`Filed: March 25, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`
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`AMNEAL PHARMACEUTICALS LLC,
`PAR PHARMACEUTICAL, INC., and WOCKHARDT BIO AG
`Petitioners,
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`v.
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`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
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`
`
`_____________________
`
`Case IPR2015-005471
`Patent 7,765,107
`_____________________
`
`
`PETITIONERS PAR PHARMACEUTICAL, INC.’S AND AMNEAL
`PHARMACEUTICALS LLC’S MOTION TO ALLOW LATE FILING OF
`EVIDENCE OBJECTIONS UNDER 37 C.F.R. § 42.5(c)
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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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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ............................................................................................1
`I.
`STATEMENT OF FACTS ...............................................................................1
`II.
`III. ARGUMENT ....................................................................................................2
`A. Good cause exists to allow Petitioners to file their evidence
`objections. ............................................................................................... 2
`Allowing Petitioners to rely on their evidence objections is in
`the interests of justice. ............................................................................ 4
`IV. CONCLUSION .................................................................................................6
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`B.
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`-i-
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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`INTRODUCTION
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`I.
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`Petitioners Par Pharmaceutical, Inc. and Amneal Pharmaceuticals LLC
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`(collectively, “Petitioners”) respectfully request the Board consider their Motion to
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`Exclude (Paper No. 56), despite the fact that Petitioners filed their evidence
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`objections more than five business days after certain exhibits were filed in the
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`Patent Owner Response (Paper No. 46).
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`II.
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`STATEMENT OF FACTS
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`Patent Owner Jazz Pharmaceuticals, Inc. (“Jazz”) filed its Patent Owner
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`Response to the Petition on November 6, 2015. On November 13, 2015, Petitioners
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`timely served—but inadvertently did not file—their objections to the evidence Jazz
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`submitted in connection with its Response. See Paper No. 55, Certificate of
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`Service. Jazz thereafter served Petitioners with supplemental evidence under 37
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`C.F.R. § 42.64(b)(2) on November 30, 2015, via e-mail. See Ex. 1059. Importantly
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`for this Motion, by rule the supplemental evidence must be responsive to the
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`objections, thus indicating that Jazz had actual notice of Petitioners’ objections
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`here. See 37 C.F.R. § 42.64(b)(2).
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`In preparing their Motion to Exclude, Petitioners discovered that 37 C.F.R.
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`§ 42.64(b)(1) had been changed in May of 2015 to require filing of evidence
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`objections, rather than mere service of the objections on the opposing party as
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`required under the previous version of the rule. Upon discovering their error,
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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
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`Petitioners e-mailed Jazz’s counsel, requesting that Jazz not object to Petitioners
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`filing their previously-served evidentiary objections. Ex. 1060 at 5. Jazz refused on
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`the sole grounds that the request was untimely. See id. at 4. Petitioners then sent an
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`e-mail to the Board requesting they be permitted to file their objections late. See id.
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`at 3. After requesting and receiving comment from Jazz’s counsel, the Board
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`permitted Petitioners to file their Motion to Exclude and the instant Motion. See id.
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`at 1, 3.
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`III. ARGUMENT
`Under 37 C.F.R. § 42.5(c), “a late action will be excused on a showing of
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`good cause or upon a Board decision that consideration on the merits would be in
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`the interests of justice.” Here, good cause exists for the late action because it does
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`not harm Jazz or the Board, and allowing the late action is in the interests of justice
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`because it promotes resolution of the objected-to evidence on the merits, rather
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`than on procedural grounds.
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`A. Good cause exists to allow Petitioners to file their evidence
`objections.
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`Petitioners do not deny that their evidence objections should have been filed
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`within five business days of Jazz’s Patent Owner Response. Petitioners’ error,
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`however, was simply complying with an outdated version of 37 C.F.R. §
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`42.64(b)(1), rather than the revised version that was promulgated in May of 2015,
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`after the filing of the Petition. Petitioners’ failure to file the evidentiary objections
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`-2-
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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
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`that were served on Patent Owner was not done with deceptive intent or to delay
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`the proceedings, and good cause exists to consider Petitioners’ Motion to Exclude,
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`despite the late filing of the objections.
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`The purpose of filing evidence objections, rather than solely serving them, is
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`to make them of record in the proceeding. See 80 Fed. Reg. 28563 (“The Office
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`Patent Trial Practice Guide states that a motion to exclude evidence requires a
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`party to identify where in the record the objection originally was made, but 37
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`C.F.R. § 42.64 (b)(1) merely requires service, which does not make such
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`objections of record.”). The Board, recognizing this purpose, has allowed parties
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`who timely served their evidence objections under the prior rule to file them with a
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`motion to exclude after promulgation of the new rule. See Final Decision at 3, n.5,
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`TRW Auto. U.S. LLC v. Magna Elecs. Inc., No. IPR2014-01348, 2016 WL 212791
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`(P.T.A.B. Jan. 15, 2016).
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`Good cause also exists to extend a deadline where delay is due to an attorney
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`error and the extension causes no prejudice. See Bronner v. Unum Life Ins. Co. of
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`Am., No. C 03-05742 JF (RS), 2008 WL 4951031, at *2 (N.D. Cal. Nov. 18, 2008).
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`Despite not being filed with the Board, Petitioners’ objections were otherwise
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`properly served on Patent Owner. In response to Petitioners’ properly served
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`objections, Jazz served four new exhibits (Exhibits 2058–2061) as supplemental
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`evidence. Because the parties otherwise followed the rules and procedures set forth
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`-3-
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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
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`by the Board, the parties have a fully developed record surrounding the
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`admissibility of the evidence in question, and permitting Petitioners to file their
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`objections with their Motion to Exclude merely completes the record. See Paper
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`No. 56.
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`Jazz argues it is prejudiced because, despite serving four new exhibits as
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`supplemental evidence, it would have done more had Petitioners taken the
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`procedural step of filing their objections with the Board. See Ex. 1060 at 2. But
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`Jazz cannot legitimately assert it was prejudiced by choosing to avail itself of the
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`option to serve only some supplemental evidence. If Jazz truly believed more
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`supplemental evidence was necessary, it could have submitted more.
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`The act of filing objections with the Board is a procedural step to complete
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`the public record. Here, the objections were timely served, and Jazz had a full
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`opportunity to respond (and, in fact, did respond with supplemental evidence).
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`Good cause thus exists to consider the merits of Petitioners’ Motion to Exclude
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`despite the late filing of the objections.
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`B. Allowing Petitioners to rely on their evidence objections is in the
`interests of justice.
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`Allowing Petitioners to rely on their properly served evidentiary objections
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`here is in the interests of justice. Generally, “the interests of justice favor the
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`resolution of motions . . . on their merits, as opposed to resolution by procedural
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`-4-
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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
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`default.” Lopez v. Burris Logistics Co., No. 3:12-CV-1039 CSH, 2013 WL
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`5962100, at *3 (D. Conn. Nov. 6, 2013). Here, Jazz seeks to avoid resolution of
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`Petitioners’ Motion to Exclude on the merits, citing Petitioners’ procedural error in
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`serving, but not filing, their evidence objections in time. The interests of justice
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`favor considering Petitioners’ objections based on the record the parties have fully
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`developed, rather than on a procedural grounds.
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`Allowing late filing of Petitioners’ evidence objections also would be in the
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`interests of justice because Jazz availed itself of the option to more fully develop
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`the evidentiary record. Jazz, in fact, stated that it was serving its supplemental
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`evidence “under 37 C.F.R. § 42.64(b)(2).” Ex. 1059. Had Petitioners’ objections
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`truly been untimely and improper, Jazz would not have had the opportunity to
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`serve supplemental evidence at all. See Final Decision at 11–12, Valeo N. Am. v.
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`Magna Elecs., No. IPR2014-01208, 2015 WL 1037849 (P.T.A.B. Dec. 21, 2015)
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`(Petitioner not permitted to serve supplemental evidence in response to improper
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`objections). It would be fundamentally unfair for Jazz to avail itself of an
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`opportunity to develop the factual record in response to Petitioners’ evidence
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`objections, while simultaneously holding those objections waived.2
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`2 It bears noting that, but for a “goodwill” extension of time that Petitioners
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`granted to Jazz, two of the exhibits Petitioners seek to exclude—Exs. 2054 and
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`-5-
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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
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`Finally, the Board should reject any argument that Jazz may present that it
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`notified Petitioners of the procedural defect in Petitioners’ objections, and that any
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`delay in bringing this Motion is Petitioners’ fault. While in its November 30, 2015
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`e-mail Jazz made a boilerplate reservation of the right “to argue that Petitioners
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`have waived their objections,” Jazz failed to point to any procedural defect—or
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`any reason at all. See Ex. 1059. Absent any detail, Jazz’s boilerplate statement
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`provided no notice that any waiver of objections specifically was due to
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`Petitioners’ failure to file them. Had Jazz provided such detail, the parties may
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`have been able to resolve this dispute amicably and correct it more quickly.
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`IV. CONCLUSION
`For the foregoing reasons, the Board should proceed to consider Petitioners’
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`Motion to Exclude (Paper No. 56), despite Petitioners’ failure to file the evidence
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`objections within five business days of Jazz serving its Patent Owner Response.
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`2057—would never have been ready for use in this proceeding. See Paper No. 43.
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`Jazz sought Petitioners’ courtesy to timely submit this evidence, yet now aims to
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`frustrate the Board’s consideration of its admissibility solely on procedural
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`grounds.
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`IPR2015-00547 — Patent No. 7,765,107
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
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`Respectfully Submitted,
`MADDOX EDWARDS, PLLC
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`
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`____________________________________
`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
`Pharmaceutical LLC and Par
`Pharmaceutical, Inc.
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`Date: March 25, 2016
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`-7-
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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 “Petitioners Par
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`Pharmaceutical, Inc.’s and Amneal Pharmaceuticals LLC’s Motion to Allow Late
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`Filing Of Evidence Objections Under 37 C.F.R. § 42.5(c)” and Exhibits 1059-1060
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`were served in their entirety on March 25, 2016, upon the following parties via e-
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`mail:
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`John V. Biernacki
`jvbiernacki@jonesday.com
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
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`
`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.
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`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 No. 7,765,107
`Certificate of Service
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`Respectfully Submitted,
`MADDOX EDWARDS, PLLC
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`
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`____________________________________
`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
`Pharmaceutical LLC and Par
`Pharmaceutical, Inc.
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`Date: March 25, 2016
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