`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner
`_______________________
`
`Case PGR2019-00048
`U.S. Patent No. 10,195,214
`_______________________
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`Description
`EX
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`2002 Chart Comparing Arguments Made By Petitioner in PGR2019-00048 and
`in the District Court Litigation
`2003
`January 16, 2019 Email from U. Everett to Counsel
`2004 Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., No. 18-cv-
`3632, D.I. 31 (D.N.J. Oct. 23, 2018)
`2005 Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., No. 18-cv-
`3632, D.I. 73 (D.N.J. June 4, 2019)
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`2009 R.A. Feelders et al., “The burden of Cushing’s disease: clinical and health-
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`reveal insights into differential mechanisms of antiprogestin action,”
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`Serum of Patients Suffering from Mental Disorders Treatable with
`Glucocorticoid Receptor Antagonists”)
`
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`PGR2019-00048
`U.S. Patent No. 10,195,214
`
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`following treatment of severe Cushing’s syndrome,” Netherlands J. Med.,
`65(6):215-17 (2007)
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`2018
`Sporanox (itraconazole) Full Prescribing Information (April 2015)
`2019 Nizoral (ketoconazole) Full Prescribing Information (2013)
`2020
`E. Charmandari et al., “Adrenal Insufficiency,” Lancet, 383(9935):2152-
`67 (2014)
`2021 A. Viera et al., “Potassium Disorders: Hypokalemia and Hyperkalemia,”
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`2022 M. Basina et al., “Successful Long-Term Treatment of Cushing Disease
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`ketoconazole as an index inhibitor of cytochrome P450-3A in drug-drug
`interaction studies,” Brit. J. Clin. Pharmacol., 80(3):342-50 (2015)
`2024
`Incivek (telaprevir) Full Prescribing Information (October 2013)
`2025 VFEND (voriconazole) Full Prescribing Information (February 2015)
`2026 Victrelis (boceprevir) Full Prescribing Information (January 2017)
`2027
`Tybost (cobicistat) Full Prescribing Information (June 2016)
`2028 Vaprisol (conivaptan hydrochloride) Full Prescribing Information (October
`2016)
`2029 Crixivan (indinavir sulfate) Full Prescribing Information (September 2016)
`2030 Kaletra (lopinavir and ritonavir) Full Prescribing Information (November
`2016)
`2031 Viracept (nelfinavir mesylate) Full Prescribing Information (September
`2016)
`Technivie (ombitasvir, paritaprevir and ritonavir) Full Prescribing
`Information (February 2017)
`
`2032
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`- 2 -
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`
`
`2033
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`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`2035
`
`Invirase (saquinavir mesylate) Full Prescribing Information (September
`2016)
`2034 D. Cuevas-Ramos & M. Fleseriu, “Treatment of Cushing’s disease: a
`mechanistic update,” J. Endocrinol., 223(2):R19-39 (2014)
`T. Carroll & J.W. Findling, “The Use of Mifepristone in the Treatment of
`Cushing’s Syndrome,” Drugs of Today, 48(8):509-18 (2012)
`E. Dunnigan et al., “Mifepristone (RU-486) in the treatment of Refractory
`Cushing’s Disease,” Endocrine Rev., Suppl. 1, 31(3):S1201 (2010)
`2037 Nefazodone Hydrochloride Tablets Full Prescribing Information (May
`2014)
`2038 Noxafil (posaconazole) Full Prescribing Information (September 2016)
`2039 Norvir (ritonavir) Full Prescribing Information (December 2016)
`2040
`Excerpts of Physician’s Desk Reference (58th ed. 2004)
`2041
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`2042
`European Medicines Agency, “European Medicines Agency recommends
`suspension of marketing authorisations for oral ketoconazole,” July 26,
`2013
`2043 M. Tran & J. Grillo, “Translation of Drug Interaction Knowledge to
`Actionable Labeling,” Clin. Pharmacol. & Therapeutics, 105(6):1292-95
`(2019)
`2044 M. Fleseriu et al., “Changes in Plasma ACTH Levels and Corticotroph
`Tumor Size in Patients With Cushing’s Disease During Long-term
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`and Inducers,” U.S. Food and Drug Administration (Nov. 14, 2017),
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`and-drug-interactions-table-substrates-inhibitors-and-inducers
`2047
`September 6, 2019 Email from D. Sterling to Counsel
`2048 Declaration of Nicholas A. LoCastro
`
`2036
`
`2045
`
`2046
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`- 3 -
`
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`
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`U.S. Patent No. 10,195,214
`
`2053
`
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`interactions: design and interpretation,” Chapter 24 in ENZYME- AND
`TRANSPORTER-BASED DRUG-DRUG INTERACTIONS: PROGRESS AND FUTURE
`CHALLENGES (2010)
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`effectiveness,” Eur. J. Obstetrics & Gynecol & Reproductive Biol.,
`101(2):113-20 (2002)
`2051 D.J. Greenblatt, “Drug-Drug Noninteractions,” Cardiovascular
`Therapeutics, 27:226-29 (2009)
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`Ketoconazole: Review of the Published Evidence,” J. Clin. Pharmacol.,
`54(12):1321-29 (2014)
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`in Vivo,” Biochem. Pharmacol., 55:113-22 (1998)
`2054 D.J. Greenblatt et al., “Kinetic and dynamic interaction study of zolpidem
`with ketoconazole, itraconazole, and fluconazole,” Clin. Pharmacol. &
`Therapeutics, 64:661-71 (1998)
`2055 D. Roman, Cross Discipline Team Leader Review, NDA 202107 (2012)
`2056 Declaration of F. Peter Guengerich, Ph.D.
`2057 Declaration of Ty Carroll, M.D.
`2058 Declaration of Laurence Katznelson, M.D.
`2059 Deposition Transcript of Dr. Greenblatt
`2060 O. Heikinheimo et al., “Antiprogesterone RU 486 – A Drug for Non-
`Surgical Abortion,” Annals of Medicine, 22:75-84 (1990)
`2061 Y. Shi et al., “Pharmacokinetic study of RU 486 and its metabolites after
`oral administration of single doses to pregnant and non-pregnant women,”
`Contraception, 48:133-149 (1993)
`2062 Y. Huang et al., “Pharmacokinetics and Dose Proportionality of
`Ketoconazole in Normal Volunteers,” Antimicrobial Agents &
`Chemotherapy, 30(2):206-10 (1986)
`“FDA advises against using oral ketoconazole in drug interaction studies
`due to serious potential side effects,” Oct. 18, 2013. Internet Archive,
`
`2063
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`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`https://web.archive.org/web/20131018234822/http://www.fda.gov/Drugs/
`DrugSafety/ucm371017.htm
`2064 D.G. Bailey et al., “Grapefruit–medication interactions: Forbidden fruit or
`avoidable consequences?” CMAJ, 185(4):309-16 (2013)
`2065 A. Im & L.J. Appleman, “Mifepristone: pharmacology and clinical impact
`in reproductive medicine, endocrinology and oncology,” Expert Opin.
`Pharmacother., 11(3):481-88 (2010)
`L.L. Von Moltke et al., “Metabolism of Drugs by Cytochrome P450 3A
`Isoforms: Impligbecations for Drug Interactions in Psychopharmacology,”
`Clin. Pharmacokinetics, 29(Suppl. 1):33-44 (1995)
`2067 R. Clayton, “Mortality in patients with Cushing’s disease more than 10
`years after remission: a multicentre, multinational, retrospective cohort
`study,” Lancet Diabetes-Endocrinol., 4:569-76 (2016)
`2068 Declaration of Daniel C. Wiesner
`
`2066
`
`- 5 -
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`Date: June 16, 2020
`
`Respectfully Submitted,
`
`F. Dominic Cerrito (Reg. No. 38,100)
`Eric C. Stops (Reg. No. 51,163
`Daniel C. Wiesner (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`John Galanek (Reg. No. 74,512)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`johngalanek@quinnemanuel.com
`
`Counsel for Patent Owner
`
`- 6 -
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner
`_______________________
`
`Case PGR2019-00048
`U.S. Patent No. 10,195,214
`_______________________
`
`CERTIFICATE OF SERVICE
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on the date indicated below a copy of the
`
`foregoing Patent Owner’s Exhibit List was served electronically by filing these
`
`documents through the PTAB E2E System, as well as by e-mailing copies to
`
`counsel of record for Petitioners at dsterling-PTAB@sternekessler.com,
`
`opartington-PTAB@sternekessler.com, jcrozendaal-PTAB@sternekessler.com,
`
`ueverett-PTAB@sternekessler.com, wmilliken-PTAB@sternekessler.com.
`
`Date: June 16, 2020
`
`Respectfully Submitted,
`
`F. Dominic Cerrito (Reg. No. 38,100)
`Eric C. Stops (Reg. No. 51,163
`Daniel C. Wiesner (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`John Galanek (Reg. No. 74,512)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`johngalanek@quinnemanuel.com
`
`Counsel for Patent Owner
`
`