Samsung Bioepis Co., Ltd. vs Janssen Biotech, Inc. - IPR2023-01103

Termination Decision: Pre-DI settlement

Joint Request to File Settlement Agreement as Business Confidential Information

Joint Motion to Terminate Proceeding

Settlement and License Agreement

Notice: Notice filing date accorded

Patent Owner's Power of Attorney

Notice : Mandatory Notice

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

Petition for Inter Partes Review of U.S. Patent No. 10,961,307

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

Declaration of Michael S. Epstein, M.D.

NCT02407236

Stelara® Prescribing Information (Sept. 2016)

Ochsenkühn et al. (Feb. 2018)

Entyvio (vedolizumab) Prescribing Information (May 2014)

Humira (adalimumab) Prescribing Information (July 2016)

Remicade (infliximab) Prescribing Information (Jan. 2015)

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

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

Ahern et al. (Aug. 2010)

Uhlig et al. (Aug. 2006)

Yen et al. (May 2006)

Aggeletopoulou et al. (Sept. 2018)

Pedersen et al. (Jan. 2014)

Coskun et al. (Feb. 2017)

Sandborn et al. (2008)

U.S. Patent No. 6,902,734

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

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

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

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

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

Stelara Prescribing Information (Sept. 2009) (“First Approved Label”)

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

Feagan et al. (Nov. 17, 2016)

Janssen Research & Development NCT02407236 Clinical Protocol

Affidavit of Nathaniel E Frank-White - Part 1

Affidavit of Nathaniel E Frank-White - Part 2

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

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

Sands et al. (2019)

Janssen Press Release (Oct. 21, 2019)

Tarr et al. (2014)

Kolios et al. (2018)

Afonso et al. (2017)

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

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

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

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

D’Haens et al. (2007)

Dhanda et al. (2012)

Glossary of Common Site Terms, ClinicalTrials.gov (Oct. 2021)

Harvard Catalyst (July 11, 2018)

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

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

Kim, et al. (2016)

U.S. Patent Application Publication 2020/0262908

Pithadia & Jain (2011)

Higgins, et al. (2005)

International Publication Number WO 2017/049035

International Publication Number WO 2015/119841

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

Stelara, European Medicines Agency Website

Nakov, et al. (2017)

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

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

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

Sequence published with International Publication Number WO 2015/119841

Webarchive of Janssen Research & Development, LLC published clinical

Webarchive of Chemical Database for Ustekinumab ....

Webarchive of Label: STELARA - ustekinumab...

Webarchive of Label: STELARA - ustekinumab injection...

Labeling Archives, search results for ustekinumab

STELARA- ustekinumab solution Archived Drug Label

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

Declaration of Noah S. Frank

Listing of Challenged Claims of the ’307