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CSPC Pharmaceutical Group Limited et al. vs Ipsen Biopharm Ltd. et al.

The detailed information for PTAB case with proceeding number IPR2025-00505 filed by CSPC Pharmaceutical Group Limited et al. against Ipsen Biopharm Ltd. et al. on Jan 17, 2025. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2025-00505
Filing Date
Jan 17, 2025
Petitioner
CSPC Pharmaceutical Group Limited et al.
Respondent
Ipsen Biopharm Ltd. et al.
Status
Pending
Respondent Application Number
15809815
Respondent Tech Center
1600
Respondent Patent Number
11344552

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

Petitioners' Updated Mandatory Notices Pursuant to 37 C.F.R. § 42.8(b)

Jul 18, 2025PAPERPETITIONER

Director Discretionary Decision: Refer

Jul 16, 2025PAPERBOARD

Ex. 3101

Jul 2, 2025EXHIBITBOARD

Petitioners' Response to Patent Owner's Request for Discretionary Denial of Institution

Jun 23, 2025PAPERPETITIONER

Supplemental Expert Declaration of Mark J. Ratain, MD

Jun 23, 2025EXHIBITPETITIONER

Chung, et al., Journal of Clinical Oncology, 43(17 suppl): LBA4175 (2025)

Jun 23, 2025EXHIBITPETITIONER

Chung, et al., NAPOLI 3 Phase 3 Trial of NALIRIFOX

Jun 23, 2025EXHIBITPETITIONER

Rochefort, et al., The Oncologist, 24:1543-1548 (2019)

Jun 23, 2025EXHIBITPETITIONER

Translation Certification of the English Translation of Conroy Protocol (Ex. 1004)

Jun 23, 2025EXHIBITPETITIONER

U.S. Patent No. 9,492,442

Jun 23, 2025EXHIBITPETITIONER

NCCN Clinical Practice Guidelines for Pancreatic Adenocarcinoma published on February 3, 2025.

Jun 23, 2025EXHIBITPETITIONER

Patel, et al., Journal of Clinical Oncology, 43(4 suppl):716 (2025)

Jun 23, 2025EXHIBITPETITIONER

Patent Owner's Discretionary Denial Brief

May 23, 2025PAPERPATENT OWNER

Ex. 2001

May 23, 2025EXHIBITPATENT OWNER

Ex. 2002

May 23, 2025EXHIBITPATENT OWNER

Ex. 2003

May 23, 2025EXHIBITPATENT OWNER

Ex. 2004

May 23, 2025EXHIBITPATENT OWNER

Ex. 2005

May 23, 2025EXHIBITPATENT OWNER

Ex. 2006

May 23, 2025EXHIBITPATENT OWNER

Ex. 2007

May 23, 2025EXHIBITPATENT OWNER

Ex. 2008

May 23, 2025EXHIBITPATENT OWNER

Ex. 2009

May 23, 2025EXHIBITPATENT OWNER

Ex. 2010

May 23, 2025EXHIBITPATENT OWNER

Ex. 2011

May 23, 2025EXHIBITPATENT OWNER

Ex. 2012

May 23, 2025EXHIBITPATENT OWNER

Ex. 2013

May 23, 2025EXHIBITPATENT OWNER

Patent Owner's Preliminary Response

May 23, 2025PAPERPATENT OWNER

Ex. 2014

May 23, 2025EXHIBITPATENT OWNER

Ex. 2015

May 23, 2025EXHIBITPATENT OWNER

Ex. 2016

May 23, 2025EXHIBITPATENT OWNER

Ex. 2017

May 23, 2025EXHIBITPATENT OWNER

Ex. 2018

May 23, 2025EXHIBITPATENT OWNER

Ex. 2019

May 23, 2025EXHIBITPATENT OWNER

Ex. 2020

May 23, 2025EXHIBITPATENT OWNER

Ex. 2021

May 23, 2025EXHIBITPATENT OWNER

Ex. 2022

May 23, 2025EXHIBITPATENT OWNER

Ex. 2023

May 23, 2025EXHIBITPATENT OWNER

Ex. 2024

May 23, 2025EXHIBITPATENT OWNER

Ex. 2025

May 23, 2025EXHIBITPATENT OWNER

Ex. 2026

May 23, 2025EXHIBITPATENT OWNER

Ex. 2027

May 23, 2025EXHIBITPATENT OWNER

Ex. 2028

May 23, 2025EXHIBITPATENT OWNER

Ex. 2029

May 23, 2025EXHIBITPATENT OWNER

Ex. 2030

May 23, 2025EXHIBITPATENT OWNER

Ex. 2031

May 23, 2025EXHIBITPATENT OWNER

Ex. 2032

May 23, 2025EXHIBITPATENT OWNER

Ex. 2033

May 23, 2025EXHIBITPATENT OWNER

Ex. 2034

May 23, 2025EXHIBITPATENT OWNER

Ex. 2035

May 23, 2025EXHIBITPATENT OWNER

NOTICE Extending Deadline for Discretion Briefing

Apr 24, 2025PAPERBOARD

Corrected Certificate of Service

Mar 4, 2025PAPERPETITIONER

Notice: Notice filing date accorded

Feb 25, 2025PAPERBOARD

Notice: Power of Attorney

Feb 17, 2025PAPERPATENT OWNER

Notice: Mandatory Notice

Feb 17, 2025PAPERPATENT OWNER

U.S. Patent No. 11,344,552 to Bayever et al. ("the '552 patent")

Jan 17, 2025EXHIBITPETITIONER

Conroy, et al., N. Engl. J. Med., 364(19):1817-25 (2011) (“Conroy”)

Jan 17, 2025EXHIBITPETITIONER

Certified English Translation of the Protocol of Conroy, et al.

Jan 17, 2025EXHIBITPETITIONER

Mahaseth, et al., Pancreas, 42(8):1311-15 (2013) (“Mahaseth”)

Jan 17, 2025EXHIBITPETITIONER

International Publication No. WO2013/188586 A1 to Bayever (“Bayever”)

Jan 17, 2025EXHIBITPETITIONER

Saif, Journal of the Pancreas, 15(3):278-79 (2014) (“Saif”)

Jan 17, 2025EXHIBITPETITIONER

Ko, et al., British J. of Cancer, 109(4):920-25 (2013) (“Ko”)

Jan 17, 2025EXHIBITPETITIONER

Cantore, et al., Oncology, 67(2):93-97 (2004) (“Cantore”)

Jan 17, 2025EXHIBITPETITIONER

Nichetti, et al., JAMA Network Open, 7(1):1-13 (2024) (“Nichetti”)

Jan 17, 2025EXHIBITPETITIONER

Nevala-Plagemann and Garrido-Laguna, Nature Reviews Clinical Oncology

Jan 17, 2025EXHIBITPETITIONER

Masi, et al., Annals of Oncology, 15:1766-72 (2004) (“Masi”)

Jan 17, 2025EXHIBITPETITIONER

Carnevale and Ko, Future Oncology, 12(4):453-464 (2016) (“Carnevale”)

Jan 17, 2025EXHIBITPETITIONER

Dean, et al., J Clin Oncol, 34(4 Suppl.):tps482 (2016) (“Dean”)

Jan 17, 2025EXHIBITPETITIONER

U.S. Provisional Application No. 62/208,209 to Bayever et al.

Jan 17, 2025EXHIBITPETITIONER

Ginocchi, et al., Annals of Oncology, 23(9 Suppl.):ix238 (2012) (“Ginocchi”

Jan 17, 2025EXHIBITPETITIONER

Conroy Supplementary Appendix, N. Engl. J. Med. (“Conroy Appendix”)

Jan 17, 2025EXHIBITPETITIONER

Wainberg, et al., Ann Oncol., 3l (Suppl. 3):S241 (2020)

Jan 17, 2025EXHIBITPETITIONER

Wainberg, et al., European Journal of Cancer, 151:14-24 (2021)

Jan 17, 2025EXHIBITPETITIONER

U.S. Non-Provisional Patent Application No. 15/241,106 to Bayever, et al.

Jan 17, 2025EXHIBITPETITIONER

Hatachi, et al., Cancer Diagn & Progn, 2(1):101-06 (2022)

Jan 17, 2025EXHIBITPETITIONER

Zaniboni, et al., Cancer Chemother Pharmacol., 69(6):1641-45 (2012)

Jan 17, 2025EXHIBITPETITIONER

Tsai, et al., J Gastrointest Oncol., 2(3):185-94 (2011)

Jan 17, 2025EXHIBITPETITIONER

U.S. Patent No. 8,147,867 to Hong, et al (“the ’867 patent”)

Jan 17, 2025EXHIBITPETITIONER

Press Release by Merrimack Pharmaceuticals, Inc. on August 1, 2011

Jan 17, 2025EXHIBITPETITIONER

International Publication No. WO 2016/094402 A1 to Bayever (“Bayever II”)

Jan 17, 2025EXHIBITPETITIONER

Alcindor, et al., Curr Oncol, 18(1):18-25 (2011)

Jan 17, 2025EXHIBITPETITIONER

U.S. Provisional Application No. 62/216,736 to Bayever et al.

Jan 17, 2025EXHIBITPETITIONER

U.S. Provisional Application No. 62/273,244 to Bayever et al.

Jan 17, 2025EXHIBITPETITIONER

U.S. Provisional Application No. 62/281,473 to Bayever et al.

Jan 17, 2025EXHIBITPETITIONER

U.S. Provisional Application No. 62/302,341 to Bayever et al.

Jan 17, 2025EXHIBITPETITIONER

U.S. Provisional Application No. 62/323,245 to Bayever et al.

Jan 17, 2025EXHIBITPETITIONER

Leucovorin Calcium Injection Label (2011)

Jan 17, 2025EXHIBITPETITIONER

Gemcitabine Injection Label (2012)

Jan 17, 2025EXHIBITPETITIONER

Abraxane Paclitaxel Label (2013)

Jan 17, 2025EXHIBITPETITIONER

XELODA Capecitabine Label (2000)

Jan 17, 2025EXHIBITPETITIONER

Camptosar FDA Label (2006)

Jan 17, 2025EXHIBITPETITIONER

Eloxatin Oxaliplatin Injection Label (2012)

Jan 17, 2025EXHIBITPETITIONER

Tarceva Erlotinib Tablets Label (2013)

Jan 17, 2025EXHIBITPETITIONER

Fluorouracil Injection Label (2012)

Jan 17, 2025EXHIBITPETITIONER

Conroy, et al., Curr Oncol Rep., 15(2):182-9 (2013)

Jan 17, 2025EXHIBITPETITIONER

Ko, J Clin Oncol, 29(28):3727–29 (2011)

Jan 17, 2025EXHIBITPETITIONER

Blazer, et al., ASCO Meeting Abstr. 32(Suppl. 3):275 (2014)

Jan 17, 2025EXHIBITPETITIONER

Alessandretti, et al., ASCO Meeting Abstr. 31 (Suppl. 15): e15176 (2013)

Jan 17, 2025EXHIBITPETITIONER

Paller, et al., Clin Cancer Res., 20(16); 4210–17 (2014)

Jan 17, 2025EXHIBITPETITIONER

Hamberg, et al., Eur J Cancer, 46(16):2870-78 (2010)

Jan 17, 2025EXHIBITPETITIONER

Hess, et al., Annals of Oncology, 21(12):2390-95 (2010)

Jan 17, 2025EXHIBITPETITIONER

Goel, et al., Anti-Cancer Drugs, 18(3):263-71 (2007)

Jan 17, 2025EXHIBITPETITIONER

Rachamalla, et al., Anticancer Drugs, 15(3):211-7 (2004)

Jan 17, 2025EXHIBITPETITIONER

Wildiers, Eur J Cancer, 43(15):2235-41 (2007)

Jan 17, 2025EXHIBITPETITIONER

Gajra, et al., J Geriatr Oncol, 6(2):133-40 (2015)

Jan 17, 2025EXHIBITPETITIONER

Shayne, et al., Cancer, 110(7):1611-20 (2007)

Jan 17, 2025EXHIBITPETITIONER

Sharma, et al., J Clinical Oncology, 32(3 Suppl.): 562 (2014)

Jan 17, 2025EXHIBITPETITIONER

Chang, et al., Cancer Chemother Pharmacol., 75(3):579-86 (2015)

Jan 17, 2025EXHIBITPETITIONER

Roy, et al., Annals of Oncology, 24(6):1567-73 (2013)

Jan 17, 2025EXHIBITPETITIONER

Slingerland, et al., Drug Discov Today, 17(3-4):160-66 (2012)

Jan 17, 2025EXHIBITPETITIONER

Chen, et al., J Clin Oncol, 26(15 Suppl.):2565 (2008)

Jan 17, 2025EXHIBITPETITIONER

Kim, et al., Cancer Res., 72(14 Suppl.): A41 (2012)

Jan 17, 2025EXHIBITPETITIONER

Hann, et al., Cancer Res, 67(9 Suppl.): 5648 (2007)

Jan 17, 2025EXHIBITPETITIONER

U.S. Non-Provisional Patent Application No. 62/343,313 to Bayever et al.

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 1 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 2 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 3 of 40

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File History of U.S. Patent No. 11,344,552 Part 4 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 5 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 6 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 7 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 8 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 9 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 10 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 11 of 40

Jan 17, 2025EXHIBITPETITIONER

File History of U.S. Patent No. 11,344,552 Part 12 of 40

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File History of U.S. Patent No. 11,344,552 Part 13 of 40

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File History of U.S. Patent No. 11,344,552 Part 14 of 40

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File History of U.S. Patent No. 11,344,552 Part 15 of 40

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File History of U.S. Patent No. 11,344,552 Part 16 of 40

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File History of U.S. Patent No. 11,344,552 Part 17 of 40

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File History of U.S. Patent No. 11,344,552 Part 18 of 40

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File History of U.S. Patent No. 11,344,552 Part 19 of 40

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File History of U.S. Patent No. 11,344,552 Part 20 of 40

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File History of U.S. Patent No. 11,344,552 Part 21 of 40

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File History of U.S. Patent No. 11,344,552 Part 22 of 40

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File History of U.S. Patent No. 11,344,552 Part 23 of 40

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File History of U.S. Patent No. 11,344,552 Part 24 of 40

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File History of U.S. Patent No. 11,344,552 Part 25 of 40

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File History of U.S. Patent No. 11,344,552 Part 26 of 40

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File History of U.S. Patent No. 11,344,552 Part 27 of 40

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File History of U.S. Patent No. 11,344,552 Part 28 of 40

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File History of U.S. Patent No. 11,344,552 Part 29 of 40

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File History of U.S. Patent No. 11,344,552 Part 30 of 40

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File History of U.S. Patent No. 11,344,552 Part 31 of 40

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File History of U.S. Patent No. 11,344,552 Part 32 of 40

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File History of U.S. Patent No. 11,344,552 Part 33 of 40

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File History of U.S. Patent No. 11,344,552 Part 34 of 40

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File History of U.S. Patent No. 11,344,552 Part 35 of 40

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File History of U.S. Patent No. 11,344,552 Part 36 of 40

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File History of U.S. Patent No. 11,344,552 Part 37 of 40

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File History of U.S. Patent No. 11,344,552 Part 38 of 40

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File History of U.S. Patent No. 11,344,552 Part 39 of 40

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File History of U.S. Patent No. 11,344,552 Part 40 of 40

Jan 17, 2025EXHIBITPETITIONER

National Cancer Institute, "FDA Approves Irinotecan Liposome..." (2015)

Jan 17, 2025EXHIBITPETITIONER

Declaration of Dr. Mark Retain

Jan 17, 2025EXHIBITPETITIONER

Petition: as filed

Jan 17, 2025PAPERPETITIONER

Notice: Power of Attorney

Jan 17, 2025PAPERPETITIONER