Paper No. __
`Date Filed: January 31, 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.,
`BRECKENRIDGE PHARMACEUTICAL, INC. AND
`ROXANE LABORATORIES, INC.
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`Case IPR2016-000841
`U.S. Patent 5,665,772
`
`
`
`PATENT OWNER’S OBJECTIONS TO PETITIONERS’
`DEMONSTRATIVE EXHIBITS FOR ORAL HEARING
`
`
`
`
`1 Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
`
`
`Date Filed: January 31, 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.,
`BRECKENRIDGE PHARMACEUTICAL, INC. AND
`ROXANE LABORATORIES, INC.
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`Case IPR2016-000841
`U.S. Patent 5,665,772
`
`
`
`PATENT OWNER’S OBJECTIONS TO PETITIONERS’
`DEMONSTRATIVE EXHIBITS FOR ORAL HEARING
`
`
`
`
`1 Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
`
`
`
`
`
`Pursuant to the Board’s January 17, 2017 Order regarding the Trial Hearing,
`
`Patent Owner Novartis AG (“Novartis”) objects to the following demonstratives
`
`served on January 24, 2017, by Petitioners Par Pharmaceuticals, Inc., Roxane
`
`Laboratories, Inc., and Breckenridge Pharmaceutical, Inc. (“Petitioners”) on the
`
`grounds set forth below. Pursuant to the Board’s Order, the parties held a meet and
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`confer on January 30, 2017, to discuss their respective objections to demonstrative
`
`exhibits, but were unable to resolve the objections set forth below.
`
`I.
`
`Novartis’s Objections To Petitioners’ Slides Containing
`New Arguments Not Presented In The Petition Or Reply
`
`Slide 35: Novartis objects to the second bullet and the box that follows
`
`thereafter in Slide 35, set forth below:
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`
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`Novartis objects to this bullet and box as an improper new argument because
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`Petitioners have not previously argued in the Petition or Reply, nor has Novartis
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`admitted in the Patent Owner Response (Paper 27 at 11) or Klibanov Declaration
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`(Ex. 2092 ¶¶ 45-46 & n.5), that Lemke’s solubility teachings are limited to
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`“hydrophilicity,” Petitioners have not previously included the equation in the box
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`above in the Petition or Reply, and the Petitioners have not previously cited or
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`relied on Klibanov Decl. ¶ 46 & n.5.
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`1
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`Slides 43, 51, 53: Novartis objects to item number 2 in Slides 43, 51, and
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`53, set forth below:
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`
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`Novartis objects to item number 2 as an improper new argument because
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`Petitioners have not disputed that everolimus satisfied a long-felt but unmet need
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`for an immunosuppressant regimen for liver transplant recipients, as set forth in the
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`Patent Owner Response, Paper 27 at 68.
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`Slide 49: Novartis objects to the first bullet in Slide 49, set forth below:
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`
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`Novartis objects to this bullet as an improper new argument because Petitioners
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`have not previously argued in the Petition or Reply that “[c]yclosporine interferes
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`with metabolism of everolimus and rapamycin, leading to increase in plasma
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`concentrations,” and Petitioners’ citation to Ratain Decl. ¶ 46 as support for their
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`reliance on these exhibits would constitute an improper incorporation by reference.
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`
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`Slide 52: Novartis objects to the bullets under the second heading in Slide
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`52, set forth below:
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`2
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`
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`Novartis objects to each of these bullets as improper new arguments because
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`Petitioners have not previously argued in the Petition or Reply that a need remains
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`for breast cancer treatment or that other treatments for breast cancer are superior to
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`everolimus.
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`II. Novartis’s Objections To Petitioners’ Slides Citing New
`Evidence Not Previously Cited In The Petition Or Reply
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`
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`Slide 37: Novartis objects to the second sub-bullet in Slide 37, set forth
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`below:
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`Novartis objects to this sub-bullet and citation to Ex. 1117 as an improper new
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`argument because Petitioners have not previously cited Ex. 1117 in the Petition or
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`
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`Reply.
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`Slide 46: Novartis objects to the sub-bullets listed under the third main
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`bullet in Slide 46, set forth below:
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`3
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`Novartis objects to Petitioners’ citation to and discussion of Exs. 2178, 2177, 2173,
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`1087, 1088, 2163, 1098, 1099, and 1093 in these sub-bullets as an improper new
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`argument because Petitioners have not previously cited these exhibits in the
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`Petition or Reply to assert that everolimus’s antitumor activity is no different than
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`rapamycin’s, and Petitioners’ citation to Ratain Decl. ¶¶ 62-100 as support for their
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`reliance on these exhibits constitutes an improper incorporation by reference.
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`
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`Slide 48: Novartis objects to Petitioners’ citation of Ex. 1120 and Fig. 1 in
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`Slide 48, set forth below:
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`
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`Novartis objects to Petitioners’ citation of Ex. 1120 and reliance on Fig. 1 of Ex.
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`1120 as an improper new argument because Petitioners have not previously cited
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`Ex. 1120 in the Petition or Reply, and Petitioners’ citation to Ratain Decl. ¶¶ 101-
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`108 as support for their reliance on these exhibits constitutes an improper
`
`incorporation by reference.
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`
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`4
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`
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`III. Novartis’s Objections To Petitioners’
`Slides Containing Improper Reply Arguments2
`
`Slide 21: Novartis objects to the second bullet and following box in Slide
`
`21, set forth below:
`
`
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`Novartis objects to this bullet and box as an improper new basis for selecting
`
`rapamycin as a lead compound (that rapamycin was more potent than CsA or
`
`FK506 and that a person of ordinary skill in the art would be attracted to the most
`
`potent compounds) that could and should have been raised as part of their prima
`
`facie case, but was not included in the Petition (see, Paper 63 ¶ 1).
`
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`2 As permitted by the Board, Novartis previously objected to certain arguments
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`and/or exhibits that Petitioners improperly included in the Reply (Paper 46), as set
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`forth in Patent Owner’s Identification Of Portions Of Petitioners’ Reply That
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`Exceed The Proper Scope Of Reply Or Raise New Arguments, Paper 63.
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`Petitioners have included those improper arguments and/or exhibits in Petitioners’
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`Slides 21, 24, 27, 34, and 37, as explained herein. Novartis, however, maintains its
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`objections presented in Paper 63.
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`5
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`Slide 24: Novartis objects to the second bullet and statement quoted from
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`Ex. 1034 in Slide 24, set forth below:
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`
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`Novartis objects to this bullet and the statement quoted from Ex. 1034 as an
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`improper reply argument because Petitioners rely on new evidence (Ex. 1034 at
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`116) to assert that it was known in the art that rapamycin’s solubility led to
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`formulation problems, when this argument and evidence could and should have
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`been raised as part of their prima facie case, but were not included in the Petition
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`(see Paper 63 ¶ 3).
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`Slide 27: Novartis objects to the first bullet and statement quoted from
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`Exhibit 1034 in Slide 27, set forth below:
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`Novartis objects to the bullet and the statement from Ex. 1034 quoted thereafter as
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`an improper reply argument because Petitioners rely on new evidence (Ex. 1034)
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`to assert a motivation to chemically modify rapamycin, when this evidence could
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`6
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`and should have been raised as part of their prima facie case, but was not included
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`in the Petition (see Paper 63 ¶ 4).
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`
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`Slide 34: Novartis objects to the following figure in Slide 34:
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`
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`Novartis objects to this figure as an improper reply argument because Petitioners
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`attempt to explain why everolimus qualifies as a long-chain derivative of
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`rapamycin with more than 6 atoms in the chain, when such arguments and
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`evidence could and should have been raised as part of their prima facie case, but
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`were not included in the Petition, and when Petitioners’ declarant, Dr. Jorgensen,
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`refused to answer questions at his August 9, 2016 deposition about the length of
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`everolimus’s side chain (see Novartis’s Patent Owner Response, Paper 27 at 22
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`and 22 n.4; see also Paper 63 ¶ 6).
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`
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`Slide 37: Novartis objects to the second sub-bullet in Slide 37, set forth
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`below:
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`
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`7
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`
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`Novartis objects to this sub-bullet and citation to Ex. 1117 as an improper reply
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`argument attempting to explain the relationship between ideal solubility and real
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`systems when such arguments and evidence could and should have been raised as
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`part of their prima facie case, but were not included in the Petition (see Paper 63
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`Respectfully submitted,
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`8
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`¶ 7).
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`Dated: January 31, 2017
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`/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
`
`
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`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Objections To
`
`Petitioners’ Demonstrative Exhibits For Oral Hearing was served on January
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`31, 2017, by causing it to be sent by email to counsel for Petitioners at the
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`following email addresses:
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`Daniel G. Brown (daniel.brown@lw.com)
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`Robert Steinberg (bob.steinberg@lw.com)
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`Brenda L. Danek (Brenda.danek@lw.com)
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`
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`Jonathan M. Strang (jonathan.strang@lw.com)
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`Matthew L. Fedowitz (mfedowitz@merchantgould.com)
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`B. Jefferson Boggs (jboggs@merchantgould.com)
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`Daniel R. Evans (devans@merchantgould.com)
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`Keith A. Zullow (kzullow@goodwinlaw.com)
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`Marta Delsignore (mdelsignore@goodwinprocter.com)
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`Dated: January 31, 2017
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`1
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`/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
`
`
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