Formycon AG vs Regeneron Pharmaceuticals, Inc.

Notice: refund approved

Petitioner’s Request for Refund

EXPUNGED

Institution Decision: Deny

PATENT OWNER’S SURREPLY IN SUPPORT OF PRELIMINARY RESPONSE

YESAFILI Label

Email from D. Berl to District Court

Formycon’s Reply ISO Its Motion to Partially Adopt SB’s Motion, 24-md-3103, Dkt. 502 (N.D.W. Va.)

Executed Summons Returned in Regeneron Pharmaceuticals, Inc. v. Formycon AG, Civil Action No., 1:23-CV-97

Minute entry for proceedings held before Chief District Judge Kleeh, scheduling conference held on 5/17/2024

Defendants' Motion For Status Conference In Re Aflibercept Patent Litigation

Samsung Bioepis Co., Ltd's Motion for Entry of Scheduling Order Pursuant to Rule 16

Formycon AG's Motion to Partially Adopt and Join Samsung Bioepis's Motion for Entry of Scheduling Order

Celltrion's Motion for Status Conference and Notice of Partial Adoption and Joinder of Samsung Bioepis's Scheduling Motion

Email from Arthur Argall to Louis Fogel

Lex Machina, Timing metrics for Federal District Court Cases for Judge Thomas Shawn Kleeh

Lex Machina, Timing metrics for Federal District Court Cases in ND.W.Va.

Stipulation and Order Vacating Permanent Injunction Previously Issued

Transcript from Oral Argument in Regeneron Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc.

Celltrion v. Regeneron Pharmaceuticals IPR2023-00462, Decision Granting Institution of IPR, Paper 11

Petitioner's Reply to Patent Owner's Preliminary Response to Address Discretionary Denial

Conduct of the Proceeding Granting Request for Additional Briefing 37 C.F.R. § 42.5

Exhibit 3001

Regeneron's Preliminary Patent Owner Response (IPR2025-00233)

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, 24-md-3103, Dkt. 483 (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 (2009)

Regeneron v. Mylan, 22-cv-61, Trial Ex. DTX-3619A, Fusion Proteins Disclosed in Papadopoulos

D. Ghate & H.F. Edelhauser, Ocular Drug Delivery (2006)

T.L. Jackson et al., Human Retinal Molecular Weight Exclusion Limit and Estimate of Species Variation (2003)

N. Ferrara et al., Development of Ranibizumab, an Anti–Vascular Endothelial Growth Factor Antigen Binding Fragment, as Therapy for Neovascular Age-Related Macular Degeneration (2006)

A.M. Sinclair & S. Elliott, Glycoengineering: The Effect of Glycosylation on the Properties of Therapeutic Proteins (2005)

J.A. Marinaro et al., O-glycosylation Delays the Clearance of Human IGF-Binding Protein-6 from the Circulation (2000)

R.L. Shields et al., High Resolution Mapping of the Binding Site on Human IgG1 for FcγRI, FcγRII, FcγRIII, and FcRn and Design of IgG1 Variants with Improved Binding to the FcγR* (2001)

WO 2006/047325

W. Wang, Protein Aggregation and Its Inhibition in Biopharmaceutics (2005)

W. Wang, Instability, Stabilization, and Formulation of Liquid Protein Pharmaceuticals (1999)

P.J. Rosenfeld et al., Maximum Tolerated Dose of a Humanized Anti–Vascular Endothelial Growth Factor Antibody Fragment for Treating Neovascular Age-Related Macular Degeneration (2005)

Stedmans Medical Dictionary 265360

Declaration of Kenneth S. Graham, dated April 18, 2024

U.S. Patent Application Publication No. 2001/0014326

U.S. Patent Application Publication No. 2003/0113316

FDA Guidance for Industry, Stability Testing

Thomas et al., Comparative Effectiveness of Aflibercept for the Treatment of Patients with Neovascular Age-Related Macular Degeneration (2013)

N. Ferrara et al., Discovery and Development of Bevacizumab, an Anti-VEGF Antibody for Treating Cancer (2004)

AHZANTIVE(R) Label

Eylea® Label

Petitioner's Reply in Support of Conditional Motion for Joinder

Petitioner's Updated Mandatory Notices

Response to Petitioner's Conditional Motion for Joinder

Notice: Mandatory Notice

Notice: Power of Attorney

Notice: Notice filing date accorded

U.S. Patent No. 11,084,865 (“’865 Patent”)

File History of U.S. Application No. 16/739,559

Ferrara & Kerbel, Angiogenesis as a Therapeutic Target (“Ferrara 2005”)

Fraser, Single Injections of Vascular Endothelial Growth Factor ("Fraser")

Holash, VEGF-Trap: A VEGF Blocker with Potent Antitumor Effects (“Holash”)

February 3, 2006 Angiogenesis Presentation

February 8, 2006 Merrill Lynch Presentation

March 8, 2006 Lehman Brothers Presentation

Press Release, VEGF trap oncology program with Sanofi-Aventis

Rudge, VEGF Trap as a Novel Antiangiogenic Treatment (“Rudge”)

Wulff, Prevention of Thecal Angiogenesis (“Wulff”)

Press Release, Regeneron’s VEGF trap demonstrates positive preliminary

Chang, Practical Approaches to Protein Formulation Development (Chang 2002)

U.S. Patent No. 7,374,758 to Papadopoulos et al. (“’758 Patent”)

Nayar, High throughput formulation: strategies for rapid dev (“Nayar”)

U.S. Patent No. 8,110,546 to Dix et al. (“Dix”)

September 27, 2005 UBS Global Life Sciences Conference Presentation

U.S. Patent Publication No. 2003/0113316 to Kaisheva et al.

U.S. Patent Publication No. 2003/0138417 to Kaisheva et al.

U.S. Patent Publication No. 2004/0197324 to Liu et al. (“Liu”)

U.S. Patent Publication No. 2004/0265309 to Kandel et al.

U.S. Patent Publication No. 2005/0112061 to Holash et al.

International Publication No. WO 00/75319 to Papadopoulos et al.

International Publication No. WO 97/04801 to Andya et al.

Merriam Webster Vial Definition

AVASTIN Label

RAPTIVA Label

REMICADE Label

SIMULECT Label

HERCEPTIN Label

XOLAIR Label

FDA Container Closure Guidance

US Patent Pub No 20060058234

Chirila (1998)

Neto 2023

Eldeeb 2017

Macugen Label

Vitravene Label

Vernon 2005

Jaffe 2006

Jaffe 2006 Rosenfeld 2006

Rosenfeld 2003

Costa 2006

Corderio 2006

Rosenfeld 2005

Bonni-Filho 2005

Gillies 2003

Eyetech Study

Hida 1986

Jonas 2003

Danis 2000

Young 2001

Jonas 2005

Gallemore

Kupperman I

Kuppermann II

Vitrase Label

Gaudreault 2005

Lucentis Label

Macugen Approval Letter

CATT Study

Oliveira 2001

Wang 2004

Tezel 1998

Tsui 2012

Sakuma 2005

Gandorfer 2004

Malik 2014

Application for Extension of Patent Term to US Patent No 7374758

US Patent Pub No 20040014667

US Patent Pub No 20050175610

Drickamer 1998

Kimura 1997

Baker 2001

Kobata 2000

Dwek 1995

Liu 2015

Jefferis 2005

’992 IPR POR

Ronin 1981

Imperiali 1995

Anguita 2021

Hart 1992

Jager 2004

Garcia-Valldecabres 2004

Andya 2003

Parkins 2000

Nov 22 OA Response

US Patent Pub No 20050281822

Garcia-Carmona 2003

Manning Declaration - IPR2021-00881

Sigma Polysorbate 20 Product Information

Ansel 2005

Cheng 2005

Illingworth 1981

Chan 1998

Hanna 2004

Oakton 2005

Regeneron Appeal Responsive Brief

McNally, Protein Formulation and Delivery, Drugs and the Pharmaceutical

Kenalog Label

Forrest Curriculum Vitae

Lefkowitz Declaration (“Lefkowitz”)

Lefkowitz Curriculum Vitae

Zhou Declaration (“Zhou”)

Zhou Curriculum Vitae

Petitioner's Conditional Motion for Joinder

Petition for IPR of US 11084865

Notice : Power of Attorney

Forrest Declaration (“Forrest”)