IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Petitioner,
`
`v.
`
`CORCEPT THERAPEUTICS, INC.
`Patent Owner.
`
`_____________________
`
`Case PGR2019-00048
`U.S. Pat. No. 10,195,214 B2
`_____________________
`
`PETITIONER’S EXHIBIT LIST
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Petitioner,
`
`v.
`
`CORCEPT THERAPEUTICS, INC.
`Patent Owner.
`
`_____________________
`
`Case PGR2019-00048
`U.S. Pat. No. 10,195,214 B2
`_____________________
`
`PETITIONER’S EXHIBIT LIST
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`PGR2019-00048
`Patent 10,195,214
`Teva
`Exhibit #
`
`Description
`
`1001
`
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`Belanoff, J.K., “Concomitant Administration Of Glucocorticoid
`Receptor Modulators And CYP3A Inhibitors,” U.S. Patent No.
`10,195,214 B2 (filed June 19, 2017; issued February 5, 2019)
`Declaration of David J. Greenblatt, M.D.
`Curriculum Vitae for David J. Greenblatt. M.D.
`Korlym Label (2012)
`Lee et al., Office of Clinical Pharmacology Review NDA 20687
`(Addendum, KorlymTM, Mifepristone) (2012)
`FDA Approval Letter for Korlym (mifepristone) tablets, NDA
`20217, dated February 17, 2012
`Tsunoda, S.M., et al., “Differentiation of intestinal and hepatic
`cytochrome P450 3A activity with use of midazolam as an in vivo
`probe: Effect of ketoconazole,” Clin. Pharmacol. Ther. 66(5): 461-
`471 (1999)
`Ullmann, A., et al., “Method For Treating Cushing’s Syndrome,”
`U.S. Patent Application Publication No. 2010/0261693 A1 (filed
`October 13, 2008; published October 14, 2010)
`Sartor, O. and Cutler, G.B., “Mifepristone: Treatment of Cushing’s
`Syndrome,” Clinical Obstetrics and Gynecology 39(2): 506-510
`(1996)
`Pozza, C., et al., “Management Strategies for Aggressive Cushing’s
`Syndrome: From Macroadenomas to Ectopics,” J. Oncol. 109: 1-9
`(2012)
`Castinetti, F., “Medical Treatment of Cushing’s Syndrome:
`Glucocorticoid Receptor Antagonists and Mifepristone,”
`Neuroendocrinology 92(suppl. 1): 125–130 (2010)
`Nieman, L.K., “Successful Treatment of Cushing's Syndrome with
`the Glucocorticoid Antagonist RU 486*,” J. Clin. Endocrinol.
`Metab. 61(3): 536-540 (1985)
`
`
`
`- 2 -
`
`
`
`PGR2019-00048
`Patent 10,195,214
`Teva
`Exhibit #
`
`Description
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`Brogden, R.N., et al., ” Mifepristone A Review of its
`Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic
`Potential,” Drugs 45(3): 384-409 (1993)
`Molitch, M.E., “Current approaches to the pharmacological
`management of Cushing’s disease,” Mol. Cell. Endocrinol. 408:
`185–189 (2015)
`Sitruk-Ware, R. and Spitz, I.M., “Pharmacological properties of
`mifepristone: toxicology and safety in animal and human studies,”
`Contraception 68: 409–420 (2003)
`Heikinheimo, O., “Pharmacokinetics of The Antiprogesterone RU
`486 in Women During Multiple Dose Administration,” J. Steriod.
`Biochem. 32(1A): 21-25 (1989)
`Heikinheimo, O., et al., “The pharmacokinetics of mifepristone in
`humans reveal insights into differential mechanisms of antiprogestin
`action,” Contraception 68: 421–426 (2003)
`Blasey, C.M., et al., “Efficacy and Safety of Mifepristone for the
`Treatment of Psychotic Depression,” J. Clin. Psychopharmacol.
`31:436-440 (2011)
`Belanoff, J.K., “Optimizing Mifepristone Levels in Plasma Serum
`of Patients Suffering from Mental Disorders Treatable with
`Glucocorticoid Receptor Antagonists,” U.S. Patent No. 8,921,348
`B2 (filed October 29, 2013; issued December 30, 2014)
`Belanoff, J.K., “Optimizing Mifepristone Levels in Plasma Serum
`of Patients Suffering from Mental Disorders Treatable with
`Glucocorticod Receptor Antagonists,” U.S. Patent No. 8,598,149 B2
`(filed August 27, 2008; issued December 3, 2013)
`Castinetti, F., et al., “Merits and pitfalls of mifepristone in
`Cushing’s syndrome,” Eur. J. Endocrinol.160: 1003–1010 (2009)
`Jang, G.R., et al., “Identification of CYP3A4 as the Principal
`Enzyme Catalyzing Mifepristone (RU 486) Oxidation in Human
`Liver Microsomes,” Biochem. Pharmacol. 52: 753-761 (1996)
`
`
`
`- 3 -
`
`
`
`PGR2019-00048
`Patent 10,195,214
`Teva
`Exhibit #
`
`Description
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`Greenblatt, D., “In Vitro Prediction of Clinical Drug Interactions
`With CYP3A Substrates: We Are Not There Yet,” Clin. Pharm.
`Ther. 95(2): 133-135 (2014)
`Greenblatt, D.J., et al., “Mechanism of cytochrome P450-3A
`inhibition by ketoconazole,” J. Pharm. Pharmacol. 63: 214–221
`(2011)
`Greenblatt, D.J. and von Moltke, L.L., “Clinical Studies of Drug-
`Drug Interactions: Design and Interpretation,” in Enzyme- and
`Transporter-Based Drug-Drug Interactions: Progress and Future
`Challenges. Pang, K.S. et al., ed., pp. 625-649, New York, Springer
`(2010)
`Greenblatt, D.J., et al., “The CYP3 Family” in Cytochromes P450:
`Role in the Metabolism and Toxicity of Drugs and other
`Xenobiotics. Ionnides, C., ed., pp. 354-383, Royal Society of
`Chemistry: (2008)
`Ohno, Y., et al., “General Framework for the Quantitative
`Prediction of CYP3A4-Mediated Oral Drug Interactions Based on
`the AUC Increase by Coadministration of Standard Drugs,” Clin.
`Pharmacokinet. 46(8): 681-696 (2007)
`Archive History of NCT00936741 History of Changes for Study:
`NCT00936741 An Extension Study of CORLUX in the Treatment
`of Endogenous Cushing's Syndrome (July 9, 2009) on
`ClinicalTrials.gov
`Fleseriu, M., et al., “Mifepristone, a Glucocorticoid Receptor
`Antagonist, Produces Clinical and Metabolic Benefits in Patients
`with Cushing’s Syndrome,” J. Clin. Endocrinol. Metab.
`97(6):2039–2049 (2012)
`Morgan, F.H. and Laufgraben, M.J., “Mifepristone for Management
`of Cushing’s Syndrome,” Pharmacotherapy 33(3):319-329 (2013)
`Schteingart, D.E., “Drugs in the medical treatment of Cushing's
`syndrome,” Expert Opin. Emerging Drugs 14(4):661-671 (2009)
`
`
`
`- 4 -
`
`
`
`PGR2019-00048
`Patent 10,195,214
`Teva
`Exhibit #
`
`Description
`
`Dang, C.N. and Trainor, P., “Pharmacological Management of
`Cushing’s Syndrome: An Update,” Arq. Bras. Endocrinol. Metab.
`51(8):1339-1348 (2007)
`Zhang, L., et al., “Predicting Drug–Drug Interactions: An FDA
`Perspective,” The AAPS Journal 11(2): 300-306 (2009)
`Nguyen, D. and Minze, S., “Effects of Ketoconazole on the
`Pharmacokinetics of Mifepristone, a Competitive Glucocorticoid
`Receptor Antagonist, in Healthy Men,” Adv. Ther. 34:2371–2385
`(2017)
`File History of U.S. Patent No. 10,195,214 B2
`Korlym Label Revised: 05/2017 (2017)
`Kaesar, B., et al., “Drug-Drug Interaction Study of Ketoconazole
`and Ritonavir-Boosted Saquinavir,” Antimicrobial Agents and
`Chemotherapy 53(2): 609–614 (2009)
`Truong, H.L., et al., “Budget impact of pasireotide for the treatment
`of Cushing’s disease, a rare endocrine disorder associated with
`considerable comorbidities,” J. Med. Economics 17(4): 299-295
`(2014)
`Belanoff, J. and Gross, C., “Optimizing Mifepristone Levels for
`Cushing's Patients,” U.S. Patent No. 9,943,526 B2 (filed April 20,
`2016; issued April 17, 2018)
`“A Guide to Drug Safety Terms,” FDA Consumer Health
`Information / U. S. Food and Drug Administration, (2012)
`downloaded from www.tinyurl.com/y6oao2sj
`“Guidance for Industry Drug Interaction Studies — Study Design,
`Data Analysis, and Implications for Dosing and Labeling,” 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) (2006)
`File History for U.S. Patent No. 9,943,526 B2
`
`1032
`
`1033
`
`1034
`
`1035
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`
`
`- 5 -
`
`
`
`PGR2019-00048
`Patent 10,195,214
`Teva
`Exhibit #
`
`Description
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`Corcept Therapeutics Incorporated Announces FDA Approval of
`Korlym(TM) (Mifepristone): First and Only Approved Medication
`for Cushing's Syndrome Patients,” Ex. 99 from Corcept
`Therapeutics Press Release (2012), downloaded from
`https://www.sec.gov/Archives/edgar/data/1088856/0001193125123
`47804/d357533d10q.htm
`Form 8-K, Corcept Therapeutics, Inc. (2012), downloaded from
`https://www.sec.gov/Archives/edgar/data/1088856/0001102624120
`00138/corcepttherapeutics8k.htm
`Form 10-Q, Corcept Therapeutics, Inc. (2012), downloaded from
`https://www.sec.gov/Archives/edgar/data/1088856/0001102624120
`00138/corcepttherapeuticsincorpora.htm
`Greenblatt, D.J, et al., “Ketoconazole inhibition of triazolam and
`alprazolam clearance: Differential kinetic and dynamic
`consequences,” Clin. Pharmacol. Ther. 64(3):237-247 (1998)
`Drugs@FDA: FDA Approved Drug Products, downloaded from
`https://www.accessdata.fda.gov/scripts/cder/daf/
`Korlym (mifepristone) Tablets, 300 mg. 05 April 2016.[
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107_
`korlym_toc.cfm] Internet Archive.
`[https://web.archive.org/web/20160405152243/https://www.accessd
`ata.fda.gov/drugsatfda_docs/nda/2012/202107_korlym_toc.cfm]
`Center For Drug Evaluation and Research. Application Number:
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`[http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107O
`rig1s000Lbl.pdf] Internet Archive.
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`ta.fda.gov/drugsatfda_docs/nda/2012/202107Orig1s000Lbl.pdf]
`
`
`
`- 6 -
`
`
`
`PGR2019-00048
`Patent 10,195,214
`Teva
`Exhibit #
`
`Description
`
`Center For Drug Evaluation and Research. Application Number:
`202107Orig1s000.Clinical Pharmacology and Biopharmaceuticals
`Review(s). 18 February 2017.
`[http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107O
`rig1s000ClinPharmR.pdf] Internet Archive.
`[https://web.archive.org/web/20170218063600/http://www.accessda
`ta.fda.gov/drugsatfda_docs/nda/2012/202107Orig1s000ClinPharmR
`.pdf]
`Center For Drug Evaluation and Research. Application Number:
`202107Orig1s000. Approval Letter. 17 February 2017.
`[http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107O
`rig1s000Approv.pdf]. Internet Archive.
`[https://web.archive.org/web/20170217191413/http://www.accessda
`ta.fda.gov/drugsatfda_docs/nda/2012/202107Orig1s000Approv.pdf]
`Guidance for Industry. Drug Interaction Studies-Study Design, Data
`Analysis, and Implications for Dosing and Labeling. 02 November
`2016. [http://www.fda.gov/cder/guidance/6695dft.pdf] Internet
`Archive.
`[https://web.archive.org/web/20061102162753/http://www.fda.gov/
`cder/guidance/6695dft.pdf]
`FDA Guidance Documents, downloaded from
`https://www.fda.gov/regulatoryinformation/guidances/
`Declaration of Atul Kaushik
`Wilkinson, G., “Pharmacokinetics The Dynamics of Drug
`Absorption, Distribution and Elimination,” in Goodman & Gilmans’
`The Pharmacological Basis of Therapeutics, Tenth Edition,
`Hardman, J., ed., pp. 3-29, McGraw-Hill, New York (2001)
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`escribinginfo.pdf]
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` NEJM 293:702-705 (1975)
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`
`
`
`- 7 -
`
`
`
`PGR2019-00048
`Patent 10,195,214
`Teva
`Exhibit #
`
`Description
`
`1058
`
`1059
`
`1060
`1061
`1062
`
`1063
`
`1064
`
`Greenblatt, D.J. and Abourjaily, P.N., “Pharmacokinetics and
`Pharmacodynamics for Medical Students: A Proposed Course
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`Declaration of J.C. Rozendaal
`Declaration of Uma N. Everett
`Declaration of William H. Milliken
`Consolidation and Scheduling Order, Corcept Therapeutics, Inc. v.
`Teva Pharmaceuticals USA, Inc., Case No. 18-cv-03632 (D.N.J.,
`Feb. 21, 2019)
`Proposed Pretrial Scheduling Order, Corcept Therapeutics, Inc. v.
`Teva Pharmaceuticals USA, Inc., Case No. 18-cv-03632 (D.N.J.,
`Feb. 7, 2019)
`
`
` Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`
`
`
`
`
`
`
` Deborah A. Sterling, Ph.D.
`
`Date: September 23, 2019
` Lead Attorney for Petitioner
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`
`
`
`- 8 -
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that the above-captioned “Petitioner’s
`
`Exhibit List”, along with Exhibits TEVA1063 and 1064, were served in their
`
`entirety upon the Patent Owner on September 23, 2019, via email to the following
`
`individuals:
`
`F. Dominic Cerrito
`Eric C. Stops
`John P. Galanek
`Frank C. Calvosa
`Quinn Emanuel Urquhart & Sullivan, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`johngalanek@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`
`
`
`
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
` Deborah Sterling, Ph.D.
`Date: September 23, 2019
` Lead Attorney for Petitioner
`
`
`
`
`
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
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