Filed on behalf of: Abraxis Bioscience, LLC
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`Filed: October 24, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`ACTAVIS LLC,
`Petitioner
`v.
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`_______________________
`Case IPR2017-01101
`U.S. Patent No. 7,820,788
`_______________________
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`PATENT OWNER OBJECTIONS TO EVIDENCE SERVED WITH
`PETITION FOR INTER PARTES REVIEW
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`Filed: October 24, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`ACTAVIS LLC,
`Petitioner
`v.
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`_______________________
`Case IPR2017-01101
`U.S. Patent No. 7,820,788
`_______________________
`
`
`PATENT OWNER OBJECTIONS TO EVIDENCE SERVED WITH
`PETITION FOR INTER PARTES REVIEW
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Abraxis Bioscience, LLC (“Patent
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`Owner”) hereby submits the following objections to exhibits served with Actavis
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`LLC’s Petition for Inter Partes Review (“Petition”). These objections are timely
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`filed and served within ten business days of the PTAB’s October 10, 2017
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`Institution Decision (Paper 7).
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`Pursuant to 37 C.F.R. § 42.62, Patent Owner’s objections apply the Federal
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`Rules of Evidence. Patent Owner’s objections and the basis for each objection are
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`as follows:
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`I.
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`OBJECTIONS TO EXHIBIT 1002
`Patent Owner objects to Exhibit 1002, “Declaration of Cory J. Berkland,
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`Ph.D.” Specifically, Patent Owner objects to the following paragraphs and
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`associated headings in Exhibit 1002 pursuant to Fed. R. Evid. 702, Fed. R. Evid.
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`703 (insufficient qualification or support for expert testimony), Fed. R. Evid. 602
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`(lack of personal knowledge, speculation) and 37 C.F.R. § 42.65 (expert testimony
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`does not disclose the underlying facts or data): ¶¶ 4, 15- 27, 35, 37, 38, 52-55, 67-
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`76, 78-85, 90, 92, 93, 95, 97-120, 122-157, and 160-191. Patent Owner further
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`objects to ¶ 86 pursuant to Fed. R. Evid. 402 (relevance) and Fed. R. Evid. 403
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`(excluding relevant evidence for prejudice, confusion, waste of time, or other
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`reasons).
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`-2-
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`II. OBJECTIONS TO EXHIBITS 1008–1013, 1015, 1016, and 1019–1025
`Patent Owner objects to Exhibits 1009–1010, pursuant to Fed. R. Evid. 402
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`(relevance) and Fed. R. Evid. 403 (excluding relevant evidence for prejudice,
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`confusion, waste of time, or other reasons). Petitioner does not assert these
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`documents as prior-art references that anticipate or combine to render obvious the
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`challenged patent claims, and as such are not listed as specific grounds for
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`challenging the patent claims. Because these documents are used improperly by
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`Petitioner’s expert to attempt to fill in absent claim elements where the asserted art
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`itself is silent, the prejudice they would cause outweighs any purported probative
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`value.
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`Patent Owner also objects to Exhibits 1009–1010, pursuant to 37 C.F.R. §
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`42.6(a)(3) (improper incorporation by reference). “Arguments must not be
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`incorporated by reference from one document into another document.” 37 C.F.R.
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`§ 42.6(a)(3). Petitioner does not cite to or discuss the content of Exhibits 1009–
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`1010 in its Petition. However, Petitioner’s expert cites to and discusses these
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`exhibits in his declaration in support of Petitioner’s argument that Desai would
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`have motivated a skilled artisan as of December 2002 to formulate paclitaxel and
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`albumin as particles with a size less than 200 nm (Exhibit 1002 ¶ 125, n.1).
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`Accordingly, Exhibits 1009–1010 are improperly incorporated by reference.
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`-3-
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`Patent Owner also objects to Exhibits 1009–1013, 1015, 1016, and 1019–
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`1025, pursuant to Fed. R. Evid. 402 (relevance) and Fed. R. Evid. 403 (excluding
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`relevant evidence for prejudice, confusion, waste of time, or other reasons) to the
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`extent Petitioner may intend to rely on these exhibits as prior art to the challenged
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`patent claims. Each of these documents are either dated after the priority date of
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`the challenged patent claims, or lack sufficient information to determine whether
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`any publication occurred before or after the challenged patent claims.
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`Patent Owner further objects to the dates in Exhibits 1009, 1010, and 1016
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`pursuant to Fed. R. Evid. 802 (hearsay) as evidence of when those exhibits were
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`allegedly published or would have been publicly available or accessible to an
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`ordinarily skilled artisan.
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`Patent Owner further objects to Exhibits 1011–1013 pursuant to Fed. R.
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`Evid. 402 (relevance), Fed. R. Evid. 403 (excluding relevant evidence for
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`prejudice, confusion, waste of time, or other reasons) and Fed. R. Evid. 802
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`(hearsay). These documents are not relevant because they consist of judgments
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`and proceedings on other patents that occurred after the priority date of the ’788
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`patent and that are not commensurate in scope with the ’788 patent. Patent Owner
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`further objects to the extent that these documents and statements within these
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`documents are being offered for the truth of the matter asserted therein.
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`-4-
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`Patent Owner further objects to Exhibits 1008, 1016, and 1019-1025
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`pursuant to Fed. R. Evid. 106, 1002 and 1006. These documents appear to be
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`incomplete excerpts of larger documents.
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`Dated: October 24, 2017
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`
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`/ J. Patrick Elsevier, Ph.D. /
`J. Patrick Elsevier, Ph.D. (Reg. No. 44,668)
`Anthony M. Insogna (Reg. No. 35,203)
`Cary Miller, Ph.D. (Reg. No. 54,708)
`Lisamarie LoGiudice, Ph.D. (Reg. No. 71,047)
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121-3134
`Tel: (858) 314-1200
`Fax: (844) 345-3178
`jpelsevier@jonesday.com
`aminsogna@jonesday.com
`cmiller@jonesday.com
`llogiudice@jonesday.com
`
`F. Dominic Cerrito (Reg. No. 38,100)
`Andrew S. Chalson (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7450
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`andrewchalson@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
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`
`
`
`
`Counsel for Patent Holder
`Abraxis Bioscience, LLC
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`-5-
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that on the date indicated below a copy of the
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`foregoing PATENT OWNER OBJECTIONS TO EVIDENCE SERVED WITH
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`PETITION FOR INTER PARTES REVIEW PURSUANT TO 37 C.F.R. §
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`42.64(b)(1) was served electronically by filing these documents through the PTAB
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`E2E System, as well as by e-mailing copies to the following counsel of record for
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`Petitioner Actavis LLC:
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`Lead Counsel
`Samuel S. Park, Reg. No. 59,656
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`AbraxaneIPR@winston.com
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`Dated: October 24, 2017
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`Backup Counsel
`George C. Lombardi
`Charles B. Klein
`Kevin E. Warner
`Eimeric Reig-Plessis
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`AbraxaneIPR@winston.com
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`
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`
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`/J. Patrick Elsevier, Ph.D./
`J. Patrick Elsevier, Ph.D. (Reg. No. 44,668)
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121-3134
`Telephone: (858) 314-1200
`Facsimile: 858-314-1150
`
`Counsel for Patent Holder
`Abraxis Bioscience, LLC
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