The detailed information for PTAB case with proceeding number IPR2018-01714 filed by Alvogen Pine Brook LLC et al. against Celgene Corporation on Sep 12, 2018. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2018-01714
Filing Date
Sep 12, 2018
Petitioner
Alvogen Pine Brook LLC et al.
Respondent
Celgene Corporation
Status
Institution Denied
Respondent Application Number
10438213
Respondent Tech Center
1600
Respondent Patent Number
7968569
Institution Decision Date
Mar 14, 2019

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Notice of Refund

Dec 17, 2019PAPERBOARD

Petitioner's Request for Refund of Post-Institution Fees

Dec 11, 2019PAPERPETITIONER

Trial Instituted Document

Mar 14, 2019PAPERBOARD

Patent Owner Preliminary Response

Dec 18, 2018PAPERPATENT OWNER

Ex. 2003 (Hatch Act)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2005 (Barker)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2007 (Fishman)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2001 (Hideshima 2008)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2002 (August 2018 Guide)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2004 (Merck)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2006 (Lynch)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2008 (File History Excerpt)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2009 (Marriott 2002)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2010 (Zangari 2001)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2011 (Zangari 2003)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2013 (Remes)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2014 (Barlogie 1991)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2012 (Gordon)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2015 (Harousseau et al 1992)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2016 (Lokhorst et al 1992)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2017 (Troussard)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2019 (Goudarzipour et al 2013)

Dec 18, 2018EXHIBITPATENT OWNER

Ex. 2018 (Weick 2002)

Dec 18, 2018EXHIBITPATENT OWNER

Patent Owner's Mandatory Notices

Oct 3, 2018PAPERPATENT OWNER

Patent Owner Power of Attorney

Oct 3, 2018PAPERPATENT OWNER

Notice of Accord Filing Date

Sep 18, 2018PAPERBOARD

Petition for Inter Partes Review of US Patent No. 7,968,569

Sep 12, 2018PAPERPETITIONER

Power of Attorney

Sep 12, 2018PAPERPETITIONER

Sampaio et al., "Thalidomide selectively inhibits tumor necrosis factor alpha production by stimulated human monocytes," J. Exp. Med., 173(3): 699-703 (1991).

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

Singhal et al., "Antitumor Activity of Thalidomide in Refractory Multiple Myeloma," N. Engl. J. Med., 341:1565-1571 (1999)

Sep 12, 2018EXHIBITPETITIONER

Durie & Stepan, "Efficacy of Low Dose Thalidomide in Multiple Myeloma," Electronic Journal of Oncology, 1:1-8 (2000).

Sep 12, 2018EXHIBITPETITIONER

U.S. Patent No. 7,968,569 ("the '569 patent")

Sep 12, 2018EXHIBITPETITIONER

Prosecution History excerpts for U.S. Patent No. 7,968,569

Sep 12, 2018EXHIBITPETITIONER

Expert Declaration of Dr. Guido Tricot

Sep 12, 2018EXHIBITPETITIONER

Muller et al., "Amino-substituted Thalidomide Analogues: Potent Inhibitors of TNF-¿¿ Productions," Bioorganic & Medicinal Chemistry Letters, 9:1625-1630 (1999).

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

Corral & Kaplan, "Immunomodulation by thalidomide and thalidomide analogues," Ann. Rheum. Dis., 58: I107-I113 (1999).

Sep 12, 2018EXHIBITPETITIONER

Celgene Corp., Press Release, August 28, 2001.

Sep 12, 2018EXHIBITPETITIONER

Celgene Corp., "Celgene Corporation Receives Orphan Drug Designation for Revimid(TM) For Multiple Myeloma," October 8, 2001.

Sep 12, 2018EXHIBITPETITIONER

Hideshima, et al., "Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy," Blood, 96:2943-2950 (2000).

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

Celesti et al., "The association of cyclophosphamide and dexamethasone in advanced refractory multiple myeloma patients," Haematologica, 82(3):351-353 (1997).

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

Rajkumar & Kyle, "Thalidomide in the Treatment of Plasma Cell Malignancies," J. of Clinical Oncology, 19(16):3593-3595 (Aug. 2001).

Sep 12, 2018EXHIBITPETITIONER

Celgene Corp., Press Release, May 8, 2001.

Sep 12, 2018EXHIBITPETITIONER

Palumbo, et al, "Low-dose thalidomide plus dexamethasone is an effective salvage therapy for advanced myeloma," Hematologica, 86(4):399-403 (April 2001).

Sep 12, 2018EXHIBITPETITIONER

V. T. DeVita, Jr., "Chapter 16: Principles of Chemotherapy," Cancer: Principles and Practice of Oncology, Fourth Edition (1993).

Sep 12, 2018EXHIBITPETITIONER

Jacobs et al., "Prednisone in MOPP chemotherapy for Hodgkin's disease," Br. Med. J., 2:1469-1471 (1976).

Sep 12, 2018EXHIBITPETITIONER

Koo et al., "Vancomycin-induced neutropenia," Drug Intell. Clin. Pharm., 20(10):780-782 (1986).

Sep 12, 2018EXHIBITPETITIONER

Cytovene¿¿-IV, Physicians' Desk Reference 2623-2629 (54th ed. 2000)

Sep 12, 2018EXHIBITPETITIONER

Revlimid Label

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

Pomalyst Label

Sep 12, 2018EXHIBITPETITIONER

U.S. Patent No. 6,281,230 ("the '230 Patent")

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

Rajkumar, S.V., et al., "Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma," Blood, 106:4050-4053 (2005)

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

Weber, D., et al., "Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America," N. Engl. J. Med. 357(21):2133-2142 (2007)

Sep 12, 2018EXHIBITPETITIONER

Palumbo, A., et al., "Lenalidomide: A new therapy for multiple myeloma," Cancer Treatment Reviews 34:283-291 (2008)

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

Malpas, "Management of Multiple Myeloma," Br Med J., 2:163-165 (1969)

Sep 12, 2018EXHIBITPETITIONER

Palmer et al., "Dose Intensity Analysis of Melphalan and Prednisone in Multiple Myeloma" J Natl Cancer Inst, 80:414-418 (1988)

Sep 12, 2018EXHIBITPETITIONER

Oken et al., "Contribution of Prednisone to the Effectiveness of Hexamethylmelamine in Multiple Myeloma," Cancer Treatment Reports, 71:807-811 (1987)

Sep 12, 2018EXHIBITPETITIONER

Bell et al., "Chapter 5. The Hematopoietic System and Development of Blood Cells," The Johns Hopkins Atlas of Human Functional Anatomy, 4th ed. 1997

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

Moreira et al., "Thalidomide exerts its inhibitory action on tumor necrosis factor alpha by enhancing mRNA degradation," J Exp Med., 177:1675-1680 (1993)

Sep 12, 2018EXHIBITPETITIONER

Barlogie et al., "Effective treatment of advanced multiple myeloma refractory to alkylating agents," N Engl J Med., 310(21):1353-1356 (1984).

Sep 12, 2018EXHIBITPETITIONER

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).

Sep 12, 2018EXHIBITPETITIONER

J. Blade and J. Esteve, "Treatment Approaches for Relapsing and Refractory Multiple Myeloma," Acta Oncologica, 39(7):843-847 (2000).

Sep 12, 2018EXHIBITPETITIONER

Dimopoulos, M., et al., "Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma," N. Engl. J. Med. 357(21):2123-2132 (2007)

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

Armoiry, X., et al., "Lenalidomide in the treatment of multiple myeloma: a review," J. Clin. Pharm. Ther. 33:219-226 (2008)

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

Gennaro, A., Remington: The Science and Practice of Pharmacy, 20th Edition (2000)

Sep 12, 2018EXHIBITPETITIONER

U.S. Provisional Application No. 60/380,842

Sep 12, 2018EXHIBITPETITIONER

Affidavit of Christopher Butler, Internet Archive

Sep 12, 2018EXHIBITPETITIONER

Declaration of James L. Mullins, Ph.D. (Part 1 of 5)

Sep 12, 2018EXHIBITPETITIONER

Declaration of James L. Mullins, Ph.D. (Part 2 of 5)

Sep 12, 2018EXHIBITPETITIONER

Declaration of James L. Mullins, Ph.D. (Part 3 of 5)

Sep 12, 2018EXHIBITPETITIONER

Declaration of James L. Mullins, Ph.D. (Part 5 of 5)

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

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)

Sep 12, 2018EXHIBITPETITIONER

Declaration of James L. Mullins, Ph.D. (Part 4 of 5)

Sep 12, 2018EXHIBITPETITIONER

21 C.F.R. 300-499 (as of April 1, 2001)

Sep 12, 2018EXHIBITPETITIONER

Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook LLC's First Set of Requests for Admission (Nos. 1-3)

Sep 12, 2018EXHIBITPETITIONER

Lotus Pharmaceutical Co., Ltd. and Alvogen Pine Brook LLC's First Set of Interrogatories (Nos. 1-31)

Sep 12, 2018EXHIBITPETITIONER

Malpas and Rohatiner, "Principles of Cancer Chemotherapy," Advances in Oncology 1:317-350 (1996)

Sep 12, 2018EXHIBITPETITIONER

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Patent and Exclusivity for: N021880

Sep 12, 2018EXHIBITPETITIONER