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

Filing 1217

MOTION to Admit Exhibits into Evidence by Amgen Inc.. (Attachments: #1 Exhibit A#2 Exhibit B)(Gottfried, Michael)

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

Doc. 1217 Att. 1

Case 1:05-cv-12237-WGY

Document 1217-2

Filed 10/01/2007

Page 1 of 11

EXHIBIT A

Dockets.Justia.com

Amgen, Inc. v. F. Hoffmann-LaRoche Ltd. et al
Case No. 1:05CV12237 WGY LIST OF EXHIBITS

ANCIENT DOCUMENTS (CATEGORY A)
Tab Ex. # Date Description Goldwasser, et al., "On the mechanism of erythropoietin-induced differentiation: XIII. The role of sialic acid in erythropoietin action," J. Biol. Chem. 249(13):4202-6 (1974) Korninger, C., et al., "Turnover of Human Extrinsic Plasminogen Activator in Rabbits," Thromb. Haemostasis 46, 658661 (1981) Lodish, "Post-Translational Modification of Proteins," Enzyme Microb Technol. 1981 Jul; 3(3):177-280, at 186 Gutterman, et al., "Recombinant Leukocyte A Interferon: Pharmacokinetics, Single Dose Tolerance, and Biological Effects in Cancer Patients," Annals of Internal Medicine 96:549-566 (1982) Kelker et al., "Effects of Glycosidase Treatment on the Physiochemical Properties and Biological Activity of Human Interferon-" J. Biol. Chem. 258:8010-13 (1983) Prior art Relevance

1.

DOK

00/00/1974

Prior art

2.

DRF

00/00/1981

Prior art

3.

DSB

07/00/1981

Prior art

4.

DPI

00/00/1982

Prior art

5.

DQQ

00/00/1983

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Case No. 1:05CV12237 WGY LIST OF EXHIBITS Tab 6. Ex. # DRC Date 00/00/1983 Description Konrad, M. et al., "Applications of genetic engineering to the pharmaceutical industry," Ann N Y Acad Sci. 413:12-22 (1983) Colby, C.B., et al., "Immunologic differentiation between E. coli and CHO cell-derived recombinant and natural human beta-interferons," J. Immunol. 133(6):30915 (1984) Gaylis, F.D., et al., "In vitro models of human testicular germ-cell tumors." World J. of Urol. 2:2-5, 5 (1984) Hagiwara, et al., "Erythropoietin production in a primary culture of human renal carcinoma cells maintained in nude mice." Blood 63(4):828-835 (1984) Little, S.P., et al., "Functional Properties of Carbohydrate Depleted Tissue Plasminogen Activator," Biochemistry 23, 6191-6195 (1984) Nilsson, T., et al., "In vivo metabolism of human tissue-type plasm" Scand. J. Haematol. 33, 49-53 (1984) Kopito et al., "Primary structure and transmembrane orientation of the murine anion exchange protein", Nature (1985) 316: pp. 234-238 Prior art Prior art Relevance

7.

DIU

00/00/1984

Prior art Prior art

8.

DNY

00/00/1984

9.

CXJ

04/00/1984

Prior art

10.

DAH

00/00/1984

Prior art Reflects the state of the prior art as of 19831984.

11.

DCI

00/00/1984

12.

GWV

07/18/1985

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Case No. 1:05CV12237 WGY LIST OF EXHIBITS Tab 13. Ex. # DCD Date 00/00/1985 Description Mueckler et al., "Sequence and structure of a human glucose transporter," Science, Vol. 229, pp. 941-5 Spiess et al., "Sequence of Human Asialoglycoprotein Receptor cDNA", Journal of Bio Chem., 260: pp. 1979-1982 Relevance Reflects the state of the prior art as of 19831984. Reflects the state of the prior art as of 19831984.

14.

GWW

02/25/1985

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Case No. 1:05CV12237 WGY LIST OF EXHIBITS Tab 15. Ex. # ABZ Date 10/21/1985 Description Paper 16, "Amendment," from certified file history of U.S. Patent No. 4,766,075 Relevance Excerpt from certified file history of patent previously put in evidence by Roche as invalidating prior art (Exhibit 2030) Reflects the state of the prior art as of 19831984: ("It would have been appreciated by those skilled in the art at the time this invention was made [1982-83] that the expression of human t-PA in transformed cells would be fraught with many potential difficulties. The art of recombinant DNA technology appears to be deceptively straightforward but is inherently unpredictable.") ("Thus, it would certainly have been unpredictable before the fact that one could obtain by recombinant DNA technology a biologically active protein such as the one forming the basis of the present invention.") See Intellectual Prop. Dev., Inc. v. UAColumbia Cablevision, Inc., 1998 U.S. Dist. LEXIS, No. 94-cv-6296, at *29 (S.D.N.Y. Mar. 26, 1998) (noting that statements in other prosecution histories "may help inform a Court's understanding of the state of the art at the time") 4
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Case No. 1:05CV12237 WGY LIST OF EXHIBITS Tab Ex. # Date Description Erslev, A.J., and Caro, J., "Physiologic and molecular biology of erythropoietin," Med. Oncol. Tumor. Pharmacother. 3(3-4):15964 (1986) Opdenakker et al., "Influence of Carbohydrate Side Chains on Activity of Tissue-Type Plasminogen Activator," Proc. Soc. Experimental Biology and Medicine 182:248-257 (1986) Relevance Reflects the state of the prior art as of 19831984: ("The exact cellular source for erythropoietin production in the kidney is still unknown.") Reflects the state of the prior art as of 19831984: ("The biological significance of the carbohydrate moiety has until now not been documented. Here we describe experiments which demonstrate that alterations in the carbohydrate can affect in vitro enzymatic activity of tissue-type plasminogen activator.") Reflects the state of the prior art as of 19831984 ("Although preliminary studies on t-PA produced by a melanoma cell line were promising (Weimar et al. 1981; Van de Werf et al. 1984), it was not clear whether sufficient material could be produced to make a sufficient fibrinolytic product at a cost-effective price using the natural sources (Collen et al. 1982). The application of recombinant DNA techniques to solve this problem led initially to the expression of the protein in bacteria (Pennica et al. 1983).")

16.

CUE

00/00/1986

17.

DCQ

00/00/1986

Vehar et al., "Characterization studies of human tissue-type plasminogen activator produced by recombinant DNA technology." Cold Spring Harbor Symp. On Quant. Biol. 51:551-562 (1986) 18. DHA 00/00/1986

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Case No. 1:05CV12237 WGY LIST OF EXHIBITS Tab 19. 20. 21. 22. 23. 24. Ex. # CVS DNJ GWL DTL DMJ FJT Date 07/00/1983 00/00/1980 00/00/1967 08/00/1971 04/15/1971 08/2/1984 Description Fisher. Control of erythropoietin production. Proc Soc Exp Biol. Med. 1983 Jul;173(3):289-305 Fisher. Mechanism of the anemia of chronic renal failure. Nephron. 1980; 25(3):106-11. Van Dyke et al., Erythropoietin Therapy in the Renoprival Patient, U.S. Atomic Energy Commission, UCRL (1967) 17481:127-132 Nakao et al. Erythropoiesis in anephric or kidney transplanted patients. Isr. J. Med. Sci. 1971 Jul-Aug;7(7):986-90. Erslev. The search for erythropoietin. N. Engl. J. Med. 1971 Apr 15;284(15):849-50 Letter from Schmergel to Albert Einstein College of Medicine re Failure of GI to express EPO from cell line (authenticated via WYETH declaration) Prior art Prior art and objective evidence of nonobviousness as of 1983-1984. Prior art and objective evidence of nonobviousness as of 1983-1984. Prior art and objective evidence of nonobviousness as of 1983-1984. Prior art and objective evidence of nonobviousness as of 1983-1984. Secondary considerations ­ failure of others. Reflects failure of Genetics Institute to clone the EPO gene using cDNA cloning technique. Relevance

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Case No. 1:05CV12237 WGY LIST OF EXHIBITS

ADMISSIONS BY PARTY OPPONENT (CATEGORY B)
Tab Ex.# Date Description Roche patent, U.S. Patent No. 6,544,748 B2, "Preparation of Erythropoietin by Endogenous Gene Activation," (Assignee Roche Diagnostics GmbH) Relevance Roche admits human EPO includes a protein having a length of both 166 amino acids and 165 amino acids. (Col. 6: 26-31.)

25.

AJK

11/02/2001

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Case No. 1:05CV12237 WGY LIST OF EXHIBITS

PUBLIC RECORDS (CATEGORY C)
Tab 26. Ex.# AHF Date 07/02/1996 Description Paper 6, "Amendment," from certified file history of U.S. Patent No. 5,869,314 Relevance Excerpt from certified file history of a patent that claims priority to a patent that was previously put in evidence by Roche as invalidating prior art (Exhibit 2030) Reflects the state of the prior art as of 19831984: ("As argued previously, at the time the invention was made [1982-83] it was unknown (a) what effect glycosylation differences would have on the biological activity of a protein, and (b) whether the cell type used for expression of the protein would effect the glycosylation pattern. Thus, it would not have been predictable whether such glycosylation differences would, in fact, produce intact, functionally biologically active glycoprotein.") See Intellectual Prop. Dev., Inc. v. UAColumbia Cablevision, Inc., 1998 U.S. Dist. LEXIS, No. 94-cv-6296, at *29 (S.D.N.Y. Mar. 26, 1998) (noting that statements in other prosecution histories "may help inform a Court's understanding of the state of the art at the time") 8
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Case No. 1:05CV12237 WGY LIST OF EXHIBITS Tab 27. Ex.# AHQ Date 11/21/1996 Description Paper 6, "Amendment," from certified file history of U.S. Patent No. 5,753,486 Relevance Excerpt from certified file history of a patent that claims priority to a patent that was put in evidence by Roche as invalidating prior art (Exhibit 2030) Reflects the state of the prior art as of 19831984: ("The applicants submit that at the time the invention was made [1982-83], and even today, it would not have been predictable whether such glycosylation differences would in fact produce intact, functionally biologically active glycoprotein.") ("These articles are . . . powerfully instructive as to the contemporary state of the art, emphasizing the patentable difference glycosylation makes, especially in 1982 when this application was effectively filed.") See Intellectual Prop. Dev., Inc. v. UAColumbia Cablevision, Inc., 1998 U.S. Dist. LEXIS, No. 94-cv-6296, at *29 (S.D.N.Y. Mar. 26, 1998) (noting that statements in other prosecution histories "may help inform a Court's understanding of the state of the art at the time")

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Amgen, Inc. v. F. Hoffmann-LaRoche Ltd. et al
Case No. 1:05CV12237 WGY LIST OF EXHIBITS

MARKET REPORT / COMMERCIAL PUBLICATION (CATEGORY D)
Tab Ex.# Date Description US Renal Data Service Annual Report on incidence of ESRD (2006) Relevance Objective evidence of non-obviousness as of 1983-1984. Provides historical data about the numbers of ESRD patients in need of treatment

28.

FUP

2006

10
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