Free Opening Brief in Support - District Court of Delaware - Delaware

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 1 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 2 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 3 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 4 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 5 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 6 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 7 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 8 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 9 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 10 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 11 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 12 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 13 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 14 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 15 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 16 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 17 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 18 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 19 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 20 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 21 of 22

Case 1:07-cv-00821-JJF

Document 25

Filed 07/09/2008

Page 22 of 22

Case 1:07-cv-00821-JJF

Document 25-2

Filed 07/09/2008

Page 1 of 11

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 2 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 1 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

GREGORY G. KATSAS Acting Assistant Attorney General C. FREDERICK BECKNER III Deputy Assistant Attorney General EUGENE M. THIROLF, Director ANDREW E. CLARK Senior Trial Counsel Office of Consumer Litigation U.S. Department of Justice P.O. Box 386 Washington, D.C. 20044 (202) 307-0067 [email protected] THOMAS P. O'BRIEN United States Attorney LEON W. WEIDMAN Assistant United States Attorney Chief, Civil Division KATHERINE M. HIKIDA Assistant United States Attorney Cal. Bar No. 153268 Room 7516, Federal Building 300 North Los Angeles Street Los Angeles, California 90012 Telephone: (213) 894-2285 Facsimile: (213) 894-7819 [email protected] Attorneys for Federal Defendants MICHAEL O. LEAVITT, Secretary of U.S. Department of Health and Human Services; ANDREW C. VON ESCHENBACH, M.D., Commissioner of the Food and Drug Administration UNITED STATES DISTRICT COURT

18

FOR THE CENTRAL DISTRICT OF CALIFORNIA
19

SOUTHERN DIVISION
20 21 INTERNATIONAL, 22 23 24 25 26 27 28

) ) ) ) Plaintiff, ) ) v. ) ) MICHAEL O. LEAVITT, in his official ) capacity as Secretary of the U.S. Department of Health and Human Services, ) and ANDREW C. VON ESCHENBACH, ) ) M.D., in his official capacity as ) Commissioner of the Food and Drug ) Administration, ) ) Defendants. ) VALEANT PHARMACEUTICALS

NO. SA CV 08-00449-AG DEFENDANTS' EX PARTE APPLICATION TO STAY PROCEEDINGS AND REFER MATTER TO AGENCY; DECLARATION IN SUPPORT THEREOF No Hearing Scheduled Before the Honorable Andrew J. Guilford

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 3 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 2 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Federal Defendants hereby apply for an Order referring this matter back to the Food and Drug Administration ("FDA") and holding judicial review in abeyance pending FDA's administrative reconsideration of this matter. As set forth more fully in the accompanying memorandum of points and authorities and declaration, FDA has initiated administrative reconsideration of Spear's abbreviated new drug application ("ANDA") for 5% fluorouracil ("5-FU") cream pursuant to 21 C.F.R. § 10.33(a) & (h). Concomitantly therewith, IntervenorDefendant Spear Pharmaceuticals, Inc. ("Spear") has agreed to the entry of an administrative stay of its ANDA approval under 21 C.F.R. § 10.35(a). See Clark Declaration Exhibit A (Administrative Reconsideration and Stay of Action); Exhibit B (Letter from Steven Lieberman, May 14, 2008). FDA hopes to conclude its administrative reconsideration by May 30, 2008. In the interim, consistent with agency regulations, FDA requests that the Court refer the matter back to the agency and hold judicial review of the challenged agency action in abeyance pending the completion of FDA's administrative reconsideration process. See 21 C.F.R. § 10.33(h). Because Spear's ANDA approval is stayed through May 30, 2008, and Spear may not sell, market, or ship its product during that period, Plaintiff Valeant Pharmaceuticals International ("Valeant") will suffer no harm during the pendency of FDA's administrative reconsideration. On May 14, 2008, defendants' counsel contacted counsel for Valeant and Spear concerning this application. Spear's counsel indicated that Spear did not oppose the application. Valeant's counsel indicated that Valeant would oppose the application. Clark Declaration ¶ 4.

Pursuant to Local Rule 7-19, Federal Defendants set forth below the identity of Valeant's counsel as follows:
1

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 4 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 3 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Richard de Bodo J. Drew Diamond David G. Chang HOGAN & HARTSON LLP 1999 Avenue of the Stars, Suite 1400 Los Angeles, California 90067 Telephone: (310) 785-4600 Facsimile: (310) 785-4601 Pursuant to Local Rule 7-19, Federal Defendants set forth below the identity of Spear's counsel as follows: Gail J. Standish Peter E. Perkowski WINSTON & STRAWN LLP 333 South Grand Avenue, 38th Floor Los Angeles, California 90071-1543 Telephone: (213) 615-1700 Facsimile: (213) 615-1750 Steven Lieberman Minaksi Bhatt Lisa N. Phillips ROTHWELL FIGG ERNST & MANBECK 1425 K Street, N.W. Washington, D.C. 20005 Telephone: (202) 783-6040 Facsimile: (202) 783-6031 DATED: May 14, 2008 GREGORY G. KATSAS Acting Assistant Attorney General C. FREDERICK BECKNER III Deputy Assistant Attorney General EUGENE M. THIROLF
2

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 5 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 4 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Director ANDREW E. CLARK Senior Trial Counsel Office of Consumer Litigation U.S. Department of Justice THOMAS P. O'BRIEN United States Attorney LEON W. WEIDMAN Assistant United States Attorney Chief, Civil Division __________/s/___________________ KATHERINE M. HIKIDA Assistant United States Attorney Attorneys for Federal Defendants Of Counsel: THOMAS R. BARKER Acting General Counsel GERALD F. MASOUDI Associate General Counsel Food and Drug Division ERIC M. BLUMBERG Deputy Chief Counsel, Litigation WENDY S. VICENTE JAMES JOHNSON Associate Chief Counsel, Litigation U.S. Dept. of Health & Human Services Office of the General Counsel

3

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 6 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 5 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

MEMORANDUM OF POINTS AND AUTHORITIES On April 25, 2008, Valeant filed an Application for a Temporary Restraining Order ("TRO"), seeking an order suspending FDA's approval of Spear's ANDA for its 5% fluorouracil ("5-FU") cream. On May 1, 2008, this Court granted a stay of the TRO proceedings until May 14, 2008, based on FDA's identification of an issue in the administrative record that required agency review and consideration, and Spear's commitment to the Court to suspend marketing, sales and shipment activities for the duration of the stay. As of this date, however, FDA has not yet reached a final determination concerning the previously identified administrative record issue. Moreover, in the course of its review, FDA identified an additional issue concerning Spear's ANDA which, in the agency's judgment, necessitates administrative reconsideration of the ANDA approval.1 Accordingly, on May 14, 2008, FDA initiated administrative reconsideration of Spear's ANDA pursuant to 21 C.F.R. § 10.33(a) & (h). Concomitantly therewith, Spear has agreed to the entry of an administrative stay of its ANDA approval under 21 C.F.R. § 10.35(a), as well as the suspension of all sales, marketing, and shipping of its Fluorouracil product. See Clark Declaration Exhibit A (Administrative Reconsideration and Stay of Action); Exhibit B (Letter from Steven Lieberman, May 14, 2008). FDA hopes to conclude its administrative reconsideration by May 30, 2008, and anticipates that it will be prepared on that date to inform the Court about its decision regarding the administrative reconsideration. In the interim, consistent with agency regulations, FDA requests that the Court refer the matter back to the agency and hold its review in abeyance pending the completion of FDA's administrative reconsideration process. See 21

Although this issue concerns whether FDA required the submission of all necessary and appropriate scientific information in support of approval of Spear's 28 ANDA, it is unrelated to the issues raised by Valeant in its TRO motion.
27 4

1

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 7 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 6 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

C.F.R. § 10.33(h).2 FDA will inform the Court and the parties if it concludes its administrative reconsideration sooner than May 30, 2008, and determines that the stay should be dissolved before that date. Valeant will suffer no harm during the pendency of FDA's reconsideration. Indeed, Valeant has represented to this Court that "[t]he only way for the FDA to moot Valeant's TRO application would be to suspend or stay approval of Spear's ANDA application pursuant to 21 C.F.R. § 10.35(a)." Valeant's Opp. to Stay at 5 (filed May 1, 2008). Because FDA has now stayed approval of Spear's ANDA 77524 through May 30. 2008, and prohibited all marketing, sales and shipment of product during the pendency of the administrative stay, Valeant's TRO motion has been mooted until that date. Furthermore, because FDA's reconsideration could affect the approval status of Spear's ANDA, it is in the best interest of the parties and consistent with principles of judicial economy to stay any further litigation until that date. Accordingly, pursuant to 21 C.F.R. § 10.33(h), FDA respectfully requests that the Court refer this matter back to FDA and/or hold all proceedings in this case in abeyance until the conclusion of FDA's administrative reconsideration. FDA counsel has consulted with counsel for Valeant and Spear concerning this application. Spear's counsel stated that Spear does not oppose the application. Valeant's counsel stated that Valeant would oppose the application. Clark Declaration ¶ 4.

21 C.F.R. § 10.33(h) provides: "The Commissioner may initiate the reconsideration of all or part of a matter at any time after it has been decided or action 26 has been taken. If review of the matter is pending in the courts, the Commissioner may request that the court refer the matter back to the agency or hold its review in abeyance 27 pending administrative reconsideration. The administrative record of the proceeding is 28 to include all additional documents relating to such reconsideration."
25 5

2

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 8 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 7 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

For the foregoing reasons, Federal Defendants respectfully request that the Court grant this application. DATED: May 14, 2008 GREGORY G. KATSAS Acting Assistant Attorney General C. FREDERICK BECKNER III Deputy Assistant Attorney General EUGENE M. THIROLF Director ANDREW E. CLARK Senior Trial Counsel Office of Consumer Litigation U.S. Department of Justice THOMAS P. O'BRIEN United States Attorney LEON W. WEIDMAN Assistant United States Attorney Chief, Civil Division ______/s/_________________________ KATHERINE M. HIKIDA Assistant United States Attorney Attorneys for Federal Defendants Of Counsel: THOMAS R. BARKER Acting General Counsel GERALD F. MASOUDI Associate General Counsel Food and Drug Division ERIC M. BLUMBERG Deputy Chief Counsel, Litigation WENDY S. VICENTE JAMES JOHNSON Associate Chief Counsel, Litigation U.S. Dept. of Health & Human Services Office of the General Counsel

6

Case 8:08-cv-00449-AG-AGR Document 58 Filed 07/09/2008 Page 9 of of 8 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 8 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

DECLARATION OF ANDREW E. CLARK I, Andrew E. Clark, under penalty of perjury do represent the following: 1. I am Senior Trial Counsel in the Office of Consumer Litigation in the United States Department of Justice, 450 5th St., N.W., Washington, D.C. 20001. I am one of the attorneys assigned to represent the federal defendants in the abovecaptioned case. 2. I am informed that, on May 14, 2008, FDA initiated administrative reconsideration of, and stayed approval of, Spear Pharmaceuticals Inc.'s (Spear) Abbreviated New Drug Application (ANDA) 77-524 for 5-fluorouracil. See Exhibit A annexed hereto (Administrative Reconsideration and Stay of Action). 3. I am also informed that Spear has agreed to the above-referenced administrative stay and has committed that it will not market, sell or ship its fluorouracil product until the earlier of noon (EDT) on May 30, 2008, or dissolution of the administrative stay. See Exhibit B annexed hereto (Letter from Steven Lieberman, May 14, 2008). 4. As set forth in our Ex Parte Application, I telephoned counsel for Valeant and Spear on May 14, 2008, to advise them of this application and seek their position thereon. Spear's counsel indicated that Spear did not oppose the application. Valeant's counsel subsequently spoke with Eugene Thirolf of this Office and indicated that Valeant would oppose the application. 5. I declare under penalty of perjury that the statements are true and correct. Dated this 14th day of May, 2008, in Washington, D.C. ______/s/________________ Andrew E. Clark Senior Trial Counsel Office of Consumer Litigation United States Department of Justice

7

Case 8:08-cv-00449-AG-AGR Document 58-2Filed 07/09/2008 Page 10 of 11 2 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 1 of

Case 8:08-cv-00449-AG-AGR Document 58-2Filed 07/09/2008 Page 11 of 11 2 Case 1:07-cv-00821-JJF Document 25-2 Filed 05/14/2008 Page 2 of

Case 1:07-cv-00821-JJF

Document 25-3

Filed 07/09/2008

Page 1 of 2

Case 1:07-cv-00821-JJF

Document 25-3

Filed 07/09/2008

Page 2 of 2

Case 1:07-cv-00821-JJF

Document 25-4

Filed 07/09/2008

Page 1 of 2

Case 1:07-cv-00821-JJF

Document 25-4

Filed 07/09/2008

Page 2 of 2