Celltrion, Inc. vs Regeneron Pharmaceuticals, Inc.

Director Discretionary Decision: Deny

Patent Owner’s Surreply in Support of Preliminary Patent Owner Response

Celltrion’s Motion to Dismiss for Lack of Personal Jurisdiction, or Alternatively, to Transfer Venue, 23-cv-89, Dkt. 68 (N.D.W. Va. Jan. 17, 2024)

Petitioner’s Surreply to Patent Owner’s Discretionary Denial Reply

Patent Owner's Discretionary Denial Reply

Petitioner's Reply to Patent Owner Preliminary Response

Email Correspondence

Patent Owner's Preliminary Response

Regeneron Pharmaceuticals, Inc.’s Memorandum in Support of its Motion for Alternative Service, Dkt. 43-1 (N.D.W. Va.)

Defendant Celltrion, Inc.’s Response to Plaintiff’s Motion For Alternative Service, Dkt. 52 (N.D.W. Va.)

Order Setting Briefing Schedule on Motions to Dismiss and Setting Schedule for Preliminary Injunction Proceedings, Dkt. 61 (N.D.W. VA.)

Order Granting Motions for Alternative Service, Dkt. 219 (N.D.W. Va.)

Summons, Proof of Service of Complaint, Dkt. 223 (N.D.W. Va.)

Returned Summons, Dkt. 224 (N.D.W. Va.)

Regeneron v. Mylan, 22-cv-61, Trial Transcript (Public Excerpts) (N.D.W. Va.)

J.L. Fast et al., Physical Instability of a Therapeutic Fc Fusion Protein: Domain Contributions to Conformational and Colloidal Stability, 48 Biochem. 11724 (2009)

Appellant Celltrion's Reply Brief, Dkt. 33 (Fed. Cir.)

EX1050 - Summons in a Civil Action, Regeneron Pharmaceuticals, Inc. v. Celltrion, No. 1:23-CV-89 (N.D.W.Va. 2023)

EX1051 - Petitioner’s Reply to Patent Owner’s Preliminary Response, Samsung Bioepis Co., Ltd., v. Regeneron Pharmaceuticals, Inc., IPR2025-00176 (Apr. 23, 2025)

EX1052 - Reply to Patent Owner’s Preliminary Response, Formycon AG, v. Regeneron Pharmaceuticals, Inc., IPR2025-00233 (Apr. 23, 2025)

EX1053 - Decision, Adverse Judgment After Institution of Trial, Celltrion Inc. v. Regeneron Pharmaceuticals, Inc., IPR2023-00462 (Feb. 21, 2024)

EX1054 - Stipulation and Order Vacating Permanent Preliminary Injunction, In re: Aflibercept Patent Litigation, No. 1:24-MD-3103-TSK (N.D.W.Va. 2025)

EX1055 - Exhibit 1122 (Email from Williams & Connolly LLP Regarding Alvotech), Formycon AG, v. Regeneron Pharmaceuticals, Inc., IPR2025-00233 (Apr. 18, 2025)

EX1056 - Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First, Federal Register (Apr. 15, 2025), https://www.federalregister.gov/documents/2025/04/18/2025-06837/lowering-drug-prices-by-once-again-putting-americans-first

EX1057 - Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices, The White House (Apr. 15, 2025), https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-announces-actions-to-lower-prescription-drug-prices/

EX1058 - Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices, The White House (Apr. 15, 2025), https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-announces-actions-to-lower-prescription-drug-prices

EX1059 - Klobuchar, Grassley Introduce Bipartisan Bills to Reduce Drug Prices by Promoting Competition and Taking on Big Pharma, United States Senator Amy Klobuchar (Mar. 26, 2025), https://www.klobuchar.senate.gov/public/index.cfm/2025/3/klobuchar-grassley-introduce-bipartisan-bills-to-reduce-drug-prices-by-promoting-competition-and-taking-on-big-pharma

EX1060 - Senate Judiciary Committee Advances Grassley-Led Bills to Lower Prescription Drug Prices, U.S. Senate Committee on the Judiciary (Apr. 3, 2025), https://www.judiciary.senate.gov/press/rep/releases/ senate-judiciary-committee-advances-grassley-led-bills-to-lower-prescription -drug-prices

EX1061 - The U.S. Generic & Biosimilar Medicines Savings Report, Association for Accessible Medicines (Sept. 2024).

EX1062 - Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, The White House (May 12, 2025), https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients

EX1063 - Nonconfidential Opening Brief for Defendant-Appellant Samsung Bioepis Co., Ltd., Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, No. 24-1965 (Fed. Cir. July 17, 2024)

Petitioner's Opposition to Patent Owner's Discretionary Denial Brief

Notice: Extending Deadline for Discretion Briefing

Patent Owner's Discretionary Denial Brief

Mylan Redacted Trial Decision, 22-cv-61, Dkt. 692 (N.D.W. Va.)

SB Redacted PI Decision, 24-md-3103, Dkt. 194 (N.D.W. Va.)

Formycon Redacted PI Decision, 24-md-3103, Dkt. 247 (N.D.W. Va.)

Celltrion Redacted PI Decision, 24-md-3103, Dkt. 248 (N.D.W. Va.)

SB Appeal Decision, 24-1965, Dkt. 76 (Fed. Cir.)

Formycon Appeal Decision, 24-2009, Dkt. 67 (Fed. Cir.)

Celltrion Appeal Decision, 24-2058, Dkt. 62 (Fed. Cir.)

Exhibit A, Samsung Bioepis’s Proposed Schedule, 24-md-3103, Dkt. 478-1 (N.D.W. Va.)

Regeneron Pharmaceuticals, Inc.’s Response to Defendant Samsung Bioepis Co., Ltd.’s Motion for Entry of Scheduling Order Pursuant to Rule 16 or, in the Alternative, a Status Conference, 24-md-3103, Dkt. 483 (N.D.W. Va.)

Celltrion’s Opening Appeal Brief, 24-2058, Dkt. 25 (Fed. Cir.)

Celltrion’s Reply in Support of Celltrion’s Motion for Status Conference, 24-md-3103, Dkt. 504 (Fed. Cir.)

Celltrion’s Redacted Brief in Opposition to Regeneron’s Preliminary Injunction Motion, 23-cv-89, Dkt. 142-3 (N.D.W. Va.)

Notice: Notice filing date accorded

Notice: Power of Attorney

Notice: Mandatory Notice

EX1001 - US 11,084,865 B2

EX1002 - Tessier Declaration

EX1003 - Tessier CV

EX1004 - Furfine (U.S. Publication No. 2007_0293432A1)

EX1005 - Sigl (WO2017129685A1)

EX1006 - 16_739559 File History (Full)

EX1007 - 16_582486 File History (Full)

EX1008 - 16_159269 File History (Full)

EX1009 - 15_879294 File HIstory (Excerpts)

EX1010 - 15_095606 File History (Excerpts)

EX1011 - 14_330096 File History (Excerpts)

EX1012 - 13_914996 File History (Excerpts)

EX1013 - 13_329770 File History (Excerpts)

EX1014 - 12_933417 File History (Full)

EX1015 - 12_560885 File History (Excerpts)

EX1016 - 11_818463 File History (Excerpts)

EX1017 - Wulff (2002)

EX1018 - Kerwin (WO2018094316A1)

EX1019 - Eylea November 2011 PI (PI2011)

EX1020 - Andya (2003)

EX1021 - IPR2023-00462-2047 (Klibanov Decl POR)

EX1022 - Liu (U.S. Publication No. 2004_0197324A1)

EX1023 - Kostanski (2004)

EX1024 - Opinion in Regeneron v. Mylan (122-CV-61 (N.D. WV))

EX1025 - Furfine (U.S. Provisional 60_814484)

EX1026 - IPR2023-00462 Paper 24 (PO Response)

EX1027 - IPR2023-00462-2001 (Klibanov Decl. POPR)

EX1028 - Holash (2002)

EX1029 - Papadopoulos (WO0075319A1)

EX1030 - Ferrara (2005)

EX1031 - Liu (2015)

EX1032 - Jefferis (2005)

EX1033 - Krapp (2003)

EX1034 - Mimura (2001)

EX1037 - Panka (1997)

EX1038 - Chang (2002)

EX1039 - Parkins (2000)

EX1040 - Mimura (2000)

EX1041 - Mahler (2005)

EX1042 - Andersen (1990)

EX1043 - Daly (U.S. Publication No. 2006_0058234)

EX1044 - Wiegand (U.S. Publication No. 2005_0175610)

EX1045 - Yumioka (2009)

EX1046 - Ejima (2005)

EX1047 - Gandhi (2017)

EX1048 - Regeneron Response Brief

EX1049 - Testimony of K. Graham in 122-cv-61

Notice: Power of Attorney

Petition: as filed