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`On Behalf Of:
`
`Noven Pharmaceuticals, Inc.
`And Mylan Pharmaceuticals Inc.
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`
`NOVEN PHARMACEUTICALS, INC.
`AND MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`_________________________________
`
`
`Inter Partes Review No.: 2014-005501
`
`U.S. Patent No. 6,335,031
`
`PETITIONERS’ OBJECTIONS TO EVIDENCE SUBMITTED BY PATENT
`OWNERS
`
`
`1
`Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`1
`
`Noven Exhibit 1051
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`1 of 7
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioners Noven Pharmaceuticals, Inc.
`
`(“Noven”) and Mylan Pharmaceuticals Inc. (“Mylan” and jointly “Petitioners”)
`
`object to the admissibility of the following exhibits filed by Patent Owners
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG (“Patent Owners”).
`
`
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence, a
`
`reference to “C.F.R.” means the Code of Federal Regulations, “’031 patent”
`
`means U.S. Patent No. 6,335,031, and “’023 patent” means U.S. Patent No.
`
`6,316,023. All objections under F.R.E. 802 (hearsay) apply to the extent that
`
`Patent Owners rely on the exhibits identified in connection with that objection for
`
`the truth of the matters asserted therein.
`
`
`
`Petitioners’ objections are as follows:
`
`Exhibit 2058
`
`Petitioners object to Exhibit 2058 under F.R.E. 901 (lacking authentication)
`
`and F.R.E. 802 (hearsay). Petitioners also object to Exhibit 2058 under F.R.E. 106
`
`(completeness), F.R.E. 402 (relevance), and F.R.E. 403 (confusing, misleading) as
`
`the document is not, contrary to the assertion in Patent Owners’ Exhibit List 5, a
`
`“U.S. Patent No. 4,948,807 Prosecution History,” but instead purports to be a copy
`
`of an abandoned application no. 06/835466, to which the ’807 patent claims
`
`priority. The application for the ’807 patent (Rosin, Exhibit 1008) was accorded
`
`serial number 320,700, according to its face.
`2
`
`
`
`Noven Exhibit 1051
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`2 of 7
`
`
`
`To the extent that Patent Owners attempt to rely on Exhibit 2058 or on any
`
`testimony from the April 20, 2015 deposition of Dr. Kydonieus relating to Exhibit
`
`2058, Petitioners object under F.R.E. 611 and 37 C.F.R. § 42.53(d)(5)(ii) as being
`
`outside the scope of the direct testimony set forth in Dr. Kydonieus’ Reply
`
`Declaration (Ex. 1031). To the extent that Patent Owners attempt to rely on
`
`Exhibit 2058 to rebut any opinions provided by Dr. Kydonieus, Petitioners object
`
`to the use of the document as violating the scheduling order (Paper 11), which set
`
`forth the timing of Patent Owners’ Response and did not provide for a Sur-reply.
`
`Exhibit 2059
`
`Petitioners object to Exhibit 2059 under F.R.E. 802 (hearsay), F.R.E. 901
`
`(lacking
`
`authentication),
`
`and
`
`under F.R.E.
`
`1001
`
`and
`
`1002
`
`(best
`
`evidence). Petitioners also object
`
`to Exhibit 2059 under F.R.E. 106
`
`(completeness), as the document is incomplete and includes only a select portion of
`
`a larger document. Petitioners object to Exhibit 2059 under F.R.E. 402 (relevance)
`
`and F.R.E. 403 (confusing, waste of time) because it is not relevant to any issue in
`
`this IPR proceeding at least because Patent Owners failed to have an expert explain
`
`the significance of the document or how it relates to any issue, opinion or position
`
`by any party in this proceeding. To the extent Patent Owners attempt to rely on
`
`Exhibit 2059 to show the results of stress testing/degradation pathways, Petitioners
`
`
`
`3
`
`Noven Exhibit 1051
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`3 of 7
`
`
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`object under 37 C.F.R. § 42.65 and F.R.E. 1006 at least because Patent Owners
`
`failed to provide supporting facts and data and did not provide an affidavit
`
`providing necessary information. To the extent that Patent Owners attempt to rely
`
`on Exhibit 2059 or on any testimony from the April 18, 2015 deposition of Dr.
`
`Schöneich relating to Exhibit 2059, Petitioners object under F.R.E. 611 and 37
`
`C.F.R. § 42.53(d)(5)(ii) as being outside the scope of the direct testimony set forth
`
`in Dr. Schöneich’s Reply Declaration (Ex. 1032). To the extent that Patent Owners
`
`attempt to rely on Exhibit 2059 to rebut any opinions provided by Dr. Schöneich,
`
`Petitioners object to the use of the document as violating the scheduling order
`
`(Paper 11), which set forth the timing of Patent Owners’ Response and did not
`
`provide for a Sur-reply.
`
`Exhibit 2060
`
`
`
`Petitioners object to Exhibit 2060 under F.R.E. 402 (relevance), F.R.E. 403
`
`(unduly prejudicial, confusing, misleading or cumulative), and under F.R.E. 106
`
`(completeness).
`
`
`
`To the extent that Patent Owners attempt to rely on Exhibit 2060 or on any
`
`testimony from the April 18, 2015 deposition of Dr. Schöneich relating to Exhibit
`
`2060, Petitioners object under F.R.E. 611 and 37 C.F.R. § 42.53(d)(5)(ii) as being
`
`outside the scope of the direct testimony set forth in Dr. Schöneich’s Reply
`
`
`
`4
`
`Noven Exhibit 1051
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`4 of 7
`
`
`
`Declaration (Ex. 1032).
`
`Exhibit 2061
`
`Petitioners object to Exhibit 2061 under F.R.E. 901 (lacking authentication),
`
`F.R.E. 802 (hearsay), F.R.E. 402 (relevance), and F.R.E. 403 (unduly prejudicial,
`
`confusing, misleading or cumulative), as it purports to be testimony but is not in
`
`affidavit form and is self-serving hearsay by Patent Owners’ employee. Petitioners
`
`also object to Exhibit 2061 under F.R.E. 106 (completeness) and F.R.E. 403
`
`(confusing, misleading) as the document is incomplete and includes only a select
`
`portion of a larger document. Petitioners also object to Exhibit 2061 under 37
`
`C.F.R. § 42.53(a) as an incomplete transcript from a proceeding that did not
`
`include Noven or Mylan.
`
`To the extent that Patent Owners attempt to rely on Exhibit 2061 or on any
`
`testimony from the April 20, 2015 deposition of Dr. Kydonieus relating to Exhibit
`
`2061, Petitioners object under F.R.E. 611 and 37 C.F.R. § 42.53(d)(5)(ii) as being
`
`outside the scope of the direct testimony set forth in Dr. Kydonieus’ Reply
`
`Declaration (Ex. 1031). To the extent that Patent Owners attempt to rely on Exhibit
`
`2061 to rebut any opinions provided by Dr. Kydonieus, Petitioners object to the
`
`use of the document as violating the scheduling order (Paper 11), which set forth
`
`the timing of Patent Owners’ Response and did not provide for a Sur-reply.
`5
`
`
`
`Noven Exhibit 1051
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`5 of 7
`
`
`
`
`
`Dated: April 24, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Michael K. Levy/
`Steven J. Lee (Reg. No. 31,272)
`Michael K. Levy (Reg. No. 40,699)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`
`Counsel for Petitioner Noven Pharmaceuticals,
`Inc.
`
`
`
`6
`
`Noven Exhibit 1051
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`6 of 7
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify pursuant to 37 C.F.R. § 42.6(e) that a copy of the foregoing
`
`Petitioners’ Objections to Evidence was served electronically on April 24, 2015 to
`
`counsel
`
`for
`
`Patent Owners
`
`at
`
`the
`
`following
`
`
`address:
`
`ExelonPatchIPR@fchs.com.
`
`Dated: April 24, 2015
`
`
`
`
`
`
`
`
`
`
`
`/Christopher J. Coulson/
`Christopher J. Coulson (Reg. No. 61,771)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: 212-425-7200
`Fax: 212-425-5288
`Counsel for Petitioner Noven Pharmaceuticals,
`Inc.
`
`
`
`
`1
`
`Noven Exhibit 1051
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`7 of 7
`
`
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