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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
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`EVERGREEN THERAGNOSTICS, INC.
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`Petitioner
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`– vs. –
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`ADVANCED ACCELERATOR APPLICATIONS SA
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`Patent Owner
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`____________________
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`CASE NO. PGR2021-00001
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`PETITIONER EVERGREEN THERAGNOSTICS, INC.’S
`UPDATED LIST OF EXHIBITS
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`LIST OF EXHIBITS
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`Exhibit
`1001
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`Number Not Used
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`Description
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`U.S. Patent No. 10,596,278 (“the ’278 patent”)
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`Number Not Used
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`Prosecution History of U.S. Patent No. 10,596,278 (Application
`Serial No. 16/175,239) (“the ’239 application”)
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`Number Not Used
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`Declaration of Stephan Maus Under 37 C.F.R. § 1.68 in Support of
`Petition for Post Grant Review of U.S. Patent No. 10,596,278 (All
`Claims)
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`Number Not Used
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`Expert Declaration of Ingrid Hsieh-Yee, Ph.D. Under 37 C.F.R.
`§ 1.68 (“Hsieh-Yee Declaration”)
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`S. Maus, et al., Aspects on radiolabeling of 177Lu-DOTA-TATE: After
`C18 purification re-addition of ascorbic acid is required to maintain
`radiochemical purity, Int. J. Diagnostic Imaging, 1(1):5-12, 2014
`(“the Maus article”)
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`D. Kwekkeboom et al., [177Lu-DOTA0,Tyr3]octreotate: comparison
`with [111In-DTPA0]octreotide in patients, Eur. J. Nucl. Med.,
`28(9):1319-1325, Sept. 2001 ( “Kwekkeboom”)
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`J. Strosberg et al., Phase 3 Trial of 177Lu-Dotatate for Midgut
`Neuroendocrine Tumors, N. Engl. J. Med., 376(2):125–135, Jan. 12,
`2017 (“Strosberg”)
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`1012
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`Protocol associated with Strosberg (Ex. 1011) providing the protocol
`used in the clinical study reported in Strosberg (“Protocol”)
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`2
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`1013
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`1014
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`1015
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`1016
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`1017
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`U.S. Patent No. 6,261,536 (“the ’536 patent”)
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`L. De León-Rodríguez et al., The Synthesis and Chelation Chemistry
`of DOTA−Peptide Conjugates, Bioconjugate Chem., 19(2):391-402,
`Feb. 2008 (“De León-Rodríguez”)
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`Number Not Used
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`S. Banerjee et al., Lutetium-177 Therapeutic Radiopharmaceuticals:
`Linking Chemistry, Radiochemistry, and Practical Applications,
`Chem. Rev., 115:2934−2974, 2015 (“Banerjee”)
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`E. de Blois et al., Application of single-vial ready-for-use formulation
`of 111In- or 177Lu-labelled somatostatin analogs, Applied Radiation
`and Isotopes, 85:28-33, 2014 (“de Blois”)
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`1018
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`United States Security and Exchange Commission Form F-1 for
`Advanced Accelerator Applications S.A., 2014 (“SEC Statement”)
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`1019
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`Number Not Used
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`1020 W. Breeman et al., Optimising conditions for radiolabelling of
`DOTA-peptides with 90Y, 111In and 177Lu at high specific activities,
`Eur. J, Nuc. Med. and Molecular Imaging, 30(6):917-920, June 2003
`(“Breeman 2003”)
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`1021
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`1022
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`T. Das et al., Formulation of Patient Dose of 177Lu-DOTA-TATE in
`Hospital Radiopharmacy in India: Preparation Using In Situ
`Methodology Vis-a-Vis Freeze-Dried Kit, Cancer Biotherapy and
`Radiopharmaceuticals, 29(7):301-302, 2014 (“Das 1”)
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`T. Das et al., Preparation of DOTA-TATE and DOTA-NOC freeze-
`dried kits for formulation of patient doses of 177Lu-labeled agents and
`their comparison for peptide receptor radionuclide therapy
`application, J. Radioanal. Nucl. Chem., 299:1389-1398, 2014 (“Das
`2”)
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`1023
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`S. Liu et al., Stabilization of 90Y-Labeled DOTA-Biomolecule
`Conjugates Using Gentisic Acid and Ascorbic Acid, Bioconjugate
`Chem., 12:554-558, 2001 (“Liu”)
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`3
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`1024
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`Number Not Used
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`1025 M. Luna-Gutiérrez et al., Freeze-dried multi-dose kits for the fast
`preparation of 177Lu-Tyr3-octreotide and 177Lu-PSMA(inhibitor)
`under GMP conditions, J. Radioanal. Nucl. Chem., pp. 2181-2188,
`published on-line Nov. 2, 2017 (“Luna-Gutierrez”)
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`1026
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`J. Sosabowski et al., Conjugation of DOTA-like chelating agents to
`peptides and radiolabeling with trivalent metallic isotopes, Nature
`Protocols, 1(2):972-976, 2006 (“Sosabowski”)
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`1027 W. Breeman et al., Overview of Development and Formulation of
`177Lu-DOTA-TATE for PRRT, Current Radiopharmaceuticals, 9:8-18,
`2016 (“Breeman 2016”)
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`1028
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`1029
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`1030
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`1031
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`1032
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`A. Filice et al., Radiolabeled Somatostatin Analogues Therapy in
`Advanced Neuroendocrine Tumors: A Single Centre Experience, J.
`Oncology, 2012:1-10, Aug. 9, 2012 (“Filice”)
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`Number Not Used
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`Guidance for Industry, Q1A(R2) Stability Testing of New Drug
`Substances and Products, U.S. Department of Health and Human
`Services, Food and Drug Administration, Center for Drug Evaluation
`and Research (CDER), Center for Biologics Evaluation and Research
`(CBER), Nov. 2003 (“FDA Guidance”)
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`T. Das et al., On the preparation of a therapeutic dose of 177Lu-
`labeled DOTA–TATE using indigenously produced 177Lu in medium
`flux reactor, Applied Radiation and Isotopes, 65:301-308, 2007 (“Das
`3”)
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`A. Aslani et al., Lutetium-177 DOTATATE Production with an
`Automated Radio-pharmaceutical Synthesis System, Asia Oceania J.
`Nucl. Med. Biol., 3(2):107-115, 2015 (“Aslani”)
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`1033 W. Lambert, Considerations in Developing a Target Product Profile
`for Parenteral Pharmaceutical Products, AAPS Pharm. Sci. Tech.,
`11(3):1476-1481, Sept. 2010 (“Lambert”)
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`4
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`1034
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`Number Not Used
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`1035 W. Breeman et al., The addition of DTPA to [177Lu-DOTA0,
`Tyr3]octreotate prior to administration reduces rat skeleton uptake of
`radioactivity, Eur. J. Nucl. Med. Mol. Imaging, 30(2):312-315, Feb.
`2003 (“Breeman 2003B”)
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`1036
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`A. Frilling et al., Treatment with 90Y- and 177Lu-DOTATOC in
`patients with metastatic neuroendocrine tumors, Surgery,140(6):968-
`977, 2006 (“Frilling”)
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`1037
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`Declaration of Paul E. Dietz, Ph.D., Esq. in Support of Reply to
`Patent Owner’s Preliminary Response, with Exhibits A, B, and C
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`5
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`CERTIFICATE OF SERVICE
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner Evergreen Theragnostics, Inc.’s Updated List of Exhibits by
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`email on this 22nd day of February, 2021 on the following attorneys of record:
`
`Jane M. Love, Ph.D.
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue
`New York, NY 10166
`jlove@gibsondunn.com
`
`Kyanna Sabanoglu
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Ave
`New York, NY 10166
`ksabanoglu@gibsondunn.com
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`Respectfully submitted,
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`February 22, 2021
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`/C. Kyle Musgrove/
`C. Kyle Musgrove
`Registration No. 40,742
`Attorney for Evergreen Theragnostics, Inc.
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