Paper No. ____
`Date filed: October 2, 2020
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@venable.com
`(212) 218-2100
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`PAR PHARMACEUTICAL, INC.,
`ARGENTUM PHARMACEUTICAL LLC, AND
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED
`Petitioners,
`v.
`NOVARTIS AG,
`Patent Owner.
`
`
`
`
`Case IPR2016-014791
`Patent No. 9,006,224
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 11
`
`
`
`
`
`1 IPR2017-01063 and IPR2017-01078 have been joined to this proceeding (Paper
`33, September 25, 2017). Par Pharmaceutical Inc. has been terminated as a party to
`this proceeding (Paper 52, February 7, 2018).
`
`
`
`
`Date filed: October 2, 2020
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@venable.com
`(212) 218-2100
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`PAR PHARMACEUTICAL, INC.,
`ARGENTUM PHARMACEUTICAL LLC, AND
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED
`Petitioners,
`v.
`NOVARTIS AG,
`Patent Owner.
`
`
`
`
`Case IPR2016-014791
`Patent No. 9,006,224
`
`
`
`
`PATENT OWNER’S EXHIBIT LIST 11
`
`
`
`
`
`1 IPR2017-01063 and IPR2017-01078 have been joined to this proceeding (Paper
`33, September 25, 2017). Par Pharmaceutical Inc. has been terminated as a party to
`this proceeding (Paper 52, February 7, 2018).
`
`
`
`
`
`
`
`
`
`Description
`Expert Declaration Of Matthew H. Kulke,
`M.D., M.M.Sc. (November 18, 2016)
`
`Abbreviation
`
`Kulke Decl.
`
`Curriculum Vitae of Matthew H. Kulke,
`M.D., M.M.Sc. (May 20, 2016)
`
`Kulke C.V.
`
`Exhibit
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`
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`Cancer: A Glossary Of Cancer-Related
`Terms, page 4 (2002)
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`
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`Urology 163:408-417 (2000)
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`Surgical, & Radiation Oncology, 9th
`Edition (2005)
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`
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`
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`22(23):4762-4771 (2004)
`
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`
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`Gemcitabine For Metastatic
`Neuroendocrine Tumors,” Cancer
`101(5): 934-939 (2004)
`
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`Metastatic Melanoma: A Phase II Trial
`Of The California Cancer Consortium,”
`Cancer 104(5): 1045-1048 (2005)
`
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`
`Delaunoit
`
`Kulke 2003a
`
`Kulke 2004
`
`Margolin
`
`“Novartis Drug Afinitor Is First
`Treatment For Advanced Pancreatic NET
`To Provide Overall Survival Of More
`Than 3.5 Years In Phase III Trial,”
`
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`
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`
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`
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`(2005), pages 1844-1849 (Entry for
`Gemzar® (Gemcitabine HCl))
`
`Gemzar®
`Prescribing
`Information 2005
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`Tumors,” N. Eng. J. Med. 340(11): 858-
`868 (1999)
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`of M. Ratain, Pfizer Inc. et al. v. Mylan
`Pharms. Inc., (C.A. No. 10-528-GMS),
`(D. Del. November 29, 2012), Pages 778-
`79, 950, 995
`
`Excerpts of 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), 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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`
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`but not
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`Declaration of Nicholas N. Kallas
`Regarding Exhibits 2016, 2022, And
`2028
`
`
`
`4
`
`
`
`2030
`(served
`but not
`filed)
`
`2031
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`but not
`filed)
`
`2032
`(served
`but not
`filed)
`
`2033
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`but not
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`but not
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`but not
`filed)
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`Publication Process, available at
`http://www.nejm.org/page/media-
`center/publication-process
`
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`Scope, available at
`http://www.nature.com/bjc/about/aims_sc
`ope.html
`
`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)
`
`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)
`
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`Evaluate The Response To Treatment In
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`92(3): 205-216 (2000)
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`Structure Of The Rapamycin Human
`Immunophilin FKBP-12 Complex,” J.
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`Expression In Gastroenteropancreatic
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`675 (1997)
`World Health Organization, Chapter 10,
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`The Digestive System, pages 219-
`251(Hamilton, S.R. & Aaltonen, L.A.
`eds. 2000)
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`“Tumours Of The Endocrine Pancreas,”
`World Health Organization
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`Termination Of Phase 3 Clinical Program
`With Oral Temsirolimus In Women With
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`3 Studies With I.V. Temsirolimus In
`Renal Cell Carcinoma And Mantle Cell
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`Review No. 2016-00084) (Pat. Tr. App.
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`Ratain Dep. Tr. II
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`Book (2005), available at
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`nci/budget/fact-book/archive/2005-fact-
`book.pdf (accessed 08/25/2017)
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`2107
`
`2108
`
`2109
`
`2110
`
`2111
`
`Transcript Of The August 28, 2017
`Deposition Of Mark J. Ratain
`
`2112
`(served
`
`National Cancer Institute, National
`Institutes of Health, U.S. Department of
`
`16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`but not
`filed)
`
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`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)
`
`2115
`(served
`but not
`filed)
`
`Torisel® (temsirolimus) Label (July
`2017), available at
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`a_docs/label/2016/022088s019lbl.pdf
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`
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`
`2116
`
`2117
`
`2118
`
`Email chain between Andrew Kellogg,
`Supervisory Paralegal, USPTO and Jared
`L. Stringham, Attorney, Fitzpatrick,
`Cella, Harper & Scinto (Sept. 20-25,
`2017)
`
`December 14, 2017 Trial Opinion in
`Novartis Pharm. Corp. v. West-Ward
`Pharm. Int’l Ltd., No. 15-cv-474-RGA
`(D. Del.) (D.I. 100)
`
`Confidential settlement agreement
`between Petitioner Par and Patent Owner
`Novartis [request submitted to treat as
`
`17
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`business confidential information and
`keep separate from the file of the
`involved patent]
`
`2119
`
`Confidential settlement agreement
`between Petitioner Hikma and Patent
`Owner Novartis [request submitted to
`treat as business confidential
`information and keep separate from the
`file of the involved patent]
`
`2120
`
`Protective Order submitted by Petitioner
`Hikma and Patent Owner Novartis
`governing Exhibit 2119
`
`
`
`
`
`
`
`
`18
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 11 was
`
`served on October 2, 2020 by causing it to be sent by email to counsel for
`
`Petitioners at the following email addresses:
`
`
`Kevin Laurence (klaurence@lpiplaw.com)
`
`Matthew Phillips (mphillips@lpiplaw.com)
`
`Tyler C. Liu (tliu@agpharm.com)
`
`Keith A. Zullow (kzullow@goodwinprocter.com)
`
`Marta E. Delsignore (mdesignore@goodwinprocter.com)
`
`
`
`Dated: October 2, 2020
`
`
`
`
`
`
`
`
`
`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`VENABLE LLP
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`19
`
`
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