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`Filed on behalf of: Par Pharmaceutical, Inc.
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`Filed: September 22, 2017
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`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
`U.S. Patent No. 9,006,224
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
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`PETITIONER’S RESPONSE TO PATENT OWNER’S SUR-REPLY
`
`
`Pursuant to the Board’s email of September 20, 2017 (Ex. 1127), Petitioner
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`Par Pharmaceutical, Inc. (“Par”) submits this one-page table in response to
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`Novartis’s Sur-Reply (Paper 26).
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`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`Novartis’s Alleged “New” Argument
`(using Novartis’s numbering)
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`(1) CA20948 is a model for NETs
`(citing Pet. 32, Reply 17)
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`(2) Citation to AR42J cell line as a
`model for NETs (citing Reply 17-18)
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`(3) Alleged new combination of Oberg
`2004 and Duran (citing Pet. 4, Reply 4,
`13-16, 18-20)
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`(4) Discussion of Duran’s government
`funding and support for connection
`between NETs and mTOR
`
`(5) Citation to Merck & Co. v. Teva
`Pharm. USA, Inc., 395 F.3d 1364 (Fed.
`Cir. 2005)
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`(6) Citation to the ’224 specification
`and Exs. 1123 and 1124 characterizing
`class of mTOR inhibitors
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`Citation to Record Where Argument
`Was Previously Presented
`or
`Responds to Argument Raised by
`Novartis in Response
`Pet. 43; Ex. 1003, ¶¶ 112, 117, 137
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`POR 30-33, 42-43; Ex. 2041, ¶¶ 131,
`132, 135, 136; Ex. 1070, 62:2-64:19,
`68:21-70:3
`
`POR 29-30, 42-46, 48-52; Ex. 2041
`¶¶214-217 (no reasonable expectation
`of success)
`POR 15-21 (role of mTOR inhibitors in
`NETs uncertain); Pet. 29-32, 36-37
`
`POR 15-21, 48-52; Ex. 2041, ¶¶ 66-99,
`212-219
`
`No response necessary
`
`Pet. 22-25, 27-28, Ex. 1003, ¶¶ 75-78,
`86-87, 90-92
`POR 15-18, 28; Ex. 2041, ¶¶ 220-223,
`229-239
`
`(7) Prior cytotoxic chemotherapy is
`irrelevant
`
`Identification of exhibits not
`(8)
`explicitly cited in the Reply
`
`No response necessary
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`No response necessary
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`1
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`Dated: September 22, 2017
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`Respectfully submitted,
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`By: /Daniel G. Brown/
`
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`
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`Daniel G. Brown (Reg. No. 54,005)
`daniel.brown@lw.com
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
`
`Counsel for Petitioner Par
`Pharmaceutical, Inc.
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`2
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 2 2 n d day of
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`September, 2017, a copy of Petitioner’s Response to Patent Owner’s Sur-reply
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`was served by electronic mail on Patent Owner’s lead and backup counsel at the
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`following email addresses:
`
`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Charlotte Jacobsen (pro hac vice)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`By: /Daniel G. Brown/
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`
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`Daniel G. Brown (Reg. No. 54,005)
`daniel.brown@lw.com
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
`
`Counsel for Petitioner Par
`Pharmaceutical, Inc.
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`3
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