UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner
`
`v.
`
`HYPERION THERAPEUTICS, INC.,
`Patent Owner
`
`__________
`
`
`
`Case IPR2015-01117
`Patent 8,642,012
`
`__________
`
`
`
`PATENT OWNER HORIZON THERAPEUTICS, INC.’S PRELIMINARY
`RESPONSE PURSUANT TO 35 U.S.C. § 313 AND 37 C.F.R. § 42.107
`
`
`
`

`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 2
`
`A.
`
`B.
`
`The Texas Litigation and Petition ......................................................... 2
`
`The Jazz Decision .................................................................................. 4
`
`III. THE PETITION IS FATALLY DEFECTIVE BECAUSE IT FAILS
`TO NAME ALL REAL PARTIES-IN-INTEREST ........................................ 5
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`Legal Standard ....................................................................................... 6
`
`The Business of Par Co. ........................................................................ 8
`
`Par Co. “Call[ed] the Shots” in at Least One Other Proceeding. .......... 9
`
`Par Co. Controls the Petition and This Proceeding. ............................ 10
`
`Unified Nature of Par Co. and the Petitioner ...................................... 14
`
`Failure to Identify All Real Parties-in-Interest Cannot be Cured ....... 16
`
`It “is of No Moment” That Par Co. Was Not Named as a
`Defendant in the Texas Litigation ....................................................... 16
`
`IV. THE CHALLENGES IN THE PETITION ARE REDUNDANT. ............... 17
`
`A.
`
`B.
`
`Each of Grounds 9, 3, and 7 and Each of Grounds 9, 1, and 5 is
`Vertically Redundant. .......................................................................... 17
`
`Each of Grounds 1 and 5, Grounds 2 and 6; Grounds 4, 8, and
`10, and Grounds 2 and 3 is Horizontally Redundant. ......................... 18
`
`V.
`
`THE OFFICE HAS ALREADY CONSIDERED THE PRIOR ART. ......... 19
`
`VI. CONCLUSION .............................................................................................. 23
`
`
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`TABLE OF AUTHORITIES
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`Cases
`Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., IPR2014-01288,
`Paper 13 (PTAB Feb. 20, 2015) ...................................................................... 9
`
`Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc., IPR2013-
`00453, Paper 88 (PTAB Jan. 6, 2015) ................................................. 9, 10, 14
`
`Galderma S.A. v. Allergan Industrie, SAS, IPR2014-01422, Paper 14
`(PTAB Mar. 5, 2015) ..............................................................................passim
`
`Gonzalez v Banco Cent. Corp., 27 F.3d 751 (1st Cir. 1994) ............................... 8, 15
`
`Hyperion Therapeutics, Inc. v. Par Pharm., Inc., Case No. 2:14- cv-
`00384-JRG-RSP (E.D. Tex.) ........................................................... 3, 5, 11, 16
`
`Liberty Mut. Ins. Co. v. Progressive Cas. Ins., CBM2012-00003,
`Paper 7 (Oct. 25, 2012) .................................................................................. 18
`
`Par Pharm., Inc. v. Hyperion Therapeutics, Inc., IPR2015-01127,
`Paper 2 (PTAB Apr. 29, 2015) ........................................................................ 3
`
`Par Pharm., Inc. v. Jazz Pharm., Inc., IPR2015-00548, Paper 19
`(PTAB July 28, 2015) ...................................................................................... 4
`
`Par Pharm., Inc. v. Jazz Pharm., Inc., IPR2015-00551, Paper 19
`(PTAB July 28, 2015) ........................................................................ 4, 5, 9, 12
`
`Par Pharm., Inc. v. Jazz Pharm., Inc., IPR2015-00554, Paper 20
`(PTAB July 28, 2015) ...................................................................................... 4
`
`Reflectix, Inc. v. Promethean Insulation Tech. LLC, IPR2015-00039,
`Paper 18 (PTAB Apr. 24, 2015) .......................................................... 6, 14, 16
`
`Taylor v. Sturgell, 553 U.S. 880 (2008) ..................................................................... 7
`
`TRW Auto. US LLC v. Magna Elecs. Inc., IPR2014-01499, Paper 7
`(PTAB Mar. 19, 2015) ................................................................................... 12
`
`Zerto, Inc. v. EMC Corp., IPR2014-01254, Paper 35 (PTAB Mar. 3,
`2015) .................................................................................................... 6, 14, 16
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`Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-00606,
`Paper 13 (PTAB Mar. 20, 2014).................................................................... 15
`
`Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-00609,
`Paper 15 (PTAB Mar. 20, 2014)...................................................................... 7
`
` Statutes
`
`35 U.S.C. § 102(b) ...................................................................................................22
`
`35 U.S.C. § 103(a) ...................................................................................................22
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`35 U.S.C. § 271(e)(2)(A) ........................................................................................... 3
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`35 U.S.C. § 312 (a)(2) ................................................................................................ 1
`
`35 U.S.C. § 312(a) .................................................................................................5, 6
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 315(b) .......................................................................................... 1, 5, 16
`
`35 U.S.C. § 325(d) ...................................................................................... 19, 20, 23
`
`
`
`Other Authorities
`
`18A Charles Alan Wright, Arthur R. Miller & Edward H. Cooper,
`Federal Practice & Procedure (2d ed. 2011) ............................................. 7, 14
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756 (Aug. 14,
`2012) .................................................................................................. 3, 6, 7, 14
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`
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`Rules
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`37 C.F.R. § 1.132 .....................................................................................................22
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`37 C.F.R. § 42.106 ...............................................................................................5, 16
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`37 C.F.R. § 42.107 ..................................................................................................... 1
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`37 C.F.R. § 42.8(b)(1) ................................................................................................ 5
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`I.
`
`INTRODUCTION
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`The Patent Owner Horizon Therapeutics, Inc. (f/k/a Hyperion Therapeutics,
`
`Inc.) (“Horizon” or “Patent Owner”) submits this Preliminary Response pursuant
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`to 35 U.S.C. § 313 and 37 C.F.R. § 42.107, in response to the Petition for Inter
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`Partes Review of U.S. Patent No. 8,642,012 (Paper 2, herein “Petition”) filed by
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`Par Pharmaceutical, Inc. (“Par Inc.” or “Petitioner”). As set forth below, this
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`Preliminary Response mandates that inter partes review be denied.
`
`As a threshold matter, the Petition fails to identify all real parties-in-interest,
`
`as statutorily required for a petition for inter partes review. 35 U.S.C. § 312 (a)(2).
`
`Evidence indicates that the Petitioner’s parent, Par Pharmaceutical Companies, Inc.
`
`(“Par Co.”), is an involved parent that controls its wholly-owned subsidiary Par
`
`Inc., including the Petition and these proceedings. But Par Co. was not identified
`
`as a real party-in-interest. And since the Petition was filed exactly one year after
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`the Petitioner was served with a complaint for infringement, the Petitioner’s failure
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`to name all real parties-in-interest is a fatal flaw that cannot be cured by refiling its
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`Petition. 35 U.S.C. § 315(b).
`
`Moreover, the evidence uncovered to date that is specific to the Petition and
`
`this proceeding, as well as additional evidence that may not have been considered
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`by the Board, distinguish this proceeding from a recent Institution Decision in
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`another proceeding finding that the Petitioner’s parents were not real parties-in-
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`interest. Finally, all of the grounds in this Petition are either horizontally
`
`redundant, vertically redundant, or rely on previously considered art. The Board
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`should deny this Petition in its entirety.
`
`II. BACKGROUND
`
`A. The Texas Litigation and Petition
`
`Horizon markets an FDA approved drug product under the tradename
`
`RAVICTI®. RAVICTI® is approved for use as a nitrogen-binding agent for
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`chronic management of adult and pediatric patients at least two years of age with
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`urea cycle disorders. Horizon is the holder of an approved new drug application
`
`(NDA) for the RAVICTI® product (NDA No. 20-3284) which was first approved
`
`on February 1, 2013.
`
`Horizon is the owner of U.S. Patent No. 8,642,012 (the ʼ012 patent). The
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`ʼ012 patent qualified for listing in the Orange Book (formally known as Approved
`
`Drug Products With Therapeutic Equivalence Evaluations) in connection with
`
`NDA No. 20-3284 because it claims the approved drug product and an approved
`
`use of the drug product that is the subject of that NDA.
`
`Par Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA
`
`seeking to obtain approval to manufacture and sell a generic version of the
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`RAVICTI® product before the expiration of the ʼ012 patent. That ANDA was filed
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`with a “Paragraph IV” certification stating that the ʼ012 patent is invalid or would
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`not be infringed by the manufacture, use, or sale of the generic product for which
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`Par Inc. filed the ANDA.
`
`The subject Petition was filed exactly one year after the Petitioner was
`
`served with a complaint for infringement of the ʼ012 patent.1 The complaint was
`
`filed by Hyperion Therapeutics, Inc. (Horizon’s previous name) in a pending suit
`
`styled Hyperion Therapeutics, Inc. v. Par Pharmaceutical, Inc., Case No. 2:14- cv-
`
`00384-JRG-RSP (E.D. Tex.) (the Texas litigation).2 (Exs. 2001, 2010.)
`
`The Petition only identified Par Inc. and Hyperion Therapeutics, Inc.
`
`(Horizon) as the real parties-in-interest. (Petition, at 7.)3 And while the Petition
`
`
`1 See 35 U.S.C. § 271(e)(2)(A) (ANDA submission is “act of infringement”).
`
`2 The Texas litigation also included a claim for infringement of U.S. Patent No.
`
`8,404,215, which is the subject of another inter partes review (“IPR”) petition
`
`filed by Par Inc. Par Pharm., Inc. v. Hyperion Therapeutics, Inc., IPR2015-
`
`01127, Paper 2 (PTAB Apr. 29, 2015). A similar Preliminary Response has
`
`been filed in response to that IPR petition.
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`3 It is unclear why Petitioner identified Patent Owner Hyperion Therapeutics, Inc.
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`(Horizon) as a real party-in-interest since Horizon neither “desires review of the
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`patent” nor is a party “at whose behest the petition has been filed.” Office
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`also mentions two of Par Inc.’s four parents in a footnote, including Par Co., they
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`are not identified as real parties-in-interest. (Id., fn. 4.) Moreover, the Petitioner’s
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`counsel stated during a call with the Patent Trial and Appeal Board (“Board”) on
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`June 26, 2015, that the parents listed in the footnote were not identified as real
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`parties-in-interest.
`
`B.
`
`The Jazz Decision
`
`On July 28, 2015, the Board entered a Decision to institute inter partes
`
`review in a proceeding in which Par Inc. was a petitioner. Par Pharm., Inc. v. Jazz
`
`Pharm., Inc., IPR2015-00551, Paper 19 (PTAB July 28, 2015) (“Jazz Decision”)
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`(Ex. 2002).4 The Jazz Decision confirmed that Par Inc. was a wholly-owned
`
`subsidiary of Par Co., and that Petitioner and its parents act as a single unit in
`
`certain capacities. (Id., at 15). However, based on the evidence considered by the
`
`
`Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012)
`
`(“Practice Guide”).
`
`4 Decisions were also entered in Par Pharm., Inc. v. Jazz Pharm., Inc., IPR2015-
`
`00554, Paper 20 (PTAB July 28, 2015) and Par Pharm., Inc. v. Jazz Pharm.,
`
`Inc., IPR2015-00548, Paper 19 (PTAB July 28, 2015). Each of those decisions
`
`reached the same conclusion as to the real party-in-interest. For ease of
`
`reference, the Decision in IPR2015-00551 (Paper 19) will be referenced herein.
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`Board in that proceeding, the Board determined that none of the parents of Par Inc.
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`was a real party-in-interest.5
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`III. THE PETITION IS FATALLY DEFECTIVE BECAUSE IT FAILS TO
`NAME ALL REAL PARTIES-IN-INTEREST
`
`The Petition fails to name Par Co. as a real party-in-interest. The Petition
`
`thus violates the statutory and regulatory requirements for receiving a filing date
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`under 37 C.F.R. § 42.106. See 35 U.S.C. § 312(a) and 37 C.F.R. § 42.8(b)(1).
`
`And because the Petition was filed exactly one year after Par Inc. was served with
`
`the complaint in the Texas litigation, the failure to name all the real-parties-in-
`
`interest cannot be cured. 35 U.S.C. § 315(b).
`
`Par Co. is both an active company and an involved parent that controls its
`
`wholly-owned subsidiary Par Inc. For example, as discussed further below, Par
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`Co. markets generic drugs and owns trademarks/service marks, including the mark
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`that appears on the heading of the website (www.parpharm.com) that is common to
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`Par Co. and Petitioner. It also acts in concert with, and exercises control over, its
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`wholly-owned subsidiary Par Inc. in certain matters, including the Petition and
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`these proceedings.
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`
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`5 References to the Jazz Decision in this Preliminary Response will refer to Par
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`Co., Petitioner’s immediate parent, rather than the Par parents.
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`A. Legal Standard
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`A petition for inter partes review “may be considered only if – … (2) the
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`petition identifies all real parties in interest.” 35 U.S.C. § 312(a) (emphases
`
`added). This statutory requirement is a threshold issue on which Par Inc. has the
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`burden of persuasion. See Reflectix, Inc. v. Promethean Insulation Tech. LLC,
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`IPR2015-00039, Paper 18, at 8 (PTAB Apr. 24, 2015); Zerto, Inc. v. EMC Corp.,
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`IPR2014-01254, Paper 35, at 6-7 (PTAB Mar. 3, 2015).
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`The requirement that a petition name all real parties-in-interest is not a mere
`
`technicality; it is fundamental to the statutory framework of the America Invents
`
`Act. It not only assists member of the Board in identifying potential conflicts of
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`interest, it also assures the proper application of the statutory estoppel provisions.
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`Practice Guide, 77 Fed. Reg. at 48,759. The latter seeks to protect patent owners
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`from harassment via successive petitions by the same or “related parties,” to
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`prevent parties from having a “second bite at the apple,” and to “protect the
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`integrity of both the USPTO and Federal Courts by assuring that all issues are
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`promptly raised and vetted.” Id.
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`Whether an unnamed party is a real party-in-interest is a “highly fact-
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`dependent question.” Id. (citing Taylor v. Sturgell, 553 U.S. 880 (2008))6. But
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`fundamentally, the real party-in-interest is the “party that desires review of the
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`patent” – the petitioner itself and/or “the party or parties at whose behest the
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`petition has been filed.” Id.; Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp.,
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`IPR2013-00609, Paper 15, at 10 (PTAB Mar. 20, 2014).
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`Determination of whether a non-party is a real party-in-interest involves a
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`consideration of control, that is, “whether the non-party exercised or could have
`
`exercised control over a party’s participation in a proceeding.” Practice Guide, 77
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`Fed. Reg. at 48,759. The Board has stated that evidence that a non-party wields
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`“substantial control” in a matter “may be overt or covert, and the evidence of it
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`may be direct or circumstantial–so long as the evidence as a whole shows that the
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`nonparty possessed effective control over a party’s conduct . . . as measured from a
`
`practical, as opposed to a purely theoretical, standpoint.” Galderma S.A. v.
`
`Allergan Industrie, SAS, IPR2014-01422, Paper 14, at 7 (PTAB Mar. 5, 2015)
`
`
`
`6 Also referencing 18A Charles Alan Wright, Arthur R. Miller & Edward H.
`
`Cooper, Federal Practice & Procedure §§ 4449, 4451 (2d ed. 2011) (“Wright &
`
`Miller”).
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`(quoting Gonzalez v Banco Cent. Corp., 27 F.3d 751, 759 (1st Cir. 1994)). In the
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`vernacular, such control is the power–whether exercised or not–to call the shots.
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`Id. at 8 (emphasis in Galderma) (quoting Gonzalez, 27 F.3d at 758).
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`B.
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`The Business of Par Co.
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`Both the Petitioner and Par Co. have stated in a pleading filed in a patent suit
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`that “[Par Co.] is a pharmaceutical company engaged in developing,
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`manufacturing, and distributing, inter alia, generic pharmaceutical products. . . .”
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`(Ex. 2003, ¶ 4.) And according to an SEC filing, “[Par Co.]. . . is a leading U.S.
`
`pharmaceutical company specializing in developing, licensing, manufacturing,
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`marketing and distributing generic drugs.” (Ex. 2004, pg. 42.) These activities are
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`also evidenced by Par Co.’s website. (Ex. 2005 (Par Co. “resumed shipping” and
`
`“has begun shipping” certain products).) Par Co. also owns trademarks and service
`
`marks associated with those activities. (Ex. 2006).
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`To be sure, that SEC filing also states, “[Par Co.] operate[s] primarily in the
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`United States in two business segments: Par Pharmaceutical, which includes
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`generic products marketed under Par Pharmaceutical and sterile products marketed
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`under Par Sterile, and Par Specialty, which markets two branded products,
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`Nascobal® Nasal Spray and Megace® ES.” (Ex. 2004, at 42-43). However, merely
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`engaging in certain business operations through a related entity, such as the
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`Petitioner, does not mean that Par Co. cannot be a real party-in-interest.
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`In Galderma, the petitioner’s parent was established so that the petitioner
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`could “operate as the pharmaceutical arm” of the parent. Galderma, Paper 14, at
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`10-13. In fact, in addition to overlapping management (as is the case here), the
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`Board found that assertions that petitioner would “form the foundation” and
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`“operate as the pharmaceutical arm” of its parent supported a finding that the
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`parent was a real party-in-interest. Id.; see also Atlanta Gas Light Co. v. Bennett
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`Regulator Guards, Inc., IPR2013-00453, Paper 88, at 2, 13 (PTAB Jan. 6, 2015)
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`(parent held to be a real party-in-interest notwithstanding the fact that it was a
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`“holding company that . . . conducts substantially all of its operations through its
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`subsidiaries.”).
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`Similar to the facts in Galderma, the Petitioner “operate[s] as the [generic]
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`pharmaceutical arm” of its parent, Par Co. And, just as in Galderma, the Petitioner
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`and its parent, Par Co., have overlapping management.
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`C.
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`Par Co. “Call[ed] the Shots” in at Least One Other Proceeding.
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`The Jazz Decision noted that a proper inquiry is the degree of control that a
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`nonparty could exert over the inter partes review. (Ex. 2002, at 14 (emphasis
`
`added) (citing Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., IPR2014-01288,
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`Paper 13, at 12 (PTAB Feb. 20, 2015).) It also noted that the Petitioner and Par
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`Co. act as single unit in certain capacities, and that such a parent-subsidiary
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`relationship is a factor that weighs in favor of finding a parent company to be a real
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`party-in-interest. (Ex. 2002, at 15 (citing Atlanta Gas Light, Paper 88, at 11).)
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`Accordingly, it is worth noting an example of the significant control that Par Co.
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`exercises over the Petitioner, further evidencing the power– whether exercised or
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`not– to call the shots in this proceeding. See Galderma, Paper 14, at 8.
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`A striking example of the control exercised by Par Co. over the Petitioner is
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`seen in its binding of the Petitioner to certain provisions of a plea agreement with
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`the Department of Justice under which Par Co. pled guilty to charges of
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`introducing or delivering a misbranded drug into interstate commerce. (Ex.2007,
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`pg. 1.) That agreement was signed by Paul Campanelli as CEO of Par Co. on
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`March 4, 2013. (Id., pg. 9.) Among other things, the plea agreement required Par
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`Co. to take certain actions on behalf of the Petitioner in connection with litigation
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`to which the Petitioner was a party. (Id., pg. 4.) It also subjected the Petitioner to
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`(1) enhanced corporate rehabilitative compliance measures and certifications
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`(Exhibit 1 to plea agreement) (id., pgs. 3, 12-16), and (2) a Corporate Integrity
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`Agreement (Exhibit 2 to plea agreement) (id., pgs. 3, 18-111). Moreover, the
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`obligations in Exhibits 1 and 2 of the plea agreement indicate that they are ongoing
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`for five years. (Id., pgs. 12 and 18.)
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`D.
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`Par Co. Controls the Petition and This Proceeding.
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`Horizon has uncovered evidence that the Petition was filed, and these
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`proceedings are being prosecuted, by Par Co. in addition to Petitioner. (Ex 2004.)
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`Specifically, evidence from an SEC filing indicates that Par Co. is acting in concert
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`with the Petitioner in connection with the Texas litigation, the Petition, and this
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`proceeding.
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`On May 11, 2015, just a few days after the Petition was filed against
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`Horizon, Par Co. made the following representations to the SEC and the public:
`
`Par Pharmaceutical Companies, Inc. operates
`primarily through its wholly owned subsidiary, Par
`Pharmaceutical, Inc. (collectively referred to herein as
`“the Company,” “we,” “our,” or “us”) . . .
`
`(Ex. 2004, pg. 8 (emphases added)).
`
`On April 23, 2014, Hyperion Therapeutics filed a
`lawsuit against us in the U.S. District Court for the
`Eastern District of Texas. The complaint alleges
`infringement of U.S. Patent Nos. 8,404,215 and
`8,642,012. . . . On April 29, 2015, we filed Inter Partes
`Review petitions seeking institution of a trial on
`invalidity at the U.S. Patent and Trademark Office for
`both of the patents asserted in the Texas litigation. We
`intend to defend and prosecute, as applicable, these
`actions vigorously.
`
`(Ex. 2004, pg. 36 (emphases added).)
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`No such additional representation was made in the SEC filing in connection
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`with the Jazz IPR proceedings giving rise to the Jazz Decision. (Compare Ex.
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`2004, pg. 36, 1st and 4th full paragraphs.)
`
`Notably, these statements by Par Co. are not mere “generic references to the
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`existence of a parent/subsidiary business relationship in SEC documents.” See
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`TRW Auto. US LLC v. Magna Elecs. Inc., IPR2014-01499, Paper 7, at 11 (PTAB
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`Mar. 19, 2015). In TRW the Board found that “without more” than merely the
`
`existence of a traditional parent/subsidiary relationship, the parent was not a real
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`party-in-interest, noting that the SEC documents and press releases “do not
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`establish or suggest that the parent funds, directs, or controls the IPR petition or
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`proceeding. . . .” Id. Of course that is precisely what the Par Co. SEC document
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`suggests and establishes. (Ex. 2004, pgs. 8 and 36).
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`It should also be noted that the use of the pronoun “we” in that section of the
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`SEC document, as referring to Par Co. and Par Inc. collectively, was deliberate. In
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`that section, the pronoun “we” is used, inter alia, in reference to the plea
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`agreement discussed above that included agreements binding both the Petitioner
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`and Par Co. (Ex. 2004, pgs. 38-39; Ex.2007.) And that SEC document also
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`specifically calls out “Par Pharmaceutical, Inc.” individually when it wants to do
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`so. (See, e.g., Ex. 2004, pgs. 8 and 57.)
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`Lending yet further support that the collective “we,” i.e., Par Co. together
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`with Par Inc., filed the Petition and “intend to defend and prosecute, as applicable,
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`these actions vigorously,” is the fact that the collective definition for “we” was
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`replaced in the following section of the SEC document with the following
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`definition that defines “we” as Par Co. alone:
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`Par Pharmaceutical Companies, Inc. (the
`“Company,” “we,” “us” or “our”) is a leading U.S.
`pharmaceutical company specializing in developing,
`licensing, manufacturing, marketing and distributing
`generic drugs. . . . We operate primarily in the United
`States in two business segments: Par Pharmaceutical,
`which includes generic products marketed under Par
`Pharmaceutical and sterile products marketed under Par
`Sterile, and Par Specialty, which markets two branded
`products, Nascobal® Nasal Spray and Megace® ES.
`
`(Ex.2004, pg. 42-43 (emphases added).)
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`In other words, Par Co. deliberately utilized two different definitions of the
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`pronoun “we” in the SEC document. The first definition, i.e., the one used in the
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`section related to the Petition, encompassed Par Inc. The second definition did not.
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`In short, the word “we” in reference to the Petition and these proceedings was not a
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`typographical error.
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`These statements strongly suggest, at a minimum, that Par Co. is a party “at
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`whose behest the petition has been filed.” See Practice Guide, 77 Fed. Reg. at
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`48,759. Furthermore, “it should be enough that the nonparty [Par Co.] has the
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`actual measure of control or opportunity to control that might reasonably be
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`expected between two formal coparties.” Id. (quoting Wright & Miller § 4451).
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`These facts alone should be dispositive of the failure to name Par Co. as a real
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`party-in-interest. See Reflectix, Paper 18, at fn. 3 (“the relationship between [the
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`Petitioner] and its parent corporations, and their control of the instant Petitions, is
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`dispositive of these proceedings”).
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`E.
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`The Unified Nature of Par Co. and the Petitioner
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`The actions of Petitioner and Par Co. as a “single unit” are not surprising
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`given their unified ownership and management. Of course, unified ownership is
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`common in cases denying petitions for inter partes review for failure to identify
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`real parties-in-interest. See, e.g., Atlanta Gas Light, Paper 88, at 11; Reflectix,
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`Paper 18, at 4; Zerto, Paper 35, at 10.
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`Unified and overlapping management is also found in cases denying
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`petitions for inter partes review for failure to identify real parties-in-interest. See,
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`e.g., Reflectix, Paper 18, at 4-5 (“Several individuals are employees and/or
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`corporate officers of [Petitioner] and [one of two parents]” and all three companies
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`“share in-house legal counsel”).
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`In the present case, for example, Thomas J. Haughey is the General Counsel
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`and CAO of both Par Co. and the Petitioner, and also the President of the
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`Petitioner. (Ex. 2008, pg. 70 and Ex. 2009.) This fact is notably similar to the
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`facts in Galderma where the Board found that the presence of one individual (Mr.
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`Antunes) at the helm of both the petitioner’s parent and the petitioner (the parent’s
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`“pharmaceutical arm”) strongly implied “an involved and controlling parent
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`corporation representing the unified interests of itself and Petitioner.” Galderma,
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`Paper 14, at 12 (quoting Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp.,
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`IPR2013-00606, Paper 13, at 10 (PTAB Mar. 20, 2014)). The Board went on to
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`state as follows:
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`As President and CEO of both parent and
`subsidiary, Mr. Antunes wields a significant degree of
`effective control over the present matter. We need not
`consider whether Mr. Antunes did or did not, directly or
`indirectly, exercise this control. It is sufficient that he
`had, in the words of Gonzales [sic], “the power– . . . to
`call the shots.” Gonzales [sic], 27 F.3d at 758.
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`Galderma, Paper 14, at 12.
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`Similarly, as the General Counsel and CAO of both Par Co. and the
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`Petitioner, and President of the Petitioner, Thomas J. Haughey had “the power to
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`call the shots” and Par Co. should have been named as a real party-in-interest. See
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`id. (emphasis added).
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`F.
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`Failure to Identify All Real Parties-in-Interest Cannot be Cured.
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`The Petition was accorded a filing date of April 29, 2015. (Paper 3).
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`Furthermore, correction of the Petition to include Par Co. as a real party-in-interest
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`would require assignment of a new filing date. 37 C.F.R. § 42.106; see Zerto,
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`Paper 35, at 15. However, granting a new filing date would be futile because the
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`earliest filing date that could be accorded to the Petition would fall outside the one-
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`year time bar for filing an inter partes review. 35 U.S.C. § 315(b); see Zerto,
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`Paper 35, at 15.
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`G.
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`It “is of No Moment” That Par Co. Was Not Named as a
`Defendant in the Texas Litigation.
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`Par Co. was not sued by Horizon in the Texas litigation. But the fact that
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`Par Inc. is the only defendant in the Texas litigation is not relevant to the issue of
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`whether Par Co. should have been identified as a real party-in-interest. In
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`Reflectix, the Board noted that the proper real party-in-interest analysis focuses on
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`the relationship of the unnamed parent to the IPR proceedings, and the degree to
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`which it exercised, or could have exercised, control over the petitions. Reflectix,
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`Paper 18, at 12. The fact that the parent was dismissed from an infringement
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`action, and not named as a defendant in a subsequent action, “is of no moment.”
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`Id.
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`IV. THE CHALLENGES IN THE PETITION ARE REDUNDANT.
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`A. Each of Grounds 9, 3, and 7 and Each of Grounds 9, 1, and 5 is
`Vertically Redundant.
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`The Petition involves a plurality of prior art applied both in partial
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`combination and in full combination. The table below illustrates that redundancy
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`Asserted Bases for Obviousness of Claims 2 and 9
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`Ground 9
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`Ground 3
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`Ground 7
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`Brusilow ’91 Brusilow ’91 with Sherwin,
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`Brusilow ’91 with Simell ʼ86 and
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`Shiple, and the ʼ647 patent
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`the ʼ647 patent
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`Asserted Bases for Obviousness of Claims 1, 3, 4, 7, 10, and 12
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`Ground 9
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`Ground 1
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`Ground 5
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`Brusilow ’91 Brusilow ’91 with Sherwin
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`Brusilow ’91 with Simell ʼ86
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`and Shiple
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`The Petition does not include a bi-directional explanation of why the
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`reliance in part may be the stronger assertion in certain instances and, in other
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`instances, why the reliance in whole may be stronger. See Liberty Mut. Ins. Co. v.
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`Progressive Cas. Ins., CBM2012-00003, Paper 7, at 3 (Oct. 25, 2012).
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`Accordingly, those grounds are vertically redundant and the Patent Owner and the
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`Board should not be burdened with addressing them. The Board should not adopt
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`Grounds 1, 3, 5, 7, or 9.
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`B.
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`Each of Grounds 1 and 5, Grounds 2 and 6; Grounds 4, 8, and 10,
`and Grounds 2 and 3 is Horizontally Redundant.
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`The Petition also relies on similar secondary references which essentially
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`provide the same teaching to allegedly meet the same claim limitations. For
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`example, with regard to claims 1, 3, 4, 7, 10, and 12, in Ground 1, the Petition
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`applies Brusilow ’91 in view of Sherwin and Shiple. But in Ground 5, the Petition
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`applies Brusilow ’91 in view of Simell ’86 against the same claims. In other
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`words, in Ground 5, the Petition substitutes the teachings of Simell ’86 with the
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`combined teachings of Sherwin and Shiple.
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`That same substitution of Simell ’86 for the combined teachings of Sherwin
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`and Shiple is found in the Petition’s treatment of claim 5. In Ground 6, Brusilow
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`’91 is combined with Simell ’86 and Fernandes. In Ground 2, the Petition swaps
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`out Simell ’86 for Sherwin and Shiple.
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`A similar substitution is made with regard to claims 6 and 11. In Ground 8,
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`the Petition applies Brusilow ’91 in view of Simell and Kasumov. In Ground 4,
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`the Petition again substitutes Simell ’86 for Sherwin and Shiple. But with regard
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`to claims 6 and 11, the Petition makes yet another s