UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC.,
`
`and
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-011171
`Patent 8,642,012
`_____________________
`
`PETITIONER’S UNOPPOSED
`MOTION TO FILE PREVIOUSLY SERVED
`OBJECTIONS TO EVIDENCE OUT OF TIME 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 IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC.,
`
`and
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-011171
`Patent 8,642,012
`_____________________
`
`PETITIONER’S UNOPPOSED
`MOTION TO FILE PREVIOUSLY SERVED
`OBJECTIONS TO EVIDENCE OUT OF TIME 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 IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Motion to File Objections Out of Time
`
`
`INTRODUCTION
`
`Petitioner Par Pharmaceutical, Inc. (“Petitioner”) moves to file its previously
`
`served objections to evidence presented in Patent Owner Horizon Therapeutics,
`
`Inc. (“Patent Owner”) Response (“Patent Owner’s Response”) out of time. There
`
`is good cause to grant the requested relief because Petitioner timely served its
`
`objections within the proscribed five-day period, the deadline to file motions to
`
`exclude evidence is over six weeks away and Patent Owner does not oppose
`
`Petitioner’s motion. In addition, the late filing of Petitioner’s objections will
`
`promote the interests of justice by having evidentiary disputes decided on the
`
`merits.
`
`STATEMENT OF FACTS
`On April 29, 2015, Petitioner filed its Petition for Inter Partes Review of
`
`U.S. Patent No. 8,642,012 (“the ’012 patent”). (Paper No. 2.) On November 4,
`
`2015, the Patent Trial and Appeal Board (“the Board”) issued a decision instituting
`
`inter partes review of the ’012 patent. (Paper No. 13.) On March 28, 2016, Patent
`
`Owner filed a response to the petition (“Patent Owner’s Response”) and exhibits
`
`thereto. (Paper Nos. 25-26, Ex. Nos. 2011-2028.)
`
`On April 4, 2016, Petitioner served objections under 37 C.F.R. § 42.64 to
`
`evidence submitted in the Patent Owner’s Response. (See Exhibit 1034.)
`
`Petitioner did not concurrently file the objections on the case docket. On April 23,
`
`2
`
`
`
`2016, Petitioner discovered that Petitioner had inadvertently failed to file its
`
` IPR2015-01117
`Patent No. 8,642,012
`Motion to File Objections Out of Time
`
`
`objections to evidence presented in Patent Owner’s Response. On April 25, 2016,
`
`Petitioner notified Patent Owner of this oversight, and further requested Patent
`
`Owner’s position in regards to the present motion. (See Exhibit 1036.) On April
`
`26, 2016, Patent Owner informed Petitioner that it would not oppose the present
`
`motion. (Id.)
`
` The deadline for Petitioner to file a motion to exclude evidence presented in
`
`Patent Owner’s Response is June 16, 2016. (Paper Nos. 14 and 19.)
`
`ARGUMENT
`
`Petitioner seeks to file its previously served objections out of time to correct
`
`a procedural oversight and preserve Petitioner’s right to move to exclude evidence
`
`presented in Patent Owner’s Response at a future time by making the same
`
`objections part of the record. See 37 C.F.R. § 42.64(b)(1). The Board has
`
`authority to excuse a late action on “a showing of good cause” or where
`
`“consideration on the merits would be in the interests of justice.” 37 C.F.R.
`
`§ 42.5(c)(3). Here, both good cause and the interests of justice favor allowing
`
`Petitioner to file its objections out of time.
`
`3
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Motion to File Objections Out of Time
`
`
`GOOD CAUSE EXISTS TO ALLOW PETITIONER TO
`FILE ITS PREVIOUSLY SERVED OBJECTIONS OUT OF TIME.
`
`
`I.
`
`Petitioner served its objections to evidence presented in Patent Owner’s
`
`Response within five business days of the filing of Patent Owner’s Response.
`
`(Exhibit 1034 at 7.) Petitioner inadvertently complied with a pre-amendment
`
`version of the regulation requiring only that the objections be “served.” 2 Because
`
`Petitioner’s motion seeks to file precisely the same objections as those timely
`
`served on April 4, 2016, there is no prejudice to Patent Owner by allowing a late
`
`filing. In fact, Patent Owner does not oppose the present motion. (Exhibit 1036.)
`
`Furthermore, the filing of Petitioner’s objections out of time will not burden the
`
`Board or compound proceedings because the deadline to file motions to exclude
`
`evidence is June 16, 2016. (Paper Nos. 14 and 19.)
`
`Petitioner recognizes that the regulation, as amended May 19, 2015, requires
`
`that evidentiary objections be concurrently filed and served. 37 C.F.R.
`
`§ 42.64(b)(1). The spirit of the regulation, as amended, remains placing the
`
`opposing party on notice of the objection, and the added requirement that
`
`
`2 In confirming that the prior version of the regulation did not require that
`objections be filed in the record, the Board stated that the regulation “d[id] not
`require, nor ha[d] [the Board] authorized, the parties to file objections to evidence
`with the Board” and “[s]uch objections . . . are only to be filed with the Board in
`the event they later become the basis of a Motion to Exclude Evidence.” Order at
`2, Mitsubishi Plastics, Inc. v. Celgard, LLC, Case No. IPR2014-00524 (PTAB
`October 15, 2014) (Paper No. 17).
`
`4
`
`
`
`objections be filed in the record was designed to fill a procedural gap in the
`
` IPR2015-01117
`Patent No. 8,642,012
`Motion to File Objections Out of Time
`
`
`requirements for filing a motion to exclude evidence. 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.”). Thus, the purpose of the “filing” requirement is to ensure
`
`that a later-filed motion to exclude evidence is based on an objection that is
`
`identified in the record. Here, Petitioner served its objections, identified a
`
`procedural oversight and promptly sought to rectify its mistake over six weeks
`
`before the deadline for filing a motion to exclude evidence. Accordingly, good
`
`cause exists to grant Petitioner’s motion to file its objections out of time.
`
` ALLOWING PETITIONER TO RELY ON ITS PREVIOUSLY
`II.
`SERVED OBJECTIONS PROMOTES THE INTERESTS OF JUSTICE.
`
`The interests of justice favor considering Petitioner’s objections, if asserted
`
`in a motion to exclude, based on the record the parties have fully developed, rather
`
`than a procedural ground. 37 C.F.R. § 42.5(c). See also, e.g., Kucik v. Yamaha
`
`Motor Corp., U.S.A., C.A. No. 08-cv-161, 2009 WL 3401978 at *2 (N.D. Ind. Oct.
`
`16, 2009) (“the Court prefers to resolve cases on their merits and to rule on
`
`motions with the benefit of all relevant evidence and argument, as an approach that
`
`best serves the interests of justice.”) (citation omitted). For example, Petitioner
`
`5
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Motion to File Objections Out of Time
`
`timely served objections to evidence relied on in Patent Owner’s Response without
`
`sufficient basis, including, for example, a supporting expert declaration, as
`
`“improper expert opinion.” (See Exhibit 1034 at 2-4.) In addition, Petitioner
`
`timely served objections to evidence presented in Patent Owner’s Response
`
`because the evidence does not qualify as prior art based on its publication date.
`
`(See id. at 3-4.) Thus, the interest of justice would be best served by permitting
`
`Petitioner to file its previously served objections on the record and evaluating the
`
`admissibility of the evidence presented in Patent Owner’s Response on the merits,
`
`if such objections are raised in a motion to exclude the evidence.
`
`CONCLUSION
`
`For the foregoing reasons, the Board should grant Petitioner’s Motion to File
`
`Previously Served Objections to Evidence Out of Time under 37 C.F.R. § 42.5(c).
`
`Respectfully Submitted,
`
`
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`Date: June 14, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`
`6
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
` IPR2015-01117
`Patent No. 8,642,012
`Certificate of Service
`
`
`The undersigned hereby certifies that the above-captioned “PETITIONER’S
`
`UNOPPOSED MOTION TO FILE PREVIOUSLY SERVED OBJECTIONS TO
`
`EVIDENCE OUT OF TIME UNDER 37 C.F.R. § 42.5(C)” was served in its
`
`entirety on June 14, 2016 through the Patent Review Processing System, and
`
`additionally upon the following parties via Electronic Mail:
`
`For Patent Owner:
`
`For Petitioner Lupin:
`
`Elizabeth J. Holland
`Cynthia Lambert Hardman
`GOODWIN PROCTER LLP
`eholland@goodwinproctor.com
`chardman@goodwinprocter.com
`
`Respectfully Submitted,
`
`
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`Lauren Stevens:
`lstevens@horizonpharma.com
`Matthew C. Phillips:
`matthew.phillips@renaissanceiplaw.com
`Dennis Bennett:
`dennisbennett@globalpatentgroup.com
`
`Robert Green:
`rgreen@greengriffith.com
`Emer Simic: esimic@greengriffith.com
`Jessica Tyrus: jtyrus@greengriffith.com
`
`
`Date: June 14, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`
`7
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