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

Filing 502

DECLARATION re #498 MOTION for Summary Judgment of No Obviousness-Type Double Patenting BY HARVEY F. LODISH, Ph.D. by Amgen Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C#4 Exhibit D-1#5 Errata D-2#6 Exhibit D-3#7 Errata D-4#8 Exhibit E-1#9 Exhibit E-2 (part 1)#10 Exhibit E-2 (part 2)#11 Exhibit E-3#12 Exhibit E-4#13 Exhibit E-5 (part 1)#14 Exhibit E-5 (Part 2)#15 Exhibit E-5 (part 3)#16 Exhibit E-6)(Gottfried, Michael)

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

Doc. 502 Att. 2

Case 1:05-cv-12237-WGY

Document 502-3

Filed 06/14/2007

Page 1 of 28

Exhibit B

Lodish Decl re Amgen's Motion for SJ of No ODP
Dockets.Justia.com

Case 1:05-cv-12237-WGY

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Exhibit B Materials Reviewed or Relied Upon
Materials Reviewed or Relied Upon - 04/06/2007 Lodish Expert Report Aledort LM. "What is the prospective impact of the recombinant DNA technique on the production of human plasma derivatives? Which are the derivates where donor plasma could be replaced?" Vox Sang. 1983;44(6):390-5. Alessi MC et al., "Purification and characterization of natural and recombinant human plasminogen activator inhibitor-1 (PAI-1)." Eur J Biochem. 1988 Aug 15;175(3):531-40. Alexander S et al., "HLA-DR antigens of autologous melanoma and B lymphoblastoid cell lines: differences in glycosylation but not protein structure." J Immunol. 1984 Jul;133(1):315-20. Amin AR et al., "Specificity of the murine IgD receptor on T cells is for N-linked glycans on IgD molecules." Proc Natl Acad Sci U S A. 1991 Oct 15;88(20):9238-42. Baenziger JU et al., "Circulatory half-life but not interaction with the lutropin/chorionic gonadotropin receptor is modulated by sulfation of bovine lutropin oligosaccharides." Proc Natl Acad Sci U S A. 1992 Jan 1;89(1):334-8. Baenziger JU et al. "Pituitary glycoprotein hormone oligosaccharides: structure, synthesis and function of the asparagine-linked oligosaccharides on lutropin, follitropin and thyrotropin." Biochim Biophys Acta. 1988 Jun 9;947(2):287-306. Baenziger JU. "Glycosylation: to what end for the glycoprotein hormones?" Endocrinology. 1996 May;137(5):1520-2. Baenziger JU. "Protein-specific glycosyltransferases: how and why they do it!" FASEB J. 1994 Oct;8(13):1019-25. Balaguer E et al., "Glycoform characterization of erythropoietin combining glycan and intact protein analysis by capillary electrophoresis - electrospray time-of-flight mass spectrometry." Electrophoresis. 2006 Jul;27(13):2638-50. Baynes JW et al., "Effect of glycosylation on the in vivo circulating half-life of ribonuclease." J Biol Chem. 1976 Oct 10;251(19):6016-24. Bazill GW et al., "Characterization and partial purification of a haemopoietic cell growth factor in WEHI-3 cell conditioned medium." Biochem J. 1983 Mar 15;210(3):747-59. Belalcazar V et al. "Assessing the instability of the isoelectric focusing patterns of erythropoietin in urine." Electrophoresis. 2006 Nov;27(22):4387-95. Bennett WF. "Two forms of tissue-type plasminogen activator (tPA) differ at a single specific glycosylation site." Protein Biochem. Dept. Genentech Inc. So. San Francisco, CA USA Abstract Berger EG et al., "Structure, biosynthesis and functions of glycoprotein glycans." Experientia. 1982 Oct 15;38(10):1129-62. Review Beyer TA et al., "Biosynthesis of mammalian glycoproteins. Glycosylation pathways in the synthesis of the nonreducing terminal sequences." J Biol Chem. 1979 Dec 25;254(24):12531-4. Bocci V et al., "The role of liver in the catabolism of human alpha- and betainterferon." J Gen Virol. 1982 Jun;60(Pt 2):397-400. Bock SC et al., "Cloning and expression of the cDNA for human antithrombin III." Nucleic Acids Res. 1982 Dec 20;10(24):8113-25. N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A AM-ITC 00351419 AM-ITC 00351453 N/A N/A N/A

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Exhibit B Materials Reviewed or Relied Upon
Bos TJ et al., "Eukaryotic expression of cloned cDNA for influenza viral glycoproteins using an SV40 vector: use of recombinant DNA mutants to study structure-function relationships." Proc Symp Mol Biol Negat, Strand Viruses Meeting 1983; Bowman KG et al., "Carbohydrate sulfotransferases: mediators of extracellular communication." Chem Biol. 1999 Jan;6(1):R9-R22. Brake A et al., "Alpha-factor-directed synthesis and secretion of mature foreign proteins in Saccharomyces cerevisiae." Proc Natl Acad Sci U S A. 1984 Aug;81(15):4642-6. Breidbach et al., "Detection of recombinant human erythropoietin in urine by isoelectric focusing." Clin. Chem. 2003 Jun;49(6 Pt 1):901-7. Breitfeld PP et al., "Influence of the N-linked oligosaccharides on the biosynthesis, intracellular routing, and function of the human asialoglycoprotein receptor." J Biol Chem. 1984 Aug 25;259(16):10414-21. Brigss et al., "Hepatic clearance of intact and desialylated erythropoietin," Amer. J. of Physiology 227:1385-1388 (1974) Brooks SA., "Protein glycosylation in diverse cell systems: implications for modification and analysis of recombinant proteins." Expert Rev Proteomics. 2006 Jun;3(3):345-59. Review. Browne JK et al., "Erythropoietin: gene cloning, protein structure, and biological properties." Cold Spring Harb Symp Quant Biol. 1986;51 Pt 1:693-702 Cabilly S et al., "Generation of antibody activity from immunoglobulin polypeptide chains produced in Escherichia coli." Proc Natl Acad Sci U S A. 1984 Jun;81(11):3273-7. Calvo F et al., "Inhibition of adenylyl cyclase activity in rat corpora luteal tissue by glycopeptides of human chorionic gonadotropin and the alpha-subunit of human chorionic gonadotropin." Biochemistry. 1985 Apr 9;24(8):1953-9. Canaani D et al., "Regulated expression of human interferon beta 1 gene after transduction into cultured mouse and rabbit cells." Proc Natl Acad Sci U S A. 1982 Sep;79(17):5166-70. Caro JF et al., "Is glycosylation in the liver needed for insulin binding, processing, and action? Evidence for heterogeneity." J Biol Chem. 1984 Oct 25;259(20):12810-6. Carter WA., "Glycosylation, intraspecies molecular heterogeneity and transspecies activity of mammalian interferons." Life Sci. 1979 Aug 27;25(9):717-28. Carter WA. "Mechanisms of cross-species activity of mammalian interferons." Pharmacol Ther. 1979;7(2):245-52. Catlin D."False-positive Epo test concerns unfounded." Blood. 2006 Sep 1;108(5):1778. Catlin et al., "Comparison of the isoelectric focusing patterns of darbepoetin alfa, recombinant human erythropoietin, and endogenous erythropoietin from human urine." Clin Chem. 2002 Nov;48(11):2057-9. Catlin et al., "Performance-enhancing drugs, fair competition, and Olympic sport." JAMA. 1996 Jul 17;276(3):231-7. AM-ITC 00017585 AM-ITC 00017591 N/A N/A N/A N/A AM27058559AM27058562 N/A AM-ITC 00947246 AM-ITC 00947255 N/A N/A AM-ITC 00004823 AM-ITC 00004827 N/A N/A N/A N/A N/A N/A

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Catlin et al., "Use and abuse of anabolic and other drugs for athletic enhancement." Adv Intern Med. 1991;36:399-424. JAMA. 1996 Jul 17;276(3):231-7. Cavalieri RL et al., "Synthesis of human interferon by Xenopus laevis oocytes: two structural genes for interferons in human cells." Proc Natl Acad Sci U S A. 1977 Aug;74(8):3287-91. Chan SJ et al., "Biosynthesis and periplasmic segregation of human proinsulin in Escherichia coli." Proc Natl Acad Sci U S A. 1981 Sep;78(9):5401-5. Chen CY et al., "Homologous versus heterologous gene expression in the yeast, Saccharomyces cerevisiae." Nucleic Acids Res. 1984 Dec 11;12(23):8951-70. Chen HC et al., "Characterization and biological properties of chemically deglycosylated human chorionic gonadotropin. Role of carbohydrate moieties in adenylate cyclase activation." J Biol Chem. 1982 Dec 10 ;257(23):14446-52. Cheng S et al. "Effect of deglycosylation on the binding and immunoreactivity of human thyroxine-binding globulin." J Biol Chem. 1979 Sep 25;254(18):8830-5. Chiba S et al., "Stabilization of urinary erythropoietin." Biochem Biophys Res Commun. 1972 Jun 28;47(6):1372-7. Chu FK et al., "The effect of carbohydrate depletion on the properties of yeast external invertase." J Biol Chem. 1978 Dec 25;253(24):8691-3. Clamp JR et al., "Heterogeneity of glycopeptides from a homogeneous immunoglobulin." Biochem J. 1966 Sep;100(3):35contd-36c. Cointe D et al., "Unusual N-glycosylation of a recombinant human erythropoietin expressed in a human lymphoblastoid cell line does not alter its biological properties." Glycobiology. 2000 May;10(5):511-9. Colby CB et al., "Immunologic differentiation between E. coli and CHO cellderived recombinant and natural human beta-interferons." J Immunol. 1984 Dec;133(6):3091-5. Collen D et al., "Biological properties of human tissue-type plasminogen activator obtained by expression of recombinant DNA in mammalian cells." J Pharmacol Exp Ther. 1984 Oct;231(1):146-52. Collen D et al., "Thrombolysis with human extrinsic (tissue-type) plasminogen activator in rabbits with experimental jugular vein thrombosis. Effect of molecular form and dose of activator, age of the thrombus, and route of administration." J Clin Invest. 1983 Feb;71(2):368-76. Conradt HS et al., "Structure of the carbohydrate moiety of human interferonbeta secreted by a recombinant Chinese hamster ovary cell line." J Biol Chem. 1987 Oct 25;262(30):14600-5. Cotes PM., "Immunoreactive erythropoietin in serum. I. Evidence for the validity of the assay method and the physiological relevance of estimates." Br J Haematol. 1982 Mar;50(3):427-38. Cowing C et al., "T cells discriminate between Ia antigens expressed on allogeneic accessory cells and B cells: a potential function for carbohydrate side chains on Ia molecules." Proc Natl Acad Sci U S A. 1983 Oct;80(19):6000-4. Cullen S et al., "Differential glycosylation of murine B cell and spleen adherent cell Ia antigens." J Immunol. 1981 Oct;127(4):1478-84. N/A N/A N/A N/A N/A N/A AM-TC 00997841AM-TC 00997846 N/A N/A N/A AM AM-ITC 00270500AM-ITC 00270507 N/A

N/A AM-ITC 01032432AM-ITC 01032446 N/A N/A

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Exhibit B Materials Reviewed or Relied Upon
Cumming DA. "Glycosylation of recombinant protein therapeutics: control and functional implications." Glycobiology. 1991 Mar;1(2):115-30. D'Andrea, A. et al., "Expression Cloning of the Murine Erythropoietin Receptors." Cell Vol. 57, 277-285 (1989) Darling RJ et al., Glycosylation of erythropoietin affects receptor binding kinetics: role of electrostatic interactions." Biochemistry. 2002 Dec 10;41(49):14524-31. Davis AR et al., "Active influenza virus neuraminidase is expressed in monkey cells from cDNA cloned in simian virus 40 vectors." Proc Natl Acad Sci U S A. 1983 Jul;80(13):3976-80. De Frutos M et al., "Differences in capillary electrophoresis profiles of urinary and recombinant erythropoietin." Electrophoresis. 2003 Feb;24(4):678-80. Derynck R et al., "Expression of the human interferon-gamma cDNA in yeast." Nucleic Acids Res. 1983 Mar 25;11(6):1819-37. Devos R et al., "Purification of recombinant glycosylated human gamma interferon expressed in transformed Chinese hamster ovary cells." J Interferon Res. 1984 Fall;4(4):461-8. Dharmesh SM et al. Estrogen modulates expression of the glycosyltransferases that synthesize sulfated oligosaccharides on lutropin. Proc Natl Acad Sci U S A. 1993 Dec 1;90(23):11127-31. Dordal MS et al., "The role of carbohydrate in erythropoietin action." Endocrinology. 1985 Jun;116(6):2293-9. Dove A., "The bittersweet promise of glycobiology." Nat Biotechnol. 2001 Oct;19(10):913-7. Dube S et al., "Glycosylation at specific sites of erythropoietin is essential for biosynthesis, secretion, and biological function." J Biol Chem. 1988 Nov 25;263(33):17516-21. Eagon PK et al., "Glycoprotein biosynthesis in myeloma cells. Characterization on nonglycosylated immunoglobulin light chain secreted in presence of 2-deoxyD-glucose." J Biol Chem. 1977 Apr 10;252(7):2372-83. Egrie JC et al., "Characterization and biological effects of recombinant human erythropoietin." Immunobiology. 1986 Sep;172(3-5):213-24. Egrie JC et al., "Characterization of recombinant monkey and human erythropoietin." Prog Clin Biol Res. 1985;191:339-50. Egrie JC et al., "Development and characterization of novel erythropoiesis stimulating protein (NESP)." Br J Cancer. 2001 Apr;84 Suppl 1:3-10. Elliott S et al., "Control of rHuEPO biological activity: the role of carbohydrate." Exp Hematol. 2004 Dec;32(12):1146-55. Erslev, A.J., and Caro, J., "Physiologic and molecular biology of erythropoietin," Med Oncol Tumor Pharmacother 3(3-4):159-64 (1986) Eschbach JW et al., "Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial." N Engl J Med. 1987 Jan 8;316(2):73-8. Eschbach JW et al., "The anemia of chronic renal failure in sheep. Response to erythropoietin-rich plasma in vivo." J Clin Invest. 1984 Aug;74(2):434-41. AM-ITC 00102074AM-ITC 00102089 AM-ITC 01020637AM-ITC 01020647 N/A N/A N/A N/A AM-ITC_01020650AM-ITC_01020660 N/A AM-ITC_01073006AM-ITC_01073012 N/A AM-ITC_00962074AM-ITC_00962079 N/A AM-ITC_00338629AM-ITC_00338640 AM-ITC_01007731AM-ITC_01007742 N/A N/A

AM-ITC_01013790AM-ITC_01013795 AM-ITC_00163627AM-ITC_00163636

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Eschbach JW et al., "The history of renal anaemia (anaemia and erythropoietin)." Nephrology. 1998;4:279-87 Esko JD et al., "Animal cell mutants defective in glycosaminoglycan biosynthesis." Proc Natl Acad Sci U S A. 1985 May;82(10):3197-201 Esko JD et al., "Sulfate transport-deficient mutants of Chinese hamster ovary cells. Sulfation of glycosaminoglycans dependent on cysteine." J Biol Chem. 1986 Nov 25;261(33):15725-33. Espada J et al., "Purification of human urinary erythropoietin." Acta Physiol Lat Am. 1970;20(2):122-9. Spanish. Espada J et al., "Human erythropoietin: studies on purity and partial characterization." Biochim Biophys Acta. 1972 Dec 28;285(2):427-35. Espada J et al., "Molecular heterogeneity of human erythropoietin." Biochim Biophys Acta. 1974 Aug 8;359(2):369-78. Espada J et al. "Proceedings: Properties and characterization of human erythropoietin." Acta Physiol Lat Am. 1973;23(6):540-2. Essers U et al., "Effect of erythropoietin in normal men and in patients suffering from chronic uraemia (author's transl)" Klin Wochenschr. 1973 Oct 15;51(20):1005-9. German. Essers U et al., "Further studies on the effectiveness of erythropoietin in renal failure (author's transl)" Dtsch Med Wochenschr. 1974 Aug 9;99(32):1618-20 passim. German. Essers U et al., "Effect of erythropoietin in normal men and in patients with renal insufficiency." Proc Eur Dial Transplant Assoc. 1975;11:398-402. Falany CN., "Enzymology of human cytosolic sulfotransferases." FASEB J. 1997 Mar;11(4):206-16. Falany CN., "Sulfation and sulfotransferases. Introduction: changing view of sulfation and the cytosolic sulfotransferases." FASEB J. 1997 Jan;11(1):1-2. Fan H et al., "Construction and characterization of Moloney murine leukemia virus mutants unable to synthesize glycosylated gag polyprotein." Proc Natl Acad Sci U S A. 1983 Oct;80(19):5965-9. Fiers W et al., "The human fibroblast and human immune interferon genes and their expression in homologous and heterologous cells." Philos Trans R Soc Lond B Biol Sci. 1982 Sep 24;299(1094):29-38. Fiers W et al., "The human fibroblast interferon gene(s) and their expression in heterologous cells." Princess Takamatsu Symp. 1982;12:227-36. Fiete D et al., "A hepatic reticuloendothelial cell receptor specific for SO44GalNAc beta 1,4GlcNAc beta 1,2Man alpha that mediates rapid clearance of lutropin." Cell. 1991 Dec 20;67(6):1103-10. Fiete D et al., "Isolation of the SO4-4-GalNAcbeta1,4GlcNAcbeta1,2Manalphaspecific receptor from rat liver." J Biol Chem. 1997 Jun 6;272(23):14629-37. Fischinger PJ et al., "Detection of a recombinant murine leukemia virus-related glycoprotein on virus-negative thymoma cells." Proc Natl Acad Sci U S A. 1981 Mar;78(3):1920-4. Fisher JW., "Control of erythropoietin production." Proc Soc Exp Biol Med. 1983 Jul;173(3):289-305. AM-ITC_00944864AM-ITC_00944872 N/A N/A AM-ITC_00193740AM-ITC_00193747 AM-ITC_00997847AM-ITC_00997855 AM-ITC_01032373AM-ITC_01032385 AM-ITC_01032368AM-ITC_01032372 AM-ITC_00885776AM-ITC_00885788 AM-ITC_00885761AM-ITC_00885775 AM-ITC_01013853AM-ITC_01013865 N/A N/A AM-ITC_022331-AMITC_022335 AM-ITC_013542-AMITC_013551 N/A N/A N/A AM-ITC 00007472AM-ITC 00007476 AM-ITC 00951524AM-ITC 00951543

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Fujisawa J et al., "Nonglycosylated mouse L cell interferon produced by the action of tunicamycin." J Biol Chem. 1978 Dec 25;253(24):8677-9. Fukuda et al., "Survival of recombinant erythropoietin in the circulation: the role of carbohydrates." Blood. 1989 Jan;73(1):84-9. Fukuda M et al., "Carbohydrate-modifying sulfotransferases: structure, function, and pathophysiology." J Biol Chem. 2001 Dec 21;276(51):47747-50. Gagneux P et al., "Human-specific regulation of alpha 2-6-linked sialic acids." J Biol Chem. 2003 Nov 28;278(48):48245-50. Garoff H et al., "Expression of Semliki Forest virus proteins from cloned complementary DNA. II. The membrane-spanning glycoprotein E2 is transported to the cell surface without its normal cytoplasmic domain." J Cell Biol. 1983 Sep;97(3):652-8. Gerard C et al., "Identification of classical anaphylatoxin as the des-Arg form of the C5a molecule: evidence of a modulator role for the oligosaccharide unit in human des-Arg74-C5a." Proc Natl Acad Sci U S A. 1981 Mar;78(3):1833-7. Gething MJ et al., "Comparison of different eukaryotic vectors for the expression of hemagglutinin glycoprotein of influenza virus. Modern Approaches to Vaccines, Cold Spring Harbor Lab. (1984); 263-268 Gething MJ et al., "Construction of influenza haemagglutinin genes that code for intracellular and secreted forms of the protein." Nature. 1982 Dec 16;300(5893):598-603. Goeddel D et al., "Human leukocyte interferon produced by E. coli is biologically active." Nature. 1980 Oct 2;287(5781):411-6. Goeddel DV et al., "Expression in Escherichia coli of chemically synthesized genes for human insulin." Proc Natl Acad Sci U S A. 1979 Jan;76(1):106-10. Goldwasser E et al., "On the mechanism of erythropoietin-induced differentiation. 13. The role of sialic acid in erythropoietin action." J Biol Chem. 1974 Jul 10;249(13):4202-6. Goldwasser E et al., "Progress in the purification of erythropoietin." Ann N Y Acad Sci. 1968 Mar 29;149(1):49-53. Goldwasser E., "From protein to gene to protein: the molecular biology of erythropoietin." Am J Kidney Dis. 1991 Oct;18(4 Suppl 1):10-3. Review. Gooche CF et al., Evironmental effects on protein glycosylation. Biotechnology (N Y). 1990 May;8(5):421-7. Review Gooche CF et al. "The oligosaccharides of glycoproteins: bioprocess factors affecting oligosaccharide structure and their effect on glycoprotein properties." Biotechnology (N Y). 1991 Dec;9(12):1347-55. Review Goto M et al., "Production of recombinant human erythropoietin in mammalian cells: host-cell dependency of the biological activity of the cloned glycoprotein." Biotechnology (N Y). 1988 Jan;6:67-71. Gottschalk A., "Biosynthesis of glycoproteins and its relationship to heterogeneity." Nature. 1969 May 3;222(5192):452-4. N/A AM-ITC 00982905AM-ITC 00982910 N/A N/A AM-ITC 00007477AM-ITC 00007483 N/A AM-ITC 00007484AM-ITC 00007490 AM-ITC 00013701AM-ITC 00013706 AM-ITC 00013741AM-ITC 00013746 AM-ITC 01054161AM-ITC 01054165 AM-ITC 00013810AM-ITC 00013814 AM-ITC 00005349AM-ITC 00005353 AM-ITC 00022574AM-ITC 00022577 AM-ITC 00013847AM-ITC 00013853 AM-ITC 00018254AM-ITC 00018262 AM-ITC_00266043AM-ITC_00266047 N/A

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Gough NM et al., "Immunoprecipitation of specific polysomes using Staphylococcus aureus: purification of the immunoglobulin k chain messenger RNA from the mouse myeloma MPC11." Biochemistry. 1978 Dec 12;17(25):5560-6. Gralnick HR et al., "Role of carbohydrate in multimeric structure of factor VIII/von Willebrand factor protein." Proc Natl Acad Sci U S A. 1983 May;80(9):2771-4. Gray PW et al., "Cloning and expression of murine immune interferon cDNA." Proc Natl Acad Sci U S A. 1983 Oct;80(19):5842-6. Gray PW et al., "Expression of human immune interferon cDNA in E. coli and monkey cells." Nature. 1982 Feb 11;295(5849):503-8. Gray PW et al., "Two interleukin 1 genes in the mouse: cloning and expression of the cDNA for murine interleukin 1 beta." J Immunol. 1986 Dec 1;137(11):36448. Green ED et al., "Asparagine-linked oligosaccharides on lutropin, follitropin, and thyrotropin. I. Structural elucidation of the sulfated and sialylated oligosaccharides on bovine, ovine, and human pituitary glycoprotein hormones." J Biol Chem. 1988 Jan 5;263(1):25-35. Green ED et al., "Asparagine-linked oligosaccharides on lutropin, follitropin, and thyrotropin. II. Distributions of sulfated and sialylated oligosaccharides on bovine, ovine, and human pituitary glycoprotein hormones." J Biol Chem. 1988 Jan 5;263(1):36-44. Green ED et al., "Biosynthesis of sulfated asparagine-linked oligosaccharides on bovine lutropin." J Biol Chem. 1986 Dec 15;261(35):16309-16. Green ED et al., "Cell-free sulfation of human and bovine pituitary hormones. Comparison of the sulfated oligosaccharides of lutropin, follitropin, and thyrotropin." J Biol Chem. 1985 Dec 15;260(29):15631-8. Green ED et al., "Differential processing of Asn-linked oligosaccharides on pituitary glycoprotein hormones: implications for biologic function." Mol Cell Biochem. 1986 Nov-Dec;72(1-2):81-100. Green ED et al., "Structural requirements for sulfation of asparagine-linked oligosaccharides of lutropin." Proc Natl Acad Sci U S A. 1985 Dec;82(23):78504. Gutterman JU et al., "Recombinant leukocyte A interferon: pharmacokinetics, single-dose tolerance, and biologic effects in cancer patients."Ann Intern Med. 1982 May;96(5):549-56. Harris TJR., "Second-generation plasminogen activators." Protein Eng. (1987) Dec;1(6):449-58. Review. Hartman JB et al., "Human influenza virus hemagglutinin is expressed in monkey cells using simian virus 40 vectors." Proc Natl Acad Sci U S A. 1982 Jan;79(2):233-7. Haselbeck A et al., "Structural characterization of glycoprotein carbohydrate chains by using diagoxigenin-labeled lectins on blots." Anal Biochem. 1990 Nov 15;191(1):25-30. AM-ITC 00013888AM-ITC 00013894 N/A AM-ITC 00277572AM-ITC 00277577 AM-ITC 00153899AM-ITC 00153904 N/A

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Haselbeck A., "Epoetins: differences and their relevance to immunogenicity." Curr Med Res Opin. 2003;19(5):430-2. Haynes et al., "Constitutive, long-term production of human interferons by hamster cells containing multiple copies of a cloned interferon gene." Nucleic Acids Res. 1983 Feb 11;11(3):687-706. Haynes J et al., "Production of a glycosylated human protein by recombinant DNA technology." Humoral Factors in Host Defense; 11-129. Higuchi M et al., "Role of sugar chains in the expression of the biological activity of human erythropoietin." J Biol Chem. 1992 Apr 15;267(11):7703-9. Hitzeman RA et al., "Expression of a human gene for interferon in yeast." Nature. 1981 Oct 29; 293(5835):717-22. HItzeman RA et al., "Expression of hepatitis B virus surface antigen in yeast." Nucleic Acids Res. 1983 May 11;11(9):2745-63. Hitzeman RA et al., "Isolation and characterization of the yeast 3phosphoglycerokinase gene (PGK) by an immunological screening technique." J Biol Chem. 1980 Dec 25;255(24):12073-80. Hitzeman RA et al., "Secretion of human interferons by yeast." Science. 1983 Feb 11;219(4585):620-5. Hokke CH et al., "Sialylated carbohydrate chains of recombinant human glycoproteins expressed in Chinese hamster ovary cells contain traces of Nglycolylneuraminic acid." FEBS Lett. 1990 Nov 26;275(1-2):9-14. Hokke CH et al., "Structural analysis of the sialylated N- and O-linked carbohydrate chains of recombinant human erythropoietin expressed in Chinese hamster ovary cells. Sialylation patterns and branch location of dimeric Nacetyllactosamine units." Eur J Biochem. 1995 Mar 15;228(3):981-1008. Hooper LV et al., "From legumes to leukocytes: biological roles for sulfated carbohydrates." FASEB J. 1996 Aug;10(10):1137-46. Hsieh P et al., "Host-dependent variation of asparagine-linked oligosaccharides at individual glycosylation sites of Sindbis virus glycoproteins." J Biol Chem. 1983 Feb 25;258(4):2548-54. Imai N et al., "Physicochemical and biological characterization of asialoerythropoietin. Suppressive effects of sialic acid in the expression of biological activity of human erythropoietin in vitro." Eur J Biochem. 1990 Dec 12;194(2):457-62. Imai N et al., "Physicochemical and biological comparison of recombinant human erythropoietin with human urinary erythropoietin." J Biochem (Tokyo). 1990 Mar;107(3):352-9. Inoue N et al., "Structures of mucin-type sugar chains on human erythropoietins purified from urine and the culture medium of recombinant Chinese hamster ovary cells." Arch Biochem Biophys. 1993 Mar;301(2):375-8. Inoue N et al., "The production of recombinant human erythropoietin." Biotechnol Annu Rev. 1995;1:297-313. Irie A et al., "The molecular basis for the absence of N-glycolylneuraminic acid in humans." J Biol Chem. 1998 Jun 19;273(25):15866-71. N/A N/A AM-ITC 00169080AM-ITC 00169098 N/A AM-ITC 01054232AM-ITC 01054237 N/A N/A N/A AM-ITC 00360052AM-ITC 00360065 AM-ITC 01014123AM-ITC 01014150 N/A N/A

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AM-ITC 00102067AM-ITC 00102073 AM-ITC 00103319AM-ITC 00103322 N/A AM-ITC 01015014AM-ITC 01015024 AM-ITC 01015044AM-ITC 01015053 N/A AM-ITC 00015853AM-ITC 00015858

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Yuen CT et al., "Relationships between the N-glycan structures and biological activities of recombinant human erythropoietins produced using different culture conditions and purification procedures." Br J Haematol. 2003 May;121(3):51126. Yuen CT et al., "Relationships between the N-glycan structures and biological activities of recombinant human erythropoietins produced using different culture conditions and purification procedures." Adv Exp Med Biol. 2005;564:141-2. Zamarron C et al., "Kinetics of the activation of plasminogen by natural and recombinant tissue-type plasminogen activator." J Biol Chem. 1984 Feb 25;259(4):2080-3. Zhang X et al., "Stable expression of human alpha-2,6-sialyltransferase in Chinese hamster ovary cells: functional consequences for human erythropoietin expression and bioactivity." Biochim Biophys Acta. 1998 Nov 27;1425(3):44152. Jelkman, W. "The enigma of the metabolic fate of circulating erythropoietin (Epo) in view of the pharmacokinetics of the recombinant drugs rhEpo and NESP" Eur. J. Haemotol. 2002 69:265-274 ACTIVASE Product Label CERA pamphlet copies US Patent 6,583,272: Human Tissue Plasminogen Activator Bailon et al. Amgen v. Chugai, 13 U.S.P.Q.2d 1737 (D. Mass. 1989), aff'd in relevant part 927 F.2d 1200 (Fed. Cir. 1991) Fritsch v. Lin 21 USPQ.2d (BNA) 1739 (Process Interference) Fritsch v. Lin 21 USPQ.2d (BNA) 1737 ({Product Interference) Fritsch v. Lin 21 USPQ.2d (BNA) 1731 Brief for the Senior Party Lin (Interference No. 102,097) USDC ­ Lodish Infringement Report EPO Timetable TKT Exhibit AH - Parent Applications for U.S. Patent No. 5,547,933 (024; 185; 841; 298) `933 Color Coded Patent Specification U.S. Patent Prosecution 675,298 Watson J.D., "Molecular Biology of the Gene 3rd Ed. (WA Benjamin, Inc. Menlo Park at 703 Varki et al., "Essentials of Glycobiology" Cold Spring Harbor Labs (1999)

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AM44 1591670-679 N/A N/A N/A N/A N/A N/A N/A AM-ITC 00337649AM-ITC 00337715 N/A AM-ITC 00164462-470 AM-ITC 00948381-441, 00470468-531, 00470717-813, 00447565-385 N/A AM-ITC 00873340-803 N/A AM-ITC 01015154-799 at 784, 782 N/A

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