The detailed information for PTAB case with proceeding number IPR2023-00998 filed by Samsung Bioepis Co., Ltd. against Alexion Pharmaceuticals, Inc. et al. on May 31, 2023. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2023-00998
Filing Date
May 31, 2023
Petitioner
Samsung Bioepis Co., Ltd.
Respondent
Alexion Pharmaceuticals, Inc. et al.
Status
Terminated-Settled
Respondent Application Number
15148839
Respondent Tech Center
1600
Respondent Patent Number
9718880
Institution Decision Date
Dec 8, 2023
Termination Date
Sep 4, 2024

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

Termination Decision: Post-DI Settlement

Sep 4, 2024PAPERBOARD

EXPUNGED

Aug 30, 2024PAPERPATENT OWNER

Joint Motion to Terminate

Aug 30, 2024PAPERPATENT OWNER

EX2109

Aug 30, 2024EXHIBITPATENT OWNER

Joint Motion to Treat Settlement Agreement as Confidential

Aug 30, 2024PAPERPATENT OWNER

ORDER Setting Oral Argument

Aug 26, 2024PAPERBOARD

Patent Owner's Request for Oral Argument

Aug 7, 2024PAPERPATENT OWNER

Petitioner's Request for Oral Hearing

Aug 7, 2024PAPERPETITIONER

Patent Owner's Updated Exhibit List

Jul 26, 2024PAPERPATENT OWNER

Patent Owner's Sur-Reply

Jul 26, 2024PAPERPATENT OWNER

2108 - 2024.07.16 Jeffrey Ravetch Deposition Transcript (FULL)

Jul 26, 2024EXHIBITPATENT OWNER

Notice of Deposition of J. Ravetch, M.D., Ph.D.

Jul 11, 2024PAPERPATENT OWNER

SECOND MODIFIED SCHEDULING ORDER 37 C.F.R. ยง 42.5(c)

Jul 9, 2024PAPERBOARD

Exhibit 3005

Jul 9, 2024EXHIBITBOARD

Stipulation Modifying Due Dates

Jul 8, 2024PAPERPATENT OWNER

Petitioner's Reply ISO Petition

Jun 10, 2024PAPERPETITIONER

Petitioner's Updated Exhibit List

Jun 10, 2024PAPERPETITIONER

Deposition of Arturo Casadevall, January 24, 2020

Jun 10, 2024EXHIBITPETITIONER

Reply Declaration of Jeffrey V. Ravetch, M.D., Ph.D.

Jun 10, 2024EXHIBITPETITIONER

Joint Stipulation Modifying Due Dates

May 14, 2024PAPERPETITIONER

Patent Owner Response

Mar 12, 2024PAPERPATENT OWNER

2006 - Dmytrijuk

Mar 12, 2024EXHIBITPATENT OWNER

2014 - Greenspan

Mar 12, 2024EXHIBITPATENT OWNER

2023 - CV Arturo Casadevall

Mar 12, 2024EXHIBITPATENT OWNER

2025 - CV Bernhardt Trout 880

Mar 12, 2024EXHIBITPATENT OWNER

2028 - Hill 2007

Mar 12, 2024EXHIBITPATENT OWNER

2029 - 1997 FDA pts to Consider MAbs

Mar 12, 2024EXHIBITPATENT OWNER

2030 - Alexion Press Releasae 3-16-2007

Mar 12, 2024EXHIBITPATENT OWNER

2031 - Janeway Appx 2005

Mar 12, 2024EXHIBITPATENT OWNER

2033 - Kim 2005

Mar 12, 2024EXHIBITPATENT OWNER

2034 - Hwang 2005

Mar 12, 2024EXHIBITPATENT OWNER

2035 - Shepherd Appx 2000

Mar 12, 2024EXHIBITPATENT OWNER

2036 - Lo 2004

Mar 12, 2024EXHIBITPATENT OWNER

2037 - Welt 1997

Mar 12, 2024EXHIBITPATENT OWNER

2038 - Haller 2008

Mar 12, 2024EXHIBITPATENT OWNER

2039 - Torres 2007 PLOS Article

Mar 12, 2024EXHIBITPATENT OWNER

2040 - Torres 2005

Mar 12, 2024EXHIBITPATENT OWNER

2042 - Mathieu 2004

Mar 12, 2024EXHIBITPATENT OWNER

2043 - Andersen 2004

Mar 12, 2024EXHIBITPATENT OWNER

2044 - Chadd 2001

Mar 12, 2024EXHIBITPATENT OWNER

2045 - 2007 USP Dictionary of USAN and Int'l Drug Names

Mar 12, 2024EXHIBITPATENT OWNER

2046 - 1997 INN Naming Guidelines

Mar 12, 2024EXHIBITPATENT OWNER

2047 - McClean 2005

Mar 12, 2024EXHIBITPATENT OWNER

2049 - HemeOnc Today

Mar 12, 2024EXHIBITPATENT OWNER

2050 - Fatimah 2016

Mar 12, 2024EXHIBITPATENT OWNER

2051 - Foote 1992

Mar 12, 2024EXHIBITPATENT OWNER

2052- Xiang 1995

Mar 12, 2024EXHIBITPATENT OWNER

2053 - Soliris Current Label (06-2019 Label)

Mar 12, 2024EXHIBITPATENT OWNER

2054 - Alexion Press Release 9-20-2006

Mar 12, 2024EXHIBITPATENT OWNER

2055 - Alexion Press Release 9-26-2006

Mar 12, 2024EXHIBITPATENT OWNER

2075 - GenScript Final Report

Mar 12, 2024EXHIBITPATENT OWNER

2079 - Chang 2002

Mar 12, 2024EXHIBITPATENT OWNER

2080 - Wang 1999

Mar 12, 2024EXHIBITPATENT OWNER

2081 - Hermeling 2004

Mar 12, 2024EXHIBITPATENT OWNER

2082 - Frokjaer 2005

Mar 12, 2024EXHIBITPATENT OWNER

2083 - Rosenberg 2006

Mar 12, 2024EXHIBITPATENT OWNER

2084 - ICH Topic Q5C

Mar 12, 2024EXHIBITPATENT OWNER

2085 - Q1AR2 Stability Testing Guidance

Mar 12, 2024EXHIBITPATENT OWNER

2086 - Stebbings 2013

Mar 12, 2024EXHIBITPATENT OWNER

2088 - Amgen Biosimilar Pipeline

Mar 12, 2024EXHIBITPATENT OWNER

2089 - Generium Elizaria

Mar 12, 2024EXHIBITPATENT OWNER

2090 - Samsung Biosimilar Pipeline

Mar 12, 2024EXHIBITPATENT OWNER

2091 - Harlowe and Lane 1988

Mar 12, 2024EXHIBITPATENT OWNER

2104 - 2024.02.23 Jeffrey Ravetch Deposition Transcript (FULL)

Mar 12, 2024EXHIBITPATENT OWNER

2105 - Declaration of A. Casadevall (for POR) FINAL [880]

Mar 12, 2024EXHIBITPATENT OWNER

2106 - 2024.02.20 Cindy Ippoliti Deposition Transcript (FULL)

Mar 12, 2024EXHIBITPATENT OWNER

2107 - Declaration of B. Trout (for POR) FINAL [880]

Mar 12, 2024EXHIBITPATENT OWNER

EXPUNGED

Feb 12, 2024EXHIBITBOARD

FIRST MODIFIED SCHEDULING ORDER

Feb 12, 2024PAPERBOARD

Ex 3004

Feb 12, 2024EXHIBITBOARD

Patent Owner's Notice of Deposition of Cindy Ippoliti, Pharm.D.

Feb 7, 2024PAPERPATENT OWNER

Patent Owner's Notice of Deposition of Jeffrey V. Ravetch, M.D., Ph.D.

Feb 7, 2024PAPERPATENT OWNER

Institution Decision: Grant

Dec 8, 2023PAPERBOARD

US10703809

Nov 15, 2023EXHIBITBOARD

US10590189

Nov 15, 2023EXHIBITBOARD

Patent Owner's Sur-Reply to Petitioner's Reply to Preliminary Response

Oct 20, 2023PAPERPATENT OWNER

Petitioner's Reply to Patent Owner's Preliminary Response

Oct 5, 2023PAPERPETITIONER

Exhibit 3001

Sep 22, 2023EXHIBITBOARD

Patent Owner Preliminary Response

Sep 12, 2023PAPERPATENT OWNER

2005 - SOLIRIS Label

Sep 12, 2023EXHIBITPATENT OWNER

2007 - Janeway and Travers

Sep 12, 2023EXHIBITPATENT OWNER

2008 - McCloskey

Sep 12, 2023EXHIBITPATENT OWNER

2009 - Torres

Sep 12, 2023EXHIBITPATENT OWNER

2010 - Janda

Sep 12, 2023EXHIBITPATENT OWNER

2011 - Pritsch 1996

Sep 12, 2023EXHIBITPATENT OWNER

2012 - Pritsch 2000

Sep 12, 2023EXHIBITPATENT OWNER

2013 - McLean

Sep 12, 2023EXHIBITPATENT OWNER

2015 - Radbruch

Sep 12, 2023EXHIBITPATENT OWNER

2016 - Bowdish 7,482,435

Sep 12, 2023EXHIBITPATENT OWNER

2017 - Hawkins

Sep 12, 2023EXHIBITPATENT OWNER

2018 - Alexion Pharmaceuticals Form 10K

Sep 12, 2023EXHIBITPATENT OWNER

2019 - Ricklin and Lambris

Sep 12, 2023EXHIBITPATENT OWNER

2020 - Alexion Press Release

Sep 12, 2023EXHIBITPATENT OWNER

2021 - Alexion BusinessWire

Sep 12, 2023EXHIBITPATENT OWNER

2022 - Arturo Casadevall Declaration

Sep 12, 2023EXHIBITPATENT OWNER

2026 - Michel Nussenzweig Declaration 880

Sep 12, 2023EXHIBITPATENT OWNER

2098 - Harlow and Lane Chapter 1

Sep 12, 2023EXHIBITPATENT OWNER

2100 - Rother 2007

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 1 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 2 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 3 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 4 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 5 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 6 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 7 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 8 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 9 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 10 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 11 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 12 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 13 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2102 - [1002] - Part 14 - Prosecution History for U.S. Patent No. 10,590,189 B2

Sep 12, 2023EXHIBITPATENT OWNER

2103 - [1002] Prosecution History for US Patent No. 9,725,504 B2

Sep 12, 2023EXHIBITPATENT OWNER

Notice: Notice filing date accorded

Jun 14, 2023PAPERBOARD

Notice : Power of Attorney

Jun 8, 2023PAPERPATENT OWNER

Notice : Mandatory Notice

Jun 8, 2023PAPERPATENT OWNER

Notice : Power of Attorney

May 31, 2023PAPERPETITIONER

U.S. Patent No. 9,718,880 B2 issued to Leonard Bell et al.

May 31, 2023EXHIBITPETITIONER

Part 1 - Prosecution History of U.S. Patent No. 9,718,880

May 31, 2023EXHIBITPETITIONER

Part 2 - Prosecution History for U.S. Patent No. 9,718,880

May 31, 2023EXHIBITPETITIONER

U.S. Patent Appl Publ No. 2003/0232972 to Bowdish

May 31, 2023EXHIBITPETITIONER

U.S. Patent No. 6,355,245 B1 issued to Mark Evans

May 31, 2023EXHIBITPETITIONER

Mueller, et al., 34 Molecular Immunology 441 (1997)

May 31, 2023EXHIBITPETITIONER

U.S. Patent Appl. Publ. No. 2005/0191298 A1 to Leonard Bell

May 31, 2023EXHIBITPETITIONER

Tacken et al., 106 Blood 1278 (2005)

May 31, 2023EXHIBITPETITIONER

WO 97/11971 issued to Mueller et al.

May 31, 2023EXHIBITPETITIONER

Thomas et al., 33 Molecular Immunology 1389 (1996)

May 31, 2023EXHIBITPETITIONER

Hillmen et al., 350 N. Engl. J. Med. 552 (2004)

May 31, 2023EXHIBITPETITIONER

Hill et al., 104 BVlood 772a (2004)

May 31, 2023EXHIBITPETITIONER

Hill et al., 106 Blood 2559 (2005)

May 31, 2023EXHIBITPETITIONER

Hillmen et al., 355 N. Engl. J. Med. 1233 (2006)

May 31, 2023EXHIBITPETITIONER

Young et al., 108 Blood 290a (2006)

May 31, 2023EXHIBITPETITIONER

Hillmen et al., 100 Blood 44a (2002)

May 31, 2023EXHIBITPETITIONER

Hillmen et al., 102 Blood 509a (2003)

May 31, 2023EXHIBITPETITIONER

Excerpts from 17 WHO Drug Information 115, World Health Organization (2003)

May 31, 2023EXHIBITPETITIONER

Guidelines on the Use of Int'l Nonproprietary Names (INNs) etc., WHO (1997)

May 31, 2023EXHIBITPETITIONER

Alexion Press Release, Alexion Issued Key C5 etc. (March 15, 2002)

May 31, 2023EXHIBITPETITIONER

WO 2005/007809 A2 issued to Rother et al.

May 31, 2023EXHIBITPETITIONER

WO 2005/110481 A2 issued to Rother et al.

May 31, 2023EXHIBITPETITIONER

Kaplan, Eculizumab Alexion, 3 Curr. Opin. Investig. Drugs 1017 (2002)

May 31, 2023EXHIBITPETITIONER

Amgen v. Alexion - IPR2019-00740, Paper 15, Decision dated August 30, 2019

May 31, 2023EXHIBITPETITIONER

Amgen v. Alexion, IPR2019-00740, Paper 22, PO Response dated Nov. 22, 2019

May 31, 2023EXHIBITPETITIONER

Amgen v. Alexion, IPR2019-00740, Paper 48, Termination dated June 1, 2020

May 31, 2023EXHIBITPETITIONER

Oppsn File History for EP No. 1 720 571 B1

May 31, 2023EXHIBITPETITIONER

File History for EP No. 3 167 888

May 31, 2023EXHIBITPETITIONER

Excerpt from File History for 11/127,438, Amdmt to Resp 8/2/2011

May 31, 2023EXHIBITPETITIONER

Appl. Ext. Patent Term - 5,355,245, Alexion Pharma dated May 11, 2007

May 31, 2023EXHIBITPETITIONER

Certificate Extending Term, No. 6,355,245 dated June 11, 2010

May 31, 2023EXHIBITPETITIONER

Excerpt from File History - 10,590,189 IDS dated May 31, 2019

May 31, 2023EXHIBITPETITIONER

Yoo et al., 170 J. Immunol. 3134 (2003)

May 31, 2023EXHIBITPETITIONER

Excerpt from File History, 10,590,189, Non Final Rejection dated 6/11/2019

May 31, 2023EXHIBITPETITIONER

Excerpt from File History 10,590,189, Ntc of Allowance dated 1/22/2020

May 31, 2023EXHIBITPETITIONER

Excerpt from File History 10,590,189, Amdmt in Resp dated 12/11/2019

May 31, 2023EXHIBITPETITIONER

Wypych et al., 283 J. Biol. Chem. 16194 (2008)

May 31, 2023EXHIBITPETITIONER

Bournazazos et al., 588 Nature 485 (2020)

May 31, 2023EXHIBITPETITIONER

Bournazos et al., 124 J. Clinical Investigation 725 (2014)

May 31, 2023EXHIBITPETITIONER

Baudino et al., 181 J. Immunology 4107 (2008)

May 31, 2023EXHIBITPETITIONER

Takai et al., 76 Cell 519 (1994)

May 31, 2023EXHIBITPETITIONER

Nimmerjahn et al., 8 Nat. Rev. Immunol. 34 (2008)

May 31, 2023EXHIBITPETITIONER

Ravetch et al., 9 Annu. Rev. Immunol. 457 (1991)

May 31, 2023EXHIBITPETITIONER

US Pat. Appl. Publ. No. 2005/0271660 A1 issued to Wang

May 31, 2023EXHIBITPETITIONER

Janeway et al., Immunobiology etc., pp. 1-34, 93-122 (5th ed 2001)

May 31, 2023EXHIBITPETITIONER

Excerpts from Juo, Concise Dict. of Biomed & Molecular Biol (2d ed. 2001)

May 31, 2023EXHIBITPETITIONER

Volkel et al., 14 Protein Engineering 815 (2001)

May 31, 2023EXHIBITPETITIONER

Lobo et al., 93 Journal of Pharmaceutical Sciences 2645 (2004)

May 31, 2023EXHIBITPETITIONER

Lipman, et al., 46 ILAR Journal 258 (2005)

May 31, 2023EXHIBITPETITIONER

Lo, ...Methods in Molecular Biology, Vol. 248: etc., pp. 135-159 (2004)

May 31, 2023EXHIBITPETITIONER

Riechmann et al., 332 Nature 323 (1988)

May 31, 2023EXHIBITPETITIONER

Reichert, 4 mAbs 413 (2012)

May 31, 2023EXHIBITPETITIONER

Alberts et al., etc., Molecular Biology of the Cell, pp. 551-98 (1994)

May 31, 2023EXHIBITPETITIONER

Adderson, et al., 89 J. Clin. Invest. 729 (1992)

May 31, 2023EXHIBITPETITIONER

Genentech, Inc., Avastin 2004 Package Insert

May 31, 2023EXHIBITPETITIONER

Millennium, Campath 2001 Package Insert

May 31, 2023EXHIBITPETITIONER

ImClone Systems, Inc., Erbitux 2004 Package Insert

May 31, 2023EXHIBITPETITIONER

Genentech, Inc. Herceptin 1998 Package Insert

May 31, 2023EXHIBITPETITIONER

Centocor, Inc., Remicade 1998 Package Insert

May 31, 2023EXHIBITPETITIONER

Genentech, Inc. Rituxan 1997 Package Insert

May 31, 2023EXHIBITPETITIONER

Daugherty et al., 58 Advanced Drug Delivery Reviews 686 (2006)

May 31, 2023EXHIBITPETITIONER

Note for Guidance on Excipients, Antioxidants etc., EU Agcy Eval...(2003)

May 31, 2023EXHIBITPETITIONER

Petition : as filed

May 31, 2023PAPERPETITIONER

Declaration of Jeffrey V. Ravetch MD PhD

May 31, 2023EXHIBITPETITIONER

Declaration of Cindy Ippoliti Pharm.D.

May 31, 2023EXHIBITPETITIONER