Free Declaration - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SANOFI-AVENTIS and SANOFI-AVENTIS U.S. LLC, Plaintiffs, v. APOTEX INC. and APOTEX CORP., Defendants. ) ) ) ) ) ) ) ) ) )

C.A. No. 07-792 (GMS) (MPT)

DECLARATION OF KATHRYN M. LIBERATORE IN SUPPORT OF PLAINTIFFS' OPENING BRIEF IN SUPPORT OF ITS MOTION TO ENJOIN SECOND FILED, DUPLICATIVE LITIGATION I, Kathryn M. Liberatore, declare: I am an attorney with the law firm Kirkland & Ellis LLP, counsel for sanofiaventis and sanofi-aventis U.S. LLC. I submit this declaration in support of Plaintiffs' Opening Brief In Support Of Its Motion To Enjoin The Parties From Prosecuting Second Filed, Duplicative Litigation and have personal knowledge of the facts set forth herein. 1. Attached hereto as Exhibit A is a true and accurate copy of Apotex Inc. -

Corporate Info, http://www.apotex.com/CorporateInformation/Default.asp?flash=Yes (last visited March 4, 2008). 2. Attached hereto as Exhibit B is a true and accurate copy of a letter dated

August 14, 2007 from Bernard C. Sherman to Sanofi-Aventis US and Sanofi-Aventis and Jagotec AG. 3. Attached hereto as Exhibit C is a true and accurate copy of a letter dated

October 25, 2007 from Bernard C. Sherman to Sanofi-Aventis US and Sanofi-Aventis and Jagotec AG.

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4.

Attached hereto as Exhibit D is a true and accurate copy of the Complaint

dated September 21, 2007 filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Actavis South Atlantic LLC, et al., Civil Action No. 07-572 (GMS) (MPT), in the District Court for the District of Delaware. 5. Attached hereto as Exhibit E is a true and accurate copy of the Complaint

dated September 21, 2007 filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Barr Laboratories, Inc., Civil Action No. 07-574 (GMS) (MPT), in the District Court for the District of Delaware. 6. Attached hereto as Exhibit F is a true and accurate copy of a letter dated

October 1, 2007 from William T. Vuk to Bernice Tao. 7. · Attached hereto as Exhibit G are true and correct copies of: excerpts from Defendants Apotex Inc.'s and Apotex Corp.'s Answer, Defenses, and Counterclaims dated June 11, 2007 filed in Allergan, Inc. v. Apotex, Inc. and Apotex Corp., Civil Action No. 07-278-GMS, in the District Court for the District of Delaware; excerpts from Defendants Apotex Inc.'s and Apotex Corp.'s Answer, Defenses, and Counterclaims dated May 30, 2007 filed in Medpointe Healthcare Inc. v. Apotex Inc. and Apotex Corp., Civil Action No. 07-204SLR, in the District Court for the District of Delaware; excerpts from Answer of Apotex Inc. and Apotex Corp. to Plaintiff's Amended Complaint, Affirmative Defenses and Counterclaims dated April 14, 2006 filed in Medpointe Healthcare Inc. v. Apotex Inc. and Apotex Corp., Civil Action No. 06- 164 (SLR), in the District Court for the District of Delaware; excerpts from Defendant Apotex, Inc.'s Answer, Affirmative Defenses and Counterclaims dated May 9, 2006 filed in Merck & Co., Inc. v. Apotex, Inc., Civil Action No. 06-230-GMS, in the District Court for the District of Delaware; and Complaint for Declaratory Judgment and Demand for Jury Trial dated October 29, 2003 filed in Torpharm Inc., Apotex Corp., and Apotex , Inc., v. Pfizer Inc. and Warner-Lambert Company, Civil Action No. 03-990, in the District Court for the District of Delaware. 2

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8.

Attached hereto as Exhibit H is a true and accurate copy of a letter dated

December 6, 2007 from William T. Vuk to Dr. Bernard Sherman and Tammy McIntyre. 9. Attached hereto as Exhibit I is a true and accurate copy of an email dated

December 11, 2007 from Maryellen Noreika to Sherry L. Rollo. 10. Attached hereto as Exhibit J is a true and accurate copy of a letter dated

December 31, 2007 from Maryellen Noreika to Sherry L. Rollo. 11. Attached hereto as Exhibit K is a true and accurate copy of a letter dated

January 7, 2008 from Steven E. Feldman to William T. Vuk. 12. Attached hereto as Exhibit L is a true and accurate copy of a letter dated

January 7, 2008 from William T. Vuk to Steven E. Feldman. 13. Attached hereto as Exhibit M is a true and accurate copy of an email dated

February 28, 2008 from James Parrett to Paul Molino, et al. 14. Attached hereto as Exhibit N is a true and accurate copy of Apotex Inc.'s

and Apotex Corp.'s Response and Opposition to Plaintiffs' Motion For Transfer of Action Pursuant to 28 U.S.C. § 1407 filed on February 25, 2008 in MDL. No. 1941, In re Alfuzosin Hydrochloride Patent Litigation. 15. Attached hereto as Exhibit O is a true and accurate copy of the Complaint

dated December 10, 2007 filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 16. Attached hereto as Exhibit P is a true and accurate copy of Plaintiffs'

Motion to Transfer or Stay and Supporting Memorandum of Law dated January 8, 2008, without exhibits, filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp.,

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Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 17. Attached hereto as Exhibit Q is a true and accurate copies of Motion of

Plaintiffs for Transfer to the District of Delaware Pursuant to 28 U.S.C. 5 1407 and Brief in Support of Plaintiffs' Motion for Transfer of Action Pursuant to 28 U.S.C. 5 1407, without exhibits, in MDL. No. 1941, In re Alfuzosin Hydrochloride Patent Litigation. 18. Attached hereto as Exhibit R is a true and accurate copy of the Answer of

Apotex Inc. And Apotex Corp. To Complaint, Affirmative Defenses And Counterclaims dated December 28, 2007 filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 19. Attached hereto as Exhibit S is a true and accurate copy of the Answer of

Apotex Inc. and Apotex Corp. to Complaint, Affirmative Defenses And Amended Counterclaims dated January 2, 2008 filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 20. Attached hereto as Exhibit T is a true and accurate copy of Defendants

Apotex Inc.'s and Apotex Corp.'s Rule 26(a)(1) Initial Disclosures dated January 17, 2008 served in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 21. Attached hereto as Exhibit U is a true and accurate copy of a letter dated

January 17, 2008 from William T. Vuk to Steven E. Feldman and Stephen J. Bronis.

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22.

Attached hereto as Exhibit V is a true and accurate copy of Plaintiffs'

Initial Disclosures Pursuant To Rule 26(a)(1) dated January 31, 2008 served in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800CIVMORENO/SIMONTON, in the District Court for the Southern District of Florida. 23. Attached hereto as Exhibit W is a true and accurate copy of Defendants'

First Request For The Production Of Documents And Things To Plaintiff, served January 18, 2008 in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 24. Attached hereto as Exhibit X is a true and accurate copy of Defendants'

First Interrogatories To Plaintiffs, served February 8, 2008 in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIVMORENO/SIMONTON, in the District Court for the Southern District of Florida. 25. Attached hereto as Exhibit Y is a true and accurate copy of Plaintiffs'

Responses And Objections To Defendants' First Request For Production Of Documents And Things To Plaintiff, served on February 19, 2008 in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 26. Attached hereto as Exhibit Z is a compendium of the unreported cases

cited in Plaintiffs' Opening Brief In Support Of Its Motion To Enjoin Second Filed, Duplicative Litigation. 27. Attached hereto as Exhibit AA is a true and accurate copy of the

Transcript of Scheduling Conference Before the Honorable Shelby Highsmith, United States

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District Judge, dated July 10, 2000, from Abbott Laboratories v. Andrx Corporation, et al., Civil Action No. 00-6500-CV-SH, in the District Court of the Southern District of Florida. 28. Attached hereto as Exhibit BB is a true and accurate copy of Plaintiffs'

Motion For Status Conference And Incorporated Memorandum Of Law dated February 27, 2008 filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 29. Attached hereto as Exhibit CC is a true and accurate copy of Defendants

Apotex Inc.'s And Apotex Corp.'s Memorandum In Opposition To Plaintiffs' Motion To Transfer Or Stay dated January 28, 2008 filed in sanofi-aventis and sanofi-aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Civil Action No. 07-61800-CIV-MORENO/SIMONTON, in the District Court for the Southern District of Florida. 30. Attached hereto as Exhibit DD is a true and accurate copy of Defendants

Actavis South Atlantic LLC's And Par Pharmaceutical, Inc.'s Response In Support Of Motion To Transfer And Consolidate filed on February 25, 2008 in MDL. No. 1941, In re Alfuzosin Hydrochloride Patent Litigation. I declare under penalty of perjury that the foregoing is true and accurate. /s/ Kathryn M. Liberatore Kathryn M. Liberatore New York, New York March 4, 2008
1751370

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CERTIFICATE OF SERVICE I hereby certify that on March 4, 2008 I electronically filed the foregoing with the Clerk of the Court using CM/ECF, which will send notification of such filing to:. Richard L. Horwitz, Esquire POTTER ANDERSON & CORROON LLP I further certify that I caused to be served copies of the foregoing document on March 4, 2008 upon the following in the manner indicated: Richard L. Horwitz, Esquire POTTER ANDERSON & CORROON LLP Hercules Plaza ­ 6th Floor 1313 North Market Street Wilmington, DE 19801 Robert B. Breisblatt, Esquire Steven E. Feldman, Esquire Sherry L. Rollo, Esquire WELSH & KATZ LTD. 120 S. Riverside Plaza 22nd Floor Chicago, IL 60606 VIA ELECTRONIC MAIL And HAND DELIVERY

VIA ELECTRONIC MAIL

/s/ James W. Parrett, Jr. (#4292)
James W. Parrett, Jr. (#4292)

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EXHIBIT A

Case 1:07-cv-00792-GMS Apotex Inc - CorporateInformation

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Select a Country

Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with approximately 5,800 employees now occupy over 3.4 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, Calgary and Vancouver. In the last few years, Apotex has hired over 1200 new employees in Production, Engineering, Operations, Quality and Research. Out of the total employee base, there are over 2,100 scientific staff including over 110 PhD's. To meet the growing world demand for Apotex medicines, hundreds of new qualified technical professionals need to be hired. Apotex produces more than 300 generic pharmaceuticals in over 4000 dosages and formats which, in Canada, are used to fill over 85 million prescriptions a year - the largest amount of any pharmaceutical company in this country.

Chairman's Message

President's Message

Today, Apotex is a necessary and trusted member of Canada's healthcare community. The company's pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in the Czech Republic, Mexico, China, Poland, New Zealand, France, and Italy, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value. Although the company's own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use. The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year. Leading the Way With Research and Development
Maintained by Apotex Inc., Canada Privacy Policy | Accessibility | Site Terms | ©Apotex Inc. 2007 Last Modified: February 29, 2008 2:33:17 PM

http://www.apotex.com/CorporateInformation/Default.asp?flash=Yes

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EXHIBIT E

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EXHIBIT O

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EXHIBIT P

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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA M IAM I DIVISION Ca eNo 0 - 1 0 s . 7 6 8 0 CIV- ORENO/ ONTON M SIM

S ANOF IAVENTI a d S n S ANOF IAVENTI U.S LLC, S . P anif, lit s f v. s AP OTEX I a d NC. n AP OTEX CORP ., Dee d ns fn a t. /

PLAINTIFFS' OTION TO TRANSFER OR STAY M AND SUPPORTING M EM ORANDUM OF LAW P anif s n f-v ni a ds n f-v ni U.S LLC rs e tul mo eteCo r t lit s a o ia e t n a o ia e t f s s . e p cf l y v h u to ta se ti a t nt teDitit f lwaewh r a ie t a, aallfrtflda t ni rn fr hs ci o h src o Dea r ee n d ni lp rl , is-i ci s o c e e o c re t p n ig Dee d nsAp txCo p a dAp txI c d n t o ts p ro a u rnl e dn . y fn a t oe r. n oe n . o o c ne t es n l jrs it ni Dea r a da mita v n ei ta f r m i p o e. P anif' h ieo u idci n lwae n d th t e u n h t o u s r p r lit s c oc f o f f r m,h frtfldr l, n teitrsso jsiea dc n e in et tep risa d o u te is-i ue a d h nee t f u t n o v ne c o h at n e c e wi e s sfv rta se o ti a t nt Dea r wh r iwi p o e db f r tes meJ d e t se a o rn fr f hs ci o lwae ee t l r c e eo e h a n o l ug a dM a itaeJ d ea t rltda t n iv lig13 oh rd fn a t a dtep rl l cin n gsrt u g s wo eae ci s n ovn o te ee d ns n h aal a t e o a an t oe Co p a dAp txI c Al r aiey P anif rs e tul mo eti Co r t g is Ap tx r . n oe n . t n t l, lit s e p cf l e v f y v hs u t o sa tep e e t cinp n igteds o i o o a yta se is e rie b Dee d nsi te ty h rs n a t o e dn h ip st n f n rn fr su s as d y fn a t n h i frtfldf r m. is-i o u e Co n e f rP anif c riyta p ru n t Lo a Rue7 u s l o lit s et h t u s a to c l l .1.A.3()ih sme a d f f a ta tn c n erdwi c u s l o Dee d nsi a ef r t rs leteis e rie b P anif' o fre t o n e f r fn a t n n fo to e ov h su s as d y lit s h f M oint Trn fro S a . Th p risweeu a l t rs leto eis e . t o a se r ty o e at e r n be o e ov h s su s

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W HEREFORE, Plaintiffs sanofi-aventis and sanofi-aventis U.S. LLC respectfully req uests that the Court enter an Order granting Plaintiffs' Motion to Transfer or Stay. MEMORANDUM OF LAW This is an action brought under 35U.S.C. §10 et seq. and the Hatch-W axman Act for 1 the infringement of a patent covering the drug Uroxatral® by the filing of an Abbreviated New Drug Application (" ANDA" seek FDA approval of a generic version of that drug. Plaintiffs ) ing sanofi-aventis and sanofi-aventis U.S. LLC (collectively " sanofi-aventis" respectfully submit ) this memorandum in support of their motion to transfer this action to the District of Delaware where an identical, parallel, first-filed action and two related cases against 13 other defendants are currently pending. Alternatively, Plaintiffs req uest that the Court stay this action pending the resolution of any venue issues raised in the Delaware action by Defendants Apotex Corp. and Apotex Inc. (collectively " Apotex" ). The District of Delaware is Plaintiffs' forum of choice and the first-filed forum. This is true not only for the parallel proceeding against Apotex, but also for sanofi-aventis's claims against 13 other defendants. Plaintiffs would not have even filed this action if Apotex had timely confirmed what it has now admitted in its pleadings and in its representations to Plaintiffs -- that it does not contest personal jurisdiction in Delaware and that venue is appropriate in that forum. But rather than proceeding in Delaware where actions are currently pending against all accused infringers, Apotex seek to game the system and engage in forum-shopping by arguing s that the Southern District of Florida is more convenient and will adjudicate the parties' claims more q ly. There is scant support for either of these assertions as the majority of Apotex's uick documents and witnesses are lik located in Canada where it develops its generic products, and ely the issues involved in this patent litigation are sufficiently complex, and potential discovery so far-reaching, that they will lik tak a considerable time to adjudicate regardless of the forum ely e 2
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in which they proceed. If Apotex's attempt to make an end-run around sanofi-aventis's choice of forum is successful, the result will be contrary to the interests of justice, leading to a waste of time and resources on duplicative discovery and other pretrial proceedings, potentially inconsistent rulings on issues that impact the certainty of patent rights, as well as great inconvenience to the parties and witnesses which will have to proceed in two separate districts. Apotex's tactics will not only impact the parties in this case, but also the 13 additional defendants in Delaware where sanofi-aventis's other patent infringement actions will proceed regardless of what happens in this jurisdiction. Consequently, the Court should follow the time-honored rule of allowing actions to proceed in the first-filed forum and transfer this case to Delaware so that all claims for patent infringement may proceed in the same court and before the same Judge and Magistrate Judge in a coordinated manner. Alternatively, if the Court does not transfer at this time, Plaintiffs respectfully request that it stay the present action and defer to the first-filed District of Delaware on the issue of venue while the parties continue to litigate their claims and defenses in that forum. BACKGROUND I. Th Pari e tes Plaintiff sanofi-aventis is one of the world's leading innovators in the research, development and marketing of drugs and vaccines. It is a French corporation with places of business throughout the world, including its principal place of business in Paris, France. Plaintiff sanofi-aventis U.S. LLC is sanofi-aventis's United States affiliate. It is a Delaware Limited Liability Company with its North American headquarters in the state of New Jersey. Defendant Apotex Inc. is a Canadian Company, with a place of business in Toronto, Ontario, Canada. Defendant Apotex Corp. is a Delaware Corporation, and has places of business in a number of states, including Florida, New York and Indiana. Apotex Inc. and Apotex Corp. 3
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sell generic drugs throughout the United States, including Delaware; according to Apotex Inc.'s website, "worldwide sales of the Apotex Group of companies exceed $ billion (Canadian $ per 1 ) year." Ex. 1, The Apotex Group Corporate Info.1 II. Sanofi-aventis's Patents And Innovator Drug Plaintiff sanofi-aventis is the current assignee of United States Patent No. 4,6 1,49 6 1 (issued April 28, 19 ("the '49 patent"), titled "Alfuz 87) 1 osine Compositions and Use." It is also a current assignee of United States Patent No. 6 ,9 (issued November 21, 2000) ("the '9 ,149 40 40 patent"), titled "Tablet with Controlled Release of Alfuz osine Chlorhydrate."2 Both patents are listed in the FDA's Approved Drug Products With Thera peutic Equivaen Evaua s ("the l ce l tion Orange Book") for Uroxatral® brand alfuz osin hydrochloride 10 mg extended release tablets, the innovator drug for which Plaintiff sanofi-aventis U.S. LLC holds New Drug Application ("NDA") No. 21-287. III. Infringement Of Sanofi-Aventis's Patents ByThe ANDA Fil ers In the Summer of 2007, nine separate ANDAs for generic versions of Uroxatral® were submitted by, on behalf of, or with participation from 15 entities, to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), including ANDA 79 -013 filed by Apotex Inc. with the participation and/or contribution of Apotex Corp. Each of these ANDAs seeks FDA approval for the commercial manufacture, use and sale of the ANDA filer's proposed generic product prior to the expiration of one or both of sanofi-aventis's patents. As part of each ANDA, the ANDA filers included "paragraph IV certifications," alleging that the claims of the '49 patent and/or the '9 patent are invalid and/or not infringed by the manufacture, use or sale 1 40 1 True and accurate copies of the exhibits cited herein are attached to the accompanying Declaration of William T. Vuk in Support of Plaintiffs' Motion to Transfer or Stay. 2 Non-party Jagotec AG is also a current assignee of the '9 patent. Plaintiff sanofi-aventis has 40 an exclusive license to Jagotec AG's interests in the '9 patent. 40 4
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of the proposed generic products. Sanofi-aventis received notification of the ANDAs and paragraph IV certifications in letters dated between August 14, 2007 and October 25, 2007, including notification of Apotex's ANDA and '940 patent paragraph IV certification by letter dated August 14, 2007 and notification that Apotex amended its ANDA to include a '491 patent paragraph IV certification by letter dated October 25, 2007. Ex. 2, 08/14/07 B. Sherman ltr to Plaintiffs and Jagotec AG; Ex. 3, 10/25/07 B. Sherman ltr to Plaintiffs and Jagotec AG. The submission of these ANDAs and paragraph IV certifications permitted sanofi-aventis to sue for infringement of the '491 patent and/or the '940 patent. See 35 U.S.C. § 271(e)(2)(A). To litigate this infringement under the protections provided by the Hatch-Waxman Act, which affords a 30-month stay of generic approval while a patent litigation is pending, sanofi-aventis was required to file an action against each submitting party or parties within forty-five days of receiving notice of their respective paragraph IV certifications. 21 U.S.C. § 355(j)(5)(B)(iii). IV. Commencement Of The First-Filed District Of Delaware Actions A. Plaintiffs Initially Sued 13Defendants For Infringement of the '4 1 and/or 9 '9 0 Patents In the District of Delaware 4

After receiving notice of the ANDAs and paragraph IV certifications, sanofi-aventis evaluated various personal jurisdiction issues and determined that the most logical venue for litigating its claims against all 15 potential defendants, including Apotex, was the District of Delaware. In light of this fact and the judicial economy and efficiency of having the same court try each of sanofi-aventis's claims against all defendants, sanofi-aventis commenced Civil Actions Nos. 07-572 (GMS) (MPT) and 07-574 (GMS) (MPT) on September 21, 2007 in the United States District Court for the District of Delaware against 13 defendants for infringement of the '491 and/or the '940 patent by the filing of their respective paragraph IV certifications. 3

3 In these two actions, sanofi-aventis asserted both patents against nine defendants and the '940 5
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See Ex. 4, Delaware Complaint No. 07-572; Ex. 5, Delaware Complaint No. 07-574. B. Plaintiffs Sued Apotex For Infringement Of The '491 Patent In The District Of Delaware Shortly Thereafter

At the time of filing the first two Delaware complaints, Apotex's ANDA only included a paragraph IV certification against the '940 patent. In reliance on Apotex's representations regarding its proposed generic product, sanofi-aventis informed Apotex that it would not file an action for infringement of the '940 patent unless Apotex's representations were incorrect or Apotex amended its ANDA to change the composition of its proposed generic product. Ex. 6, 10/01/07 W. Vuk ltr to B. Tao. Sanofi-aventis then received a second paragraph IV certification from Apotex dated October 25, 2007, alleging that its proposed generic product did not infringe any valid claim of the '491 patent. In response, sanofi-aventis commenced Civil Action No. 07792 (GMS) (MPT) against Apotex in Delaware on December 6, 2007 for infringement of the '491 patent. Ex. 7, Apotex Delaware Complaint. That action was designated as related to the earlier-filed complaints and assigned to the same Judge and Magistrate Judge. C. Apotex Agreed Not To Contest J urisdiction In The District Of Delaware Only After The Expiration Of Plaintiffs' 45 -Day Window To Bring Suit

Despite having previously admitted personal jurisdiction in several prior actions in the District of Delaware,4 Apotex ignored sanofi-aventis's request to consent to jurisdiction prior to the expiration of the 45-day window to bring suit under the Hatch-Waxman Act. See Ex. 9, 12/06/07 W. Vuk ltr to B. Sherman. It was only after that period ran that Apotex represented

patent alone against four additional defendants. 4 On at least four separate occasions with respect to other ANDA litigations, Apotex has admitted that the District of Delaware has jurisdiction over it. Ex. 8, Answer in Allergan, nc. v. I ApotexI nc.et al, Civ. No. 07-278-GMS at 2-3; Answer in Medpointe Healthcare I v. Apotex nc. I et al. No. Civ. 07-204-SLR at 3; Answer in Medpointe Healthcare I v. ApotexI et al., nc. nc. nc. No. Civ. 06-164-SLR at 3-4; Answer in Merck& Co., nc. v. ApotexI No. Civ. 06-230-GMS I nc., at 2. In fact, Apotex has also availed itself of the Delaware court as a plaintiff. Ex. 8, Complaint in Torpharm I et al. v. Pf er I et al., No. Civ. 03-990-SLR at 4. nc. iz nc. 6
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that it would not contest jurisdiction in Delaware. Ex. 10, 12/11/07 M. Noreika email to S. Rollo; Ex. 11, 12/31/07 M. Noreika ltr to S. Rollo. On January 2, 2008, Apotex answered the complaint in Delaware and conceded that jurisdiction and venue were proper in Delaware: · "Apotex Corp. admits that [ Delaware]Court has personal jurisdiction over it in the this District for the purposes of this action." See Ex. 12, Apotex Delaware Answer And Counterclaims ¶ 7. "For purposes of this action, Apotex Inc. does not contest the [ Delaware]Court's jurisdiction over it . . . ." Id. ¶ 8; "Apotex Inc. and Apotex Corp. do not dispute this judicial district is a possible venue for this action . . . . " Id. ¶ 10.

·

·

Despite these clear admissions to the Delaware court as to the appropriateness of jurisdiction and venue, Apotex has indicated that it will move to transfer the first-filed Delaware action to the Southern District of Florida because that is "a more convenient venue" and "will proceed more quickly to resolution." See Ex. 12 ¶10; Ex. 13, 01/07/08 S. Feldman ltr to W. Vuk; Ex. 14, 01/07/08 W. Vuk ltr to S. Feldman. All three first-filed Delaware actions are designated as related cases and all are proceeding before the same Judge and the same Magistrate Judge. As of January 7, 2008, all 15 defendants, including Apotex, have filed their answers and counterclaims and sanofi-aventis has filed all of its replies. The parties now await an order setting the Rule 26(f) scheduling conference. See Ex. 15, Delaware Docket Sheets. 5 V. Plaintiffs Brought The Present Action To Protect Their Rights Under The HatchWaxman Regime In Response To Apotex's Failure To Confirm That It Would Not Contest Jurisdiction In Delaware Apotex's refusal to consent to jurisdiction in Delaware within the 45-day window to bring

5 One additional protective suit is currently pending against Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. Plaintiffs have not served the complaint in that action and expect that their claims against the Aurobindo defendants will proceed in the District of Delaware where jurisdiction and venue are proper with respect to both parties. 7
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suit placed sanofi-aventis in a significant dilemma. Under the Hatch-Waxman Act, a patentee has a "strict statutory 45-day window" in which to file an infringement action after receiving notice that an ANDA has been filed seeking approval to market a generic version of a patented drug product. Abbott Labs. v. Mylan Pharm., Inc., No. 05 C 6561, 2006 WL 850916, at * 8 (N.D. Ill. Mar. 28, 2006) (citing 21 U.S.C. § 355 (j)(5)(B)(iii)). Sanofi-aventis met this deadline with respect to 13 defendants by its September 21, 2007 complaints in Delaware and with respect to Apotex by its December 6, 2007 complaint in Delaware. But it is unclear whether a patentee still enjoys the benefits of a suit under the Hatch-Waxman Act (as opposed to a suit for infringement generally under the patent laws) if its action, properly brought within the 45-day window, is dismissed for lack of personal jurisdiction after the 45-day period has expired. See PDL BioPharma, Inc. v. Sun Pharm. Inds., Ltd., No. 07-11709, 2007 WL 2261386, at * (E.D. 2 Mich. Aug. 6, 2007); Abbott, 2006 WL 850916, at * 8. Although sanofi-aventis believed that the District of Delaware could properly exercise personal jurisdiction over Apotex, this is the only district in which sanofi-aventis knew Apotex would not contest personal jurisdiction based on prior litigation conduct and representations made in Apotex's certification letters. Given the uncertain consequences surrounding the unlikely, but possible dismissal of the Delaware action, sanofi-aventis had no choice but to bring this second-filed action within the 45-day window on December 10, 2007. 6 Ex. 16, Florida

6 The consequences of losing the protections of the Hatch-Waxman Act are significant to the parties and the courts. Under the Act, approval of the proposed generic product is stayed by the FDA for 30 months and the action can be litigated in an orderly fashion without any damages issues or questions of emergency injunctions. 21 U.S.C. § 355(j)(5)(B)(iii); Dr. Reddy' Labs., s Inc. v. Thompson, 302 F. Supp. 2d 340, 344 (D.N.J. 2003) ("The purpose of the 30-month stay is to allow time for patent infringement litigation."); Ben Venue Labs., Inc. v. Novartis Pharm. Corp., 146 F. Supp. 2d 572, 579 (D.N.J. 2001). Absent these protections, cases can devolve into free-for-alls with generic defendants seeking to launch "at-risk" and patentee plaintiffs seeking temporary restraining orders, preliminary injunctions and significant damages. 8
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Complaint. As discussed above, Apotex subsequently agreed not to contest jurisdiction in Delaware, but would not confirm that agreement in writing so that sanofi-aventis could voluntarily dismiss the Florida complaint. It is now clear that this tactic was an attempt to make an end rule around Plaintiffs' choice of forum. Apotex filed its Answer and Counterclaims in this action on December 28, 2007, one business day before answering the first-filed Delaware action, in a thinly-veiled attempt to manufacture an argument that this action is at a more advanced state than the first-filed Delaware actions.7 See Ex. 17, Florida Answer And Counterclaims; Ex. 18, Florida Amended Answer And Counterclaims. It appears that Apotex's strategy was to ignore sanofi-aventis's inquiry as to whether it would contest jurisdiction in Delaware, in an effort to force sanofi-aventis to file a protective action in Apotex's forum of choice. Apotex now seeks to buttress its argument that this forum is "more convenient" with the "fact" that this action has progressed farther than the Delaware actions because it filed its answer in Florida one business day before answering in Delaware. As discussed below, similar attempts by ANDA filers to game the system and to secure the forum of their choice at the expense of the plaintiff have failed. ARGUMENT I. All Relevant Factors Favor Transfer To Delaware Where Identical Claims And Counterclaims Are Pending With Related Claims Against 13 Other Defendants Where venue is proper, a federal court, "[f]or the convenience of parties and witnesses, in the interest of justice, may transfer any civil action to any other district or division where it might have been brought." 28 U.S.C. § 1404(a). Thus, the question of whether to transfer is a two-part inquiry. First, the transferee forum must be one in which the action could originally have been 7 In its Florida answer, Apotex "den[ies] that Apotex Inc. is subject to personal jurisdiction in the Delaware action . . . ." Ex. 17 ¶ 19. Apotex then contradicted that denial in its Delaware Answer, stating that it does not contest the Delaware court's personal jurisdiction over Apotex Inc. Ex. 12 ¶ 8; see also Ex. 10; Ex. 11. 9
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brought. Second, the Court must balance factors such as the plaintiff's choice of forum, the interests of justice, and the convenience of the parties and witnesses in deciding whether on the whole they favor transfer. Manuel v. Convergys Corp., 430 F.3d 1132, 1135 n.1 (11th Cir. 2005). There is no dispute that this Court has the power to transfer this action to the District of Delaware as, unlike the circumstances of many motions to transfer, sanofi-aventis and Apotex agree that jurisdiction and venue are proper in Delaware. The Court should exercise its power and transfer this action to the first-filed forum for adjudication with the parties' identical claims pending in that court along with two related patent infringement litigations involving the same patents-in-suit and reference drug--actions that will proceed regardless of what happens in this forum. First, Delaware is both Plaintiffs' forum of choice and the first-filed forum, two factors that weigh heavily in favor of transfer. Second, transfer would avoid the duplicative efforts and costs of two separate courts conducting extensive pretrial activities and prevent potentially inconsistent rulings on critical issues such as claim construction and summary judgment. Finally, although Apotex claims that it would be more convenient for it to proceed in this forum, that convenience is minimal as most of its relevant witnesses and documents are likely located in Canada where it develops generic products. Additionally, it is likely that this action will take a significant amount of time to adjudicate regardless of where it proceeds in light of the complex nature of the case and the expected scope of discovery. Any minimal added burden of litigating in Delaware, where Apotex has recently litigated several other ANDA actions without moving to transfer, is heavily outweighed by the interests of judicial economy and certainty of patent rights as well as the inconvenience the parties would experience by litigating the same issues in two separate judicial districts. See Abbott, 2006 WL 850916, at *8 (finding an ANDA filer's convenience argument less persuasive when it had litigated multiple ANDA cases in the forum without complaint). 10
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A.

Both the Plaintiffs' Choice of Forum and the First-Filed Rule Favor Transfer

Plaintiff's choice of forum weighs in favor of a request to transfer and should not be disturbed unless clearly outweighed by other considerations. Cf. Robinson v. Giarmarco & Bill, P.C., 74 F.3d 253, 260 (11th Cir. 1996) (refusing to transfer outside of plaintiffs' forum where such a transfer would merely shift the burdens on the parties). Here, sanofi-aventis chose the District of Delaware because it was the district where Plaintiffs could bring each of the ANDA filers and related defendants under the jurisdiction of the court so that all claims and counterclaims concerning Uroxatral® and the listed patents could be adjudicated in a single forum. Plaintiffs were only forced to bring this second-filed action because Apotex refused to confirm that it would not contest jurisdiction in Delaware within the 45-day window Plaintiffs had to bring suit under the Hatch-Waxman Act. See, e.g., Ex. 9. As discussed above, the law remains unclear as to whether a patentee still enjoys the benefits of a suit under the HatchWaxman Act, namely the 30-month stay of approval of the proposed generic product, if its action, properly brought within the 45-day window, is later dismissed for lack of personal jurisdiction. See Abbott, 2006 WL 850916, at *8; PDL, 2007 WL 2261386, at *2. Now that Apotex has acknowledged that it does not contest personal jurisdiction in Delaware, the Court should transfer this action to Plaintiffs' forum of choice. See Ex. 10; Ex. 11; Ex. 12 ¶¶ 7-10. Transfer under this set of facts would also comport with the 11th Circuit's "first-filed" rule. Under that standard, if two actions involving the same parties and identical issues are pending in different districts, the first-filed action should typically be given priority and be allowed to proceed in favor of the later action. See Manuel, 430 F.3d at 1135-38 ("[W]here two actions involving overlapping issues and parties are pending in two federal courts, there is a strong presumption across the federal circuits that favors the forum of the first-filed suit under the first-filed rule."); Philibert v. Ethicon, Inc., No. 04-81101-CIV, 2005 WL 525330, at *1 (S.D. 11
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Fla. Jan. 14, 2005). Contrary to Apotex's unsupported assertions, this rule applies even where plaintiff files both actions, a measure that courts have recognized as necessary under the HatchWaxman Act. Ex. 14; PDL, 2007 WL 2261386, at *2; see also Cordis Corp. v. SiemensPacesetter, Inc., 682 F. Supp. 1200, 1202-03 (S.D. Fla. 1987) (rejecting defendants' assertion that a plaintiff must show a change of circumstances when moving under § 1404 and ordering transfer to the first filed forum where four related litigations involving these and other defendants were already pending).8 Sanofi-aventis filed the Delaware action against Apotex on December 6, 2007. The Florida action was filed on December 10, 2007, but never served. Both the Delaware and the Florida actions raise the same issues--namely, whether Apotex's proposed generic version of Uroxatral® infringes any valid and enforceable claim of the '491 patent, and to the extent Apotex's counterclaims are not dismissed, whether that product infringes any valid and enforceable claim of the '940 patent. Consequently, the Court should transfer this action under the first-filed rule. Philibert, 2005 WL 525330 at *2 (transferring to the first-filed forum where identical claims were pending to serve the interests of justice); Tiber Labs., LLC v. Cypress Pharm., Inc., No. 2:07-CV-0014-RWS, 2007 WL 3216625, at *2-3 (N.D. Ga. May 11, 2007).

8 The first-filed rule is measured by which action was filed first, not by when counterclaims are first filed. Consequently, Delaware is the first-filed forum in this case, even though Apotex's counterclaims with respect to the '940 patent were filed in this District one business day before filing them in Delaware. See KimberlyClark Corp. v. McNeilPPC, Inc., 260 F. Supp. 2d 738, 740-41 (E.D. Wis. 2003) (rejecting a similar argument concerning declaratory judgment counterclaims asserted in the second-filed action concerning patents not initially at issue in the first-filed action because "[t]he issue, however, is not which of the claims was filed first, but rather which action was filed first."); Versus Tech., Inc. v. Hillenbrand Indus., Inc., No. 1:04CV-168, 2004 WL 3457629, at *6-7 (W.D. Mich. Nov. 23, 2004); cf. Holmes Group, Inc. v. Vornado Air Circulation Sys. Inc., 535 U.S. 826, 831-32 (2002) (holding that counterclaims cannot serve as the basis for "arising under" jurisdiction under the well-pleaded complaint rule). 12
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B.

The Interests of Justice Can Only Be Served By Transfer To The Forum Where All Others Claims Concerning The Patents Are Pending

As the Federal Circuit has held, "consideration of the interest of justice, 'may be determinative to a particular transfer motion, even if the convenience of the parties and witnesses might call for a different result.'" Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1565 (Fed. Cir. 1997). For example, in Alere Medical, Inc. v. Health Hero Network, Inc., a first-filed action was brought in Illinois for infringement of plaintiff's patent. No. C- 07-05054 CRB, 2007 WL 4351019, at *1 (N.D. Cal. Dec. 12, 2007). The accused infringer subsequently filed a separate declaratory judgment action in California concerning seven other patents owned by the patentee, but not at issue in the first-filed action. The second-filed court granted the accused infringer's motion to transfer its declaratory judgment action to the first-filed forum because, inter alia, the related actions "share[] common technology and products, common parties, and overlapping issues of infringement and validity. Having all the patents before a single judge will obviate the need for duplicative tutorials and evidence, and will facilitate a global settlement." Id. Rejecting the patentee's argument that transfer would be inconvenient in light of the location of relevant witnesses, parties, and documents, the court stated that "the pertinent question is not simply whether this action would be more conveniently litigated in Illinois than California, but whether it would be more convenient to litigate the California and Illinois actions separately or in a coordinated fashion." Id. at *2; Cordis Corp., 682 F. Supp. at 1202 (S.D. Fla. 1987). Likewise, in Tingley Systems, Inc. v. Bay State HMO Management, Inc., the second-filed court granted defendant's motion to transfer to the first-filed forum even though defendant had not proven that its witnesses would be more inconvenienced than plaintiff's witnesses without a transfer. 833 F. Supp. 882, 886 (M.D. Fla. 1993). What defendant had established, however, was that "all parties and witnesses would be greatly burdened if all were required to travel 13
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between two forums because the two related cases in which they were all involved were being tried in different states." Id. By transferring the second-filed action in the interest of justice, the Court held that all the parties would benefit because: The two actions should be consolidated before one judge thereby promoting judicial efficiency, pretrial discovery could be conducted in a more orderly manner, witnesses could be saved the time and expense of appearing at trial in more than one court, duplicative litigation involving the filing of records in both courts could be avoided eliminating unnecessary expense and the possibility of inconsistent results could be avoided." Id. at 888 (internal quotations omitted). The facts supporting transfer are even more compelling here where sanofi-aventis has multiple suits pending in the District of Delaware that share the same claims and counterclaims concerning the '491 and '940 patents. In addition to the parallel action against Apotex, there are two other cases concerning infringement of the same patents by eight additional ANDAs referencing Uroxatral®, which will proceed regardless of what happens in this forum. Each of these actions has been assigned to the same Judge and Magistrate Judge. All answers and replies have been filed and the parties now await an initial scheduling order from the court. Plaintiffs expect that the Delaware court will coordinate pretrial activities in all three pending cases, and may consolidate all three actions for pretrial proceedings, in order to avoid duplicative discovery efforts and improve the efficiency of its docket. By transferring this action for coordination with the Delaware cases, the Court will avoid duplicating pretrial activities, thus preserving judicial resources and reducing costs for the parties. For example, as the issues with respect to Plaintiffs' activities concerning the reference product Uroxatral® and the patents-in-suit are identical, transfer will avoid multiple depositions of witnesses concerning the development of Uroxatral® and prosecution of the patents-in-suit, as well as all regulatory and marketing issues on which the ANDA filers may seek discovery.

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Likewise, transfer will avoid duplicative discovery disputes concerning these issues being adjudicated by separate courts. Moreover, transfer to Delaware will obviate the need for multiple courts to learn the technology associated with the patents-in-suit, the alleged prior art, and the proposed generic products. Finally, transfer will prevent potentially inconsistent rulings on critical issues such as the validity and enforceability of the asserted claims, and, to the extent the ANDA filers allege similar defenses, whether the proposed generic products infringe those claims. This factor is especially important with respect to the specialized Markman hearing courts must hold to construe the meaning of asserted claim terms as a matter of law, where inconsistent rulings could result in identical claim terms having different meaning for different defendants. See Cordis, 682 F. Supp. at 1202; cf. MRL, LLC v. U.S. Robotics Corp., No. 02 C 2898, 2003 WL 685504, at *12 (N.D. Ill. Feb. 26, 2003) (denying motion to stay under an exception to the first-filed rule in favor of the second action where patentee's claims for infringement were pending before all accused infringers and would proceed regardless of whether the stay was granted); Eason v. Linden Avionics, Inc., 706 F. Supp. 311, 330 (D.N.J. 1989) ("[L]itigation of related claims in the same tribunal is strongly favored because 'it facilitates efficient, economical and expeditious pretrial proceedings and discovery and avoids [duplicative] litigation and inconsistent results.'"). C. Apotex's Unsupported Convenience And Congestion Arguments Are Sub stantially Outweighed By The Other Relevant Factors

Apotex argues that it would be more convenient for the witnesses and the parties to proceed in the Southern District of Florida, because Apotex Corp. is based in this District. Ex. 12 ¶ 10; Ex. 18 ¶ 19. As discussed above, Apotex is part of a multinational, billion dollar group of companies and has proceeded in Delaware in several other ANDA litigations without moving to transfer. In this case, as in the Alere and Tingley cases discussed above, any marginal convenience to Apotex of proceeding in Florida is vastly outweighed by the courts' and the 15
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parties' interests in avoiding duplicative pretrial activities, in preventing potentially inconsistent rulings, and the inconvenience to the parties of having to proceed in two separate jurisdictions. Apotex recently tried unsuccessfully to transfer an ANDA infringement action from the Southern District of Indiana to this forum even though there were no related actions pending in Indiana, let alone claims against 13 other defendants as in the case at bar. See Alcon Mfg., Ltd. v. Apotex Inc., No. 1:06-cv-1642-RLY-TAB, 2007 WL 854026 (S.D. Ind. Mar. 14, 2007). In Alcon, Apotex argued that (1) this forum was more convenient to Apotex and its witnesses and no less convenient for the plaintiff and (2) the interests of justice favored this forum because it had an interest in deciding local controversies and could conduct a more speedy trial. The Alcon court rejected both of Apotex's arguments. First, the court found that Florida was not a more convenient forum because the parties were spread throughout the United States and internationally; thus, any financial burden of proceeding in the first-filed forum was insufficient to overcome the deference in plaintiff's choice of forum, even though it was not the plaintiff's home district. Alcon, 2007 WL 854026, at *2-3. Second, Apotex failed to show that transfer to Florida would be more convenient to the witnesses, as Apotex's development of its proposed generic product and preparation of the ANDA took place in Canada and plaintiffs' research and development of the patented product took place in Texas and Japan; thus, both parties' witnesses would have to travel to either the first- or second-filed forum, with the only apparent exception being the president of Apotex USA. Id.;see also Abbott, 2006 WL 850916, at *7 ("In a case where all of the witnesses of the [generic] defendant will be its employees, however, the location is not as important a factor as it would be if the witnesses were not under the control of the defendant."). Finally, the court rejected Apotex's interest of justice arguments as the suit was likely to affect consumers nationwide, not just in Florida, and because the case involved complex issues concerning patent infringement, it would likely take several years to 16
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adjudicate, regardless of the venue. Alcon, 2007 WL 854026, at *4. This case falls squarely within the Alcon court's rationale. Sanofi-aventis's witnesses and documents are likely to be found in Europe, New Jersey, and Pennsylvania, not Florida. As in Alcon, Apotex Inc., the Canadian corporation, is the holder of the ANDA, and it is likely that Canada is the situs of events such as preparation of that ANDA and its underlying research and development as well as the documents concerning and the witnesses with knowledge of those issues. Likewise, Apotex can make no showing this is a local dispute over which Florida has any specialized interest because Uroxatral® is sold throughout the country and Plaintiffs expect that Apotex will seek to market its products well beyond the borders of this forum as it has with its other generic products developed and manufactured abroad. Apotex has indicated that the interest of a speedy trial necessitates proceeding in this Court. Ex. 13, Ex. 14. That argument failed in Alcon and should fail here as well. This is a complex litigation that will require the resolution of a variety of patent-specific issues, such as claim construction, infringement, and validity that will take a significant amount of time to adjudicate. Plaintiffs expect that Apotex will seek discovery on a wide-range of issues concerning the development of sanofi-aventis's inventions, patent prosecution, alleged prior art, and various marketing and regulatory activities. Many of the hundreds of thousands of potentially relevant documents are decades old and are located overseas where they must be reviewed in compliance with the European Union and member-state privacy directives prior to transport to the United States. Considering the number of inventors and other potentially relevant witnesses, including third parties, Plaintiffs expect the parties to conduct a large number of depositions, some of which may require Apotex to seek relief under the Hague Convention. Consequently, sanofi-aventis will ask Apotex to consent, or otherwise move the Court, to place this action on a Complex Track under Local Rule 16.1.A to ensure that the parties conduct 17
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