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Case number IPR2018-01714

Alvogen Pine Brook LLC v. Celgene Corporation > Documents

Date Field Doc. No.PartyDescription
Dec 17, 2019 9 Notice of Refund Download
Dec 11, 2019 8 Petitioner's Request for Refund of Post-Institution Fees Download
Mar 14, 2019 7 Trial Instituted Document Download
Dec 18, 2018 2014 Ex. 2014 (Barlogie 1991) Download
Dec 18, 2018 2002 Ex. 2002 (August 2018 Guide) Download
Dec 18, 2018 2011 Ex. 2011 (Zangari 2003) Download
Dec 18, 2018 2013 Ex. 2013 (Remes) Download
Dec 18, 2018 2005 Ex. 2005 (Barker) Download
Dec 18, 2018 2006 Ex. 2006 (Lynch) Download
Dec 18, 2018 2019 Ex. 2019 (Goudarzipour et al 2013) Download
Dec 18, 2018 2016 Ex. 2016 (Lokhorst et al 1992) Download
Dec 18, 2018 2008 Ex. 2008 (File History Excerpt) Download
Dec 18, 2018 2010 Ex. 2010 (Zangari 2001) Download
Dec 18, 2018 2003 Ex. 2003 (Hatch Act) Download
Dec 18, 2018 2017 Ex. 2017 (Troussard) Download
Dec 18, 2018 2007 Ex. 2007 (Fishman) Download
Dec 18, 2018 6 Patent Owner Preliminary Response Download
Dec 18, 2018 2018 Ex. 2018 (Weick 2002) Download
Dec 18, 2018 2001 Ex. 2001 (Hideshima 2008) Download
Dec 18, 2018 2004 Ex. 2004 (Merck) Download
Dec 18, 2018 2012 Ex. 2012 (Gordon) Download
Dec 18, 2018 2009 Ex. 2009 (Marriott 2002) Download
Dec 18, 2018 2015 Ex. 2015 (Harousseau et al 1992) Download
Oct 3, 2018 4 Patent Owner's Mandatory Notices Download
Oct 3, 2018 5 Patent Owner Power of Attorney Download
Sep 18, 2018 3 Notice of Accord Filing Date Download
Sep 12, 2018 1021 Gordon et al., "A Phase I Trial of Recombinant Human Interleukin-11 (Neumega rhIL-11 Growth Factor) in Women With Breast Cancer Receiving Chemotherapy," Blood J., 87: 3615-3624 (1996). Download
Sep 12, 2018 1060 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Patent and Exclusivity for: N021880 Download
Sep 12, 2018 1004 Sampaio et al., "Thalidomide selectively inhibits tumor necrosis factor alpha production by stimulated human monocytes," J. Exp. Med., 173(3): 699-703 (1991). Download
Sep 12, 2018 1054 Affidavit of Christopher Butler, Internet Archive Download
Sep 12, 2018 1044 Dimopoulos, M.A., et al., "Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma," Leukemia 23:2147-2152 (2009) Download
Sep 12, 2018 1036 Rajkumar, S.V., et al., "Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma," Blood, 106:4050-4053 (2005) Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 5 of 5) Download
Sep 12, 2018 1013 Celgene Corp., Press Release, August 28, 2001. Download
Sep 12, 2018 1040 Weber, D., et al., "Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America," N. Engl. J. Med. 357(21):2133-2142 (2007) Download
Sep 12, 2018 1057 Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook LLC's First Set of Requests for Admission (Nos. 1-3) Download
Sep 12, 2018 1026 Revlimid Label Download
Sep 12, 2018 1041 Armoiry, X., et al., "Lenalidomide in the treatment of multiple myeloma: a review," J. Clin. Pharm. Ther. 33:219-226 (2008) Download
Sep 12, 2018 1028 U.S. Patent No. 6,281,230 ("the '230 Patent") Download
Sep 12, 2018 1011 Rajkumar & Kyle, "Thalidomide in the Treatment of Plasma Cell Malignancies," J. of Clinical Oncology, 19(16):3593-3595 (Aug. 2001). Download
Sep 12, 2018 1022 Celesti et al., "The association of cyclophosphamide and dexamethasone in advanced refractory multiple myeloma patients," Haematologica, 82(3):351-353 (1997). Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 5 of 5) Download
Sep 12, 2018 1059 Malpas and Rohatiner, "Principles of Cancer Chemotherapy," Advances in Oncology 1:317-350 (1996) Download
Sep 12, 2018 1052 U.S. Provisional Application No. 60/380,842 Download
Sep 12, 2018 1037 Dimopoulos, M., et al., "Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma," N. Engl. J. Med. 357(21):2123-2132 (2007) Download
Sep 12, 2018 1045 Gandhi, A.K., "Dexamethasone Synergizes with Lenalidomide to Inhibit Multiple Myeloma Tumor Growth, But Reduces Lenalidomide-Induced Immunomodulation of T and NK Cell Function," Curr. Cancer Drug Targets, 10:155-167 (2010) Download
Sep 12, 2018 1056 21 C.F.R. 300-499 (as of April 1, 2001) Download
Sep 12, 2018 1027 Pomalyst Label Download
Sep 12, 2018 1006 Singhal et al., "Antitumor Activity of Thalidomide in Refractory Multiple Myeloma," N. Engl. J. Med., 341:1565-1571 (1999) Download
Sep 12, 2018 1017 V. T. DeVita, Jr., "Chapter 16: Principles of Chemotherapy," Cancer: Principles and Practice of Oncology, Fourth Edition (1993). Download
Sep 12, 2018 1047 Palmer et al., "Dose Intensity Analysis of Melphalan and Prednisone in Multiple Myeloma" J Natl Cancer Inst, 80:414-418 (1988) Download
Sep 12, 2018 1005 Tramontana et al., "Thalidomide Treatment Reduces Tumor Necrosis Factor ¿¿ Production and Enhances Weight Gain in Patients with Pulmonary Tuberculosis," Molecular Medicine, 1:384-397 (1995) Download
Sep 12, 2018 1007 Durie & Stepan, "Efficacy of Low Dose Thalidomide in Multiple Myeloma," Electronic Journal of Oncology, 1:1-8 (2000). Download
Sep 12, 2018 1042 Morgan J. et al., "Overall survival with dexamethasone in phase III multiple myeloma trials after adjustment for cross-over to lenalidomide," Haematologica 93(s1), Abstract 0441 (2008) Download
Sep 12, 2018 1003 Expert Declaration of Dr. Guido Tricot Download
Sep 12, 2018 1010 Corral & Kaplan, "Immunomodulation by thalidomide and thalidomide analogues," Ann. Rheum. Dis., 58: I107-I113 (1999). Download
Sep 12, 2018 1050 Gennaro, A., Remington: The Science and Practice of Pharmacy, 20th Edition (2000) Download
Sep 12, 2018 1048 Oken et al., "Contribution of Prednisone to the Effectiveness of Hexamethylmelamine in Multiple Myeloma," Cancer Treatment Reports, 71:807-811 (1987) Download
Sep 12, 2018 1039 Gay, F., et al., "Lenalidomide plus dexamethasone versus thalidomide plus dexamethasone in newly diagnosed multiple myeloma: a comparative analysis of 411 patients," Blood, 115:1343-1350 (2010) Download
Sep 12, 2018 1029 Parameswaran et al., "CCNU (lomustine), idarubicin and dexamethasone (CIDEX): an effective oral regimen for the treatment of refractory or relapsed myeloma," Br. J. Haematol., 109(3):571-575 (2000). Download
Sep 12, 2018 1035 J. Blade and J. Esteve, "Treatment Approaches for Relapsing and Refractory Multiple Myeloma," Acta Oncologica, 39(7):843-847 (2000). Download
Sep 12, 2018 1033 Marisavljevic et al., "Results of treatment of patients with advanced multiple myeloma with the vincristine-adriamycin-dexamethasone protocol," Srp Arh Celok Lek, 124(11-12):292-296 (1996). Download
Sep 12, 2018 2 Power of Attorney Download
Sep 12, 2018 1025 Imashuku et al., "Management of severe neutropenia with cyclosporin during initial treatment of Epstein-Barr virus-related hemophagocytic lymphohistiocytosis," Leuk. Lymphoma, 36(3-4):339-346 (2000). Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 5 of 5) Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 5 of 5) Download
Sep 12, 2018 1012 Celgene Corp., Press Release, May 8, 2001. Download
Sep 12, 2018 1031 Moreira et al., "Thalidomide exerts its inhibitory action on tumor necrosis factor alpha by enhancing mRNA degradation," J Exp Med., 177:1675-1680 (1993) Download
Sep 12, 2018 1015 Palumbo, et al, "Low-dose thalidomide plus dexamethasone is an effective salvage therapy for advanced myeloma," Hematologica, 86(4):399-403 (April 2001). Download
Sep 12, 2018 1049 Bell et al., "Chapter 5. The Hematopoietic System and Development of Blood Cells," The Johns Hopkins Atlas of Human Functional Anatomy, 4th ed. 1997 Download
Sep 12, 2018 1 Petition for Inter Partes Review of US Patent No. 7,968,569 Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 5 of 5) Download
Sep 12, 2018 1058 Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook LLC's First Set of Interrogatories (Nos. 1-31) Download
Sep 12, 2018 1043 Palumbo, A., et al., "Lenalidomide: A new therapy for multiple myeloma," Cancer Treatment Reviews 34:283-291 (2008) Download
Sep 12, 2018 1001 U.S. Patent No. 7,968,569 ("the '569 patent") Download
Sep 12, 2018 1016 Hideshima, et al., "Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy," Blood, 96:2943-2950 (2000). Download
Sep 12, 2018 1023 Koo et al., "Vancomycin-induced neutropenia," Drug Intell. Clin. Pharm., 20(10):780-782 (1986). Download
Sep 12, 2018 1020 Gebbia et al., "Single agent 2',2'-difluorodeoxycytidine in the treatment of metastatic urothelial carcinoma: a phase II study," La Clinica Terapeutica, 150(1):11-15 (1999). Download
Sep 12, 2018 1038 Lacy, M.Q., et al., "Long-term Results of Response to Therapy, Time to Progression, and Survival With Lenalidomide Plus Dexamethasone in Newly Diagnosed Myeloma," Mayo Clin. Proc. 82(10):1179-1184 (2007) Download
Sep 12, 2018 1019 Jacobs et al., "Prednisone in MOPP chemotherapy for Hodgkin's disease," Br. Med. J., 2:1469-1471 (1976). Download
Sep 12, 2018 1014 Celgene Corp., "Celgene Corporation Receives Orphan Drug Designation for Revimid(TM) For Multiple Myeloma," October 8, 2001. Download
Sep 12, 2018 1032 Barlogie et al., "Effective treatment of advanced multiple myeloma refractory to alkylating agents," N Engl J Med., 310(21):1353-1356 (1984). Download
Sep 12, 2018 1008 Muller et al., "Amino-substituted Thalidomide Analogues: Potent Inhibitors of TNF-¿¿ Productions," Bioorganic & Medicinal Chemistry Letters, 9:1625-1630 (1999). Download
Sep 12, 2018 1024 Cytovene¿¿-IV, Physicians' Desk Reference 2623-2629 (54th ed. 2000) Download
Sep 12, 2018 1002 Prosecution History excerpts for U.S. Patent No. 7,968,569 Download
Sep 12, 2018 1046 Malpas, "Management of Multiple Myeloma," Br Med J., 2:163-165 (1969) Download
Sep 12, 2018 1034 Browman et al., "Modified adriamycin-vincristine-dexamethasone (m-VAD) in primary refractory and relapsed plasma cell myeloma: an NCI (Canada) pilot study," Br. J. Haematol., 82(3):555-559 (1992). Download
Sep 12, 2018 1009 Corral et al., "Differential Cytokine Modulation and T Cell Activation by Two Distinct Classes of Thalidomide Analogues That are Potent Inhibitors of TNF-¿¿," J. Immunol., 163: 380-386 (1999). Download
Sep 12, 2018 1030 Bilgrami et al., "Dexamethasone, paclitaxel, etoposide, cyclophosphamide (d-TEC) and G-CSF for stem cell mobilisation in multiple myeloma," Bone Marrow Transplantation, 28:137-143 (July 2001). Download
Sep 12, 2018 1051 U.S. Food and Drug Administration, "List of Orphan Designations and Approvals," available at https://www.accessdata.fda.gov/scripts/opdlisting/oopd/ (published online and in print October 2001) Download
Sep 12, 2018 1053 Barlogie et al., "Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients," Blood 98(2):492-494 (July 2001) Download
Sep 12, 2018 1018 Enzinger et al., "Phase II clinical trial of 13-cis-retinoic acid and interferon-¿¿-2a in patients with advanced esophageal carcinoma," Cancer, 85:1213-1217 (1999). Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 1 of 5) Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 2 of 5) Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 4 of 5) Download
Sep 12, 2018 1055 Declaration of James L. Mullins, Ph.D. (Part 3 of 5) Download
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