Date Field | Doc. No. | Party | Description |
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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 |