Paper No. ____
`Date filed: September 5, 2017
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2016-01479
`
`Patent No. 9,006,224
`
`
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 7
`
`
`
`
`
`
`
`
`Date filed: September 5, 2017
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2016-01479
`
`Patent No. 9,006,224
`
`
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 7
`
`
`
`
`
`
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
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`2001
`
`Expert Declaration Of Matthew H. Kulke,
`M.D., M.M.Sc. (November 18, 2016)
`
`Kulke Decl.
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`2002
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`M.D., M.M.Sc. (May 20, 2016)
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`
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`Of The California Cancer Consortium,”
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`
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`(2005), pages 1844-1849 (Entry for
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`Pharms. Inc., (C.A. No. 10-528-GMS),
`(D. Del. November 29, 2012), Pages 778-
`79, 950, 995
`
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`of M. Ratain, Novartis v. Breckenridge,
`Roxane and Par (C.A. Nos. 14-1043-
`RGA, 14-1196-RGA and 14-1289-RGA)
`(D. Del. August 31, 2016), Pages 769-
`772, 957, 993-94, 1003, 1010, 1012, 1014
`
`Excerpts of Transcript of Deposition of
`M. Ratain, Novartis v. Breckenridge,
`Roxane and Par (C.A. Nos. 14-1043-
`RGA, 14-1196-RGA and 14-1289-RGA)
`(D. Del. Apr. 11, 2016), Pages 1-5, 34,
`156, 340
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`Mammalian Target Of Rapamycin,”
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`(served
`but not
`filed)
`
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`Regarding Exhibits 2016, 2022, And
`2028
`
`2030
`(served
`but not
`filed)
`
`The New England Journal of Medicine,
`Publication Process, available at
`http://www.nejm.org/page/media-
`center/publication-process
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`2031
`(served
`but not
`filed)
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`Scope, available at
`http://www.nature.com/bjc/about/aims_sc
`ope.html
`
`2032
`(served
`but not
`filed)
`
`Transcript of Trial Testimony of M.
`Ratain, Pfizer Inc. et al. v. Mylan
`Pharms. Inc., (C.A. No. 10-528-GMS),
`(D. Del. November 29, 2012)
`
`2033
`(served
`but not
`filed)
`
`Transcript of Trial Testimony of M.
`Ratain, Novartis v. Breckenridge, Roxane
`and Par (C.A. Nos. 14-1043-RGA, 14-
`1196-RGA and 14-1289-RGA) (D. Del.
`August 31, 2016)
`
`Transcript of Deposition of M. Ratain,
`Novartis v. Breckenridge, Roxane and
`Par (C.A. Nos. 14-1043-RGA, 14-1196-
`RGA and 14-1289-RGA) (D. Del. Apr.
`11, 2016)
`
`Declaration Of Julie Masow Pursuant to
`Fed. R. Evid. 902(11)
`
`2034
`(served
`but not
`filed)
`
`2035
`(served
`but not
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`
`
`
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`
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`(2004), pages 1812-1817 (Entry for
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`
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`37 C.F.R. § 42.10
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`Evaluate The Response To Treatment In
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`The Digestive System, pages 219-
`251(Hamilton, S.R. & Aaltonen, L.A.
`eds. 2000)
`
`World Health Organization, Chapter 4,
`“Tumours Of The Endocrine Pancreas,”
`World Health Organization
`Classification Of Tumours, Pathology
`And Genetics, Tumours Of Endocrine
`Organs, pages 183-208 (DeLellis, R.A. et
`al., eds. 2004)
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`
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`
`
`
`14
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`“Wyeth Pharmaceuticals Announces
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`With Oral Temsirolimus In Women With
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`3 Studies With I.V. Temsirolimus In
`Renal Cell Carcinoma And Mantle Cell
`Lymphoma Continue,” Wyeth
`Pharmaceuticals (March 16, 2006)
`
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`(streptozocin) (accessed 5/8/2017)
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`
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`Study With Sunitinib Malate (SU11248)
`In Patients (pts) With Advanced
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`Review No. 2016-00084) (Pat. Tr. App.
`Bd. December 16, 2016), Pages 1-5, 119-
`120, 141
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`Ponnusamy, S., et al., “Deciphering The
`Inactivation Of Human Pancreatic α-
`Amylase, An Anti-Diabetic Target, By
`Bisdemethoxycurcumin, A Small
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`Yoshikumi, Y.K., et al., “Up Regulation
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`Diabetic Regenerating Islets,” Endocrine
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`
`
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`
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`
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`
`
`
`
`
`
`
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`(served
`but not
`filed)
`
`Arnold, R., et al., Chapter
`15,“Neuroendocrine Gastro-Entero-
`Pancreatic (GEP) Tumors,”
`Gastrointestinal And Liver Tumors, pages
`195-233 (Scheppach, W., et al., eds.
`2004)
`
`2110
`(served
`but not
`filed)
`
`National Cancer Institute, National
`Institutes of Health, U.S. Department of
`Health and Human Services, 2005 Fact
`Book (2005), available at
`https://www.cancer.gov/about-
`nci/budget/fact-book/archive/2005-fact-
`book.pdf (accessed 08/25/2017)
`
`2111
`
`Transcript Of The August 28, 2017
`Deposition Of Mark J. Ratain
`
`2112
`(served
`but not
`filed)
`
`National Cancer Institute, National
`Institutes of Health, U.S. Department of
`Health and Human Services, 2004 Fact
`Book (2004), available at
`https://www.cancer.gov/about-
`nci/budget/fact-book/archive/2005-fact-
`book.pdf (accessed 09/05/2017)
`
`2113
`(served
`but not
`filed)
`
`Transcript of Deposition of M. Ratain,
`Novartis v. Par (Inter Partes Review No.
`2016-00084) (Pat. Tr. App. Bd.
`December 16, 2016)
`
`2114
`(served
`but not
`filed)
`
`Torisel® (temsirolimus) Label (July
`2017), available at
`https://www.accessdata.fda.gov/drugsatfd
`a_docs/label/2016/022088s019lbl.pdf
`(accessed 06/01/2017)
`
`
`
`17
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2115
`(served
`but not
`filed)
`
`Afinitor® (everolimus) Label (June
`2016), available at
`https://www.accessdata.fda.gov/drugsatfd
`a_docs/label/2016/022334s038lbl.pdf
`(accessed 06/01/2017)
`
`
`
`
`
`18
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 7 was
`
`served on September 5, 2017 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`
`Daniel G. Brown (daniel.brown@lw.com)
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`Brenda L. Danek (brenda.danek@lw.com)
`
`
`
`Dated: September 5, 2017
`
`
`
`
`
`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`
`
`
`
`19
`
`
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