Paper No. __
`Filed: April 8, 2016
`
`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 IPR2015-005541
`Patent 7,668,730 B2
`_____________________
`
`PETITIONERS PAR PHARMACEUTICAL, INC.’S AND AMNEAL
`PHARMACEUTICALS LLC’S REPLY TO PATENT OWNER’S OPPOSITION
`TO PETITIONERS’ 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: April 8, 2016
`
`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 IPR2015-005541
`Patent 7,668,730 B2
`_____________________
`
`PETITIONERS PAR PHARMACEUTICAL, INC.’S AND AMNEAL
`PHARMACEUTICALS LLC’S REPLY TO PATENT OWNER’S OPPOSITION
`TO PETITIONERS’ 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’ Reply to Opposition to Motion to Exclude Evidence
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`Page
`INTRODUCTION ..........................................................................................1
`ARGUMENT..................................................................................................1
`A.
`The Board should exclude the objected-to portions of the
`DiPiro and Bergeron Declarations, and Exs. 2049–2050 and
`2054. .....................................................................................................1
`1.
`Petitioners’ objections provided sufficient notice to Jazz. ........1
`2. Whether a POSA would have reviewed Ex. 1015 is
`irrelevant to whether a POSA could have located the
`ACA. ..........................................................................................1
`Ex. 2054—the Van Buskirk deposition—is inadmissible
`hearsay..................................................................................................3
`1.
`Ex. 2054 is not admissible under the residual exception...........4
`2.
`Dr. DiPiro’s supplemental declaration—Ex. 2059—does
`not make Ex. 2054 admissible. ..................................................4
`Jazz’s supplemental evidence shows that Ex. 2057 is
`inadmissible hearsay.............................................................................5
`III. CONCLUSION...............................................................................................5
`
`B.
`
`C.
`
`-i-
`
`
`
`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
`
`I.
`
`INTRODUCTION
`
`The Board should exclude paragraphs 50–57 of Ex. 2046 and paragraphs
`
`36–38 of Ex. 2047—the objected-to portions of
`
`the DiPiro and Bergeron
`
`Declarations—and Exs. 2049–2050 and 2054 as irrelevant because they do nothing
`
`to show whether a POSA could have located the Federal Register notice of the
`
`Xyrem Advisory Committee meeting (Ex. 1015). The Board should also exclude
`
`Exs. 2054 and 2057 because they are hearsay, and Jazz’s arguments and evidence
`
`do not support their admissibility.
`
`II.
`
`ARGUMENT
`
`A.
`
`The Board should exclude the objected-to portions of the DiPiro
`and Bergeron Declarations, and Exs. 2049–2050 and 2054.
`
`1.
`
`Petitioners’ objections provided sufficient notice to Jazz.
`
`Jazz asserts that Petitioners’ objections to the DiPiro and Bergeron
`
`Declarations and Exs. 2049–2050 were insufficiently particular to provide them the
`
`opportunity to serve supplemental evidence. Paper No. 61 (“Opp.”) at 2.
`
`Petitioners, however, identified specific objectionable portions of the Declarations,
`
`and the legal basis for those objections.
`
`2. Whether a POSA would have reviewed Ex. 1015 is
`irrelevant to whether a POSA could have located the ACA.
`
`Jazz repeatedly misstates the legal standard for public accessibility, and in
`
`doing so demonstrates why the DiPiro and Bergeron Declarations, as well as Exs.
`
`-1-
`
`
`
`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
`
`2049–2050 and 2054, are irrelevant. Jazz repeatedly states that public accessibility
`
`turns on a POSA “actually locating prior art.” Opp. at 4, 5; see also id. at 4 n.2. But
`
`that is not the standard: public accessibility of prior art turns on whether a POSA
`
`“exercising reasonable diligence could locate it.” See Bruckelmeyer v. Ground
`
`Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (emphasis added). Moreover,
`
`“[a]ccessibility goes to the issue of whether interested members of the relevant
`
`public could obtain the information if they wanted to. If accessibility is proved,
`
`there is no requirement to show that particular members of the public actually
`
`received the information.” Constant v. Advanced Micro-Devices, Inc., 848 F.2d
`
`1560, 1569 (Fed. Cir. 1988) (emphasis added).
`
`Under this correct standard, Jazz’s evidence regarding whether a POSA
`
`would have reviewed the Federal Register notice (Ex. 1015) is irrelevant to public
`
`accessibility of the ACA. Congress has legislated that notices such as Ex. 1015 are
`
`deemed given to every person in the United States upon publication. 44 U.S.C. §
`
`1508. And, despite Jazz’s assertion to the contrary, this notice function extends to
`
`both legally protected interests as well as “scientific or technical one[s].” Opp. at
`
`2–3. For example, at least one court has held that a Federal Register statement that
`
`a technical support document was available was sufficient notice for interested
`
`individuals to seek out not only that document, but the technical data underlying
`
`-2-
`
`
`
`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
`
`that document. See S. Terminal Corp. v. E.P.A., 504 F.2d 646, 659 (1st Cir. 1974).2
`
`Whether a POSA actually would have reviewed Ex. 1015 is irrelevant to the
`
`ACA’s public availability, as a POSA could have located the ACA from Ex. 1015.
`
`Jazz’s evidence directed to whether Ex. 1015, and thus the ACA, would
`
`have been located by a POSA is therefore irrelevant. See Opp. at 5. Since there is
`
`no requirement
`
`to show that a POSA actually reviewed publicly accessible
`
`information, Jazz’s evidence has no probative value, and should be excluded.
`
`B.
`
`Ex. 2054—the Van Buskirk deposition—is inadmissible hearsay.
`
`Jazz does not dispute that Ex. 2054 is hearsay under Rule 801.3
`
`Nevertheless, Jazz asserts it is admissible under the residual exception of Rule 807,
`
`or because Dr. DiPiro relied upon it in a declaration served as supplemental
`
`evidence. See Ex. 2059. Neither is true.
`
`2 The technical document supported an Environmental Protection Agency
`
`plan restricting “parking spaces available for use” in certain areas of Boston-
`
`hardly a legally protected interest. S. Terminal Corp., 504 F.2d at 657.
`
`3 Contrary to Jazz’s assertion, Ex. 2054 is not an excerpt of a deposition
`
`from “the co-pending district court litigation addressing the patents-at-issue in the
`
`IPR.” Opp. at 7. Claims and discovery regarding the patent at issue here were
`
`bifurcated and stayed in that case at Jazz’s request. See Jazz Pharm., Inc. v. Roxane
`
`Labs., Inc., No. 10-cv-6108, ECF No. 316 (D.N.J. Mar. 24, 2013) (Ex. 1061). +-
`
`-3-
`
`
`
`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
`
`1.
`
`Ex. 2054 is not admissible under the residual exception.
`
`Dr. Van Buskirk’s testimony should not be admissible under the residual
`
`exception of Rule 807. That exception is reserved for “exceptional cases.” See
`
`Paper No. 52 at 9, Neste Oil OYJ v. Reg Synthetic Fuels, LLC, IPR2013-00578
`
`(P.T.A.B. Mar. 12, 2015). This is not one: Ex. 2054 is garden-variety hearsay.
`
`Further, Ex. 2054 does not even meet the requirements of Rule 807. For Dr.
`
`Van Buskirk’s deposition to be admissible, it must be more probative than other
`
`evidence Jazz could have obtained through reasonable efforts. See Fed. R. Evid.
`
`807(3). But Jazz offers other evidence on the same point—namely, paragraphs 51–
`
`58 of Dr. DiPiro’s declaration. Jazz never attempted to subpoena Dr. Van
`
`Buskirk’s deposition in this proceeding. Ex. 2054 should thus be excluded.
`
`2.
`
`Dr. DiPiro’s supplemental declaration—Ex. 2059—does not
`make Ex. 2054 admissible.
`
`In an effort to keep Dr. Van Buskirk’s testimony in, Jazz argues that Dr.
`
`DiPiro’s reliance on it in a declaration, served as supplemental evidence, renders it
`
`admissible. Opp. at 9. While experts may rely on inadmissible evidence, Dr.
`
`DiPiro’s reliance on Ex. 2054 does not magically make it admissible. Dr. DiPiro
`
`stated at his deposition that he only knew Dr. Van Buskirk from Ex. 2054, did not
`
`know of his employer, and had no opinion regarding whether he is a respected
`
`pharmacist or if he would even qualify as a POSA. See Ex. 1056, 305:19–306:8;
`
`309:12–14. No evidence indicates that a POSA would reasonably rely upon Dr.
`
`-4-
`
`
`
`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
`
`Van Buskirk’s testimony in forming opinions, meaning it cannot properly form a
`
`basis of DiPiro’s opinions and be admitted as such. See Fed. R. Evid. 703.
`
`Moreover, the new opinions in Ex. 2059 solely go to the merits—not admissibility
`
`of Ex. 2054—making it improper supplemental evidence. See
`
`at 2–3, Handi
`
`Quilter, Inc. v. Bernina Int’l AG, IPR2013-00364 (P.T.A.B. June 12, 2014). Ex.
`
`2054 should thus be excluded.
`
`C.
`
`Jazz’s supplemental evidence shows that Ex. 2057 is inadmissible
`hearsay.
`
`Jazz admits that Ex. 2057—Ms. Przybylski’s declaration—solely recounts
`
`what two librarians told her to prove the truth of the contents of the library in 2015,
`
`making her testimony textbook hearsay. See Opp. at 11–12. Jazz, however, argues
`
`that
`
`the Rule 807 residual hearsay exception should apply.
`
`Id. But
`
`their
`
`supplemental evidence—Ex. 2058, a declaration from one of those librarians—
`
`shows that Ms. Pryzbylski’s declaration cannot be “more probative on the point for
`
`which it is offered than any other evidence that the proponent could obtain
`
`through reasonable efforts,” and thus not admissible under Rule 807. Jazz offers
`
`no explanation why it could not have submitted Ex. 2058 instead of Ms.
`
`Przybylski’s declaration. Ex. 2057 should thus be excluded.
`
`III. CONCLUSION
`
`For these reasons, the Board should exclude paragraphs 50–57 of Exhibit
`
`2046, paragraphs 36–38 of Exhibit 2047, and Exhibits 2049, 2050, 2054, and 2057.
`
`-5-
`
`
`
`IPR20] 5-00554—Patent No. 7,668, 730
`Petitioners’ Reply to Opposition to M'otion to Exclude Evidence
`
`Date: April 8, 2016
`
`Respectfully submitted,
`
`
`
`ARENT Fox LLP
`
`1717 K Street, NW
`
`Washington, DC 20006
`202.857.6000
`
`Attorneyfor Petitioner Par Pharmaceutical,
`Inc. and Amneal Pl1armaceutz'ca.ls LLC
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Certificate of Service
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e)
`
`The undersigned hereby certifies that the above-captioned “Petitioners Par
`
`Pharmaceutical, Inc.’s and Amneal Pharmaceuticals LLC’s Reply to Patent
`
`Owner’s Opposition to Petitioners’ Motion to Exclude Evidence” and Exhibit 1061
`
`were served in their entirety on April 8, 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
`
`-1-
`
`
`
`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: April 8, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`-2-
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