Paper No. __
`Filed: March 18, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730
`_____________________
`
`PETITIONERS PAR PHARMACEUTICAL, INC.’S AND AMNEAL
`PHARMACEUTICALS LLC’S MOTION TO EXCLUDE EVIDENCE
`
`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 IPR2015-01818 has been joined with this proceeding.
`
`
`Filed: March 18, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730
`_____________________
`
`PETITIONERS PAR PHARMACEUTICAL, INC.’S AND AMNEAL
`PHARMACEUTICALS LLC’S MOTION TO EXCLUDE EVIDENCE
`
`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 IPR2015-01818 has been joined with this proceeding.
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ............................................................................................1
`I.
`STATEMENT OF FACTS...............................................................................1
`II.
`III. ARGUMENT....................................................................................................3
`A.
`The objected-to portions of
`the DiPiro and Bergeron
`Declarations and Exhibits 2049–2050 are irrelevant
`to the
`public accessibility of the ACA materials..............................................3
`1.
`The objected-to portions of the DiPiro and Bergeron
`Declarations and Exhibits 2049–2050 are irrelevant as a
`matter of law. ...............................................................................3
`Paragraphs 54–56 of the DiPiro Declaration are irrelevant
`because they are not directed to the actions of “interested
`POSAs.” .......................................................................................6
`The excerpt of Dr. Glenn Van Buskirk’s deposition testimony
`(Ex. 2054)
`is
`impermissible hearsay,
`improper
`expert
`testimony, and irrelevant........................................................................8
`1.
`Exhibit 2054 constitutes impermissible hearsay..........................8
`2.
`Exhibit 2054 is proffered as improper expert testimony. ............9
`3.
`Exhibit 2054 is used for an irrelevant purpose. ........................ 10
`The Declaration of Lyndsey Pryzbylski
`(Ex. 2057)
`is
`impermissible hearsay and irrelevant...................................................10
`1.
`Exhibit 2057 is textbook impermissible hearsay...................... 10
`2.
`Exhibit 2057 is offered for an irrelevant purpose..................... 11
`IV. CONCLUSION.............................................................................................. 12
`
`B.
`
`C.
`
`2.
`
`-i-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`I.
`
`INTRODUCTION
`
`Petitioner Par Pharmaceutical, Inc. and Amneal Pharmaceuticals LLC
`
`(“Petitioners”) respectfully request the Board to exclude several exhibits relied
`
`upon by Patent Owner Jazz Pharmaceuticals, Inc. as irrelevant, impermissible
`
`hearsay and/or improper opinion testimony.
`
`II.
`
`STATEMENT OF FACTS
`
`Petitioners served their objections to Exhibits 2046–2047, 2049–2050, 2054,
`
`and 2057 on November 13, 2015—four business days after Patent Owner served its
`
`response on November 6, 2015. See Paper No 53.2 Jazz served supplemental
`
`Exhibits 2058–2061 on Petitioners on November 30, 2015, but did not file the
`
`exhibits in this proceeding or identify how it was relying on the exhibits to cure
`
`Petitioners’ objections.
`
`2 Petitioners are providing this Motion and the associated evidence
`
`objections (Paper No. 53) pursuant to the Board’s March 18, 2016 e-mail directing
`
`Petitioners to file this Motion pending a decision on a motion from Petitioners to
`
`allow for late filing of their evidence objections under 37 C.F.R. § 42.5(c)(3),
`
`which is to be filed on March 25, 2016.
`
`-1-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`Jazz relies on each of the objected-to exhibits in its Patent Owner Response
`
`(Paper No. 39) (“Response”). See Response at 17–20. The following table details
`
`where Jazz relies on each exhibit to which Petitioners object:
`
`Exhibit
`
`Location in Patent Owner Response
`
`¶¶ 50–57 of Ex. 2046
`
`p.18, l.20 – p.21, l.7; p.22, l.13 – p. 22, l. 1.
`
`(“DiPiro Declaration”)
`
`¶¶ 36–38 of Ex. 2047
`
`p.21, ll.11–17; p.22, l.13 – p. 22, l. 1.
`
`(“Bergeron Declaration”)
`
`Ex. 2049
`
`Ex. 2050
`
`Ex. 2054
`
`Ex. 2057
`
`p.20, n.6.; p.23, ll.9–13.
`
`p.21, ll.10–11.
`
`p.18, ll.12–19.
`
`p.22, n.7.
`
`In its Response, Jazz argues that the ACA materials (Exs. 1003–1006) were
`
`not publicly accessible as prior art. See Response at 3–24. Jazz relies on the
`
`objected-to portions of the DiPiro and Bergeron Declarations, as well as Exhibits
`
`2049–2050 and 2054, as evidence that a person of ordinary skill
`
`in the art
`
`(“POSA”) would not have been motivated to look for, or able to locate, Federal
`
`Register notices of Advisory Committee meetings such as Exhibit 1015. See
`
`-2-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`generally Response at 16–24. Separately, Jazz uses Exhibit 2057 in an effort to
`
`impeach certain testimony of Petitioners’ expert, Dr. Valuck. See Response at 22,
`
`n.7. Each of these objected-to exhibits should be excluded for the following
`
`reasons.
`
`III. ARGUMENT
`
`A.
`
`The objected-to portions of the DiPiro and Bergeron Declarations
`and Exhibits 2049–2050 are irrelevant to the public accessibility
`of the ACA materials.
`
`The objected-to portions of the DiPiro and Bergeron Declarations, as well as
`
`Exhibits 2049–2050, are irrelevant to the issue of public accessibility of the ACA,
`
`both as a matter of law and as a matter of fact.
`
`1.
`
`the DiPiro and Bergeron
`The objected-to portions of
`Declarations and Exhibits 2049–2050 are irrelevant as a
`matter of law.
`
`Evidence is relevant if (1) it has any tendency to make a fact more or less
`
`probable than it would be without the evidence, and (2) the fact is of consequence
`
`in determining the action. Fed. R. Evid. 401. Jazz’s evidence regarding the Federal
`
`Register is neither, because it attempts to undermine the notice function of the
`
`Federal Registera function that is established by Federal law.
`
`Jazz proffers the objected-to exhibits as evidence that a POSA would not
`
`have been motivated to look for, or able to locate, Federal Register notices of
`
`Advisory Committee meetings such as Exhibit 1015, and therefore would not have
`
`-3-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`located the ACA materials. See Response at 16–24. Notably,
`
`the proffered
`
`evidence is solely directed to the question of whether a POSA would have located
`
`Exhibit 1015i.e., whether Exhibit 1015 provided sufficient notice of the Xyrem
`
`Advisory Committee meeting. See Petition (Paper No. 1) at 14–15.
`
`Jazz’s evidence is irrelevant as a matter of law. Under Federal law, every
`
`person in the United States, which of course includes POSAs, is deemed to have
`
`been given sufficient notice for items published in the Federal Register.
`
`A notice of hearing or of opportunity to be heard,
`required or authorized to be given by an Act of
`Congress, or which may otherwise properly be given,
`shall be deemed to have been given to all persons
`residing within the States of the Union and the District
`of Columbia . . . when the notice is published in the
`Federal Register at such a time that the period between
`the publication and the date fixed in the notice for the
`hearing or for the termination of the opportunity to be
`heard is—
`(1) not less than the time specifically prescribed
`for the publication of the notice by the appropriate Act of
`Congress; or
`less than fifteen days when time for
`(2) not
`publication is not specifically prescribed by the Act,
`without prejudice, however, to the effectiveness of a
`
`-4-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`notice of less than fifteen days where the shorter period is
`reasonable.
`
`44 U.S.C. § 1508.
`
`Upon publication, an item in the Federal Register is deemed proper notice to
`
`all persons in the United States, so long as it was published timely, required or
`
`authorized by law, and regarding an “opportunity to be heard.” See id.; see also N.
`
`Ala. Express, Inc. v. United States, 585 F.2d 783, 787 n.2 (5th Cir. 1978) (“[I]t is
`
`well settled that publications in the Federal Register are deemed legally sufficient
`
`notice to all interested persons.”) Jazz has not alleged that Exhibit 1015 is not a
`
`timely or required notice, or that the Xyrem Advisory Committee meeting was not
`
`an “opportunity to be heard.” As such, POSAs were deemed to have knowledge of
`
`the Xyrem Advisory Committee meeting as a matter of law, as of the date it was
`
`published. See Moreau v. F.E.R.C., 982 F.2d 556, 569 (D.C. Cir. 1993); see also S.
`
`Terminal Corp. v. E.P.A., 504 F.2d 646, 659 (1st Cir. 1974) (EPA’s statement, in a
`
`Federal Register notice of a hearing, that a technical support document was
`
`available for public review was sufficient to provide notice of that document’s
`
`availability to interested persons.).
`
`Consideration of paragraphs 37–39 of the Bergeron Declaration and of
`
`paragraphs 51–58 of the DiPiro Declaration is thus inappropriate, as both are used
`
`in an attempt to prove a fact contradictory to Federal law—i.e., that the publication
`
`-5-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`of Exhibit 1015 in the Federal Register did not provide adequate notice to
`
`interested parties, including POSAs. Consideration of Exhibits 2049 and 2050 is
`
`also improper, because they are offered for the same improper purpose. Whether
`
`certain individuals would have regularly reviewed the Federal Register, or how
`
`many pages were in the Federal Register in 2001, cannot be relevant to the
`
`question of whether a POSA had adequate notice of the Xyrem Advisory
`
`Committee meeting, or would have been able to locate materials associated with it.
`
`2.
`
`Paragraphs 54–56 of the DiPiro Declaration are irrelevant
`because they are not directed to the actions of “interested
`POSAs.”
`
`Evidence is relevant if (1) it has any tendency to make a fact more or less
`
`probable than it would be without the evidence, and (2) the fact is of consequence
`
`in determining the action. Fed. R. Evid. 401; see also AZ v. Shinseki, 731 F.3d
`
`1303, 1311 (Fed. Cir. 2013) (Relevant evidence is that which tends “to prove or
`
`disprove a material fact.”). Paragraphs 55–57 of the DiPiro Declaration are neither,
`
`as whether a person meeting certain qualifications of a POSA, but not interested in
`
`drug distribution, safety, or abuse, would have located the ACA materials is not of
`
`consequence in this action.
`
`The question of whether a reference was a printed publication turns on
`
`whether it was publicly accessible. See Bruckelmeyer v. Ground Heaters, Inc., 445
`
`-6-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`F.3d 1374, 1378 (Fed. Cir. 2006). In turn, whether a reference was publicly
`
`accessible turns on whether a “person of ordinary skill in the art interested in the
`
`subject matter of the patents in suit and exercising reasonable diligence” could
`
`locate it. Id.
`
`Paragraphs 54–56 of the DiPiro Declaration are irrelevant because they do
`
`not relate to that question. The DiPiro Declaration alleges that a POSA, as defined
`
`by Dr. Valuck, has no “focus on drug distribution, safety, and abuse or regulatory
`
`affairs,” Ex. 2046, ¶ 55.3 The ’730 patent, however, is directed to “distribution of
`
`drugs, and in particular . . . distribution of sensitive drugs.” Ex. 1001, col. 1:4–7.
`
`The DiPiro Declaration only relates to what persons uninterested in the subject
`
`matter of the ’730 patent would have done, and is thus irrelevant to accessibility by
`
`persons “interested in the subject matter of the patents.” Bruckelmeyer, 445 F.3d at
`
`1378.
`
`Accordingly, under Fed. R. Evid. 401, paragraphs 55–57 of the DiPiro
`
`Declaration are irrelevant to show the ACA materials were not publicly accessible.
`
`In the alternative, these paragraphs should be excluded under Fed. R. Evid. 403
`
`3 The DiPiro Declaration offers no counter-definition of a POSA, and Jazz
`
`does not challenge Petitioner’s definition of a POSA.
`
`-7-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`because their minimal probative value is outweighed by their tendency to confuse
`
`issues.
`
`B.
`
`The excerpt of Dr. Glenn Van Buskirk’s deposition testimony (Ex.
`2054) is impermissible hearsay, improper expert testimony, and
`irrelevant.
`
`Exhibit 2054, a five-page excerpt of deposition testimony from an unrelated
`
`case to which Petitioners are not parties, fails to clear multiple evidentiary hurdles,
`
`and therefore should be excluded.
`
`1.
`
`Exhibit 2054 constitutes impermissible hearsay.
`
`Hearsay is an out-of-court statement offered to prove the truth of the matter
`
`asserted, and is inadmissible unless a hearsay exception applies. See Fed. R. Evid.
`
`801(c), 802. Jazz relies on Exhibit 2054 as evidence that a POSA would not have
`
`been aware of the Xyrem Advisory Committee meeting, and would not have
`
`monitored the Federal Register for Advisory Committee meeting notices. See
`
`Response at 18. Exhibit 2054, an excerpt of deposition testimony from Dr. Glenn
`
`Van Buskirk, should be excluded because Jazz seeks to rely on it for a hearsay
`
`purpose to which no hearsay exception applies.
`
`Dr. Van Buskirk is not a declarant or witness in the present proceeding. On
`
`its face, Exhibit 2054 is from another proceeding—Jazz Pharmaceuticals v.
`
`Roxane Laboratories—to which Petitioners are not parties. Thus, neither of the
`
`-8-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`exceptions in Rule 801(d) apply. The Board should exclude Exhibit 2054 as
`
`impermissible hearsay.
`
`The additional exhibits Jazz served as supplemental evidence fail to cure this
`
`issue. Exhibit 2059—a third declaration of Dr. DiPiro—refers to Exhibit 2054, but
`
`does not identify in any way how Exhibit 2054 is not impermissible hearsay. Jazz
`
`also has never made Exhibit 2059 of record in this proceeding, and has neither
`
`identified how it cured Petitioners’ objections nor how Jazz was relying on the
`
`supplemental evidence. Accordingly, Petitioners reserve the right to comment on
`
`Exhibit 2059 and its admissibility and relevance to the admissibility of Exhibit
`
`2054 in a reply to any opposition Jazz files in response to this Motion.
`
`2.
`
`Exhibit 2054 is proffered as improper expert testimony.
`
`Exhibit 2054 is improperly relied upon as expert opinion testimony. Federal
`
`Rule of Evidence 702 states that a witness may testify in the form of an opinion if
`
`“qualified as an expert by knowledge, skill, experience, training, or education.”
`
`Fed. R. Evid. 702; see also Sundance, Inc. v. DeMonte Fabricating, 550 F.3d
`
`1356, 1362 (Fed. Cir. 2008). Jazz offers Exhibit 2054 as an opinion that
`
`“individuals with pharmacy degrees do not conduct such monitoring [of the
`
`Federal Register].” Response at 18. But Jazz has not qualified the deponent, Dr.
`
`Van Buskirk, as an expert in this proceeding. There is no evidence that Dr. Van
`
`-9-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`Buskirk was competent to testify as to the knowledge and skill of a POSA as of the
`
`critical date. As such, the Board should exclude Exhibit 2054 as improper expert
`
`testimony.
`
`3.
`
`Exhibit 2054 is used for an irrelevant purpose.
`
`Finally, Jazz offers Exhibit 2054 as evidence that a POSA would not have
`
`been aware of the Xyrem Advisory Committee meeting and would not have
`
`monitored Federal Register notices. See Response at 18. But, as discussed in §
`
`III.A.1, supra, such evidence is not relevant. Whether Dr. Van Buskirk, in 2015,
`
`was personally aware of the Xyrem Advisory Committee meeting in 2001, or
`
`whether he monitors the Federal Register for notices, is irrelevant to whether the
`
`ACA materials were publicly accessible to a POSA. As such, Exhibit 2054 is
`
`irrelevant under Fed. R. Evid. 401, and should be excluded.
`
`C.
`
`The Declaration of Lyndsey Pryzbylski
`impermissible hearsay and irrelevant.
`
`(Ex.
`
`2057)
`
`is
`
`Exhibit 2057, a declaration from Jazz’s counsel’s paralegal, Lyndsey
`
`Pryzbylski, similarly fails to clear evidentiary burdens, and therefore should be
`
`excluded.
`
`1.
`
`Exhibit 2057 is textbook impermissible hearsay.
`
`In Exhibit 2057, Ms. Pryzbylski relates the substance of a conversation she
`
`purportedly had with three employees at the University of Colorado Denver Health
`
`-10-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`Sciences Library. Jazz relies on Exhibit 2057 as evidence that the Colorado Health
`
`Sciences Library presently has no paper copies of the 2001 Federal Register. See
`
`Response at 22, n.7. This is textbook hearsay: Ms. Pryzbylski’s testimony (and the
`
`exhibit attached thereto) solely contains out-of-court statements by others to prove
`
`the truth of the matter assertedi.e., the contents of the library. See Fed. R. Evid.
`
`801(c).
`
`The additional exhibits Jazz served as supplemental evidence fail to cure this
`
`issue. Jazz has never made Exhibit 2058 part of record in this proceeding, and has
`
`neither identified how it cured Petitioners’ objections nor how Jazz was relying on
`
`the supplemental evidence. Accordingly, Petitioners reserve the right to comment
`
`on Exhibit 2058 and its admissibility in a reply to any opposition Jazz files in
`
`response to this Motion.
`
`2.
`
`Exhibit 2057 is offered for an irrelevant purpose.
`
`Jazz offers Exhibit 2057 for the purpose of impeaching Dr. Valuck’s
`
`testimony that, as of 2001, he typically reviewed the Federal Register in paper
`
`form. See Response at 22, n.7 (citing Ex. 2044 at 24:22–26:20;4 Ex. 2045 at
`
`341:19–342:6). But, even assuming arguendo that Exhibit 2057 is proper
`
`4 This section of Dr. Valuck’s transcript makes no reference to him
`
`reviewing the Federal Register.
`
`-11-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Motion to Exclude Evidence
`
`impeachment testimony, the portions of Ms. Pryzbylski’s testimony Jazz relies
`
`upon are regarding the contents of the Colorado Health Sciences Library as of
`
`November 2015. See Ex. 2057, ¶ 3, Ex. 1. But what the library has in its collection
`
`now is not probative of what the library had in its collection in 2001. As such,
`
`Exhibit 2057 is irrelevant and should be excluded.
`
`IV. CONCLUSION
`
`Jazz proffers paragraphs 50–57 of the DiPiro Declaration (Ex. 2046),
`
`paragraphs 37–39 of the Bergeron Declaration (Ex. 2047), and Exhibits 2049–2050
`
`and 2054 to contradict a point already established by Federal law: that publication
`
`of Exhibit 1015 in the Federal Register was sufficient notice to interested persons
`
`of the June 6, 2001 Advisory Committee meeting and its direction to the ACA
`
`Materials as a matter of law. This evidence should thus not be considered. The
`
`Board should further exclude Exhibit 2054 as impermissible hearsay and improper
`
`opinion testimony, and exclude Exhibit 2057 as impermissible hearsay and
`
`irrelevant as well.
`
`-12-
`
`
`
`1PR201.5-00554
`Patent No. 7,668,730
`Petitioners' Motion to Exclude Evidence
`
`Date: March 18, 2016 (cid:9)
`
`Respectfully submitted,
`
`n
`anine (cid:9)
`Regist lion No. 42,387
`ARENT Fox LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`Attorney for Petitioners Par
`Pharmaceutical, Inc. and Amneal
`Pharmaceuticals LLC
`
`-13-
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Certificate of Service
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned “Petitioners Par
`
`Pharmaceutical, Inc.’s and Amneal Pharmaceuticals LLC’s Motion to Exclude
`
`Evidence” including its supporting evidence, was served in its entirety on March
`
`18, 2016, upon the following parties via e-mail:
`
`John V. Biernacki
`jvbiernacki@jonesday.com
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`F. Dominic Cerrito
`nickcerrito@quinnemanuel.com
`Eric C. Stops
`ericstops@quinnemanuel.com
`Evangeline Shih
`evangelineshih@quinnemanuel.com
`Frank Calvosa
`frankcalvosa@quinnemanuel.com
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`Counsel for Patent Owner Jazz Pharmaceuticals, Inc.
`
`Jordana Garallek
`Patrick C. Gallagher
`JGarallek@duanemorris.com
`PCGallagher@duanemorris.com
`DUANE MORRIS LLP
`DUANE MORRIS LLP
`1540 Broadway
`190 South LaSalle Street, Suite 3700
`New York, NY 10036-4086
`Chicago, IL 60603-3433
`Counsel for Petitioner Wockhardt Bio AG
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Certificate of Service
`
`Respectfully Submitted,
`
`Bradford C. Frese
`Registration No. 69,772
`Attorney for Petitioner Par Pharmaceutical,
`Inc.
`
`Date: March 18, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`-2-
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