Paper No. __
`Filed: March 25, 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 MOTION TO ALLOW LATE FILING OF
`EVIDENCE OBJECTIONS UNDER 37 C.F.R. § 42.5(C)
`
`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 25, 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 MOTION TO ALLOW LATE FILING OF
`EVIDENCE OBJECTIONS UNDER 37 C.F.R. § 42.5(C)
`
`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 Allow Late Filing of Evidence Objections
`
`TABLE OF CONTENTS
`
`Page
`
`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
`
`B.
`
`-i-
`
`
`
`IPR2015-00554 — Patent No. 7,668,730
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`INTRODUCTION
`
`I.
`
`Petitioners Par Pharmaceutical, Inc. and Amneal Pharmaceuticals LLC
`
`(collectively, “Petitioners”) respectfully request the Board consider their Motion to
`
`Exclude (Paper No. 54), despite the fact that Petitioners filed their evidence
`
`objections more than five business days after certain exhibits were filed in the
`
`Patent Owner Response (Paper No. 39).
`
`II.
`
`STATEMENT OF FACTS
`
`Patent Owner Jazz Pharmaceuticals, Inc. (“Jazz”) filed its Patent Owner
`
`Response to the Petition on November 6, 2015. On November 13, 2015, Petitioners
`
`timely served—but inadvertently did not file—their objections to the evidence Jazz
`
`submitted in connection with its Response. See Paper No. 54, Certificate of
`
`Service. Jazz thereafter served Petitioners with supplemental evidence under 37
`
`C.F.R. § 42.64(b)(2) on November 30, 2015, via e-mail. See Ex. 1059. Importantly
`
`for this Motion, by rule the supplemental evidence must be responsive to the
`
`objections, thus indicating that Jazz had actual notice of Petitioners’ objections
`
`here. See 37 C.F.R. § 42.64(b)(2).
`
`In preparing their Motion to Exclude, Petitioners discovered that 37 C.F.R.
`
`§ 42.64(b)(1) had been changed in May of 2015 to require filing of evidence
`
`objections, rather than mere service of the objections on the opposing party as
`
`required under the previous version of the rule. Upon discovering their error,
`
`-1-
`
`
`
`IPR2015-00554 — Patent No. 7,668,730
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`
`Petitioners e-mailed Jazz’s counsel, requesting that Jazz not object to Petitioners
`
`filing their previously-served evidentiary objections. Ex. 1060 at 5. Jazz refused on
`
`the sole grounds that the request was untimely. See id. at 4. Petitioners then sent an
`
`e-mail to the Board requesting they be permitted to file their objections late. See id.
`
`at 3. After requesting and receiving comment from Jazz’s counsel, the Board
`
`permitted Petitioners to file their Motion to Exclude and the instant Motion. See id.
`
`at 1, 3.
`
`III. ARGUMENT
`
`Under 37 C.F.R. § 42.5(c), “a late action will be excused on a showing of
`
`good cause or upon a Board decision that consideration on the merits would be in
`
`the interests of justice.” Here, good cause exists for the late action because it does
`
`not harm Jazz or the Board, and allowing the late action is in the interests of justice
`
`because it promotes resolution of the objected-to evidence on the merits, rather
`
`than on procedural grounds.
`
`A.
`
`Good cause exists to allow Petitioners to file their evidence
`objections.
`
`Petitioners do not deny that their evidence objections should have been filed
`
`within five business days of Jazz’s Patent Owner Response. Petitioners’ error,
`
`however, was simply complying with an outdated version of 37 C.F.R. §
`
`42.64(b)(1), rather than the revised version that was promulgated in May of 2015,
`
`after the filing of the Petition. Petitioners failure to file the evidentiary objections
`
`-2-
`
`
`
`IPR2015-00554 — Patent No. 7,668,730
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`
`that were served on Patent Owner was not done with deceptive intent or to delay
`
`the proceedings, and good cause exists to consider Petitioners’ Motion to Exclude,
`
`despite the late filing of the objections.
`
`The purpose of filing evidence objections, rather than solely serving them, is
`
`to make them of record in the proceeding. See 80 Fed. Reg. 28563 (“The Office
`
`Patent Trial Practice Guide states that a motion to exclude evidence requires a
`
`party to identify where in the record the objection originally was made, but 37
`
`C.F.R. § 42.64 (b)(1) merely requires service, which does not make such
`
`objections of record.”). The Board, recognizing this purpose, has allowed parties
`
`who timely served their evidence objections under the prior rule to file them with a
`
`motion to exclude after promulgation of the new rule. See Final Decision at 3, n.5,
`
`TRW Auto. U.S. LLC v. Magna Elecs. Inc., No. IPR2014-01348, 2016 WL 212791
`
`(P.T.A.B. Jan. 15, 2016).
`
`Good cause also exists to extend a deadline where delay is due to an attorney
`
`error and the extension causes no prejudice. See Bronner v. Unum Life Ins. Co. of
`
`Am., No. C 03-05742 JF (RS), 2008 WL 4951031, at *2 (N.D. Cal. Nov. 18, 2008).
`
`Despite not being filed with the Board, Petitioners’ objections were otherwise
`
`properly served on Patent Owner. In response to Petitioners’ properly served
`
`objections, Jazz served four new exhibits (Exhibits 2058–2061) as supplemental
`
`evidence. Because the parties otherwise followed the rules and procedures set forth
`
`-3-
`
`
`
`IPR2015-00554 — Patent No. 7,668,730
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`
`by the Board,
`
`the parties have a fully developed record surrounding the
`
`admissibility of the evidence in question, and permitting Petitioners to file their
`
`objections with their Motion to Exclude merely completes the record. See Paper
`
`No. 54.
`
`Jazz argues it is prejudiced because, despite serving four new exhibits as
`
`supplemental evidence,
`
`it would have done more had Petitioners taken the
`
`procedural step of filing their objections with the Board. See Ex. 1060 at 2. But
`
`Jazz cannot legitimately assert it was prejudiced by choosing to avail itself of the
`
`option to serve only some supplemental evidence. If Jazz truly believed more
`
`supplemental evidence was necessary, it could have submitted more.
`
`The act of filing objections with the Board is a procedural step to complete
`
`the public record. Here, the objections were timely served, and Jazz had a full
`
`opportunity to respond (and, in fact, did respond with supplemental evidence).
`
`Good cause thus exists to consider the merits of Petitioners’ Motion to Exclude
`
`despite the late filing of the objections.
`
`B.
`
`Allowing Petitioners to rely on their evidence objections is in the
`interests of justice.
`
`Allowing Petitioners to rely on their properly served evidentiary objections
`
`here is in the interests of justice. Generally, “the interests of justice favor the
`
`resolution of motions . . . on their merits, as opposed to resolution by procedural
`
`-4-
`
`
`
`IPR2015-00554 — Patent No. 7,668,730
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`
`default.” Lopez v. Burris Logistics Co., No. 3:12-CV-1039 CSH, 2013 WL
`
`5962100, at *3 (D. Conn. Nov. 6, 2013). Here, Jazz seeks to avoid resolution of
`
`Petitioners’ Motion to Exclude on the merits, citing Petitioners’ procedural error in
`
`serving, but not filing, their evidence objections in time. The interests of justice
`
`favor considering Petitioners’ objections based on the record the parties have fully
`
`developed, rather than on a procedural grounds.
`
`Allowing late filing of Petitioners’ evidence objections also would be in the
`
`interests of justice because Jazz availed itself of the option to more fully develop
`
`the evidentiary record. Jazz, in fact, stated that it was serving its supplemental
`
`evidence “under 37 C.F.R. § 42.64(b)(2).” Ex. 1059. Had Petitioners’ objections
`
`truly been untimely and improper, Jazz would not have had the opportunity to
`
`serve supplemental evidence at all. See Final Decision at 11–12, Valeo N. Am. v.
`
`Magna Elecs., No. IPR2014-01208, 2015 WL 1037849 (P.T.A.B. Dec. 21, 2015)
`
`(Petitioner not permitted to serve supplemental evidence in response to improper
`
`objections). It would be fundamentally unfair for Jazz to avail
`
`itself of an
`
`opportunity to develop the factual record in response to Petitioners’ evidence
`
`objections, while simultaneously holding those objections waived.2
`
`2 It bears noting that, but for a “goodwill” extension of time that Petitioners
`
`granted to Jazz, two of the exhibits Petitioners seek to exclude—Exs. 2054 and
`
`-5-
`
`
`
`IPR2015-00554 — Patent No. 7,668,730
`Petitioners’ Motion to Allow Late Filing of Evidence Objections
`
`Finally, the Board should reject any argument that Jazz may present that it
`
`notified Petitioners of the procedural defect in Petitioners’ objections, and that any
`
`delay in bringing this Motion is Petitioners’ fault. While in its November 30, 2015
`
`e-mail Jazz made a boilerplate reservation of the right “to argue that Petitioners
`
`have waived their objections,” Jazz failed to point to any procedural defect—or
`
`any reason at all. See Ex. 1059. Absent any detail, Jazz’s boilerplate statement
`
`provided no notice that any waiver of objections specifically was due to
`
`Petitioners’ failure to file them. Had Jazz provided such detail, the parties may
`
`have been able to resolve this dispute amicably and correct it more quickly.
`
`IV. CONCLUSION
`
`For the foregoing reasons, the Board should proceed to consider Petitioners’
`
`Motion to Exclude (Paper No. 54), despite Petitioners’ failure to file the evidence
`
`objections within five business days of Jazz serving its Patent Owner Response.
`
`2057—would never have been ready for use in this proceeding. See Paper No. 36.
`
`Jazz sought Petitioners’ courtesy to timely submit this evidence, yet now aims to
`
`frustrate the Board’s consideration of its admissibility solely on procedural
`
`grounds.
`
`-6-
`
`
`
`IPR2015-00554 — Patent No. 7,668,730
`Petitioners' Motion to Allow Late Filing of Evidence Objections
`
`Date: March 25, 2016 (cid:9)
`
`Respectfully submitted,
`
`• di% an
`Registration No. 42,387
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`Attorney for Petitioner Par
`Pharmaceutical, Inc.
`
`-7-
`
`
`
`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 Allow Late
`
`Filing of Evidence Objections Under 37 C.F.R. § 42.5(c)” and Exhibits 1059–1060
`
`were served in their entirety on March 25, 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: March 25, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`-2-
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