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Samsung Bioepis Co., Ltd. vs Alexion Pharmaceuticals, Inc. et al. - IPR2023-01069

Explore the PTAB proceeding IPR2023-01069 filed by Samsung Bioepis Co., Ltd. against Alexion Pharmaceuticals, Inc. et al. on Jun 16, 2023. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number: IPR2023-01069
Filing Date: Jun 16, 2023
Petitioner: Samsung Bioepis Co., Ltd.
Respondent: Alexion Pharmaceuticals, Inc. et al.
Status: Terminated-Settled
Respondent Application Number: 15642096
Respondent Tech Center: 1600
Respondent Patent Number: 10590189
Institution Decision Date: Dec 20, 2023
Termination Date: Sep 4, 2024

Decision Documents New

Decision documents related to this case provide insights into the outcomes of proceedings. These documents are crucial for understanding the legal determinations and implications for the parties involved.

Document Name	Filing Date	Category	Filing Party
Termination Decision: Post-DI Settlement	Sep 4, 2024	PAPER	BOARD
Institution Decision: DECISION Institution of Inter Partes Review 35 U.S.C. § 314(a)	Dec 20, 2023	PAPER	BOARD
Amgen v. Alexion, IPR2019-00739, #15, Decision - Inst of IPR 8/30/2019	Jun 16, 2023	EXHIBIT	PETITIONER

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.

Show Exhibit Documents

Document Name	Filing Date	Category	Filing Party
Alert me when new update on this case
Termination Decision: Post-DI Settlement	Sep 4, 2024	PAPER	BOARD
Joint Motion to Terminate	Aug 30, 2024	PAPER	PATENT OWNER
EX2109	Aug 30, 2024	EXHIBIT	PATENT OWNER
Joint Motion to Treat Settlement Agreement as Confidential	Aug 30, 2024	PAPER	PATENT OWNER
ORDER Setting Oral Argument	Aug 26, 2024	PAPER	BOARD
Patent Owner's Request for Oral Argument	Aug 7, 2024	PAPER	PATENT OWNER
Petitioner's Request for Oral Hearing	Aug 7, 2024	PAPER	PETITIONER
Patent Owner's Updated Exhibit List	Jul 29, 2024	PAPER	PATENT OWNER
Patent Owner's Sur-Reply	Jul 29, 2024	PAPER	PATENT OWNER
2108 - 2024.07.16 Jeffrey Ravetch Deposition Transcript (FULL)	Jul 29, 2024	EXHIBIT	PATENT OWNER
Notice of Deposition of J. Ravetch, M.D., Ph.D.	Jul 11, 2024	PAPER	PATENT OWNER
SECOND MODIFIED SCHEDULING ORDER 37 C.F.R. § 42.5(c)	Jul 9, 2024	PAPER	BOARD
Exhibit 3005	Jul 9, 2024	EXHIBIT	BOARD
Stipulation Modifying Due Dates	Jul 8, 2024	PAPER	PATENT OWNER
Petitioner's Reply ISO Petition	Jun 10, 2024	PAPER	PETITIONER
Petitioner's Updated Exhibit List	Jun 10, 2024	PAPER	PETITIONER
Deposition of Arturo Casadevall, January 24, 2020	Jun 10, 2024	EXHIBIT	PETITIONER
Reply Declaration of Jeffrey V. Ravetch, M.D., Ph.D.	Jun 10, 2024	EXHIBIT	PETITIONER
Joint Stipulation Modifying Due Dates	May 14, 2024	PAPER	PETITIONER
2006 - Dmytrijuk	Mar 13, 2024	EXHIBIT	PATENT OWNER
2014 - Greenspan	Mar 13, 2024	EXHIBIT	PATENT OWNER
2023 - Arturo Casadevall MD PhD CV	Mar 13, 2024	EXHIBIT	PATENT OWNER
2025 - CV Bernhardt Trout 504	Mar 13, 2024	EXHIBIT	PATENT OWNER
2028 - Hill 2007	Mar 13, 2024	EXHIBIT	PATENT OWNER
2029 - 1997 FDA Pts to Consider MAbs	Mar 13, 2024	EXHIBIT	PATENT OWNER
2030 - Alexion Press Release 3-16-2007	Mar 13, 2024	EXHIBIT	PATENT OWNER
2031 - Janeway Appx 2005	Mar 13, 2024	EXHIBIT	PATENT OWNER
2033 - Kim 2005	Mar 13, 2024	EXHIBIT	PATENT OWNER
2034 - Hwang 2005	Mar 13, 2024	EXHIBIT	PATENT OWNER
2035 - Shepherd Appx 2000	Mar 13, 2024	EXHIBIT	PATENT OWNER
2036 - Lo 2004	Mar 13, 2024	EXHIBIT	PATENT OWNER
2037 - Welt 2003	Mar 13, 2024	EXHIBIT	PATENT OWNER
2038 - Haller 2008	Mar 13, 2024	EXHIBIT	PATENT OWNER
2039 - Torres 2007 PLOS Article	Mar 13, 2024	EXHIBIT	PATENT OWNER
2040 - Torres 2005	Mar 13, 2024	EXHIBIT	PATENT OWNER
2042 - Mathiew 2004	Mar 13, 2024	EXHIBIT	PATENT OWNER
2043 - Andersen 2004	Mar 13, 2024	EXHIBIT	PATENT OWNER
2044 - Chadd 2001	Mar 13, 2024	EXHIBIT	PATENT OWNER
2045 - 2007 USP Dictionary of USAN and Int'l Drug Names	Mar 13, 2024	EXHIBIT	PATENT OWNER
2046 - 1997 INN Naming Guidelines	Mar 13, 2024	EXHIBIT	PATENT OWNER
2047 - McClean 2005	Mar 13, 2024	EXHIBIT	PATENT OWNER
2049 - HemeOnc Today	Mar 13, 2024	EXHIBIT	PATENT OWNER
2050 - Fatimah 2016	Mar 13, 2024	EXHIBIT	PATENT OWNER
2051 - Foote 1992	Mar 13, 2024	EXHIBIT	PATENT OWNER
2052 - Xiang 1995	Mar 13, 2024	EXHIBIT	PATENT OWNER
2053 - Soliris Current Label (06-2019 Label)	Mar 13, 2024	EXHIBIT	PATENT OWNER
2054 - Alexion Press Release 9-20-2006	Mar 13, 2024	EXHIBIT	PATENT OWNER
2055 - Alexion Press Release 9-26-2006	Mar 13, 2024	EXHIBIT	PATENT OWNER
2075 - GenScript Final Report	Mar 13, 2024	EXHIBIT	PATENT OWNER
2079 - Chang 2002	Mar 13, 2024	EXHIBIT	PATENT OWNER
2080 - Wang 1999	Mar 13, 2024	EXHIBIT	PATENT OWNER
2081 - Hermeling 2004	Mar 13, 2024	EXHIBIT	PATENT OWNER
2082 - Frokjaer	Mar 13, 2024	EXHIBIT	PATENT OWNER
2083 - Rosenberg 2006	Mar 13, 2024	EXHIBIT	PATENT OWNER
2084 - ICH Topic Q5C	Mar 13, 2024	EXHIBIT	PATENT OWNER
2085 - Q1AR2 Stability Testing Guidance	Mar 13, 2024	EXHIBIT	PATENT OWNER
2086 - Stebbings 2013	Mar 13, 2024	EXHIBIT	PATENT OWNER
2088 - Amgen Biosimilar Pipeline	Mar 13, 2024	EXHIBIT	PATENT OWNER
2089 - Generium Elizaria	Mar 13, 2024	EXHIBIT	PATENT OWNER
2090 - Samsung Bisolimilar Pipeline	Mar 13, 2024	EXHIBIT	PATENT OWNER
2091 - Harlowe and Lane 1988	Mar 13, 2024	EXHIBIT	PATENT OWNER
2104 - 2024.02.23 Jeffrey Ravetch Deposition Transcript (FULL)	Mar 13, 2024	EXHIBIT	PATENT OWNER
2105 - Declaration of A. Casadevall (for POR) FINAL [189]	Mar 13, 2024	EXHIBIT	PATENT OWNER
2106 - 2024.02.20 Cindy Ippoliti Deposition Transcript (FULL)	Mar 13, 2024	EXHIBIT	PATENT OWNER
2107 - Declaration of B. Trout (for POR) FINAL [189]	Mar 13, 2024	EXHIBIT	PATENT OWNER
Patent Owner Response	Mar 13, 2024	PAPER	PATENT OWNER
EXPUNGED	Feb 12, 2024	EXHIBIT	BOARD
FIRST MODIFIED SCHEDULING ORDER	Feb 12, 2024	PAPER	BOARD
Ex 3004	Feb 12, 2024	EXHIBIT	BOARD
Patent Owner's Notice of Deposition of Cindy Ippoliti, Pharm.D.	Feb 7, 2024	PAPER	PATENT OWNER
Patent Owner's Notice of Deposition of Jeffrey V. Ravetch, M.D., Ph.D.	Feb 7, 2024	PAPER	PATENT OWNER
Institution Decision: DECISION Institution of Inter Partes Review 35 U.S.C. § 314(a)	Dec 20, 2023	PAPER	BOARD
Patent Owner's Sur-Reply to Petitioner's Reply to Preliminary Response	Dec 1, 2023	PAPER	PATENT OWNER
US10703809	Nov 15, 2023	EXHIBIT	BOARD
EXPUNGED	Nov 15, 2023	EXHIBIT	BOARD
Petitioner's Reply to Patent Owner's Preliminary Response	Nov 10, 2023	PAPER	PETITIONER
Ex. 3001	Oct 19, 2023	EXHIBIT	BOARD
Patent Owner Preliminary Response	Oct 13, 2023	PAPER	PATENT OWNER
2005 - SOLIRIS Label	Oct 13, 2023	EXHIBIT	PATENT OWNER
2007 - Janeway and Travers	Oct 13, 2023	EXHIBIT	PATENT OWNER
2008 - McCloskey	Oct 13, 2023	EXHIBIT	PATENT OWNER
2009 - Torres	Oct 13, 2023	EXHIBIT	PATENT OWNER
2010 - Janda	Oct 13, 2023	EXHIBIT	PATENT OWNER
2011 - Pritsch 1996	Oct 13, 2023	EXHIBIT	PATENT OWNER
2012 - Pritsch 2000	Oct 13, 2023	EXHIBIT	PATENT OWNER
2013 - McLean	Oct 13, 2023	EXHIBIT	PATENT OWNER
2015 - Radbruch	Oct 13, 2023	EXHIBIT	PATENT OWNER
2017 - Hawkins	Oct 13, 2023	EXHIBIT	PATENT OWNER
2018 - Alexion Pharmaceuticals Form 10K	Oct 13, 2023	EXHIBIT	PATENT OWNER
2019 - Ricklin and Lambris	Oct 13, 2023	EXHIBIT	PATENT OWNER
2020 - Alexion Press Release	Oct 13, 2023	EXHIBIT	PATENT OWNER
2021 - Alexion BusinessWire	Oct 13, 2023	EXHIBIT	PATENT OWNER
2022 - Arturo Casadevall Declaration	Oct 13, 2023	EXHIBIT	PATENT OWNER
2024 - Bernhardt L. Trout PhD Declaration	Oct 13, 2023	EXHIBIT	PATENT OWNER
2026 - Michel Nussenzweig Declaration	Oct 13, 2023	EXHIBIT	PATENT OWNER
2098 - Harlow and Lane Chapter 1	Oct 13, 2023	EXHIBIT	PATENT OWNER
2100 - Rother 2007	Oct 13, 2023	EXHIBIT	PATENT OWNER
2101 - [1002] - Part 1 - Prosecution History for US Patent 9,718,880	Oct 13, 2023	EXHIBIT	PATENT OWNER
2101 - [1002] - Part 2 - Prosecution History for US Patent 9,718,880	Oct 13, 2023	EXHIBIT	PATENT OWNER
2103 - [1002] - Prosecution History for US Patent No. 9,725,504 B2	Oct 13, 2023	EXHIBIT	PATENT OWNER
NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE	Jul 14, 2023	PAPER	BOARD
Notice : Mandatory Notice	Jul 6, 2023	PAPER	PATENT OWNER
Notice : Power of Attorney	Jul 6, 2023	PAPER	PATENT OWNER
Notice : Power of Attorney	Jun 16, 2023	PAPER	PETITIONER
Petition : as filed	Jun 16, 2023	PAPER	PETITIONER
U.S. Patent No. 10,590,189 B2 issued to Leonard Bell et al.	Jun 16, 2023	EXHIBIT	PETITIONER
Part 1 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 2 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 3 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 4 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 5 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 6 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 7 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 8 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 9 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 10 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 11 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 12 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 13 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Part 14 - Prosecution History for U.S. Patent No. 10,590,189 B2	Jun 16, 2023	EXHIBIT	PETITIONER
Declaration of Jeffrey V. Ravetch, M.D., Ph.D.	Jun 16, 2023	EXHIBIT	PETITIONER
U.S. Pat. Appl. Publ. No. 2003/0232972 A1 issued to Katherine S. Bowdish	Jun 16, 2023	EXHIBIT	PETITIONER
U.S. Patent No. 6,355,245 B1 issued to Mark J. Evans et al.	Jun 16, 2023	EXHIBIT	PETITIONER
Mueller, et al., Humanized Porcine VCAM-Specific...34 M.Imm. 441 (1997)	Jun 16, 2023	EXHIBIT	PETITIONER
U.S. Pat. Appl. Publ. No. 2005/0191298 A1 issued to Leonard Bell et al.	Jun 16, 2023	EXHIBIT	PETITIONER
Tacken, Effective induction of naive and recall..., 106 Blood 1278 (2005)	Jun 16, 2023	EXHIBIT	PETITIONER
WO 97/11971 issued to John P. Mueller et al.	Jun 16, 2023	EXHIBIT	PETITIONER
Thomas, Inhibition of Complement Activity..., 33 M.Imm. 1389 (1996)	Jun 16, 2023	EXHIBIT	PETITIONER
Hillmen, Effect of Eculizumab..., 305 N.Engl.J.Med. 552 (2004)	Jun 16, 2023	EXHIBIT	PETITIONER
Hill, Abstract #2823...104 Blood 772a (2004)	Jun 16, 2023	EXHIBIT	PETITIONER
Hill, Sustained response..., 106 Blood 2559 (2005)	Jun 16, 2023	EXHIBIT	PETITIONER
Hillmen, The Complement Inhibitor..., 355 N.Engl.J.Med, 1233 (2006)	Jun 16, 2023	EXHIBIT	PETITIONER
Young, Abstract # 971...., 108 Blood 290a (2006)	Jun 16, 2023	EXHIBIT	PETITIONER
Hillmen, Abstract #154..., 100 Blood 44a (2002)	Jun 16, 2023	EXHIBIT	PETITIONER
Hillmen, Abstract #1858...., 102 Blood 590a (2003)	Jun 16, 2023	EXHIBIT	PETITIONER
Excerpts from Recommended INN ..., 17 WHO Drug Info 115, WHO (2003)	Jun 16, 2023	EXHIBIT	PETITIONER
Guidelines...INN..., Div. Drug Management & Policies, WHO, Geneva (1997)	Jun 16, 2023	EXHIBIT	PETITIONER
Alexion Press Rel., Alexion Issued Key C5....(Mar. 15, 2002)	Jun 16, 2023	EXHIBIT	PETITIONER
WO 2005/007809 A2 issued to Russell P. Rother, et al.	Jun 16, 2023	EXHIBIT	PETITIONER
WO 2005/110481 A2 issued to Russell P. Rother, et al.	Jun 16, 2023	EXHIBIT	PETITIONER
Kaplan, Eculizumab Alexion, 3 Curr. Opin. Investig. Drugs 1017 (2002)	Jun 16, 2023	EXHIBIT	PETITIONER
Amgen v. Alexion, IPR2019-00739, #15, Decision - Inst of IPR 8/30/2019	Jun 16, 2023	EXHIBIT	PETITIONER
Amgen v. Alexion, IPR2019-00739, #22, PO Response 11/22/2019	Jun 16, 2023	EXHIBIT	PETITIONER
Amgen v. Alexion, IPR2019-00739, #48, Termination 6/1/2020	Jun 16, 2023	EXHIBIT	PETITIONER
Opposition File History for EP 1 720 571 B1	Jun 16, 2023	EXHIBIT	PETITIONER
File History for P 3 167 888	Jun 16, 2023	EXHIBIT	PETITIONER
Excerpt from File History of US Pat Appl 11/127,438 - Amdmt to Resp 8/2/11	Jun 16, 2023	EXHIBIT	PETITIONER
Appl. for Extension of Patent Term US Pat 6,355,245	Jun 16, 2023	EXHIBIT	PETITIONER
Certificate Extending Patent Term, US Pat No. 6,355,245 6/11/2010	Jun 16, 2023	EXHIBIT	PETITIONER
Yoo, Human IgG2...170 J. Immunol. 3134 (2003)	Jun 16, 2023	EXHIBIT	PETITIONER
Wypych, Human IgG2....283 J. Biol. Chem. 16194 (2008)	Jun 16, 2023	EXHIBIT	PETITIONER
Bournazos, Fc-optimized antibodies..., 588 Nature 485 (2020)	Jun 16, 2023	EXHIBIT	PETITIONER
Bournazos, Human IgG Fc domain...124 J. Clinical Investigation 725 (2014)	Jun 16, 2023	EXHIBIT	PETITIONER
Baudino, Impact of a Three Amino..., 181 J. Immunology 4107 (2008)	Jun 16, 2023	EXHIBIT	PETITIONER
Takai, FcR Y Chain Deletion...., 76 Cell 519 (1994)	Jun 16, 2023	EXHIBIT	PETITIONER
Nimmerjahn, Fcy receptors...., 8 Nat. Rev. Immunol. 34 (2008)	Jun 16, 2023	EXHIBIT	PETITIONER
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US Pat Appl Publ No. 2005/0271660 A1 issued to Yi Wang	Jun 16, 2023	EXHIBIT	PETITIONER
Janeway, Chapter 1...Chapter 3, Immunobio: .. 1-34, 93-122 (5th ed. 2001)	Jun 16, 2023	EXHIBIT	PETITIONER
Excerpts from Juo, Concise Dict. Biomed & Molecular Biol (2d ed. 2001)	Jun 16, 2023	EXHIBIT	PETITIONER
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Alberts, Chapter 12....Molecular Bio of the Cell, pp. 551-98 (1994)	Jun 16, 2023	EXHIBIT	PETITIONER
Adderson, Immunoglobulin Light Chain...89 J. Clin. Invest. 729 (1992)	Jun 16, 2023	EXHIBIT	PETITIONER
Genentech, Avastin 2004 Package Insert	Jun 16, 2023	EXHIBIT	PETITIONER
Millenniumm, Campath 2001 Package Insert	Jun 16, 2023	EXHIBIT	PETITIONER
ImClone Systems, Inc., Erbitux 2004 Package Insert	Jun 16, 2023	EXHIBIT	PETITIONER
Genentech, Herceptin 1998 Package Insert	Jun 16, 2023	EXHIBIT	PETITIONER
Centocor, Remicade 1998 Package Insert	Jun 16, 2023	EXHIBIT	PETITIONER
Genentech, Rituxan 1997 Package Insert	Jun 16, 2023	EXHIBIT	PETITIONER
Daugherty, Formulation and delivery...58 Adv. Drug Delivery Rev. 686 (2006)	Jun 16, 2023	EXHIBIT	PETITIONER
Declaration of Cindy Ippoliti, Pharm.D.	Jun 16, 2023	EXHIBIT	PETITIONER
Note for Guidance on Excipients, Antioxidants and Antimicrobial...(2003)	Jun 16, 2023	EXHIBIT	PETITIONER
Excerpt from File History Pat. No. 9,718,880, Resp to NonFinal 5/12/2017	Jun 16, 2023	EXHIBIT	PETITIONER