`Filed: April 8, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`
`
`AMNEAL PHARMACEUTICALS LLC,
`PAR PHARMACEUTICAL, INC., and WOCKHARDT BIO AG,
`Petitioners,
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`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`_____________________
`
`Case IPR2015-005471
`Patent 7,765,107
`_____________________
`
`
`PETITIONERS PAR PHARMACEUTICAL, INC.’S AND AMNEAL
`PHARMACEUTICALS LLC’S REPLY TO PATENT OWNER’S OPPOSITION
`TO PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
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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
`
`
`1 Case IPR2015-01820 has been joined with this proceeding.
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`IPR2015-00547—Patent 7,765,107
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION .......................................................................................... 1
`I.
`II. 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
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`B.
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`C.
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`IPR2015-00547—Patent 7,765,107
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
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`INTRODUCTION
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`I.
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`The Board should exclude paragraphs 50-57 of Ex. 2046 and paragraphs 36–
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`38 of Ex. 2047—the objected-to portions of
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`the DiPiro and Bergeron
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`Declarations—and Exs. 2049–2050 and 2054 as irrelevant because they do nothing
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`to show whether a POSA could have located the Federal Register notice of the
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`Xyrem Advisory Committee meeting (Ex. 1015). The Board should also exclude
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`Exs. 2054 and 2057 because they are hearsay, and Jazz’s arguments and evidence
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`do not support their admissibility.
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`II. ARGUMENT
`A. The Board should exclude the objected-to portions of the DiPiro
`and Bergeron Declarations, and Exs. 2049–2050 and 2054.
`1.
`Jazz asserts that Petitioners’ objections to the DiPiro and Bergeron
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`Petitioners’ objections provided sufficient notice to Jazz.
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`Declarations and Exs. 2049–2050 were insufficiently particular to provide them the
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`opportunity to serve supplemental evidence. Paper No. 63 (“Opp.”) at 2.
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`Petitioners, however, identified specific objectionable portions of the Declarations,
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`and the legal basis for those objections.
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`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
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`doing so demonstrates why the DiPiro and Bergeron Declarations, as well as Exs.
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`IPR2015-00547—Patent 7,765,107
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
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`2049–2050 and 2054, are irrelevant. Jazz repeatedly states that public accessibility
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`turns on a POSA “actually locating prior art.” Opp. at 4, 5; see also id.at 4 n.2. But
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`that is not the standard: public accessibility of prior art turns on whether a POSA
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`“exercising reasonable diligence could locate it.” See Bruckelmeyer v. Ground
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`Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (emphasis added). Moreover,
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`“[a]ccessibility goes to the issue of whether interested members of the relevant
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`public could obtain the information if they wanted to. If accessibility is proved,
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`there is no requirement to show that particular members of the public actually
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`received the information.” Constant v. Advanced Micro-Devices, Inc., 848 F.2d
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`1560, 1569 (Fed. Cir. 1988) (emphasis added).
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`Under this correct standard, Jazz’s evidence regarding whether a POSA
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`would have reviewed the Federal Register notice (Ex. 1015) is irrelevant to public
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`accessibility of the ACA. Congress has legislated that notices such as Ex. 1015 are
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`deemed given to every person in the United States upon publication. 44 U.S.C. §
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`1508. And, despite Jazz’s assertion to the contrary, this notice function extends to
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`both legally protected interests as well as “scientific or technical one[s].” Opp. at
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`2–3. For example, at least one court has held that a Federal Register statement that
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`a technical support document was available was sufficient notice for interested
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`individuals to seek out not only that document, but the technical data underlying
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`IPR2015-00547—Patent 7,765,107
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
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`that document. See S. Terminal Corp. v. E.P.A., 504 F.2d 646, 659 (1st Cir. 1974).2
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`Whether a POSA actually would have reviewed Ex. 1015 is irrelevant to the
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`ACA’s public availability, as a POSA could have located the ACA from Ex. 1015.
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`Jazz’s evidence directed to whether Ex. 1015, and thus the ACA, would
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`have been located by a POSA is therefore irrelevant. See Opp. at 4-5. Since there is
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`no requirement to show that a POSA actually reviewed publicly accessible
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`information, Jazz’s evidence has no probative value, and should be excluded.
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`Ex. 2054—the Van Buskirk deposition—is inadmissible hearsay.
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`B.
`Jazz does not dispute that Ex. 2054 is hearsay under Rule 801.3
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`Nevertheless, Jazz asserts it is admissible under the residual exception of Rule 807,
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`or because Dr. DiPiro relied upon it in a declaration served as supplemental
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`evidence. See Ex. 2059. Neither is true.
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`2 The technical document supported an Environmental Protection Agency
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`plan restricting “parking spaces available for use” in certain areas of Boston-hardly
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`a legally protected interest. S. Terminal Corp., 504 F.2d at 657.
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`3 Contrary to Jazz’s assertion, Ex. 2054 is not an excerpt of a deposition
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`from “the co-pending district court litigation addressing the patents-at-issue in the
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`IPR.” Opp. at 7. Claims and discovery regarding the patent at issue here were
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`bifurcated and stayed in that case at Jazz’s request. See Jazz Pharm., Inc. v. Roxane
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`Labs., Inc., No. 10-cv-6108, ECF No. 316 (D.N.J. Mar. 24, 2013) (Ex. 1061).
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`IPR2015-00547—Patent 7,765,107
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
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`Ex. 2054 is not admissible under the residual exception.
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`1.
`Dr. Van Buskirk’s testimony should not be admissible under the residual
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`exception of Rule 807. That exception is reserved for “exceptional cases.” See
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`Paper No. 52 at 9, Neste Oil OYJ v. Reg Synthetic Fuels, LLC, IPR2013-00578
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`(P.T.A.B. Mar. 12, 2015). This is not one: Ex. 2054 is garden-variety hearsay.
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`Further, Ex. 2054 does not even meet the requirements of Rule 807. For Dr.
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`Van Buskirk’s deposition to be admissible, it must be more probative than other
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`evidence Jazz could have obtained through reasonable efforts. See Fed. R. Evid.
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`807(3). But Jazz offers other evidence on the same point—namely, paragraphs 50–
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`57 of Dr. DiPiro’s declaration. Jazz never attempted to subpoena Dr. Van
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`Buskirk’s deposition in this proceeding. Ex. 2054 should thus be excluded.
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`2.
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`Dr. DiPiro’s supplemental declaration—Ex. 2059—does not
`make Ex. 2054 admissible.
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`In an effort to keep Dr. Van Buskirk’s testimony in, Jazz argues that Dr.
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`DiPiro’s reliance on it in a declaration, served as supplemental evidence, renders it
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`admissible. Opp. at 9. While experts may rely on inadmissible evidence, Dr.
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`DiPiro’s reliance on Ex. 2054 does not magically make it admissible. Dr. DiPiro
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`stated at his deposition that he only knew Dr. Van Buskirk from Ex. 2054, did not
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`know of his employer, and had no opinion regarding whether he is a respected
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`pharmacist or if he would even qualify as a POSA. See Ex. 1056, 305:19–306:8;
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`309:12–14. No evidence indicates that a POSA would reasonably rely upon Dr.
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`IPR2015-00547—Patent 7,765,107
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
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`Van Buskirk’s testimony in forming opinions, meaning it cannot properly form a
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`basis of DiPiro’s opinions and be admitted as such. See Fed. R. Evid. 703.
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`Moreover, the new opinions in Ex. 2059 solely go to the merits—not admissibility
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`of Ex. 2054—making it improper supplemental evidence. See Paper No. 30 at 2–3,
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`Handi Quilter, Inc. v. Bernina Int’l AG, IPR2013-00364, (P.T.A.B. June 12, 2014).
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`Ex. 2054 should thus be excluded.
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`C.
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`Jazz’s supplemental evidence shows that Ex. 2057 is inadmissible
`hearsay.
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`Jazz admits that Ex. 2057—Ms. Przybylski’s declaration—solely recounts
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`what two librarians told her to prove the truth of the contents of the library in 2015,
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`making her testimony textbook hearsay. See Opp. at 11–12. Jazz, however, argues
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`that the Rule 807 residual hearsay exception should apply. Id. But their
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`supplemental evidence—Ex. 2058, a declaration from one of those librarians—
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`shows that Ms. Pryzbylski’s declaration cannot be “more probative on the point for
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`which it is offered than any other evidence that the proponent could obtain
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`through reasonable efforts,” and thus not admissible under Rule 807. Jazz offers
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`no explanation why it could not have submitted Ex. 2058 instead of Ms.
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`Przybylski’s declaration. Ex. 2057 should thus be excluded.
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`III. CONCLUSION
`For these reasons, the Board should exclude paragraphs 50–57 of Exhibit
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`2046, paragraphs 36–38 of Exhibit 2047, and Exhibits 2049, 2050, 2054, and 2057.
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`IPR2015-00547—Patent 7,765,107
`Petitioners’ Reply to Opposition to Motion to Exclude Evidence
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`Respectfully submitted,
`MADDOX EDWARDS P.L.L.C.
`
`
`____________________________________
`Matthew C. Ruedy
`Registration No. 64,823
`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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`-6-
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`Date: April 8, 2016
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`IPR2015-00547
`Patent 7,765,107
`Certificate of Service
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e)
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`The undersigned hereby certifies that the above-captioned “Petitioners Par
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`Pharmaceutical, Inc.’s and Amneal Pharmaceuticals LLC’s Reply to Patent
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`Owner’s Opposition to Petitioners’ Motion to Exclude Evidence” and Exhibit 1061
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`were served in their entirety on April 8, 2016, upon the following parties via e-
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`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
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`IPR2015-00547
`Patent 7,765,107
`Certificate of Service
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`Respectfully submitted,
`MADDOX EDWARDS P.L.L.C.
`
`
`____________________________________
`Matthew C. Ruedy
`Registration No. 64,823
`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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`-2-
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`Date: April 8, 2016