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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`NEPTUNE GENERICS, LLC
`Petitioner,
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`v.
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`CORCEPT THERAPEUTICS, INC.
`Patent Owner.
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`____________________
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`Case IPR2018-01494
`Patent No. 8,921,348 B2
`__________________
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`NEPTUNE GENERICS, LLC’S MOTION TO SUBMIT
`LABELED EXHIBITS AND CORRECT EXHIBIT 1008
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`RELIEF REQUESTED
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`Petitioner Neptune Generics, LLC hereby requests entry of attached
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`labeled Exhibits 1001-1034 to replace Exhibits 1001-1034 filed with the
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`original Petition for Inter Partes Review filed in this case on August 2, 2018.
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`The Board may, in its own judgment, after correction, expunge the Exhibits
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`filed with the original Petition.
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`IPR2018-01494
`U.S. Patent No. 8,921,348
`II. STATEMENT OF FACTS AND REASONS FOR THIS MOTION
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`Petitioner electronically filed the original Petition in this case on
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`August 2, 2018, along with Exhibits 1001-1034. The original Exhibits were
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`inadvertently improperly labeled in accordance with 37 C.F.R. § 42.63(d). In
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`addition, the electronically-filed version of Exhibit 1008 was inadvertently
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`misfiled – it was, in fact, a duplicate of Exhibit 1007, and not Exhibit 1008.
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`On August 23, 2018, the Board issued Paper No. 3 in this case, according
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`the Petition the filing date of August 2, 2018, but also stating that “the Petitioner
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`must label each exhibit and correctly file Exhibit 1008. After correction, each
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`exhibit filed August 2, 2018, will be expunged.” Paper No. 3 at 2. “Petitioner must
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`correct the defect(s) within FIVE BUSINESS DAYS from this notice. Failure to
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`correct the defect(s) may result in an order to show cause as to why the Board
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`should institute the trial.” Id.
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`Accordingly, Petitioner now timely files this motion along with the correct
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`and properly labeled Exhibits 1001-1034 in response to the Board’s direction. The
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`Table of Exhibits from the original Petition is reproduced below. Petitioner
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`respectfully requests that the Board grant this motion and enter attached Exhibits
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`1001-1034 into the record.
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`Date: August 28, 2018
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`IPR2018-01494
`U.S. Patent No. 8,921,348
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`Respectfully Submitted,
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`By: /Kenneth M. Goldman/
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`Kenneth M. Goldman
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`Kenneth M. Goldman (Reg. No. 34,174)
`MASSEY & GAIL LLP
`50 E. Washington Street, Suite 400
`Chicago, Illinois 60602
`Telephone: (312) 283-1590
`Fax: (312) 379-0467
`Email: kgoldman@masseygail.com
`Attorneys for Petitioner
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`IPR2018-01494
`U.S. Patent No. 8,921,348
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`Table of Exhibits for Petition for Inter Partes Review Of
`U.S. Patent No. 8,921,348
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`Exhibit
`1001
`1002
`1003
`1004
`1005
`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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`1012
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`1013
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`1014
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`1015
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`U.S. Patent 8,921,348 to Belanoff
`U.S. Application 14/065792 File History
`U.S. Application 12/199114 File History
`Declaration of Mikko A. Oskari Heikinheimo, M.D., Ph.D.
`Curriculum Vitae of Dr. Heikinheimo
`Possible Use of Glucocorticoid Receptor Antagonists in the Treatment of
`Major Depression: Preliminary Results Using RU 486 – Murphy et al. (1993)
`J. Psychiatr Neurosci, Vol. 18, No. 5, 209-213.
`An Open Label Trial of C-1073 (Mifepristone) for Psychotic Major Depression
`by Belanoff et al., Biol. Psychiatry (2002) 52:386-392 .
`Pharmacological properties of mifepristone: toxicology and safety in animal
`and human studies by Sitruk-Ware et al., (2003) Contraception 68, 409–420
`Rapid Reversal of Acute Psychosis in the Cushing Syndrome with the Cortisol-
`Receptor Antagonist Mifepristone (RU 486) by van der Lely et al., Annals of
`Internal Medicine. (1991) 114:143-144.
`U.S. Patent 6,964,953 B2 to Belanoff entitled “Methods for treating stress
`disorder using glucocorticoid receptor specific antagonists” issued November
`15, 2005
`Clinical Pharmacokinetics of Mifepristone, Heikinheimo, Clin. Pharmacokinet.
`1997 July, 33 (I): 7-17 (Ex. 1011)
`“Plasma concentrations and receptor binding of RU 486 and its metabolites in
`humans,” Heikinheimo, et al. J. Steroid Biochem Vol. 26: 279-284, 1987
`Pharmacokinetics of the Antiporgesterone RU 486 in Women During Multiple
`Dose Administration, Heikinheimo, et al. J. Steroid Biochem. Vol. 32, No.
`1A, pp. 21-25, 1989.
`Pharmacokinetics of Mifepristone After Low Oral Doses,
`Kekkonen, et al. Contraception 1996; 54:229-234.
`A Study of the Effect of Mifepristone (Antiprogesterone) Followed by
`Prostaglandin on Uterine Activity and Fetal Heart Rate in Patients Having a
`Termination of Pregnancy,
`Pulkkinen, et al. Arch Gynecol Obstet (1989) 244:75-
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`1016
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`1018
`1019
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`1020
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`IPR2018-01494
`U.S. Patent No. 8,921,348
`Pharmacokinetic study of RU 486 and its metabolites after oral administration
`of single doses to pregnant and non-pregnant women, Shi, et al. Contraception
`August 1993:48, 133-149
`1017 Mifepristone (RU-486) treatment for depression and psychosis: a review of the
`therapeutic implications, Gallagher et al, Neuropsychiatric Disease and
`Treatment 2006:2(1) 33–42
`“Express Scripts – Specialty Drug Update”
`Differential kinetics of serum and cervical insulin-like
`growth factor-binding protein-1 during mifepristone±
`misoprostol-induced medical termination of early
`pregnancy, Honkanen et al., Molecular Human Reproduction Vol. 10, No. 1
`pp. 65-70, 2004.
`Pharmacokinetic Properties of the Antiglucocorticoid and
`Antiprogesterone Steroid RU 486 in Man,” Kawai et al, Pharmacol, And
`Experimental Therapeutics 241:401-406 (1987).
`1021 US 6,150,349 to Schatzberg and Belanoff
`National Center for Biotechnology Information. PubChem Compound
`1022
`Summary for CID 55245; available at
`http://pubchem.ncbi.nlm.nih.gov/compound/55245#section=Top
`Successful Long-Term Treatment of Refractory Cushing’s Disease with High-
`Dose Mifepristone (RU 486), Chu, Belanoff et al. The Journal of Clinical
`Endocrinology & Metabolism 86(8):3568–3573 (2001)
`US 2004/0029848 to Belanoff “Methods for Treating Delirium
`Glucocorticoid Receptor-Specific Antagonists” published February 12, 2004
`“Rapid Reversal of Psychotic Depression Using
`Mifepristone,” Belanoff et al., (2001) Journal of Clinical
`Psychopharmacology Vol. 21, No. 5, 516-521
`US 6,362,173 to Schatzberg and Belanoff
`US 8,450,379 to Belanoff (published 2004-07-08 as US 2004/013270)
`US 7,361,646 to Belanoff (published 2004-08-26 as US 2004/0167110)
`DeBattista C, Belanoff J., “The use of mifepristone in the treatment of
`neuropsychiatric disorders.” Trends Endocrinol Metab. Apr;17(3):117-21.
`Epub 2006 Mar 10.
`DeBattista, Belanoff et al., “Mifepristone versus Placebo in the Treatment of
`Psychosis in Patients with Psychotic Major Depression” Biol Psychiatry. Dec
`15;60(12):1343-9. Epub 2006 Aug 4.
`Annual Report of Corcept Therapeutics Incorporated for the fiscal year ending
`December 31, 2016, Form 10-K available at
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`1026
`1027
`1028
`1029
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`1023
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`1024
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`1025
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`1030
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`1031
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`1032
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`IPR2018-01494
`U.S. Patent No. 8,921,348
`https://www.sec.gov/Archives/edgar/data/1088856/000156459017003493/cort-
`10k_20161231.htm
`Korlym FDA-approved labeling of Feb. 17, 2012 available at
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202107s000lbl.pdf
`1033 Mifeprex FDA-approved labeling of Sept. 28, 2000 available at
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf
`“Successful Treatment of Cushing’s Syndrome with the Glucocorticoid
`Antagonist RU 486”, Nieman et al. Journal of Clinical Endocrinology and
`Metabolism 61:536-540 (1985).
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`1034
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`IPR2018-01494
`U.S. Patent No. 8,921,348
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a true and correct copy of the
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`above-captioned “Neptune Generics, LLC’S Motion to Submit Labeled
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`Exhibits and Correct Exhibit 1008” (and Exhibits 1001-1034 attached thereto)
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`was served by electronic mail on August 28, 2018 upon Patent Owner’s lead
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`and backup counsel at the following email addresses:
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`Robert Steinberg (Reg. No. 33,144)
`Latham & Watkins LLP
`555 Eleventh Street, NW, Ste. 1000
`Washington, DC 20004-1304
`bob.steinberg@lw.com
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`David P. Frazier (Reg. No. 47,576)
`Latham & Watkins LLP
`555 Eleventh Street, NW, Ste. 1000
`Washington, DC 20004-1304
`david.frazier@lw.com
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`Date: August 28, 2018
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`50 E. Washington Street
`Suite 400
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`Chicago, Illinois 60602
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`/Kenneth M. Goldman/
`Kenneth M. Goldman
`Reg. No. 34,174
`Attorney for Petitioner
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