Astrazeneca Pharmaceuticals LP v. Burwell et al

MEMORANDUM re Scheduling Order

D.D.C.July 11, 2016

1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ) ASTRAZENECA PHARMACEUTICALS LP, et al. ) ) Plaintiffs, ) ) v. ) Civil Action No. 16-cv-01336-RDM ) SYLVIA MATHEWS BURWELL, et al. ) ) Defendants. ) ) INTERVENOR-DEFENDANTS’ COMMENTS REGARDING PLAINTIFFS’ PROPOSED PROTECTIVE ORDER Intervenor-Defendants 1 write in response to the Court’s Memorandum and Order, dated July 11, 2016, ordering that “[t]o the extent that FDA or the intervenors have any comments on the proposed protective order submitted by AstraZeneca, see Dkt. 50, they shall file their comments with the Court by 2 p.m. on July 11, 2016.” Dkt. 52, p. 10. Intervenor-Defendants comment as follows: 1. Intervenor-Defendants propose that the Court remove Paragraph 2(e) of Dkt. 50, which permits disclosure of confidential information to “[a]ny witness at a hearing or other proceeding to whom disclosure is deemed reasonably necessary by counsel for the prosecution or defense of this action.” As drafted, this provision leaves it to the discretion of the parties’ counsel to disclose any document “deemed reasonably necessary” to a witness. This exception swallows the rule and does not adequately safeguard Intervenor-Defendants’ confidential information. Removal of this paragraph is particularly relevant here, where AstraZeneca has provided a declaration from Rod Wooten, its Vice President, Global Product Strategy. Should 1 Intervenors are Apotex Corp. and Apotex Inc. (“Apotex”); Par Pharmaceutical, Inc. (“Par”); Glenmark Pharmaceuticals Inc., USA and Glenmark Pharmaceuticals Ltd. (“Glenmark”); Sandoz Inc. (“Sandoz”); and Sun Pharma Global FZE and Sun Pharmaceuticals Industries Inc. (“Sun”). Case 1:16-cv-01336-RDM Document 55 Filed 07/11/16 Page 1 of 6 2 AstraZeneca offer live testimony from Mr. Wooten, he would be given unfettered access to the highly confidential labeling from the Intervenor-Defendants, subject to the sole discretion of AstraZeneca’s counsel. Intervenor-Defendants suggest that if an evidentiary hearing that requires testimony from witnesses becomes necessary, the parties negotiate a procedure for disclosure of confidential documents to witnesses at such time pursuant to Paragraph 2(f) of the proposed Protective Order (Dkt. 50). 2. In order to protect any and all confidential information in the administrative record as opposed to draft labeling specifically, Intervenor-Defendants suggest that the confidentiality markings be adjusted to read “HIGHLY CONFIDENTIAL – ATTORNEY’S EYES ONLY” rather than making them specific to labeling. Further, if the Court enters a protective order with scope that extends beyond labeling, Intervenor-Defendants suggest the following definition for confidential information: “For purposes of this Protective Order, ‘HIGHLY CONFIDENTIAL INFORMATION’ includes any document, correspondence, or other material, and includes all documents, correspondence, and materials of the type FDA customarily maintains in confidence pursuant to any statute, regulation, or agency practice, including but not limited to 21 U.S.C. § 331(j), 18 U.S.C. § 1905, 21 C.F.R. § 314.430, 21 C.F.R. § 20.61(a), or 21 C.F.R. § 20.61(b). Any such confidential information shall be marked as ‘HIGHLY CONFIDENTIAL – ATTORNEY’S EYES ONLY.’” 3. Intervenor-Defendants suggest adding a provision clarifying that confidential information be used solely for the action and be destroyed following termination of the action and suggest the following language: “Information designated as HIGHLY CONFIDENTIAL – ATTORNEY’S EYES ONLY shall be used solely for purposes of this Action and not for any other purposes, such as for patent applications, FDA submissions, or other litigation. A Party in Case 1:16-cv-01336-RDM Document 55 Filed 07/11/16 Page 2 of 6 3 possession of any information that has been designated HIGHLY CONFIDENTIAL – ATTORNEY’S EYES ONLY must destroy that information after termination of this Action, including all appeals, and the Parties will confirm in writing that such destruction of HIGHLY CONFIDENTIAL – ATTORNEY’S EYES ONLY information has occurred. Notwithstanding the foregoing, however, outside counsel of record for each Party shall be permitted to keep copies of any briefs opinions, declarations, orders, the administrative record, and/or any other filings containing information designated as HIGHLY CONFIDENTIAL – ATTORNEY’S EYES ONLY even following termination of this Action, including any appeals.” Dated: July 11, 2016 /s/ Lyle B. Vander Schaaf____ Lyle B. Vander Schaaf (D.C. Bar No. 422380) BRINKS GILSON & LIONE 1775 Pennsylvania Avenue, NW, Suite 900 Washington, DC 20006 Tel: (202) 296-8700 Fax: (202) 296-8701 lvanderschaaf@brinksgilson.com Of Counsel: Mark H. Remus (pro hac vice) Laura A. Lydigsen (pro hac vice) Brinks, Gilson & Lione 455 N. Cityfront Plaza Drive, Suite 3600 Chicago, IL 60611 Tel: (312) 321-4200 Fax: (312) 321-34299 Email: mremus@brinksgilson.com Email: llydigsen@brinksgilson.com Attorneys for Intervenor-Defendants, Glenmark Pharmaceuticals Inc., USA and Glenmark Pharmaceuticals Ltd. /s/ Chad A. Landmon Chad A. Landmon (D.C. Bar No. 990347) Aziz Burgy (D.C. Bar No. 483517) AXINN, VELTROP & HARKRIDER LLP Case 1:16-cv-01336-RDM Document 55 Filed 07/11/16 Page 3 of 6 4 950 F Street, N.W. Washington, D.C. 20004 (202) 912-4700 (telephone) (202) 912-4701 (facsimile) David Silverstein (pro hac vice) Suchira Ghosh (pro hac vice) AXINN, VELTROP & HARKRIDER LLP 114 West 47th Street 22nd Floor New York, NY 10036 (212) 728-2200 (telephone) (212) 728-2201 (facsimile) Attorneys for Par Pharmaceutical, Inc., Apotex Inc. and Apotex Corp. /s/ Douglas B. Farquhar Douglas B. Farquhar (D.C. Bar No. 386573) John R. Fleder (D.C. Bar No. 176123) Kurt R. Karst (D.C. Bar No. 482615) HYMAN, PHELPS & MCNAMARA, P.C. 700 13th Street, N.W., Suite 1200 Washington, D.C. 20005 Phone: (202) 737-5600 Fax: (202) 737-9329 Email: dfarquhar@hpm.com Attorneys for Sandoz Inc. /s/ Charles B. Klein Charles B. Klein (D.C. Bar No. 450984) Steffen N. Johnson (D.C. Bar No. 500636) Eimeric Reig-Plessis (pro hac vice pending) WINSTON & STRAWN LLP 1700 K Street N.W. Washington, D.C. 20006 Tel.: (202) 582-5000 Fax: (202) 582-5100 Samuel S. Park (pro hac vice) WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, Illinois 60601 Phone: (312) 558-5600 Fax: (312) 558-5700 Case 1:16-cv-01336-RDM Document 55 Filed 07/11/16 Page 4 of 6 5 Attorneys for Sun Pharma Global FZE and Sun Pharmaceutical Industries Ltd. Case 1:16-cv-01336-RDM Document 55 Filed 07/11/16 Page 5 of 6 CERTIFICATE OF SERVICE I hereby certify that on this 11th day of July, 2016, the foregoing INTERVENORS’ COMMENTS REGARDING ASTRAZENECA’S PROPOSED PROTECTIVE ORDER were filed via the Court’s CM/ECF system and served upon ECF-registered counsel for all parties to this proceeding. Dated: July 11, 2016 /s/ Lyle B. Vander Schaaf____ Lyle B. Vander Schaaf DC Bar No. 422380 BRINKS GILSON & LIONE 1775 Pennsylvania Avenue, NW, Suite 900 Washington, DC 20006 Tel: (202) 296-8700 Fax: (202) 296-8701 lvanderschaaf@brinksgilson.com Attorneys for (Proposed) Intervenor-Defendants, Glenmark Pharmaceuticals Inc., USA and Glenmark Pharmaceuticals Ltd. Case 1:16-cv-01336-RDM Document 55 Filed 07/11/16 Page 6 of 6