Paper No. 16
`Date Filed: December 14, 2016
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`
`
`PATENT OWNERS’ OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED BY PETITIONERS DURING
`A PRELIMINARY PROCEEDING
`
`
`
`
`
`
`
`
`Date Filed: December 14, 2016
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`
`
`PATENT OWNERS’ OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED BY PETITIONERS DURING
`A PRELIMINARY PROCEEDING
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Alkermes Pharma Ireland Limited and
`
`Alkermes Controlled Therapeutics, Inc. (“Patent Owners”) object to the
`
`admissibility of the following exhibits on the grounds set forth below. All evidence
`
`objected to below was submitted by Petitioners Luye Pharma Group Limited, Luye
`
`Pharma (USA) Limited, Shandong Luye Pharmaceutical Company, Limited, and
`
`Nanjing Luye Pharmaceutical Co., Limited, (“Petitioners” or “Luye”) with their
`
`Petition seeking inter parties review of U.S. Patent No. 6,667,061 (“the ’061
`
`patent”). The Board partially instituted review of the ’061 patent on November 30,
`
`2016. See Paper 13. Therefore, these objections are timely.
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence,
`
`and a reference to “C.F.R.” means the Code of Federal Regulations. All objections
`
`under F.R.E. 802 (hearsay) apply to the extent Petitioners rely on the exhibits
`
`identified in connection with that objection for the truth of the matters asserted
`
`therein.
`
`Patent Owners object as follows:
`
`
`Exhibit 1001: ’061 Patent
`
`Patent Owners object to Exhibit 1001 under F.R.E. 802 and 37 C.F.R
`
`§ 42.61(c) (hearsay).
`
`
`
`
`
`1
`
`
`
`Exhibit 1002: Declaration of Dr. Patrick P. DeLuca
`
`Patent Owners object to Exhibit 1002 under F.R.E. 802 (hearsay), 702
`
`(improper expert testimony) and 703 (bases for expert opinion) as the testimony is
`
`not based on sufficient facts or data, is not the product of reliable principles and
`
`methods, and the principles and methods have not been reliably applied to the facts
`
`of the case.
`
`Patent Owners object to Exhibit 1002 under 35 U.S.C. § 312(a)(3); 37
`
`C.F.R. §§ 42.65(a) and 42.104(b)(5); and F.R.E. 702 (improper expert testimony),
`
`402 (relevance), and 403 (confusing, waste of time) for failing to identify with
`
`particularity the underlying facts and data on which the opinion is based: ¶¶ 9-13,
`
`25, 33, 34, 39, 46, 48, 50-52, 60-62, 66-68, 71, 74-75, 78, 80-86 fail to cite any
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`support at all, or include at least one statement that does not cite any support; and
`
`¶¶ 20, 36, 40, 42, 44 cite or refer to entire exhibits without identifying which
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`aspects of those references are relied upon.
`
`Patent Owners also object to Exhibit 1002 ¶¶ 1-3, 17, 23, 31, 33, 45-46, 83-
`
`91 under F.R.E. 402 (relevance) and 403 (confusing, waste of time) as these
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`paragraphs are not cited in the Petition.
`
`Patent Owners further object to Exhibit 1002 ¶¶ 32, 64-66, 72-74 under
`
`F.R.E. 402 (relevance) and 403 (confusing, waste of time) as these paragraphs are
`
`
`
`2
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`
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`not cited in the Petition with respect to grounds for which inter partes review was
`
`instituted.
`
`Patent Owners also object to Exhibit 1002 ¶¶ 10, 14-32, 34-44, 47-65, 67-
`
`73, 75-82 under F.R.E. 702 (improper expert testimony), 703 (bases of an expert
`
`opinion), 402 (relevance), and 403 (confusing, waste of time) as these paragraphs
`
`include expert opinion based on documents that are inadmissible under at least
`
`F.R.E. 802 (hearsay), 702 (improper expert testimony), 703 (bases of an expert
`
`opinion), 402 (relevance), or 403 (confusing, waste of time). Patent Owners further
`
`object to Exhibit 1002 ¶ 25 because it cites to an exhibit number that does not exist
`
`in the Petitioners’ exhibit list.
`
`Patent Owners also object to Exhibit 1002 ¶¶ 36, 55, 66, 68, 74-77, 80, 82-
`
`86 under F.R.E. 702 (improper expert testimony), 703 (bases of an expert opinion),
`
`402 (relevance), and 403 (confusing, waste of time). The declarant is not stated to
`
`have expertise with respect to legal patent analysis. The exhibit does not include a
`
`section discussing the legal framework upon which his invalidity opinions are
`
`based. Additionally, the declarant does not specify the basis for his arguments or
`
`conclusions on invalidity, including at least obviousness. Thus, the declarant has
`
`not based the opinions in this exhibit on proper legal standards.
`
`
`
`
`
`3
`
`
`
`Exhibit 1005: WO 95/13799 (“Ramstack”)
`
`Patent Owners object to Exhibit 1005 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time). Patent Owners also object to
`
`Exhibit 1005 to the extent Petitioners seek to rely on it to establish the presence of
`
`any claim limitation in a ground upon which Exhibit 1005 was not instituted.
`
`
`Exhibit 1006: Select Entries from U.S. Pharmacopeia
`
`Patent Owners object to Exhibit 1006 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time). Patent Owners also object to
`
`Exhibit 1006, which was not cited in the grounds upon which review was
`
`instituted, to the extent Petitioners seek to rely on it to establish the presence of any
`
`claim limitation.
`
`
`Exhibit 1007: Select Entries from European Pharmacopoeia Entries
`
`Patent Owners object to Exhibit 1007 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time). Patent Owners also object to
`
`Exhibit 1007, which was not cited in the grounds upon which review was
`
`instituted, to the extent Petitioners seek to rely on it to establish the presence of any
`
`claim limitation.
`
`
`
`
`
`4
`
`
`
`Exhibit 1008: Select Entries from Handbook of Pharmaceutical Excipients
`
`Patent Owners object to Exhibit 1008 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time). Patent Owners also object to
`
`Exhibit 1008 to the extent Petitioners seek to rely on it to establish the presence of
`
`any claim limitation in a ground upon which Exhibit 1008 was not instituted.
`
`
`Exhibit 1009: U.S. Patent No. 5,654,010 (“Johnson”)
`
`Patent Owners object to Exhibit 1009 under F.R.E. 802 and 37 C.F.R.
`
`§ 42.61(c) (hearsay), F.R.E. 402 (relevance), and 403 (confusing, waste of time).
`
`Patent Owners also object to Exhibit 1009 to the extent Petitioners seek to rely on
`
`it to establish the presence of any claim limitation in a ground upon which Exhibit
`
`1009 was not instituted.
`
`
`Exhibit 1010: U.S. Patent No. 5,656,299 (“Kino”)
`
`Patent Owners object to Exhibit 1010 under F.R.E. 802 and 37 C.F.R.
`
`§ 42.61(c) (hearsay), F.R.E. 402 (relevance), and 403 (confusing, waste of time).
`
`Patent Owners also object to Exhibit 1010 to the extent Petitioners seek to rely on
`
`it to establish the presence of any claim limitation in a ground upon which Exhibit
`
`1010 was not instituted.
`
`
`
`
`
`5
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`
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`Exhibit 1011: WO 199714408 (“Gustafsson”)
`
`Patent Owners object to Exhibit 1011 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time). Patent Owners also object to
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`Exhibit 1011 to the extent Petitioners seek to rely on it to establish the presence of
`
`any claim limitation in a ground upon which Exhibit 1011 was not instituted.
`
`
`Exhibit 1014: Select Excerpts from Pharmaceutical Dosage Forms: Disperse
`Systems, Vol. 1 by Herbert A. Lieberman
`
`Patent Owners object to Exhibit 1014 under F.R.E. 802 (hearsay), 402
`
`(relevance), 403 (confusing, waste of time), and 106 (completeness) as this excerpt
`
`includes only portions of a larger document that in fairness ought to be considered
`
`in connection with Exhibit 1014. Patent Owners also object to Exhibit 1014, which
`
`was not cited in the grounds upon which review was instituted, to the extent
`
`Petitioners seek to rely on it to establish the presence of any claim limitation.
`
`
`Exhibit 1015: U.S. Patent No. 6,495,164
`
`Patent Owners object to Exhibit 1015 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 402 (relevance), and 403 (confusing,
`
`waste of time) as the document is not cited in the Petition and Luye has failed to
`
`identify which aspects of the document are relied upon. Patent Owners also object
`
`to Exhibit 1015 under F.R.E. 802 and 37 C.F.R. § 42.61(c) (hearsay). Patent
`
`Owners also object to Exhibit 1015, which was not cited in the grounds upon
`
`
`
`6
`
`
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`which review was instituted, to the extent Petitioners seek to rely on it to establish
`
`the presence of any claim limitation.
`
`
`Exhibit 1016: Office Action for Serial No. 10/259,949 (April 9, 2003)
`
`Patent Owners object to Exhibit 1016 under F.R.E. 901 (authenticity), 403
`
`(confusing, waste of time), and 106 (completeness) because there is no indication
`
`that this excerpt is from a certified copy of the file history, and this excerpt
`
`includes only a portion of a larger document that in fairness ought to be considered
`
`in connection with Exhibit 1016. Patent Owners also object to Exhibit 1016, which
`
`was not cited in the grounds upon which review was instituted, to the extent
`
`Petitioners seek to rely on it to establish the presence of any claim limitation.
`
`
`Exhibit 1017: Applicants’ Response to Office Action for Serial No. 09/577,875
`(May 14, 2003)
`
`Patent Owners object to Exhibit 1017 under F.R.E. 901 (authenticity), 403
`
`(confusing, waste of time), and 106 (completeness) because there is no indication
`
`that this excerpt is from a certified copy of the file history, and this excerpt
`
`includes only a portion of a larger document that in fairness ought to be considered
`
`in connection with Exhibit 1017. Patent Owners also object to Exhibit 1017, which
`
`was not cited in the grounds upon which review was instituted, to the extent
`
`Petitioners seek to rely on it to establish the presence of any claim limitation.
`
`
`
`
`
`7
`
`
`
`Exhibit 1018: Declaration of Mark A. Tracy for Serial No. 09/577,875 (May
`17, 2002)
`
`Patent Owners object to Exhibit 1018 under F.R.E. 901 (authenticity) and
`
`106 (completeness) because there is no indication that this excerpt is from a
`
`certified copy of the file history, and this excerpt includes only a portion of a larger
`
`document that in fairness ought to be considered in connection with Exhibit 1018.
`
`Patent Owners also object to Exhibit 1018 under 37 C.F.R. § 42.104(b)(2)
`
`and (b)(4) because the excerpt does not qualify as a printed publication, such that it
`
`was made available to the extent that persons interested and ordinarily skilled in
`
`the subject matter or art, exercising reasonable diligence, could have located it as
`
`of the filing date of the application, May 25, 2000. Patent Owners also object to
`
`Exhibit 1018 under F.R.E. 802 (hearsay). Patent Owners further object to Exhibit
`
`1018, which was not cited in the grounds upon which review was instituted, to the
`
`extent Petitioners seek to rely on it to establish the presence of any claim
`
`limitation.
`
`
`Exhibit 1019: Notice of Allowability for Serial No. 10/259,949 (July 24, 2003)
`
`Patent Owners object to Exhibit 1019 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), 403
`
`(confusing, waste of time), and 106 (completeness) as the document is not cited in
`
`the Petition, Luye has failed to identify which aspects of the document are relied
`
`
`
`8
`
`
`
`upon, and this excerpt includes only a portion of a larger document that in fairness
`
`ought to be considered in connection with Exhibit 1019. Patent Owners also object
`
`to Exhibit 1019, which was not cited in the grounds upon which review was
`
`instituted, to the extent Petitioners seek to rely on it to establish the presence of any
`
`claim limitation.
`
`
`Exhibit 1020: Select Excerpts of Pharmaceutical Dosage Forms: Parenteral
`Medications, Second Edition
`
`Patent Owners object to Exhibit 1020 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), 403
`
`(confusing, waste of time), and 106 (completeness) as the document is not cited in
`
`the Petition, Luye has failed to identify which aspects of the document are relied
`
`upon, and this excerpt includes only portions of a larger document that in fairness
`
`ought to be considered in connection with Exhibit 1020. Patent Owners also object
`
`to Exhibit 1020, which was not cited in the grounds upon which review was
`
`instituted, to the extent Petitioners seek to rely on it to establish the presence of any
`
`claim limitation.
`
`
`Exhibit 1021: Select Excerpts from the Theory and Practice of Industrial
`Pharmacy by Leon Lachman
`
`Patent Owners object to Exhibit 1021 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), 403
`
`
`
`9
`
`
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`(confusing, waste of time) and 106 (completeness) as the document is not cited in
`
`the Petition, Luye has failed to identify which aspects of the document are relied
`
`upon, and this excerpt includes only portions of a larger document that in fairness
`
`ought to be considered in connection with Exhibit 1021. Patent Owners also object
`
`to Exhibit 1021, which was not cited in the grounds upon which review was
`
`instituted, to the extent Petitioners seek to rely on it to establish the presence of any
`
`claim limitation.
`
`
`Exhibit 1022: Selected Excerpts from Pharmaceutical Dosage Forms:
`Disperse Systems, Vol. 1 by Herbert A. Lieberman
`
`Patent Owners object to Exhibit 1022 under F.R.E. 802 (hearsay), 402
`
`(relevance), 403 (confusing, waste of time), and 106 (completeness) as this excerpt
`
`includes only a portion of a larger document that in fairness ought to be considered
`
`in connection with Exhibit 1022. Patent Owners also object to Exhibit 1022, which
`
`was not cited in the grounds upon which review was instituted, to the extent
`
`Petitioners seek to rely on it to establish the presence of any claim limitation.
`
`
`Exhibit 1023: Orange Book entries for Risperdal®
`
`Patent Owners object to Exhibit 1023 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time). It is not clear from
`
`the face of Exhibit 1023 when it was first published. There are markings at the top
`
`center of the first page and center left of the third page which may be text, but are
`
`
`
`10
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`
`
`illegible. The URL listed at the bottom of the pages is cut off. Exhibit 1023
`
`contains pages from different documents. Thus, Patent Owners also object to
`
`Exhibit 1023 under 37 CFR § 42.6(a)(3), stating that combined documents are not
`
`permitted, and 37 C.F.R. § 42.63 at least by failing to provide individual
`
`documents in the form of an exhibit, failing to uniquely number individual
`
`documents with a sequential exhibit number, and failing to provide each document
`
`with an exhibit label. Patent Owners also object to Exhibit 1023, which was not
`
`cited in the grounds upon which review was instituted, to the extent Petitioners
`
`seek to rely on it to establish the presence of any claim limitation.
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`Respectfully submitted,
`
` /Scott Reed/
`
`
`
`
`
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Counsel for Patent Owners
`
`
`
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`11
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`December 14, 2016
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`CERTIFICATE OF SERVICE
`
`
`
`I certify that a copy of the foregoing PATENT OWNERS’ OBJECTIONS
`
`UNDER 37 C.F.R. § 42.64 TO EVIDENCE SUBMITTED BY PETITIONERS
`
`DURING A PRELIMINARY PROCEEDING was served on December 14, 2016
`
`by causing it to be sent by email to counsel for Petitioners, who have consented to
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`electronic service, at the following email addresses:
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`wmentlik.ipr@lernerdavid.com
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`pkochanski@lernerdavid.com
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`tvanbuskirk@lernerdavid.com
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`nvaleyko@lernerdavid.com
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`
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`December 14, 2016
`
`Respectfully submitted,
`
`
`
`
`
`
`
` /Scott Reed/
`
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Counsel for Patent Owners
`
`
`
`12
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