`Patent No. 8,518,987 B2
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________
`
`LUPIN LIMITED
`Petitioner
`v.
`JANSSEN SCIENCES IRELAND UC
`Patent Owner
`
`________________________________
`
`Case IPR2015-01030
`Patent 8,518,987 B2
`________________________________
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`
`
`PETITIONER LUPIN LIMITED’S REPLY REGARDING
`THE IDENTIFICATION OF REAL PARTIES-IN-INTEREST
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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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`IPR2015-01030
`Patent No. 8,518,987 B2
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`TABLE OF CONTENTS
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`TABLE OF AUTHORITIES .................................................................................... ii
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`I.
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`II.
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`INTRODUCTION. .......................................................................................... 1
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`LEGAL STANDARD. .................................................................................... 1
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`III.
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`FACTUAL BACKGROUND. ......................................................................... 2
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`IV. PETITIONER LUPIN LTD. IS THE REAL PARTY-IN-INTEREST. .......... 3
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`A.
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`B.
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`Lupin Ltd. Exercises Sole Discretion and Control Here. ...................... 4
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`The Lupin Subsidiaries Lack a Tangible Interest in the Petition. ......... 5
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`i.
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`ii.
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`Janssen’s evidence is insufficient to confer RPI status on
`non-parties Lupin Inc. and Lupin Atlantis. ................................. 5
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`The Board’s prior decisions regarding parent and
`subsidiary relationships are distinct from the instant case.......... 9
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`V.
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`CONCLUSION. ............................................................................................. 10
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`i
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`IPR2015-01030
`Patent No. 8,518,987 B2
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`TABLE OF AUTHORITIES
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`Federal Cases
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`Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc.,
`IPR2013-00453, slip op. (Paper 88) (P.T.A.B. Jan. 6, 2015) ....................... 12, 13
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`Butamax™ Advanced Biofuels LLC v. Gevo, Inc.,
`IPR2013-00215, slip op. (Paper 47) (P.T.A.B. Sept. 23, 2014) ............................. 9
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`Compass Bank v. Intellectual Ventures II,
`IPR2014-00719, slip op. (Paper No. 11) (P.T.A.B. Oct. 24, 2014) ..................... 11
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`Galderma S.A. v. Allergan Industrie, SAS,
`IPR2014-01422, slip op. (Paper 14) (P.T.A.B. Mar. 5, 2015) ................ 10, 11, 12
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`Intellectual Ventures Mgmt., LLC v. Xilinx, Inc.,
`IPR2012-00018, Paper 12 (P.T.A.B. Jan. 24, 2013) .............................................. 1
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`Par Pharm., Inc. et al. v. Jazz Pharm., Inc.,
`IPR2015-00546, slip op. (Paper 25) (P.T.A.B. July 28, 2015) ....................... 2, 13
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`RPX Corp. v. VirnetX Inc.,
`IPR2014-00171, slip op. (Redacted Paper 49) (P.T.A.B. July 14, 2014) .............. 5
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`TRW Auto. U.S. LLC v. Magna Elecs. Inc.,
`IPR2014-01499, slip op. (Paper 7) (P.T.A.B. Mar. 19, 2015) ........................ 8, 11
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`ZOLL Lifecor Corp. v. Philips Elecs. N. Am. Corp.,
`IPR2013-00609, slip op. (Paper 15) (P.T.A.B. Mar. 20, 2014) .................. 3, 7, 12
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`35 U.S.C. § 312(a) ................................................................................................... 10
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`Federal Statutes
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`IPR2015-01030
`Patent No. 8,518,987 B2
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`Other Authorities
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`Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012) ........................................................ 1, 2, 3, 5
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`iii
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`IPR2015-01030
`Patent No. 8,518,987 B2
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`I.
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`INTRODUCTION.
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`Pursuant to the Board’s Order on August 14, 2015 (Paper 10), Petitioner
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`Lupin Limited (“Lupin Ltd.”) replies to Patent Owner Janssen Sciences Ireland
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`UC’s (“Janssen”) assertion that the above-captioned inter partes review Petition
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`improperly failed to name Lupin Ltd.’s unrelated subsidiaries as “real parties-in-
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`interest” (“RPIs”). Janssen has failed to show such subsidiaries qualify as RPIs.
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`II. LEGAL STANDARD.
`Patent owners challenging a petitioner’s RPI disclosure must sufficiently
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`show the disclosure is inadequate. Intellectual Ventures Mgmt., LLC v. Xilinx,
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`Inc., IPR2012-00018, Paper 12 at 4 (P.T.A.B. Jan. 24, 2013). The RPI is “the
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`party that desires review of the patent,” and “at whose behest the petition has been
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`filed.” Trial Practice Guide, 77 Fed. Reg. 48,755, 48,759 (Aug. 14, 2012). The
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`RPI requirement exists to ensure that a non-party is not “litigating through a
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`proxy.” See Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., IPR2014-01288,
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`slip op. (Paper 13) at 12 (P.T.A.B. Feb. 20, 2015) (“Aruze”). The RPI analysis is a
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`narrowly tailored inquiry into the “relationship between a party and a proceeding,”
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`not “the relationship between parties.” Id. at 11.
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`Whether a party, not a named participant in a given proceeding, is a RPI to
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`that proceeding “is a highly fact-dependent question.” Trial Practice Guide, 77
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`Fed. Reg. at 48,759; see also Par Pharm., Inc. et al. v. Jazz Pharm., Inc., IPR2015-
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`IPR2015-01030
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`00546, slip op. (Paper 25) at 14 (P.T.A.B. July 28, 2015) (“Par”). Factors to
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`consider include, inter alia, (i) whether a non-party “funds and directs and
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`controls” an IPR petition or proceeding; (ii) the non-party’s relationship with the
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`petitioner; (iii) the non-party’s relationship to the petition itself, including the
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`nature and degree of involvement in the filing; and (iv) the nature of the entity
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`filing the petition. Trial Practice Guide, 77 Fed. Reg. at 48,760; see also Par, slip
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`op. at 14. Mere associations with another party in an unrelated endeavor separate
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`from an AIA proceeding does not make a party a RPI. Trial Practice Guide, 77
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`Fed. Reg. at 48,760. The evidence as a whole must show that the non-party
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`possessed effective control over the IPR proceeding. ZOLL Lifecor Corp. v.
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`Philips Elecs. N. Am. Corp., IPR2013-00609, slip op. (Paper 15) at 10 (P.T.A.B.
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`Mar. 20, 2014) (“ZOLL”).
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`III. FACTUAL BACKGROUND.
`Lupin Ltd. is a parent to many subsidiaries, e.g., Lupin Pharmaceuticals, Inc.
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`(“Lupin Pharma”), Lupin Inc., and Lupin Atlantis Holdings SA (“Lupin Atlantis”).
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`(Ex. 1093, Singh Decl. ¶ 3). Lupin Ltd.’s business is making, distributing and
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`selling pharmaceuticals. (Id. ¶ 2). Lupin Ltd. holds all rights, title, and decision-
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`making power for the various manufactured doses of darunavir tablets described in
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`Lupin Ltd.’s Abbreviated New Drug Application No. 202-073 (“Lupin Ltd.’s
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`ANDA Products”) and related amendments submitted to the Food and Drug
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`IPR2015-01030
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`Administration (“FDA”). (Ex. 1093 ¶ 4). Lupin Ltd.’s ANDA includes, inter alia,
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`a “Paragraph IV” certification that U.S. Patent No. 8,518,987 B2 (“the ‘987
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`patent”) is invalid and/or would not be infringed by Lupin Ltd.’s ANDA Products.1
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`Based on that Paragraph IV ANDA filing, Janssen has sued Lupin Ltd. and Lupin
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`Pharma for infringement of the ‘987 patent (and other patents) seeking a
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`declaration that Lupin Ltd.’s ANDA Products would infringe the ‘987 patent upon
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`FDA approval of Lupin Ltd.’s ANDA. (See Paper 8 at 2-5; Paper 3 at 1-9).
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`Despite nearly five years of litigation, Janssen has never sued either Lupin Atlantis
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`and/or Lupin Inc. for infringement of the ‘987 patent or any other patents. (Ex.
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`1093 ¶ 6; see also Paper 1 at 6 (referencing Civil Action No. 10-5954)).
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`IV. PETITIONER LUPIN LTD. IS THE REAL PARTY-IN-INTEREST.
`Far from being a “nominal plaintiff” with “no substantial interest,” Petitioner
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`Lupin Ltd. is the only Lupin entity with a cognizable interest in this Petition.2,3
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`1 Janssen sued Lupin Ltd. and Lupin Pharma on darunavir polymorph and process
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`patents. (See, e.g., Paper 3). Two were tried; an appeal is pending.
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`2 Lupin Ltd. has filed eight inter partes review petitions and has not listed Lupin
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`Inc. or Lupin Atlantis for reasons discussed herein. (Ex. 1093 ¶ 7).
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`3 Janssen (erroneously) named Lupin Pharma as a party in the district court
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`complaint Janssen filed regarding the ‘987 patent. (Paper 3 at 1-9). Even so,
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`Lupin Ltd. identified Lupin Pharma in the instant Petition to deter accusations that
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`Janssen lacks credible evidence that Lupin Ltd. lacks Petition control, or that Lupin
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`Ltd. is a mere proxy for Lupin Inc. or Lupin Atlantis so as to render them RPIs.4
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`A. Lupin Ltd. Exercises Sole Discretion and Control Here.
`Whether Lupin Inc. or Lupin Atlantis is a RPI depends on the relationship
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`between each entity and these inter partes review proceedings, not the relationship
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`either entity may have with Lupin Ltd. Aruze, slip op. at 12. The former inquiry
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`focuses on whether the non-party: 1) has an interest in the proceeding; and 2) the
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`opportunity to control the proceeding to see that its interests are carried out. Trial
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`Practice Guide, 77 Fed. Reg. at 48,759. While Janssen argues Lupin Inc. and
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`Lupin Atlantis share relationships with Lupin Ltd. and Lupin Pharma, Janssen has
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`not shown that Lupin Inc. or Lupin Atlantis do or could exercise control over the
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`instant Petition and proceedings.
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`Lupin Ltd. alone prepared and owns ANDA No. 202-073 to darunavir
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`tablets, and alone submitted a “Paragraph IV” certification asserting such ANDA
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`products will not infringe the ‘987 patent and/or that the ‘987 patent is invalid.
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`it sought to avoid this proceeding’s preclusive effects. RPX Corp. v. VirnetX Inc.,
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`IPR2014-00171, slip op. (Redacted Paper 49) at 6 (P.T.A.B. July 14, 2014).
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`4 Notably, Janssen named its parent, Johnson & Johnson, as an RPI, but not each of
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`the 250+ subsidiaries that Johnson & Johnson owns or controls. (See Ex. 1094,
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`Johnson & Johnson 2014 Form 10-K (Annual Report) at Exhibit 21: Subsidiaries).
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`(Ex. 1093 ¶ 4). From Lupin Ltd.’s Paragraph IV certification, Janssen only sued
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`Lupin Ltd. and Lupin Pharma in the pending litigation concerning the ‘987
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`patent—Lupin Ltd. named both as RPIs in Lupin Ltd.’s Petition. (Paper 1 at 5).
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`But Lupin Ltd. is the only Lupin entity to direct, control, or fund the preparation
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`and filing of this Petition. (Ex. 1093 ¶ 7). Lupin Ltd.’s ability to sell its ANDA
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`Products will benefit if the Board institutes inter partes review of this Petition and
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`finds the claims of the ‘987 patent unpatentable. Lupin Inc. and Lupin Atlantis are
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`not parties to Lupin Ltd.’s ANDA (or the litigation concerning that ANDA and the
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`‘987 patent). Thus, Lupin Ltd. (and Lupin Pharma, given its defendant status)
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`properly are the only named RPIs.
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`The Lupin Subsidiaries Lack a Tangible Interest in the Petition.
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`B.
`Janssen’s arguments offer little more than proclamations that parent-
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`subsidiary relationships exist between Lupin entities. That simply is not enough.
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`i.
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`Janssen’s evidence is insufficient to confer RPI status on
`non-parties Lupin Inc. and Lupin Atlantis.
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`Janssen’s handful of disconnected and general assertions concerning the
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`corporate structure of Lupin entities fails to contradict the salient key fact under the
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`relevant legal test: Lupin Ltd.—ultimate corporate parent to all entities Janssen
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`lists—is the petitioner with the control over this Petition and proceedings.
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`Janssen first argues “failure to identify the parent corporation[s],” Lupin
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`Inc. and Lupin Atlantis to Lupin Pharma, “violates the statutory and regulatory
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`requirements that the petition identify all real parties-in-interest.” (Paper 9 at 7
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`(quoting ZOLL, slip op. at 11 (emphasis added))). But Janssen admits Lupin Ltd.
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`is the “ultimate” parent of Lupin Atlantis, Lupin Inc., and Lupin Pharma. (Id. at 4-
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`5). The ultimate parent corporation, Lupin Ltd., is not only a named RPI, but is the
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`sole petitioner (Paper 1 at 5)—a critical distinction under ZOLL.
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`Janssen next argues, “distinction between the Lupin entities is blurred in
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`presentations to the public” (Paper 9 at 6) in view of Lupin’s website descriptions
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`and signage use of “Lupin” to refer to various entities, which Janssen urges
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`encourages the perception Lupin entities all function as a single entity. (Id.) The
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`Board has rejected attempts to parse the semantics of public statements for
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`evidence of a non-party RPI. TRW Auto. U.S. LLC v. Magna Elecs. Inc., IPR2014-
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`01499, slip op. (Paper 7) at 7-10 (P.T.A.B. Mar. 19, 2015) (“TRW Auto.”). The
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`Board has rejected attempts to base a non-party’s RPI status on such “generic
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`references to the existence of a parent/subsidiary business relationship in SEC
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`documents.” TRW Auto., slip op. at 11. The Board has also found that a shared
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`website between sister companies did not make a non-party an RPI. See Aruze,
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`slip op. at 17-18. Similarly, that Lupin Inc. and Lupin Atlantis share with Lupin
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`Ltd. or Lupin Pharma a corporate structure or website, or that they generically
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`constitute “Lupin,” insufficiently shows control over this Petition.
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`Janssen argues “[s]hared corporate leadership” amongst the different Lupin
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`entities results in Lupin Inc. and Lupin Atlantis being missing RPIs. (Paper 9 at 5).
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`Janssen lists a handful of Lupin Ltd. officers holding positions at another Lupin
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`entity (while conceding other Lupin Ltd. officers lack such second positions),
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`reporting two Lupin Inc. officers as “high-ranking officials” within Lupin Pharma.
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`(Id.) But this, again, ignores that: 1) Lupin Ltd., the ultimate parent, is the
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`petitioner and a named RPI; and 2) this Board rejects the premise that different
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`entities that share one or more corporate officers necessarily means the non-party
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`controls the named RPI. See Butamax™ Advanced Biofuels LLC v. Gevo, Inc.,
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`IPR2013-00215, slip op. (Paper 47) at 6 (P.T.A.B. Sept. 23, 2014).
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`Janssen also generally asserts Lupin entities have “intertwined business
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`relationships.” (Paper 9 at 5-6). This is immaterial when the ultimate parent,
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`Lupin Ltd., is the petitioner; a named RPI; and has the control over the ANDA
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`Products, instant Petition and proceedings. While Janssen cites to Lupin Atlantis
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`holding New Drug Applications and ANDAs generally (id. at 6), it blatantly
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`ignores Lupin Ltd. undisputedly is the owner of and controls decisions regarding
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`ANDA No. 202-073, the subject of the ‘987 patent litigation. (Ex. 1093 ¶¶ 4, 6).
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`Janssen also makes general statements regarding Lupin Inc.’s and Lupin
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`Atlantis’ business activities—but lacks specific facts about the instant Petition, the
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`‘987 patent, or Lupin Ltd.’s ANDA No. 202-073. (Paper 9 at 5-6).
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`And, despite Janssen’s arguments that “intertwined business relationships”
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`exist between certain Lupin entities, Janssen nowhere mentions it sued only Lupin
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`Ltd. and Lupin Pharma regarding Lupin Ltd.’s ANDA No. 202-073 and the ‘987
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`patent. Janssen has not amended its complaint to add Lupin Inc. or Lupin Atlantis.
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`Thus, by Janssen’s own pre-IPR considerations, Lupin Inc. and Lupin Atlantis
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`were not real parties-in-interest; they were not even parties Janssen deemed worthy
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`of suit in litigation, under a far lower standard for legal interests compared to the
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`narrow one before this Board: control over the petition itself.
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`Janssen’s reliance on general statements and assertions is fatal; the “real
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`party-in-interest inquiry is ‘highly fact-dependent.’” (Paper 9 at 4 (citing
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`Galderma S.A. v. Allergan Industrie, SAS, IPR2014-01422, slip op. (Paper 14) at 7
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`(P.T.A.B. Mar. 5, 2015) (“Galderma”))). As the Board has consistently held, the
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`“RPI does not describe the relationship between the parties” but the “relationship
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`between a party and a proceeding.” Aruze, slip op. at 11. Lupin Ltd. is the sole
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`petitioner and sole party responsible for directing, controlling, and funding the
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`preparation and filing of the instant Petition. (Ex. 1093 ¶ 7). The mere existence
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`of a parent-subsidiary relationship “does not establish a relationship sufficient to
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`make the [non-party] a real party in interest.” TRW Auto., slip op. at 11. Janssen
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`had to sufficiently demonstrate with evidence that the non-party controls a party’s
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`participation. See Compass Bank v. Intellectual Ventures II, IPR2014-00719, slip
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`op. (Paper No. 11) at 8 (P.T.A.B. Oct. 24, 2014). None of the Lupin Ltd.
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`subsidiaries participated in the decision to file the instant Petition, nor did they
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`provide any funding or other compensation to Lupin Ltd. for the preparation and
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`filing of the petition. (Ex. 1093 ¶ 7). There never was, and never will be,
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`opportunities for Lupin subsidiaries to control this Petition or the proceedings
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`concerning same, and certainly not in contravention of Petitioner.
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`ii.
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`The Board’s prior decisions regarding parent and
`subsidiary relationships are distinct from the instant case.
`Janssen cites three proceedings where the Board decided a non-party parent
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`entity exercised sufficient control over the petition and/or proceedings to qualify as
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`a RPI. (See Paper 9 at 4-7 (citing Galderma, Paper 14; ZOLL, Paper 13; Atlanta
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`Gas Light Co. v. Bennett Regulator Guards, Inc., IPR2013-00453, slip op. (Paper
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`88) (P.T.A.B. Jan. 6, 2015) (“Atlanta Gas Light”))). All three decisions evaluated
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`situations where: (i) a parent entity was not named as an RPI; and (ii) this non-
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`named parent entity had control, or an opportunity to control, the petition and the
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`proceedings. Galderma, slip op. at 8-13; ZOLL, slip op. at 8-11; Atlanta Gas
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`Light, slip op. at 9-13. That is the opposite of what occurred here. While Lupin
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`Pharma is a named RPI, Lupin Ltd. the ultimate parent, is the RPI; is the sole
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`petitioner; and all facts confirm Lupin Ltd. controls the Petition; these proceedings;
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`the darunavir ANDA; and litigation related to the ‘987 patent. (Ex. 1093 ¶¶ 4-7;
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`Paper 3 at 2-3, 5). Janssen proffers no facts showing Lupin Pharma, or non-named
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`entities, Lupin Inc. or Lupin Atlantis, have control, or an opportunity to control,
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`this Petition or the proceedings, let alone override their corporate parent’s
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`decisions. (Id.; see also generally Paper 9).
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`Thus, since the “evidence indicates that [Lupin Ltd.] calls the shots as it
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`pertains to the inter partes review and related litigation,” and Janssen failed to
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`show Lupin Ltd. “acted as a proxy for” Lupin Inc. or Lupin Atlantis, Janssen’s RPI
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`challenge fails. See Par, slip op. at 17 (parent entity not an RPI due to lack of
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`control of petition, proceedings, and litigations involving the patents-at-issue in the
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`related petitions), 18 (not a proxy).
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`V. CONCLUSION.
`Petitioner Lupin Ltd. is the only entity funding, directing, or controlling this
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`inter partes review. Janssen’s parent-subsidiary arguments fail to show Lupin Ltd.
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`lacks control, or is an improper Lupin Inc. or Lupin Atlantis proxy. Petitioner
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`satisfied the requirements of § 312(a); the current Petition filing date should be
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`maintained; and review of the ‘987 patent should be instituted.
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`Dated: August 28, 2015
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`Respectfully submitted,
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`/s/ Deanne M. Mazzochi
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`Deanne M. Mazzochi (Reg. No. 50,158)
`Tara M. Raghavan (Reg. No. 55,557)
`6 West Hubbard, Suite 500
`Chicago, IL
`(312) 222-6305 (telephone)
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`(312) 222-6325 (facsimile)
`dmazzochi@rmmslegal.com
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`Attorneys for Petitioner Lupin Limited
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`IPR2015-01030
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`IPR2015-01030
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, the undersigned certifies that on August 28,
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`2015, a copy of the foregoing document “LUPIN LIMITED’S REPLY
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`REGARDING THE
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`IDENTIFICATION OF REAL PARTIES-IN-
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`INTEREST” and accompanying exhibits were served by delivering a copy via
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`Federal Express for overnight delivery, upon the following:
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`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
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`Counsel for Patent Owner
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`Baker & Hostetler LLP
`ATTN: Stephanie A. Lodise
`Cira Centre, 12th Floor
`2929 Arch Street
`Philadelphia, PA 19104-2891
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`Patent Owner’s correspondence
`address of record for U.S. Patent No.
`8,518,987
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`Dated: August 28, 2015
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`Irena Royzman
`PATTERSON BELKNAP WEBB &
`TYLER LLP
`1133 Avenue of the Americas
`New York, NY 10036
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`/Deanne M. Mazzochi/
`Deanne M. Mazzochi
`Registration No. 50,158
`6 West Hubbard, Suite 500
`Chicago, IL
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`(312) 222-6305 (telephone)
`(312) 222-6325 (facsimile)
`dmazzochi@rmmslegal.com
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`Attorney for Petitioner Lupin Limited
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`IPR2015-01030
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