HAS NOT SOUGHT TO SEAL PUBLIC INFORMATION

Similarly, Orexo incorrectly contends—without citation or specifics—that Mylan is 

seeking to seal citations to publicly available evidence. (Orexo Opp’n Br. at 3.) Orexo’s failure 

to cite any alleged publicly available evidence that Mylan is seeking to seal is telling—because 

Mylan is not seeking to seal any publicly available evidence. Mylan invites the Court to review 

Exhibit C to the Koutsoubas Declaration, which provides a line-by-line description of the nature 

of each piece of information that Mylan seeks to seal. As shown in Exhibit C, Mylan is seeking 

to seal only 1) Mylan’s own proposed constructions;2

 2) Mylan’s or Orexo’s characterizations of 

Mylan’s constructions; or 3) Mylan’s additional commentary related to its own citation of 

evidence that reveals Mylan’s proposed constructions. Contrary to Orexo’s statements, and even 

 

2

 Mylan notes that its motion also seeks to seal Orexo’s proposed constructions of the same 

terms. Orexo’s proposed constructions reveal Mylan’s confidential information when viewed 

together with Mylan’s proposed constructions. If Mylan’s proposed constructions—and any 

discussion related to Mylan’s proposed constructions—are sealed, the public filing of Orexo’s 

constructions no longer provides sufficient information to disclose Mylan’s confidential 

information. Accordingly, Mylan withdraws its request to seal Orexo’s proposed constructions 

and submits a revised proposed order and redacted version of the Joint Claim Construction and 

Prehearing Statement to that effect, attached hereto as Exhibits A and B to the Koutsoubas 

Declaration, respectively. 

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taking into consideration Orexo’s constructions, Mylan has not sought to seal citations to 

publicly available information. 

CONCLUSION

Orexo’s agreement that it is proper to seal information from Mylan’s ANDA and Mylan’s 

formulation should end the inquiry. Orexo bases its opposition to Mylan’s motion on 

mischaracterizations of the limited information that Mylan seeks to seal. Mylan respectfully 

requests that the Court seal the portions of the Joint Claim Construction and Prehearing 

Statement (and exhibits) identified in its revised proposed order. 

Dated: July 30, 2012 Respectfully submitted, 

 SAIBER LLC 

Attorneys for Defendants/Counterclaim Plaintiffs 

Mylan Pharmaceuticals Inc. and Mylan Inc.

s/ Arnold B. Calmann 

 Arnold B. Calmann (abc@saiber.com) 

Jeffrey Soos (js@saiber.com) 

Katherine A. Escanlar (kae@saiber.com) 

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, Illinois 60606 

312-867-7070 

312-867-7096 (facsimile) 

Beth D. Jacob (BJacob@KelleyDrye.com) 

Clifford Katz (CKatz@KelleyDrye.com) 

Sung W. Kim (SuKim@KelleyDrye.com) 

KELLEY DRYE & WARREN LLP

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101 Park Avenue, Suite 1700 

New York, New York 10178 

212-808-7800 

212-808-7897 (facsimile) 

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