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

Explore the PTAB proceeding IPR2024-01418 filed by HIKMA PHARMACEUTICALS USA INC. on 2024-09-25. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2024-01418

Filing Date

2024-09-25

Accorded Filing Date

2024-09-25

Institution Decision Date

—

Last Modified Date

2025-03-12

Proceeding Type

IPR

Termination Date

2025-03-12

Trial Status

Terminated-Settled

Parties & Counsel

Petitioner

HIKMA PHARMACEUTICALS USA INC.

Represented By

Border, Scottet al

Patent Owner / Respondent

Axsome Malta Ltd. et al.

Represented By

Cerrito, Nicket al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 17091222

Respondent Patent Number 11560354

External Links

Espacenet

Google Patents

Respondent Inventor Fionn Hurley

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

4 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name THE FIRM OF HUESCHEN AND SAGE

Customer Number 25666

Address SEVENTH FLOOR, KALAMAZOO BUILDING, 107 WEST MICHIGAN AVENUE, KALAMAZOO, MI, 49007, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
29714	Adda Gogoris	914-288-0022
37710	G. Sage Ii	269-382-0030
55093	Michele Cudahy	269-382-0030
56942	Katherine Weiland	269-382-0030

Proceeding Documents

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

2025-03-12 FILING PARTY: BOARD

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

2025-03-06 FILING PARTY: PETITIONER

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Joint Motion To Terminate Proceeding MOTION

2025-03-06 FILING PARTY: PETITIONER

Download

2022

Ex. 2022 - Board Email Authorizing Preliminary Reply Filing Exhibit

2025-02-19 FILING PARTY: PATENT OWNER

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Patent Owner Sur-Reply OTHER

2025-02-19 FILING PARTY: PATENT OWNER

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

Proceeding Overview

Parties & Counsel

Petitioner

HIKMA PHARMACEUTICALS USA INC.

Represented By

Patent Owner / Respondent

Axsome Malta Ltd. et al.

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

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

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

Joint Motion To Terminate Proceeding MOTION

Ex. 2022 - Board Email Authorizing Preliminary Reply Filing Exhibit

Patent Owner Sur-Reply OTHER

Ex1020 - Sotera Stipulation Exhibit

Petitioner Reply to POPR OTHER

Ex. 2002 - Sunosi Label 2023 Exhibit

Ex. 2013 - Notice of Filing Date Accorded to Petition Exhibit

Ex. 2019 - US20050143396A1 Exhibit

Ex. 2005 - Geodon Label 2022 Exhibit

Ex. 2004 - Sunosi Treatment Guide Exhibit

Ex. 2008 - Valcyte Label 2021 Exhibit

Ex. 2016 - ChyallCV_Mar2024 Exhibit

Ex. 2012 - Complaint 23-20354 DI 001 Exhibit

Patent Owner Preliminary Response POPR

Ex. 2018 - US8178674 Exhibit

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

Ex. 2001 - Declaration of Leonard Chyall Exhibit

Ex. 2017 - US5312925 Exhibit

Ex. 2009 - Prozac Label 2023 Exhibit

Ex. 2006 - Risperdal Label 2022 Exhibit

Ex. 2011 - US4831031 Exhibit

Ex. 2021 - EP0380924A1 Exhibit

Ex. 2007 - Uroxatral Label 2020 Exhibit

Ex. 2003 - Sunosi Approval Letter Exhibit

Ex. 2014 - Excerpts from Defendants' Joint Invalidity Contentions_Redacted Exhibit

Ex. 2010 - US5955499 Exhibit

Ex. 2020 - CA2549244A1 Exhibit

CORRECTION OF EXHIBIT 1006 IN P-TACTS NOTICE

Correct Exhibit 1006 Exhibit

Notice: Notice filing date accorded NOTICE

Notice : Mandatory Notice NOTICE

Notice : Power of Attorney NOTICE

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

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

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

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

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

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

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

Ex. 1013 - Stipulated Consolidation and Scheduling Order Exhibit

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

Notice : Power of Attorney NOTICE

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

Ex. 1009 - Z. Sobol, Genotoxicity Profiles Exhibit

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

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

Ex. 1018 - Guideline on the Limits of Genotoxic Impurities Exhibit

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

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

Ex. 1006 -US 2005/0080268 Exhibit

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

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

Ex. 1007 - S. Kim, Pharmaceutical Industry Practices Exhibit

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

Petition : IPR Petition PETITION

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

Corrected Certificate of Service NOTICE