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Claims for Patent: 9,402,874

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Claims for Patent: 9,402,874

Title:Low frequency glatiramer acetate therapy
Abstract: A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient.
Inventor(s): Klinger; Ety (Tel Aviv, IL)
Assignee: YEDA RESEARCH & DEVELOPMENT CO., LTD. (Rehovot, IL)
Application Number:14/673,257
Patent Claims: 1.sub.--suppl/S1.citation> submitted as Exhibit 1037 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Ford et al., "A Prospective Open-Label Study of Glatiramer Acetate: Over a Decade of Continuous Use in Multiple Sclerosis Patients", 12 Multiple Sclerosis, 309-320 (2006), submitted as Exhibit 1038 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Manso et al., "Life Cycle Management of Ageing Pharmaceutical Assets", 3:7 Pharmaceutical Law Insight, (2006), submitted as Exhibit 1041 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Almeida et al., "Localized Panniculitis Secondary to Subcutaneous Glatiramer Acetate Injections for the Treatment of Multiple Sclerosis: A Clinicopathologic and Immunohistcchemical Study", J. Am. Acad. Dermatol 55:968-74 (2006), submitted as Exhibit 1042 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Klauer and Zettl, "Compliance, Adherence and the Treatment of Multiple Sclerosis", J. Neurol. 255 [Supp1.6]:87-92 (2008), submitted as Exhibit 1043 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Teva Provides Update on Forte Trial, published on Jul. 7, 2008 at Jerusalem, Israel by Teva Pharmaceutical Industries Ltd. submitted as Exhibit 1046 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Interferon Beta 1b (Extavia.RTM.), Abbreviated National Drug Monograph, published Sep. 2010 by VA Pharmacy Benefits Management Services, Medical Advisory Panel and VISN Pharmacist Executives, submitted as Exhibit 1053 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Copaxone.RTM., Food and Drug Administration Approved Labeling, Jan. 2014, submitted as Exhibit 1057 in Inter Partes Review Case No. IPR2015-00643. cited by applicant .
Thixia, "Copaxone". In Multiple Sclerosis All about MS [online], Apr. 11, 2008 [retrieved on Feb. 5, 2015]. Retrieved from the Internet: <URL:scamparoo.wordpress.com/2008/04/11/ms-therapies-copaxone/>, submitted as Exhibit 1058 in Inter Partes Review Case No. IPR2015-00643, and Exhibit 1062 in Inter Partes Review Case Nos. IPR2015-00644. cited by applicant .
Guidance for Industry Population Pharmacokinetics [online]. Food and Drug Administration, Feb. 1999 [retrieved on Jun. 23, 2015]. Retrieved from the Internet: <URL:www.fds.gov/downloads/Drugs/Guidances/UCM072137.pdf>, submitted at Exhibit 1063 in IPR2015-00643 and Exhibit 1059 in Inter Partes Review Case Nos. IPR2015-00644 and IPR2015-00830. cited by applicant .
Mar. 25, 2013 Office Action, issued in connection with Taiwanese Patent Application No. 100103482 together with an English language translation thereof. cited by applicant .
Sep. 25, 2013 Communication in Response to Mar. 25, 2013 Office Action, filed in connection with Taiwanese Patent Application No. 100103482 together with an English language translation thereof. cited by applicant .
Feb. 25, 2014 Office Action, issued in connection with Mexican Patent Application No. Mx/a/2012/000687 together with an English language summary thereof. cited by applicant .
Jun. 25, 2014 Amendment in Response to Feb. 25, 2014 Office Action, filed in connection with Mexican Patent Application No. Mx/a/2012/000687 together with an English language translation thereof. cited by applicant .
Oct. 10, 2014 Office Action, issued in connection with Mexican Patent Application No. Mx/a/2012/000687 together with an English language summary thereof. cited by applicant .
Dec. 19, 2014 Amendment in Response to Oct. 20, 2014 Office Action, filed in connection with Mexican Patent Application No. Mx/a/2012/000687 together with an English language translation thereof. cited by applicant .
Mar. 4, 2015 Office Action, issued in connection with Mexican Patent Application No. Mx/a/2012/000687 together with an English language summary thereof. cited by applicant .
Dec. 11, 2014 Amendment in Response to Aug. 11, 2014 Official Action, filed in connection with Eurasian Patent Application No. 201270167 together with an English language translation thereof. cited by applicant .
Aug. 11, 2014 Office Action, issued in connection with Eurasian Patent Application No. 201270167 together with an English language translation thereof. cited by applicant .
Mar. 21, 2014 Office Action, issued in connection with Eurasian Patent Application No. 201270167 together with an English language translation thereof. cited by applicant .
Jul. 21, 2014 Amendment in Response to Mar. 21, 2014 Official Action, filed in connection with Eurasian Patent Application No. 201270167 together with an English language translation thereof. cited by applicant .
Feb. 14, 2014 Amendment in Response to Oct. 16, 2013 Office Action, filed in connection with Eurasian Patent Application No. 201270167 together with an English language translation thereof. cited by applicant .
Oct. 16, 2013 Office Action, issued in connection with Eurasian Patent Application No. 201270167 together with an English language translation thereof. cited by applicant .
Aug. 19, 2014 Office Action, issued in connection with Japanese Patent Application No. 2012-520598 together with an English language translation thereof. cited by applicant .
Dec. 19, 2014 Amendment in Response to Aug. 19, 2014 Office Action, filed in connection with Japanese Patent Application No. 2012-520598 together with an English language translation thereof. cited by applicant .
Jul. 18, 2013 Application to Amend a Complete Specification, filed in connection with South African Application No. 2012/00586 (Klinger). cited by applicant .
Jan. 15, 2015 Official Action Issued in Connection With Canadian Application No. 2,760,802, filed Aug. 19, 2012 (Klinger). cited by applicant .
Sep. 23, 2014 Reply to Oppositions filed against EP2405739B in the name of Yeda Research Development Co Ltd. By Activis Group PTC ehf and others in connection with European Application No. 10810282.3 (Klinger). cited by applicant .
Jun. 4, 2015 Amendment in Response to Jan. 7, 2014 Official Action filed in Connection With Japanese Application No. 2012-525530, filed Feb. 20, 2012 (Klinger) together with an English translation thereof. cited by applicant .
May 26, 2015 Yeda's Patent Owner Preliminary Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,232,250 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00643). cited by applicant .
May 26, 2015 Yeda's Patent Owner Preliminary Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,399,413 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00644). cited by applicant .
Jun. 19, 2015 Yeda's Patent Owner Preliminary Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,969,302 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00830). cited by applicant .
Teva Provides Update on Forte Trial, published on Jul. 7, 2008 at Jerusalem, Israel by Teva Pharmaceutical Industries Ltd., submitted as Exhibit 2001 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Franscisco J. Quintana et al., "Systems Biology Approaches for the Study of Multiple Sclerosis", 12 J. Cell. Mol. Med. 4, 1087-93 (2008), submitted as Exhibit 2002 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
David J. Virley, "Developing Therapeutics for the treatment of multiple sclerosis", 2 The Journal of the American Society for Experimental NeuroTherapeutics, 638-49 (Oct. 2005), submitted as Exhibit 2003 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Manuel A. Friese et al., "The value of animal models for drug development in multiple sclerosis", 129 Brain, 1940-52 (2006), submitted as Exhibit 2004 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2105-00644 and IPR2015-00830. cited by applicant .
Copaxone.RTM., Food and Drug Administration Approved Labeling, Jan. 2014, submitted as Exhibit 2005 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Dvora Teitelbaum et al., "Suppression of experimental allergic encephalomyelitis by a synthetic polypeptide", 1 Eur. J. Immunol., 242-248 (Aug. 1971), submitted as Exhibit 2006 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Jill Conner, "Glatiramer acetate and therapeutic peptide vaccines for multiple sclerosis", 1 J. Autoimmunity and Cell Responses 3 (2014), submitted as Exhibit 2007 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Copaxone.RTM., Physicians' Desk Reference, 62nd ed. Montvale, NJ, Thomson Healthcare Inc., pp. 3231-3235 (2008), submitted as Exhibit 2008 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Wiebke Schrempf and Tjalf Ziemssen, "Glatiramer acetate: Mechanisms of action in multiple sclerosis", 6 Autoimmunity Reviews, 469-475 (2007), submitted as Exhibit 2009 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
V.Wee Yong, "Differential mechanisms of action of interferon-.beta. and glatiramer acetate in MS", 59 Neurology, 802-8 (Apr. 2002), submitted as Exhibit 2010 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Suhayl Dhib-Jalbut, "Mechanisms of action of interferons and glatiramer acetate in multiple sclerosis", 58 Neurology (8 Suppl 4), S3-9 (2002), submitted as Exhibit 2011 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Oliver Neuhaus et al., "Pharmacokinetics and pharmacodynamics of the interferon-betas, glatiramer acetate, and mitoxantrone in multiple sclerosis", 259 Journal of the Neurological Sciences, 27-37 (2007), submitted as Exhibit 2012 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Oded Abramsky et al., "Effect of a Synthetic Polypeptide (COP 1) on Patients With Multiple Sclerosis and With Acute Disseminated Encephalomyelitis. Preliminary Report", 31 Journal of the Neurological Sciences, 433-38 (1977), submitted as Exhibit 2013 in Inter Partes Review Case Nos. IPR2015-0C643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Murry B. Bornstein et al., "Treatment of Multiple Sclerosis with a Synthetic Polypeptide: Preliminary Results", in Transactions of the American Neurological Association, 1980, vol. 105 (New York, Springer Publishing Company), pp. 348-50, submitted as Exhibit 2014 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Murry B. Bornstein et al., "Treatment Multiple Sclerosis: Trial of a Synthetic Polypeptide", 11 Ann. Neurol., 317-19 (Mar. 1982), submitted as Exhibit 2015 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Murry B. Bornstein et al., "A Pilot Trial of COP 1 in Exacerbating-Remitting Multiple Sclerosis", 13 N. Engl. J. Med., 408-14 (Aug. 13, 1987), submitted as Exhibit 2016 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Table of Contents--Sep. 2008; 14(1 suppl) [online]. Sage Journals [retrieved May 22, 2015]. Retrieved from the Internet: <URL msj.sagepub.com/content/14/1.sub.--suppl.toc>, submitted as Exhibit 2017 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Massimo Filippi et al., "Effects of oral glatiramer acetate on clinical and MRI monitored disease activity in patients with relapsing multiple sclerosis: a multicentre, double-blind, randomised, placebo- controlled study", Lancet Neurol. Jan. 20, 2006 [online], Retrieved from the Internet <URL:neurology.thelancet.com> <DOI:10.1016/S1474-4422(06)70327-1>, submitted as Exhibit 2018 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Yuval Ramot et al., "Comparative Long-Term Preclinical Safety Evaluation of Two Glatiramoid Compounds (Glatiramer Acetate, Copaxonel, and TV- 5010, Protiramer) in Rats and Monkeys", 40 Toxicol. Path., 40-54 (2012), submitted as Exhibit 2019 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
U.S. Patent Application No. 2007/0161566 A1 ("Pinchasi"), submitted as Exhibit 2020 in inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Tjalf Ziemssen et al., "Risk-Benefit Assessment of Glatiramer Acetate in Multiple Sclerosis", 24 Drug Safety, 13, 979-90 (2001), submitted as Exhibit 2021 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
"News Release, Phase III Data Published in Annals of Neurology Show That a Higher Concentration Dose of Glatiramer Acetate Given Three Times a Week Reduced Annualized Relapse Rates in the Treatment of Relapsing-Remitting Multiple Sclerosis" [online] Teva Pharmaceutical Industries Ltd. Jul. 1, 2013 [retrieved on May 22, 2015]. Retrieved from the Internet: <URL:ir.tevapharm.com/phoenix.zbtml?c=73925&p=irol-newsArticle Print&ID= 1834170>, submitted as Exhibit 2022 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Omar Khan et al., "Three Times Weekly Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis", 73 Ann. Neurol., 705-13 (2013), submitted as Exhibit 2023 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2C15-00644 and IPR2015-00830. cited by applicant .
"Teva Reports First Quarter 2015 Results"; Apr. 30, 2015, Jerusalem, Teva Press Release, submitted as Exhibit 2024 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Kate McKeage, "Glatiramer Acetate 40 mg/mL in Relapsing-Remitting Multiple Sclerosis: A Review", CNS Drugs, Apr. 24, 2015, submitted as Exhibit 2025 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
K.P. Johnson et al., "Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: Results of a phase I11 multicenter, double- blind, placebo- controlled trial", 45 Neurology, 1268-76 (1995), submitted as Exhibit 2026 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 and IPR2015-00830. cited by applicant .
Webster's Ninth New Collegiate Dictionary, Merriam-Webster, Inc., 1985, p. 872, submitted as Exhibit 2027 in Inter Partes Review Case No. IPR2015-00830. cited by applicant .
Decision rejecting the opposition (Art. 101(2) EPC) issued by the European Patent Office on Jan. 19, 2016 in connection with Opposition filed against EP2405749B. cited by applicant .
Dec. 7, 2015 Information on Oral Proceedings issued by the European Patent Office in connection with Opposition filed against EP2405749B. cited by applicant .
Apr. 23, 2015 Summons to attend oral proceedings pursuant to Rule 115(1) EPC and Communication accompanied by Summons (EPO form 2906) issued by the European Patent Office in connection with Opposition filed against EP2405749B. cited by applicant .
Oct. 7, 2015 Letter accompanied by Comments in advance to Oral Proceedings scheduled for 7th Dec. 2015 filed by Yeda Research Development Co., Ltd. with the European Patent Office in connection with Opposition filed against EP2405749B. cited by applicant .
Nov. 9, 2015 Reply, filed by Synthon B.V. with the European Patent Office in connection with Opposition filed against EP2405749B. cited by applicant .
Patent Application Publication No. 2007-0161566, published Jul. 12, 2007 (Pinchasi), submitted as Exhibit D1 of Opposition filed against EP2405749B. cited by applicant .
Fletcher et al., "Comparison of glatiramer acetate (Copaxone.RTM.) and interferon .beta.-1b (Betaferon .RTM.) in multiple sclerosis patients: an open-label 2-year follow-up" J. Neural Sci vol. 197, pp. 51-55, submitted as Exhibit D2 of Opposition filed against EP2405749B. cited by applicant .
Fletcher et al., "Copolymer 1 (Glatiranler Acetate) in Relapsing Forms of Multiple Sclerosis: Open Multicenter Study of Alternate-Day Adn1inistration" Clin Neuropharm 2002, vol. 25(1), pp. 11-15, submitted as Exhibit D3 of Opposition filed against EP2405749B. cited by applicant .
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 Multiple Sclerosis 2008, vol. 14, 5295, submitted as Exhibit D4 of Opposition filed against EP2405749B. cited by applicant .
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 Rrms" Neurobiology 2008, vol. 68 (12), Suppl 3, submitted as Exhibit D5 of Opposition filed against EP2405749B. cited by applicant .
Cohen et al. "Randomized, double-blind, dose-comparision study of glatiramer acetate relapsing-remitting MS", Neurology 2007, vol. 68 (12), pp. 939-944, submitted as Exhibit D6 of Opposition filed against EP2405749B. cited by applicant .
Simpson et al., "Glatiramer Acetate: A review of its Use in relapsing-Remitting Multiple Sclerosis" Adis Drug Evaluation, Glatiramer Acetate, 2002, submitted as Exhibit D7 of Opposition filed against EP2405749B. cited by applicant .
Teva Provides Update on Forte Trial, published on Jul. 7, 2008 at Jerusalem, Israel by Teva Pharmaceutical Industries Ltd., submitted as Exhibit D8 of Opposition filed against EP2405749B. cited by applicant .
"News Release, Teva to Present Positive Data for Glatiramer Acetate 40 mg/lml Given Three Times Weekly for Relapsing-Remitting MS" [online] Teva Pharmaceutical Industries Ltd. Oct. 10, 2012 [retrieved on Apr. 2, 2013]. Retrieved from the Internet: <URL://www.tevapharm.com/Media/News/Pages/2012/1743500.aspx?year=2012&- page . . . >, submitted as Exhibit D9 of Opposition filed against EP2405749B. cited by applicant .
Kahn et al, "Late Breaking News II: A phase 3 trial to assess the efficacy and Safety of glatiramer acetate injections 40mg administered 3 times a week compared to placebo", abstract presented on Oct. 13, 2012 at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis held at Lyon France on Oct. 10-13, 2012, submitted as Exhibit D10 of Opposition filed against EP2405749B. cited by applicant .
"Copaxone 20mg/ml, Solution for Injection, Pre-filled Syringe" [online] Teva Pharmaceutical Ltd., Feb. 3, 2009 [retrieved on Jan. 27, 2013]. Retrieved from the Internet: <URL://www.medicines.org.uk/EMC/printfriendlydocument.aspx?documentid=- 17516>>, submitted as Exhibit D11 of Opposition filed against EP2405749B. cited by applicant .
PCT International Application Publication No. WO 2005/00120542, Published Dec. 22, 2005 (Rasmussen at al.), submitted as Exhibit D12 of Opposition filed against EP2405749B. cited by applicant .
US Application Publication No. 2005-0014696, published Jan. 20, 2005 (Yong et al.), submitted as Exhibit D13 of Opposition filed against EP2405749B. cited by applicant .
US Application Publication No. 2009-0149541, published Jun. 11, 2009 (Stark et al.), submitted as Exhibit D14 of Opposition filed against EP2405749B. cited by applicant .
Yong et al. "Immunological response to different doses of GA in MS: Analyses from the FORTE trial" dated Apr. 28 2009, Abstract only, submitted as Exhibit D15 of Opposition filed against EP2405749B. cited by applicant .
Jul. 1, 2009 Response to Apr. 2, 2009 Final Office Action filed with the U.S. Patent and Trademark Office in connection with U.S Appl. No. 11/651,212, submitted as Exhibit D16 of Opposition filed against EP2405749B. cited by applicant .
International Application Publication No. WO 00/18794, published Apr. 6, 2000 (Gad et al.), submitted as Exhibit D17 of Opposition filed against EP2405749B. cited by applicant .
Sep. 13, 2012 Response to Aug. 8, 2015 Communication pursuant to Article 94(3) EPC filed with the European Patent Office in connection with European Patent Application No. 10810282.3, submitted as Exhibit D18 of Opposition filed against EP2405749B. cited by applicant .
Comi et al. "Results from a phase II, 1-year, Randomized, Double- blind, Parallel-Group, Dose Comparison Study with Glatiramer Acetate in Relapsing-remitting Multiple Sclerosis", abstract at the World Congress on Treatment and Research in Multiple Sclerosis--Montreal 2008, presented on Sep. 20, 2008, [online] [retrieved on Aug. 21, 2015]. Retrieved from the Internet: <URL://www.multiwebcast.com/wctrims/2008/msmontreal/2448/chair.giancar- lo.comi.r . . . >submitted as Exhibit D19 of Opposition filed against EP2405749B. cited by applicant .
Slides of G. Comi, Forte: Results from a phase II, 1-year, Randomized, Double-blind, Parallel-Group, Dose Comparison Study with Glatiramer Acetate in Relapsing-remitting Multiple Sclerosis, Presented at World Congress on Treatment and Research in Multiple Sclerosis: 2008 Joint Meeting of the American, European, and Latin America Committees on Treatment and Research in Multiple Sclerosis, San Raffaele, Italy (ACTRIMS, ECTRIMS, LACTRIMS) (2008), submitted as Exhibit D19a of Opposition filed against EP2405749B. cited by applicant .
Oct. 2, 2015 Expert Report of Dr Simon Day, submitted as Exhibit D20 of Opposition filed against EP2405749B. cited by applicant .
"News Release: Teva Initiates Phase III Study to Confirm Increased Efficacy of Higher Dose of Glatiramer Acetate for the Treatment of Relapsing-Remitting Multiple Sclerosis" [online] Teva Pharmaceutical Industries Ltd., Jul. 27, 2006 [retrieved on Apr. 6, 2015]. Retrieved from the Internet: <URL://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=15- 57343>, submitted as Exhibit D21 of Opposition filed against EP2405749B. cited by applicant .
"News Release: Data Published in Neurology Showed That Higher Dose of Copaxone.RTM. Increased Efficacy in Relapsing-Remitting Multiple Sclerosis (Rrms)" [online] Teva Pharmaceutical Industries Ltd., Apr. 17, 2007 [retrieved on Apr. 6, 2015]. Retrieved from the Internet: <URL://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=15- 54611>, submitted as Exhibit D22 of Opposition filed against EP2405749B. cited by applicant .
"Medscape Medical News: Doubling the Dose of Glatiramer Acetate Does Not Increase Efficacy" [online] Medscape, Sep. 22, 2008, [retrieved on Jan. 6, 2015]. Retrieved from the Internet: <URL://www.medscape.com/viewartice/580865>, submitted as Exhibit D23 of Opposition filed against EP2405749B. cited by applicant .
"Daily News: High-dosage Copaxone trial results are bad news for Teva" [online] PharmaTimes, Jul. 7, 2008, [retrieved on Nov. 6, 2015]. Retrieved from the Internet: <URL://http://www.pharmatimes.com/article/08-07-07/High-dosage.sub.--C- opaxone.sub.--trial.sub.--results . . . >, submitted as Exhibit D24 of Opposition filed against EP2405749B. cited by applicant .
Committee for Medicinal Products for Human Use (CHMP) "Guidelines on Clinical Investigation of Medicinal Products for the Treatment of Multiple Sclerosis", European Medicines Agency, Nov. 16, 2006, submitted as Exhibit D25 of Opposition filed against EP2405749B. cited by applicant .
Varkoni et al. "The glatiramoid class of immunomodulator Drugs" Expert Opinion on Pharmacotherapy 2009 10(4) 657-668, submitted as Exhibit D26 of Opposition filed against EP2405749B. cited by applicant .
Meiner et al. in "Frontiers in Multiple Sclerosis: Clinical research and Therapy" Eds Abramsky & Ovadia (1997) 213-221, submitted as Exhibit D27 of Opposition filed against EP2405749B. cited by applicant .
McKeage "Glatiramer Acetate 40 mg/mL in Relapsing-Remitting Multiple Sclerosis: A Review" ADIS Drug Evaluation, Apr. 2015, submitted as Exhibit D28 of Opposition filed against EP2405749B. cited by applicant .
Wolinsky "Reduced frequency severity of injection site reactions with glatiramer acetate 40mg/mL three times weekly dosing" ECTRIMS/ECTRIMS Conference, Sep. 10-13, 2014, poster, submitted as Exhibit D29 of Opposition filed against EP2405749B. cited by applicant .
Wolinsky et al. "Reduced frequency severity of injection site reactions with glatiramer acetate 40mg/mL three times weekly dosing", poster presented at the Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting, held on Sep. 10-13, 2014 at Boston MA, submitted as Exhibit D30 of Opposition filed against EP2405749B. cited by applicant .
Oct. 5, 2015 Expert Report of Professor Wolfgang Bruck, submitted as Exhibit D31 of Opposition filed against EP2405749B. cited by applicant .
Multiple Sclerosis Society of Canada "Talking About Clinically Isolated Syndrome or CIS" published by Communications and Services, Multiple Sclerosis Society of Canada, Quebec Division, dated 2009, submitted as Exhibit D32 of Opposition filed against EP2405749B. cited by applicant .
Affidavit of Marlene S. Bobka dated Nov. 10, 2014, submitted as Exhibit D35 of Opposition filed against EP2405749B. cited by applicant .
Aug. 25, 2015 Decision on Institution of Inter Partes Review, entered in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co., Ltd. for U.S. Pat. No. 9,232,250 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00643). cited by applicant .
Aug. 25, 2015 Decision on Institution of Inter Partes Review, entered in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co., Ltd. for U.S. Pat. No. 8,399,413 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00644). cited by applicant .
Sep. 1, 2015 Decision on Institution of Inter Partes Review, entered in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co., Ltd. for U.S. Pat. No. 8,969,302 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00830). cited by applicant .
Nov. 20, 2015 Yeda's Patent Owner Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,232,250 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00643). cited by applicant .
Nov. 20, 2015 Yeda's Patent Owner Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,399,413 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00644). cited by applicant .
Nov. 25, 2015 Yeda's Patent Owner Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,969,302 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00830). cited by applicant .
Declaration of Edward J. Fox, Md., PhD in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2129 in Inter Partes Review Case No. IPR2015-00643. cited by applicant .
Declaration of Edward J. Fox, Md., PhD in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2129 in Inter Partes Review Case No. IPR2015-00644. cited by applicant .
Declaration of Edward J. Fox, Md., PhD in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 25, 2015, submitted as Exhibit 2129 in Inter Partes Review Case No. IPR2015-00830. cited by applicant .
Declaration of Henry G. Grabowski, Ph.D. in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2133 in Inter Partes Review Case No. IPR2015-00643. cited by applicant .
Declaration of Henry G. Grabowski, Ph.D. in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2133 in Inter Partes Review Case No. IPR2015-00644. cited by applicant .
Declaration of Henry G. Grabowski, Ph.D. in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 25, 2015, submitted as Exhibit 2133 in Inter Partes Review Case No. IPR2015-00830. cited by applicant .
Declaration of Robert William Gristwood, Ph.D. in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2134 in Inter Partes Review Case No. IPR2015-00643. cited by applicant .
Declaration of Robert William Gristwood, Ph.D. in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2134 in Inter Partes Review Case No. IPR2015-00644. cited by applicant .
Declaration of Robert William Gristwood, Ph.D. in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 25, 2015, submitted as Exhibit 2134 in Inter Partes Review Case No. IPR2015-00830. cited by applicant .
Declaration of Tjalf Ziemssen, M.D., Ph.D in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2135 in Inter Partes Review Case No. IPR2015-00643. cited by applicant .
Declaration of Tjalf Ziemssen, M.D., Ph.D in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 20, 2015, submitted as Exhibit 2135 in Inter Partes Review Case No. IPR2015-00644. cited by applicant .
Declaration of Tjalf Ziemssen, M.D., Ph.D in Support of Patent Owner Yeda's Response to Institution of Inter Partes Review filed on Nov. 25, 2015, submitted as Exhibit 2135 in Inter Partes Review Case No. IPR2015-00830. cited by applicant .
Deposition of Stephen J. Peroutka, M.D., Ph.D., taken on behalf of the Patent Owner Yeda, at 901 New York Avenue, Washington, D.C., beginning at 9:30 a.m. on Oct. 29, 2015, before Michele E. Eddy, RPR, CRR, CLR, and Notary Public for the District of Columbia, submitted as Exhibit 1066 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830 on Nov. 18, 2015. cited by applicant .
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Mariana Castells, "Rapid Desensitization for Hypersensitivity Reactions to Medications", 29 Immunology and Allergy Clinics of North America 585 (2009), submitted as Exhibit 2093 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Robert Zivadinov et al., Poster titled "MRI Indicators of Brain Tissue Loss: 3-Year Results of the Glatiramer Acetate Low-Frequency Administration (GALA) Open-Label Extension Study in Relapsing-Remitting Multiple Sclerosis", Presented at the American Academy of Neurology 2015 Annual Meeting, Washington, DC (Apr. 18-25, 2015), submitted as Exhibit 2094 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
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Daniel Wynn et.al., Poster titled "Patient Experience with Glatiramer Acetate 40mg/1 ml Three-Times Weekly Treatment for Relapsing-Remitting Multiple Sclerosis: Results from the Glacier Extension Study", Presented at The 8th Congress of the Pan-Asian Committee for Treatment and Research in Multiple Sclerosis, Seoul, Republic of Korea (Nov. 19-21, 2015), submitted as Exhibit 2096 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Avonex.RTM. (Inferon beta-1a) IM Injection, published 2008 by Biogen Idec Inc., submitted as Exhibit 2097 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Rebif Prescribing Information, published 2009 by Pfizer, submitted as Exhibit 2098 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Extavia Highlights of Prescribing Information, published Aug. 2009 by Novartis, submitted as Exhibit 2099 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Curriculum Vitae of Edward J. Fox. Md., PhD., FAAN, submitted as Exhibit 2100 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
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Jan J.M. de Vijlder, "Primary congenital hypothyroidism: defects in iodine pathway", 149 Eur. J. Endocrinology 247 (2003), submitted as Exhibit 2102 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
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Curriculum Vitae of Dr. Henry George Grabowski, submitted as Exhibit 2104 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
List of Testimony of Henry G. Grabowski, submitted as Exhibit 2105 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Documents Relied Upon by Grabowski, submitted as Exhibit 2106 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Table: Approval Timeline, Multiple Sclerosis Drugs, submitted as Exhibit 2107 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Copaxone.RTM. 40mg/mL Wholesale Dollar Sales (Ql 2014- Q3 2015), submitted as Exhibit 2108 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Copaxone.RTM. 40mg/mL Extended Units (Q1 2014- Q3 2015), submitted as Exhibit 2109 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Copaxone.RTM. 40mg/mL Total Prescriptions (Q1 2014- Q3 2015), submitted as Exhibit 2110 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Copaxone.RTM. 40mg/mL New Prescriptions (Q1 2014- Q3 2015), submitted as Exhibit 2111 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Multiple Sclerosis Drugs Share of Wholesale Dollar Sales (Q4 2009- Q3 2015), submitted as Exhibit 2112 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Multiple Sclerosis Drugs Share of Total Prescriptions (Q4 2009- Q3 2015), submitted as Exhibit 2113 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Multiple Sclerosis Drugs Share of New Prescriptions (Q4 2009- Q3 2015), submitted as Exhibit 2114 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Figure: Rationale for Requesting Copaxone, submitted as Exhibit 2115 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Figure: Perception of 3-times-a-week Copaxone 40mg compared to Daily Copaxone 20mg, submitted as Exhibit 2116 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Figure: Rationale for Discussing 20mg and 40mg for First Line Patients, submitted as Exhibit 2117 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Figure: Perceptions of Copaxone.RTM. 40mg compared to Daily Generic GA, submitted as Exhibit 2118 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Figure: Perceptions of Copaxone.RTM. 40mg vs. 20mg, submitted as Exhibit 2119 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Copaxone.RTM. Total Prescriptions (Q4 2009- Q3 2015), submitted as Exhibit 2120 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Redacted Figure: Copaxone.RTM. 20 mg/mL, Copaxone.RTM. 40 mg/mL, and GlatopaTM Net Prescriptions Flow (10/26/12-10/9/15), submitted as Exhibit 2121 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Table: Total Promotional Spending to Sales Ratio, submitted as Exhibit 2122 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
G. Comi et al., "Early Treatment with glatiramer acetate is efficacious in delaying conversion to clinically definite multiple sclerosis in patients presenting with clinically isolated syndrome and brain lesions detected by MRI", 374 Lancet 1503 (Oct. 31, 2009), submitted as Exhibit 2123 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
R.M. Valenzuela et al., "Clinical response to glatiramer acetate correlates with modulation of IFN-.gamma. and IL-4 expression in multiple sclerosis", 13 Multiple Sclerosis 754 (2007), submitted as Exhibit 2124 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Y. Blanco et al., "Effect of glatiramer acetate (Copaxone.RTM.) on the immunophenotypic and cytokine profile and BDNF production in multiple sclerosis: a longitudinal study", 406 Neuroscience Letters 270 (2006), submitted as Exhibit 2125 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
M. Chen et al., "Sustained immunological effects of Glatiramer acetate in patients with multiple sclerosis treated for over 6 years", 201 J. of Neurological Sciences 71 (2002), submitted as Exhibit 2126 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Zhao Rong Chen et al., "MU Receptor Binding of Some Commonly Used Opioids and Their Metabolites", 48 Life Sciences 2165 (1991), submitted as Exhibit 2127 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Alison Palkhivala, "Doubling the Dose of Glatiramer Acetate Does Not Increase Efficacy", Medscape Medical News (Sep. 22, 2008), submitted as Exhibit 2128 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Curriculum Vitae of Robert William Gristwood PhD, submitted as Exhibit 2130 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Curriculum Vitae of Tjalf Ziemssen, submitted as Exhibit 2131 in Inter Partes Review Case No. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Ziemssen's MS clinical trials, submitted as Exhibit 2132 in Inter Partes Review Case Nos. IPR2015-00643 and IPR2015-00644 on Nov. 20, 2015 and in IPR2015-00830 on Nov. 25, 2015. cited by applicant .
Deposition of Stephen J. Peroutka, taken at Washington, D.C., on Oct. 29, 2015, submitted as Exhibit 1066 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830 on Nov. 18, 2015. cited by applicant .
Aug. 25, 2015 Decision on Institution of Inter Partes Review, entered in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,232,250 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00643). cited by applicant .
Aug. 25, 2015 Decision on Institution of Inter Partes Review, entered in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,399,413 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00644). cited by applicant .
Sep. 1, 2015 Decision on Institution of Inter Partes Review, entered in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Pat. No. 8,969,302 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00830). cited by applicant .
Oliver Neuhaus, et al., Pharmacokinetics and pharmacodynamics of the interferon-bets, glatiramer acetate, and mitoxantrone in multiple sclerosis, 259 J. Neurol. Sci., 2007. cited by applicant .
O. Khan, et al., Randomized, prospective, rater-blinded, four-year, pilot study to compare the effect of daily versus every-other-day [GA] 20 mg subcutaneous injections in relapsing-remitting multiple sclerosis, S295 Multiple Sclerosis, 902 (2008). cited by applicant .
S. Fletcher et al., Copolymer 1 (Glatiramer Acetate) in Relapsing Forms of Multiple Sclerosis: Open Multicenter Study of Alternate-Day Administration, 25(1) Clin. Neuropharmacology, 11-15 (2002). cited by applicant .
Teva Provides Upate on FORTE Trial (Jul. 7, 2008). cited by applicant .
J.A. Cohen et al., Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS, 68:12 Neurology, 939-44 (2007). cited by applicant .
Teva Press Release, Phase III Data Published in Annals of Neurology Show That a Higher Concentration Dose of Glatiramer Acetate Given Three Times a Week Reduced Annualized Relapse Rates in the Treatment of Relapsing-Remitting Multiple Sclerosis dated Jul. 1, 2013. cited by applicant .
Omar Khan et al., Three Times Weekly Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis, 73 Ann. Neurol., 705-13 (2013). cited by applicant .
Kate McKeage, Glatiramer Acetate 40 mg/mL in Relapsing-Remitting Multiple Sclerosis: A Revies, CNS Drugs (Apr. 24, 2015). cited by applicant .
Feb. 16, 2016 Petition for Post Grant Review of U.S. Pat. No. 9,155,776 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. PGR2016-00010). cited by applicant .
Expert Declaration of Ari Green, M.D. in Support of Petition for Post-Grant Review of U.S. Pat. No. 9,155,776, dated Feb. 7, 2016, submitted as Exhibit 1003 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
A Study in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo (GALA), NCT01067521 [online]. ClinicalTrials.gov [retrieved on Feb. 5, 2016]. Retrieved from the Internet: <URL:clinicaltrials.gov/ct2/show/NCT01067521>, submitted as Exhibit 1004 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Safety and Tolerability of Glatiramer Acetate (GLACIER), NCT01874145 [online]. ClinicalTrials.gov [retrieved on Feb. 5, 2016]. Retrieved from the Internet: <URL:clinicaltrials.gov/ct2/show/NCT01874145, submitted as Exhibit 1005 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Plaintiffs' Supplemental Opening Claim Construction Brief, In re Copaxone 40 mg Consolidated Cases, No. 1:14-cv-01171-GMS (D.Del), dated Dec. 18, 2015, submitted as Exhibit 1006 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Citizen Petition Requesting That FDA Refrain from Approving any Abbreviated New Drug Application Referencing Copaxone.RTM. (glatiramer acetate injection) Until Certain Conditions Are Met, dated Jul. 2, 2014, filed with U.S. Food and Drug Administration, submitted as Exhibit 1009 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Citizen Petition Requesting That FDA Consider New Scientific Information and Refrain from Approving Any Abbreviated New Drug Information and Refrain from Approving Any Abbreviated New Drug Application Referencing Copaxone .RTM. (glatiramer acetate injection) Until Certain Conditions Are Met, dated Mar. 31, 2015, filed with U.S. Food and Drug Administration, submitted as Exhibit 1010 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Kate McKeage, "Glatiramer Acetate 40 mg/mL in Relapsing-Remitting Multiple Sclerosis: A Review", CNS Drugs, Apr. 24, 2015, submitted as Exhibit 1011 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Copaxone.RTM., Food and Drug Administration Approved Labeling, Jan. 2014, submitted as Exhibit 1012 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Defendant's Opening Claim Construction Brief Regarding U.S. Pat. No. 9,155,776, dated Dec. 18, 2015, in re Copaxone 40 mg Consolidated Cases, No. 1:14-cv-01171-GMS (D.Del.), submitted as Exhibit 1013 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Plaintiff's Opening Claim Construction Brief, dated Sep. 11, 2015, in re Copaxone 40 mg Consolidated Cases, No. 1:14-cv-01171-GMS (D.Del.), submitted as Exhibit 1014 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Yeda's Preliminary Patent Owner Response, dated May 26, 2015, for Case No. IPR2015-00643, submitted as Exhibit 1015 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Deposition of Tjalf Ziemssen, dated Feb. 2, 2016, submitted as Exhibit 1016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Giancarlo Comi, et al., Phase III Dose-Comparison Study of Glatiramer Acetate for Multiple Sclerosis, Ann. Neurol. 2011; 69:75-82 (2011), submitted as Exhibit 1017 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Teva Announces Top-line Results from GALA Phase III Trial Evaluating a New Dosage for Glatiramer Acetate Given Three Times Weekly for Relapsing-Remitting Multiple Sclerosis, [online]. [retrieved on Feb. 5, 2016]. Retrieved from the Internet: <URL:www.tevapharm.com/news/teva.sub.--announces.sub.--top.sub.--line.- sub.--results.sub.--from.sub.--gala.sub.--phase.sub.--iii.sub.--trial.sub.- --evaluating.sub.--a.sub.--new.sub.--dosage.sub.--for.sub.--glatiramer.sub- .--acetate.sub.--given.sub.--three.sub.--times.sub.--weekly.sub.--for.sub.- --relapsing.sub.--remitting.sub.--multipie.sub.--sclerosis.sub.--06.sub.--- 12.aspx>, submitted as Exhibit 1018 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Wolinsky et al. "Reduced frequency severity of injection site reactions with glatiramer acetate 40mg/mL three times weekly dosing" presented at the Jount Americas Committee for Treatment and Reseasrch in Multiple Sclerosis (ACTRIMS) European Committee for Treatment of Research in Multiple Sclerosis (ECTRIMS), Boston, MA, Sep. 10-13, 2014, poster, submitted as Exhibit 1019 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Deposition of Edward J. Fox, M.D., dated Jan. 26, 2016, submitted as Exhibit 1020 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Stipulation, In re Copaxone 40 mg Consolidated Cases, No. 1:14-cv-01171-GMS (D. Del.) (ECF No. 190), dated Feb. 10, 2016, submitted as Exhibit 1021 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Plaintiffs' Opening Claim Construction Brief, In re Copaxone 40 mg Consolidated Cases, No. 1:14-cv-01171-GMS (D. Del.) (ECF No. 91), dated Sep. 11, 2015, submitted as Exhibit 1023 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Yeda's Patent Owner Response, dated Nov. 20, 2015, for IPR2015-00643, submitted as Exhibit 1024 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Yeda's Patent Owner Response, dated Nov. 20, 2015, for IPR2015-00644, submitted as Exhibit 1025 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Yeda's Patent Owner Response, dated Nov. 25, 2015, for IPR2015-00830, submitted as Exhibit 1026 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Miller, The Importance of Early Diagnosis of Multiple Sclerosis, J.Managed Care Pharmacy 10:S4-S11 (Jun. 2004), submitted as Exhibit 1027 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Thomas M. Stewart, Injectable Multiple Sclerosis Medications: A Patient Survey of Factors Associated with Injection-Site Reactions, 14 Int'l J. MS Care 46, 48 (2012), submitted as Exhibit 1028 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Pelidou et al., Multiple sclerosis presented as clinically isolated syndrome: the need for early diagnosis and treatment, Ther. Clin. Risk Management 4:627-30 (Jun. 2008), submitted as Exhibit 1029 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Lynn McEwan et al., Best Practices in Skin Care for the Multiple Sclerosis Patient Receiving Injectable Therapies, 12 Int'l J. MS Care 177, 187 (2010), submitted as Exhibit 1030 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Barry Singer et al., Comparative Injection-site Pain and Tolerability of Subcutaneous Serum-free Formulation of Interferon.beta.-1a Versus Subcutaneous interferon.beta.-1b: Results of the Randomized, Multicenter, Phase IIIb Reforms Study, 12 BMC Neurology, Dec. 2012, submitted as Exhibit 1031 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
U.S. Department of Health and Human Services, Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, published May 28, 2009, submitted as Exhibit 1032 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Frohman, Multiple Sclerosis--The Plaque and its Pathogenesis, New England J.Med. 354:942-55 (2006), submitted as Exhibit 1033 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Haines et al., Linkage of the MHC to familial multiple sclerosis suggests genetic heterogeneity. The multiple sclerosis genetics group, HUM.MOL. GENET. 7:1229-34 (1998), submitted as Exhibit 1034 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
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, Annals Neurol. 49:290-297 (2001) submitted as Exhibit 1035 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Ge et al., Glatiramer acetate (Copaxone) treatment in relapsing-remitting MS, Quantitative MR assessment, Neurol. 54:813-17 (Feb. 2000), submitted as Exhibit 1036 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Soares et al., Localized panniculitis secondary to subcutaneous glatiramer acetate injections for the treatment of multiple sclerosis: a clinicopathologic and immunohistochemical study, J. Am. Acad. Derm. 55:968-74 (2006), submitted as Exhibit 1037 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Jerry S. Wolinsky et al., GLACIER: An Open-Label, Randomized, Multicenter Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 MG Three-Times Weekly Versus 20 MG Daily in Patients with Relapsing-Remitting Multiple Sclerosis, 4 Multiple Sclerosis & Related Disorders 370, 371 (2015), submitted as Exhibit 1038 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Rich et al., Stepped-care approach to treating MS: A managed care treatment algorithm, J.Managed Care Pharm. 10(3) (Suppl. S-b):S26-S32 (Jun. 2004), submitted as Exhibit 1039 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Bakshi et al., Imaging of multiple sclerosis: Role in neurotherapeutics, J. Am. Soc. Exper. Neurotherapeutics 2:277-303 (Apr. 2005), submitted as Exhibit 1040 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Stuart, Clinical management of multiple sclerosis: The treatment paradigm and issues of patient management, J. Managed Care Pharmacy 10(3)(Suppl. S-b):S19-S25 (Jun. 2004), submitted as Exhibit 1041 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Edgar et al., Lipoatrophy in patients with multiple sclerosis on glatiramer acetate, Canadian J. Neurol. Sci. 31:58-63 (2004), submitted as Exhibit 1042 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Johnson et al., Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis, Neurology 45:1268-76 (1995), submitted as Exhibit 1043 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Betaseron.RTM. Product Label (Oct. 2003), Berlex Laboratories, submitted as Exhibit 1044 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Rebif.RTM. (interferon beta-1a) Product Label, Jun. 2015, Pfizer Inc., submitted as Exhibit 1045 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Avonex.RTM. (Interferon beta-1a) Product Label, Feb. 2007, Biogen Idec Inc., submitted as Exhibit 1046 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Interferon Beta 1b (Extavia.RTM.), Abbreviated National Drug Monograph, published Sep. 2010 by VA Pharmacy Benefits Management Services, Medical Advisory Panel and VISB Pharmacist Executives, submitted as Exhibit 1047 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Tysabri.RTM. Product Label (Oct. 2008), Biogen Idec Inc., submitted as Exhibit 1048 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
U.S. Pat. No. 3,849,550, submitted as Exhibit 1007 in Post Grant Review Case No. PGR2016-00010 issue date: Nov. 19, 1974. cited by applicant .
File wrapper of NDA 20-622, cited as D34 in opposition procedure against EP2405749 [online]. European Patent Register, submitted Nov. 9, 2015 [retrieved on Dec. 16, 2015]. Retrieved from the Internet: <URL://register.ep.org/application?documentId=EX8Q9F3Q8243DSU&number=E- P10810282&lng=en&npl=true>. cited by applicant .
Mar. 9; 2015 Mylan's Reply to Yeda's Patent Owner Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd, for U.S. Pat. No. 8,232,250 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00643). cited by applicant .
Mar. 9, 2015 Mylan's Reply to Yeda's Patent Owner Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd, for U.S. Pat. No. 8,399,413 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00644). cited by applicant .
Mar. 9, 2015 Mylan's Reply to Yeda's Patent Owner Response filed in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd. for U.S. Patent No, 3,969,302 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. IPR2015-00830). cited by applicant .
Expert Declaration of Ari Green, M.D. in Support of Petitioner's Reply to Patent Owner's Response, dated Mar. 9, 2016, submitted as Exhibit 1085 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Declaration of Prof. Joel W. Hay (public version), dated Mar. 9, 2016, submitted as Exhibit 1099 on Mar. 22, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Deposition Transcript of Joel W. Hay, Ph.D., which deposition took place on Apr. 4, 2016, submitted as Exhibit 1141 on Apr. 12, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Deposition Transcript of an Green, M.D., which deposition took place on Apr. 4, 2016, submitted as Exhibit 1142 on Apr. 12, 2016 in Inter Partes Review Case Nos. IPR2015-00643; IPR2015-00644 and IPR2015-00830. cited by applicant .
Deposition Transcript of Dr. Jerry S. Wolinsky (public version) taken in In re Copaxone 40 mg Consolidated Cases, No. 14-1171 (D. Del), which deposition took place on Feb. 15, 2016, submitted as Exhibit 1140 on Apr. 12, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Deposition Transcript of Robert W. Gristwood, Ph.D., which deposition took place on Jan. 13, 2016, submitted as Exhibit 2145 on Mar. 1, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Deposition Transcript of Edward J. Fox, M.D., which deposition took place on Jan. 26, 2016, submitted as Exhibit 2146 on Mar. 1, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Deposition Transcript of Tjalf Ziemssen, which deposition took place on Feb. 2, 2016, submitted as Exhibit 2147 on Mar. 1, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Deposition Transcript of Henry G. Grabowski, Ph. D., which deposition took place on Feb. 10, 2016, submitted as Exhibit 2148 on Mar. 7, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2016-00830. cited by applicant .
O. Khan, et al., Glatiramer acetate 20mg subcutaneous twice-weekly versus daily injections: results of a pilot, prospective, randomised, and rater-blinded clinical and MRI 2-year study in relapsing-remitting multiple sclerosis, Multiple Sclerosis 2009; 15:S151-S269, S249-S250 (2009), submitted as Exhibit 1068 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
G. Pardo, et al., Impact of an oral antihistamine on local injection site reactions with glatiramer acetate, Multiple Sclerosis, 2007; 13:S7-S2753, S134 (2007), submitted as Exhibit 1069 on Mar. 8, 2016 in Inter Partes Review Cases Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
S. Rains, et al., Glatiramer acetate: successful desensitazation for treatment of multiple sclerosis, Annals of Allergy, Asthma & Immunology, 2010;104:321-325, submitted as Exhibit 1070 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
E. Fisher, et al., Gray Matter Atrophy in Multiple Sclerosis: A Longitudinal Study, Annals of Neurology, 2008;64:255-265, submitted as Exhibit 1071 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2018-00830. cited by applicant .
Fourth Declaration of Edward J. Fox, M.D., Ph.D., In re Copaxone 40 mg Consolidated Cases, Civil Action No. 1:14-cv-001171, ECF No. 158 (D. Del.) dated. Jan. 8, 2016 together with Exhibits A-C, submitted as Exhibit 1072 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
G. Anderson, et al., Tolerability and safety of novel half milliliter formulate of glatiramer acetate for subcutaneous injection: An open-label, multicenter, randomized comparative study, Journal of Neurology (2010) 257:1917-1923, submitted as Exhibit 1073 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
G. Shaw, Exorbitant Drug Costs May Price. Out Patients, The Washington Diplomat (Apr. 27, 2011) submitted as Exhibit 1074 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
T. Ziemssen, et al., A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease--modifying therapies: the Coptimize trial, Journal of Neurology (2014) 261:2101-2111, submitted as Exhibit 1079 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
T. Ziemssen, et al., Sub-analysis of geographical variations in the 2-year observational Coptimize trial of patients with relapsing-remitting-multiple sclerosis converting to glatiramer acetate, BMC Neurology (2015) 15:189, submitted as Exhibit 1080 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
T. Ziemssen, et al., QualiCOP: An Open-Label, Prospective, Observational Study of Glatiramer Acetate in Patients with Relapsing-Remitting Multiple Sclerosis, submitted as Exhibit 1081 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00044 and IPR2015-00830. cited by applicant .
N. Kleiner, et al., Immunological Response to Glatiramer Acetate in MS Patients after Different Pretreatments--The CopImmunoNet Study, P06.178, A554 Neurology 74, Suppl 2 (Mar. 2, 2010), submitted as Exhibit 1082 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Teva News Release, New Study Demonstrated Significant Reduction in Annualized Relapse Rate and Halting of Disability Progression in MS Patients Switching to Copaxone.RTM. (Apr. 14, 2011), submitted as Exhibit 1083 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
R. Aharoni, et al., Glatiramer acetate-specific T cells in the brain express T helper 2/3 cytokines and brain-derived neurotrophic factor in situ, PNAS 100(24):14157-14102 (Nov. 25, 2003), submitted as Exhibit 1084 on Mar. 8, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Teva's Shared Solutions.RTM. How to Prepare for Your Injection, "Preparation" [online]. Teva Neuroscience [retrieved on Mar. 7, 2016]. Retrieved from the internet: <URL://www.copaxone.com/injection-assistance/preparing-your-injection.- html>, submitted as Exhibit 1086 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Louise Gagnon, "Every-Other-Day Dosing of Glatiramer Acetate Reduces Adverse Reactions with Comparable Efficacy to Daily Dosing: Presented at WCTRMS" [online]. PeerView Press, Sep. 21, 2008 [retrieved on Mar. 8, 2016]. Retrieved from the internet: <URL://peerviewpress.com/every-other-day-dosing-flatiramer-acetate-red- uces-adverse-reactions-comparable-efficacy-daily-dosing-presented-wctrms&g- t;, submitted as Exhibit 1087 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
J. Wolinsky, Glatiramer acetate for the treatment of multiple sclerosis, Expert Opinion on Pharmacotherapy, 5(4):875-891 (2004), submitted as Exhibit 1088 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
O. Khan et al., Glatiramer acetate 20mg subcutaneous twice-weekly versus daily injections: results of a pilot, prospective, randomised, and rater-blinded clinical and MRI 2-year study in relapsing-remitting multiple sclerosis, Multiple Sclerosis, 15(S151-S269 (2009), submitted as Exhibit 1089 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
M.S. Weber et al. , Mechanism of Action of Glatiramer Acetate in Treatment of Multiple Sclerosis, Neurotherapeutics, 4(4):647-653 (2007), submitted as Exhibit 1090 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
W. F. Hickey et al. , T-Lymphocyte Entry Into the Central Nervous. System, J. of Neuroscience Research, 28(2):254-260 (1991), submitted as Exhibit 1091 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
T.M. Stewart et al., Injectable Multiple Sclerosis medications: A Patient Survey of Factors Associated with injection-Site Reactions, Int'l J. MS Care, 14(1):46-53 (2012), submitted as Exhibit 1092 on Mar. 9, 2016 in Inter Partes Review-Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
U.S. Dep't Health & Human Services., Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.03 Jun. 14, 2010), published May 28, 2009, submitted as Exhibit 1093 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
B. Singer et al., Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferon.beta.-1a verus subcutaneous interferon.beta.-1b: results of the randomized, multicenter, Phase IIIb REFORMS study, BMC Neurology, 12:154 (2012), submitted as Exhibit 1094 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
L. McEwan et al., Best Practices in Skin Care for the Multiple Sclerosis Patient Receiving Injectable Therapies, Int'l J. MS Care, 12:177-189 (2010), submitted as Exhibit 1095 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644, IPR2015-00830. cited by applicant .
R. Bermel et al., The measurement and clinical relevance of brain atrophy in multiple sclerosis, Lancer Neurol., 5(2):158-70 (2006), submitted as Exhibit 1096 on Mar. 9, 2016 in Inter Partes Review Cases Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
E. Fisher et al., Gray Matter Atrophy in Multiple Sclerosis: A Longitudinal Study, Ann. Neurol., 4:255-265 (2008), submitted as Exhibit 1097 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Lauren LeBano, Gray Matter Atrophy May Serve as an Effective Outcome measure for MS Clinical Trials [online] Neurol. Reviews, 20(2):8 (2012) [retrieved on Mar. 8, 2016]. Retrieved from the internet: <URL://www.neurologyreviews.com/specialty-focus/multiple-sclerosis-ms/- article/gray-matter-atrophy-mayserve-as-an-effective-outcome-measure-for-m- s-clinical-trials/5f1c2ba2adde725b8a583502b5c332e1.html?trendmd-shared=1&g- t;, submitted as Exhibit 1098 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Xinke Zhang et al., Cost Effectivesness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-.beta.1a in Relapsing-Remitting Multiple Sclerosis 29(1) CNS Dugs 71 (2015), submitted as Exhibit 1100 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Carly Helfand, Why is Novartis' Copaxone copy lagging? It'all about coverage, analyst explains[online]Fierce Pharma Sep. 11, 2015, [retrieved on Dec. 28, 2015]. Retrieved from the internet: <URL://www.fiercepharma.com/story/why-novartis-copaxone-copy-lagging-i- ts-all-about-coverage-analyst-explains/2015-09-11>, submitted as Exhibit 1105 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Biogen Press Release, Biogen 2015 Revenues Increase 11% to $10.8 Billion [online] BioGen.com, Jan. 27, 2016, Retrieved from the internet: <URL://media.biogen.com/press-release/investor-relations/biogen-2015-r- evenues-increase-11-108-billion>, submitted as Exhibit 1107 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
A to Z of MS Alemtuzumab (Lemtrada), Multiple Sclerosis Trust--information, education, research and support [online] Multiple Sclerosis Trust, Dec. 16, 2014 [retrieved on Jun. 2, 2015]. Retrieved from the Internet: URL://www.mstrust.org.uk/atoz/alemtuzumab-lemtrada.jsp>, submitted as Exhibit 1108 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
R. Osborne, Buzz around Campath proof-of-concept trial, in MS, 27(1) Nature Biotechnology 6 (2009), submitted as Exhibit 1109 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015- 00830. cited by applicant .
J. A. Cohen et al., Alemtuzumab versus interferon beta la as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomized controlled phase 3 trial, 380 LANCET, 3801519 (2012), submitted as Exhibit 1110 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
IMS Institute for Health Informatics, Medicine Use and Shifting Costs of Healthcare, Chart Notes, Apr. 2014, submitted as Exhibit 1111 on Mar. 9, 2015 in Inter Partes Review Case Nos. IPR2015-00543, IPR2015-00644 and IPR2015-00830. cited by applicant .
IMS institute for Health Informatics, Declining Medicine Use and Costs: For Better or Worse, May 2013, submitted as Exhibit 1112 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Valeant Pharms. Int'l, Inc., Transcript of Jun. 17, 2014 Investor Presentation [online] SEC.gov [retrieved on May 26, 2015]. Retrieved from the internet: URL://www.sec.gov/Archives/edgar/data/850693/000119312614239987/d745316d4- 25.htm>, submitted as Exhibit 1113 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Brian Orelli, Momenta Slowed (Temporarily) [online] The Motley Fool, Nov. 7, 2015 [retrieved on Dec. 28, 2015]. Retrieved from the Internet: <URL://www.fool.com/investing/general/2015/11/07/momenta-slowed- temporarily.aspx>, submitted as Exhibit 1114 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IRR2013-00644 and IPR2015-00830. cited by applicant .
Carly Helfand, The top 10 best-selling multiple sclerosis drugs of 2013 [online]. FiercePharma, Sep. 9, 2014 [retrieved on May 27, 2015]. Retrieved from the internet:<URL://www.fiercepharma.com/special-reports/top-10-best-selli- ng-multiple-sclerosis-drugs-2013, submitted as Exhibit 1115 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Tracy Staten, Sanofi tags newly OK'd MS drug Lemtrada at $158K, ready to tout head-to-head Rebif data [online], FiercePharmamarketing, Nov. 17, 2014. [retrieved on May 27, 2015]. Retrieved from the internet: <URL://www.fiercepharmamarketing.com/node/2101/print>, submitted as Exhibit 1116 on Mar. 9, 2016 in Inter Partes Review Case Nos, IPR2015-00643, IPR2015-00644 and IP2015-00830. cited by applicant .
Kim Frick et al., Serono to sell Amgen multiple sclerosis drug [Novantrone] in U.S. [online], Firstword Pharma, Nov. 13, 2002 [retrieved on May 27, 2015]. Retrieved from the internet: <URL://www.firstwordpharma.com/print/212958?tsid=17>, submitted as Exhibit 1117 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Christopher Luzzio & B. Mark Keegan, Multiple Sclerosis Medication [online]; Medscape Reference, Nov. 24, 2014 [retrieved on May 28, 2015]. Retrieved from the internet: <URL://emedicine.medscape.com/article/1146199-medication#1>, submitted as Exhibit 1118 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
IMS Health, U.S. Pharmaceutical Market: Trends Issues & Outlook, Sep. 15, 2013, submitted as Exhibit 1120 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Jesse David & Marion B. Stewart, Commercial Success: Economic Principles Applied to Patent Litigation, in Economic Damages in Intellectual Property: A Hands-On Guide to Litigation 159-170, Daniel Slottje ed., John Wiley & Sons, Inc. 2006, submitted as Exhibit 1121 on Mar. 9, 2016 in inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Angela Maas, New Copaxone Formulation. Could Help Teva Retain Market Share [online], AIS Health, Feb. 19, 2014 [retrieved on Dec. 31, 2015]. Retrieved from the internet: <URL://aishealth.com/blog/pharmacy-benefit-management/new-copaxone-for- mulation-could-help-teva-retain-market-share>, submitted as Exhibit 1122 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00630. cited by applicant .
Gina Shaw, Glatopa Is Strong Out of the Gate [online] , Specialty Pharmacy Continuum (Jul. 22, 2015), Retrieved from the internet: <URL://www.specialtypharmacycontinuum.com/Article/PrintArticle? articleID=33101>, submitted as Exhibit 1124 on Mar. 9, 2016 in Inter Partes Review Case. Nos. IPR2015-00643, IPR2015-00644 and IPR2016-00830. cited by applicant .
David Risinger et al., Morgan Stanley Analyst Report: Teva Pharmaceutical industries Ltd. (Mar. 14, 2014), submitted as Exhibit 11.25 on Mar. 9, 2015 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Organization Disclosures [online], MS Coalitton [retrieved on Mar. 6, 2016] , Retrieved from the internet: <URL://www.ms-coalition.orgj/emergingtherapies/disclosures/organizatio- n-disclosures>, submitted as Exhibit 1128 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00543, IPR2015-00644 and IPR2015-00830. cited by applicant .
Alisa Woods, The Costs of Multiple Sclerosis Treatment [online], Everyday Health (Feb. 22, 2016) [retrieved on Mar. 6, 2016], Retrieved from the internet: <URL://www.everydayhealth.com/multiple-sclerosis/treatment/c- osts-of-ms-treatment/>, submitted as Exhibit 1129 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Geeta Anand, Through Charities, Drug Makers Help People--and Themselves [online], Wall St. J. (Dec. 1, 2005) [retrieved on Mar. 8, 2016]. Retrieved from the Internet: <URL://www.wsj.com/articies/SB113339802749110822>, submitted as Exhibit 1130 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Malcolm Gladwell, High Prices: How to think about prescription drugs [online], New Yorker (Oct. 25, 2004) [retrieved on Sep. 8, 2012]. Retrieved from the internet: <URL://www.newyorker.com/magazine/2004/10/25/high-prices>, submitted as Exhibit 1131 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Ernst R. Berndt et al., An Analysis of the Diffusion of New Antidepressants: Variety, Quality, and Marketing Efforts, 5(1) J. of Mental Health Pol'y and Econs. 3 (2002), submitted as Exhibit 1132 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Ernst R. Berndt et al., Information, marketing, and pricing in the U.S. antiulcer drug market, 85(2) Am. Econ. Rev. 100 (1995), submitted as Exhibit 1133 on Mar. 9, 2016 in inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
FDA approves new MS treatment regimen developed at Wayne State University by Dr. Omar Khan [online], Division of Research--Research@wayne [retrieved on Mar. 8, 2016]. Retrieved from the Internet: <URL://research.wayne.edu/rwnews/article.php?id=1319>, submitted as Exhibit 1134 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Order Construing the Terms of U.S. Patent Nos. 8,232,250, 8,399,413, 8,969,302, and 9,155,770, In Re Copaxone 40 mg Consolidated Cases, No. 14-1171-GMS (consolidated) (D. Del. Mar, 7, 2016), ECF No. 214, submitted as Exhibit 1136 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Stipulation and [Proposed] Order Concerning Claim Construction Dispute, In Re Copaxone 40 mg Consolidated Cases, No. 14-1171-GMS (consolidated) (D. Del. Feb. 12, 2016) , ECF No. 194, submitted as Exhibit 1137 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Transcript of Trial Testimony, Teva Pharms. USA, Inc. v. Sandoz, Inc., No. 109-cv-08824 (S.D.N.Y. Sep. 7, 2011), ECF No. 205, submitted as Exhibit 1138 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Ampyra.RTM. Prescribing Information, published Dec. 2014 by Acorda Therapeutics, Inc, submitted as Exhibit 1139 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IRR2015-00644 and IPR2015-00830. cited by applicant .
Xinke Zhang & Joel W. Hay, Cost-effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon Beta-1a in Relapsing-remitting Multiple Sclerosis, poster presentation aileqedly at Monday Morning, PND20, ISPOR 19th Annual International Conference, Montreal, Quebec, Canada, allegedly on May 2014, submitted as Exhibit 1101 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Xinke Zhang & Joel W. Hay, Cost-effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon Beta-1a in Relapsing-remitting Multiple Sclerosis, poster presentation allegedly at the American Society for Health Economics 5th Biennial Conference, Los Angeles, CA, allegedly on Jun. 2014, submitted as Exhibit 1102 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-06043, IPR2015-00644 and IPR2015-00830. cited by applicant .
3-Times-A-Week Copaxone.RTM. 40 Mg [online], Teva [retrieved date unknown]. Retrieved from the internet <URL://www.copaxone.com/about-copaxone/copaxone-40-mg>, submitted as Exhibit 1106 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
10 Disease-modifying Treatments [online], MomentumMagazineOnline.com; allegedly on Nov. 2013 [retrieved date unknown]. Retrieved from the Internet: <URL://bit.ly/1eVa0jT>, submitted as Exhibit 1119 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Specialty Maximum Allowable Cost (MAC) [online], Missouri Dep't of Soc. Servs., alleged date Mar. 1, 2016 [retrieved date unknown]. Retrieved from the internet: <URL://dss.mo.gov/mhd/cs/pharmacy/pdf/madspec.pdf>, submitted as Exhibit 1123 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, 1PR2015-00644 and IPR2015-00830. cited by applicant .
Financial Support [online] , Teva Neuroscience 2015, [Retrieved allegedly on Dec. 2, 2015]. Retrieved from the internet <URL://www.copaxone.com/shared-solutions/copaxone-savings-and-benefits- >, submitted as Exhibit 1126 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Copaxone [online], Teva Neuroscience 2015, [Retrieved allegedly on Jan. 8, 2016]. Retrieved from the Internet: <URL://www.copaxone.com>, submitted as Exhibit 1127 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2015-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
File wrapper of U.S. Appl. No. 11/651,212, dated Jan. 9, 2007 to Mar. 9, 2010, submitted as Exhibit 1135 on Mar. 9, 2016 in Inter Partes Review Case Nos. IPR2019-00643, IPR2015-00644 and IPR2015-00830. cited by applicant .
Sixth Updated List of Petitioners' Exhibits, submitted as Notice 76 on Apr. 22, 2016 in Inter Partes Review Case Nos. IPR2015-00643. cited by applicant .
Sixth Updated List of Petitioners' Exhibits, submitted as Notice 77 on Apr. 22, 2016 in Inter Partes Review Case Nos. IPR2015-00644. cited by applicant .
Sixth Updated List of Petitioners' Exhibits, submitted as Notice 71 on Apr. 22, 2016 in Inter Partes Review Case Nos. IPR2015-00830. cited by applicant .
Updated List of Patent Owner's Exhibits, submitted as Notice 73 on Apr. 22, 2016 in Inter Partes Review Case Nos, IPR2015-00643. cited by applicant .
Updated List of Patent Owner's Exhibits, submitted as Notice 74 on Apr. 22, 2016 in Inter Partes Review Case Nos. IPR2015-00644. cited by applicant .
Updated List of Patent Owner's Exhibits, submitted as Notice 68 on Apr. 22, 2016 in Inter Partes Review Case Nos. IPR2015-00830. cited by applicant .
Redacted Expert Report of Ari Green, M.D., dated Apr. 19, 2016, which was prepared in connection with In Re Copaxone 40 Mg Cases, Case No. 1:14-cv-1171-GMS (Consolidated) in the United States District Court for District of Delaware. cited by applicant .
Redacted Opening Expert Report of Andrew R. Pachner, Ph. D., dated Apr. 19, 2016, which was prepared in connection with In Re Copaxone 40 Mg Cases, Case No. 1:14-cv-1171-GMS (Consolidated) in the United States District Court for District of Delaware. cited by applicant .
Redacted Opening Expert Report of Samuel J. Pleasure, M.D., Ph. D., dated Apr. 19, 2016, which was prepared in connection with In Re Copaxone 40 Mg Case, Case. No. 1:14-cv-1171-GMS (Consolidated) in the United States District Court for District of Delaware. cited by applicant .
Patent Owner Yeda Research & Development Co. Ltd.'s Preliminary Response, dated May 24, 2016, which was filed on May 24, 2016 in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd., Post Grant Review of. U.S. Pat. No. 9,155,776 in the United States Patent and Trademark Office Trial and Appeal Board (Case No. PGR2016-00010). cited by applicant .
Declaraction of Edward J. Fox, M.D., Ph.D. in Support of Patent Owner Yeda's Preliminary Response, dated May 23, 2016, which was filed on May 24, 2016 as Exhibit 2001 in connection with Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd., Post Grant Review of U.S. Pat. No. 9,155,776 in the United States Patent and Trademark Office Patent Trial and Appeal Board (Case No. PGR2016-00010). cited by applicant .
U.S. Appl. No. 61/274,687, filed Aug. 20, 2009 submitted as Exhibit 2002 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Claim Chart of U.S. Appl. No. 9,155,776, issued Oct. 13, 2015 submitted as Exhibit 2003 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
U.S. Appl. No. 13/770,677, filed Feb. 19, 2013 and Preliminary Amendment dated Feb. 19, 2013 filed in connection with U.S. Appl. No. 13/770,677, filed Feb. 19, 2013, submitted together as Exhibit 2004 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Defendant's Initial Joint Invalidity Contentions Regarding U.S. Pat. No. 9,155,776 B2, which was filed in connection with In Re Copaxone 40 Mg Cases, Case No. 1:14-cv-1171-GMS (Consolidated) in the United States District Court for District of Delaware, submitted as Exhibit 2005 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
U.S. Appl. No. 12/806,684, filed Aug. 19, 2010 and Preliminary Amendment dated Aug. 19, 2010 filed in connection with U.S. Appl. No. 12/806,684, filed Aug. 19, 2010, submitted together as Exhibit 2006 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
U.S. Appl. No. 61/337,612, filed Feb. 11, 2010, submitted as Exhibit 2007 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Khan et al., "Three Times Weekly Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis," Ann. Neurol., 2013; 73:705-713, submitted as Exhibit 2008 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Business Wire, "Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage for Glatiramer Acetate Given Three Times Weekly for Relapsing-Remitting Multiple Sclerosis, " dated Jun. 14, 2012, submitted as Exhibit 2009 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Reuters Press Release, "New Data Presented at the 28th ECTRIMS Congress Showcase Teva's Ongoing Commitment to Multiple Sclerosis Research," dated Oct. 8, 2012, submitted as Exibit 2010 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Khan et al., "A phase 3 trial to assess the efficacy and safety of glatiramer acetate injections 40 mg administered 3 times a week compared to placebo," Abstract 166, Multiple Sclerosis Journal 2012; 18(54)509-520, submitted as Exhibit 2011 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
U.S. Appl. No, 14/630,326, filed Feb. 24, 2015, and Application Data Sheet dated Feb. 24, 2015 and Preliminary Amendment: dated Feb. 24, 2015, filed in connection with U.S. Appl. No. 14/630,326, filed Feb. 24, 2015, submitted together as Exhibit 2012 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
Cobert, et al., "Practical Drug Safety from A to Z," Jones and Bartlett Publishers, 2009, pp, 327-329, submitted as Exhibit 2013 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant .
World Health Organization, "A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines," 2009, 129-133, submitted as Exhibit 2014 on May 24, 2016 Case No. PGR2016-00010. cited by applicant .
Patent Owner's Exhibit List, dated May 24, 2016, submitted as Exhibit 2000 on May 24, 2016 in Post Grant Review Case No. PGR2016-00010. cited by applicant.

Primary Examiner: Richter; Johann R
Assistant Examiner: Peebles; Katherine
Attorney, Agent or Firm: White; John P. Gershik; Gary J. Cooper & Dunham LLP
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