Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 180

DECLARATION re 179 Emergency MOTION for Order Requiring Plaintiff to File Under Seal Documents Containing Defendants' Confidential and Trade Secret Materials of Patricia Rocha-Tramaloni by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Rizzo, Nicole)

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Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 180 Case 1:05-cv-12237-WGY Document 180 Filed 12/18/2006 Page 1 of 5 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., Plaintiff, v. F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC., Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) CIVIL ACTION No.: 05-CV-12237WGY DECLARATION OF PATRICIA ROCHA-TRAMALONI IN SUPPORT OF EMERGENCY MOTION FOR ORDER REQUIRING PLAINTIFF TO FILE UNDER SEAL DOCUMENTS CONTAINING DEFENDANTS' CONFIDENTIAL AND TRADE SECRET MATERIALS I, Patricia Rocha-Tramaloni, declare that the following is true and correct, under penalty of perjury, pursuant to 28 U.S.C. 1746: 1. Jersey. I am an attorney admitted to practice law in the States of New York and New I am in-house counsel for Hoffmann-La Roche Inc., one of the Defendants in this matter. 2. I make this declaration based upon my own personal knowledge and company information. 3. On December 15, 2006, Plaintiff served on Defendants an un-redacted version of its Motion to Compel Production of Documents, Memorandum of Points and Authorities in Support of same, and the Declaration of Krista M. Carter in Support of same, with Exhibits 1-30. Dockets.Justia.com Case 1:05-cv-12237-WGY Document 180 Filed 12/18/2006 Page 2 of 5 4. The un-redacted Memorandum and Declaration and Exhibits contain highly confidential, trade secret material belonging to Defendants. Defendants maintain this information in strict confidentiality and maintain close safeguards to ensure that it does not become public. 5. The un-redacted Memorandum contains highly confidential, trade secret information belonging to Defendants, including information from highly confidential internal Roche documents regarding clinical trials, Roche's Biologics License Application ("BLA") and Investigational Drug Applications ("IND"), as well as deposition testimony related to same, at pages 9 and 12-13 of the Memorandum. 6. The un-redacted Declaration similarly reveals highly confidential, trade secret information regarding the contents of the BLA and INDs, as well as detailed information regarding the Exhibits discussed in paragraphs 8-21 below, at pages 3-4, 9-16 and 19-20 of the Declaration. 7. Many of the Exhibits attached to the un-redacted Declaration contain highly confidential, trade secret information belonging to Defendants. These Exhibits are or contain excerpts of Defendants' highly confidential BLA and INDs, highly confidential internal Roche documents, deposition testimony related to same, or attorney correspondence discussing same. 8. Specifically, Exhibits 6 and 7 are printouts of internal Roche slide presentations regarding highly confidential, trade secret analysis of Roche's drug development strategy. 9. Exhibit 8 is a portion of a draft of Defendants' IND containing highly confidential, trade secret information. 2 Case 1:05-cv-12237-WGY Document 180 Filed 12/18/2006 Page 3 of 5 10. Exhibit 9 is an internal Roche e-mail string discussing highly confidential, trade secret information regarding customs, export, and drug development information. 11. Exhibit 11 is an excerpt from the transcript of the deposition of Joanne Franzino, a senior scientist at Roche, taken on June 8, 2006, in an International Trade Commission ("ITC") proceeding, containing highly confidential, trade secret information regarding Defendants' drug development strategies and procedures. 12. Exhibit 12 is an internal Roche spreadsheet showing highly confidential, trade secret information regarding the composition of drugs under development. 13. Exhibit 13 is a Roche intra-company letter containing highly confidential, trade secret information regarding shipments of drugs under development. 14. Exhibit 14 is an internal Roche document showing highly confidential, trade secret information regarding drug development and manufacturing strategy. 15. Exhibit 15 is an internal Roche document containing highly confidential, trade secret information relating to the shipping of drugs under development. 16. Exhibit 16 is an internal Roche document containing highly confidential, trade secret information regarding drugs under development. 17. Exhibits 19-21 are excerpts from Defendants' BLA containing highly confidential, trade secret information regarding drug development. 18. Exhibit 23 is an is an excerpt from the transcript of the deposition of Hoffman- LaRoche, Inc. (by Dr. Cynthia Dinella), pursuant to Rule 30(b)(6), taken on June 13, 2006, in an International Trade Commission ("ITC") proceeding, containing highly confidential, trade secret information regarding Defendants' drug development strategies and procedures. 3 Case 1:05-cv-12237-WGY Document 180 Filed 12/18/2006 Page 4 of 5 19. Exhibit 24 and Exhibit 25 are letters between counsel for Amgen and counsel for Roche dated June 30, 2006, and July 7, 2006, which summarize and quote highly confidential, trade secret information from the deposition of Dr. Dinella, referenced in paragraph 18, above. 20. Exhibit 26 and Exhibit 27 are excerpts from Defendants' BLA containing highly confidential, trade secret information regarding drug development and clinical trials. 21. Exhibit 28 is a letter from counsel for Amgen to counsel for Roche dated June 6, 2006, which contains highly confidential, trade secret information regarding Roche's systems for tracking and managing drug development. 22. In the highly competitive pharmaceutical industry, it is standard company practice to maintain the confidentiality of trade secrets and proprietary information. 23. Maintenance of the confidentiality of such information is deemed necessary by Defendants in order to safeguard their trade secrets and competitive business information and to avoid giving competitive advantage to competitors or others who might use the information to the detriment of Defendants' business. 24. Defendants would be severely disadvantaged and harmed by the disclosure of the above-referenced highly confidential, trade secret information in the public record where it would be available to all without restriction or limitation, including its competitors and others. 25. Accordingly, it is of critical importance that Defendants' highly confidential, trade secret information not be disclosed in the public record. 4 Case 1:05-cv-12237-WGY Document 180 Filed 12/18/2006 Page 5 of 5 Signed under the penalties of perjury this 18th day of December, 2006. /s/ Patricia Rocha-Tramaloni Patricia Rocha-Tramaloni CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies will be sent to those indicated as non registered participants on December 18, 2006. /s/ Nicole A. Rizzo Nicole A. Rizzo 03099/00501 587821.1 5

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