The detailed information for PTAB case with proceeding number IPR2016-00649 filed by Frontier Therapeutics, LLC against MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH et al. on Feb 22, 2016. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2016-00649
Filing Date
Feb 22, 2016
Petitioner
Frontier Therapeutics, LLC
Respondent
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH et al.
Status
Terminated-Settled
Respondent Application Number
12374528
Respondent Tech Center
1600
Respondent Patent Number
8664231
Institution Decision Date
Sep 1, 2016
Termination Date
Dec 8, 2016

Proceeding Documents

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


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Termination Settlement after Institution

Dec 8, 2016PAPERBOARD

Corrected Joint Request to Treat Settlement Agreement (Exhibit 2090) as Business Confidential Information

Dec 6, 2016PAPERPATENT OWNER

Joint Stipulation to Modify Due Date 1

Dec 2, 2016PAPERPATENT OWNER

Joint Motion to Terminate Proceeding

Nov 22, 2016PAPERPATENT OWNER

EXPUNGED

Nov 22, 2016PAPERPATENT OWNER

Settlement Agreement - Confidential

Nov 22, 2016EXHIBITPATENT OWNER

Patent Owners Updated Exhibit List - November 22, 2016

Nov 22, 2016PAPERPATENT OWNER

Amended Mandatory Notice

Oct 4, 2016PAPERPETITIONER

Order - Conduct of the Proceeding

Sep 30, 2016PAPERBOARD

Patent Owner Objections to Evidence Submitted with Petition

Sep 15, 2016PAPERPATENT OWNER

Trial Instituted Document

Sep 1, 2016PAPERBOARD

Scheduling Order

Sep 1, 2016PAPERBOARD

Patent Owner Preliminary Response

Jun 2, 2016PAPERPATENT 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, 2016EXHIBITPATENT OWNER

WA Secretary of State Registration Detail for Frontier Therapeutics, LLC

Jun 2, 2016EXHIBITPATENT OWNER

WA Secretary of State Registration Detail for Jason Paul Greer Enterprises LLC

Jun 2, 2016EXHIBITPATENT OWNER

JPG dba JP Group - search of the State of Washington Business Licensing Service

Jun 2, 2016EXHIBITPATENT OWNER

Whois Data for Frontiertherapeuticsnw.com

Jun 2, 2016EXHIBITPATENT OWNER

Declaration of Dr. Michael E. Weinblatt, dated June 17, 2014

Jun 2, 2016EXHIBITPATENT OWNER

Redline comparison of Gershwin Declaration and Weinblatt Declaration

Jun 2, 2016EXHIBITPATENT OWNER

Gershwin and Methotrexate publications list, NCBI.com

Jun 2, 2016EXHIBITPATENT OWNER

Andrea T. Borchers et al., The Use of Methotrexate in Rheumatoid Arthritis, Seminars in Arthritis and Rheumatism (Aug. 2004)

Jun 2, 2016EXHIBITPATENT OWNER

Jiri Grim et al., Pharmacokinetics and Pharmacodynamics of Methotrexate in Non-Neoplastic Diseases, Special Populations (2003)

Jun 2, 2016EXHIBITPATENT OWNER

Drugs at FDA - FDA Approved Drug Products (Mexate)

Jun 2, 2016EXHIBITPATENT OWNER

Bingham SJ et al. Parenteral methotrexate should be given before biological therapy, Rheumatology (2003)

Jun 2, 2016EXHIBITPATENT OWNER

U.S. Patent No. 8,480,631

Jun 2, 2016EXHIBITPATENT OWNER

Breslin, et al., Improving Tolerance and Bioavailability of Methotrexate by Switching from Oral to Subcutaneous Route of Administration, Rheumatology 388 (2005)

Jun 2, 2016EXHIBITPATENT OWNER

Balis, et al., Pharmacokinetics of Subcutaneous Methotrexate, Journal of Clinical Oncology (1988)

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Declaration of Elena Massarotti, MD

Jun 2, 2016EXHIBITPATENT OWNER

Goodman and Gilman_s The Pharmacological Basis of Therapeutics, 7th Ed, 1985

Jun 2, 2016EXHIBITPATENT OWNER

2007 CDC Guidelines for Injection

Jun 2, 2016EXHIBITPATENT OWNER

SICOR Pharmaceuticals ANDA Suitability Petition Methotrexate Injection, USP (100mb_mL), dated April 28, 2006

Jun 2, 2016EXHIBITPATENT OWNER

Brazaeu et al. Current Perspectives on Pain Upon Injection of Drugs, J. Pharm. Sci., 1998

Jun 2, 2016EXHIBITPATENT OWNER

Day 75 Response Report

Jun 2, 2016EXHIBITPATENT OWNER

Chapter 3 - Drug Administration, Drug Therapy In Nursing, 3rd Ed., Aschenbrenner DS and Venable SJ, Wolters Kluwer Health (2009)

Jun 2, 2016EXHIBITPATENT OWNER

Chapter 16 - Human - Veterinary Technology Cross Over, Long Acting Animal Health Drug Products - Fundamentals and Applications, Baird et al., Springer (2013)

Jun 2, 2016EXHIBITPATENT OWNER

Drugs at FDA Summary Table

Jun 2, 2016EXHIBITPATENT OWNER

Drugs at FDA Search Results for Methotrexate

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Declaration of Maria Salgado

Jun 2, 2016EXHIBITPATENT OWNER

Declaration of Michael Duffey

Jun 2, 2016EXHIBITPATENT OWNER

Expert Declaration of Dr. Sean Nicholson

Jun 2, 2016EXHIBITPATENT OWNER

MTX Information with Strength (MEDAC-NJ 0002040)

Jun 2, 2016EXHIBITPATENT OWNER

Ashburn, T. et al., Drug Repositioning - Identifying and Developing New Uses for Existing Drugs, Nature Reviews Drug Discovery (2004)

Jun 2, 2016EXHIBITPATENT OWNER

Augustin, M. et al., Adherence in the Treatment of Psoriasis - A Systematic Review, Dermatology, Vol. 222, pp. 363-374 (2011)

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Beyer, V. et al., Recent Trends in Systemic Psoriasis Treatment Costs, Archives of Dermatology (2010)

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Kalb, R. et al., Methotrexate and Psoriasis - 2009 National Psoriasis Foundation Consensus Conference, Journal of American Academy of Dermatology (2009)

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Michaud, K. et al., Direct Medical Costs and Their Predictors in Patients with Rheumatoid Arthritis, Arthritis and Rheumatism (2003)

Jun 2, 2016EXHIBITPATENT OWNER

Mount, C. et al., Rheumatoid Arthritis Market, Nature Reviews Drug Discovery (2005)

Jun 2, 2016EXHIBITPATENT OWNER

Paul, S. et al., How to Improve R_D Productivity - The Pharmaceutical Industry_s Grand Challenge, Nature Reviews Drug Discovery (2010)

Jun 2, 2016EXHIBITPATENT OWNER

Rachakonda, T. et al., Psoriasis Prevalence Among Adults in the United States, Journal of the American Academy of Dermatology (2014)

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Smith, K., Systemic Therapy of Psoriasis Using Methotrexate, Skin Therapy Letter (2000)

Jun 2, 2016EXHIBITPATENT OWNER

Steinwachs, D., Pharmacy Benefit Plans and Prescription Drug Spending, Journal of the American Medical Association (2002)

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Eisenberg, R., Patents and Regulatory Exclusivity, The Oxford Handbook of The Economics of the Biopharmaceutical Industry, Oxford University Press (2012)

Jun 2, 2016EXHIBITPATENT OWNER

Malani, A. et al., The Regulations of Medical Products, The Oxford Handbook of the Economics of the Biopharmaceutical Industry (2012)

Jun 2, 2016EXHIBITPATENT OWNER

October 2006 ASP Pricing File - Updated 12/19/07, Centers for Medicare and Medicaid Services

Jun 2, 2016EXHIBITPATENT OWNER

October 2014 ASP Pricing File 09-12-14, Centers for Medicare and Medicaid Services

Jun 2, 2016EXHIBITPATENT OWNER

Declaration of Brian Gummow

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Supply of a Cancer Drug May Run Out Within Weeks, New York Times (2012)

Jun 2, 2016EXHIBITPATENT OWNER

About Rasuvo TM Medac Pharma

Jun 2, 2016EXHIBITPATENT OWNER

Antares Pharma_s (ATRS) CEO Paul Wotton on Q1 2014 Results - Earnings Call Transcript, Seeking Alpha, May 9, 2014

Jun 2, 2016EXHIBITPATENT OWNER

Antares - Thoughts on the Upcoming Otrexup TM Launch, Seeking Alpha (2013)

Jun 2, 2016EXHIBITPATENT OWNER

Antares - My View of How Otrexup TMand Medac_s New Product Rasuvo TMMay Compete, SmithOnStocks, (2014)

Jun 2, 2016EXHIBITPATENT OWNER

Arthritis Today Drug Guide, Arthritis Foundation

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Drug Guide - DMARDs, Arthritis Foundation

Jun 2, 2016EXHIBITPATENT OWNER

FDA Approval Letter - Otrexup TM, Drugs at FDA, Oct. 11, 2013

Jun 2, 2016EXHIBITPATENT OWNER

FDA Approval Letter - Rasuvo TM Drugs at FDA, July 10, 2014

Jun 2, 2016EXHIBITPATENT OWNER

FDA OKs a New Methotrexate Injection Device, Arthritis Foundation, Aug. 15, 2014

Jun 2, 2016EXHIBITPATENT OWNER

FDA Summary Review - Otrexup TM, Drugs at FDA, Oct. 13, 2013

Jun 2, 2016EXHIBITPATENT OWNER

Frequently Asked Questions on Prescription Drug User Fees (PDUFA), U.S. Food and Drug Administration

Jun 2, 2016EXHIBITPATENT OWNER

Guidance for Industry - Applications Covered by Section 505(b)(2),U.S. Food and Drug Administration, Oct. 1999

Jun 2, 2016EXHIBITPATENT OWNER

Highlights of Prescribing Information - OXTREXUP TM, Drugs FDA, Nov. 2014

Jun 2, 2016EXHIBITPATENT OWNER

Highlights of Prescribing Information - RASUVO TM Drugs at FDA, July 2014

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Jefferies Boosts PT on Antares Pharma (ATRS) 20 per cent into OTREXUP TM PDUFA, Maintains Buy, StreetInsiden.com, Oct. 8, 2013

Jun 2, 2016EXHIBITPATENT OWNER

Juvenile Idiopathic Arthritis (JIA), NYU Langone Medical Center Division of Pediatric Rheumatology

Jun 2, 2016EXHIBITPATENT 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, 2016EXHIBITPATENT OWNER

Methotrexate Fact Sheet, American College of Rheumatology, May 2012

Jun 2, 2016EXHIBITPATENT OWNER

Prescription Drug Trends, Kaiser Family Foundation, Fact Sheet No. 3057-30, Oct. 2004

Jun 2, 2016EXHIBITPATENT OWNER

Psoriasis Treatments with Next Generation Vitamin D Analogs, Wisconsin Alumni Research Foundation

Jun 2, 2016EXHIBITPATENT OWNER

Questions and Answers about Juvenile Arthritis, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Aug. 2013

Jun 2, 2016EXHIBITPATENT OWNER

Rheumatoid Arthritis Signs and Symptoms, Johns Hopkins Arthritis Center

Jun 2, 2016EXHIBITPATENT OWNER

State and County QuickFacts, United States Census Bureau

Jun 2, 2016EXHIBITPATENT OWNER

FDA Orange Book Data File Patent.txt

Jun 2, 2016EXHIBITPATENT OWNER

FDA Orange Book Data File Products.txt

Jun 2, 2016EXHIBITPATENT OWNER

FDA Orange Book Data File Exclusivity.txt

Jun 2, 2016EXHIBITPATENT OWNER

Compilation of Drug Labels

Jun 2, 2016EXHIBITPATENT OWNER

Notice of Accepting Corrected Petition

Mar 9, 2016PAPERBOARD

Power of Attorney

Mar 9, 2016PAPERINDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER.

Related Matters

Mar 9, 2016PAPERINDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER.

response to notice of filing date

Mar 8, 2016PAPERPETITIONER

table of exhibits

Mar 8, 2016PAPERPETITIONER

exhibit 1007

Mar 8, 2016EXHIBITPETITIONER

Notice of Filing Date/Defective Petition

Mar 2, 2016PAPERBOARD

petition

Feb 22, 2016PAPERPETITIONER

Power of Attorney

Feb 22, 2016PAPERPETITIONER

exhibit 1001

Feb 22, 2016EXHIBITPETITIONER

exhibit 1002

Feb 22, 2016EXHIBITPETITIONER

Exhibit 1003

Feb 22, 2016EXHIBITPETITIONER

Exhibit 1004

Feb 22, 2016EXHIBITPETITIONER

exhibit 1005

Feb 22, 2016EXHIBITPETITIONER

exhibit 1006

Feb 22, 2016EXHIBITPETITIONER

exhibit 1007

Feb 22, 2016EXHIBITPETITIONER

exhibit 1008

Feb 22, 2016EXHIBITPETITIONER

exhibit 1009

Feb 22, 2016EXHIBITPETITIONER

exhibit 1010

Feb 22, 2016EXHIBITPETITIONER

exhibit 1011

Feb 22, 2016EXHIBITPETITIONER

exhibit 1012

Feb 22, 2016EXHIBITPETITIONER

exhibit 1013

Feb 22, 2016EXHIBITPETITIONER

exhibit 1014

Feb 22, 2016EXHIBITPETITIONER

exhibit 1015

Feb 22, 2016EXHIBITPETITIONER

exhibit 1016

Feb 22, 2016EXHIBITPETITIONER

exhibit 1017

Feb 22, 2016EXHIBITPETITIONER

exhibit 1018

Feb 22, 2016EXHIBITPETITIONER

exhibit 1019

Feb 22, 2016EXHIBITPETITIONER

exhibit 1020

Feb 22, 2016EXHIBITPETITIONER

exhibit 1021

Feb 22, 2016EXHIBITPETITIONER

exhibit 1022

Feb 22, 2016EXHIBITPETITIONER

exhibit 1023

Feb 22, 2016EXHIBITPETITIONER

exhibit 1024

Feb 22, 2016EXHIBITPETITIONER

exhibit 1025

Feb 22, 2016EXHIBITPETITIONER

exhibit 1026

Feb 22, 2016EXHIBITPETITIONER

exhibit 1027

Feb 22, 2016EXHIBITPETITIONER

exhibit 1028

Feb 22, 2016EXHIBITPETITIONER

exhibit 1029

Feb 22, 2016EXHIBITPETITIONER

exhibit 1030

Feb 22, 2016EXHIBITPETITIONER

exhibit 1031

Feb 22, 2016EXHIBITPETITIONER

exhibit 1032

Feb 22, 2016EXHIBITPETITIONER

exhibit 1033

Feb 22, 2016EXHIBITPETITIONER