Paper No. _______
`Date Filed: January 12, 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 IDENTIFICATION OF PORTIONS
`OF PETITIONERS’ REPLY THAT EXCEED THE
`PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS
`
`
`1 The Board on October 27, 2016 joined Breckenridge’s IPR2016-01023 and
`Roxane’s IPR2016-01103 with Par’s IPR2016-00084 challenging claims 1-3 and
`8-10 of the ’772 patent.
`
`
`
`
`Date Filed: January 12, 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 IDENTIFICATION OF PORTIONS
`OF PETITIONERS’ REPLY THAT EXCEED THE
`PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS
`
`
`1 The Board on October 27, 2016 joined Breckenridge’s IPR2016-01023 and
`Roxane’s IPR2016-01103 with Par’s IPR2016-00084 challenging claims 1-3 and
`8-10 of the ’772 patent.
`
`
`
`
`
`
`
`Pursuant to the Board’s email of January 6, 2017, Novartis submits the
`
`following numbered list setting forth the portions of Petitioners’ Reply (Paper 46)
`
`that exceed the proper scope of reply or raise new arguments, along with a one-
`
`sentence statement of the basis for the objection.
`
`1.
`
`Page 3, line 20 – page 4, line 3, and page 4, lines 13-15. Petitioners
`
`assert a new basis for selecting rapamycin as a lead compound (“potency”) that
`
`could and should have been raised as part of their prima facie case, but was not
`
`included in the Petition.
`
`2.
`
`Page 4, lines 10-12 and 17-20 (see also page 1, lines 17-20).
`
`Petitioners assert a new basis for selecting rapamycin as a lead compound
`
`(“researchers regularly selected rapamycin”) that relies on evidence (exhibits cited
`
`in Ex. 2093 ¶¶ 63-83) that could and should have been raised as part of their prima
`
`facie case, but were not included in the Petition.
`
`3.
`
`Page 6, lines 3-16. Petitioners rely on new evidence (Ex. 1034 at 116;
`
`Ex. 1118 ¶¶ 25-26) to assert that it was known in the art that rapamycin’s solubility
`
`led to formulation problems, when this argument and evidence could and should
`
`have been raised as part of their prima facie case, but were not included in the
`
`Petition.
`
`4.
`
`Page 6, lines 5-16. Petitioners rely on new evidence (Ex. 1034; Ex.
`
`1118 ¶¶ 26, 32-35) to assert a motivation to chemically modify rapamycin, when
`
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`1
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`
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`this evidence could and should have been raised as part of their prima facie case,
`
`but was not included in the Petition.
`
`5.
`
`Page 10, lines 10-12 and 14-17. To the extent Petitioners are arguing
`
`that (i) Lemke (Ex. 1008) discusses internal entropy and/or (ii) Yalkowsky (Ex.
`
`1007) discusses polar groups and hydrophilicity, these arguments could and should
`
`have been raised as part of their prima facie case, but were not included in the
`
`Petition.
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`6.
`
`Page 12, line 1 – page 14, line 9, and page 15, line 13 – page 16, line
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`1. Petitioners attempt to explain how Yalkowsky is relevant to the instant case,
`
`including why everolimus qualifies as a long-chain derivative of rapamycin with
`
`more than 6 atoms in the chain, when such arguments and evidence could and
`
`should have been raised as part of their prima facie case, but were not included in
`
`the Petition, and when Petitioners’ declarant, Dr. Jorgensen, refused to answer
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`questions at his August 9, 2016 deposition about the length of everolimus’s side
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`chain (see Novartis’s Patent Owner Response, Paper 27 at 22 and 22 n.4).
`
`7.
`
`Page 16, lines 1-9. Petitioners attempt to explain the relationship
`
`between ideal solubility and real systems, and rely on new evidence (Ex. 1118 ¶¶
`
`13, 92-102 and exhibits cited therein including Ex. 1117), when such arguments
`
`and evidence could and should have been raised as part of their prima facie case,
`
`but were not included in the Petition.
`
`
`
`2
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`
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`
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`8.
`
`Pages 17-18, footnote 6. Petitioners rely on new evidence (Ex. 1119
`
`¶¶ 32-36, 43, 101-106 and exhibits and evidence cited therein) and make a new
`
`argument that everolimus’s antitumor activity would have been reasonably
`
`expected as of October 1992, when this evidence and argument that could and
`
`should have been raised as part of their prima facie case, but were not included in
`
`the Petition.
`
`9.
`
`Page 19, lines 10-13. Petitioners assert a new basis to assert that
`
`everolimus would have been expected to “retain[] immunosuppressant activity”
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`that relies on evidence (Ex.1118 ¶¶103-108, and exhibits cited therein, and exhibits
`
`cited in Ex. 2092 ¶ 63) that could and should have been raised as part of their
`
`prima facie case, but was not included in the Petition.
`
`
`
`
`
`
`
`
`Dated: January 12, 2017
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`
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`
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`Respectfully submitted,
`
`
`
`
`
`
`
`/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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`3
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`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Identification of
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`Portions of Petitioners’ Reply that Exceed the Proper Scope of Reply or Raise New
`
`Arguments was served on January 12, 2017 by causing it to be sent by email to
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`counsel for Petitioners at the following email addresses:
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`Daniel G. Brown (dan.brown@lw.com)
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`Robert Steinberg (bob.steinberg@lw.com)
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`Brenda L. Danek (Brenda.danek@lw.com)
`
`
`
`Jonathan M. Strang (jonathan.strang@lw.com)
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`Matthew L. Fedowitz (mfedowitz@merchantgould.com)
`
`B. Jefferson Boggs (jboggs@merchantgould.com)
`
`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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`
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`Dated: January 12, 2017
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`4
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`
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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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