Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Filing
1239
MOTION to ADMIT EXHIBITS INTO EVIDENCE FOR INFRINGEMENT PHASE OF TRIAL by Amgen Inc.. (Attachments: #1 Appendix A (Attachment A- Chart of Documents to be Admitted))(Gottfried, Michael)
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Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Doc. 1239 Att. 1
Case 1:05-cv-12237-WGY
Document 1239-2
Filed 10/02/2007
Page 1 of 2
Attachment A
Amgen v. Roche 05-cv-12237WGY MOTION TO ADMIT ROCHE ADMISSIONS
Tab
Ex.
Date
Description
Relevance
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16.
BEG CQX EOE EOI EOJ EOM EPH EPI EPV ESU ETO EVI EWU EXI EZC EZD
11/17/2003 11/00/1998 08/20/2003 6/28/1995 08/22/2001 10/27/1999 8/17/2001
CERA Investor Telephone Conf., November 17, 2003 [Roche does not object] Bailon et al., "Polyethylene Glycol-Conjugated Pharmaceutical Proteins," PSTT Vol. 1, No. 8, Nov. 1998. B. Bethell e-mail to M. Huber, Subject: SEP Phase I SAD Study, dated August 20, 2003 Certified English Translation of Memo from Koll to Scherhag re Cangene - Pegyliertes EPO Comments to CMC of SEP 1-B51 Email from Bailon to Kim re Expert Opinion on Genotox Test Requirement for PEG-EPO Report No. 1005851 Regulatory Document, "LongLasting Forms of Polyethyleneglycol Conjugated Erythropoietin (PEG-EPO)" SEP Project RDC 1- 06/13/2002
Infringement Infringement
Infringement Infringement Infringement Infringement Infringement
Infringement Infringement
9/26/2005 06/28/1995 09/22/2006 2/21/2001 1/26/2006 01/22/2005
An Investigation into the Signaling Pathways Activated by Continuous Erythropoiesis Receptor Activator (CERA) Progress Report #1, September 26, 2005 Memo from Koll to Scherhag re Cangene - Pegyliertes EPO Email from Jarsch to Haselbeck re: Module 4: Non Clinical, Question No. 55: Non Clinical Pharmacology [Roche does not object] Patient Informed Consent Form, Roche Protocol No. BA 16260 (Version A) Email from Jarsch to Escrig re CERA MOA Abstract for EDTA Pre-Clinical Studies on Mode of Action: Summary of Advisory Board, Jan, 22 NY CERA Modelling Penzberg CERA Physical and Chemical Characterization
Infringement Infringement Infringement Infringement Infringement Infringement Infringement
806707
1
Dockets.Justia.com
Case 1:05-cv-12237-WGY
Document 1239-2
Filed 10/02/2007
Page 2 of 2
Attachment A
Tab
Ex.
Date
Description
Relevance
17. 18. 19.
BLA/IND
EZH EZL FGN
11/4/1999 02/03/2004 2/18/2002
Email from Bailon to Farid re Description of PEG-EPO Email from Haselbeck to Escrig re: Slide for Macdougall about the EPO and CERA and EPO-R Email from Bailon to Ehrlich re EPO & PEG-EPO
Infringement Infringement Infringement
20. 21. 22.
GXE GXF
4/18/2006
Letter Submitting BLA for MIRCERA, Form 356h, Table of Contents and Roadmap of BLA Information for Patients and Caregivers, MIRCERA pegserepoetin alfa FOR INJECTION Drug Substance R00503821 · · · ITC-R-BLA 00004024 4032 ITC-R-BLA 00004232 4244 ITC-R-BLA 00004324 4330
Infringement Infringement Infringement
EAZ-1
23.
Drug Substance EPO Starting Material · · · EBA-1 · · · · · ITC-R-BLA 00004651 4662 ITC-R-BLA 00004667 4669 ITC-R-BLA 00004722 4740 ITC-R-BLA 00004803 4857 ITC-R-BLA 00004987 4988 ITC-R-BLA 00005073 5074 ITC-R-BLA 00005580 5581 ITC-R-BLA 00005616 5619
Infringement
24. 25.
GXB
GXD
8/16/2004
Section 2.7.2 of Roche's BLA - Summary of Clinical Pharmacology Studies Report No. 1012588, Regulatory Document, RO0503821-000: In vivo stability and tissue localization of RO0503821 after single (IV or SC) or multiple (IV) dose administration to rats (Study Nos. D01017 and D02001) Investigational New Drug Application, Form 1571 for Ro 50-3821, and Letter Submitting IND
Infringement Infringement
26.
GXC
Infringement
806707
2
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