Free Case Transferred In - District Transfer - District Court of Delaware - Delaware

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CLOSED, EGT, MEDREQ, STAYED

U.S. District Court Southern District of Florida (Ft. Lauderdale) CIVIL DOCKET FOR CASE #: 0:07-cv-61800-FAM

Sanofi-Aventis et al v. Apotex, Inc. et al Assigned to: Chief Judge Federico A. Moreno Referred to: Magistrate Judge Edwin G. Torres Cause: 35:0271 Patent Infringement Plaintiff Sanofi-Aventis

Date Filed: 12/10/2007 Date Terminated: 04/29/2008 Jury Demand: Defendant Nature of Suit: 830 Patent Jurisdiction: Federal Question

represented by Alfred John Saikali Shook Hardy & Bacon 201 S Biscayne Boulevard Suite 2400 Miami, FL 33131-4332 305-358-5171 Fax: 305-358-7470 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Email: [email protected] ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Email: [email protected] ATTORNEY TO BE NOTICED John M. Desmarais Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Fax: 446-4900

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Email: [email protected] ATTORNEY TO BE NOTICED William T. Vuk Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Email: [email protected] ATTORNEY TO BE NOTICED Plaintiff Sanofi-Aventis, U.S. LLC represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED V. Defendant Apotex, Inc. represented by Jennifer Rae Coberly Zuckerman Spaeder Taylor & Evans 201 S Biscayne Boulevard Suite 900 Miami, FL 33131 305-358-5000 Fax: 579-9749 Email: [email protected] TERMINATED: 04/09/2008 LEAD ATTORNEY Stephen Jay Bronis Carlton Fields, P.A. 100 SE 2nd Street

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Suite 4000 Miami, FL 33131 305-530-0050 Fax: 305-530-0055 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Laurel White Marc-Charles Richard & Richard 825 Brickell Bay Drive Suite 1748 Tower III Miami, FL 33131-2961 305-374-6688 Fax: 374-0384 Email: [email protected] ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Robert Burton Breisblatt Katten Muchin Rosenman LLP 525 West Monroe Street Chicago, IL 60661-3693 312-902-5200 Fax: 312-902-1061 Email: [email protected] TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo

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Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Steven E. Feldman Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Walter J. Tache Carlton Fields 4000 International Place 100 S.E. Second Street Miami, FL 33131-2114 305-530-0050 Fax: 530-0055 Email: [email protected] TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Defendant Apotex Corp. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Stephen Jay Bronis (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Laurel White Marc-Charles (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr.

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(See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Counter Claimant Apotex, Inc. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman

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(See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Counter Claimant Apotex Corp. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED V. Counter Defendant Sanofi-Aventis represented by Alexis Gorton (See above for address)

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ATTORNEY TO BE NOTICED Alfred John Saikali (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED Counter Defendant Sanofi-Aventis, U.S. LLC represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED Counter Claimant Apotex, Inc. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

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James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Counter Claimant Apotex Corp. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED

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Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED V. Counter Defendant Sanofi-Aventis represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED Counter Defendant Sanofi-Aventis, U.S. LLC represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address)

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ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED

Date Filed 12/10/2007

# 1

Docket Text COMPLAINT against Apotex, Inc., Apotex Corp. Filing fee $ 350. Receipt#: 971492, filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (dj) (Entered: 12/11/2007) ANSWER to Complaint with Jury Demand, COUNTERCLAIM and Affirmative Defenses against all plaintiffs by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 12/28/2007) ANSWER to Complaint with Jury Demand, Amended COUNTERCLAIM against all plaintiffs by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 01/02/2008) SCHEDULING ORDER; ORDER REFERRING CASE to Mediation. 15 days to appoint mediator. Jury Trial set for 5/27/2008 09:00 AM in Miami Division before Chief Judge Federico A. Moreno.Signed by Judge Federico A. Moreno on 1/3/2008.(lc1) (Entered: 01/03/2008) Pursuant to 4 , Set/Reset Scheduling Order Deadlines: Calendar Call set for 5/20/2008 02:00 PM in Miami Division before Chief Judge Federico A. Moreno. Amended Pleadings due by 1/31/2008. Discovery due by 3/27/2008. Joinder of Parties due by 1/31/2008. Mediation Deadline 4/28/2008. Motions due by 4/28/2008. Pretrial Stipulation due by 5/13/2008. (dg) (Entered: 01/04/2008) 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. Responses due by 1/23/2008 (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 01/08/2008) AFFIDAVIT signed by : William Vuk. re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Exhibit 3# 4 Exhibit 4# 5 Exhibit 5# 6 Exhibit 6# 7 Exhibit 7# 8 Exhibit 8# 9 Exhibit 9# 10 Exhibit 10# 11 Exhibit 11# 12 Exhibit 12# 13 Exhibit 13# 14 Exhibit 14# 15 Exhibit 15# 16 Exhibit 16# 17 Exhibit 17# 18 Exhibit 18# 19 Exhibit 19)(Saikali, Alfred) (Entered: 01/08/2008) Plaintiff's MOTION for Hearing re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. (Saikali, Alfred) (Entered: 01/08/2008)

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Plaintiff's MOTION to Stay Certain Deadlines and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. Responses due by 1/23/2008 (Attachments: # 1 Text of Proposed Order Proposed Order) (Saikali, Alfred) (Entered: 01/08/2008) NOTICE of Instruction to Filer: re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law filed by Sanofi-Aventis, ERROR: Motion with Multiple Reliefs Filed as One Relief; Instruction to Filer: In the future please select all applicable Reliefs (You can select multiple reliefs by using the Ctrl key). This is for FUTURE reference only, it is not necessary to refile this document. (gp) (Entered: 01/09/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for Gerald J. Flattmann, Jr., Filing Fee $75, Receipt #972917. (cw) (Entered: 01/10/2008) AFFIDAVIT signed by : William Vuk. in Support of Plaintiffs' Motion to Continue Pretrial Deadlines and Trial by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3# 4 Exhibit Exhibit 4)(Saikali, Alfred) (Entered: 01/15/2008) Plaintiff's MOTION to Continue Pretrial Deadlines and Trial and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 1/30/2008 (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 01/15/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Steven E. Feldman, Filing Fee $75, Receipt #973233. (cw) (Entered: 01/16/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for Alexis Gorton, Filing Fee $75, Receipt #973247. (cw) (Entered: 01/16/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Sherry L. Rollo, Filing Fee $75, Receipt #973233. (cw) (Entered: 01/16/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for William T. Vuk, Filing Fee $75, Receipt #973246. (cw) (Entered: 01/16/2008) ORDER granting 10 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Gerald J. Flattmann, Jr. Signed by Judge Federico A. Moreno on 1/17/2008. (lc1) (Entered: 01/17/2008) Plaintiffs' ANSWER to Counterclaim (Amended) of Apotex Inc. and

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Apotex Corp. by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC.(Saikali, Alfred) (Entered: 01/17/2008) 01/18/2008 19 ENDORSED ORDER granting 15 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. This is a paperless order. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ENDORSED ORDER granting 14 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. This is a paperless order. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ENDORSED ORDER granting 13 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. This is a paperless order. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ENDORSED ORDER granting 16 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ORDER granting 12 Motion to Continue and Revising Pretrial Deadlines. The trial is continued from May 27, 2008 to October 6, 2008. The calendar call is continued to Tuesday, September 30, 2008. Signed by Judge Federico A. Moreno on 1/22/2008. (lc1) (Entered: 01/22/2008) Set Deadlines/Hearings per Order at DE 23 : Discovery due by 8/6/2008. Pretrial Stipulation due by 9/23/2008. Calendar Call set for 9/30/2008 02:00 PM before Chief Judge Federico A. Moreno. Jury Trial set for 10/6/2008 09:00 AM before Chief Judge Federico A. Moreno. (bb) (Entered: 01/24/2008) 24 25 NOTICE /the parties have exchanged proposed mediators by SanofiAventis (tb) (Entered: 01/25/2008) MOTION for Protective Order and Incorporated Memorandum of Law by Apotex, Inc., Apotex Corp.. (Attachments: # 1 Text of Proposed Order)(Coberly, Jennifer) (Entered: 01/25/2008) MEMORANDUM in Opposition re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law filed by Apotex, Inc., Apotex Corp.. (Attachments: # 1 Exhibit # 2 Exhibit # 3 Exhibit # 4 Exhibit)(Coberly, Jennifer) (Entered: 01/28/2008) ORDER REFERRING MOTION to Magistrate Judge Andrea M. Simonton 25 MOTION for Protective Order and Incorporated Memorandum of Law filed by Apotex, Inc.,, Apotex Corp., Signed by Judge Federico A. Moreno on 1/31/2008.(lc1) (Entered: 01/31/2008) ORDER of Correction re 27 Order Referring Motion.Signed by Judge Federico A. Moreno on 1/31/2008.(lc1) (Entered: 01/31/2008)

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Defendant's MOTION for Extension of Time to File Joint Scheduling Report by Apotex, Inc., Apotex Corp.. (Attachments: # 1 Exhibit Apotex Scheduling Report)(Tache, Walter) (Entered: 01/31/2008) Plaintiff's MOTION for Leave to File Scheduling Report and Proposed Scheduling Order by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Text of Proposed Order 3)(Saikali, Alfred) (Entered: 02/01/2008) AFFIDAVIT signed by : Alexis Gorton. in Support of Plaintiffs' Emergency Motion to Stay Pending JPML Decision by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Exhibit 3# 4 Exhibit 4# 5 Exhibit 5# 6 Exhibit 6# 7 Exhibit 7# 8 Exhibit 8# 9 Exhibit 9# 10 Exhibit 10# 11 Exhibit 11# 12 Exhibit 12# 13 Exhibit 13)(Saikali, Alfred) (Entered: 02/07/2008) Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 2/22/2008 (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 02/07/2008) Plaintiff's MOTION for Hearing re 32 Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/07/2008) REPLY to Response to Motion re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/07/2008) AFFIDAVIT signed by : Alexis Gorton. re 34 Reply to Response to Motion, in Support of Motion to Transfer or Stay by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 20# 2 Exhibit 21# 3 Exhibit 22# 4 Exhibit 23)(Saikali, Alfred) (Entered: 02/07/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for John M. Desmarais, Filing Fee $75, Receipt #974606. (cw) (Entered: 02/11/2008) ORDER denying as moot 29 Motion for Extension of Time to File, denying as moot 30 Motion for Leave to File. Signed by Judge Federico A. Moreno on 02/08/2008. (lc1) (Entered: 02/08/2008) NOTICE of Instruction to Filer: re 32 Emergency MOTION to Stay re 31

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Affidavit, Pending JPML Decision and Supporting Memorandum of Law filed by Sanofi-Aventis, U.S. LLC, Sanofi-Aventis. Regarding Emergency Motions/Requests for Emergency Hearing. Pursuant to 5F in the Administrative Procedures, because the matters require the immediate attention of the Judge, the Original Emergency Motion and a Copy for the Judge must be filed in conventional paper format in the division where the Judge is chambered. This is for FUTURE reference only, it is not necessary to refile this document. (gp) (Entered: 02/08/2008) 02/11/2008 39 MEMORANDUM in Opposition re 25 MOTION for Protective Order and Incorporated Memorandum of Law filed by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/11/2008) AFFIDAVIT signed by : Alexis Gorton. re 39 Memorandum in Opposition, To Defendants' Motion for Protective Order by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3# 4 Exhibit Exhibit 4# 5 Exhibit Exhibit 5# 6 Exhibit Exhibit 6)(Saikali, Alfred) (Entered: 02/11/2008) RESPONSE in Opposition re 32 Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law filed by Apotex Corp., Apotex, Inc.. (Coberly, Jennifer) Modified on 2/14/2008 (ls). [Filers modified by Clerk] (Entered: 02/13/2008) ORDER granting 38 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. Signed by Judge Federico A. Moreno on 02/14/2008. (lc1) (Entered: 02/14/2008) REPLY to Response to Motion re 32 Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/14/2008) Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order)(Saikali, Alfred) (Entered: 02/14/2008) AFFIDAVIT signed by : William Vuk. re 44 Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Exhibit 3)(Saikali, Alfred) (Entered: 02/14/2008) Plaintiff's MOTION for Hearing re 44 Plaintiff's MOTION for Protective

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Order and Supporting Memorandum of Law by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/14/2008) 02/15/2008 47 REPLY to Response to Motion re 25 MOTION for Protective Order and Incorporated Memorandum of Law Plaintiffs' Opposition to Motion for Protective Order filed by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 02/15/2008) ORDER denying 32 Emergency Motion to Stay, denying 33 Motion for Hearing. Signed by Judge Federico A. Moreno on 02-18-2008. (lc1) (Entered: 02/19/2008) Corporate Disclosure Statement by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 02/19/2008) NOTICE of Attorney Appearance by Robert Burton Breisblatt on behalf of all defendants (Breisblatt, Robert) (Entered: 02/20/2008) ORDER granting Defendants' 25 Motion for Protective Order. Signed by Magistrate Judge Andrea M. Simonton on 2/20/08. (js) (Entered: 02/20/2008) Corporate Disclosure Statement by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/20/2008) AMENDED DOCUMENT by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Amendment to 52 Corporate Disclosure Statement/Certificate of Interested Parties. (Saikali, Alfred) (Entered: 02/21/2008) Plaintiff's MOTION to Compel Defendants to Comply with Court's 2/20/08 Order , and Incorporated Memorandum of Law, by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 3/11/2008 (Attachments: # 1 Text of Proposed Order Proposed Order) (Saikali, Alfred) (Entered: 02/26/2008) AFFIDAVIT signed by : William Vuk. re 54 Plaintiff's MOTION to Compel Defendants to Comply with Court's 2/20/08 Order , and Incorporated Memorandum of Law, by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3# 4 Exhibit Exhibit 4# 5 Exhibit Exhibit 5# 6 Exhibit Exhibit 6)(Saikali, Alfred) (Entered: 02/26/2008) Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 02/27/2008) AFFIDAVIT signed by : Alexis Gorton. re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law by

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Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1)(Saikali, Alfred) (Entered: 02/27/2008) 02/28/2008 58 Plaintiff's MOTION To Withdraw in Part Plaintiffs' Motion to Compel Defendants to Comply with the Court's 2/20/08 Order re 54 Plaintiff's MOTION to Compel Defendants to Comply with Court's 2/20/08 Order , and Incorporated Memorandum of Law, by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 02/28/2008) Notice of Supplemental Authority re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC (Attachments: # 1 Exhibit Exhibit 1)(Saikali, Alfred) (Entered: 02/28/2008) MEMORANDUM in Opposition re 44 Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law to Plaintiffs' Motion for Protective Order to Avoid Having to Respond to Outstanding Discovery filed by Apotex, Inc.. (Attachments: # 1 Exhibit A # 2Exhibit B)(Davidson, Matthew) Modified text on 3/3/2008 (tp). (Entered: 02/29/2008) TEXT ORDER denying as moot 54 Motion to Compel, granting 58 Motion to withdraw motion to compel and for extension of time file joint proposed protective order. On or before March 10, 2008, the parties shall file a proposed Protective Order in accordance with this Court's February 20, 2008 Order. This is a paperless Order.Signed by Magistrate Judge Andrea M. Simonton on 2/29/08. (AMS) (Entered: 02/29/2008) Courtesy Copy of MDL #1941 Reply Brief in Further Support of Plaintiff's Motion to Transfer and Consolidate for Pretrial Proceedings. (SDFL Case #07cv61800-FAM) (Attachments: #(1) Exhibits #1-#9 and Certificate of Service) (de) (Entered: 03/10/2008) RESPONSE to Motion re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law filed by Apotex, Inc., Apotex Corp.. Replies due by 3/14/2008. (Attachments: # 1 Exhibit A)(Coberly, Jennifer) (Entered: 03/07/2008) REPLY to Response to Motion re 44 Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 03/10/2008) AFFIDAVIT signed by : William Vuk. re 64 Reply to Response to Motion, by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 4# 2 Exhibit 5# 3 Exhibit 6)(Saikali, Alfred)

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(Entered: 03/10/2008) 03/10/2008 66 Joint MOTION for Extension of Time to File Protective Order by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 03/10/2008) AMENDED DOCUMENT by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC. Amendment to 66 Joint MOTION for Extension of Time to File Protective Order (Amended Proposed Order). (Saikali, Alfred) (Entered: 03/10/2008) NOTICE of Instruction to Filer: re 67 Amended Document, filed by Sanofi-Aventis, U.S. LLC, Sanofi-Aventis. Error: Proposed Order/Exhibit Docketed as Main Document; Instruction to Filer=Proposed Orders, unless otherwise directed by a Judge, shall be filed initially as an attachment to a motion, notice, or other filing. Please refer to the CM/ECF Administrative Procedures. This is for FUTURE reference only. It is not necessary to refile this document. (gp) (Entered: 03/11/2008) TEXT ORDER granting 66 Joint Motion for Enlargement of Time to File Proposed Protective Order. On or before March 12, 2008, the parties shall file a Proposed Protective Order in accordance with this Court's February 20, 2008 Order. This is a paperless Order. Signed by Magistrate Judge Andrea M. Simonton on 3/11/08. (js) (Entered: 03/11/2008) NOTICE of Compliance with Order GRanting Defendants' Motion for Entry of a Protective Order by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC re 51 Order on Motion for Protective Order (Attachments: # 1 Exhibit 1 (Protective Order))(Saikali, Alfred) (Entered: 03/12/2008) Statement of: Apotex Defendants' Position on Disputed Paragraph 12 of the Protective Order Pertaining to Materials Believed to be Covered by the EU Privacy Directive by Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp.. (Attachments: # 1 Exhibit A# 2 Exhibit B)(Breisblatt, Robert) (Entered: 03/13/2008) ORDER Regarding Protective Order. Signed by Magistrate Judge Andrea M. Simonton on 3/17/08.(js) (Entered: 03/17/2008) REPLY to Response to Motion re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 03/17/2008) AFFIDAVIT signed by : Alexis Gorton. re 73 Reply to Response to Motion, for Status Conference, by Sanofi-Aventis, Sanofi-Aventis, U.S.

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LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3)(Saikali, Alfred) (Entered: 03/17/2008) 03/20/2008 75 NOTICE of Compliance with Order Regarding Protective Order Dated March 17, 2008 by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC re 72 Order (Attachments: # 1 Text of Proposed Order Exhibit 1) (Saikali, Alfred) (Entered: 03/20/2008) PROTECTIVE ORDER signed by Magistrate Judge Andrea M. Simonton on 3/21/08.(js) (Entered: 03/21/2008) Courtesy Copy of MDL #1941 Notice of Related Action. (SDFL Case #07cv61800-FAM) (Attachments: # 1 Complaint, Civil Cover Sheet and Docket Sheet for District of Delaware) (de) (Entered: 03/24/2008) Defendant's MOTION to Compel Discovery Responses and Incorporated Memorandum of Law by Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp.. Responses due by 4/8/2008 (Attachments: # 1 Exhibit A)(Breisblatt, Robert) (Entered: 03/25/2008) NOTICE of Compliance by Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp. re 78 Defendant's MOTION to Compel Discovery Responses and Incorporated Memorandum of Law filed by Apotex, Inc.,, Apotex Corp., (Breisblatt, Robert) (Entered: 03/25/2008) MOTION to Withdraw as Attorney Stephen Bronis, Jennifer Coberly, Walter Tache and the Law Firm of Zuckerman Spaeder LLP by Apotex, Inc., Apotex Corp.. Responses due by 4/10/2008 (Attachments: # 1 Text of Proposed Order)(Coberly, Jennifer) (Entered: 03/27/2008) Notice of Pendency of Other Action by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC (Attachments: # 1 Exhibit 1)(Saikali, Alfred) (Entered: 03/27/2008) NOTICE of Attorney Appearance by Laurel White Marc-Charles on behalf of all defendants (Marc-Charles, Laurel) (Entered: 04/04/2008) ORDER granting 80 Motion to Withdraw as Attorney. Attorneys Walter J. Tache; Stephen Jay Bronis and Jennifer Rae Coberly terminated.Signed by Judge Federico A. Moreno on 04/07/2008. (lc1) (Entered: 04/07/2008) Case Reassignment of Paired Magistrate Judge pursuant to Administrative Order 2008-09 to Magistrate Judge Edwin G. Torres Judge Andrea M. Simonton no longer assigned to the case. (ra) (Entered: 04/08/2008) Attorney Jennifer Rae Coberly and Walter J. Tache terminated. Sent terminated attorney(s) instructions for tracking future case activity. (lk) (Entered: 04/09/2008)

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Unopposed MOTION for Extension of Time to File Opposition to Defendants' Motion to Compel Discovery Responses by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 04/10/2008) ORDER granting 85 Plaintiff's Unopposed Motion for Four-Day Enlargement of Time. Plaintiff shall file a response by no later than April 15, 2008. Signed by Judge Federico A. Moreno on 4/11/2008. (lc3) (Entered: 04/11/2008) ORDER STRIKING CASE FROM TRIAL CALENDAR. Signed by Judge Federico A. Moreno on 04/11/2008. (lc1) (Entered: 04/14/2008) Sealed Document. (vjk) (Entered: 04/16/2008) Sealed Document. (vjk) (Entered: 04/16/2008) Sealed Document. (vjk) (Entered: 04/16/2008) Unopposed MOTION to Continue Mediation Deadline by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 5/6/2008 (Attachments: # 1 Text of Proposed Order Proposed Order) (Saikali, Alfred) (Entered: 04/22/2008) Unopposed MOTION to Continue Mediation Deadline by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 5/6/2008 (Attachments: # 1 Text of Proposed Order)(Saikali, Alfred) (Entered: 04/22/2008) NOTICE of Striking Document From Court Docket, Docket Entry 91 and [91-2] by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC (Saikali, Alfred) Modified on 4/28/2008 (lk). (Entered: 04/23/2008) ORDER DENYING PLAINTIFFS' MOTION TO FILE UNDER SEAL. Signed by Judge Federico A. Moreno on 04/21/2008.(lc1) (Entered: 04/23/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for James P. White, Filing Fee $75, Receipt #979080. (cw) (Entered: 04/24/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Phillip D. Segrest, Jr., Filing Fee $75, Receipt #979079. (cw) (Entered: 04/24/2008) Plaintiff's MOTION for clarification 94 Order Denying Plaintiffs' Motion to File Under Seal by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 5/8/2008 (Saikali, Alfred) (Entered: 04/24/2008) NOTICE of Docket Correction and Instruction to Filer: re 93 Notice of

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Striking filed by Sanofi-Aventis, U.S. LLC,, Sanofi-Aventis, Error: NO Document Link; Correction=Document Relinked To DE 91 . Instruction to Filer=In the future please link the Document to the proper entry; (lk) (Entered: 04/28/2008) 04/28/2008 99 MOTION to Withdraw as Attorney and to Substitute New Lead Counsel. by Apotex, Inc., Apotex Corp.. Responses due by 5/12/2008 (Breisblatt, Robert) (Entered: 04/28/2008) ORDER RECONSIDERING ORDER DENYING EMERGENCY MOTION TO STAY, CLOSING CASE FOR STATISTICAL PURPOSES, AND PLACING MATTER IN CIVIL SUSPENSE FILE. Signed by Judge Federico A. Moreno on 04/28/2008.(lc1) (Entered: 04/29/2008) ORDER GRANTING MOTIONS FOR LIMITED APPEARANCE [96,97]. Signed by Judge Federico A. Moreno on 04/30/2008.(lc1) (Entered: 05/01/2008) ORDER GRANTING MOTION TO WITHDRAW AND TO SUBSTITUTE NEW LEAD COUNSEL. Signed by Judge Federico A. Moreno on 04/30/2008.(lc1) (Entered: 05/01/2008) Attorney Robert Burton Breisblatt terminated per 102 ; Sent terminated attorney instructions for tracking future case activity. (nm) (Entered: 05/02/2008) 103 NOTICE by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC re 100 Order Staying Case (Notice of JPML Decision) (Attachments: # 1 Exhibit A) (Saikali, Alfred) (Entered: 06/10/2008) FINAL TRANSFER ORDER and ORDER CLOSING CASE. Signed by Chief Judge Federico A. Moreno on 06/10/2008. (lc1) (Entered: 06/11/2008) TRANSFER ORDER (Dated 06/09/2008) from Judicial Panel on Multidistrict Litigation transferring case to the District of Delaware re: MDL # 1941 for consolidated pretrial proceedings pursuant to 28 USC 1407 and assigned to Judge Gregory M. Sleet. (Signed by John G. Heyburn, II, Chairman) (de) (Entered: 06/16/2008) TRANSFER ORDER (Dated 06/09/2008) from Judicial Panel on Multidistrict Litigation transferring case to the District of Delaware re: MDL # 1941 for consolidated pretrial proceedings pursuant to 28 USC 1407 and assigned to Judge Gregory M. Sleet. (Signed by John G. Heyburn, II, Chairman) (de) (Entered: 06/17/2008) Transmittal Letter Sent With Certified Docket Sheet, To: District of Delaware re MDL 1941. The District of Delaware will obtain remaining documents via PACER. (de) (Entered: 06/17/2008)

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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Case No. 07-61800-CIV-MORENO/SIMONTON SANOFI-AVENTIS and SANOFI-AVENTIS U.S. LLC, Plaintiffs, vs. APOTEX INC. and APOTEX CORP., Defendants. ______________________________/ ANSWER OF APOTEX INC. AND APOTEX CORP. TO COMPLAINT, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS Defendants, Apotex Inc. and Apotex Corp., Answer the Complaint of Plaintiffs, SanofiAventis and Sanofi-Aventis U.S. LLC (collectively "Sanofi") as follows:

Parties 1. Plaintiff sanofi-aventis is a corporation organized and existing under the laws of France, having its principal place of business at 174 avenue de France, Paris, France 75013. ANSWER: Apotex, Inc. and Apotex Corp. lack knowledge or information sufficient

to form a belief as to the truth or falsity of the averments in Paragraph 1 of the Complaint, and on that basis deny such averments. 2. Plaintiff sanofi-aventis U.S. is a limited liability company organized and

existing under the laws of Delaware with its North American headquarters located at 55 Corporate Drive, Bridgewater, New Jersey 08807.

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ANSWER:

Apotex, Inc. and Apotex Corp. lack knowledge or information sufficient

to form a belief as to the truth or falsity of the averments in Paragraph 2 of the Complaint, and on that basis deny such averments. 3. Upon information and belief, Defendant Apotex Inc. is a company organized and existing under the laws of Canada with a place of business at 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9. Upon information and belief, Apotex Inc. is a wholly owned subsidiary of Apotex Pharmaceutical Holdings Inc., which is in turn a wholly-owned subsidiary of Apotex Holdings Inc. Upon information and belief, Defendant Apotex Inc. manufacturers numerous generic drugs for sale and use throughout the United States, including in this judicial district. ANSWER: Apotex, Inc. and Apotex Corp. admit that Apotex, Inc. is a company

organized and existing under the laws of Canada with a place of business at 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9; that Apotex, Inc. is a wholly owned subsidiary of Apotex Pharmaceutical Holdings, Inc. and that Apotex, Inc. manufacturers numerous drugs that are sold and used in this judicial district. Apotex, Inc. and Apotex Corp. deny that Apotex Pharmaceutical Holdings, Inc. is a wholly-owned subsidiary of Apotex Holdings, Inc. Apotex, Inc. and Apotex Corp. lack knowledge or information sufficient to form a belief as to the truth or falsity of the remaining averments in Paragraph 3 with respect to whether its products are sold and used "throughout the United States", and on that basis deny such averments. 4. Upon information and belief, Defendant Apotex Corp. is a corporation organized and existing under the laws of Delaware with a place of business at 2400 North Commerce Parkway, Weston, Florida 33326. Upon information and belief, Apotex Corp. is a whollyowned subsidiary of Apotex Holdings Inc. ANSWER: Apotex, Inc. and Apotex Corp. admit that Apotex Corp. is a corporation

organized and existing under the laws of Delaware with a place of business at 2400 North Commerce Parkway, Weston, Florida 33326, but deny that Apotex Corp. is a wholly-owned subsidiary of Apotex Holdings Inc.

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Nature of the Action 5. This is a civil action for the infringement of United States Patent No. 4,661,491 ("the `491 patent") (Exhibit A). This action is based upon the Patent Laws of the United States, 35 U.S.C. § 1 et seq. ANSWER: Apotex, Inc. and Apotex Corp. admit that Plaintiffs' Complaint purports to

bring this action for the alleged infringement of United States Patent No. 4,661,491 ("the '491 patent") and that a copy of the '491 patent appears to be attached to the Complaint as Exhibit A. Apotex, Inc. and Apotex Corp. also admits that Plaintiffs purport to bring this action based on the Patent Laws of the United States, 35 U.S.C. §1 et seq.

Jurisdiction and Venue 6. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1338(a). ANSWER: Apotex, Inc. and Apotex Corp. admit that this Court has subject matter

jurisdiction over the subject matter of this action. 7. This Court has personal jurisdiction over each of the Defendants by virtue of the fact that, inter alia, each Defendant has committed, or aided, abetted, contributed to and/or participated in the commission of, the tortuous action of patent infringement that has led to foreseeable harm and injury to a company, Plaintiff Sanofi-Aventis U.S., which manufacturers numerous drugs for sale and use throughout the United States, including in this judicial district. This Court has personal jurisdiction over each of the Defendants for the additional reasons set forth below and for other reasons that will be presented to the Court if such jurisdiction is challenged. ANSWER: Apotex Corp. admits that this Court has personal jurisdiction over it in this

District for the purposes of this action. For purposes of this action, Apotex, Inc. does not contest the Court's personal jurisdiction over it. Apotex, Inc. and Apotex Corp. deny the averments against them to the extent they assert Apotex, Inc. and Apotex Corp. committed or aided, abetted, contributed to and/or participated in the commission of the referenced acts of patent infringement or that Plaintiff Sanofi-Aventis U.S. has been injured or otherwise harmed through

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any alleged tortious acts of Defendants. As to the remaining averments, Apotex, Inc. and Apotex Corp. lack knowledge or information sufficient to form a belief as to their truth or falsity and on that basis deny such averments. 8. This Court has personal jurisdiction over Defendant Apotex Inc. by virtue of, inter alia: (1) its presence in Florida through its sister corporation and agent Apotex Corp.; and (2) its systematic and continuous contacts with Florida, including through its sister corporation and agent Apotex Corp. ANSWER: For purposes of this action, Apotex, Inc. does not contest the Court's

jurisdiction over it, but denies the alleged basis for personal jurisdiction asserted in this paragraph, including that Apotex Corp. is Apotex, Inc.'s "sister corporation and agent." 9. This Court has personal jurisdiction over Apotex Corp. By virtue of the fact that, inter alia, Apotex Inc. is a Florida corporation. ANSWER: Apotex Corp. does not contest the Court's jurisdiction over it in this

action, but denies that Apotex Inc. is a Florida corporation. Apotex Corp. does have its principal place of business in Florida at 2400 North Commerce Parkway, Weston, Florida 33326. 10. Venue is proper in this judicial district as to each defendant pursuant to 28 U.S.C. §§ 1391 and 1400(b). ANSWER: district. Apotex, Inc. and Apotex Corp. admit that venue is proper in this judicial

The `491 Patent 11. On April 28, 1987, the `491 patent, titled "Alfuzosine Compositions and Use," was duly and legally issued by the United States Patent and Trademark Office ("PTO"). Plaintiff sanofi-aventis is the current assignee of the `491 patent. Plaintiff sanofi-aventis U.S. holds New Drug Application ("NDA") No. 21-287 on Uroxatral® brand alfuzosin hydrochloride extended release tablets, and is the exclusive distributor of Uroxatral® in the United States. The `491 patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations ("the Orange Book") for Uroxatral®.

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ANSWER:

Apotex, Inc. and Apotex Corp. admit that the '491 patent issued on April

28, 1987, but deny that this patent was duly and legally issued. Apotex, Inc. and Apotex Corp. admit that this patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations ("the Orange Book") for Uroxatral® and that Sanofi-Aventis U.S. is listed as the Applicant for NDA No. 21-287. Apotex, Inc. and Apotex Corp. are without sufficient knowledge or information to form a belief as to the truth or falsity of the remaining averments of Paragraph 11 of the Complaint, and on that basis deny such averments.

Acts Giving Rise to this Action Infringement of the `491 Patent by Defendants 12. Upon information and belief, Apotex Inc. submitted Abbreviated New Drug Application ("ANDA") 79-013 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)). That ANDA seeks FDA approval for the commercial manufacture, use, offer for sale and sale of generic extended release tablets containing 10 mg of alfuzosin hydrochloride per tablet. ANDA 79-013 specifically seeks FDA approval to market a proposed generic version of sanofi-aventis' Uroxatral® brand alfuzosin hydrochloride 10 mg tablet product prior to the expiration of the `491 patent. ANSWER: Apotex, Inc. and Apotex Corp. admit that Apotex, Inc. filed its ANDA No.

79-013 with the FDA seeking approval for generic Alfuzosin Hydrochloride Extended-release Tablets in 10mg strength. Defendants admit that Apotex, Inc. seeks FDA approval to market the proposed product identified in its ANDA prior to the expiration of the '491 patent. The remaining averments of this paragraph are denied. 13. Apotex Inc. alleged in ANDA 79-013 under § 505(j) (2) (A) (vii) (IV) of the Federal Food, Drug and Cosmetic Act that the claims of the `491 patent are invalid. Plaintiffs received written notification of the § 505(j) (2) (A) (vii) (IV) allegation related to the `491 patent in ANDA 79-013 on or about October 25, 2007. ANSWER: Apotex, Inc. and Apotex Corp. admit that Apotex, Inc. provided Plaintiffs

with notice of its ANDA No. 79-013, that such notice satisfied all statutory and regulatory

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requirements and that Plaintiffs received notice on or about October 25, 2007. The remaining averments of this paragraph are denied. 14. Apotex Inc.'s submission of ANDA 79-013 to the FDA, including the § 505(j) (2) (A) (vii) (IV) allegations, constitutes infringement of the `491 patent under 35 U.S.C. § 271(e) (2) (A). Apotex Inc.'s commercial use, offer for sale or sale of its proposed generic version of sanofi-aventis' Uroxatral® brand product would infringe the `491 patent. ANSWER: Complaint. Apotex, Inc. and Apotex Corp. deny the averments in Paragraph 14 of the

15. Apotex Corp. is jointly and severally liable for Apotex Inc.'s infringement of the `491 patent. Upon information and belief, Apotex Corp. participated in, contributed to, aided, abetted and/or induced Apotex Inc.'s submission of ANDA 79-013 and its § 505(j)(2)(A)(vii)(IV) allegation to the FDA. ANSWER: Complaint. Apotex, Inc. and Apotex Corp. deny the averments in Paragraph 15 of the

16. Apotex Corp.'s participation in, contribution to, aiding, abetting and/or inducement of the submission of ANDA 79-013 and its § 505(j) (2) (A) (vii) (IV) allegations to the FDA constitutes infringement of the `491 patent under 35 U.S.C. § 271(e) (2) (A). Moreover, Apotex Corp.'s commercial use, offer for sale or sale of its proposed generic version of sanofi-aventis' Uroxatral® brand product would infringe the `491 patent. ANSWER: Complaint. Apotex, Inc. and Apotex Corp. deny the averments in Paragraph 16 of the

17. This is an exceptional case under 35 U.S.C. § 285 because Defendants were aware of the existence of the `491 patent at the time of the submission of ANDA 79-013 and their § 505(j) (2) (A) (vii) (IV) allegations to the FDA and that filing constituted infringement of the `491 patent. ANSWER: Apotex, Inc. and Apotex Corp. deny the averments in Paragraph 17 of the

Complaint. Further, this allegation has no basis in fact or law and unless it is withdrawn, Defendants will seek sanctions under Rule 11 of the Federal Rules of Civil Procedure.

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18. Plaintiffs will be irreparably harmed by Defendants' infringing activities unless those activities are enjoined by this court. Plaintiffs do not have an adequate remedy at law. ANSWER: Complaint. Apotex, Inc. and Apotex Corp. deny the averments in Paragraph 18 of the

19. Plaintiffs have sought to enjoin Defendant Apotex Inc.'s and Defendant Apotex Corp.'s infringing activities in an action filed by Plaintiffs in the District of Delaware on December 7, 2007 Civil action No. 07-792 and will seek to have that action coordinated or consolidated with an action brought to enjoin acts of infringement of the `491 patent by numerous defendants filed by Plaintiffs in the District of Delaware on September 21, 2007, Civil Action No. 07-572 GMS (MPT). Defendant Apotex Inc. and Defendant Apotex Corp. are properly subject to personal jurisdiction in the District of Delaware and judicial economy would be promoted by all of Plaintiffs' claims for infringement of the `491 patent being addressed in the District of Delaware. Upon information and belief, Plaintiffs understand that Defendants may nevertheless contest jurisdiction in that venue. Given the possible consequences if Defendants succeeded with such unjustified action, Plaintiffs had no choice but to file this Complaint. In the event that Defendants are unsuccessful in any such challenge, Plaintiffs will dismiss this action. ANSWER: Apotex, Inc. and Apotex Corp. admit that Plaintiffs filed an action against

them in the District of Delaware. Apotex, Inc. and Apotex Corp. are without sufficient knowledge or information to form a belief as to the truth or falsity of the averments concerning Plaintiffs' intentions, knowledge or beliefs, and on that basis deny such averments. Apotex, Inc. and Apotex Corp. deny that Apotex, Inc. is subject to personal jurisdiction in the Delaware action and deny that judicial economy would be promoted by proceeding with the Delaware action as opposed to this action. GENERAL DENIAL Any allegation in Plaintiffs' Complaint not expressly admitted by Defendants are hereby denied. Having answered Plaintiffs' Complaint, Defendants deny that Plaintiffs are entitled to the relief requested in Plaintiffs' Prayer for Relief or any relief whatsoever.

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AFFIRMATIVE DEFENSES Without prejudice to the denials set forth in its Answer to the Complaint, and without admitting any allegations of the Complaint not otherwise admitted, Defendants assert the following affirmative defenses to the Complaint: FIRST AFFIRMATIVE DEFENSE The manufacture, use, sale, offer for sale or importation into the United States of the product that is the subject of Apotex Inc.'s ANDA No. 79-013 has not infringed, does not infringe, and would not, if marketed, infringe one or more of the claims of the '491 patent, either literally or under the doctrine of equivalents. SECOND AFFIRMATIVE DEFENSE The claims of the '491 patent are invalid for failure to satisfy one or more of the conditions for patentability contained in 35 U.S.C. §§ 101, 102, 103 and/or 112. THIRD AFFIRMATIVE DEFENSE Plaintiffs have failed to state a claim on which relief can be granted. Defendants reserve their right to assert any and all additional defenses and counterclaims that discovery may reveal.

COUNTERCLAIMS Apotex Inc. and Apotex Corp., (collectively "counterplaintiffs") for their Counterclaims against Sanofi-Aventis ("Sanofi-Aventis") and Sanofi-Aventis U.S. LLC ("Sanofi-Aventis U.S.") (the counter-defendants will be referred to herein collectively as "Sanofi"), allege as follows:

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The Parties 1. Apotex Inc. is a Canadian corporation having a place of business at 150 Signet Drive,

Ontario, Canada M9L 1 T9. 2. Apotex Corp. is a Delaware corporation having a place of business at 2400 North

Commerce Parkway, Suite 400, Weston Florida 33326. 3. Sanofi-Aventis U.S. has alleged that it is a limited liability company organized and

existing under the laws of Delaware with its North American headquarters located at 55 Corporate Drive, Bridgewater, New Jersey 08807. 4. Sanofi-Aventis has alleged that it is a corporation organized and existing under the

laws of France, having its principal place of business at 174 avenue de France, Paris, France 75013. Jurisdiction and Venue 5. These counterclaims arise under the Patent Laws of the United States, 35 U.S.C. §

100 et seq., the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq., as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355) (hereinafter "Hatch-Waxman Amendments"), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub.L. No. 108-173, 117 Stat. 2066 (2003) (hereinafter "MMA"). 6. The Court has original jurisdiction over the subject matter of these counterclaims

pursuant to 28 U.S.C. §§ 1331 and 1338 (a). 7. The Court has personal jurisdiction over Sanofi because Sanofi has availed

themselves to the rights and privileges of this forum by suing counterplaintiffs in this District

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and because Apotex Corp. conducts substantial business in and has regular systematic contacts with this District. 8. Venue is proper in this District under 28 U.S.C. §§ 1391(b), (c) and 1400 (b). Patents-in-Suit 9. On or about April 28, 1987, the United States Patent and Trademark Office ("PTO")

issued U.S. Patent No. 4,661,491 ("the '491 patent"), entitled "AFLUZOSINE COMPOSITIONS AND USE" to Francois Regnier. 10. 11. Sanofi-Aventis purports to own and to have the right to enforce the '491 patent. On or about November 21, 2000, the PTO issued U.S. Patent No. 6,149,940 ("the

'940 patent") entitled "TABLET WITH CONTROLLED RELEASE OF AFLUZOSINE CHLORHYDRATE" to Lauretta Maggi, Ubaldo Conte, Busto Arisizio, Pascal Grenier, Guy Vergnault, Alain Dufour, Francois Xavier Jarreau and Clemence Rauch-Desanti. 12. Sanofi-Aventis purports to own an interest in'940 patent and on information and

belief has an exclusive license and the right to unilaterally bring and proceed with lawsuits to enforce the '940 patent in its own name. 13. Sanofi-Aventis U.S. is identified as the owner of New Drug Application No. 21-287

on Uroxatral brand alfuzosin hydrochloride extended release tablets. The '491 patent and the '940 patent are listed in the Orange Book for Uroxatral. 14. Sanofi has attempted to enforce the '940 patent against multiple other ANDA filers

seeking FDA approval for alfuzosin hydrochloride extended release tablets. 15. Apotex has submitted an abbreviated new drug application (ANDA) No. 70-013 to

the FDA. Apotex Inc.'s ANDA seeks FDA approval for the commercial use, offer for sale and sale of generic extended release tablets containing 10 mg of alfuzosin hydrochloride per tablet.

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16.

Pursuant to 21 U.S.C. § 355(j) (2) (B) (ii) and 21 C.F.R. § 314.95, Apotex has

certified to Sanofi that the '491 patent and the '940 patent are invalid, unenforceable, and/or will not be infringed by the manufacture, use of sale of the new drug for which ANDA 70-013 is submitted. 17. On or about August 14, 2007, Apotex, Inc. served Sanofi with a Paragraph IV

certification letter informing Sanofi of its ANDA to obtain approval to engage in the commercial manufacture, use or sale of its alfuzosin hydrochloride extended release tablets before the expiration of the '940 patent. 18. On or about October 15, 2007, Apotex, Inc. served Sanofi with a Paragraph IV

certification letter informing Sanofi of its ANDA to obtain approval to engage in the commercial manufacture, use or sale of its alfuzosin hydrochloride extended release tablets before the expiration of the '491 patent. 19. On or about December 10, 2007, Sanofi sued Apotex Inc and Apotex Corp in this

District alleging infringement of the '491 patent under 35 U.S.C. § 271 (e)(2)(A). 20. Counterplaintiffs have a reasonable apprehension of being sued by Sanofi for alleged

infringement of the '940 patent because, inter alia, Apotex, Inc. has served Sanofi with its Paragraph IV certification letter asserting that the'940 patent was not infringed, Sanofi has sued more than ten other ANDA holders seeking to market alfuzosin hydrochloride extended release tablets for alleged infringement of the '940 patent, and Sanofi already has sued counterplaintiffs for infringement of the '491 patent in this court. 21. As a result of Sanofi's actions in listing of the '491 and '940 patents in the Orange

Book and in suing counterplaintiffs for infringement of the '491 patent, counterplaintiffs are presently prevented from selling alfuzosin hydrochloride extended release tablets and are being

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injured as a result. Counterplaintiffs seek patent certainty with respect to the '491 and '940 patents and certainty regarding the legal rights relating to Apotex, Inc.'s ANDA through a judicial declaration that the '491 and '940 patents are not infringed by the alfuzosin hydrochloride extended release tablets identified in Apotex, Inc.'s ANDA, or that the patents are invalid. 22. A real, actual, and justiciable controversy exists between counterplaintiffs and Sanofi

regarding the invalidity of the '491 and '940 patents and counterplaintiffs' non-infringement thereof, constituting a case of actual controversy within the jurisdiction of this Court under the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202. COUNT I (Declaration of Non-Infringement of the '491 Patent) 23. 1-22. 24. The manufacture, use, sale, offer for sale or importation into the United States of the Counterplaintiffs reallege and incorporate by reference the allegations of Paragraphs

alfuzosin hydrochloride extended release tablets, 10 mg, that are the subject of Apotex Inc.'s ANDA No. 79-013 have not infringed, do not infringe, and would not, if marketed, infringe any valid or enforceable claim of the '491 patent. 25. Counterplaintiffs are entitled to a declaration that the manufacture, use, sale, offer for

sale or importation into the United States of the alfuzosin hydrochloride extended release tablets, 10 mg, that are the subject of Apotex Inc.'s ANDA No. 79-013 have not infringed, do not infringe, and would not, if marketed, infringe any valid or enforceable claim of the '491 patent.

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COUNT II (Declaration of Invalidity of the '491 Patent) 26. 1-25. 27. The claims of the '491 patent are invalid under one or more provisions of 35 U.S.C. Counterplaintiffs reallege and incorporate by reference the allegations of Paragraphs

§§ 101, 102, 103 and/or 112. 28. inval