UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WOCKHARDT BIO AG,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________________
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`________________________
`
`REPLY TO PATENT OWNER PRELIMINARY RESPONSE
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313–1450
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WOCKHARDT BIO AG,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________________
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`________________________
`
`REPLY TO PATENT OWNER PRELIMINARY RESPONSE
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313–1450
`
`
`
`
`
`
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`
`
`Wockhardt
`Exhibit #
`
`UPDATED EXHIBIT LIST
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`Auerbauch, A. H. & Belldegrum, A. S., U.S. Patent No. 8,822,438
`(filed Feb. 24, 2011; issued Sep. 2, 2014) (“the ’438 patent”)
`Declaration of Paul A. Godley, MD, Ph.D., MPP
`
`Dr. Paul A. Godley’s Curriculum Vitae
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`
`i
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`Wockhardt
`Exhibit #
`
`Description
`
`1011
`
`1012
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`1013
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`1014
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`
`ii
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`Wockhardt
`Exhibit #
`
`Description
`
`U.S. Food and Drug Administration (“FDA”) News Release dated
`May 19, 2004, “FDA Approves New Indication for Taxotere—
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`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2
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`Miller, G. M. & Hinman, Jr., F., “Cortisone treatment in advanced
`carcinoma of the prostate,” J. of Urology, 72(3): 485-496 (1954)
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`iii
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`Wockhardt
`Exhibit #
`
`Description
`
`1028
`
`1029
`
`1030
`
`1031
`
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`
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`1034
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`(1986)
`
`iv
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`Wockhardt
`Exhibit #
`
`Description
`
`1038
`
`1039
`
`1040
`
`1041
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`1042
`
`1043
`
`1044
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`1045
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`1046
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`Rajfer, J. et al, “Mechanism of inhibition of human testicular
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`63:1193-1198 (1986)
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`1:74-77 (1994)
`
`v
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`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`Wockhardt
`Exhibit #
`
`Description
`
`1048
`
`1049
`
`1050
`
`1051
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`1052
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`1053
`
`1054
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`1055
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`cer/basics/definition/con-20029597?p=1 (accessed Aug. 8, 2016)
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`
`vi
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`Wockhardt
`Exhibit #
`
`Description
`
`1058
`
`1059
`
`1060
`
`1061
`
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`
`1063
`
`1064
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`
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`
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`
`vii
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`Wockhardt
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`
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`
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`dex, Set to Top Zytiga,” 4/3/2015,
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`CYP17, abiraterone acetate, confirms that castration-resistant pros-
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`IMS Health Data, 2012–2015 (submitted in Amerigen Pharms. Ltd.
`v. Janssen Oncology, Inc., IPR2016-00286, Ex. 1067)
`Declaration of Gopal Venkatesan
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`1078
`
`1079
`
`1080
`
`1081
`
`viii
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`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`TABLE OF CONTENTS
`
`
`I.
`
`II.
`
`Introduction ..................................................................................................... 1
`
`Amerigen is not a real party-in-interest to this inter partes review. ............... 2
`
`A. Wockhardt and Amerigen are separate corporate entities whose
`only relationship is as codefendants in a joint defense group. .............. 3
`
`B.
`
`The inadmissible settlement negotiations do not establish that
`Wockhardt has authority over Amerigen, nor is that relevant. ............. 5
`
`1.
`
`2.
`
`3.
`
`The confidential settlement negotiations with Ms. Reda
`are inadmissible under Fed. R. Evid. 408. ................................. 6
`
`Even if admissible, the communications do not establish
`that Wockhardt funded or controlled Amerigen’s IPR, or
`vice versa. ................................................................................... 6
`
`Neither Wockhardt, nor anyone employed at Wockhardt,
`has authority to settle a dispute on Amerigen’s behalf. ............. 7
`
`
`
`ix
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`
`I.
`
`Introduction
`
`As authorized by the Board on December 5, 2016 (Paper 17), Petitioner
`
`Wockhardt Bio AG (“Wockhardt”) responds to Patent Owner Janssen Oncology,
`
`Inc.’s (“Janssen”) allegation that Amerigen Pharmaceuticals Ltd. (“Amerigen”)
`
`should have been identified as a real party-in-interest. Because Amerigen has never
`
`funded, controlled, or in any other way been involved in this proceeding, it is not a
`
`real party-in-interest and the petition complies with 35 U.S.C. § 312(a)(2).
`
`Whether a nonparty is a “real party-in-interest” is a “highly fact-dependent
`
`question” involving whether a party provided funding or “exercised or could have
`
`exercised control over a party’s participation.” Trial Practice Guide, 77 Fed. Reg.
`
`48,756, 48,759-60 (Aug. 14, 2012). Janssen’s challenge does not demonstrate that
`
`Amerigen funded or had any ability to control this proceeding. As supported by the
`
`declaration of corporate representative Mr. Gopal Venkatesan (EX1081), Wock-
`
`hardt and Amerigen are entirely separate and unrelated corporations. Wockhardt
`
`has no corporate relationship with Amerigen, has never entered into a contract of
`
`any sort with Amerigen, has never had a financial dealings with Amerigen, and did
`
`not coordinate or otherwise collaborate with Amerigen with respect to this IPR.
`
`Wockhardt and Amerigen are nothing more than codefendants in a joint de-
`
`fense group with respect to the underlying district court litigation involving the
`
`’438 patent. But that fact is irrelevant because the Trial Practice Guide clearly ex-
`
`1
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`plains that if one member of a joint defense group files a petition, that alone does
`
`not render every other member a real party-in-interest. 77 Fed. Reg. 48,760.
`
`In this case, Wockhardt and Amerigen deliberately chose to not be involved
`
`in each other’s IPR filings. Amerigen filed its own petition against the ’438 patent.
`
`Wockhardt had no involvement in or knowledge of that petition before it was filed.
`
`(EX1081, ¶¶6-9.) Likewise, Amerigen had no involvement in the instant petition
`
`submitted by Wockhardt before it was filed. (Id., ¶7.)
`
`The communications to which Janssen cites show nothing more than an at-
`
`tempt to settle the underlying litigation. Not only should these communications be
`
`excluded under Fed. R. Evid. 408, they are irrelevant for the purpose of attempting
`
`to show Amerigen’s alleged funding or ability to control Wockhardt’s IPR.
`
`Janssen’s speculation that Amerigen exercised control over this proceeding has no
`
`basis in fact, is based on wrong assumptions, and should be rejected as unsupport-
`
`ed by evidence.
`
`II. Amerigen is not a real party-in-interest to this inter partes review.
`With respect to real party-in-interest, the key inquiry is “the relationship be-
`
`tween a party and a proceeding” not “the relationship between parties.” Aruze
`
`Gaming Macau, Ltd. v. MGT Gaming, Inc., IPR2014-01288, Paper 13 at 11
`
`(P.T.A.B. Feb. 20, 2015). A patent owner challenging a petitioner’s real party-in-
`
`interest identification must provide sufficient evidence to show that the disclosure
`
`2
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`is inadequate. Intellectual Ventures Mgmt., LLC v. Xilinx, Inc., IPR2012-00018,
`
`Paper 12 at 3 (P.T.A.B. Jan. 24, 2013). Amerigen is not a real party-in-interest to
`
`this proceeding because Amerigen has not funded and has no ability to control it.
`
`A. Wockhardt and Amerigen are separate corporate entities whose
`only relationship is as codefendants in a joint defense group.
`
`Wockhardt and Amerigen are separate corporate entities, with separate fi-
`
`nancial arrangements and separate and non-overlapping corporate directorship.
`
`(EX1081, ¶3.) Wockhardt has never entered into a contract of any kind with Amer-
`
`igen and has never had financial dealings with Amerigen. (Id., ¶4.) Indeed, the on-
`
`ly “relationship” between Wockhardt and Amerigen is the joint defense group that
`
`they are both a part of in the context of the underlying district court infringement
`
`litigation brought by the patent owner. (Id., ¶5.)
`
`Interactions between codefendants are not presumed to show funding of or
`
`control over their respective petitions. Nestle USA, Inc. v. Steuben Foods, Inc.,
`
`IPR2015-00195, Paper 51 at 11-12 (P.T.A.B. June 29, 2015) (“[W]e do not find
`
`such information-sharing and cooperation to be sufficient . . . . Indeed, that type of
`
`coordination is typical for parties in a joint defense group . . . . There is no indica-
`
`tion . . . that [the codefendant] is obligated to follow any particular strategy dictat-
`
`ed by Petitioner, or vice versa . . . .”); Petroleum Geo-Services Inc. v. Westerngeco
`
`LLC, IPR2014-01477, Paper 71 at 59 (P.T.A.B. July 11, 2016) (“Collaboration, by
`
`itself, is not evidence that [unnamed party] has any involvement either by way of
`
`3
`
`
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`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`control, or funding the filing of this Petition.”); see also Denso Corp. v. Beacon
`
`Navigation GmbH, IPR2013-00026, Paper 34 at 10-11 (P.T.A.B. Mar. 14, 2014).
`
`Amerigen never sought Wockhardt’s involvement in developing its petition,
`
`nor did it even inform Wockhardt that it was preparing one. (EX1081, ¶7.) In turn,
`
`Wockhardt deliberately chose to not join Amerigen’s IPR. (Id., ¶9.) Wockhardt did
`
`not coordinate or share information with Amerigen when Wockhardt prepared its
`
`own petition, which is materially different from Amerigen’s. (Id., ¶¶6, 8.) Indeed,
`
`Janssen’s own exhibits show that Wockhardt chose to not join Amerigen’s petition
`
`and opted instead to file its own. (Ex. 2003, ¶9.) It does not follow that Amerigen
`
`controlled Wockhardt, or vice versa. Moreover, it is entirely reasonable for a party
`
`to petition on its own and avoid being bound by another party who arranged its ar-
`
`guments and evidence without the other’s input.
`
`At best, Janssen’s exhibits show that Wockhardt was aware of Amerigen’s
`
`filing activities, which is not sufficient to demonstrate funding or an opportunity to
`
`control. See, e.g., CB Distributors, Inc. et al. v. Fontem Holdings 1 B.V., IPR2014-
`
`01529, Paper 19 at 6-7 (P.T.A.B. May 26, 2015) (“[M]ultiple parties that are co-
`
`defendants in the litigation filed IPR petitions for various patents . . . . [t]hat the co-
`
`defendants may have been aware of the upcoming filing of IPR petitions, including
`
`this one, does not convey that any of these codefendants exercises control of, or
`
`provides funding for, this proceeding.”); Pixart Imaging, Inc. v. Syncpoint Imag-
`
`4
`
`
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`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`ing, LLC, IPR2015-01347 Paper 12 at 8 (P.T.A.B. Dec. 16, 2015) (communicating
`
`filing activities to joint defendants does not evidence funding or control).
`
`Nor does any similarity between Amerigen’s and Wockhardt’s petitions
`
`demonstrate funding or control. Tradestation Group, Inc. v. Trading Technologies
`
`International, Inc., CBM2015-00161, Paper 29 at 29-30 (P.T.A.B. Jan. 27, 2016)
`
`(“[T]he fact that Petitioner admits that it substantially copied [a codefendant’s] pe-
`
`tition and exhibits . . . does not establish sufficiently that [the codefendant] had
`
`control over the filing of the Petition in this proceeding. The record in [the code-
`
`fendant’s proceeding] was publicly accessible and, on this record, Patent Owner
`
`has not directed us to sufficient evidence to question Petitioner’s assertion that [the
`
`codefendant] did not have any control over Petitioner’s decision to substantively
`
`resubmit the petition and exhibits . . . .”); JP Morgan Chase & Co. v. Maxim Inte-
`
`grated Product, Inc., CBM2014-00179, Paper 11 at 6-13 (P.T.A.B. Feb. 20, 2015)
`
`(determining that a resubmission of an identical petition previously filed in an orig-
`
`inal proceeding was not a sufficient basis for determining that a co-petitioner in the
`
`original proceedings was a real party-in-interest in the later proceeding).
`
`B.
`
`The inadmissible settlement negotiations do not establish that
`Wockhardt has authority over Amerigen, nor is that relevant.
`
`Janssen’s real party-in-interest challenge rests entirely on unsupported spec-
`
`ulation about coordination between Wockhardt and Amerigen based on settlement
`
`negotiations between Dr. Vipin Dhanorkar of Wockhardt and Ms. Jennifer Reda
`
`5
`
`
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`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`of Johnson & Johnson. Janssen’s challenge fails for three independent reasons.
`
`1.
`
`The confidential settlement negotiations with Ms. Reda are
`inadmissible under Fed. R. Evid. 408.
`
`First, the statements submitted by Janssen in support of this allegation are
`
`inadmissible under Fed. R. Evid. 408, which prohibits use of compromise offers
`
`and negotiations in certain situations. Here, the statements are offered for the pro-
`
`hibited use of “impeach[ing]” Wockhardt’s real party-in-interest identification “by
`
`a prior inconsistent statement.” Fed. R. Evid. 408. Janssen apparently does not dis-
`
`pute that the communications are confidential settlement discussions and admits
`
`that it is using them as alleged “evidence of Wockhardt’s noncompliance with the
`
`requirement to identify all real parties-in-interest.” (Paper 13 at 5 n.4.) As such,
`
`both Ms. Reda’s declaration (Ex. 2003) and the cited correspondence (Ex. 2002)
`
`are being used for a prohibited purpose and should be excluded from the record.
`
`2.
`
`Even if admissible, the communications do not establish
`that Wockhardt funded or controlled Amerigen’s IPR, or
`vice versa.
`
`Second, Dr. Dhanorkar’s settlement communications with Ms. Reda come
`
`nowhere near proving that Amerigen funded or had any ability to control Wock-
`
`hardt’s IPR, or vice versa. Wockhardt and Amerigen are separate corporate entities
`
`who did not coordinate or collaborate with each other with respect to the filing of
`
`their respective IPRs. (EX1081, ¶¶3, 6-9.) Janssen alleges that the settlement
`
`communications show that “Wockhardt and Amerigen are in effect jointly control-
`
`6
`
`
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`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`ling these IPRs.” (Paper 13 at 1.) This assertion is unsupported, but assuming ar-
`
`guendo that Janssen’s mischaracterization is correct, it at best suggests an ability to
`
`present terms of settlement on behalf of Amerigen. Janssen offers no evidence
`
`whatsoever that Amerigen can settle or control Wockhardt’s IPR.
`
`3.
`
`Neither Wockhardt, nor anyone employed at Wockhardt,
`has authority to settle a dispute on Amerigen’s behalf.
`
`Third, Dr. Dhanorkar has no authority over Amerigen and no authority to
`
`settle any dispute on Amerigen’s behalf. (EX1081, ¶10.) Nor does Amerigen have
`
`any authority over Wockhardt. (Id., ¶11.) Any suggestion that Wockhardt can bind
`
`Amerigen, or vice versa, is incorrect and unsupported. And even if Dr. Dhanorkar
`
`“was engaged by the defendants as a capable resource to present the settlement
`
`proposal on behalf of the ‘defendants’” that still “does not compel a conclusion
`
`that [the other defendants] controlled conduct of the IPRs.” Kapsch Trafficcom
`
`IVHS Inc. et al. v. Neology, Inc., IPR2015-00808, Paper 13 at 10 (P.T.A.B. Sept.
`
`14, 2015). That Dr. Dhanorkar explored a settlement opportunity does not equate
`
`to Amerigen controlling Wockhardt’s IPR, or vice versa.
`
`
`
`
`
`
`
`Date: December 13, 2016
`STERNE, KESSLER, GOLDSTEIN &
`FOX PLLC
`1100 New York Avenue, N.W.
`Washington, DC 20005
`
`
` f
`Deborah Sterling
`Registration No. 62,732
`Attorney for Petitioner
`Wockhardt Bio AG
`
`7
`
`
`
`Case IPR2016-01582
`U.S. Patent No. 8,822,438
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`The undersigned hereby certifies that the above-captioned “Reply to Patent
`
`Owner's Preliminary Response” and supporting Exhibit 1081 was served in its
`
`entirety on December 13, 2016, upon the following counsel of record via
`
`electronic mail:
`
`Dianne B. Elderkin: delderkin@akingump.com
`Barbara L. Mullin: bmullin@akingump.com
`Ruben H. Munoz: rmunoz@akingump.com
`JANS-ZYTIGA@akingump.com
`
`David. T. Pritikin: dpritikin@sidley.com
`Bindu Donovan: bdonovan@sidley.com
`ZytigaIPRTeam@sidley.com
`
`Anthony C. Tridico: anthony.tridico@finnegan.com
`Jennifer H. Roscetti: jennifer.roscetti@finnegan.com
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`
`
`
`
`Date: December 13, 2016
`1100 New York Avenue, N.W.
`Washington, DC 20005
`(202) 371-2600
`4916477_1
`
`
` f
`Deborah Sterling
`Registration No. 62,732
`Attorney for Petitioner
`
`8
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