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