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HIKMA PHARMACEUTICALS USA INC. vs Axsome Malta Ltd. et al.

The detailed information for PTAB case with proceeding number IPR2024-01418 filed by HIKMA PHARMACEUTICALS USA INC. against Axsome Malta Ltd. et al. on Sep 25, 2024. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2024-01418
Filing Date
Sep 25, 2024
Petitioner
HIKMA PHARMACEUTICALS USA INC.
Respondent
Axsome Malta Ltd. et al.
Status
Terminated-Settled
Respondent Application Number
17091222
Respondent Tech Center
1600
Respondent Patent Number
11560354
Termination Date
Mar 12, 2025

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

Settlement Prior to Institution of Trial 37 C.F.R. ยง 42.74

Mar 12, 2025PAPERBOARD

Joint Motion To Terminate Proceeding

Mar 6, 2025PAPERPETITIONER

Joint Request That Settlement Agreement Be Treated As Business Confidential Information And Be Kept Separate

Mar 6, 2025PAPERPETITIONER

Ex. 1021 - Confidential Settlement Agreement Between Parties (Sealed)

Mar 6, 2025EXHIBITPETITIONER

Patent Owner Sur-Reply

Feb 19, 2025PAPERPATENT OWNER

Ex. 2022 - Board Email Authorizing Preliminary Reply Filing

Feb 19, 2025EXHIBITPATENT OWNER

Petitioner Reply to POPR

Feb 13, 2025PAPERPETITIONER

Ex1020 - Sotera Stipulation

Feb 13, 2025EXHIBITPETITIONER

Patent Owner Preliminary Response

Jan 23, 2025PAPERPATENT OWNER

Ex. 2001 - Declaration of Leonard Chyall

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2002 - Sunosi Label 2023

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2003 - Sunosi Approval Letter

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2004 - Sunosi Treatment Guide

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2005 - Geodon Label 2022

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2006 - Risperdal Label 2022

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2007 - Uroxatral Label 2020

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2008 - Valcyte Label 2021

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2009 - Prozac Label 2023

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2010 - US5955499

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2011 - US4831031

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2012 - Complaint 23-20354 DI 001

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2013 - Notice of Filing Date Accorded to Petition

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2014 - Excerpts from Defendants' Joint Invalidity Contentions_Redacted

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2015 - Excerpts from HPLC for Pharmaceutical Scientists (John Wiley and Sons, Yuri Kazakevich and Rosario LoBrutto eds., 2007)

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2016 - ChyallCV_Mar2024

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2017 - US5312925

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2018 - US8178674

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2019 - US20050143396A1

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2020 - CA2549244A1

Jan 23, 2025EXHIBITPATENT OWNER

Ex. 2021 - EP0380924A1

Jan 23, 2025EXHIBITPATENT OWNER

Correct Exhibit 1006

Nov 19, 2024EXHIBITPETITIONER

CORRECTION OF EXHIBIT 1006 IN P-TACTS

Nov 19, 2024PAPERPETITIONER

Notice: Notice filing date accorded

Oct 23, 2024PAPERBOARD

Notice : Mandatory Notice

Oct 16, 2024PAPERPATENT OWNER

Notice : Power of Attorney

Oct 16, 2024PAPERPATENT OWNER

Ex. 1001 - U.S. Patent No. 11,560,354

Sep 25, 2024EXHIBITPETITIONER

Ex. 1002 - U.S. Patent No. 11,560,354 File History (Part 1)

Sep 25, 2024EXHIBITPETITIONER

Ex. 1002 - U.S. Patent No. 11,560,354 File History (Part 2)

Sep 25, 2024EXHIBITPETITIONER

Ex. 1002 - U.S. Patent No. 11,560,354 File History (Part 3)

Sep 25, 2024EXHIBITPETITIONER

Ex. 1002 - U.S. Patent No. 11,560,354 File History (Part 4)

Sep 25, 2024EXHIBITPETITIONER

Ex. 1004 - CV of Dr. Salvatore Lepore, Ph.D.

Sep 25, 2024EXHIBITPETITIONER

Ex. 1005 - US Pub. No. 2009/0312416

Sep 25, 2024EXHIBITPETITIONER

Ex. 1006 -US 2005/0080268

Sep 25, 2024EXHIBITPETITIONER

Ex. 1007 - S. Kim, Pharmaceutical Industry Practices

Sep 25, 2024EXHIBITPETITIONER

Ex. 1008 - C.G. Fraga, Profiling of Volatile Impurities

Sep 25, 2024EXHIBITPETITIONER

Ex. 1010 - Wayback Machine webpage -screenshots of Kaleemullah Feb-10-2016

Sep 25, 2024EXHIBITPETITIONER

Ex. 1011 - Declaration of Dr. Sylvia Hall-Ellis

Sep 25, 2024EXHIBITPETITIONER

Ex. 1012 - Unichem Dismissal, Docket No. 103, June 14, 2024

Sep 25, 2024EXHIBITPETITIONER

Ex. 1014 - David Liu et al., Recent Advances in Trace Analysis

Sep 25, 2024EXHIBITPETITIONER

Ex. 1015 - Zadeo Cimarosti et al., Application of Quality

Sep 25, 2024EXHIBITPETITIONER

Ex. 1016 - T. Kaleemullah et al., Development and Validation of Gas

Sep 25, 2024EXHIBITPETITIONER

Ex. 1017 - Courtney M. Callis et al., Risk Assessment

Sep 25, 2024EXHIBITPETITIONER

Ex. 1018 - Guideline on the Limits of Genotoxic Impurities

Sep 25, 2024EXHIBITPETITIONER

Ex. 1019 - Q. Yang et al., Controlling the Genotoxins

Sep 25, 2024EXHIBITPETITIONER

Ex. 1009 - Z. Sobol, Genotoxicity Profiles

Sep 25, 2024EXHIBITPETITIONER

Ex. 1013 - Stipulated Consolidation and Scheduling Order

Sep 25, 2024EXHIBITPETITIONER

Ex. 1003 - Declaration of Dr. Salvatore Lepore, Ph.D.

Sep 25, 2024EXHIBITPETITIONER

Petition : IPR Petition

Sep 25, 2024PAPERPETITIONER

Notice : Power of Attorney

Sep 25, 2024PAPERPETITIONER

Corrected Certificate of Service

Sep 25, 2024PAPERPETITIONER