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

Filing 1043

BRIEF by Amgen Inc. Bench Memorandum Excluding Evidence Regarding Amgen's Clinical Trial and Other Evidence that Roche Intends to Proffer During the Testimony of Dr. Spinowitz. (Attachments: #1 Exhibit A#2 Exhibit B)(Gottfried, Michael)

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Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 1043 Att. 1 Case 1:05-cv-12237-WGY Document 1043-2 Filed 09/11/2007 Page 1 of 2 EXHIBIT A Dockets.Justia.com Case 1:05-cv-12237-WGY Document 1043-2 Filed 09/11/2007 Page 2 of 2 EXHIBIT A Exhibit Number OST OTW Description of Document An Amgen memorandum dated December 3, 1984, entitled "Summary of Erythropoietin Clinical Panel Meeting." The document addresses criteria for establishing Phase I clinical trials. Amgen meeting minutes dated July 16, 1985 entitled "Washington State University/Northwest Kidney Foundation as a Potential site for the EPO Phase I study." The minutes discuss a meeting held to discuss Dr. Adamson's potential role in Phase I clinical trials. An Amgen letter to the FDA dated January 9, 1986 where Amgen submitted its application for obtaining designation of its drug, EPO, as an Orphan drug. An Amgen memorandum dated April 7, 1986 entitled "U. Washington EPO Clinical Study." It summarizes an April 4, 1986 phone conversation with Dr. Joe Eschbach regarding his clinical studies of EPO. Demonstrative SP-52 is a text cull-out of this document. A May 6, 1986 letter from Dr. John Adamson to the NIH reporting on his activities relating to Phase I clinical trials of EPO. Moreover, this is not even an Amgen document, but rather, a letter from a third party to the NIH. An April 15, 1987 letter and minutes from a March 3, 1987 "Meeting on Erythropoietin and Chronic Renal Failure." Amgen proposed protocol for its r-HuEPO Phase I clinical studies and copies of informed consent forms to be utilized in the Phase I clinical study. An Amgen document dated December 3, 1985, entitled "Recombinant Human Erythropoietin ­ Phase I Clinical Trial." An April 9, 1987 letter from Amgen to Dr. Joe Eschbach attaching a Clinical Trial Protocol and two Informed Consent addendums. A March 25, 1985 letter sent from Amgen to Dr. Goldwasser discussing protocol for human studies with EPO. OUN OUV and Demonstrative SP-52 OUY OWA QDZ PYY OVZ OTI -2MPK 132024-1.041925.0023

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