Termination Settlement after Institution | Dec 8, 2016 | PAPER | BOARD |
Corrected Joint Request to Treat Settlement Agreement (Exhibit 2090) as Business Confidential Information | Dec 6, 2016 | PAPER | PATENT OWNER |
Joint Stipulation to Modify Due Date 1 | Dec 2, 2016 | PAPER | PATENT OWNER |
Joint Motion to Terminate Proceeding | Nov 22, 2016 | PAPER | PATENT OWNER |
EXPUNGED | Nov 22, 2016 | PAPER | PATENT OWNER |
Settlement Agreement - Confidential | Nov 22, 2016 | EXHIBIT | PATENT OWNER |
Patent Owners Updated Exhibit List - November 22, 2016 | Nov 22, 2016 | PAPER | PATENT OWNER |
Amended Mandatory Notice | Oct 4, 2016 | PAPER | PETITIONER |
Order - Conduct of the Proceeding | Sep 30, 2016 | PAPER | BOARD |
Patent Owner Objections to Evidence Submitted with Petition | Sep 15, 2016 | PAPER | PATENT OWNER |
Trial Instituted Document | Sep 1, 2016 | PAPER | BOARD |
Scheduling Order | Sep 1, 2016 | PAPER | BOARD |
Patent Owner Preliminary Response | Jun 2, 2016 | PAPER | 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 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
WA Secretary of State Registration Detail for Frontier Therapeutics, LLC | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
WA Secretary of State Registration Detail for Jason Paul Greer Enterprises LLC | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
JPG dba JP Group - search of the State of Washington Business Licensing Service | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Whois Data for Frontiertherapeuticsnw.com | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Declaration of Dr. Michael E. Weinblatt, dated June 17, 2014 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Redline comparison of Gershwin Declaration and Weinblatt Declaration | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Gershwin and Methotrexate publications list, NCBI.com | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Andrea T. Borchers et al., The Use of Methotrexate in Rheumatoid Arthritis, Seminars in Arthritis and Rheumatism (Aug. 2004) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Jiri Grim et al., Pharmacokinetics and Pharmacodynamics of Methotrexate in Non-Neoplastic Diseases, Special Populations (2003) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Drugs at FDA - FDA Approved Drug Products (Mexate) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Bingham SJ et al. Parenteral methotrexate should be given before biological therapy, Rheumatology (2003) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
U.S. Patent No. 8,480,631 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Breslin, et al., Improving Tolerance and Bioavailability of Methotrexate by Switching from Oral to Subcutaneous Route of Administration, Rheumatology 388 (2005) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Balis, et al., Pharmacokinetics of Subcutaneous Methotrexate, Journal of Clinical Oncology (1988) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Declaration of Elena Massarotti, MD | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Goodman and Gilman_s The Pharmacological Basis of Therapeutics, 7th Ed, 1985 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
2007 CDC Guidelines for Injection | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
SICOR Pharmaceuticals ANDA Suitability Petition Methotrexate Injection, USP (100mb_mL), dated April 28, 2006 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Brazaeu et al. Current Perspectives on Pain Upon Injection of Drugs, J. Pharm. Sci., 1998 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Day 75 Response Report | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Chapter 3 - Drug Administration, Drug Therapy In Nursing, 3rd Ed., Aschenbrenner DS and Venable SJ, Wolters Kluwer Health (2009) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Chapter 16 - Human - Veterinary Technology Cross Over, Long Acting Animal Health Drug Products - Fundamentals and Applications, Baird et al., Springer (2013) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Drugs at FDA Summary Table | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Drugs at FDA Search Results for Methotrexate | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Kurnick D. et al., Bioavailability of oral vs. subcutaneous low-dose methotrexate in patients with Crohn_s disease, Aliment. Pharmacol. Ther.(2003) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Declaration of Maria Salgado | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Declaration of Michael Duffey | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Expert Declaration of Dr. Sean Nicholson | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
MTX Information with Strength (MEDAC-NJ 0002040) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Ashburn, T. et al., Drug Repositioning - Identifying and Developing New Uses for Existing Drugs, Nature Reviews Drug Discovery (2004) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Augustin, M. et al., Adherence in the Treatment of Psoriasis - A Systematic Review, Dermatology, Vol. 222, pp. 363-374 (2011) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Beyer, V. et al., Recent Trends in Systemic Psoriasis Treatment Costs, Archives of Dermatology (2010) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Goutsou, M. et al., Biologics Utilization for Rheumatoid Arthritis in the United States - An Observational Longitudinal Study, Journal of Medical Marketing (2013) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Helmick, C. et al., Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States, Arthritis and Rheumatism (2008) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Kalb, R. et al., Methotrexate and Psoriasis - 2009 National Psoriasis Foundation Consensus Conference, Journal of American Academy of Dermatology (2009) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Michaud, K. et al., Direct Medical Costs and Their Predictors in Patients with Rheumatoid Arthritis, Arthritis and Rheumatism (2003) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Mount, C. et al., Rheumatoid Arthritis Market, Nature Reviews Drug Discovery (2005) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Paul, S. et al., How to Improve R_D Productivity - The Pharmaceutical Industry_s Grand Challenge, Nature Reviews Drug Discovery (2010) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Rachakonda, T. et al., Psoriasis Prevalence Among Adults in the United States, Journal of the American Academy of Dermatology (2014) | Jun 2, 2016 | EXHIBIT | 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 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Smith, K., Systemic Therapy of Psoriasis Using Methotrexate, Skin Therapy Letter (2000) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Steinwachs, D., Pharmacy Benefit Plans and Prescription Drug Spending, Journal of the American Medical Association (2002) | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Eisenberg, R., Patents and Regulatory Exclusivity, The Oxford Handbook of The Economics of the Biopharmaceutical Industry, Oxford University Press (2012) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Malani, A. et al., The Regulations of Medical Products, The Oxford Handbook of the Economics of the Biopharmaceutical Industry (2012) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
October 2006 ASP Pricing File - Updated 12/19/07, Centers for Medicare and Medicaid Services | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
October 2014 ASP Pricing File 09-12-14, Centers for Medicare and Medicaid Services | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Declaration of Brian Gummow | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Supply of a Cancer Drug May Run Out Within Weeks, New York Times (2012) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
About Rasuvo TM Medac Pharma | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Antares Pharma_s (ATRS) CEO Paul Wotton on Q1 2014 Results - Earnings Call Transcript, Seeking Alpha, May 9, 2014 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Antares - Thoughts on the Upcoming Otrexup TM Launch, Seeking Alpha (2013) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Antares - My View of How Otrexup TMand Medac_s New Product Rasuvo TMMay Compete, SmithOnStocks, (2014) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Arthritis Today Drug Guide, Arthritis Foundation | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Drug Guide - DMARDs, Arthritis Foundation | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
FDA Approval Letter - Otrexup TM, Drugs at FDA, Oct. 11, 2013 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
FDA Approval Letter - Rasuvo TM Drugs at FDA, July 10, 2014 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
FDA OKs a New Methotrexate Injection Device, Arthritis Foundation, Aug. 15, 2014 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
FDA Summary Review - Otrexup TM, Drugs at FDA, Oct. 13, 2013 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Frequently Asked Questions on Prescription Drug User Fees (PDUFA), U.S. Food and Drug Administration | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Guidance for Industry - Applications Covered by Section 505(b)(2),U.S. Food and Drug Administration, Oct. 1999 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Highlights of Prescribing Information - OXTREXUP TM, Drugs FDA, Nov. 2014 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Highlights of Prescribing Information - RASUVO TM Drugs at FDA, July 2014 | Jun 2, 2016 | EXHIBIT | 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) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Jefferies Boosts PT on Antares Pharma (ATRS) 20 per cent into OTREXUP TM PDUFA, Maintains Buy, StreetInsiden.com, Oct. 8, 2013 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Juvenile Idiopathic Arthritis (JIA), NYU Langone Medical Center Division of Pediatric Rheumatology | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Memorandum Report - Comparison of First-Quarter 2012 Average Sales Prices and Average Manufacturer Prices - Impact on Medicare Reimbursement for Third Quarter (2012) | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Methotrexate Fact Sheet, American College of Rheumatology, May 2012 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Prescription Drug Trends, Kaiser Family Foundation, Fact Sheet No. 3057-30, Oct. 2004 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Psoriasis Treatments with Next Generation Vitamin D Analogs, Wisconsin Alumni Research Foundation | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Questions and Answers about Juvenile Arthritis, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Aug. 2013 | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Rheumatoid Arthritis Signs and Symptoms, Johns Hopkins Arthritis Center | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
State and County QuickFacts, United States Census Bureau | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
FDA Orange Book Data File Patent.txt | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
FDA Orange Book Data File Products.txt | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
FDA Orange Book Data File Exclusivity.txt | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Compilation of Drug Labels | Jun 2, 2016 | EXHIBIT | PATENT OWNER |
Notice of Accepting Corrected Petition | Mar 9, 2016 | PAPER | BOARD |
Power of Attorney | Mar 9, 2016 | PAPER | INDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER. |
Related Matters | Mar 9, 2016 | PAPER | INDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER. |
response to notice of filing date | Mar 8, 2016 | PAPER | PETITIONER |
table of exhibits | Mar 8, 2016 | PAPER | PETITIONER |
exhibit 1007 | Mar 8, 2016 | EXHIBIT | PETITIONER |
Notice of Filing Date/Defective Petition | Mar 2, 2016 | PAPER | BOARD |
petition | Feb 22, 2016 | PAPER | PETITIONER |
Power of Attorney | Feb 22, 2016 | PAPER | PETITIONER |
exhibit 1001 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1002 | Feb 22, 2016 | EXHIBIT | PETITIONER |
Exhibit 1003 | Feb 22, 2016 | EXHIBIT | PETITIONER |
Exhibit 1004 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1005 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1006 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1007 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1008 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1009 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1010 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1011 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1012 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1013 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1014 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1015 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1016 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1017 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1018 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1019 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1020 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1021 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1022 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1023 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1024 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1025 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1026 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1027 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1028 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1029 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1030 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1031 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1032 | Feb 22, 2016 | EXHIBIT | PETITIONER |
exhibit 1033 | Feb 22, 2016 | EXHIBIT | PETITIONER |