throbber
UNITED STATES PATENT AND TRADEMARK
`OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL
`BOARD
`
`APOTEX, INC.,
`Petitioner,
`v.
`CELGENE CORPORATION,
`Patent Owner.
`
`Case IPR2023-00512
`Patent 8,846,628
`
`PATENT OWNER’S UNOPPOSED MOTION FOR ADMISSION
`PRO HAC VICE OF NORA Q.E. PASSAMANECK
`
`

`

`IPR2023-00512
`Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`Statement of Precise Relief Requested
`Pursuant to 37 C.F.R. § 42.10(c), Patent Owner Bristol-Myers Squibb Co.
`
`
`I.
`
`requests that the Patent Trial and Appeal Board (the “Board”) admit Nora Q.E.
`
`Passamaneck pro hac vice in this proceeding, IPR2023-00512. The parties have
`
`conferred, and Petitioner does not oppose this motion.
`
`II.
`
`Statement of Facts Showing Good Cause for the Board to Recognize
`Counsel Pro Hac Vice During the Proceeding
`In accordance with 37 C.F.R. § 42.10(c), the Board may recognize counsel
`
`pro hac vice during a proceeding upon a showing of good cause, subject to the
`
`condition that lead counsel be a registered practitioner and to any other conditions
`
`the Board may impose. Section 42.10(c) indicates that, “where the lead counsel is a
`
`registered practitioner, a motion to appear pro hac vice by counsel who is not a
`
`registered practitioner may be granted upon a showing that counsel is an
`
`experienced litigating attorney and has an established familiarity with the subject
`
`matter at issue in the proceeding.” The facts here establish good cause for the
`
`Board to recognize Nora Q.E. Passamaneck pro hac vice in this proceeding.
`
`1.
`
`Lead counsel, Heather M. Petruzzi, is a registered practitioner.
`
`Backup counsel Laura Macro and Gabriel Rosanio are also registered practitioners.
`
`2.
`
`Nora Q.E. Passamaneck is an experienced attorney who has an
`
`established familiarity with the subject matter at issue in the proceeding.
`
`2
`
`

`

`IPR2023-00512
`Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`
`Accompanying this motion as Exhibit 2153 is the Declaration of Nora Q.E.
`
`Passamaneck in Support of this Motion for Admission Pro Hac Vice
`
`(“Passamaneck Decl.”). In her declaration, Ms. Passamaneck asserts:
`
`I am a member in good standing of the Bars of the Commonwealth of
`
`Massachusetts, State of New York, and State of Colorado. I am
`
`admitted to practice before the U.S. District Courts for the District of
`
`Colorado, District Court for the Eastern District of New York, and
`
`District Court for the Southern District of New York. I am also
`
`admitted to practice before the U.S. Court of Appeals for the Federal
`
`Circuit and the Tenth Circuit.
`
`Passamaneck Decl. ¶ 3 (Ex.2153). Ms. Passamaneck also demonstrates that she
`
`has a detailed working knowledge of the relevant subject matter through her
`
`familiarity with pharmaceutical technologies as a result of participation as counsel
`
`in related district court litigations on this patent as well as many prior
`
`pharmaceutical-related intellectual property cases on behalf of BMS/Celgene and
`
`other pharmaceutical companies. Passamaneck Decl. ¶ 5–6 (Ex.2153).
`
`3.
`
`In her declaration, Ms. Passamaneck also attests to each of the listed
`
`items required by the Order – Notice of Filing Date Accorded to Petition And
`
`Time For Filing Patent Owner Preliminary Response – 37 C.F.R. § 42.10(c) in
`
`3
`
`

`

`IPR2023-00512
`Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`
`IPR2023-00512. See Passamaneck Decl. ¶ 10 (Ex.2153). Ms. Passamaneck attests
`
`that she has read and will comply with the Patent Office Patent Trial Practice
`
`Guide and the Board’s Rules of Practice for Trials set forth in 35 C.F.R. § 42. Id.,
`
`¶ 11. Ms. Passamaneck further attests that she agrees to be subject to the United
`
`States Patent and Trademark Office’s Rules of Professional Conduct as set forth in
`
`37 C.F.R. §§ 11.101 et seq. and disciplinary jurisdiction under 37 C.F.R. §
`
`11.19(a). Id., ¶ 12.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4
`
`

`

`IPR2023-00512
`Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`
`III. Conclusion
`For the foregoing reasons, and in view of the Declaration submitted herewith
`
`(Ex.2153), Patent Owner respectfully requests that the Board grant this motion and
`
`admit Ms. Passamaneck pro hac vice in this proceeding. The undersigned
`
`authorizes the Office to charge $250 to Deposit Account No. 08-0219 for the fees
`
`set forth in 37 C.F.R. § 42.15(e) for this pro hac vice motion. Please charge any
`
`shortage of fees or credit any overpayments to the above Deposit Account.
`
`
`Dated: October 25, 2023
`
`
`Respectfully submitted,
`
`
`
`/Heather M. Petruzzi/
`
`Heather M. Petruzzi (Reg. No. 71,270)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`2100 Pennsylvania Ave NW
`Washington, DC 20037
`(202) 663-6028
`
`
`
`5
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`

`

`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`PATENT OWNER’S EXHIBIT LIST IPR2023-00512
`
`Exhibit No.
`
`Description
`
`2001
`
`Declaration of Dr. Corey Berkland
`
`
`
`
`
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`U.S. Food and Drug Admin., FDA approves Onureg® (azacitidine
`tablets) for acute myeloid leukemia (2020),
`https://www.fda.gov/drugs/resources-information-approved-
`drugs/fda-approves-onureg-azacitidine-tablets-acute-myeloid-
`leukemia (“FDA Approves Onureg®”)
`
`Aparicio, A. & Weber, J., Review of the clinical experience with 5-
`azacytidine and 5-aza-2’-deoxycytidine in solid tumors, 3 CURRENT
`OPINION IN INVESTIGATIONAL DRUGS 627–633 (2002) (“Aparicio”)
`
`Beisler, J., et al., Chemistry of Antitumor Triazine Nucleosides. An
`Improved Synthesis of Dihydro-5-Azacytidine, 4(5) J.
`CARBOHYDRATES NUCLEOSIDES NUCLEOTIDES 281–99 (1977)
`(“Beisler”)
`
`Reserved
`
`Canadian Product 200mg Onureg® Product Information
`
`Canadian Product 300mg Onureg® Product Information
`
`Canadian Product Monograph Onureg®
`
`Chabner, B., et al., Deamination of 5-azacytidine by a human
`leukemia cell cytidine deaminase, 22 BIOCHEMICAL PHARMACOLOGY
`2763–65 (1973) (“Chabner”)
`
`Chen, X., et al., Highly Efficient Regioselective Synthesis of 5’-O-
`lauroyl-5-azacytidine Catalyzed by Candida antarctica Lipase B, 151
`APPL. BIOCHEM. BIOTECHNOL. 21–28 (2008) (“Chen”)
`
`6
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`Cheung, Y., et al., Stability of azacitidine in infusion fluids, 41 AM.
`J. OF HOSP. PHARMACY 1156–59 (1984) (“Cheung”)
`
`Čihák, A & Šorm, F., Biochemical Effects and Metabolic
`Transformations of 5-Azacytidine in Escherichia coli, 30 COLLECT.
`CZECH. CHEM. COMMUN. 2091–2102 (1965) (“Čihák”)
`
`European Commission Decision 17.6.21
`
`CONNORS, K., ET AL., CHEMICAL STABILITY OF PHARMACEUTICALS: A
`HANDBOOK FOR PHARMACISTS 239 (2nd Ed. 1986) (“Connors”)
`
`Evans, D., et al., Measurement of gastrointestinal pH profiles in
`normal ambulant human subjects, 29 GUT 1035–41 (1988)
`(“Evans”)
`
`Perrie, Y. & Rades, T., PHARMACEUTICAL: DRUG DELIVERY AND
`TARGETING (2010) (“FASTtrack”)
`
`Gaubert, G., et al., Unnatural Enantiomers of 5-azacytidine
`Analogues: Syntheses and Enzymatic Properties, 20(4–7)
`NUCLEOSIDES, NUCLEOTIDES & NUCLEIC ACIDS 837–40 (2001)
`(“Gaubert”)
`
`Kaminskas, E., et al., FDA Drug Approval Summary: Azacitidine (5-
`azacytidine, Vidaza™) for Injectable Suspension, 10 THE
`ONCOLOGIST 176–82 (2005) (“Kaminskas”)
`
`Kissinger, L. & Stemm, N., Determination of the Antileukemia
`Agents Cytarabine and Azacitidine and Their Respective
`Degradation Products by High-Performance Liquid
`Chromatography, 353 J. OF CHROMATOGRAPHY 309–18 (1986)
`(“Kissinger”)
`
`LIEBERMAN, H., ET AL., PHARMACEUTICAL DOSAGE FORMS: TABLETS
`3 (2nd Ed. 1990) (“Lieberman”)
`
`7
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`Lin, K., et al., High -Performance Liquid Chromatographic Analysis
`of Chemical Stability of 5-Aza-2’-deoxycytidine, 70 J. OF
`PHARMACEUTICAL SCI. 1228–32 (1981) (“Lin”)
`
`Mund, C., Reactivation of Epigenetically Silenced Genes by DNA
`Methyltransferase Inhibitors: Basic Concepts and Clinical
`Applications, 1 EPIGENETICS 7–13 (2006) (“Mund”)
`
`National Cancer Institute, Bioassay of 5-azacytidine for Possible
`Carcinogenicity, U.S. DEP’T OF HEALTH, EDUC., AND WELFARE
`(1978) (“National Cancer Institute”)
`
`Notari, R. & De Young, J., Kinetics and Mechanisms of
`Degradation of the Antileukemic Agent 5-Azacytidine in Aqueous
`Solutions, 64 J. OF PHARMACEUTICAL SCI. 1148–57 (1975)
`(“Notari”)
`
`Onureg® Label
`
`International Pat. Appl. Pub. No. WO2009/139888
`(“WO2009/139888”)
`
`Piťhová, P., et al., Nucleic Acids Components and Their Analogues.
`LXVI.* Hydrolysis of 5-Azacytidine and its Connection with
`Biological Activity, 30 COLLECT. CZECH. CHEM. COMMUN. 2801–11
`(1965) (“Piťhová”)
`
`REMINGTON, THE SCIENCE AND PRACTICE OF PHARMACY 802–938
`(21st Ed. 2005) (“Remington 2005”)
`
`Stresemann, C. & Lyko, F., Modes of action of the DNA
`methyltransferase inhibitors azacytidine and decitabine, 123 INT. J.
`CANCER 8–13 (2008) (“Stresemann”)
`
`U.S. Pat. Pub. No. US20040186065A1 (“Ionescu-065”)
`
`Weiss, A., et al., Phase I Study of 5-Azacytidine 56 CANCER
`CHEMOTHERAPY REP. 413–19 (1972) (“Weiss”)
`
`8
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`Celgene v. Accord 1:21-cv-01795-RGA Doc 40
`
`U.S. Pat. No. 7,189,740 (“Zeldis”)
`
`Glover, A., et al., Azacitidine: 10 Years Later, 71 CANCER
`TREATMENT REP. 737–46 (1987) (“Glover”)
`
`U.S. Pat. No. 6,887,855 (“Ionescu-855”)
`
`U.S. Pat. No. 7,078,518 (“Ionescu-518”)
`
`U.S. Pat. No. 7,772,199 (“Ionescu-199”)
`
`U.S. Pat. Pub. No. US20060247189 (“Ionescu-189”)
`
`U.S. Pat. Pub. No. US20100298253 (“Ionescu-253”)
`
`Ward, M., et al., An oral dosage formulation of azacytidine: A pilot
`pharmacokinetic study, J. OF CLINICAL ONCOLOGY (2007) (“Ward”)
`
`International Pat. Appl. Pub. No. WO2008/028193
`(“WO2008/028193”)
`
`Gibson, M., Pharm. PREFORMULATION AND FORMULATION: A
`PRACTICAL GUIDE FROM CANDIDATE DRUG SELECTION TO
`COMMERCIAL DOSAGE FORM 1-11 (2001) (“Gibson Supplemental”)
`
`LIEBERMAN, H., ET AL., PHARMACEUTICAL DOSAGE FORMS 2 (2nd
`Ed. 1990) (“Lieberman Vol. 2”)
`
`International Pat. Appl. Pub. No. WO2004/082618
`(“WO2004/082618”)
`
`Celgene v. Accord 1:21-cv-01795-RGA Doc 35
`
`Reserved
`
`9
`
`

`

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`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`Savage, D., et al., The Gastrointestinal Epithelium and its
`Autochthonous Bacterial Flora, 127 J. OF EXPERIMENTAL MEDICINE
`67–81 (1967) (“Savage”)
`
`Pawar, et al., Integration of Biorelevant Pediatric Dissolution
`Methodology into PBPK Modeling to Predict In Vivo Performance
`and Bioequivalence of Generic Drugs in Pediatric Populations: A
`Carbamazepine Case Study, 25 AAPS J. 67 (2023) (“Pawar”)
`
`Deposition Transcript of Hannah K. Batchelor (“Batchelor Tr.”)
`
`Deposition Transcript of Graham Buckton, Ph.D. (“Buckton Tr.”)
`
`Declaration of Corey Berkland, Ph.D. (“Berkland Decl.”)
`
`Declaration of George M. Grass, Ph.D. (“Grass Decl.”)
`
`Declaration of William G. Blum, M.D. (“Blum Decl.”)
`
`Declaration of Jeffrey B. Etter, Ph.D. (“Etter Decl.”)
`
`U.S. Food and Drug Admin., FDA approves Onureg® (azacitidine
`tablets) for acute myeloid leukemia (2020),
`https://www.fda.gov/drugs/resources-information-approved-
`drugs/fda-approves-onureg-azacitidine-tablets-acute-myeloid-
`leukemia (“FDA Approves Onureg®”)
`
`Canadian Product 200mg Onureg® Product Information
`
`Canadian Product 300mg Onureg® Product Information
`
`Canadian Product Monograph Onureg®
`
`European Commission Decision 17.6.21
`
`Perrie, Y. & Rades, T., PHARMACEUTICAL: DRUG DELIVERY AND
`TARGETING (2010) (“FASTtrack”)
`
`10
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`2071
`
`2072
`
`Reserved
`
`Onureg® Label
`
`Gibson, M., Pharm. PREFORMULATION AND FORMULATION: A
`PRACTICAL GUIDE FROM CANDIDATE DRUG SELECTION TO
`COMMERCIAL DOSAGE FORM 1-11 (2001) (“Gibson Supplemental”)
`
`ALTMAN, R, & SARG, M., CANCER DICTIONARY: REVISED EDITION
`16–17, 197 (2000) (“Altman”)
`
`ALLEN, L, ET AL., ANSEL’S PHARM. DOSAGE FORMS AND DRUG
`DELIVERY SYS. (8th Ed. 2005) (“Ansel”)
`
`Antonsson, B., et al., Effect of 5-Azacytidine and Congeners on DNA
`Methylation and Expression of Deoxycytidine Kinase in the Human
`Lymphoid Cell Lines CCRF/CEM/0 and CCRF/CEM/dCk-1, 47
`CANCER RESEARCH 3762–78 (1987) (“Antonsson”)
`
`AULTON, M., PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM
`DESIGN (1988) (“Aulton”)
`
`Bankhead, C., Year in Review: Acute Myeloid Leukemia, MedPage
`Today (Nov. 29, 2020),
`https://www.medpagetoday.com/hematologyoncology/leukemia/899
`09 (“Bankhead”)
`
`Reserved
`
`Ben-Kasus, T., et al., Metabolic activation of zebularine, a novel
`DNA methylation inhibitor, in human bladder carcinoma cells, 70
`BIOCHEM. PHARM. 121–33 (2005) (“Ben-Kasus”)
`
`Carter, J., et al., Targeting multiple signaling pathways: the new
`approach to acute myeloid leukemia therapy, 5 SIGNAL
`TRANSDUCTION AND TARGETED THERAPY 288 (2020) (“Carter”)
`
`Choi, Y., et al., Oral Maintenance Chemotherapy with 6-
`Mercaptopurine and Methotrexate in Patients with Acute Myeloid
`
`11
`
`

`

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`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`Leukemia Ineligible for Transplantation, 30 KOREAN ACADEMY OF
`MED. SCI. 1416–22 (2015) (“Choi”)
`
`Cogle, C., et al., Oral Azacitidine (CC-486) for the Treatment of
`Myelodysplastic Syndromes and Acute Myeloid Leukemia, 20
`ONCOLOGIST 1404–12 (2015) (“Cogle”)
`
`Covey, J., et al., Differences in DNA Damage Produced by
`Incorporation of 5-Aza-2’-deoxycytidine or 5,6-Dihydro-5-
`azacytidine into DNA of Mammalian Cells, 46 CANCER RESEARCH
`5511–17 (1986) (“Covey”)
`
`CRAIG, C. & STITZEL, R., MODERN PHARMACOLOGY WITH CLINICAL
`APP. (6th Ed. 2004) 48–55 (“Craig”)
`
`Curtiss, F., Pharmacy Benefit Spending on Oral Chemotherapy
`Drugs, 12 J. OF MANAGED CARE PHARMACY 570–77 (2006)
`(“Curtiss”)
`
`DeSimone, J., et al., Tetrahydrouridine, Cytidine, Analogues, and
`Hemoglobin F, 18 AM. J. OF HEMATOLOGY 283–88 (1985)
`(“DeSimone”)
`
`Dressman, J., et al., Dissolution Testing as a Prognostic Tool for
`Oral Drug Absorption: Immediate Release Dosage Forms, 15
`PHARM. RESEARCH 11–22 (1998) (“Dressman”)
`
`Case Reports, 72 BRITISH J. OF HAEMATOLOGY 467–68 (1989)
`(“Dunbar”)
`
`Ellison, R., et al., Arabinosyl Cytosine: A Useful Agent in the
`Treatment of Acute Leukemia in Adults, 32 J. OF HEMATOLOGY 507–
`23 (1968) (“Ellisson”)
`
`The ASCO Post Staff, “FDA Approves Oral Azacitidine as
`Maintenance Therapy for Adults With AML in First Remission”
`(Sept. 25, 2020), https://ascopost.com/issues/september-25-
`2020/fda-approves-oral-azacitidine-as-maintenance-therapy-for-
`
`12
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`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2082
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`2083
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`2084
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`2085
`
`2086
`
`2087
`
`2088
`
`2089
`
`2090
`
`adults-with-aml-in-first-remission/ (“FDA Approves Oral
`Azacitidine”)
`
`Frisch, A., et al., How we treat older patients with acute myeloid
`leukaemia, 191 BRITISH J. OF HAEMATOLOGY 682–91 (2020)
`(“Frisch”)
`
`Futterman, B., et al., Studies on the Cytostatic Action
`Phosphorylation and Deamination of 5-Azacytidine and 5,6-
`Dihydro-5-Azacytidine in Hela Cells, 27 BIOCHEM. PHARM. 907–9
`(1978) (“Futterman”)
`
`Garcia-Manero, G., et al., Phase I Study of Oral Azacitidine in
`Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia,
`and Acute Myeloid Leukemia, 29 J. OF CLIN. ONCOLOGY 2521–27
`(2011) (“Garcia-Manero”)
`
`Goldin, A., et al., Relation of Structure of Purine and Pyrimidine
`Nucleosides to Antitumor Activity, 1 CANCER CHEMOTHERAPY 1–29,
`268 (1968) (“Goldin”)
`
`Griffiths, E., Oral hypomethylating agents: beyond convenience in
`MDS, 2021 HEMATOLOGY 439–47 (2021) (“Griffiths”)
`
`Grønbæk , K., et al., Epigenetic Changes in Cancer as Potential
`Targets for Prophylaxis and Maintenance Therapy, 103 BASIC &
`CLINICAL PHARM. & TOXICOLOGY 389–96 (2008) (“Grønbæk”)
`
`Hrodek, O. & Vesely J., 5-Azacytidine in Childhood Leukemia, 18
`NEOPLASMA 493–503 (1971) (“Hrodek”)
`
`Kantarjian, H., et al., Acute Myeloid Leukemia: Historical
`Perspective and Progress in Research and Therapy Over 5 Decades,
`21 CLIN. LYMPHOMA, MYELOMA AND LEUKEMIA 580–97 (2021)
`(“Kantarjian”)
`
`Karon, M., et al., 5-Azacytidine: A New Active Agent for the
`Treatment of Acute Leukemia, 42 BLOOD 359–65 (1973) (“Karon”)
`
`13
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`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`Kipp, D. & Wei, A., The path to approval for oral hypomethylating
`agents in acute myeloid leukemia and myelodysplastic syndromes,
`17(20) FUTURE ONCOL. 2563–71 (2021) (“Kipp”)
`
`Kornblith, A., et al., Impact of Azacytidine on the Quality of Life of
`Patients With Myelodysplastic Syndrome Treated in a Randomized
`Phase III Trial: A Cancer and Leukemia Group B Study, 20 J. OF
`CLIN. ONCOLOGY 2441–52 (2002) (“Kornblith”)
`
`Lammers, P. & Cashen, A., Azacitidine: A Review of its Use in the
`Management of Myelodysplastic Syndromes, 1 CLIN. MED.
`THERAPEUTICS 1189–97 (2009) (“Lammers”)
`
`Lin, R., Allogeneic Transplantation for Older Patients with Acute
`Myeloid Leukemia: The Dawn of a New Era, 28 TRANSPLANTATION
`AND CELLULAR THERAPY 793–94 (2022) (“Lin 2022”)
`
`Liu, H., Emerging agents and regimens for AML, 14 J.
`HEMATOLOGY & ONCOLOGY 19 (2021) (“Liu”)
`
`Lomen, V., et al., “Phase I Study of 5-Azacytidine Using 24 Hrs
`Continuous Infusion for 5 Days” 16 PROCEEDINGS OF THE AM. ASS.
`FOR CANCER RESEARCH & AM. SOC. OF CLIN. ONCOLOGY 52 (Mar.
`1975) (“Lomen”)
`
`Lӧwenberg, B., et al., Mitoxantrone Versus Daunorubicin in
`Induction-Consolidation Chemotherapy, 16 J. OF CLIN. ONCOLOGY
`872–81 (1998) (“Lӧwenberg”)
`
`Ma, X., et al., Myelodysplastic Syndromes: Incidence and Survival
`in the United States, 109 AM. CANCER SOC. 1536–42 (2007) (“Ma”)
`
`Reserved
`
`McCredie, K., Treatment of Acute Leukemia with 5-Azacytidine
`(NSC-102816), 57 CANCER CHEMOTHERAPY REP. 319–23 (1973)
`(“McCredie”)
`
`14
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2101
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`2107
`
`2108
`
`2109
`
`2110
`
`2111
`
`Neil, G., et al., Enhancement by Tetrahydrouridine (NSC-112907) of
`the Oral Activity of 5-Azacytidine (NSC-102816) in L1210 Leukemic
`Mice, 59 CANCER CHEMOTHERAPY REP. 459–65 (1975) (“Neil”)
`
`Odenike, O., Incorporating novel approaches in the management of
`MDS beyond conventional hypomethylating agents, AM. SOC. OF
`HEMATOLOGY 460–69 (2017) (“Odenike”)
`
`Goodman, A., “Oral CC-486 Maintenance Therapy Extends Survival
`in Older Patients with AML” THE ASCO POST (Jan. 25, 2020),
`https://ascopost.com/issues/january-25-2020/oral-cc-486-
`maintenance-therapy-extends-survival-in-older-patients-with-aml/
`(“Oral CC-486”)
`
`Perl, A., The role of targeted therapy in the management of patients
`with AML, 1 BLOOD ADVANCES AND HEMATOLOGY 2281–94 (2017)
`(“Perl”)
`
`Reserved
`
`Reserved
`
`PORTA, M., A DICTIONARY OF EPIDEMIOLOGY 226–27 (5th Ed. 2008)
`(“Porta”)
`
`Preisler, H., et al., Comparison of Three Remission Induction
`Regimens and Two Postinduction Strategies for the Treatment of
`Acute Nonlymphocytic Leukemia, 69 BLOOD 1441–49 (1987)
`(“Preisler”)
`
`Reserved
`
`Récher, C., The beginning of a new therapeutic era in acute myeloid
`leukemia, 2 J. HAEMATOLOGY 823–33(2021) (“Récher”)
`
`Reville, P., Maintenance Therapy in AML, 10 FRONTIERS IN
`ONCOLOGY (2021) (“Reville”)
`
`15
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2112
`
`2113
`
`2114
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`
`2121
`
`2122
`
`Shnider, B., et al., A Phase I Study of 5-Azacytidine (NSC-102816),
`16(4) J. OF CLIN. PHARMACOLOGY 205–12 (1976) (“Shnider”)
`
`Reserved
`
`Slater, H., Phase 3 QUAZAR AML-001 Trial Finds Oral Azacitidine
`Extends Survival in Older Adults with AML, Cancer Network (Jan.
`12, 2021) (“Slater”)
`
`Sochacka-Ćwikła, A., et al., FDA-Approved Drugs for
`Hematological Malignancies—The Last Decade Review, 14
`CANCERS 87 (2022) (“Sochacka-Ćwikła”)
`
`Sorm, F., et al., 5-Azacytidine, a New, Highly Effective
`Cancerostatic, 20 INSTITUTE OF ORGANIC CHEM. AND BIOCHEM.
`202–3 (1964) (“Sorm”)
`
`Reserved
`
`Sorrentino, V., et al., Hypomethylating Chemotherapeutic Agents as
`Therapy for Myelodysplastic Syndromes and Prevention of Acute
`Myeloid Leukemia, 14 PHARMACEUTICALS 641 (2021) (“Sorrentino”)
`
`Southall, J., “Oral azacytidine extends survival for patients with
`AML in remission after chemotherapy” HemOncToday (Jan. 5,
`2021) (“Southall”)
`
`Steensma, D., ASH 2010 Meeting Report—Top 10 clinically-
`oriented abstracts in myelodysplastic syndromes (MDS), 86 AM. J.
`OF HEMATOLOGY 385–91 (2011) (“Steensma”)
`
`Surbone, A., et al., Phase I and Pharmacokinetic Study of
`Arabinofuranosyl-5-azacytosine (Fazarabine, NSC 281272), 50
`CANCER RESEARCH 1220–25 (1990) (“Surbone”)
`
`Toutain, P. & Bousquet-Melou, A., Bioavailability and its
`assessment, 27 J. VET. PHARMACOLOGY. THERAP. 455–66 (2004)
`(“Toutain”)
`
`16
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`2128
`
`2129
`
`2130
`
`2131
`
`U.S. Provisional 60/824320 File History (“60/824,320”)
`
`U.S. Patent Application US 2008/0057086 (“US2008/0057086”)
`
`Vigil, C., et al., Safety and efficacy of azacitidine in myelodysplastic
`syndromes, 4 DRUG DESIGN, DEVELOPMENT AND THERAPY 221–29
`(2010) (“Vigil”)
`
`Vogler, W., et al., “Remission Induction in Refractory Myeloblastic
`Leukemia with Continuous Infusion of 5-Azacytidine” 16
`PROCEEDINGS OF THE AM. ASS. FOR CANCER RESEARCH & AM. SOC.
`OF CLIN. ONCOLOGY 155 (Mar. 1975) (“VoglerI”)
`
`Vogler, W., 5-Azacytidine (NSC 102816): A New Drug for the
`Treatment of Myeloblastic Leukemia, 48 BLOOD 331–37 (1976)
`(“VoglerII”)
`
`Von Hoff, D., et al., 5-Azacytidine A New Anticancer Drug with
`Effectiveness in Acute Myelogenous Leukemia, 85 ANNALS OF
`INTERNAL MEDICINE 237–45 (1976) (“VonHoff”)
`
`Wei, A., et al., Long-term survival with oral azacitidine for patients
`with acute myeloid leukemia in first remission after chemotherapy,
`98 AM. J. OF HEMATOLOGY E84–87 (2023) (“Wei”)
`
`Weill Cornell Medicine, “New maintenance treatment for acute
`myeloid leukemia prolongs the lives of patients” NEW ENGLAND J.
`OF MED. (Jan. 22, 2021),
`https://news.weill.cornell.edu/news/2021/01/new-maintenance-
`treatment-for-acute-myeloid-leukemia-prolongs-the-lives-of-
`patients, (“Weill Cornell”)
`
`Zielinski, W. & Sprinzl, M., Chemical synthesis of 5-azacytidine
`nucleotides and preparation of tRNAs containing 5-azacytidine in its
`3’-terminus, 12 NUCLEIC ACIDS RESEARCH 5025–36 (1984)
`(“Zielinski”)
`
`17
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2132
`
`2133
`
`2134
`
`2135
`
`2136
`
`2137
`
`2138
`
`2139
`
`2140
`
`2141
`
`2142
`
`2143
`
`2144
`
`Ziemba, A., et al., Development of an Oral Form of Azacytidine:
`2‘3‘5Triacetyl-5-Azacytidine, 2011 CHEMOTHERAPY RESEARCH AND
`PRACTICE 1–9 (2011) (“Ziemba”)
`
`Exemestane Label (“Exemestane”)
`
`Anastrozole Label (“Anastrozole”)
`
`Letrozole Label (“Letrozole”)
`
`Blum W, et al., Maintenance therapy with decitabine in younger
`adults with acute myeloid leukemia in first remission: a phase 2
`Cancer and Leukemia Group B Study (CALGB 10503), 31
`LEUKEMIA 34–39 (2017) (“Blum”)
`
`Cytarabine Label (“Cytarabine”)
`
`Dacogen Label (“Dacogen”)
`
`Mitoxantrone Label (“Mitoxantrone”)
`
`Finkel, M., The Orphan Drug Act and the Federal Government’s
`Orphan Products Development Program, 99 PUBLIC HEALTH REPS.
`313–16 (1984) (“Finkel”)
`
`Martinez, M. & Amidon, G., A Mechanistic Approach to
`Understanding the Factors Affecting Drug Absorption, 42 J. OF
`CLIN. PHARMACOLOGY 620–43 (2002) (“Martinez”)
`
`European Medicines Agency, Assessment Report of Onureg
`EMA/308711/2021(“European Medicines Report”)
`
`Hirayama, H., et al., Distribution and Excretion of Cyclocytidine in
`Monkeys, Dogs, and Rats, 65 GANN 153–61 (1974) (“Hirayama”)
`
`LIEBERMAN, H., ET AL., PHARMACEUTICAL DOSAGE FORMS: TABLETS
`1 (2nd Ed. 1989) (“Lieberman Vol. 1”)
`
`18
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`2145
`
`2146
`
`2147
`
`2148
`
`2149
`
`2150
`
`2151
`
`2152
`
`2153
`
`DEAN, D., ET AL., PHARMACEUTICAL PACKAGING TECHNOLOGY
`(2000) (“Dean”)
`
`GENNARO, A., REMINGTON’S PHARMACEUTICAL SCIENCES 257–309,
`1519–44, 1615–32 (18th Ed. 1990) (“Remington 1990”)
`
`REMINGTON, THE SCIENCE AND PRACTICE OF PHARMACY 319–37,
`702–19, 745–75, 1025–36 (21st Ed. 2005) (“Remington 2005 II”)
`
`GIBALDI, M. & PERRIER, D., PHARMACOKINETICS (2nd Ed. 2007)
`271–353 (“Gilbaldi”)
`
`First Expert Declaration of James L. Mullins, Ph.D.
`
`Huls, G., et al. Azacitidine maintenance after intensive
`chemotherapy improves DFS in older AML patients, 133 BLOOD,
`THE JOURNAL OF THE AMERICAN SOCIETY OF HEMATOLOGY 1457–64
`(2019) (“Huls”)
`
`Second Expert Declaration of James L. Mullins, Ph.D.
`
`Declaration of Andrew J. Danford in Support of Unopposed Motion
`for Admission Pro Hac Vice
`
`Declaration of Nora Q.E. Passamaneck in Support of Unopposed
`Motion for Admission Pro Hac Vice
`
`19
`
`

`

`
`
`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`CERTIFICATE OF SERVICE
`I hereby certify that on October 25, 2023, true and correct copies of the
`
`following materials:
`
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of
`
`Nora Q.E. Passamaneck
`
` Exhibit 2153, Declaration of Nora Q.E. Passamaneck in Support of
`
`Unopposed Motion for Pro Hac Vice Admission
`
` Patent Owner’s Exhibit List
`
`were served electronically via email, on the following attorneys of record:
`
`Vishal C. Gupta (Reg. No. 67,284)
`John J. Molenda (Reg. No. 47,804)
`Tyler Doh (Reg. No. 80,274)
`Steptoe & Johnson LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Tel: (212) 506-3900
`Fax: (212)-506-3950
`Robert Kappers (Reg. No. 70,202)
`Steptoe & Johnson LLP
`227 West Monroe Street
`Suite 4700
`Chicago, IL 60606
`Tel: (312)-577-1300
`Azacitidine@Steptoe.com
`
`
`
`
`
`
`
`
`
`

`

`IPR2023-00512
` Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Nora Q.E.
`Passamaneck
`
`By: /Gabriel J. Rosanio/
`
`Gabriel J. Rosanio, Ph.D., (Reg. No. 81,426)
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: 212-295-6446
`Email: Gabriel.Rosanio@wilmerhale.com
`
`
`
`
`
`
`
`

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