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

Filing 494

DECLARATION re #490 MOTION for Summary Judgment That The Claims Of Patents-In-Suit Are Invalid For Double Patenting Over Amgen 016 Patent of Dr. Edward Everett Harlow, Jr. by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Notice of Filing With Clerks Office Of Exhibits to Declaration of Dr. Edward Everett Harlow, Jr. In support of Defendants Motion For Summary Judgment That the Claims of Patents-In-Suit Are Invalid For Double Patenting Over Amgen 016 Patent)(Rizzo, Nicole)

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Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 494 Att. 1 Case 1:05-cv-12237-WGY Document 494-2 Filed 06/12/2007 Page 1 of 5 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., Plaintiff, vs. F. HOFFMANN-LA ROCHE LTD; ROCHE DIAGNOSTICS GmbH; and HOFFMANN-LA ROCHE INC. Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) CIVIL ACTION No.: 05-CV-12237WGY NOTICE OF FILING WITH CLERK'S OFFICE OF EXHIBITS TO DECLARATION OF DR. EDWARD EVERETT HARLOW, JR. IN SUPPORT OF DEFENDANTS' MOTION FOR SUMMARY JUDGMENT THAT THE CLAIMS OF PATENTS-IN-SUIT ARE INVALID FOR DOUBLE PATENTING OVER AMGEN `016 PATENT Pursuant to CMF/ECF Administrative Procedures Rule M(6) notice is hereby given that the exhibits listed below have been manually filed with the Court and are available in paper form only. The original documents are maintained in the case file in the Clerk's Office. Exhibit 1 Exhibit 2 Exhibit 3 Curriculum Vitae Li et al., "Biosynthesis of lipid-linked oligosaccharides," J. BIOL. CHEM., 254: 1600-1605 (1979) Scahill, et al., "Expression and characterization of the product of a human immune interferon cDNA gene in Chinese hamster ovary cells," PROC. NAT'L ACAD. SCI. 80: 4654-4658 (1983) Singer et al., "Characterization of a porcine genomic clone encoding a major histocompatibility antigen: Expression in mouse L cells," PROC. NAT'L ACAD. SCI. 79:1403-1407 (1982) Haynes and Weissman, "Constitutive, long-term production of human interferons by hamster cells containing multiple copies of a cloned interferon gene," NUCL. ACIDS RES., 11: 687-706 (1983) Exhibit 4 Exhibit 5 Dockets.Justia.com Case 1:05-cv-12237-WGY Document 494-2 Filed 06/12/2007 Page 2 of 5 Exhibit 6 Exhibit 7 Sherwood and Goldwasser, "A radioimmunoassay for erythropoietin," BLOOD, 54: 885-893 (1979) EPO 0 093 619 (Goeddel et al, 1983); Ex. 3, Scahill et al., "Expression and characterization of the product of a human immune interferon cDNA gene in Chinese hamster ovary cells," PROC. NAT'L ACAD. SCI. 80: 4654-4658 (1983) EPO 0 117 059, 0 117 060 (Levinson et al, 1984) McCormick et al., "Inducible expression of amplified human beta interferon genes in CHO cells," MOL. & CELL. BIOL., 4: 166-172 (1984) Devos et al., "Purification of recombinant glycosylated human gamma interferon expressed in transformed Chinese hamster ovary cells," J. INTERFERON RES., 4: 461-468 (1984) U.S. Patent No. 4,766,075 U.S. Patent No. 4,356,270 U.S. Patent No. 4,264,731 U.S. Patent No. 4,273,875 U.S. Patent No. 4,293,652 Srinivasan and Lewis, "Transfer of the Dihydrofolate Reductase Gene into Mammalian Cells Using Metaphase Chromosomes or Purified DNA," INTRODUCTION OF MACROMOLECULES INTO VIABLE MAMMALIAN CELLS, 27-45 (1980) Milbrandt et al., "Organization of a Chinese Hamster Ovary Dihydrofolate Reductase Gene Identified by Phenotypic Rescue," MOL. CELL BIOL. 3: 12661273 (1983) Nunberg et al., "Amplified dihydrofolate reductase genes are localized to a homogeneously staining region of a single chromosome in a methotrexateresistant Chinese hamster ovary cell line," PROC. NAT'L ACAD. SCI., 75: 55535556 (1978) U.S. Patent No. 4399216 Urlaub and Chasin, "Isolation of Chinese hamster cell mutants deficient in dihydrofolate reductase activity," PROC. NAT'L ACAD. SCI., 77: 4216-4220 (1980) Exhibit 8 Exhibit 9 Exhibit 10 Exhibit 11 Exhibit 12 Exhibit 13 Exhibit 14 Exhibit 15 Exhibit 16 Exhibit 17 Exhibit 18 Exhibit 19 Exhibit 20 2 Case 1:05-cv-12237-WGY Document 494-2 Filed 06/12/2007 Page 3 of 5 Exhibit 21 Exhibit 22 Exhibit 23 Exhibit 24 Exhibit 25 Exhibit 26 Exhibit 27 Exhibit 28 Schimke et al. "Gene amplification and drug resistance in cultured murine cells," SCIENCE, 202: 1051-1055 (1978) Miyake, Goldwasser et al, "Purification of Human Erythropoietin," J. BIOL. CHEM., 252: 5558-5564 (1977) Goldwasser et al., "An assay for erythropoietin in vitro at the milliunit level," ENDOCRINOLOGY, 97: 315-323 (1975) Cotes and Bangham, "Bio-assay of erythropoietin in mice made polycythæmic by exposure to air at a reduced pressure," NATURE, 191: 1065-1067 (1961) Hammond et al., "Production, utilization and excretion of erythropoietin," ANN. N.Y. ACAD. SCI., 169: 516-527 (1968) Weiss, et al., "Characterization of a monoclonal antibody to human erythropoietin," BIOCHEMISTRY, 79: 5465-5469 (1982) Gray and Goeddel, "Cloning and Expression of Murine Immune Interferon cDNA," PROC. NAT'L. ACAD. SCI., 80:5842-5846 (1983) Taniguchi et al., "Construction and Identification of a Bacterial Plasmid Containing the Human Fibroblast Interferon Gene Sequence," PROC. JAPAN ACAD., 55: 464-469 (1979) Oi et al., "Immunoglobulin gene expression in transformed lymphoid cells," PROC. NAT'L. ACAD. SCI. 80:825-829 (1983) Neuberger, "Expression and regulation of immunoglobulin heavy chain gene transfected into lymphoid cells," EMBO J. 2:1373-1378 (1983) Exhibit 29 Exhibit 30 3 Case 1:05-cv-12237-WGY Document 494-2 Filed 06/12/2007 Page 4 of 5 Exhibit 31 Sidman, "Differing requirements for glycosylation in the secretion of related glycoproteins is determined neither by the producing cell nor by the relative number of oligosaccharide units," J. BIOL. CHEM., 256: 9374-9376 (1981) Seidman et al., "Antibody Diversity," SCIENCE, 202: 11 (1978) Claim Charts Respectfully submitted, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By its attorneys, /s/ Nicole A. Rizzo_____________ Lee Carl Bromberg (BBO# 058480) Timothy M. Murphy (BBO# 551926) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel. (617) 443-9292 nrizzo@bromsun.com Leora Ben-Ami (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Christopher T. Jagoe (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. (212) 836-8000 Exhibit 32 Exhibit 33 Dated: June 12, 2007 Boston, Massachusetts 4 Case 1:05-cv-12237-WGY Document 494-2 Filed 06/12/2007 Page 5 of 5 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 the above date. /s/ Nicole A. Rizzo Nicole A. Rizzo 03099/00501 681890.1 5

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