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

Filing 1209

MOTION for Clarification Defendants' Motion For Clarification of the Court's Ruling on Roche's Motion to Admit Exhibits Into Evidence by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C)(Fleming, Thomas)

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

Doc. 1209 Att. 2

Case 1:05-cv-12237-WGY

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EXHIBIT B

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Case 1:05-cv-12237-WGY

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

AMGEN INC., Plaintiff, v. F. HOFFMANN-LA ROCHE LTD ROCHE DIAGNOSTICS GmbH and HOFFMANN-LA ROCHE INC. Defendants.

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CIVIL ACTION No.: 05-CV-12237WGY

DEFENDANTS' 35 U.S.C. § 282 NOTICE Pursuant to 35 U.S.C. § 282, Defendants F. Hoffmann-La Roche LTD, Roche Diagnostics GmbH, and Hoffmann-La Roche Inc. (collectively "Roche") hereby give notice of (i) each patent and publication that may be "relied upon as anticipation of [a] patent­in­suit or . . . as showing the state of the art," and (ii) the names and addresses of each person "who may be relied upon as the prior inventor or as having prior knowledge of or as having previously used or offered for sale the invention of [a] patent­in­suit." With respect to United States Patent Nos. 5,441,868, 5,618,698, 5,756,349, 5,955,422 and 5,547,933 (the "patents-in-suit"), Roche gives notice of the following patents, publications, and persons: A. Patents Description DE 3316297 A1 - Goeddel and Pennica, Human tissue plasminogen activator, pharmaceutical compositions containing it, processes for making it, and DNA and transformed cell

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Description Lappin et al., "The Effect of Erythropoietin and Other Factors on DNA synthesis by Mouse Spleen Cells," Exp. Hematol., 11(7), 661-666 (Aug. 1983) Lasky et al., "Production of an HSV Subunit Vaccine by Genetically Engineered Mammalian Cell Lines," Modern Approaches to Vaccines, pp. 189-194, Chanock et al., eds. Cold Spring Harbor Lab. (1984) Lasne et al., "Detection of isoelectric profiles of erythropoietin in urine: differentiation of natural and administered recombinant hormones," Anal. Biochem. 311: 119-126 (2002) Lasne et al., "Recombinant erythropoietin in urine" Nature 405: 635 (2000) Lathe, "Synthetic Oligonucleotide Probes Deduced from Amino Acid Sequence Data," J. Mol. Biol. 183, 1-12 (1985) Lau et al., "Amplification and expression of human ­globin genes in Chinese hamster ovary cells," Mol. Cell. Biol. 4:1469­75 (1984) Laub and Ritter, "Expression of the Human Insulin Gene and cDNA in a Heterologous Mammalian System," J. Biol. Chem., 258(10), 6043-6050 (May 25, 1983) Laub et al., "Synthesis of Hepatitis B Surface Antigen in Mammalian Cells: Expression of the Entire Gene and the Coding Region," J. Virol., 48(1), 271-280 (1983) Lauffer et al., "Topology of signal recognition particle receptor in endoplasmic reticulum membrane," Nature 318, 334-338 (1985) Lawn et al., "The Isolation and Characterization of Linked.delta.- and.beta.-Globin Genes from a Cloned Library of Human DNA," Cell, 15, 1157-1174 (Dec. 1978) Ledeen et al., "Gangliosides: Structure, Isolation, and Analysis," Methods in Enzymology, 83 (Part D), 139-191 (1982) Lee-Huang, "A New Preparative Method for Isolation of Human Erythropoietin With Hydrophobic Interaction Chromatography," Blood, 56(4), 620-624 (1980) Lee-Huang, "Cloning and Expression of Human EPO cDNA in E. Coli, " Proc. Natl. Acad. Sci. (USA), 81, 2708-2712 (1984) Lee-Huang, "Cloning of Human Erythropoietin," Biophysical U. 45(Part 2 of 2), ABT. M-PMA12, p. 30a (1984) Lee-Huang, "Monoclonal Antibodies to Human Erythropoietin," Abstract No. 1463, Fed. Proc., 41, 520 (1982) Lee-Huang, "The Erythropoietin Gene," Oncogenes, Genes and Growth Factors, Chap. 7, pp. 199-222, ed. Gordon Garaff, John Wiley & Sons, Inc. (1987) Lehninger, AL, "Proteins: Purification and Characterization," in Biochemistry, 2d. Ed. 157-182 (1975) Lerner et al., "Antibodies to Chemically Synthesized Peptides Predicted from DNA Sequences as Probes of Gene Expression," Cell, 23, 309-310 (1981) Lerner et al., "Chemically synthesized peptides predicted from the nucleotide sequence of the hepatitis B virus genome elicit antibodies reactive with the native envelope protein of Dane particles," P.N.A.S. (USA), 78(6), 3403-3407 (1981) Lerner, "Synthetic Vaccines," Scientific American, 248(2), 66-74 (1983) Lewin Genes, 1983, John Wiley & Sons, p. 307. Li et al., "Biosynthesis of lipid­linked oligosaccharides," J. Biol. Chem. 254:1600­05 (1979)

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Description Ullrich et al., "Insulin-like growth factor I receptor primary structure: comparison with insulin receptor suggests structural determinants that define functional specificity," EMBO J., 5(10), 2503-2512 (1986) Ullrich et al., "Isolation of the Human Insulin-like Growth Factor I Gene Using a Synthetic DNA Probe," EMBO J. 3: 361-364 (February 1984) Ullrich et al., "Rat Insulin Genes: Construction of Plasmids Containing the Coding Sequences," Science, 196, 1313-1319 (1977) Urabe et al., "The Influence of Steroid Hormone Metabolites on the In Vitro Development of Erythroid Colonies Derived from Human Bone Marrow," J. Exp. Med., 149, 1314-1325 (Jun. 1979) Urlaub & Chasin, "Isolation of Chinese hamster cell mutants deficient in dihydrofolate reductase activity," Proc. Nat'l. Acad. Sci. 77:4216­20 (1980) Van der Ploeg et al., "DNA Methylation in the Human.gamma..delta..beta.-Globin Locus in Erythroid and Nonerythroid Tissues," Cell, 19, 947-958 (Apr. 1980) Van Stone et al., "Effect of erythropoietin on anemia of peritoneally dialyzed anephric rats," Kidney Int'l., 15, 370-375 (1979) Vedovato et al., "Erythropoietin Levels in Heterozygous Beta-Thalassemia," Acta. Haematol., 71, 211-213 (1984) Veronese et al., "Anti-Inflammatory and Pharmacokinetic Properties of Superoxide Dismutase Derivatized with Polyethylene Glycol Via Active esters," J. Pharm. Pharmacol., 35: pp. 757-8 (1983) Veronese et al., "Surface Modifications of Proteins. Activation of Monomethoxy-polyethylene glycols by Phenylchloroformates and Modifications of Ribonuclease and Superoxide Dismutase," Appl. Biochem. Biotechnol., 11:141-152 (1985) Vichinsky et al., "Inadequate erythroid response to hypoxia in cystic fibrosis," J. Pediatr., 105(1), 15-21 (Jul. 1984) Vieira et al., "The pUC plasmids, an M13mp7-derived system for insertion mutagenesis and sequencing with synthetic universal primers," Gene, 19, 259-268 (1982) Villasante et al., "Binding of microtubule protein to DNA and chromatin: possibility of simultaneous linkage of microtubule to nucleic acid and assembly of the microtubule structure," Nucleic Acids Res, 9(4), 895 (1981) Walker et al., Techniques in Molecular Biology, Macmillan Pub. Co., N.Y., p. 280 (1983) Wallace et al., "A set of synthetic oligodeoxyribonucleotide primers for DNA sequencing in the plasmid vector pBR322," Gene, 16, 21-26 (1981) Wallace et al., "Directed Deletion of a Yeast Transfer RNA Intervening Sequence," Science, 209, 1396-1400 (1980) Wallace et al., "Hybridization of synthetic oligodeoxyribonucleotides to phi x 174 DNA," Nucleic Acids Res. 6(11):3543­57 (1979) Wallace et al., "Oligonucleotide Directed Mutagenesis of the Human.beta.-globin gene: A General Method for Producing Specific Point Mutations in cloned DNA," Nucleic Acids Research, 9(15), 3647-3657 (1981) Wallace et al., "The use of synthetic oligonucleotides as hybridization probes. II Hybridization

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16.

Thomas Strickland, Ph.D. Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320­1730 Daniel Vapnek, Ph.D. Avigen, Inc. 1301 Harbor Bay Parkway Alameda, CA 94502 USA

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D.

Other Description

Abstract Submission to American Federation of Clinical Research (November 1982) (FG 0000051­52) Activities by Dr. Daniel Shouval and colleagues during 1981 through 1986 concerning development and characterization of EPO producing cells (including the RC­1 cell line and EPO producing tumors, and experiments documented in DS0000001­112) Activities by Dr. Franklin Gaylis and colleagues during 1982 through 1984 concerning development and characterization of EPO producing cells (1411H), including communications between Dr. Gaylis and Amgen (Joan Egrie), Biogen (Fred Asselberg) and Dr. Eugene Goldwasser Activities by Dr. James Fisher and colleagues during 1981 through 1985 concerning development and characterization of EPO producing cells (including EPO producing cell lines and tumors) Activities from 1981 through 1985 conducted by and/or on behalf of Biogen concerning the cloning, characterization and expression of the human erythropoietin gene Activities from 1981 through 1985 conducted by and/or on behalf of Genetics Institute concerning the cloning, characterization and expression of the human erythropoietin gene Dordal M, Thesis (AM-ITC 00925913-926021) Gaylis Grant Application (February 1983) [FG 000033­45] Genentech Press Release, "Genentech has begun human evaluation of t-PA in heart victims," (2/21/84) accessible at http://www.gene.com/gene/news/press-releases/ Genentech, Inc., Product License Application for ActivaseTM (Recombinant Human Tissue­ Type Plasminogen Activator, rt­PA) clinical and pre­clinical study summaries (ROCHE­GNE 00001­00036, 00094­00136,00383­00578, 01277­01446, 01447­01959, 03009­03060) Goldwasser and Baron, Hamster studies with human urinary erythropoietin (1978) (AM-ITC 01006678-6752) Goldwasser Application for Continuation of Grant (Dept. of Health and Human Servs.), "Erythropoietin:Purification, Properties, Biogenesis" (August 31, 1984)

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