Filed on behalf of: Corcept Therapeutics, Inc.
`
`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
`
`
`
`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
`2001 August 2018 Update to the Office Patent Trial Practice Guide, 83 Fed.
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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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`114:1-11 (2013)
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`with Mifepristone,” Endocrine Practice, 19(2):313-26 (2013)
`2013 O. Heikinheimo et al., “The pharmacokinetics of mifepristone in humans
`reveal insights into differential mechanisms of antiprogestin action,”
`Contraception, 68:421-26 (2003)
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`Serum of Patients Suffering from Mental Disorders Treatable with
`Glucocorticoid Receptor Antagonists”)
`
`2010
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`- 1 -
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`PGR2019-00048
`U.S. Patent No. 10,195,214
`
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`
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`65(6):215-17 (2007)
`2017 Biaxin (clarithromycin) Full Prescribing Information (May 2016)
`2018
`Sporanox (itraconazole) Full Prescribing Information (April 2015)
`2019 Nizoral (ketoconazole) Full Prescribing Information (2013)
`E. Charmandari et al., “Adrenal Insufficiency,” Lancet, 383(9935):2152-
`2020
`67 (2014)
`2021 A. Viera et al., “Potassium Disorders: Hypokalemia and Hyperkalemia,”
`American Family Physician, 92(6):487-95 (2015)
`2022 M. Basina et al., “Successful Long-Term Treatment of Cushing Disease
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`2023 D. Greenblatt & J. Harmatz, “Ritonavir is the best alternative to
`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
`
`- 2 -
`
`
`
`2033
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
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`
`Invirase (saquinavir mesylate) Full Prescribing Information (September
`2016)
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`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
`“The Hazards of Seldane,” N.Y. TIMES (January 17, 1997)
`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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`(Jan. 2, 2019), https://www.cdc.gov/fungal/diseases/aspergillosis/
`treatment.html
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`and Inducers,” U.S. Food and Drug Administration (Nov. 14, 2017),
`https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-
`and-drug-interactions-table-substrates-inhibitors-and-inducers
`September 6, 2019 Email from D. Sterling to Counsel
`
`2036
`
`2045
`
`2046
`
`2047
`
`- 3 -
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`Date: October 3, 2019
`
`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
`
`- 4 -
`
`
`
`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: October 3, 2019
`
`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
`
`
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