The detailed information for PTAB case with proceeding number IPR2016-01370 filed by Koios Pharmaceuticals LLC against MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH et al. on Jul 20, 2016. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2016-01370
Filing Date
Jul 20, 2016
Petitioner
Koios Pharmaceuticals LLC
Respondent
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH et al.
Status
Final Written Decision
Respondent Application Number
12374528
Respondent Tech Center
1600
Respondent Patent Number
8664231
Institution Decision Date
Feb 8, 2017
Termination Date
Feb 7, 2018

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

Petitioner's Notice of Appeal

Apr 10, 2018PAPERPETITIONER

Petitioner's Updated Mandatory Notices

Feb 28, 2018PAPERPETITIONER

Termination Decision Document

Feb 7, 2018PAPERBOARD

Order - 37 C.F.R. 42.5, 42.10(e)

Feb 7, 2018PAPERBOARD

Hearing Transcript

Dec 1, 2017PAPERBOARD

Order Granting Patent Owner Motion for Pro Hac Vice Admission of Henry Huang

Nov 2, 2017PAPERBOARD

Petitioner's Motion to Withdraw Counsel

Nov 2, 2017PAPERPETITIONER

Corrected Declaration of Henry Huang

Nov 1, 2017EXHIBITPATENT OWNER

Certificate of Service

Nov 1, 2017PAPERPATENT OWNER

Order Request for Oral Argument

Oct 23, 2017PAPERBOARD

Patent Owners Reply in Support of its Motion to Exclude Evidence

Oct 23, 2017PAPERPATENT OWNER

Unopposed Motion for Pro Hac Vice Admission of Henry Huang

Oct 20, 2017PAPERPATENT OWNER

EXPUNGED

Oct 20, 2017EXHIBITPATENT OWNER

Petitioner's Response to Patent Owner's Motion to Exclude Evidence

Oct 16, 2017PAPERPETITIONER

Decision of the Court of the Hague

Oct 9, 2017EXHIBITPETITIONER

Petitioner's Updated Exhibit List

Oct 9, 2017PAPERPETITIONER

Patent Owners Surreply to Petitioners Reply

Oct 5, 2017PAPERPATENT OWNER

Patent Owners Submission of Transcript of Telephone Conference on September 29, 2017

Oct 5, 2017PAPERPATENT OWNER

Conduct of the Proceeding

Oct 4, 2017PAPERBOARD

Patent Owners Motion to Exclude Evidence

Oct 2, 2017PAPERPATENT OWNER

Patent Owners Request for Oral Hearing

Oct 2, 2017PAPERPATENT OWNER

Petitioner's Request for Oral Argument

Oct 2, 2017PAPERPETITIONER

Patent Owners Objections to Petitioners Reply Exhibits

Sep 25, 2017PAPERPATENT OWNER

Petitioner's Reply to Patent Owner's Response

Sep 18, 2017PAPERPETITIONER

Shoemaker Deposition Transcript

Sep 18, 2017EXHIBITPETITIONER

Petitioner's Reply to Patent Owner's Response

Sep 18, 2017PAPERPETITIONER

Zizic Deposition Transcript

Sep 18, 2017EXHIBITPETITIONER

Correspondence Between Counsel for Petition and Patent Owner

Sep 18, 2017EXHIBITPETITIONER

Decision of UK High Court

Sep 18, 2017EXHIBITPETITIONER

Report on Court of the Hague Decision

Sep 18, 2017EXHIBITPETITIONER

Non-Final Rejection of Application 14/635,542

Sep 18, 2017EXHIBITPETITIONER

Notice of Abandonment of Application 14/635,542

Sep 18, 2017EXHIBITPETITIONER

Joint Stipulation to Further Modify Due Date 2

Sep 8, 2017PAPERPETITIONER

Petitioner's Updated Power of Attorney

Aug 23, 2017PAPERPETITIONER

Petitioner's Updated Mandatory Notices

Aug 23, 2017PAPERPETITIONER

Order - Granting Petitioner's Motion for Admission Pro Hac Vice of Kayvan B. Noroozi - 37 CFR 42.10(c)

Aug 22, 2017PAPERBOARD

Motion for Admission Pro Hac Vice of Kayvan Noroozi

Aug 18, 2017PAPERPETITIONER

Declaration of Kayvan Noroozi

Aug 18, 2017EXHIBITPETITIONER

Petitioner's Updated Exhibit List

Aug 18, 2017PAPERPETITIONER

PATENT OWNER¿¿¿S SUPPLEMENTAL MANDATORY NOTICE

Aug 11, 2017PAPERPATENT OWNER

Petitioner's Notice of Zizic Deposition

Aug 11, 2017PAPERPETITIONER

Petitioner's Notice of Clark Deposition

Aug 11, 2017PAPERPETITIONER

Petitioner's Notice of Massarotti Deposition

Aug 11, 2017PAPERPETITIONER

Petitioner's Notice of Shoemaker Deposition

Aug 11, 2017PAPERPETITIONER

Drugs@FDA FDA Approved Drug Products

Jun 9, 2017EXHIBITPATENT OWNER

Schiff, Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis

Jun 9, 2017EXHIBITPATENT OWNER

Borchers, The Use of Methotrexate in Rheumatoid Arthritis

Jun 9, 2017EXHIBITPATENT OWNER

Grim, Pharmacokinetics and Pharmacodynamics of Methotrexate in Non-Neoplastic Diseases

Jun 9, 2017EXHIBITPATENT OWNER

Bingham, Parenteral methotrexate should be given before biological therapy

Jun 9, 2017EXHIBITPATENT OWNER

Expert Declaration of Elena Massarotti, M.D.

Jun 9, 2017EXHIBITPATENT OWNER

ASP Pricing File 2014

Jun 9, 2017EXHIBITPATENT OWNER

Goodman and Gilmans, The Pharmacological Basis of Therapeutics

Jun 9, 2017EXHIBITPATENT OWNER

ASP Pricing File 2006

Jun 9, 2017EXHIBITPATENT OWNER

2007 CDC Guidelines for Isolation Precautions Preventing Transmission of Infectious Agents in Healthcare Settings

Jun 9, 2017EXHIBITPATENT OWNER

SICOR Pharmaceuticals ANDA Suitability Petition Methotrexate Injection

Jun 9, 2017EXHIBITPATENT OWNER

Supply of a Cancer Drug

Jun 9, 2017EXHIBITPATENT OWNER

Brazeau, Current Perspectives on Pain Upon Injection of Drugs

Jun 9, 2017EXHIBITPATENT OWNER

Antares Pharmas ATRS CEO Paul Wotton on Q1 2014 Results

Jun 9, 2017EXHIBITPATENT OWNER

Antares Thoughts on the Upcoming Otrexup Launch

Jun 9, 2017EXHIBITPATENT OWNER

Antares My View of How Otrexup and Medacs New Product Rasuvo May Compete

Jun 9, 2017EXHIBITPATENT OWNER

Arthritis Today Drug Guide

Jun 9, 2017EXHIBITPATENT OWNER

DMARDs for Juvenile Idiopathic Arthritis

Jun 9, 2017EXHIBITPATENT OWNER

Drug Guide DMARDs

Jun 9, 2017EXHIBITPATENT OWNER

Parshuram, Occurrence and Impact of Unanticipated Variation in Intravenous Methotrexate Dosing

Jun 9, 2017EXHIBITPATENT OWNER

How Medicare Prescription Drug Use

Jun 9, 2017EXHIBITPATENT OWNER

Declaration of Brian Gummow

Jun 9, 2017EXHIBITPATENT OWNER

Antares Pharma Press Release

Jun 9, 2017EXHIBITPATENT OWNER

About Rasuvo

Jun 9, 2017EXHIBITPATENT OWNER

Clinical Guidelines Extravasation

Jun 9, 2017EXHIBITPATENT OWNER

Boyle, Vesicant Extravasation Myths and Realities

Jun 9, 2017EXHIBITPATENT OWNER

Drugs@FDA Summary Table

Jun 9, 2017EXHIBITPATENT OWNER

Drugs@FDA Search Results for Methotrexate

Jun 9, 2017EXHIBITPATENT OWNER

FDA Approval Letter Otrexup

Jun 9, 2017EXHIBITPATENT OWNER

FDA Approval Letter Rasuvo

Jun 9, 2017EXHIBITPATENT OWNER

Extravasation guidelines 2007

Jun 9, 2017EXHIBITPATENT OWNER

FDA OKs a New Methotrexate Injection Device

Jun 9, 2017EXHIBITPATENT OWNER

Pavy, Methotrexate therapy for rheumatoid arthritis clinical practice guidelines based on published evidence and expert opinion

Jun 9, 2017EXHIBITPATENT OWNER

FDA Summary Review Otrexup

Jun 9, 2017EXHIBITPATENT OWNER

Frequently Asked Questions on Prescription Drug User Fees

Jun 9, 2017EXHIBITPATENT OWNER

Declaration of Maria Salgado

Jun 9, 2017EXHIBITPATENT OWNER

Guidance for Industry Applications Covered by Section 505

Jun 9, 2017EXHIBITPATENT OWNER

Highlights of Prescribing Information OXTREXUP

Jun 9, 2017EXHIBITPATENT OWNER

Highlights of Prescribing Information RASUVO

Jun 9, 2017EXHIBITPATENT OWNER

Expert Declaration of Dr. Sean Nicholson

Jun 9, 2017EXHIBITPATENT OWNER

Jefferies Boosts PT on Antares Pharma

Jun 9, 2017EXHIBITPATENT OWNER

Methotrexate Fact Sheet

Jun 9, 2017EXHIBITPATENT OWNER

Ashburn, Drug Repositioning Identifying and Developing New Uses for Existing Drugs

Jun 9, 2017EXHIBITPATENT OWNER

Prescription Drug Trends

Jun 9, 2017EXHIBITPATENT OWNER

Questions and Answers about Juvenile Arthritis

Jun 9, 2017EXHIBITPATENT OWNER

Rheumatoid Arthritis Signs and Symptoms

Jun 9, 2017EXHIBITPATENT OWNER

State and County QuickFacts

Jun 9, 2017EXHIBITPATENT OWNER

Goutsou, Biologics Utilization for Rheumatoid Arthritis in the United States An Observational Longitudinal Study

Jun 9, 2017EXHIBITPATENT OWNER

Curtis

Jun 9, 2017EXHIBITPATENT OWNER

Helmick, Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States

Jun 9, 2017EXHIBITPATENT OWNER

Kalb, Methotrexate and Psoriasis 2009 National Psoriasis Foundation Consensus Conference

Jun 9, 2017EXHIBITPATENT OWNER

Kurd, The Prevalence of Previously Diagnosed and Undiagnosed Psoriasis in US Adults

Jun 9, 2017EXHIBITPATENT OWNER

Juvenile Idiopathic Arthritis

Jun 9, 2017EXHIBITPATENT OWNER

MTX Information with Strength

Jun 9, 2017EXHIBITPATENT OWNER

Memorandum Report Comparison of First-Quarter 2012 Average Sales Prices

Jun 9, 2017EXHIBITPATENT OWNER

Psoriasis Treatments with Next Generation Vitamin D Analogs

Jun 9, 2017EXHIBITPATENT OWNER

Augustin, Adherence in the Treatment of Psoriasis A Systematic Review

Jun 9, 2017EXHIBITPATENT OWNER

Van den Bemt, Medication Adherence in Patients With Rheumatoid Arthritis A Critical Appraisal of the Existing Literature

Jun 9, 2017EXHIBITPATENT OWNER

Beyer, Recent Trends in Systemic Psoriasis Treatment Costs

Jun 9, 2017EXHIBITPATENT OWNER

FDA Orange Book Data File Patent.txt

Jun 9, 2017EXHIBITPATENT OWNER

FDA Orange Book Data File Products.txt

Jun 9, 2017EXHIBITPATENT OWNER

FDA Orange Book Data File Exclusivity.txt

Jun 9, 2017EXHIBITPATENT OWNER

Gowdie, Review of Disease Modifying Anti Rheumatic Drugs in Paediatric Rheumatic Disease

Jun 9, 2017EXHIBITPATENT OWNER

Compilation of Drug Labels

Jun 9, 2017EXHIBITPATENT OWNER

Greenapple, Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers

Jun 9, 2017EXHIBITPATENT OWNER

Striesow

Jun 9, 2017EXHIBITPATENT OWNER

Expert Declaration of Dr. Thomas M. Zizic

Jun 9, 2017EXHIBITPATENT OWNER

Expert Declaration of Dr. John Clark

Jun 9, 2017EXHIBITPATENT OWNER

Gaze

Jun 9, 2017EXHIBITPATENT OWNER

Menter, Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis

Jun 9, 2017EXHIBITPATENT OWNER

Dorr, Antidotes to Vesicant Chemotherapy Extravasations

Jun 9, 2017EXHIBITPATENT OWNER

Schulmeister, Extravasation Management Clinical Update

Jun 9, 2017EXHIBITPATENT OWNER

Methotrexate 100 mg/ml Injection

Jun 9, 2017EXHIBITPATENT OWNER

Mount, Rheumatoid Arthritis Market

Jun 9, 2017EXHIBITPATENT OWNER

Paul, How to Improve R and D Productivity

Jun 9, 2017EXHIBITPATENT OWNER

Rachakonda, Psoriasis Prevalence Among Adults in the United States

Jun 9, 2017EXHIBITPATENT OWNER

Smith, Systemic Therapy of Psoriasis Using Methotrexate

Jun 9, 2017EXHIBITPATENT OWNER

Steinwachs, Pharmacy Benefit Plans and Prescription Drug Spending

Jun 9, 2017EXHIBITPATENT OWNER

Malani, The Regulations of Medical Products

Jun 9, 2017EXHIBITPATENT OWNER

Ignoffo

Jun 9, 2017EXHIBITPATENT OWNER

Michaud, Direct Medical Costs and Their Predictors in Patients with Rheumatoid Arthritis

Jun 9, 2017EXHIBITPATENT OWNER

Saag, American College of Rheumatology 2008

Jun 9, 2017EXHIBITPATENT OWNER

DiMasi, R and D Costs and Returns to New Drug Development

Jun 9, 2017EXHIBITPATENT OWNER

Eisenberg, Patents and Regulatory Exclusivity

Jun 9, 2017EXHIBITPATENT OWNER

Stoller, Use of Plasma Pharmacokinetics to Predict and Prevent Methotrexate Toxicity

Jun 9, 2017EXHIBITPATENT OWNER

Patent Owners Response

Jun 9, 2017PAPERPATENT OWNER

Order Granting Petitioner's Motion to Withdraw Counsel

Apr 26, 2017PAPERBOARD

Petitioner's Motion to Withdraw Counsel

Apr 19, 2017PAPERPETITIONER

Order Granting Patent Owner¿¿¿s Motion to Withdraw Counsel

Apr 14, 2017PAPERBOARD

Joint Stipulation to Modify Due Dates 1 and 2

Mar 16, 2017PAPERPATENT OWNER

Petitioner's Supplemental Mandatory Notice Information

Feb 13, 2017PAPERPETITIONER

Executed Power of Attorney

Feb 13, 2017PAPERPETITIONER

Certificate of Service_POA

Feb 13, 2017PAPERPETITIONER

Patent Owner's Motion to Withdraw Counsel

Feb 10, 2017PAPERPATENT OWNER

Patent Owners Supplemental Mandatory Notice Information

Feb 10, 2017PAPERPATENT OWNER

Trial Instituted Document

Feb 8, 2017PAPERBOARD

Scheduling Order

Feb 8, 2017PAPERBOARD

Patent Owners Supplemental Mandatory Notice

Dec 23, 2016PAPERPATENT OWNER

Patent Owner's Preliminary Response

Nov 10, 2016PAPERPATENT OWNER

Breslin, et al., Improving Tolerance and Bioavailability of Methotrexate by Switching from Oral to Subcutaneous Route of Administration

Nov 10, 2016EXHIBITPATENT OWNER

Balis, et al., Pharmacokinetics of Subcutaneous Methotrexate

Nov 10, 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

Nov 10, 2016EXHIBITPATENT OWNER

RA Advisory Council: Overview & Meeting Objectives, October 5, 2012

Nov 10, 2016EXHIBITPATENT OWNER

Kurnick D. et al., Bioavailability of oral vs. subcutaneous low-dose methotrexate in patients with Crohn¿¿¿s disease

Nov 10, 2016EXHIBITPATENT OWNER

Chapter 16: Human: Veterinary Technology Cross Over, Long Acting Animal Health Drug Products

Nov 10, 2016EXHIBITPATENT OWNER

Chapter 3: Drug Administration, Drug Therapy In Nursing Aschenbrenner DS and Venable SJ

Nov 10, 2016EXHIBITPATENT OWNER

Consulting Agreement between Medac Pharma, Inc. and Dr. Michael Schiff, M.D

Nov 10, 2016EXHIBITPATENT OWNER

Koios Pharmaceuticals LLC Press Release, Koios Pharmaceuticals Files Challenge to High-Cost Drug¿¿¿s Patent

Nov 10, 2016EXHIBITPATENT OWNER

Declaration of Brian Gummow

Nov 10, 2016EXHIBITPATENT OWNER

Declaration of Terri Shoemaker

Nov 10, 2016EXHIBITPATENT OWNER

U.S. Patent 8,480,631

Nov 10, 2016EXHIBITPATENT OWNER

Errata

Aug 18, 2016PAPERBOARD

Notice of Accepting Corrected Petition

Aug 12, 2016PAPERBOARD

Petitioner's Reply to Notice of Filing Date Accorded

Aug 11, 2016PAPERPETITIONER

Petitioner's Second Updated exhibit list

Aug 11, 2016PAPERPETITIONER

Notice of Accord Filing Date

Aug 10, 2016PAPERBOARD

Patent Owner Mandatory Notice

Aug 4, 2016PAPERPATENT OWNER

Power of Attorney

Aug 4, 2016PAPERPATENT OWNER

Ex. 1001--US8664231

Jul 20, 2016EXHIBITPETITIONER

Ex. 1003--US6544504

Jul 20, 2016EXHIBITPETITIONER

Ex. 1004--Hoekstra

Jul 20, 2016EXHIBITPETITIONER

Ex. 1014--Pincus

Jul 20, 2016EXHIBITPETITIONER

Ex. 1015--Insulin Admin

Jul 20, 2016EXHIBITPETITIONER

Ex. 1019--Schiff 2014

Jul 20, 2016EXHIBITPETITIONER

Ex. 1002--Prosecution History Excerpts

Jul 20, 2016EXHIBITPETITIONER

Ex. 1005--Jorgensen

Jul 20, 2016EXHIBITPETITIONER

Ex. 1006--Alsufyani

Jul 20, 2016EXHIBITPETITIONER

Ex. 1008--Brooks

Jul 20, 2016EXHIBITPETITIONER

Ex. 1010--Zackheim

Jul 20, 2016EXHIBITPETITIONER

Ex. 1011--Muller-Ladner

Jul 20, 2016EXHIBITPETITIONER

Ex. 1017--EPO prosecution

Jul 20, 2016EXHIBITPETITIONER

Ex. 1018--Weinblatt 1993

Jul 20, 2016EXHIBITPETITIONER

Ex. 1020--Weinblatt 1995

Jul 20, 2016EXHIBITPETITIONER

Ex. 1023--Arthur_et_al-2002-Journal_of_Clinical_Nursing_parenteralmtx

Jul 20, 2016EXHIBITPETITIONER

Ex. 1024--J Rheumatol-2001-Arthur-212

Jul 20, 2016EXHIBITPETITIONER

Ex. 1025--Rheumatology-2005-Moitra-256-7

Jul 20, 2016EXHIBITPETITIONER

Ex. 1027--Feagan

Jul 20, 2016EXHIBITPETITIONER

Ex. 1028--Furst

Jul 20, 2016EXHIBITPETITIONER

Ex. 1029--Giannini

Jul 20, 2016EXHIBITPETITIONER

Ex. 1009-Medac Patent Owner Preliminary Response to Frontier IPR

Jul 20, 2016EXHIBITPETITIONER

Ex. 1012--Weinblatt Decl

Jul 20, 2016EXHIBITPETITIONER

Ex. 1013--Gammon Decl

Jul 20, 2016EXHIBITPETITIONER

Ex. 1026--Bigmar

Jul 20, 2016EXHIBITPETITIONER

Ex. 1007--Massarotti Decl. ISO Medac POPR to Frontier IPR

Jul 20, 2016EXHIBITPETITIONER

Ex. 1016-- Complaint in Medac v Antares

Jul 20, 2016EXHIBITPETITIONER

Ex. 1022--PDR for Wyeth

Jul 20, 2016EXHIBITPETITIONER

Ex. 1032--BSA Calculation

Jul 20, 2016EXHIBITPETITIONER

Ex. 1034--Schiff Declaration REDACTED

Jul 20, 2016EXHIBITPETITIONER

Ex. 1031--FDA Arthritis Advisory Committee

Jul 20, 2016EXHIBITPETITIONER

Ex. 1033--Miller Declaration

Jul 20, 2016EXHIBITPETITIONER

Ex. 1034--Schiff Declaration UNREDACTED

Jul 20, 2016EXHIBITPETITIONER

Ex. 1035--Noroozi Declaration

Jul 20, 2016EXHIBITPETITIONER

Ex. 1036--Kamholz Declaration

Jul 20, 2016EXHIBITPETITIONER

Ex. 1021--Wyeth

Jul 20, 2016EXHIBITPETITIONER

Petition for Inter Partes Review of Patent 8,664,231

Jul 20, 2016PAPERPETITIONER

Petitioner's Power of Attorney

Jul 20, 2016PAPERPETITIONER

Petitioner's Updated Exhibit List

Jul 20, 2016PAPERPETITIONER

Ex. 1037--Second Kamholz Declaration

Jul 20, 2016EXHIBITPETITIONER