CAFC Decision entered 12 Oct 2018 Affirmed | Mar 21, 2019 | PAPER | BOARD |
Decision Granting-in-Part Request for Rehearing from IPR2015-00830 | Dec 2, 2016 | PAPER | BOARD |
Final Written Decision IPR2015-00830 | Dec 2, 2016 | PAPER | BOARD |
VACATED Termination Decision Document | Sep 1, 2016 | PAPER | BOARD |
Decision Granting Institution and Granting Motion for Joinder | Dec 28, 2015 | PAPER | BOARD |
Order - Conduct of the Proceeding - 37 CFR 42.5 | Dec 11, 2015 | PAPER | BOARD |
Order - Conduct of the Proceeding - 37 C.F.R. 42.5 | Nov 20, 2015 | PAPER | BOARD |
Power of Attorney | Oct 16, 2015 | PAPER | INDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER. |
Related Matters | Oct 16, 2015 | PAPER | INDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER. |
Notice of Filing Date Accorded to Petition | Sep 29, 2015 | PAPER | BOARD |
Petition for Inter Partes Review of U.S. Patent No. 8,969,302 | Sep 25, 2015 | PAPER | PETITIONER |
Power of Attorney | Sep 25, 2015 | PAPER | PETITIONER |
Petitioners Motion For Joinder | Sep 25, 2015 | PAPER | PETITIONER |
AMNEAL 1001 U.S. Patent No. 8,969,302 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1002 File History for U.S. Patent No. 8,969,302 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1003 Declaration of, Curriculum Vitae of. And Materials Reviewed by Stephen J. Peroutka, M.D., Ph.D. | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1004 Expert Declaration of, Curriculum Vitae of, and Materials Reviewed by Ari Green, M.D. | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1005 Irit Pinchasi International Publication No. WO 2007081975 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1006 Cohen et al., Randomized, double blind, dose comparison study of glatiramer acetate in relapsing remitting | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1007 Affidavit of Marlene S. Bobka dated December 9, 2014 and Jessop, Review and Evaluation of Pharmacology Toxicology Data Original NDA Review 1996 the 1996 FDA SBOA attached as Exhibit A to Exh. 1007 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1008 Flechter et al., Copolymer 1 Glatiramer Acetate in Relapsing Forms of Multiple Sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1009 Meiner et al., Copolymer 1 in relapsing remitting multiple sclerosis a multi-centre trial | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1010 Khan et al., Randomized, prospective, rater-blinded, four year, pilot study to compare the effect of daily versus every other day glatiramer acetate 20 mg subcutaneous injections in relapsing-remitting multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1011 Caon et al., Randomized, Prospective, Rater-Blinded, Four Year Pilot Study to Compare the Effect of Daily Versus Every Other Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRM | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1012 Flechter et al., Comparison of glatiramer acetate Copaxone and interferon Betaferon in multiple sclerosis patients an open-label 2-year follow up | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1013 Miller, The importance of early diagnosis of multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1014 Bornstein, Multiple Sclerosis Trial of a Synthetic Polypeptide | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1015 Bornstein et al., Clinical Trial of Copolymer I in Multiple Sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1016 Bornstein et al., A Pilot Trial of COP 1 in Exacerbating Remitting Multiple Sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1017 FDA, GUIDELINE FOR INDUSTRY Dose Response Information to Support Drug Registration | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1018 Johnson, et al., Copolymer 1 reduces relapse rate and improves disability in relapsing remitting multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1019 Affidavit of Marlene S. Bobka dated January 5, 2015 and 1996 FDA Meeting Agenda minutes from the Peripheral and Central Nervous System Drug Advisory Committee dated September 19, 1996 Exhibit A to Exhibit 1019 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1020 Arnon, The development of Cop 1 Copaxone, an innovative drug for the treatment of multiple sclerosis personal reflections | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1021 Benet et al., Pharmacokinetics The Dynamics of Drug Absorption, Distribution, and Elimination | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1022 Lobel, et al., Copolymer 1, 21 2 DRUGS OF THE FUTURE | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1023 Haines et al., Linkage of the MHC to familial multiple sclerosis suggests genetic heterogeneity. The multiple sclerosis genetics group | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1024 U.S. Patent No. 6,342,476 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1025 Ge et al., Glatiramer acetate Copaxone treatment in relapsing remitting MS Quantitative MR assessment | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1026 Comi et al., European Canadian multicenter, double-blind, randomized, placebo controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1027 Boissel and Nony, Using pharmacokinetic-pharmacodynamic relationships to predict the effect of poor compliance, Clin. Pharmacol. 41 1 6 2002 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1028 McBride, Second International Multiple Sclerosis Week Multiple Sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1029 Simpson, Adis Drug Evaluation Glatiramer Acetate A Review of its use in Relapsing Remitting Multiple Sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1030 Edgar, et al., Lipoatrophy in Patients with Multiple Sclerosis on Glatiramer Acetate | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1031 Ziemssen et al., Effects of Glatiramer Acetate on Fatigue and Days of Absence from Work in First Time Treated Relapsing Remitting Multiple Sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1032 Stuart, Clinical Management of Multiple Sclerosis The Treatment Paradigm and Issues of Patient Management | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1033 Bakshi et al., Imaging of Multiple Sclerosis Role in Neurotherapeutics | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1034 Beringer et al., Clinical Pharmacokinetics and Pharmacodynamics, in REMINGTON | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1035 Franklin et al., Drug Absorption, Action, and Disposition, in REMINGTON | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1036 James Rasmussen International Patent Publication No. WO 2005120542 A2 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1037 Devonshire et al., The Global Adherence Project A multicentre observational study on adherence to disease modifying therapies in patients suffering from relapsing-remitting multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1038 Ford et al., A prospective open label study of glatiramer acetate over a decade of continuous use in multiple sclerosis patients | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1039 Frohman, Multiple Sclerosis The Plaque and its Pathogenesis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1040 Kragt et al., How similar are commonly combined criteria for EDSS progression in multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1041 Manso et al., Life cycle management of ageing pharmaceutical assets | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1042 Soares et al., Localized panniculitis secondary to subcutaneous glatiramer acetate injections for the treatment of multiple sclerosis a clinicopathologic and immunohistochemical | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1043 Klauer and Zettl, Compliance, adherence and the treatment of multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1044 Pelidou et al., Multiple sclerosis presented as clinically isolated syndrome the need for early diagnosis and treatment | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1045 Ziemssen et al., Effects of glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1046 Teva Provides Update on Forte Trial Jerusalem, Israel | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1047 Copaxone U.S. Product Label 2001 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1048 Betaseron U.S. Product Label 2003 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1049 Rebif U.S. Product Label 2003 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1050 Avonex Product Label 2006 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1051 Tysabri Product Label 2008 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1052 Copaxone U.S. Product Label 2009 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1053 Extavia Product Label 2009 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1054 Rebif U.S. Product Label 2005 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1055 US Patent No. 3,849,550 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1056 U.S. Patent Publication No. 20090149541A1 | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1057 Concepts in clinical pharmacokinetics, in Introduction To Pharmacokinetics And Pharmacodynamics | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1058 Rich et al., Stepped-care approach to treating MS A managed care treatment algorithm | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1059 FDA Guidance For Industry Population Pharmacokinetics | Sep 25, 2015 | EXHIBIT | PETITIONER |
AMNEAL 1060 U.S. Published Patent Application No. US 20130165387 | Sep 25, 2015 | EXHIBIT | PETITIONER |