Free Motion to Stay - District Court of Delaware - Delaware


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Case 1:08-cv-00359-JJF-LPS

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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 FITZPATRlCK, 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)

MOTION DATE: April 7, 2008 NOTICE OF MOTION FOR A TEMPORARY STAY

PLEASE TAKE NOTICE that Plaintiffs ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED, IPR PHARMACEUTICALS, INC., and SHIONOGI

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SEIYAKU KABUSHIKI KAISHA ("Plaintiffs") will move before this Court at the United States District Court for the District of New Jersey, 402 E. State Street, Trenton, New Jersey, on April 7, 2008, at 10 a.m., before the Honorable John J. Hughes, U.S.M.J. for entry of an Order to stay this proceeding pending resolution of jurisdictional issues in a substantially identical first-filed patent infringement action in the District of Delaware (Civil Action No. 1:07-cv-810, Dist. Delaware) and completion of any necessary proceedings before the Judicial Panel on Multidistrict Litigation (JPMDL) necessitated by a successful challenge to the jurisdiction of the Delaware court. The Parties rely upon the Memorandum of Law and the Declaration of Jonathan M.H. Short submitted with this Motion, and upon all pleadings and proceedings on file herein. A Proposed Order granting the Parties' motion is attached.

Respectfully submitted,

Dated: February 28, 2008

/s/ Andrew T. Berry Andrew T. Berry McCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, New Jersey 07102 (973) 622-4444 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

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Henry J. Renk FITZPATRlCK, 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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CERTIFICATE OF SERVICE The undersigned hereby certifies that true copies of Plaintiffs' Motion to Stay with supporting papers were caused to be served on February 28, 2008, upon the 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

/s/ Andrew T. Berry Andrew T. Berry

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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 FITZPATRlCK, 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. : MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS' MOTION FOR A TEMPORARY STAY

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TABLE OF CONTENTS I. INTRODUCTION ....................................................................................................................... 1 II. BACKGROUND........................................................................................................................ 1 A. NATURE AND STAGE OF PROCEEDINGS ................................................................................... 1 B. JURISDICTION IN DELAWARE ................................................................................................... 3 C. DISCOVERY IN THE DELAWARE SUITS ..................................................................................... 4 III. ARGUMENT............................................................................................................................ 5 A. THE FIRST-FILED RULE DIRECTS THE SECOND-FILED NEW JERSEY ACTION TO BE STAYED ABSENT EXCEPTIONAL CIRCUMSTANCES .................................................................................... 5 B. NEITHER DEFENDANTS NOR THE PUBLIC WILL BE PREJUDICED BY A TEMPORARY STAY ...... 8 IV. CONCLUSION......................................................................................................................... 9

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TABLE OF AUTHORITIES Cases Abbott Labs. v. Mylan Pharms., Inc., No 05-6561, 2006 U.S. Dist. LEXIS 13782 (N.D. Ill. Mar. 28, 2006) ..................................................................................................................................... 3 Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 2007 WL 4284877 (D.N.J Dec. 3, 2007) 7, 8 Alltrade, Inc. v. Uniweld Prods., Inc., 946 F.2d 622 (9th Cir. 1991) ............................................. 6 American Cyanamid Co. v. Eli Lilly and Co., 903 F. Supp. 781 (D.N.J. 1995) ............................. 5 Aventis Pharma S.A. v. Sandoz Inc., 2007 WL 1101228 (D.N.J. 2007 .......................................... 3 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 EEOC v. Univ. of Pennsylvania, 850 F.2d 969 (3d Cir. 1988)................................................... 5, 6 GT Plus, Ltd. v. Ja-Ru Inc., 41 F. Supp. 2d 421 (S.D.N.Y. 1998) ................................................. 6 Nature's Benefit, Inc. v. NFI, 2007 WL 2462625 (Aug. 27, 2007 D.N.J.)..................................... 6 PDL Biopharma, Inc. v. Sun Pharm. Indus., Ltd., 2007 WL 2261386 (W.D. Mich. Aug. 6, 2007) ........................................................................................................................................ 3, 6, 7, 8 Sanofi-Aventis et al. v. Actavis South Atlantic LLC (Civil Action No. 1:07-cv-572, D. Del.) ....... 3 Schering Corp. v. Caraco Pharm. Labs., Ltd., 2007 WL 1648908 (E.D. Mich. Jun. 6, 2007) .. 3, 7 Shaw Family Archives, Ltd. v. CMG Worldwide, Inc., 434 F. Supp. 2d 203 (S.D.N.Y. 2006)...... 7 The Violet Pot, LLC v. Lowe's Companies, Inc., 2007 WL 894187 (D.N.J. Mar. 20, 2007) ......... 5 Statutes 21 U.S.C. § 355............................................................................................................................... 2

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I.

INTRODUCTION Plaintiffs, AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR

Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha (collectively "AstraZeneca"), seek a temporary stay of this Hatch-Waxman patent infringement action against Defendants Aurobindo Pharma Limited ("APL") and Aurobindo Pharma USA Inc. ("APU") (collectively "Aurobindo"), pending resolution of jurisdictional issues in a substantially identical first-filed patent infringement action in the District of Delaware and completion of any necessary proceedings before the Judicial Panel on Multidistrict Litigation (JPMDL) necessitated by a successful challenge to the jurisdiction of the Delaware court. At least five related cases involving the same patent are pending in Delaware. Aurobindo's amenability to suit is currently being litigated in Delaware. Aurobindo is also participating in Delaware in the formulation of a coordinated discovery plan without prejudice to its jurisdictional allegations. Finally, AstraZeneca has committed to seek transfer of this action to Delaware by the JPMDL for participation in consolidated discovery in the event jurisdiction in Delaware is found to be improper. Since no material prejudice can befall APL and APU by requiring them to proceed with discovery along with the other defendants in Delaware while these threshold procedural matters are being resolved, and since there is no compelling reason why AstraZeneca and this Court should be required to engage in redundant efforts in that regard, a temporary stay of these proceedings is warranted. II. BACKGROUND A. Nature and Stage of Proceedings

On October 31, 2007, Aurobindo sent AstraZeneca a notice ("Paragraph IV notice") that Aurobindo had filed an Abbreviated New Drug Application ("ANDA") with the Food and Drug

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Administration ("FDA"). In its ANDA, Aurobindo stated its intention to market and sell a generic version of AstraZeneca's well-known and highly successful drug Crestor® prior to the expiration of AstraZeneca's U.S. Patent No. RE37,314 ("the `314 patent"), which covers Crestor®. On December 11, 2007, AstraZeneca sued Aurobindo and six other generic drug manufacturers in the Federal District court of AstraZeneca's home state, Delaware (the "Delaware Action"), for infringing the `314 patent. (Civil Action No. 1:07-cv-810, Dist. Delaware). The timing of the Delaware suit was mandated by the statutory scheme, which provides for the initiation of a 30-month automatic stay of FDA final approval for an ANDA if the patent owner brings suit within 45 days of receiving notice of a Paragraph IV certification to allow adjudication of the patent issues. 21 U.S.C. § 355(j)(5)(B)(iii). The 30-month stay is an important benefit that might be lost if a timely patent infringement lawsuit is dismissed for lack of personal jurisdiction and then refiled in another jurisdiction after the 45 day period has run. See 21 U.S.C. § 355(j)(5)(B)(iii). In order to protect itself from the prejudicial consequences of dismissal of its Delaware actions, AstraZeneca subsequently brought three "protective" suits, one in West Virginia, one in Florida, and this suit in the District of New Jersey (the "New Jersey Action", or "this case") for infringement of the same patent. AstraZeneca did so in anticipation that three of the defendants, including Aurobindo, might challenge jurisdiction in Delaware, as APL now has done. The three protective suits were filed but not served. The three affected defendants were notified of AstraZeneca's intention not to serve the complaints unless it became necessary to do so and that the cases would be dismissed upon establishment of jurisdiction in Delaware. (Short

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Declaration, Ex. 2). There was no attempt at forum shopping.1 Two of the three defendants against whom protective suits were filed, recognizing the obvious judicial economies to be realized in handling this complex litigation in a single court, consented to jurisdiction in Delaware. Notwithstanding that APL is currently litigating another ANDA patent suit in Delaware before Judge Sleet,2 APL filed a motion to dismiss the Delaware Action for lack of personal jurisdiction shortly after the assignment of that case to Judge Farnan.3 That motion is currently pending and the parties have begun taking limited jurisdictional discovery. AstraZeneca's response is due April 21, 2008. In an apparent attempt to further disrupt the orderly resolution of these cases, APU answered the unserved Complaint in this Court and has sought to push discovery forward in this case ahead of that in the main action. B. Jurisdiction In Delaware

Jurisdictional discovery is underway in Delaware, and AstraZeneca cannot, therefore, fully articulate all of the bases for Delaware jurisdiction at this time. Suffice it to say that AstraZeneca brought the first-filed action in Delaware because it is AstraZeneca's home state,

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The Court in this District has recognized that filing a second, protective suit in ANDA cases is warranted. Aventis Pharma S.A. v. Sandoz Inc., 2007 WL 1101228, *4 (D.N.J. 2007) (rejecting any allegation of judge or forum shopping). Courts in other districts similarly have stayed the second-filed case in favor of the first-filed case. See, e.g. Schering Corp. v. Caraco Pharm. Labs., Ltd., 2007 WL 1648908 (E.D. Mich. Jun. 6, 2007); PDL Biopharma, Inc. v. Sun Pharm. Indus., Ltd., 2007 WL 2261386 (W.D. Mich. Aug. 6, 2007); Abbott Labs. v. Mylan Pharms., Inc., No 05-6561, 2006 U.S. Dist. LEXIS 13782 (N.D. Ill. Mar. 28, 2006).
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Sanofi-Aventis et al. v. Actavis South Atlantic LLC (Civil Action No. 1:07-cv-572, D. Del.).

Apotex, Inc., one of the seven Delaware defendants who, like APL, has voluntarily litigated for years in Delaware with judges other than Judge Farnan, also moved to dismiss upon assignment of the case to Judge Farnan. No protective suit had been filed against Apotex because it had conceded general presence in Delaware not seven months earlier. If Apotex is successful, that action would be transferred to Florida and, in a rational world, transferred back to Delaware for consolidated discovery by the JPMDL.

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because both Aurobindo defendants are believed to be subject to jurisdiction in Delaware, and because of the obvious judicial economies to be realized in discovering and trying these related cases together. The Delaware court should find general jurisdiction over both Aurobindo entities at least because (1) APU is a Delaware corporation subject to suit in Delaware, (2) APL, through its wholly-owned subsidiary APU, markets and sells APL's products throughout the U.S. and in Delaware, and (3) both Aurobindo entities are voluntarily conducting an important component of their ordinary business activities--the provocation and litigation of patent disputes in order to gain access to new markets--in Delaware. If the personal jurisdiction issue in Delaware is resolved in AstraZeneca's favor, AstraZeneca intends to move for transfer of this case to Delaware or for its voluntary dismissal. Regardless, AstraZeneca has committed to the Delaware court to seek an order from the JPMDL to transfer this case to Delaware for coordinated pretrial proceedings in the event it remains pending here. (Short Decl., Ex. 1, Transcript of Feb. 20, 2008, Conference at p. 18, lines 20-21 and p. 21, lines 8-11). C. Discovery In the Delaware Suits

As agreed during a February 20, 2008, status conference with the Delaware Court, AstraZeneca and the defendants in the Delaware suits, including APL and APU, will proceed with the development of a coordinated discovery plan in Delaware without prejudice to any jurisdictional challenges. A report is due to the Court on April 3, 2008, with a Rule 16 Conference to follow on April 10. It would be inefficient and duplicative if the other Delaware suits proceeded on a different schedule than the New Jersey Action. Additionally, any discovery taken in the Delaware Action can be utilized in the New Jersey Action if the personal jurisdiction motion should be decided in APL's favor and the JPMDL declines to transfer this case to Delaware for pretrial discovery. 4

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III.

ARGUMENT A. The First-Filed Rule Directs the Second-Filed New Jersey Action to Be Stayed Absent Exceptional Circumstances

When two federal lawsuits addressing the same parties and issues are pending, the "firstfiled" rule is applied. The Violet Pot, LLC v. Lowe's Companies, Inc., 2007 WL 894187 at *2 (D.N.J. Mar. 20, 2007). The first-filed rule instructs that "[i]n all cases of federal concurrent jurisdiction, the court which has possession of the subject must decide it." Crosley Corp. v. Hazeltine Corp., 122 F.2d 925, 929 (3d Cir. 1941); EEOC v. Univ. of Pennsylvania, 850 F.2d 969, 971 (3d Cir. 1988). Application of the first-filed rule encourages comity within the federal court system, promotes sound judicial administration, and limits the possibility of conflicting judgments. See EEOC, 850 F.2d at 971; Crosley, 122 F.2d at 930; see also Continental Grain Co. v. Barge FBL-585, 364 U.S. 19, 26 (1960) ("To permit a 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."); American Cyanamid Co. v. Eli Lilly and Co., 903 F. Supp. 781, 787 (D.N.J. 1995) (transferring second-filed action to the first-filed forum because application of the first-to-file rule favored transferring the case, related litigation was pending in the transferee forum, the convenience of the parties and the location of the documents weighed in favor of transfer, and the court in the transferee forum had already denied the accused infringer's motion to transfer the first-filed action). Given the significant interests behind this rule, "invocation of the first-filed rule will usually be the norm, not the exception." Violet Pot, 2007 WL 894187 at *3. See also American Cyanamid, 903 F. Supp. at 787 (noting that application of the first-filed rule is particularly appropriate in patent cases). Only when presented with "exceptional circumstances" should a

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court exercise its "discretion to depart from the rule." EEOC, 850 F.2d at 979. While there is no rigid definition, "exceptional circumstances" typically involve instances of bad faith, inequitable conduct, forum-shopping, or situations where the second-filed case is more fully developed than the first. Nature's Benefit, Inc. v. NFI, 2007 WL 2462625 at *4 (Aug. 27, 2007 D.N.J.). Those exceptional circumstances are not present here. When applied, the first-filed rule permits a district court, in its discretion, to "stay, dismiss, or transfer the second-filed action to avoid duplicative litigation." Nature's Benefit, 2007 WL at *3. If, however, "the first-filed action is vulnerable to dismissal on jurisdictional grounds, the court in the second-filed action should stay or transfer said action rather than dismiss it outright." Nature's Benefit, 2007 WL 2462625 at *4 (citing Alltrade, Inc. v. Uniweld Prods., Inc., 946 F.2d 622, 628 (9th Cir. 1991); GT Plus, Ltd. v. Ja-Ru Inc., 41 F. Supp. 2d 421, 424 (S.D.N.Y. 1998). There can be no dispute that application of the first-filed rule is warranted here. The New Jersey and Delaware actions involve the same issues, the same parties, and the two complaints are identical in substance. (Compare Complaint, Docket No. 1 with Short Decl., Ex. 3). Furthermore, as AstraZeneca filed its Delaware complaint on December 12, 2007 and its New Jersey complaint on December 18, 2007, the Delaware Action is clearly the first-filed. Courts in other jurisdictions have explicitly recognized the propriety of the first-filed rule where, as here, the second-filed action is initiated only as a precautionary measure in a HatchWaxman case. For example, in PDL Biopharma, Inc. v. Sun Pharm Indus., Ltd., the plaintiff first brought suit in the District of New Jersey accusing the generic defendant of patent infringement. 2007 WL 2261386 at *1 (W.D. Mich. Aug. 6, 2007). Like the instant case, plaintiff believed that the defendant might challenge jurisdiction in the first-filed case, so it

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brought a second suit in the Eastern District of Michigan as a protective measure to preserve the 30-month stay of approval of the defendant's ANDA. Id. The Michigan court held that application of the first-filed rule was appropriate and stayed the second-filed action in Michigan pending proceedings in the first-filed New Jersey action. Id. at *2-3. Similarly, in Schering Corp. v. Caraco Pharm. Labs. Ltd., the plaintiff filed first in New Jersey against twenty-one generic defendants and subsequently filed a second action in the Eastern District of Michigan against two defendants that it believed would--and in fact did-- challenge jurisdiction in New Jersey. 2007 WL 1648908 at *1 (E.D. Mich. Jun. 6, 2007). As in PDL, the Schering court applied the first-filed rule and granted plaintiff's motion to stay the second-filed action. Id. at 3. Furthermore, no exceptional circumstances exist here to justify departure from the firstfiled rule. AstraZeneca's first-filed suit is in Delaware--its home forum--which does not constitute forum shopping. See e.g., Shaw Family Archives, Ltd. v. CMG Worldwide, Inc., 434 F. Supp. 2d 203, 210 (S.D.N.Y. 2006). Nor can it be said that the second-filed suit is more fully developed than the first as both cases are at the same stage in the litigation--in both cases defendants have answered or otherwise moved to dismiss for lack of jurisdiction and discovery is only just beginning.4 Finally, there is nothing to suggest any bad faith or inequitable conduct on behalf of AstraZeneca. The filing of AstraZeneca's second-suit in New Jersey was merely to preserve the statutory 30-month stay in the event that the Delaware Action were to be dismissed for lack of jurisdiction. See Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 2007 WL 4284877 at *2 (D.N.J Dec. 3, 2007) (finding that the filing of a protective suit in another

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APL's refusal to agree to a stay of this case appears to be a thinly-veiled and improper attempt artificially to accelerate this case ahead of the main Delaware action and then eventually to try to transfer all of the Delaware suits to New Jersey. The attempt should fail.

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jurisdiction in a Hatch-Waxman case is not indicative of bad faith or forum shopping). B. Neither Defendants Nor the Public Will Be Prejudiced By a Temporary Stay

Neither Defendants nor the public will be harmed by the entry of a stay. Defendants do not yet have FDA approval of their ANDA. Therefore, even if this action could be resolved in Defendants favor tomorrow Defendants still could not sell their generic product. Nor will Defendants suffer any prejudice in their ability to adequately defend this litigation. They are voluntarily participating in pretrial proceedings in Delaware, subject to the resolution of their motions to dismiss. AstraZeneca moves only for a temporary stay of these proceedings pending resolution of Defendants' motion to dismiss for lack of personal jurisdiction in the Delaware Action and, resolution of any needed proceedings before the JPMDL. APL will be fruitfully engaged in Delaware discovery proceedings in the interim that will be fully utilizable in this Court if need be and will suffer no prejudice. Further, granting this motion is consistent with the promotion of efficient judicial administration. By temporarily staying this action pending resolution of the jurisdictional disputes in the Delaware case, both the Court and the parties avoid the need to undertake duplicative efforts and incur unnecessary expenses. See Adams, 2007 WL 4284877 at *2 (noting that permitting the second-filed suit to proceed while jurisdictional challenges in the first-filed suit are pending would be a waste of judicial resources). Finally, other courts have found that the harsh consequences facing Hatch-Waxman plaintiffs should the first-filed case be dismissed after the 45 day filing period has run weighs in favor of staying the second-filed action. See Adams, 2007 WL 4284877 at *2; PDL, 2007 WL 2261386 at *2. Clearly, AstraZeneca's protective suit in the District of New Jersey was a prudent approach to a statutory risk and the Court should stay this suit until the personal jurisdiction motion in the Delaware Action is resolved and any necessary proceedings before the 8

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Judicial Panel on Multidistrict Litigation (JPMDL) necessitated by a successful challenge to the jurisdiction of the Delaware court are completed. IV. CONCLUSION For the foregoing reasons, the Court should grant the requested temporary stay and enter an Order in the form proposed.

Dated: February 28, 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 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 FITZPATRlCK, 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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EXHIBIT 1

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EXHIBIT 2

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YORK M. FAULKNER
571.203.2775 [email protected]

December 18, 2007 William A. Rakoczy, Esq. RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois 60610 [email protected] Scott H. Blackman, Esq. Winston & Strawn LLP 1700 K Street, N.W. Washington, D.C. 20006-3817 [email protected] Robert B. Breisblatt, Esq. Welsh & Katz, Ltd. 22nd Floor 120 S. Riverside Plaza Chicago, Illinois 60606 [email protected] Edward J. Pardon, Esq. Michael Best & Friedrich LLP One South Pinckney Street Suite 700 Madison WI 53703 [email protected] Steven A. Maddox, Esq. Foley & Lardner LLP 3000 K Street, N.W. Suite 500 Washington, DC 20007 [email protected]

Edward M. Reisner, Esq. Cohen Pontani Lieberman & Pavane LLP 551 Fifth Avenue New York, NY 10176 [email protected]

Daniel G. Brown, Esq. Frommer Lawrence & Haug LLP 745 Fifth Avenue New York, NY 10151 [email protected]

Via Federal Express & E-Mail

AstraZeneca Pharmaceuticals LP, et al. v. Mylan Pharmaceuticals Inc., Docket No. 07-805; Sun Pharmaceutical Industries Ltd., et al., Docket No. 07-806; Sandoz Inc., Docket No. 07-807; Par Pharmaceutical, Inc., Docket No. 07-808; Apotex Inc., et al., Docket No. 07-809; Aurobindo Pharma Ltd., et al., Docket No. 07-810; and Cobalt Pharmaceuticals, Inc., et al., Docket No. 07-811

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Dear Counsel: AstraZeneca and Shionogi ("Plaintiffs") recently filed the above-referenced actions in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. RE 37,314, based on Abbreviated New Drug Applications submitted to the U.S. Food and Drug Administration. We represent Plaintiffs in those actions. In an effort to simplify and expedite resolution of these issues, we have brought suit against each defendant in Delaware, where we believe personal jurisdiction is proper. To facilitate the efficient advancement of the actions, please confirm whether your respective clients will agree to consolidation of these actions. We recognize that your clients have previously litigated in Delaware and assume that they will be content to do so again due to the efficiencies involved. In some instances, Plaintiffs either have or will file protective suits in alternative jurisdictions. We do not intend to serve the complaints in the protective suits, unless it becomes necessary to do so. Once these actions are underway in Delaware, Plaintiffs will dismiss the corresponding protective suits in the alternative jurisdictions. We look forward to hearing from each of you and receiving the defendants' agreement to consolidate the actions in Delaware. Sincerely,

York M. Faulkner

cc:

Mary W. Bourke, Esq.

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EXHIBIT 3

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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)

[PROPOSED] ORDER

This matter having come before the Court on Plaintiffs ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED, IPR PHARMACEUTICALS, INC., and SHIONOGI SEIYAKU KABUSHIKI KAISHA's motion to stay this proceeding pending resolution of jurisdictional issues in a substantially identical first-filed patent infringement action in the District of Delaware (Civil Action No. 1:07-cv-810, Dist. Delaware) and completion of any necessary proceedings before the Judicial Panel on Multidistrict Litigation (JPMDL) necessitated by a successful challenge to the jurisdiction of the Delaware court., and Upon consideration of all supporting and opposing papers, and oral arguments of the parties, IT IS ON THIS ___ DAY OF _____________________, 2008, ORDERED AND ADJUDGED that: 1. Plaintiffs' motion is GRANTED; and

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2.

This proceeding is stayed pending resolution of jurisdictional issues in a substantially identical first-filed patent infringement action in the District of Delaware (Civil Action No. 1:07-cv-810, Dist. Delaware) and completion of any necessary proceedings before the Judicial Panel on Multidistrict Litigation (JPMDL) necessitated by a successful challenge to the jurisdiction of the Delaware court.

SO ORDERED.

__________________________________ Hon. John J. Hughes, U.S.M.J.

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