Samsung Bioepis Co., Ltd. vs. Janssen Biotech, Inc.

Explore the PTAB proceeding IPR2023-01103 filed by Samsung Bioepis Co., Ltd. on 2023-06-21. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2023-01103

Filing Date

2023-06-21

Accorded Filing Date

2023-07-21

Institution Decision Date

—

Last Modified Date

—

Proceeding Type

IPR

Termination Date

2023-08-09

Trial Status

Terminated-Settled

Parties & Counsel

Petitioner

Samsung Bioepis Co., Ltd.

Represented By

Frank, Noahet al

Patent Owner / Respondent

Janssen Biotech, Inc.

Represented By

Morin, Michaelet 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 16580509

Respondent Patent Number 10961307

External Links

Espacenet

Google Patents

Respondent Inventor Jewel Johanns et al

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

89 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name DAVID A. LANE, JR. - JOHNSON & JOHNSON

Customer Number 27777

Address 1 JOHNSON & JOHNSON PLAZA, NEW BRUNSWICK, NJ, 08933-7003, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
32019	Paul Coletti	908-230-8324
32501	Hal Woodrow	732-718-1308
33797	Yuriy Stercho	610-420-6303
33833	Kirk Baumeister	484-418-8440
33967	Karen Harding	904-443-3074
35152	Rebecca Barrett	215-628-5142
35490	Thomas Dimauro	508-624-9627
37107	Louis Capezzuto	732-524-2218
37300	David Crichton	732-524-6131
38503	Wayne Jaeschke Jr	610-719-5316
39261	David Lane Jr	508-240-4036
39301	William Mcgowan	732-524-2197
39401	Timothy Tracy	732-524-6586
40114	Andrew Pang	714-247-8853
40732	Victor Moreno	513-337-7158
40834	Melissa Szanto	732-524-1365
41349	Brian Tomko	732-524-1239
41483	Kimberly Prior	201-213-4422
41708	Eric Dichter	215-628-7966
41747	Alana Kriegsman	732-524-1495
43319	Inna Belopolsky	215-851-8527
43703	Andrea Kamage	732-524-3957
44152	Paul Higgins	732-524-1728
44326	Michael Schwartz	260-424-8000
45092	Raef Shaltout	904-443-3693
45991	David Knasiak	732-524-1522
46709	Brett Freeman	732-524-3428
46785	Eve Frank	732-524-2797
47070	Steven Schwarz	732-524-1630
47300	Khoi Ta	513-885-6847
47785	Jeremy Mckown	732-524-6250
48138	Jason Fedon	484-755-0960
48156	Kiera Mathey	732-524-2779
48655	Cynthia Barnett	574-372-7332
48666	Raymond Scott Jr	610-719-5008
48718	Nicole Bradley	--
51336	Grace Hsu	201-981-5837
51883	Roy Kim	714-247-8232
52615	Sharon Beresford	2024084400
52628	Craig Bohlken	404-676-8668
52739	Jon Chiodo	732-524-3156
52988	Melissa Miller	(651) 736-7586
53813	Tamara Evans	714-247-8422
56247	Rajiv Shah	2138925454
56608	Robert Udal	215-963-4954
56886	Athena Bellomo	173-252-42518
58552	Craig Brown	267-946-1447
58931	Shawn Hamidinia	614-203-0961
59887	William Simmons	215-628-5512
61099	Alison Jimerson	857-270-0403
61188	Jennifer Best-Martin	619-631-3721
61264	J. Galvez	215-628-6426
61558	Matthew Chen	650-455-5264
61945	Hilary Reinhardt	513-337-7338
62816	Ping Cao	215-986-1573
63171	Sharon Walker	857-307-2404
63674	Michael Visconti Iii	508-828-3727
63696	Jeffrey Kelsey	317-231-6412
64253	Lisa Horninger	215-628-5052
64262	Christopher Stabley	610-719-5742
64395	Edward King	215-568-3100
65054	Sanjesh Sharma	714-247-8877
66166	Sergio Chung	978-538-8523
66382	Sean Brock	215-568-3100
66646	Kelly Lu	800-227-6633
66675	Gabriel Azar	904-443-3617
66955	Michelle Cristaldi	732-428-6342
67765	Michael Barber	215-986-1559
68001	George Phillips	212-326-3765
68121	Jianning Mai	650-335-7844
68681	Laura Wine	714-246-6996
69198	Harish Srinivas	724-265-0152
69217	Kristina Okafor	832-625-3858
69896	Xiaoxiao Xue	215-589-2066
69901	Amir Bishara	908-986-3744
70206	Tommy Noh	445-400-4284
71298	Kevin Houser	513-337-3531
71340	Xu Chen	215-834-1511
71740	Qing Xia	858-320-3310
72155	David Wallace	510-248-2363
72852	Leah Mae Octavio	267-273-4322
72909	Sofia Kopelevich	929-423-7401
73405	Lin Chen	215-729-9231
73902	Jolie Lechner	215-628-5846
73935	Vishal Parikh	215-963-5494
74350	Guodong Liu	000-000-0000
74904	Deborah Drazen	732-524-1976
75431	Joshua Young	513-337-7284
78243	Monika Rani	310-620-8678

Proceeding Documents

Termination Decision: Pre-DI settlement TERMINATE

2023-08-09 FILING PARTY: BOARD

Download

Joint Request to File Settlement Agreement as Business Confidential Information OTHER

2023-08-03 FILING PARTY: PETITIONER

Download

Joint Motion to Terminate Proceeding MOTION

2023-08-03 FILING PARTY: PETITIONER

Download

Notice: Notice filing date accorded NOTICE

2023-07-19 FILING PARTY: BOARD

Download

1063

Sequence published with International Publication Number WO 2015/119841 Exhibit

2023-06-21 FILING PARTY: PETITIONER

Download

Samsung Bioepis Co., Ltd. vs. Janssen Biotech, Inc.

Proceeding Overview

Parties & Counsel

Petitioner

Samsung Bioepis Co., Ltd.

Represented By

Patent Owner / Respondent

Janssen Biotech, Inc.

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

Termination Decision: Pre-DI settlement TERMINATE

Joint Request to File Settlement Agreement as Business Confidential Information OTHER

Joint Motion to Terminate Proceeding MOTION

Notice: Notice filing date accorded NOTICE

Sequence published with International Publication Number WO 2015/119841 Exhibit

Kim, et al. (2016) Exhibit

Declaration of Michael S. Epstein, M.D. Exhibit

Ustekinumab (Stelara), Canadian Agency for Drugs and Technologies in Health Exhibit

Webarchive of “Study of Vedolizumab (MLN0002) in Patients ..." Exhibit

U.S. Patent Publication No. US 2009/0181027 A1 Exhibit

Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”) - ustekinumab Exhibit

U.S. Patent No. 10,961,307 Exhibit

Aggeletopoulou et al. (Sept. 2018) Exhibit

Sands et al. (2019) Exhibit

Kolios et al. (2018) Exhibit

Tarr et al. (2014) Exhibit

Nakov, et al. (2017) Exhibit

Listing of Challenged Claims of the ’307 Exhibit

Sandborn et al. (2008) Exhibit

Excerpts from the file history for U.S. Patent No. 10,961,307 - Part 1 Exhibit

Application for Extension of Patent Term for U.S. Patent No. 7,166,285 Exhibit

American of College of Rheumatology: Ustekinumab (Stelara) (2018) Exhibit

Dhanda et al. (2012) Exhibit

Janssen Press Release (Oct. 21, 2019) Exhibit

Webarchive of Chemical Database for Ustekinumab .... Exhibit

STELARA- ustekinumab solution Archived Drug Label Exhibit

Johnson and Johnson Press Release (Sept. 26, 2016) Exhibit

International Publication Number WO 2015/119841 Exhibit

Higgins, et al. (2005) Exhibit

Affidavit of Nathaniel E Frank-White - Part 1 Exhibit

Janssen Research & Development NCT02407236 Clinical Protocol Exhibit

Yen et al. (May 2006) Exhibit

Excerpts from the file history for U.S. Patent No. 10,961,307 - Part 2 Exhibit

Uhlig et al. (Aug. 2006) Exhibit

Webarchive of “A Safety and Efficacy Study for Infliximab (Remicade)..." Exhibit

Affidavit of Nathaniel E Frank-White - Part 2 Exhibit

Feagan et al. (Nov. 17, 2016) Exhibit

Cote-Daigneault, Biologics in inflammatory bowel disease (2015) Exhibit

NCT02407236 Exhibit

Webarchive of Label: STELARA - ustekinumab... Exhibit

International Publication Number WO 2017/049035 Exhibit

Ochsenkühn et al. (Feb. 2018) Exhibit

Stelara® Prescribing Information (Sept. 2016) Exhibit

Declaration of Noah S. Frank Exhibit

U.S. Patent No. 7,166,285 Exhibit

Webarchive of “Efficacy and Safety of Adalimumab in..." Exhibit

Remicade (infliximab) Prescribing Information (Jan. 2015) Exhibit

History of Changes for Study: NCT02407236, ClinicalTrials.gov archive Exhibit

Entyvio (vedolizumab) Prescribing Information (May 2014) Exhibit

Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry (2016) Exhibit

Webarchive screenshots of www.pmda.go.jp/english/index.html Exhibit

Ahern et al. (Aug. 2010) Exhibit

U.S. Patent Application Publication 2020/0262908 Exhibit

Field Trials of Health Interventions: A Toolbox, Smith (3rd ed. 2015) Exhibit

Humira (adalimumab) Prescribing Information (July 2016) Exhibit

Pedersen et al. (Jan. 2014) Exhibit

Coskun et al. (Feb. 2017) Exhibit

Danese & Fiocchi, Ulcerative Colitis, N Engl J Med., 365:1713-1725 (2011) Exhibit

Labeling Archives, search results for ustekinumab Exhibit

Petitioner Samsung Bioepis Co., Ltd.'s Power of Attorney NOTICE

Webarchive of Label: STELARA - ustekinumab injection... Exhibit

Harvard Catalyst (July 11, 2018) Exhibit

Pithadia & Jain (2011) Exhibit

D’Haens et al. (2007) Exhibit

Application for Extension of Patent Term for U.S. Patent No. 6,902,734 Exhibit