`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICAL,
`INC. and WOCKHARDT BIO AG,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner.
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`
`
`
`
`_____________________
`
`Case IPR2015-005471
`Patent 7,765,107
`_____________________
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`
`AMNEAL PHARMACEUTICALS LLC’S AND PAR PHARMACEUTICAL,
`INC.’S OBJECTIONS TO EVIDENCE SUBMITTED BY PATENT OWNER
`PURSUANT TO 37 C.F.R. § 42.64(B)(1)
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`
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
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`1 Case IPR2015-01820 has been joined with this proceeding.
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`Pursuant to 37 C.F.R. §42.64(b)(1), Petitioners Amneal Pharmaceuticals
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`IPR2015-00547
` Patent No. 7,765,107
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`LLC and Par Pharmaceutical, Inc. object as follows to the admissibility of
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`evidence submitted by the Patent Owner on November 6, 2015:
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`1.
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`JAZZ EXHIBIT 2042 is objected to under Fed. R. Ev. 801–802
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`because it is offered as a statement of Dr. Robert Valuck, not made while testifying
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`in the present trial, for the purpose of proving factual matters regarding Dr.
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`Valuck’s expertise. JAZZ EXHIBIT 2042 is also objected to under Fed. R. Ev.
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`401–402 as no statement in the exhibit is relevant to any material issue of fact in
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`dispute in this trial. JAZZ EXHIBIT 2042 is also objected to under Fed. R. Ev.
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`403 because its minimal probative value is substantially outweighed by the fact
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`that it is misleading.
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`2.
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`Paragraphs 50-57 of JAZZ EXHIBIT 2046 are objected to under
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`Fed. R. Ev. 401–402 because they are irrelevant to the question of whether, more
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`than one year before December 17, 2002, AMN1004–AMN1006 were
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`disseminated or otherwise made available to the public to the extent that persons
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`interested and ordinarily skilled in the subject matter or art, exercising reasonable
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`diligence, could locate it. Paragraphs 50-57 of JAZZ EXHIBIT 2046 are also
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`objected to under Fed. R. Ev. 403 because its minimal probative value is
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`substantially outweighed by the fact that it is misleading. Paragraph 53 of JAZZ
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`EXHIBIT 2046 is also objected to under Fed. R. Ev. 801/802 because it contains
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`the statements of David A. Holdford and Craig T. Kirkwood offered for the
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`IPR2015-00547
` Patent No. 7,765,107
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`purpose of establishing factual matters.
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`3.
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`Paragraphs 36-38 of JAZZ EXHIBIT 2047 are objected to under
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`Fed. R. Ev. 401–402 because they are irrelevant to the question of whether, more
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`than one year before December 17, 2002, AMN1004–AMN1006 were
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`disseminated or otherwise made available to the public to the extent that persons
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`interested and ordinarily skilled in the subject matter or art, exercising reasonable
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`diligence, could locate it. Paragraphs 36-38 of JAZZ EXHIBIT 2047 are also
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`objected to under Fed. R. Ev. 403 because its minimal probative value is
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`substantially outweighed by the fact that it is misleading.
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`4.
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`JAZZ EXHIBIT 2049 is objected to under Fed. R. Ev. 401–402
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`because it is irrelevant to the question of whether, more than one year before
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`December 17, 2002, AMN1004–AMN1006 were disseminated or otherwise made
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`available to the public to the extent that persons interested and ordinarily skilled in
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`the subject matter or art, exercising reasonable diligence, could locate it. JAZZ
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`EXHIBIT 2049 is also objected to under Fed. R. Ev. 403 because its minimal
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`probative value is substantially outweighed by the fact that it is misleading.
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`5.
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`JAZZ EXHIBIT 2050 is objected to under Fed. R. Ev. 401–402
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`because it is irrelevant to the question of whether, more than one year before
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`December 17, 2002, AMN1004–AMN1006 were disseminated or otherwise made
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`available to the public to the extent that persons interested and ordinarily skilled in
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`IPR2015-00547
` Patent No. 7,765,107
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`the subject matter or art, exercising reasonable diligence, could locate it. JAZZ
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`EXHIBIT 2050 is also objected to under Fed. R. Ev. 403 because its minimal
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`probative value is substantially outweighed by the fact that it is misleading.
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`6.
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`JAZZ EXHIBIT 2052 is objected to under Fed. R. Ev. 401–402
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`because it is irrelevant to the question of whether, more than one year before
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`December 17, 2002, AMN1004–AMN1006 were disseminated or otherwise made
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`available to the public to the extent that persons interested and ordinarily skilled in
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`the subject matter or art, exercising reasonable diligence, could locate it. JAZZ
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`EXHIBIT 2052 is also objected to under Fed. R. Ev. 403 because its minimal
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`probative value is substantially outweighed by the fact that it is misleading. JAZZ
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`EXHIBIT 2052 is also objected to under Fed. R. Ev. 901 as insufficiently
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`authenticated. JAZZ EXHIBIT 2052 is also objected to under Fed. R. Ev.
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`801/802 as containing impermissible hearsay testimony.
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`7.
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`JAZZ EXHIBIT 2053 is objected to under Fed. R. Ev. 401–402
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`because it is irrelevant to the question of whether, more than one year before
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`December 17, 2002, AMN1004–AMN1006 were disseminated or otherwise made
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`available to the public to the extent that persons interested and ordinarily skilled in
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`the subject matter or art, exercising reasonable diligence, could locate it. JAZZ
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`EXHIBIT 2053 is also objected to under Fed. R. Ev. 403 because its minimal
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`probative value is substantially outweighed by the fact that it is misleading and
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`IPR2015-00547
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`needlessly cumulative. Paragraph 5 of JAZZ EXHIBIT 2053 is objected to under
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`Fed. R. Ev. 702 as Dr. Kirkwood’s statements that he does not teach about the
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`Federal Register in his drug literature course is not a fact or data on which an
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`expert in the field would reasonably rely in forming an opinion on the public
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`availability of the ACA. JAZZ EXHIBIT 2053 is further objected to under Fed.
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`R. Ev. 602 as there is insufficient evidence that Dr. Kirkwood possesses personal
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`knowledge regarding the Federal Register.
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`8.
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`JAZZ EXHIBIT 2054 is objected to under Fed. R. Ev. 401–402
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`because it is irrelevant to the question of whether, more than one year before
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`December 17, 2002, AMN1004–AMN1006 were disseminated or otherwise made
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`available to the public to the extent that persons interested and ordinarily skilled in
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`the subject matter or art, exercising reasonable diligence, could locate it. JAZZ
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`EXHIBIT 2054 is also objected to under Fed. R. Ev. 403 because its minimal
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`probative value is substantially outweighed by the fact that it is misleading. JAZZ
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`EXHIBIT 2054 is also objected to under Fed. R. Ev. 801–802 because it is offered
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`as a statement of Dr. Glenn Van Buskirk not made while testifying in the present
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`trial, offered for the purpose of proving factual matters. JAZZ EXHIBIT 2054 is
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`also objected to under Fed. R. Ev. 701/702 as opinion testimony based on
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`scientific, technical, or other specialized knowledge within the scope of Fed. R. Ev.
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`702 as it fails to sufficiently establish Dr. Van Buskirk’s qualifications to render an
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`IPR2015-00547
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`opinion on any issue in this case and it fails to show that Dr. Van Buskirk’s
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`opinion is based upon sufficient facts or data, or reliable principles and methods.
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`9.
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`JAZZ EXHIBIT 2055 is objected to under Fed. R. Ev. 401–402
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`because it is irrelevant to any issue at dispute in this litigation, and Jazz has failed
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`to identify a basis for its relevance in the Patent Owner Response.
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`10.
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`JAZZ EXHIBIT 2056 is objected to under Fed. R. Ev. 401–402
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`because it is irrelevant to the question of whether, more than one year before
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`December 17, 2002, AMN1004–AMN1006 were disseminated or otherwise made
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`available to the public to the extent that persons interested and ordinarily skilled in
`
`the subject matter or art, exercising reasonable diligence, could locate it. JAZZ
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`EXHIBIT 2056 is also objected to under Fed. R. Ev. 403 because its minimal
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`probative value is substantially outweighed by the fact that it is misleading and
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`needlessly cumulative. Paragraph 7 of JAZZ EXHIBIT 2056 is objected to under
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`Fed. R. Ev. 702 as Dr. Holdford’s statements that he does not teach about the
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`Federal Register in his drug literature course is not a fact or data on which an
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`expert in the field would reasonably rely in forming an opinion on the public
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`availability of the ACA. JAZZ EXHIBIT 2056 is further objected to under Fed.
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`R. Ev. 602 as there is insufficient evidence that Dr. Holdford possesses personal
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`knowledge regarding the Federal Register.
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`11.
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`JAZZ EXHIBIT 2057 is objected to under Fed. R. Ev. 401–402
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`IPR2015-00547
` Patent No. 7,765,107
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`because it is irrelevant to any issue at dispute in this proceeding. JAZZ EXHIBIT
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`2057 is also objected to under Fed. R. Ev. 403 because its minimal probative value
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`is substantially outweighed by the fact that it is misleading. JAZZ EXHIBIT
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`2057 is also objected to under Fed. R. Ev. 403 because its minimal probative value
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`is substantially outweighed by the fact that it is misleading. JAZZ EXHIBIT
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`2057 is also objected to under Fed. R. Ev. 801–802 and Fed. R. Ev. 805 because it
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`is offered as a statement of Deirdre Adams-Buckley and other alleged employees
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`of the Health Sciences Library not made while testifying in the present trial, for the
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`purpose of proving that the Health Sciences Library at the University of Colorado
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`Denver has only one paper copy of the Federal Register dated in 1968.
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`IPR2015-00547
` Patent No. 7,765,107
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`Respectfully submitted,
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`
`
`
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`Matthew C. Ruedy (Reg. No. 64,823)
`Maddox Edwards, P.L.L.C.
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`
`Attorney for Petitioners Amneal
`Pharmaceuticals LLC and Par
`Pharmaceutical, Inc.
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`Date: November 13, 2015
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
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`IPR2015-00547
` Patent No. 7,765,107
`Certificate of Service
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`The undersigned hereby certifies that the above-captioned AMNEAL
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`PHARMACEUTICALS LLC’S AND PAR PHARMACEUTICAL, INC.’S
`
`OBJECTIONS TO EVIDENCE SUBMITTED BY PATENT OWNER
`
`PURSUANT TO 37 C.F.R. § 42.64(B)(1), was served in its entirety on November
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`13, 2015, upon the following parties via Electronic Mail:
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`F. Dominic Cerrito
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`NickCerrito@quinnemanuel.com
`
`John V. Biernacki
`Jones Day
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`JVBiernacki@JonesDay.Com
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`IPR2015-00547
` Patent No. 7,765,107
`Certificate of Service
`
`
`
`
`Matthew C. Ruedy (Reg. No. 64,823)
`Maddox Edwards, P.L.L.C.
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`
`Attorney for Petitioners Amneal
`Pharmaceuticals LLC and Par
`Pharmaceutical, Inc.
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`
`
`
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`Date: November 13, 2015
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