Case number IPR2016-00649
Frontier Therapeutics, LLC > Documents
| Date Field | Doc. No. | Party | Description |
|---|---|---|---|
| Dec 8, 2016 | 20 | Termination Settlement after Institution Download | |
| Dec 6, 2016 | 19 | Corrected Joint Request to Treat Settlement Agreement (Exhibit 2090) as Business Confidential Information Download | |
| Dec 2, 2016 | 18 | Joint Stipulation to Modify Due Date 1 Download | |
| Nov 22, 2016 | 17 | Patent Owners Updated Exhibit List - November 22, 2016 Download | |
| Nov 22, 2016 | 15 | Joint Motion to Terminate Proceeding Download | |
| Oct 4, 2016 | 14 | Amended Mandatory Notice Download | |
| Sep 30, 2016 | 13 | Order - Conduct of the Proceeding Download | |
| Sep 15, 2016 | 12 | Patent Owner Objections to Evidence Submitted with Petition Download | |
| Sep 1, 2016 | 11 | Scheduling Order Download | |
| Sep 1, 2016 | 10 | Trial Instituted Document Download | |
| Jun 2, 2016 | 2051 | patent_owner | Steinwachs, D., Pharmacy Benefit Plans and Prescription Drug Spending, Journal of the American Medical Association (2002) Download |
| Jun 2, 2016 | 2064 | patent_owner | Antares - My View of How Otrexup TMand Medac_s New Product Rasuvo TMMay Compete, SmithOnStocks, (2014) Download |
| Jun 2, 2016 | 2052 | patent_owner | DiMasi, J. et al., R_D Costs and Returns to New Drug Development - A Review of the Evidence, The Oxford Handbook of The Economics of the Biopharmaceutical Industry (2012) Download |
| Jun 2, 2016 | 2067 | patent_owner | Drug Guide - DMARDs, Arthritis Foundation Download |
| Jun 2, 2016 | 2078 | patent_owner | Juvenile Idiopathic Arthritis (JIA), NYU Langone Medical Center Division of Pediatric Rheumatology Download |
| Jun 2, 2016 | 9 | patent_owner | Patent Owner Preliminary Response Download |
| Jun 2, 2016 | 2075 | patent_owner | Highlights of Prescribing Information - RASUVO TM Drugs at FDA, July 2014 Download |
| Jun 2, 2016 | 2081 | patent_owner | Prescription Drug Trends, Kaiser Family Foundation, Fact Sheet No. 3057-30, Oct. 2004 Download |
| Jun 2, 2016 | 2047 | patent_owner | Paul, S. et al., How to Improve R_D Productivity - The Pharmaceutical Industry_s Grand Challenge, Nature Reviews Drug Discovery (2010) Download |
| Jun 2, 2016 | 2076 | patent_owner | How Medicare Prescription Drug Plans and Medicare Advantage Plans with Prescription Drug Coverage (MA-PDs) Use Pharmacies, Formularies, and Common Coverage Rules (2015) Download |
| Jun 2, 2016 | 2082 | patent_owner | Psoriasis Treatments with Next Generation Vitamin D Analogs, Wisconsin Alumni Research Foundation Download |
| Jun 2, 2016 | 2058 | patent_owner | Declaration of Brian Gummow Download |
| Jun 2, 2016 | 2077 | patent_owner | Jefferies Boosts PT on Antares Pharma (ATRS) 20 per cent into OTREXUP TM PDUFA, Maintains Buy, StreetInsiden.com, Oct. 8, 2013 Download |
| Jun 2, 2016 | 2045 | patent_owner | Michaud, K. et al., Direct Medical Costs and Their Predictors in Patients with Rheumatoid Arthritis, Arthritis and Rheumatism (2003) Download |
| Jun 2, 2016 | 2046 | patent_owner | Mount, C. et al., Rheumatoid Arthritis Market, Nature Reviews Drug Discovery (2005) Download |
| Jun 2, 2016 | 2085 | patent_owner | State and County QuickFacts, United States Census Bureau Download |
| Jun 2, 2016 | 2066 | patent_owner | DMARDs for Juvenile Idiopathic Arthritis - A Review of the Research for Parents and Caregivers, John M Eisenberg Center for Clinical Decisions and Communications Science (2011) Download |
| Jun 2, 2016 | 2074 | patent_owner | Highlights of Prescribing Information - OXTREXUP TM, Drugs FDA, Nov. 2014 Download |
| Jun 2, 2016 | 2072 | patent_owner | Frequently Asked Questions on Prescription Drug User Fees (PDUFA), U.S. Food and Drug Administration Download |
| Jun 2, 2016 | 2083 | patent_owner | Questions and Answers about Juvenile Arthritis, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Aug. 2013 Download |
| Jun 2, 2016 | 2054 | patent_owner | Malani, A. et al., The Regulations of Medical Products, The Oxford Handbook of the Economics of the Biopharmaceutical Industry (2012) Download |
| Jun 2, 2016 | 2087 | patent_owner | FDA Orange Book Data File Products.txt Download |
| Jun 2, 2016 | 2053 | patent_owner | Eisenberg, R., Patents and Regulatory Exclusivity, The Oxford Handbook of The Economics of the Biopharmaceutical Industry, Oxford University Press (2012) Download |
| Jun 2, 2016 | 2079 | patent_owner | Memorandum Report - Comparison of First-Quarter 2012 Average Sales Prices and Average Manufacturer Prices - Impact on Medicare Reimbursement for Third Quarter (2012) Download |
| Jun 2, 2016 | 2084 | patent_owner | Rheumatoid Arthritis Signs and Symptoms, Johns Hopkins Arthritis Center Download |
| Jun 2, 2016 | 2061 | patent_owner | About Rasuvo TM Medac Pharma Download |
| Jun 2, 2016 | 2086 | patent_owner | FDA Orange Book Data File Patent.txt Download |
| Jun 2, 2016 | 2065 | patent_owner | Arthritis Today Drug Guide, Arthritis Foundation Download |
| Jun 2, 2016 | 2057 | patent_owner | October 2014 ASP Pricing File 09-12-14, Centers for Medicare and Medicaid Services Download |
| Jun 2, 2016 | 2048 | patent_owner | Rachakonda, T. et al., Psoriasis Prevalence Among Adults in the United States, Journal of the American Academy of Dermatology (2014) Download |
| Jun 2, 2016 | 2063 | patent_owner | Antares - Thoughts on the Upcoming Otrexup TM Launch, Seeking Alpha (2013) Download |
| Jun 2, 2016 | 2049 | patent_owner | Saag, K. et al., American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis Download |
| Jun 2, 2016 | 2062 | patent_owner | Antares Pharma_s (ATRS) CEO Paul Wotton on Q1 2014 Results - Earnings Call Transcript, Seeking Alpha, May 9, 2014 Download |
| Jun 2, 2016 | 2050 | patent_owner | Smith, K., Systemic Therapy of Psoriasis Using Methotrexate, Skin Therapy Letter (2000) Download |
| Jun 2, 2016 | 2073 | patent_owner | Guidance for Industry - Applications Covered by Section 505(b)(2),U.S. Food and Drug Administration, Oct. 1999 Download |
| Jun 2, 2016 | 2059 | patent_owner | Antares Pharma Announces Availability of Otrexup TM (Methotrexate) Injection for Subcutaneous Use to Treat Rheumatoid Arthritis (RA) and psoriasis in adults, and polyarticular idiopathic arthritis (pJIA) in Children, (2014) Download |
| Jun 2, 2016 | 2069 | patent_owner | FDA Approval Letter - Rasuvo TM Drugs at FDA, July 10, 2014 Download |
| Jun 2, 2016 | 2088 | patent_owner | FDA Orange Book Data File Exclusivity.txt Download |
| Jun 2, 2016 | 2070 | patent_owner | FDA OKs a New Methotrexate Injection Device, Arthritis Foundation, Aug. 15, 2014 Download |
| Jun 2, 2016 | 2044 | patent_owner | Menter, A. et al., Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis - Section 4, Journal of the American Academy of Dermatology (2009) Download |
| Jun 2, 2016 | 2089 | patent_owner | Compilation of Drug Labels Download |
| Jun 2, 2016 | 2060 | patent_owner | Supply of a Cancer Drug May Run Out Within Weeks, New York Times (2012) Download |
| Jun 2, 2016 | 2071 | patent_owner | FDA Summary Review - Otrexup TM, Drugs at FDA, Oct. 13, 2013 Download |
| Jun 2, 2016 | 2068 | patent_owner | FDA Approval Letter - Otrexup TM, Drugs at FDA, Oct. 11, 2013 Download |
| Jun 2, 2016 | 2080 | patent_owner | Methotrexate Fact Sheet, American College of Rheumatology, May 2012 Download |
| Jun 2, 2016 | 2056 | patent_owner | October 2006 ASP Pricing File - Updated 12/19/07, Centers for Medicare and Medicaid Services Download |
| Jun 2, 2016 | 2043 | patent_owner | Kurd, S. et al., The Prevalence of Previously Diagnosed and Undiagnosed Psoriasis in US Adults, Journal of the American Academy of Dermatology (2009) Download |
| Jun 2, 2016 | 2012 | patent_owner | Bingham SJ et al. Parenteral methotrexate should be given before biological therapy, Rheumatology (2003) Download |
| Jun 2, 2016 | 2010 | patent_owner | Jiri Grim et al., Pharmacokinetics and Pharmacodynamics of Methotrexate in Non-Neoplastic Diseases, Special Populations (2003) Download |
| Jun 2, 2016 | 2039 | patent_owner | Gowdie, P., Review of Disease - Modifying Anti Rheumatic Drugs in Paediatric Rheumatic Disease, 18th Expert Committee on the Selection and Use of Essential Medicines (2010) Download |
| Jun 2, 2016 | 2013 | patent_owner | U.S. Patent No. 8,480,631 Download |
| Jun 2, 2016 | 2029 | patent_owner | Pavy S. et al., Methotrexate therapy for rheumatoid arthritis - clinical practice guidelines based on published evidence and expert opinion, Joint Bone Spine (2006) Download |
| Jun 2, 2016 | 2040 | patent_owner | Greenapple, R., Trends in Biologic Therapies for Rheumatoid Arthritis - Results from a Survey of Payers and Providers, American Health and Drug Benefits (2012) Download |
| Jun 2, 2016 | 2014 | patent_owner | Breslin, et al., Improving Tolerance and Bioavailability of Methotrexate by Switching from Oral to Subcutaneous Route of Administration, Rheumatology 388 (2005) Download |
| Jun 2, 2016 | 2005 | patent_owner | Whois Data for Frontiertherapeuticsnw.com Download |
| Jun 2, 2016 | 2024 | patent_owner | Chapter 3 - Drug Administration, Drug Therapy In Nursing, 3rd Ed., Aschenbrenner DS and Venable SJ, Wolters Kluwer Health (2009) Download |
| Jun 2, 2016 | 2033 | patent_owner | MTX Information with Strength (MEDAC-NJ 0002040) Download |
| Jun 2, 2016 | 2027 | patent_owner | Drugs at FDA Search Results for Methotrexate Download |
| Jun 2, 2016 | 2026 | patent_owner | Drugs at FDA Summary Table Download |
| Jun 2, 2016 | 2003 | patent_owner | WA Secretary of State Registration Detail for Jason Paul Greer Enterprises LLC Download |
| Jun 2, 2016 | 2020 | patent_owner | 2007 CDC Guidelines for Injection Download |
| Jun 2, 2016 | 2016 | patent_owner | Schiff, et al., Head-to-head, randomized, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis, Ann Rheum Dis 0_1-3 (2014) Download |
| Jun 2, 2016 | 2002 | patent_owner | WA Secretary of State Registration Detail for Frontier Therapeutics, LLC Download |
| Jun 2, 2016 | 2004 | patent_owner | JPG dba JP Group - search of the State of Washington Business Licensing Service Download |
| Jun 2, 2016 | 2009 | patent_owner | Andrea T. Borchers et al., The Use of Methotrexate in Rheumatoid Arthritis, Seminars in Arthritis and Rheumatism (Aug. 2004) Download |
| Jun 2, 2016 | 2031 | patent_owner | Declaration of Michael Duffey Download |
| Jun 2, 2016 | 2008 | patent_owner | Gershwin and Methotrexate publications list, NCBI.com Download |
| Jun 2, 2016 | 2036 | patent_owner | Bemt, B., et al., Medication Adherence in Patients With Rheumatoid Arthritis - A Critical Appraisal of the Existing Literature, Expert Review of Clinical Immunology (2012) Download |
| Jun 2, 2016 | 2018 | patent_owner | Declaration of Elena Massarotti, MD Download |
| Jun 2, 2016 | 2015 | patent_owner | Balis, et al., Pharmacokinetics of Subcutaneous Methotrexate, Journal of Clinical Oncology (1988) Download |
| Jun 2, 2016 | 2001 | patent_owner | January 8, 2016 Letter from Jason Greer to Terri Shoemaker re Rasuvo TM and Orange Book-Listed U.S. Patent No. 8,664,231 Download |
| Jun 2, 2016 | 2042 | patent_owner | Kalb, R. et al., Methotrexate and Psoriasis - 2009 National Psoriasis Foundation Consensus Conference, Journal of American Academy of Dermatology (2009) Download |
| Jun 2, 2016 | 2025 | patent_owner | Chapter 16 - Human - Veterinary Technology Cross Over, Long Acting Animal Health Drug Products - Fundamentals and Applications, Baird et al., Springer (2013) Download |
| Jun 2, 2016 | 2035 | patent_owner | Augustin, M. et al., Adherence in the Treatment of Psoriasis - A Systematic Review, Dermatology, Vol. 222, pp. 363-374 (2011) Download |
| Jun 2, 2016 | 2022 | patent_owner | Brazaeu et al. Current Perspectives on Pain Upon Injection of Drugs, J. Pharm. Sci., 1998 Download |
| Jun 2, 2016 | 2007 | patent_owner | Redline comparison of Gershwin Declaration and Weinblatt Declaration Download |
| Jun 2, 2016 | 2034 | patent_owner | Ashburn, T. et al., Drug Repositioning - Identifying and Developing New Uses for Existing Drugs, Nature Reviews Drug Discovery (2004) Download |
| Jun 2, 2016 | 2006 | patent_owner | Declaration of Dr. Michael E. Weinblatt, dated June 17, 2014 Download |
| Jun 2, 2016 | 2030 | patent_owner | Declaration of Maria Salgado Download |
| Jun 2, 2016 | 2017 | patent_owner | Antares Pharma Press Release, Antares Pharma Announces the Publication of a Head-to-Head, Randomized, Crossover Study of Oral versus Subcutaneous Methotrexate in Patients with Rheumatoid Arthritis, Business Wire (Apr. 17, 2014) Download |
| Jun 2, 2016 | 2032 | patent_owner | Expert Declaration of Dr. Sean Nicholson Download |
| Jun 2, 2016 | 2023 | patent_owner | Day 75 Response Report Download |
| Jun 2, 2016 | 2041 | patent_owner | Helmick, C. et al., Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States, Arthritis and Rheumatism (2008) Download |
| Jun 2, 2016 | 2021 | patent_owner | SICOR Pharmaceuticals ANDA Suitability Petition Methotrexate Injection, USP (100mb_mL), dated April 28, 2006 Download |
| Jun 2, 2016 | 2037 | patent_owner | Beyer, V. et al., Recent Trends in Systemic Psoriasis Treatment Costs, Archives of Dermatology (2010) Download |
| Jun 2, 2016 | 2028 | patent_owner | Kurnick D. et al., Bioavailability of oral vs. subcutaneous low-dose methotrexate in patients with Crohn_s disease, Aliment. Pharmacol. Ther.(2003) Download |
| Jun 2, 2016 | 2038 | patent_owner | Goutsou, M. et al., Biologics Utilization for Rheumatoid Arthritis in the United States - An Observational Longitudinal Study, Journal of Medical Marketing (2013) Download |
| Jun 2, 2016 | 2019 | patent_owner | Goodman and Gilman_s The Pharmacological Basis of Therapeutics, 7th Ed, 1985 Download |
| Jun 2, 2016 | 2011 | patent_owner | Drugs at FDA - FDA Approved Drug Products (Mexate) Download |
| Mar 9, 2016 | 8 | potential_po | Related Matters Download |
| Mar 9, 2016 | 6 | board | Notice of Accepting Corrected Petition Download |
| Mar 9, 2016 | 7 | potential_po | Power of Attorney Download |
| Mar 8, 2016 | 5 | petitioner | table of exhibits Download |
| Mar 8, 2016 | 4 | petitioner | response to notice of filing date Download |
| Mar 8, 2016 | 1007 | petitioner | exhibit 1007 Download |
| Mar 8, 2016 | 1007 | petitioner | exhibit 1007 Download |
| Mar 2, 2016 | 3 | board | Notice of Filing Date/Defective Petition Download |
| Feb 22, 2016 | 1002 | petitioner | exhibit 1002 Download |
| Feb 22, 2016 | 1026 | petitioner | exhibit 1026 Download |
| Feb 22, 2016 | 1031 | petitioner | exhibit 1031 Download |
| Feb 22, 2016 | 1005 | petitioner | exhibit 1005 Download |
| Feb 22, 2016 | 1032 | petitioner | exhibit 1032 Download |
| Feb 22, 2016 | 1016 | petitioner | exhibit 1016 Download |
| Feb 22, 2016 | 1019 | petitioner | exhibit 1019 Download |
| Feb 22, 2016 | 1028 | petitioner | exhibit 1028 Download |
| Feb 22, 2016 | 1033 | petitioner | exhibit 1033 Download |
| Feb 22, 2016 | 1030 | petitioner | exhibit 1030 Download |
| Feb 22, 2016 | 1021 | petitioner | exhibit 1021 Download |
| Feb 22, 2016 | 1008 | petitioner | exhibit 1008 Download |
| Feb 22, 2016 | 1029 | petitioner | exhibit 1029 Download |
| Feb 22, 2016 | 1003 | petitioner | Exhibit 1003 Download |
| Feb 22, 2016 | 2 | petitioner | Power of Attorney Download |
| Feb 22, 2016 | 1020 | petitioner | exhibit 1020 Download |
| Feb 22, 2016 | 1017 | petitioner | exhibit 1017 Download |
| Feb 22, 2016 | 1014 | petitioner | exhibit 1014 Download |
| Feb 22, 2016 | 1018 | petitioner | exhibit 1018 Download |
| Feb 22, 2016 | 1025 | petitioner | exhibit 1025 Download |
| Feb 22, 2016 | 1 | petitioner | petition Download |
| Feb 22, 2016 | 1013 | petitioner | exhibit 1013 Download |
| Feb 22, 2016 | 1009 | petitioner | exhibit 1009 Download |
| Feb 22, 2016 | 1011 | petitioner | exhibit 1011 Download |
| Feb 22, 2016 | 1006 | petitioner | exhibit 1006 Download |
| Feb 22, 2016 | 1015 | petitioner | exhibit 1015 Download |
| Feb 22, 2016 | 1001 | petitioner | exhibit 1001 Download |
| Feb 22, 2016 | 1024 | petitioner | exhibit 1024 Download |
| Feb 22, 2016 | 1027 | petitioner | exhibit 1027 Download |
| Feb 22, 2016 | 1012 | petitioner | exhibit 1012 Download |
| Feb 22, 2016 | 1004 | petitioner | Exhibit 1004 Download |
| Feb 22, 2016 | 1022 | petitioner | exhibit 1022 Download |
| Feb 22, 2016 | 1010 | petitioner | exhibit 1010 Download |
| Feb 22, 2016 | 1023 | petitioner | exhibit 1023 Download |
| Feb 22, 2016 | 1007 | petitioner | exhibit 1007 Download |
