UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`AMNEAL PHARMACEUTICALS, LLC and
`PAR PHARMACEUTICAL, INC
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`_____________________
`
`CASE IPR2015-00554
`Patent 7,668,730
`_____________________
`
`PETITIONERS’ REPLY REGARDING THE IDENTIFICATION OF REAL
`PARTIES IN INTEREST
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`AMNEAL PHARMACEUTICALS, LLC and
`PAR PHARMACEUTICAL, INC
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`_____________________
`
`CASE IPR2015-00554
`Patent 7,668,730
`_____________________
`
`PETITIONERS’ REPLY REGARDING THE IDENTIFICATION OF REAL
`PARTIES IN INTEREST
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`IPR2015-00554
` Patent No. 7,668,730
`
`I.
`INTRODUCTION ........................................................................................... 1
`LEGAL STANDARD ..................................................................................... 1
`II.
`FACTUAL BACKGROUND .......................................................................... 2
`III.
`IV. THE PETITIONS CORRECTLY IDENTIFY PAR INC. AS THE
`REAL PARTY IN INTEREST. ....................................................................... 3
`A. None of the Par Parents Have a Tangible Interest in the
`Petitions. ................................................................................................. 4
`Par Inc. Has Exercised Sole Direction and Control Over the
`Petitions. ................................................................................................. 5
`1.
`The Board Has Found the Type of Evidence Jazz
`Presents Here Insufficient to Confer RPI Status on a
`Non-Party. ................................................................................... 5
`Prior Board Decisions Finding Non-Party Parent
`Companies To Be RPIs Are Distinct From the Present
`Case. ............................................................................................ 8
`CONCLUSION .............................................................................................. 10
`
`B.
`
`2.
`
`V.
`
`-i-
`
`
`
`
`
`
`
`IPR2015-00554
` Patent No. 7,668,730
`
`I.
`
`INTRODUCTION
`
`Pursuant to the Board’s Order on May 12, 2015 (Paper 11), Petitioner Par
`
`Pharmaceutical, Inc. (“Par Inc.”) hereby responds to Jazz Pharmaceuticals, Inc.’s
`
`(“Jazz”) assertion that the above-captioned petition for inter partes review failed to
`
`name Par Inc.’s direct and indirect parent holding companies as “real parties-in-
`
`interest” (“RPI”). The Board should reject Jazz’s arguments as they fail to establish
`
`that Par Inc.’s parent holding companies have an interest in or control over this
`
`proceeding sufficient to render them RPIs.
`
`II. LEGAL STANDARD
`The patent owner challenging a Petitioner’s RPI disclosure must provide
`
`sufficient evidence to show the disclosure is inadequate. Intellectual Ventures
`
`Mgmt, LLC v. Xilinx, Inc., IPR2012-00018, Paper 12 at 3 (P.T.A.B. Jan. 24, 2013).
`
`The RPI is “the party that desires review of the patent”—that is, the party “at
`
`whose behest the petition has been filed.” Office Patent Trial Practice Guide, 77
`
`Fed. Reg. 48,756, 48,759 (Aug. 14, 2012) (to be codified at 37 C.F.R. Pt. 42). The
`
`RPI requirement exists to ensure that a non-party is not “litigating through a
`
`proxy.” See Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., IPR2014-01288,
`
`Paper 13, at 12 (P.T.A.B. Feb. 20, 2015). Moreover, the RPI analysis is a narrowly
`
`tailored inquiry into the “relationship between a party and a proceeding;” not “the
`
`relationship between parties.” Id. at 11.
`
`
`
`-1-
`
`
`
`The mere existence of a parent-subsidiary relationship “does not establish a
`
`IPR2015-00554
` Patent No. 7,668,730
`
`
`
`relationship sufficient to make the parent a real party in interest.” TRW Automotive
`
`U.S. LLC v. Magna Elec. Inc., IPR2014-01499, Paper 7 at 11 (P.T.A.B. Mar. 19,
`
`2015). Instead, Patent Owner must sufficiently demonstrate with evidence that the
`
`parent controls a subsidiary’s participation in the inter partes review. Compass
`
`Bank v. Intellectual Ventures II, IPR2014-00719, Paper 11 at 8 (P.T.A.B. Oct. 24,
`
`2014).
`
`III. FACTUAL BACKGROUND
`Par Inc. is the wholly-owned subsidiary of a series of holding companies,
`
`including Par Pharmaceutical Companies, Inc. (“Par Co.”); Sky Growth
`
`Intermediate Holdings II, Inc. (“SGIH II”); Sky Growth Intermediate Holdings I,
`
`Inc. (“SGIH I”); and Par Pharmaceutical Holdings, Inc. (“Par Holdings”)
`
`(collectively, the “Par Parents”). (PAR1040, ¶2.) Par Inc. is engaged in the
`
`business of making, selling and distributing pharmaceuticals; the Par Parents,
`
`however, do not conduct any such operations. (Id., ¶¶ 2–4.)
`
`Par Inc. prepared and filed ANDA No. 205403 (“Par’s ANDA”) with the
`
`United States Food and Drug Administration, directed to a 500 mg/ml solution of
`
`sodium oxybate (“Par’s ANDA Product”), and holds all right and title to that
`
`ANDA (Id., ¶5.) Par’s ANDA includes “Paragraph IV” certifications that U.S.
`
`Patent Nos. 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,457,988; and 8,589,182
`
`-2-
`
`
`
`
`(collectively, “the Petition Patents”) are invalid or would not be infringed by Par’s
`
`IPR2015-00554
` Patent No. 7,668,730
`
`ANDA Product. Based on that ANDA filing, Jazz sued Par Inc.—and, after nearly
`
`eighteen months of litigation, has yet to sue any of the Par Parents—for
`
`infringement of the Petition Patents, among others, and seeking a declaration that
`
`Par’s ANDA Product would infringe them upon FDA approval. (See PAR1026 at
`
`16–23.)
`
`IV. THE PETITIONS CORRECTLY IDENTIFY PAR INC. AS THE
`REAL PARTY IN INTEREST.
`
`Far from being a “nominal plaintiff” with “no substantial interest,” Par Inc.
`
`is the only Par entity with a cognizable interest in these Petitions, and is the only
`
`Par entity that has maintained any control over their preparation and filing.1 Jazz
`
`has failed to offer credible evidence that Par Inc. is acting as a proxy for the Par
`
`Parents, or that the Par Parents control these Petitions so as to render them RPIs.2
`
`
`1 Amneal Pharmaceuticals LLC, of course, is also an RPI with respect to
`
`IPR2015-00545, -00546, -00547, and -00554.
`
`2 Notably, Jazz named Jazz Pharmaceuticals, Inc. as the sole RPI in its
`
`Mandatory Notices, (see Paper 8 at 2) despite Jazz being a wholly-owned
`
`subsidiary of Jazz Pharmaceuticals PLC, which could presumably control or direct
`
`its behavior in these proceedings as well for the same reasons. (See PAR1041 at 29
`
`-3-
`
`
`
`
`
`IPR2015-00554
` Patent No. 7,668,730
`
`A. None of the Par Parents Have a Tangible Interest in the Petitions.
`Whether the Par Parents are RPIs depends on the relationship between them
`
`and these inter partes review proceedings, not their relationship to Par Inc. See
`
`Aruze Gaming, IPR2014-01288, Paper 13 at 12. Fundamental to that inquiry is the
`
`non-party’s interest in the proceeding, and whether it has an opportunity to control
`
`that proceeding to see that interest carried out. See Office Patent Trial Practice
`
`Guide, 77 Fed. Reg. at 48,759 (“[A]t a general level, the ‘real-party-in-interest’ is
`
`the party that desires review of the patent.”) Jazz would turn that inquiry on its
`
`head: Jazz would have the Board conclude the Par Parents are RPIs solely from
`
`their ability to control Par Inc., without showing that they have in fact exercised
`
`control or what the Par Parents’ interest is.
`
`Par Inc., on the other hand, prepared, filed, and owns its ANDA. (PAR1040,
`
`¶5.) After eighteen months of litigation, Jazz has only sued Par Inc., and none of
`
`the Par Parents, for infringement. (Id., ¶6; see also PAR1026.) Par Inc. is the only
`
`Par entity that directed, controlled, and funded the preparation and filing of these
`
`Petitions. (Id.) If the Petitions are ultimately successful, Par Inc. will have cleared
`
`one obstacle towards approval of its ANDA. The Par Parents, however, have no
`
`interest in seeking review of the Petition Patents. (PAR1040, ¶8). Thus, other than
`
`and Exhibit 21.1.) In other words, even Jazz apparently does not believe that a
`
`parent-subsidiary relationship alone is enough to make a corporate parent an RPI.
`
`-4-
`
`
`
`
`those for which Amneal Pharmaceuticals LLC is a Petitioner, Par Inc. is the sole
`
`IPR2015-00554
` Patent No. 7,668,730
`
`RPI for these Petitions.
`
`B.
`
`Par Inc. Has Exercised Sole Direction and Control Over the
`Petitions.
`
`Because Jazz cannot demonstrate that the Par Parents have an actual,
`
`cognizable interest in these proceedings, Jazz’s argument is reduced to a series of
`
`superficial observations regarding the corporate ownership of Par Inc., rather than
`
`an actual showing that the Par Parents had the opportunity or relevant reason to
`
`direct or control the instant proceedings.
`
`1.
`
`The Board Has Found the Type of Evidence Jazz Presents
`Here Insufficient to Confer RPI Status on a Non-Party.
`
`Jazz claims that Par Inc. and the Par Parents “hold themselves out as a single
`
`unit,” relying heavily on public financial documents that include collective
`
`references to Par Inc. and the Par Parents through words such as “we,” “our,” and
`
`“the Company” Paper 10 at 13. But using these generic descriptors in such
`
`documents is commonplace. The Board has rejected attempts to base RPI status on
`
`such “generic references to the existence of a parent/subsidiary relationship in SEC
`
`documents.” TRW Auto., IPR2014-01499, Paper 7 at 11. The Board has similarly
`
`declined to parse the semantics of public statements for evidence of a non-party
`
`RPI. See id. at 9, 11 (finding use of “the Company” in press releases insufficient).
`
`That Par Inc. and the Par Parents operate a single website also is irrelevant.
`
`-5-
`
`
`
`
`First, the Board has previously held that a shared website between sister companies
`
`IPR2015-00554
` Patent No. 7,668,730
`
`did not make the non-party an RPI. See Aruze Gaming, IPR2014-01288, Paper 13
`
`at 17–18. Second, none of the Par Parents conduct any operations; Par Inc. is the
`
`Par entity that manufactures, sells, and distributes drugs. (PAR1040 at ¶¶3–4.) That
`
`Par Inc. is a subsidiary to the Par Parents makes it no different than the situation in
`
`Aruze; Jazz attempts to elevate form over substance and says nothing regarding the
`
`Par Parents’ relationship to these Petitions.
`
`Jazz further asserts that Par Inc. and the Par Parents “act as a single unit”
`
`and “are controlled by a single master,” Paper 10 at 13. But, even if true, the Board
`
`has found such parent/subsidiary relationships inadequate to show “sufficient
`
`opportunities to control all aspects of Petitioner’s business, including controlling
`
`this inter partes review,” for purposes of establishing a parent corporation as an
`
`RPI. TRW Auto., IPR2014-01499, Paper 7 at 9 (quotation marks omitted).
`
`Similarly, that Par Inc. shares corporate officers with the Par Parents does not
`
`mean the Par Parents control Par Inc. in this proceeding, or have the ability to do
`
`so. See Butamax Advanced Biofuels LLC v. Gevo, Inc., IPR2013-00215, Paper 47
`
`at 6 (P.T.A.B. Sept. 23, 2014) (finding that Board membership of two directors in
`
`both parent and subsidiary insufficient to make the parent an RPI).
`
`More fundamentally, however, Jazz misses the mark because it aims for the
`
`wrong target: “RPI does not describe the relationship between parties” but the
`
`-6-
`
`
`
`
`“relationship between a party and a proceeding.” Aruze Gaming, IPR2014-01288,
`
`IPR2015-00554
` Patent No. 7,668,730
`
`Paper 13 at 11. Par Inc. was the sole party responsible for directing, controlling,
`
`and funding the preparation and filing of the Petitions. (PAR1040, ¶7.) None of the
`
`Par Parents participated in the decision to file the Petitions, nor did they exercise
`
`any control over the filing or content of the Petitions, nor did they provide funding
`
`or other compensation for the preparation and filing of the Petitions. (Id.) The
`
`Petitions were not discussed at any of the Par Parents’ board meetings. (Id.) The
`
`opportunity for control was simply not present.
`
`Yet Jazz points to public statements by two of Par Inc.’s parent companies
`
`referring to the related district court litigation as “our legal proceedings.” Paper 10
`
`at 19. But simply because Par Holdings and Par Co. refer to themselves and their
`
`wholly-owned subsidiary in the first-person plural is hardly “telling”3 that Par
`
`Holdings and Par Co. intend to defend against Jazz’s enforcement of its patents. in
`
`light of the fact that—after eighteen months of litigation—Jazz has not named the
`
`
`3 Likewise, Jazz’s latest 10-K states “[i]n this report, unless otherwise indicated or
`
`the context otherwise requires, all references to ‘Jazz Pharmaceuticals,’ ‘the
`
`registrant,’ ‘we,’ ‘us,’ and ‘our’ refer to Jazz Pharmaceuticals plc and its
`
`consolidated subsidiaries.” (see PAR1041 at 3), despite the fact that Jazz never
`
`named Jazz Pharmaceuticals plc as an RPI.
`
`-7-
`
`
`
`
`Par Parents as defendants, nor have the Par Parents intervened in those litigations
`
`IPR2015-00554
` Patent No. 7,668,730
`
`or filed declaratory judgments on any of the Petition Patents. (PAR1040, ¶8.)
`
`Second, Jazz relies on the LinkedIn page of David Silverstein—the attorney
`
`who signed the power-of-attorney for the instant petitions—to show he is
`
`employed by Par Co. But, in fact, David Silverstein is, in fact, employed on behalf
`
`of Par Inc. (id., ¶7) and signed the Power of Attorney on Par Inc’s behalf. (See
`
`Paper 3). And while Jazz cites two pleadings showing Par Inc.’s outside counsel
`
`are also litigation counsel for Par Co. in unrelated proceedings, using common
`
`litigation counsel hardly makes a non-party an RPI. See Aruze Gaming, IPR2014-
`
`01288, Paper 13 at 19. Thus, Jazz offers no credible evidence of a relationship
`
`between the Par Parents and these Petitions—much less control over them.
`
`2.
`
`Prior Board Decisions Finding Non-Party Parent
`Companies To Be RPIs Are Distinct From the Present Case.
`
`The Board has previously found a petitioner’s parent corporation to be an
`
`RPI in certain proceedings where “the parent corporation ‘has had control, or could
`
`have controlled the petitioner, in all aspects of its business,’ which would include
`
`… the inter partes review.” TRW Auto., IPR2014-01499, Paper 7 at 10 (quoting
`
`Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-00609, Paper 15 at 12
`
`(P.T.A.B. Mar. 20, 2014)). But each of those cases involved a situation where a
`
`Petitioner’s parent stood to gain or lose financially from an underlying patent
`
`-8-
`
`
`
`
`infringement suit. See Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc.,
`
`IPR2015-00554
` Patent No. 7,668,730
`
`IPR2013-00453, Paper 88 at 3 (P.T.A.B. Jan 6, 2015); Zoll, IPR2013-00609, Paper
`
`15 at 11–12; Galderma S.A. v. Allergan Industrie, IPR2014-01422, Paper 14 at 12–
`
`13 (P.T.A.B. Mar. 5, 2015). That situation is not present here: the Par Parents have
`
`no direct interest in these proceedings. (PAR1040, ¶8.)
`
`Moreover, in those cases, the Petitioner’s parent showed a greater degree of
`
`control over the subject matter of the Petitions than can be shown here. In Zoll, the
`
`Patent Owner provided evidence showing “unified actions by Petitioner and
`
`[parent company] in [a] ‘multi-state patent war’ … with Patent Owner,” and
`
`highlighting
`
`that
`
`the non-party parent’s management
`
`team—rather
`
`than
`
`petitioner’s—participated in a court-ordered mediation in a related proceeding.
`
`Zoll, IPR2013-00609, Paper 15 at 12. Similarly, in Atlanta Gas, the crucial finding
`
`was that officers for the parent engaged in related negotiations on behalf of both
`
`the Petitioner and its parent regarding triggering indemnity provisions in
`
`connection with the patent litigation. IPR2013-00453, slip op., Paper 88 at 9–10
`
`(P.T.A.B. Jan. 6, 2015). In Galderma, the Board found “historical evidence for a
`
`pattern of control” of the parent over the subsidiary with respect to the specific
`
`products at issue in a parallel patent suit. See IPR2014-01422, Paper 14 at 11–12
`
`(while also noting “the existence of a parent-subsidiary relationship alone” is
`
`insufficient to show RPI status. Id. at 12.)
`
`-9-
`
`
`
`None of these facts are present here. Rather, Jazz relies on allegations that
`
`IPR2015-00554
` Patent No. 7,668,730
`
`
`
`the “same corporate officers… control the decision making for all of the Par
`
`companies as a whole,” Paper 10 at 16, without evidence that those corporate
`
`officers directed or controlled these Petitions or the litigation. And Jazz has offered
`
`no basis to conclude that these corporate officers would have directed or controlled
`
`these Petitions or the litigation in their role as officers for the Par Parents. Jazz
`
`alleges nothing more than the existence of parent holding companies above Par
`
`Inc., which is insufficient to warrant a judgment that the Par Parents are RPIs.
`
`V. CONCLUSION
`The evidence shows Par Inc. is the only Par entity that has funded, directed,
`
`or controlled these inter partes reviews. Jazz’s claims amount to nothing more than
`
`generic references to a traditional parent-subsidiary relationship. Par Inc. has thus
`
`fully satisfied the requirements of § 312(a) and the Board should maintain the
`
`current Petition filing dates and institute review of the Petition Patents.
`
`Respectfully Submitted,
`
`Date: May 26, 2015
`Arent Fox LLP
`
`1717 K Street NW
`Washington, DC 20006
`202.857.6000
`
`
`
`
`
`
`
`
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`
`
`
`-10-
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`IPR2015-00554
` Patent No. 7,668,730
`Certificate of Service
`
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Reply Regarding the Identification Of Real-Parties-in-Interest” including its
`
`supporting evidence (EXHIBITS PAR1040-1041), was served in its entirety on
`
`May 26, 2015 by filing these documents through the Patent Review Processing
`
`System, as well as e-mailing copies to the following:
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`nickcerrito@quinnemanuel.com
`
`
`
`John V. Biernacki
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`jvbiernacki@jonesday.com
`
`
`
`
`
`Additional addresses known to
`Petitioner as likely to effect service
`
`
`
`
`
`
`
`
`
`IPR2015-00554
` Patent No. 7,668,730
`Certificate of Service
`
`
`Respectfully Submitted,
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`
`
`
`
`
`
`
`Date: May 26, 2015
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
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