Case 1:22-cv-00061-TSK-JPM Document 576-1 Filed 07/07/23 Page 1 of 5 PageID #:
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`APPENDIX TO DEFENDANTS’
`OPENING POST TRIAL BRIEF
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`Case 1:22-cv-00061-TSK-JPM Document 576-1 Filed 07/07/23 Page 2 of 5 PageID #:
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`APPENDIX OF EXHIBITS
`
`Description
`Exhibit
`DTX 0007 Certified U.S. Patent No. 7,070,959
`DTX 0013 Certified U.S. Patent No. 10,406,226
`DTX 0019 Certified U.S. Patent No. 10,973,879
`DTX 0204
`James A. Dixon et al., VEGF Trap-Eye for the treatment of neovascular age-
`related macular degeneration, 18(10) Expert Opinion on Investigational Drugs
`1573 (2009)
`2004-01-30 Cedarbaum email re VEGF Trap AMD Press Release
`DTX 0207
`2005-03-03 Simitchieva email re Release of results AVASTIN in WET AMD
`DTX 0210
`2006-03-21 Cedarbaum email re Final ASRS 0508 Abstract
`DTX 0216
`2006-05-09 Cedarbaum email re Rosnfeld’s Lucentis PRONTO press release
`DTX 0218
`2007-08-12 Ingerman email re NCT00509795.htm
`DTX 0231
`DTX 0232 CLEAR-IT 2: Interim Results Poster
`DTX 0234
`2007-05-07 Poole email to Yancopoulos re ARVO, with attachments
`DTX 0710
`2004-03-01 Email from J. Cedarbaum re Extra-ocular delivery of Lucentis
`DTX 0711
`2004-12-08 Email from N. Dugrenier re FW: Specification for Intravitreal
`VEGF trap.
`2005-01-27 Email from N. Stahl re Lucentis-itv pk
`DTX 0714
`2005-04-12 Email from E. Furfine re FW: avastatin amea discussion.pdf
`DTX 0716
`2005-08-18 Email from K. Frye re Avastatin & Macugen formulations
`DTX 0718
`2006-03-21 Email from K. DeWald re FW: Sucrose VGT formulation help
`DTX 0722
`2006-05-08 Email from K. Graham re VEGF Trap formulations for ITV
`DTX 0725
`DTX 0726 U.S. Patent Application WO 2006/047325 A1
`DTX 0728 Christine Wulff et al., Prevention of Thecal Angiogenesis, Antral Follicular
`Growth, and Ovulation in the Primate by Treatment with Vascular Endothelial
`Growth Factor Trap R1R2, 143(7) Endocrinology 2797 (2002)
`DTX 0729 Hamish M. Fraser et al., Single Injections of Vascular Endothelial Growth
`Factor Trap Block Ovulation in the Macaque and Produce a Prolonged, Dose-
`Related Suppression of Ovarian Function, 90(2) Journal of Clinical
`Endocrinology & Metabolism 1114 (2005)
`DTX 0730 US Patent Application Publication No. US 2004/0197324 A1
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`DTX 0900
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`DTX 0917
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`DTX 2035
`
`2023-01-12 Regeneron Pharmaceuticals, Inc.’s Objections and Responses to
`Defendant’s First Set of Interrogatories (Nos. 1-17)
`2010-11-22 Email from news desk re Bayer and Regeneron Report Positive
`Top-Line Results of Two Phase 3 Studies with VEGF Trap-Eye in Wet Age-
`related Macular Degeneration
`“Ongoing Treatment for Patients with Neovascular AMD”, Retinal Physician
`Article (2007-10-01)
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`1
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`Case 1:22-cv-00061-TSK-JPM Document 576-1 Filed 07/07/23 Page 3 of 5 PageID #:
`44635
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`Description
`Exhibit
`PAT Survey Policies and Guidelines, dated 2010
`DTX 2040
`DTX 2062 U.S. Patent No. 7,374,758, dated 05-20-2008
`DTX 2264 Avery et al., "Intravitreal Bevacizumab (Avastin) for Neovascular Age-
`Related Macular Degeneration", Ophtal 113(3):363-372 (2006)
`DTX 2265 Gaudreault et al., "Preclinical Pharmacokinetics of Ranibizumab (rhuFabV2)
`after a Single Intravitreal Administration", Inv. Ophthal & Vis. Sci. 46(2):726-
`733 (2005)
`DTX 2730 U.S. Patent No. 7,303,747
`DTX 2733 Geeta A. Lalwani et al., Anti-VEGF Therapy in Diabetic Macular Edema: An
`Overview of New Agents Under Investigation, RETINA TODAY 45 (Sept.
`2009)
`Saishin paper
`DTX 2751
`Lucentis Label 2006
`DTX 3040
`DTX 3058 Rosenfeld 2005
`DTX 3102 Do 2009
`DTX 3198 Regeneron Press Release Enrollment Completed in Regeneron and Bayer
`HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related
`Macular Degeneration (Wet AMD)
`Eylea Label 11-2011
`DTX 3316
`959 Patent Petition for Patent Term Extension
`DTX 3501
`DTX 3510 Avastin PI
`DTX 3549 Holash, VEGF-Trap: A VEGF blocker with potent antitumor effects dated
`7/2/02 (received for review 4/19/02) (also admitted into evidence as DTX
`2745)
`DTX 3588 Remington Vol 2 (ophthalmic solutions) 1995 (Hecht)
`DTX 3592 Rudge
`DTX 3610 US Publication 2003 0113316A1 Kaisheva I
`DTX 3619 WO 2000 075319A1 Papadopoulos
`DTX 4008 Adis R&D Profile, Aflibercept: AVE 0005, AVE 005, AVE0005, VEGF Trap
`– Regeneron, VEGF Trap (R1R2), VEGF Trap-Eye, 9 Drugs R&D 261 (2008)
`(“Adis”)
`Ziad F. Bashshur et al., Intravitreal Bevacizumab for Treatment of
`Neovascular Age-related Macular Degeneration: A One-year Prospective
`Study, 145 Am. J. Ophthalmology 249 (2008)
`DTX 4041 Napoleone Ferrara & Robert S. Kerbel, Angiogenesis as a Therapeutic Target,
`438 Nature 967 (2005)
`DTX 4116 U.S. Patent No. 7,306,799
`DTX 4120 U.S. Patent No. 7,531,173
`DTX 4121 U.S. Patent Application Publication No. 2006/0217311 A1 (“Dix”)
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`DTX 4013
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`2
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`Case 1:22-cv-00061-TSK-JPM Document 576-1 Filed 07/07/23 Page 4 of 5 PageID #:
`44636
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`DTX 4986
`
`Description
`Exhibit
`DTX 4135 Mylan Pharms. Inc. v. Regeneron Pharms., Inc., IPR2021-00881 (P.T.A.B),
`Paper 94 (Nov. 9, 2022) (“FWD”)
`DTX 4229 U.S. Patent Application Publication No. US2005/0175610 A1
`DTX 4900 U.S. Patent No. 7,303,746
`DTX 4903 U.S. Patent No. 7,374,757
`DTX 4956 Regeneron Pharmaceuticals, Inc. Form 10-K for the year ended December 31,
`2004
`DTX 4957 Regeneron Pharmaceuticals, Inc. Form 10-K for the year ended December 31,
`2005
`Second Amendment to Collaboration Agreement, dated 1/7/05, available at
`https://www.sec.gov/Archives/edgar/ data/872589/
`000095012305000248/y04663exv10w1.htm
`DTX 5036 REMICADE® Label
`DTX 5037 XOLAIR® Label
`DTX 5038 RAPTIVA® Label
`DTX 5040 HERCEPTIN® Label
`DTX 5073 BLA No. 125387, 2.7.1 Summary of Biopharmaceutic Studies and Associate
`Analytical Methods
`Internal Regeneron R&D document
`DTX 5385
`DTX 5429 Ruti Sella et al., Subconjunctival Aflibercept for the Treatment of Formed
`Corneal Neovascularization, 47(7) Eye & Contact Lens 180 (2021)
`DTX 5430 Abtin Shahlaee et al., Translational and Clinical Advancements in
`Management of Proliferative Vitreoretinopathy, 33(3) Current Opinion in
`Ophthalmology 219 (2022)
`Toktam Shahraki et al., Pterygium: An Update on Pathophysiology, Clinical
`Features, and Management, 13 Therapeutic Advances in Ophthalmology 1
`(2021)
`DTX 8180 Heier et al., “The 1‐year Results of CLEAR‐IT 2, a Phase 2 Study of Vascular
`Endothelial Growth Factor Trap‐Eye Dosed As‐needed After 12‐week Fixed
`Dosing”, Am. Acad. Ophthal. 118(6): 1098‐1106
`Provisional application No. 60/665,125 (“Dix Provisional”)
`DTX 8194
`DTX 8206 United States Patent Application Publication No. US20050163798A1
`DTX 8207 United States Patent Application Publication No. US20050245447A1
`DTX 8208 United States Patent Application Publication No. US20050260203A1
`DTX 8209 United States Patent Application Publication No. US20060030529A1
`DTX 9006 Aflibercept: Drugs of the Future
`DTX 9030
`Subconjunctival Bevacizumab Immediately After Excision of Primary
`Pterygium: The First Clinical Trial
`Prevention of Recurrent Ptergium with Topical Bevacizumab 0.05% Eye
`Drops
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`DTX 5431
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`DTX 9031
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`3
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`Case 1:22-cv-00061-TSK-JPM Document 576-1 Filed 07/07/23 Page 5 of 5 PageID #:
`44637
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`DTX 9033
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`DTX 9035
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`DTX 9036
`
`Description
`Exhibit
`DTX 9032 A comparative study of different concentrations of topical bevacizumab on the
`recurrence rate of excised primary pterygium: a short-term follow-up study
`Efficacy of Intravitreal Injection of Bevacizumab in Vitrectomy for Patients
`with Proliferative Vitreoretinopathy Retinal Detachment
`Intrasilicone oil injection of bevacizumab at the end of retinal reattachment
`surgery for severe proliferative vitreoretinopathy
`"Intravitreal Bevacizumab (Avastin) for Neovascular Age-Related Macular
`Degeneration" by Dr. Avery (With Date Stamp)
`Ziv-Aflibercept as a Possible Alternative to Aflibercept by Chang, J.S., et al.,
`DTX 9038
`PTX-0001 Certified U.S. Patent No. 10,888,601
`PTX-0002 Certified U.S. Patent No. 11,084,865
`PTX-0003 Certified U.S. Patent No. 11,253,572
`PTX-1758
`PCT Patent Publication No WO2005/102303
`PTX-1825 Amendment 7 0 to Stability Study Protocol VGFT-SS207
`PTX-1832 Chang 2002 - Chang et al, Practical Approaches to Protein Formulation
`Development, in Rational Design of Stable Protein Formulations 1, 14 (J F
`Carpenter & M C Manning eds, 2002)
`International Journal of Retina and Vitreous
`
`PTX-3348
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`4
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