Free Reply to Response to Motion - District Court of Delaware - Delaware

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Andrew T. Berry Jonathan M.H. Short McCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, NJ 07102 Telephone: (973) 622-4444 Facsimile: (973) 624-7070 Attorneys for Plaintiffs AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha

Of Counsel: Ford F. Farabow, Jr. Charles E. Lipsey York M. Faulkner FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P. 901 New York Avenue, N.W. Washington, DC 20001 Telephone: (202) 408-4000 Facsimile: (202) 408-4400 Henry J. Renk FITZPATRICK, CELLA, HARPER & SCINTO 30 Rockefeller Plaza New York, NY 10112 Telephone: (212) 218-2100 Facsimile: (212) 218-2200

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY : ASTRAZENECA PHARMACEUTICALS : Civil Action No. 3:07-cv-06020 (MLC)(JJH) LP, ASTRAZENECA UK LIMITED, IPR : : PHARMACEUTICALS, INC., and : SHIONOGI SEIYAKU KABUSHIKI : KAISHA, : : Plaintiffs, : : vs. : AUROBINDO PHARMA LIMITED, and : : AUROBINDO PHARMA USA INC. : : Defendants. : REPLY MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS' MOTION FOR A TEMPORARY STAY

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TABLE OF CONTENTS I. INTRODUCTION ....................................................................................................................... 1 II. ARGUMENT ............................................................................................................................. 3 A. DEFENDANTS HAVE NOT DEMONSTRATED "EXCEPTIONAL CIRCUMSTANCES" TO WARRANT DEPARTURE FROM APPLICATION OF THE FIRST-FILED RULE ...................................................... 3 B. DEFENDANTS' ARGUMENTS AGAINST APPLICATION OF THE FIRST-FILED RULE FAIL ........... 4 C. GRANTING A TEMPORARY STAY WOULD NOT SLOW THE LITIGATION OF THIS DISPUTE ........ 8 III. CONCLUSION......................................................................................................................... 8

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TABLE OF AUTHORITIES Cases Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 2007 WL 4284877 (W.D. Mich. Dec. 3, 2007) ....................................................................................................................................... 4, 6 Arthur-Magna Inc. v. Del-Val Financial Corp., 1991 WL 13725 (D.N.J. 1991)........................... 2 Aventis Pharma Deutschland GMBH v. Lupin Ltd., 403 F. Supp. 2d 484 (E.D. Va. 2005)........... 6 Aventis Pharma S.A. v. Sandoz Inc., 2007 WL 1101228 (D.N.J. 2007)......................................... 4 Continental Grain Co. v. Barge FBL-585, 364 U.S. 19 (1960)...................................................... 5 Crosley Corp. v. Hazeltine Corp., 122 F.2d 925 (3d Cir. 1941)................................................. 5, 6 Dentsply International, Inc. v. Kerr Mfg., Co., 734 F. Supp. 656 (D. Del. 1990).......................... 7 EEOC v. University of Pennsylvania, 850 F.2d 969, 971, 976 (3d Cir. 1988) ...................... passim Egon v. Del-Val Financial Corp., 1991 WL 13726 (D.N.J. 1991)................................................. 2 GlaxoSmithKline Consumer Health Care, L.P. v. Merix Pharmaceutical Corp., 2005 WL 1116318 (D.N.J. May 10, 2005) ............................................................................................. 5, 7 Hertz Corp. v. The Gator Corp., 250 F. Supp.2d 421 (D.N.J. 2003) ............................................. 2 Landis v. North American Co., 299 U.S. 248 (1936)...................................................................... 7 Martin v. Townsend, 1990 WL 159923 (D.N.J. Oct. 15, 1990) ..................................................... 5 Nature's Benefit, Inc. v. NFI, 2007 WL 2462625 (D.N.J. Aug. 27, 2007)..................................... 5 Siemens Financial Services, Inc. v. Open Advantage M.R.I. II L.P., 2008 WL 564707 (D.N.J. Feb. 29, 2008) ............................................................................................................................. 4 Teva Pharms. USA, Inc., v. Pfizer, Inc., 405 F.3d 990 (Fed. Cir. 2005) ........................................ 2 The Violet Pot, LLC v. Lowe's Companies, Inc., 2007 WL 894187 (D.N.J. Mar. 20, 2007) ......... 4 Triangle Conduit & Cable Co. v. National Electric Products Corp., 125 F.2d 1008 (3d Cir. 1942) ........................................................................................................................................... 4 Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294 (11th Cir. 2003)................................... 2 Statutes 28 U.S.C. § 1407............................................................................................................................. 2

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35 U.S.C. § 271............................................................................................................................... 2

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I.

INTRODUCTION We wish to be perfectly clear: AstraZeneca requests only that this Court grant a

temporary stay pending the outcome of Defendants' motion to dismiss the first-filed Delaware Action and the outcome of AstraZeneca's recently filed motion with the Judicial Panel on Multidistrict Litigation ("JPMDL") to transfer this action for coordinated or consolidated pretrial proceedings to the District of Delaware, where seven related patent infringement actions are pending. 1 This temporary stay is meant to avoid the unnecessary duplication and inefficiencies that will arise if both the Delaware Action and this second-filed New Jersey Action continue to proceed concurrently. Discovery related to Aurobindo's motion to dismiss for lack of personal jurisdiction in the Delaware Action has commenced, and the parties have a briefing schedule. The parties will fully brief the motion by May 1, 2008. AstraZeneca's transfer motion before the JPMDL will be fully briefed by the end of April. Thus, the temporary stay will likely be of short duration. In the meantime, the parties in the Delaware actions, including Aurobindo, are collaborating on a coordinated discovery plan for the Delaware Court's Rule 16 conference on April 10. Any discovery taken as part of that coordinated schedule in Delaware can be used interchangeably in this action if necessary. Accordingly, the temporary stay AstraZeneca seeks is not intended to forestall discovery or the advancement of this litigation. Instead, it is intended to ensure that discovery proceeds in a coordinated fashion until the Delaware Court rules on Aurobindo's motion to dismiss, and the JPMDL has had an opportunity to hear and rule on

1

AstraZeneca filed its transfer motion with the JPMDL, yesterday, March 13, 2008. A copy of the motion and supporting brief are attached to the Reply Declaration of Jonathan M.H. Short ("Short Reply Decl.") as Exhibit B.

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AstraZeneca's transfer motion.2 Until those things happen, AstraZeneca's litigation with Aurobindo can, and should, proceed in Delaware, coordinated with the other seven suits that involve virtually identical claims and defenses, regarding the patent asserted in this action. The filing of protective suits in ANDA cases is an accepted procedure in this Court and other Districts. If the District of Delaware were to dismiss the Delaware Action beyond the 45 day filing period, AstraZeneca would suffer an extraordinarily harsh outcome absent this protective suit.3 Furthermore, the first-filed rule is alive and well here in the Third Circuit, although it may not be recognized in other, less-relevant jurisdictions. Therefore, this Court is well within its power, precedent, and common sense to follow the first-filed rule. Temporarily staying the New Jersey Action would not slow the resolution of this dispute in the slightest, as the Delaware actions are proceeding efficiently. In fact, it is odd that the Defendants want this case to proceed in New Jersey instead of Delaware, when Delaware has a documented track record of moving cases through trial significantly faster than New Jersey. (Short Reply Decl., Ex. A).

2

Courts in this District have temporarily stayed all litigation pending the resolution by the JPMDL of a motion, pursuant to 28 U.S.C. § 1407, for multidistrict consolidation. See Hertz Corp. v. The Gator Corp., 250 F. Supp.2d 421 (D.N.J. 2003); Egon v. Del-Val Financial Corp., 1991 WL 13726 (D.N.J. 1991); Arthur-Magna Inc. v. Del-Val Financial Corp., 1991 WL 13725 (D.N.J. 1991).
3

Defendants recognize the hazard of not filing within the 45 day window pursuant to 35 U.S.C. § 271(e)(2). (Def. Br. at 5). Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294, 1297 n.5 (11th Cir. 2003) ("The patent holder is, of course, free to sue the applicant for infringement under 35 U.S.C. § 271(e)(2)(A) after the 45 day window expires. The 30-month stay of FDA approval, however, will not be triggered."); Teva Pharms. USA, Inc., v. Pfizer, Inc., 405 F.3d 990, 998 n.2 (Fed. Cir. 2005) ("To be sure, Pfizer's failure to bring suit within the 45day period specified in section 21 U.S.C. § 355(j)(5)(B)(iii) means that the approval of the ANDA will not be delayed under that section."). 2

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II.

ARGUMENT A. Defendants Have Not Demonstrated "Exceptional Circumstances" To Warrant Departure From Application Of The First-Filed Rule

The first-filed rule is undoubtedly applicable in this case. Defendants acknowledge that in all cases of federal concurrent jurisdiction, the court that first has possession of the subject must decide it and exceptions to the first-filed rule are rare. EEOC v. University of Pennsylvania, 850 F.2d 969, 971, 976 (3d Cir. 1988). (Def. Br. at 4). Exceptions to that rule are few, indeed, because "[c]ourts must be presented with exceptional circumstances before exercising their discretion to depart from the first-filed rule." EEOC, 850 F.2d at 979. AstraZeneca demonstrates in its opening brief that no exceptional circumstances of the type recognized by the Third Circuit exist in this case. Defendants assert nothing to the contrary--in fact, the words "exceptional circumstances" do not even appear in Defendants' opposition brief. While the first-filed rule is not rigid or inflexible and should not be mechanically applied, Defendants simply have not shown that exceptional circumstances exist in this case. Defendants rely on EEOC v. University of Pennsylvania for the proposition that the Court need not apply the first-filed rule. However, the court in EEOC merely held that the district court did not abuse its discretion in denying a party's motion to dismiss a second-filed enforcement action, in favor of a first-filed constitutional challenge to the enforcement statute when "at least one of the filing party's motives is to circumvent local law and preempt an imminent subpoena enforcement action." 850 F.2d at 978. EEOC, therefore, illustrates the point that the Court should apply the first-filed rule unless exceptional circumstances exist. In EEOC, the Third Circuit affirmed the district court's refusal to apply the first-filed rule, finding that the University's first-filed suit in the District of Columbia was "an attempt to preempt an imminent

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subpoena enforcement in the Eastern District of Pennsylvania." EEOC, 850 F.2d at 977. Such tactics are generally viewed as exceptional circumstances, warranting departure from the rule. Id. Filing a protective suit is not. Aventis Pharma S.A. v. Sandoz Inc., 2007 WL 1101228, *4 (D.N.J. 2007) (recognizing that filing a second, protective suit in ANDA cases is warranted and rejecting any allegation of judge or forum shopping); see also Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 2007 WL 4284877, at *2 (W.D. Mich. Dec. 3, 2007) ( "Plaintiff filed the duplicate of [ANDA] actions only because of the extraordinary time limit placed on the filing of suits under the Hatch-Waxman Act"). Defendants fail to show exceptional circumstances in this case. Therefore the first-filed rule should apply to avoid unnecessarily burdening the courts, parties and witnesses, and to eliminate the potential risk of conflicting pretrial rulings. B. Defendants' Arguments Against Application Of The First-Filed Rule Fail

Instead of asserting arguments on exceptional circumstances, Defendants rely on ancillary contentions that are both unconvincing and irrelevant. First, Defendants assert that the first-filed rule cannot apply where the same party filed both lawsuits at issue. (Def. Br. at 4). Such an assertion calls for a rigid application of the firstfiled rule, rigidity that Defendants themselves criticize. Application of the first-filed rule is not foreclosed merely because AstraZeneca filed both actions. Rather, as this Court recently recognized, "cases that involve the same parties and issues are within the ambit of the [first-filed] rule." Siemens Financial Services, Inc. v. Open Advantage M.R.I. II L.P., 2008 WL 564707, at *4 (D.N.J. Feb. 29, 2008) (citing Triangle Conduit & Cable Co. v. National Electric Products Corp., 125 F.2d 1008, 1009 (3d Cir. 1942)); see also The Violet Pot, LLC v. Lowe's Companies, Inc., 2007 WL 894187, at *2 (D.N.J. Mar. 20, 2007). This is true, even where both the first and second actions were filed by the same party. Adams Respiratory, 2007 WL 4284877, at *2 (refusing to depart from the first-filed rule simply because the plaintiff filed both actions). This 4

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case involves identical parties and identical issues, and therefore warrants application of the firstfiled rule. See EEOC, 850 F.2d at 977 (noting that application of the first-filed rule is warranted simply because a "similar" complaint had already been filed in another federal court); Nature's Benefit, Inc. v. NFI, 2007 WL 2462625, at *3 (D.N.J. Aug. 27, 2007) (instructing that "[n]either identical parties nor identical issues are needed, only a `substantial overlap' is sufficient to invoke the first-filed rule); GlaxoSmithKline Consumer Health Care, L.P. v. Merix Pharmaceutical Corp., 2005 WL 1116318, at * 9 (D.N.J. May 10, 2005) (noting that "[t]he critical inquiry of the first-filed rule is whether the issues substantially overlap; there is no requirement that the issues or the parties be identical"). Considering that the complaints in both the Delaware and New Jersey Actions are substantively identical, the substantial overlap threshold for application of the first-filed rule is clearly met. Furthermore, this District has previously invoked the first-filed rule when the same party filed both the first and second-filed lawsuits. See Martin v. Townsend, 1990 WL 159923, at *1; 4 (D.N.J. Oct. 15, 1990) (applying the first-filed rule to dismiss the second-filed New Jersey action when the same plaintiff filed an identical complaint six weeks prior in the District of Delaware). This is directly contrary to Defendants' position. The first-filed rule is meant to prevent the waste of judicial resources caused by duplicative litigation and to guard against the possibility of conflicting judgments. The Third Circuit long ago recognized, "Courts already heavily burdened with litigation with which they must of necessity deal should therefore not be called upon to duplicate each other's work in cases involving the same issues and the same parties." Crosley Corp. v. Hazeltine Corp., 122 F.2d 925, 929 (3d Cir. 1941) ("What has been said applies, we think, with especial force to patent suit . . . ."); see also Continental Grain Co. v. Barge FBL-585, 364 U.S. 19, 26 (1960) ("To permit a

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situation in which two cases involving precisely the same issues are simultaneously pending in different District Courts leads to the wastefulness of time, energy, and money."); EEOC, 850 F.2d at 971; Crosley Corp., 122 F.2d at 930; American Cyanamid Co. v. Eli Lilly and Co., 903 F. Supp. 781, 787 (D.N.J. 1995) ("[f]ailure to apply the `first-filed' rule would result in nearly identical litigation in different fora. Such duplicative litigation is precisely what the Supreme Court and numerous lower courts have attempted to avoid."). Clearly, the parties and issues here are the same. Application of the first-filed rule is therefore warranted for purposes of granting a temporary stay pending resolution of the jurisdictional issues in the Delaware Action. Failure to stay the New Jersey Action would, at the very least, lead to a waste of the parties' and courts' resources.4 The first-filed rule is applicable in Hatch-Waxman cases where the plaintiff files a protective suit in a second jurisdiction. Other federal courts have invoked the first-filed rule to stay the second-filed "protective suit" in Hatch-Waxman cases.5 (Pl. Br., pp. 6-7) (citing Adams Respiratory, 2007 WL 4284877, at *2; PDL Biopharma, Inc. v. Sun Pharm Indus., Ltd., 2007
4

For example, defendants have been attempting to push this action ahead of the main Delaware actions in an uncoordinated manner. Despite agreeing to participate with AstraZeneca and the other Delaware defendants in the upcoming April 10 Rule 16 scheduling conference in Delaware, on March 3, Defendants served document requests and interrogatories on AstraZeneca in this action, which will likely lead to uncoordinated, parallel discovery in both New Jersey and Delaware.
5

The Eastern District of Virginia's decision Aventis Pharma Deutschland GMBH v. Lupin Ltd., 403 F. Supp. 2d 484 (E.D. Va. 2005) does not change this outcome. The Court in Adams disregarded this decision because such a mechanical application of the first-filed rule was unsupported by Sixth Circuit law. Adams Respiratory, 2007 WL 4284877 at *2. Additionally, Defendants attack PDL and Adams because the defendants in those cases consented to personal jurisdiction in the first-filed district. However, the Courts in PDL and Adams stayed the cases during the pendency of the defendants' motions to transfer because going forward with both actions simultaneously would waste judicial resources and present the possibility of conflicting rulings or judgments. The situations in PDL and Adams are analogous to the situation in the immediate case. The fact that the cases differ as to the type of pending motion -- motion to dismiss v. motion to transfer -- is irrelevant to the analysis. 6

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WL 2261386, at *1 (W.D. Mich. Aug. 6, 2007); Schering Corp. v. Caraco Pharm. Labs. Ltd., 2007 WL 1648908, at *1 (E.D. Mich. Jun. 6, 2007); see also American Cyanamid, 903 F. Supp. at 787 (noting that application of the first-filed rule is particularly appropriate in patent cases). Contrary to Defendants' position, the first-filed rule applies in Hatch-Waxman cases. Additionally, Defendants assert that the first-filed rule is not the appropriate standard because equitable considerations must govern the analysis. (Def. Br. at 9). Defendants rely upon two cases to support that proposition. Landis v. North American Co., 299 U.S. 248, 249-51 (1936) and Dentsply International, Inc. v. Kerr Mfg., Co., 734 F. Supp. 656, 658-89 (D. Del. 1990).6 However, in both Landis and Dentsply, the parties in the first-filed cases differ from the parties in the second-filed cases so the first-filed rule would not even be available. These cases are therefore distinguishable from the instant case where the parties and issues are identical. Furthermore, the court should only entertain other considerations -- including equitable considerations -- where the overlap between the two pending cases is "less than complete," and even then only when the non-moving party has demonstrated the existence of exceptional circumstances. GlaxoSmithKline, 2005 WL 1116318, at *10 (finding that equitable considerations will not be given any weight unless the defendant has shown that special circumstances warrant deviation from the first-filed rule). Here, there is complete overlap between the two cases, and Defendants failed to demonstrate exceptional circumstances. Therefore, application of the first-filed rule is proper.

6

Defendants reference Gold v. Johns-Mansville Sales Corp., 723 F.2d 1068 (3d Cir. 1983) in their citation to Dentsply, but this is a bankruptcy case decided before the Third Circuit's seminal ruling in EEOC and inapposite.

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C.

Granting a Temporary Stay Would Not Slow the Litigation of this Dispute

AstraZeneca's request for a temporary stay does not stop the progress of the litigation of the underlying dispute between AstraZeneca and the Defendants. As explained in AstraZeneca's opening brief, discovery is going forward in the Delaware Action, discovery that the parties can eventually use in whichever case eventually proceeds. (Pl. Brief, § II.A and C). Furthermore, Defendants' conjecture that the Delaware Action would proceed slower than the New Jersey Action is unsupported by statistical data. According to the Administrative Office of the U.S. Courts, the District of Delaware proved speedier in civil cases when trials were completed. (Short Reply Decl., Ex. A). Specifically, cases took a median of 27 months for trial completion in the District of Delaware versus 36 months in the District of New Jersey. (Id.). This includes the time period after Judge Kent A. Jordan left the District of Delaware bench, a departure that Defendants cite as causing the docket to stagnate. (Docket No. 30-2 and 30-3). Therefore, Defendants will not be prejudiced if the temporary stay is granted because the parties will continue to engage in discovery. However, contrary to Defendants' position, the dispute may take longer to resolve through trial if it remains in the District of New Jersey. III. CONCLUSION For the foregoing reasons, the Court should grant the requested temporary stay and enter an Order in the form proposed.

Dated: March 14, 2008

By:

S/Andrew T. Berry Andrew T. Berry Jonathan M.H. Short McCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, NJ 07102 Telephone: (973) 622-4444 Facsimile: (973) 624-7070

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Of Counsel: Ford F. Farabow, Jr. Charles E. Lipsey York M. Faulkner FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P. 901 New York Avenue, N.W. Washington, DC 20001 Telephone: (202) 408-4000 Facsimile: (202) 408-4400 Henry J. Renk FITZPATRICK, CELLA, HARPER & SCINTO 30 Rockefeller Plaza New York, NY 10112 Telephone: (212) 218-2100 Facsimile: (212) 218-2200 Attorneys for Plaintiffs AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha

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Andrew T. Berry Jonathan M.H. Short McCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, NJ 07102 Telephone: (973) 622-4444 Facsimile: (973) 624-7070 Attorneys for Plaintiffs AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha

Of Counsel: Ford F. Farabow, Jr. Charles E. Lipsey York M. Faulkner FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P. 901 New York Avenue, N.W. Washington, DC 20001 Telephone: (202) 408-4000 Facsimile: (202) 408-4400 Henry J. Renk FITZPATRICK, CELLA, HARPER & SCINTO 30 Rockefeller Plaza New York, NY 10112 Telephone: (212) 218-2100 Facsimile: (212) 218-2200

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY : ASTRAZENECA PHARMACEUTICALS : LP, ASTRAZENECA UK LIMITED, IPR : : PHARMACEUTICALS, INC., and : SHIONOGI SEIYAKU KABUSHIKI : KAISHA, : : Plaintiffs, : : vs. : AUROBINDO PHARMA LIMITED, and : : AUROBINDO PHARMA USA INC. : : Defendants. :

Civil Action No. 3:07-cv-06020 (MLC)(JJH)

REPLY DECLARATION OF JONATHAN M.H. SHORT IN FURTHER SUPPORT OF PLAINTIFFS' MOTION FOR A TEMPORARY STAY

Jonathan M.H. Short, of full age, hereby declares as follows:

ME1 7169991v.1

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1.

I am a member of the bar of this court and am associated with the firm of

McCarter & English, LLP, attorneys for Plaintiffs AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha ("AstraZeneca") in this matter. 2. I submit this declaration in support of AstraZeneca's Reply Memorandum of Law

in Support of Plaintiffs' Motion to Temporarily Stay These Proceedings. 3. Attached as Exhibit A hereto is a true and correct copy of2007 Judicial Business

of the United States Courts - Annual Report of the Director, Table C-I0 (U.S. District CourtsMedian Time Intervals from Filing to Trial of Civil Cases in Which Trials Were Completed, by District, During the 12-Month Period Ending September 30, 2007), which is publicly available at http://www.uscourts.gov/judbu.s2007/appendices/CI0Sep07.pd.f. 4. Attached as Exhibit B hereto is a true and correct copy of the Motion of

AstraZeneca for Transfer of Actions to the District of Delaware Pursuant to 28 U.S.C. § 1407 for Coordinated or Consolidated Pretrial Proceedings and accompanying documents.

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

Dated: March 14, 2008

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EXHIBIT A

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Table C-10. U.S. District Courts--Median Time Intervals from Filing to Trial of Civil Cases in Which Trials Were Completed, by District, During the 12-Month Period Ending September 30, 2007
Total Trials Number of Trials
3,366 28 1ST ME MA NH RI PR 2ND CT NY,N NY,E NY,S NY,W VT 3RD DE NJ PA,E PA,M PA,W VI 4TH MD NC,E NC,M NC,W SC VA,E VA,W WV,N WV,S 157 9 94 7 12 35 336 52 27 84 151 11 11 321 29 57 104 75 50 6 229 40 44 6 11 48 33 25 8 14

Nonjury Trials Number of Trials
1,109 12 54 3 33 1 6 11 108 13 4 23 61 4 3 78 9 17 25 10 15 2 110 21 41 5 3 11 16 6 2 5

Jury Trials Number of Trials
2,257 16 103 6 61 6 6 24 228 39 23 61 90 7 8 243 20 40 79 65 35 4 119 19 3 1 8 37 17 19 6 9

Circuit and District
TOTAL DC

Median Time Interval in Months *
24.6 44.0 29.7 33.5 23.0 28.0 31.0 27.0 40.5 34.6 25.6 57.0 19.0 28.4 27.0 36.0 19.4 26.3 33.8 17.0 21.5 16.5 21.0 18.5 9.0 14.5 21.0

Median Time Interval in Months *
21.0 44.0 28.0 36.0 21.0 25.5 30.0 33.0 21.0 27.5 33.5 15.0 23.5 33.0 15.4 17.0 14.0 22.0 9.0 -

Median Time Interval In Months *
25.2 42.0 29.4 30.0 32.0 33.0 26.0 40.0 35.0 29.0 28.0 28.0 38.5 19.5 26.5 34.0 18.0 24.0 18.0 8.2 16.0 -

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Table C-10. (September 30, 2007--Continued)
Total Trials Number of Trials
460 71 15 38 27 47 49 50 103 60 267 15 20 74 13 27 21 31 32 34 232 105 24 35 16 19 9 24 207 64 16 9 6 27 28 20 23 3 11

Nonjury Trials Number of Trials
177 42 6 20 5 9 20 10 41 24 60 1 2 14 5 6 3 11 11 7 66 36 3 9 1 4 6 7 57 23 2 3 2 11 5 5 3 3

Jury Trials Number of Trials
283 29 9 18 22 38 29 40 62 36 207 14 18 60 8 21 18 20 21 27 166 69 21 26 15 15 3 17 150 41 14 6 6 25 17 15 18 8

Circuit and District
5TH LA,E LA,M LA,W MS,N MS,S TX,N TX,E TX,S TX,W 6TH KY,E KY,W MI,E MI,W OH,N OH,S TN,E TN,M TN,W 7TH IL,N IL,C IL,S IN,N IN,S WI,E WI,W 8TH AR,E AR,W IA,N IA,S MN MO,E MO,W NE ND SD

Median Time Interval in Months *
20.2 19.7 38.0 34.0 23.0 23.4 19.4 18.0 20.3 15.8 26.0 24.0 31.0 25.8 28.0 20.0 28.4 23.0 26.5 23.5 27.8 29.7 29.0 31.5 21.5 24.0 10.4 22.1 19.7 13.0 29.0 22.5 22.0 22.0 34.0

Median Time Interval in Months *
20.1 18.0 36.0 16.5 20.0 20.0 15.4 20.0 16.0 18.0 14.0 27.0 27.5 21.5 19.0 20.0 -

Median Time Interval In Months *
20.6 19.5 25.0 22.5 20.5 21.0 17.0 19.7 16.4 27.2 24.0 31.0 28.7 19.0 28.7 25.0 32.0 23.0 28.0 33.0 31.0 37.0 21.5 25.0 10.0 22.3 20.0 13.5 31.0 22.5 25.0 20.0 -

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Table C-10. (September 30, 2007--Continued)
Total Trials Number of Trials Median Time Interval in Months * Nonjury Trials Number of Trials Median Time Interval in Months * Number of Trials Jury Trials Median Time Interval In Months *

Circuit and District

9TH AK AZ CA,N CA,E CA,C CA,S HI ID MT NV OR WA,E WA,W GUAM NMI 10TH CO KS NM OK,N OK,E OK,W UT WY 11TH AL,N AL,M AL,S FL,N FL,M FL,S GA,N GA,M GA,S

557 6 55 73 46 186 39 10 11 11 34 38 13 32 3 178 49 27 25 12 8 18 25 14 394 52 22 21 19 84 116 49 8 23

25.4 30.5 24.9 38.0 21.3 24.0 17.0 25.7 18.0 29.5 25.0 23.0 18.0 22.3 29.0 23.0 20.4 17.0 15.0 28.0 14.5 21.8 25.0 16.0 14.5 22.0 19.0 17.9 27.9 31.0

212 2 21 23 11 78 14 5 2 3 19 11 5 17 1 51 9 7 8 4 5 11 7 124 2 6 3 8 33 53 17 2 -

21.5 27.0 20.5 42.0 18.7 21.0 29.5 23.0 18.4 26.5 31.0 18.5 18.3 17.0 27.4 -

345 4 34 50 35 108 25 5 9 8 15 27 8 15 2 127 40 20 17 8 3 18 14 7 270 50 16 18 11 51 63 32 6 23

27.6 34.0 28.0 38.0 24.8 27.0 36.0 27.0 19.0 22.5 29.0 22.0 19.5 15.0 21.7 23.0 26.0 16.0 14.0 22.0 22.0 17.4 27.5 31.0

NOTE: INCLUDES TRIALS CONDUCTED BY DISTRICT AND APPELLATE JUDGES ONLY. ALL TRIALS CONDUCTED BY MAGISTRATE JUDGES ARE EXCLUDED. EXCLUDES THE FOLLOWING TRIALS: LAND CONDEMNATION; FORFEITURES AND PENALTY CASES; PRISONER PETITIONS (HABEAS CORPUS, MOTIONS TO VACATE SENTENCE UNDER 28 U.S.C. 2255, HEARINGS ON EVIDENTIARY MATTERS); BANKRUPTCY PETITIONS; AND THREE-JUDGE COURT CASES. FOR CIVIL CASES RESULTING IN A COMPLETED TRIAL, THE MEDIAN TIME IS BASED ON THE ORIGINAL FILING DATE AND THE DATE THE TRIAL WAS COMPLETED. FOR REOPENED CIVIL CASES RESULTING IN A SECOND COMPLETED TRIAL, THE MEDIAN TIME REMAINS BASED ON THE ORIGINAL FILING DATE AND THE DATE THE TRIAL WAS COMPLETED.

* TIME INTERVALS COMPUTED ONLY FOR 10 OR MORE TRIALS.

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Andrew T. Berry Jonathan M.H. Short McCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, NJ 07102 Telephone: (973) 622-4444 Facsimile: (973) 624-7070 Attorneys for Plaintiffs AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha

Of Counsel: Ford F. Farabow, Jr. Charles E. Lipsey York M. Faulkner FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P. 901 New York Avenue, N.W. Washington, DC 20001 Telephone: (202) 408-4000 Facsimile: (202) 408-4400 Henry J. Renk FITZPATRICK, CELLA, HARPER & SCINTO 30 Rockefeller Plaza New York, NY 10112 Telephone: (212) 218-2100 Facsimile: (212) 218-2200

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY : ASTRAZENECA PHARMACEUTICALS : Civil Action No. 3:07-cv-06020 (MLC)(JJH) LP, ASTRAZENECA UK LIMITED, IPR : : PHARMACEUTICALS, INC., and : SHIONOGI SEIYAKU KABUSHIKI : KAISHA, : : Plaintiffs, : : vs. : AUROBINDO PHARMA LIMITED, and : : AUROBINDO PHARMA USA INC. : : Defendants. : CERTIFICATE OF SERVICE The undersigned hereby certifies that true copies of Plaintiffs' Reply Brief in Support of its Motion to Stay with supporting papers were caused to be served on March 14, 2008, upon the

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following via ECF and/or Overnight Mail: Arnold B. Calmann SAIBER LLC One Gateway Center 13th Floor Newark, NJ 07102-5311 Jeffrey S. Ward MICHAEL BEST & FRIEDRICH LLP One South Pinckney Street P.O. Box 1806 Madison, WI 53701-1806

By:

S/Andrew T. Berry Andrew T. Berry Jonathan M.H. Short McCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, NJ 07102 Telephone: (973) 622-4444 Facsimile: (973) 624-7070 Of Counsel: Ford F. Farabow, Jr. Charles E. Lipsey York M. Faulkner FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P. 901 New York Avenue, N.W. Washington, DC 20001 Telephone: (202) 408-4000 Facsimile: (202) 408-4400 Henry J. Renk FITZPATRICK, CELLA, HARPER & SCINTO 30 Rockefeller Plaza New York, NY 10112 Telephone: (212) 218-2100 Facsimile: (212) 218-2200 Attorneys for Plaintiffs AstraZeneca Pharmaceuticals LP, AstraZeneca UK

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Limited, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha

3