UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`Inter Partes Review No. IPR2016-01332
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`U.S. Patent No. 8,822,438
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`REPLY IN SUPPORT OF MYLAN’S MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`Inter Partes Review No. IPR2016-01332
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`U.S. Patent No. 8,822,438
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`REPLY IN SUPPORT OF MYLAN’S MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
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`TABLE OF CONTENTS
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`TABLE OF CONTENTS
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`JOINDER IS TO BE LIBERALLY GRANTED ......................................... 2
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`JOINDER IS TO BE LIBERALLY GRANTED ....................................... ..2
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`UNDER TORRENT, JOINDER IS PROPER AND EFFICIENT ................ 3
`UNDER TORRENT, JOINDER IS PROPER AND EFFICIENT .............. ..3
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`THE CASES JANSSEN CITED ARE DISTINGUISHABLE .................... 4
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`THE CASES JANSSEN CITED ARE DISTINGUISHABLE .................. ..4
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`I.
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`I.
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`II.
`II.
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`III.
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`III.
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`- i -
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`TABLE OF AUTHORITIES
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`Cases
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`Microsoft Corp. v. VirnetX Inc.,
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`IPR2014-00404, Paper 24 (PTAB Oct. 3, 2014) .................................................... 4
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`NetApp, Inc. v. PersonalWeb Techs., LLC,
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`IPR2013-00319, Paper 18 (PTAB July 22, 2013) .................................................. 5
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`Samsung Elecs. Co., Ltd. v. Arendi S.A.R.L.,
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`IPR2014-01144, Paper 11 (PTAB Oct. 2, 2014) .................................................... 5
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`Sony Corp. v. Network-1 Sec. Solutions, Inc.,
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`IPR2013-00386, Paper 16 (PTAB July 29, 2013) .................................................. 5
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`Torrent Pharms. Ltd. v. Novartis AG,
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`IPR2014-00784, Paper 112 (PTAB Sept. 24, 2015) .............................................. 4
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`Torrent Pharms. Ltd. v. Novartis AG,
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`IPR2014-00784, Paper 18 (PTAB Feb. 17, 2015) ................................................. 3
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`Toyota Motor Corp. v. Am. Vehicular Scis. LLC,
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`IPR2015-00261, Paper 10 (PTAB Jan. 29, 2015) .................................................. 5
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`Toyota Motor Corp. v. Am. Vehicular Scis. LLC,
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`IPR2015-00261, Paper 4 (PTAB Nov. 24, 2014). ................................................. 5
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`- ii -
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`ZTE Corp. v. Adaptix, Inc.,
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`IPR2015-01184, Paper 10 (PTAB July 24, 2015) .................................................. 4
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`Statutes
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`35 U.S.C. § 315(c) ..................................................................................................... 2
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`Other Authorities
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`157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl) .................. 2
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`- iii -
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`The Board should institute Mylan’s IPR2016-01332, challenging the
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`patentability of U.S. Patent No. 8,822,438 (“’438 patent”), and join it to the trial
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`instituted in Amerigen Pharms. Ltd. v. Janssen Oncology, Inc., IPR2016-00286.
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`Mylan’s petition, which is not time-barred, establishes the unpatentability of
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`the ’438 patent, on the same grounds as the Amerigen petition and for the same
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`reasons. Boiled down, Janssen’s complaint is its need to take the deposition of one
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`expert, Dr. Marc Garnick,1 an internationally-renowned expert in medical oncology
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`and urologic cancer at Beth Israel Deaconess Medical Center and a professor at
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`Harvard Medical School, who has dedicated his career to developing new therapies
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`for the treatment of prostate cancer.
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`Dr. Garnick’s testimony as an unquestionable authority in the field of
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`prostate cancer is valuable in resolving the unpatentability of the ’438 patent.
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`Mylan offered every reasonable arrangement to Janssen to join these petitions in an
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`efficient manner.2 Yet Janssen refused these offers, apparently favoring two trials
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`1 The Declaration of Scott Serels supports Amerigen’s petition. Dr. Serels is surely
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`highly qualified, but he is not Mylan’s expert and, as of this filing, Amerigen has
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`not agreed that Mylan can retain Dr. Serels. Thus, Mylan would not today be in a
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`position to compel Dr. Serels to appear for cross examination.
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`2 Mylan agreed that it would not seek additional briefing or additional pages in any
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`briefing, that it would work with Amerigen to speak with one voice in any [cont.]
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`- 1 -
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`on the unpatentability of the ’438 patent over just one. It is incredible that one of
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`the world’s largest pharmaceutical companies and two of the country’s largest law
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`firms would argue that taking a single deposition presents the type of prejudicial
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`burden that counsels in favor of denying joinder.
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`I.
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`JOINDER IS TO BE LIBERALLY GRANTED
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`Joinder of petitions is governed by 35 U.S.C. § 315(c). The statute does not
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`require that joined petitions be verbatim copies or supported by the same expert,
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`and the AIA’s legislative history makes clear that joinder is to be liberally granted:
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`The Office anticipates that joinder will be allowed as of right—if an
`inter partes review is instituted on the basis of a petition, for example,
`a party that files an identical petition will be joined to that proceeding,
`and thus allowed to file its own briefs and make its own arguments. If
`a party seeking joinder also presents additional challenges to validity
`that satisfy the threshold for instituting a proceeding, the Office will
`either join that party and its new arguments to the existing proceeding,
`or institute a second proceeding for the patent.
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`157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl).
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`Discretionary denial of joinder was to be a “safety valve” in case of a “deluge of
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`joinder petitions in a particular case.” Id.
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`Here, the Board should exercise the liberal joinder policy and allow joinder
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`pleadings or hearings, and that it would not seek additional time in the schedule if
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`joinder were promptly granted.
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`- 2 -
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`because Mylan’s petition seeks review on the same grounds and arguments as the
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`Amerigen petition. Janssen complains that Mylan relies on new exhibits, Opp. 6,
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`but even a cursory review of the record reveals the emptiness of that complaint.
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`Setting aside Mylan’s expert declaration, the remaining exhibits simply complete
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`the record. See Exs. 1068-1077 (file history support for statements in the Amerigen
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`petition); Exs. 1078-10803 (further support for arguments already in Amerigen’s
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`expert’s report). Janssen’s allegation that this “new testimony” “would necessarily
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`and significantly complicate the Amerigen IPR” is empty and baseless. It is no
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`complication to address invalidity grounds that Mylan adopted from the Amerigen
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`IPR. Janssen even asserts that related discovery would be an “undue burden,” but
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`the experience in Torrent Pharms. Ltd. v. Novartis AG, IPR2014-00784, suggests
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`the opposite: the extra discovery is essentially no burden, and would not delay trial.
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`II. UNDER TORRENT, JOINDER IS PROPER AND EFFICIENT
`In Torrent, the Board granted Mylan’s motion for joinder under the
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`circumstances present here, where Mylan: (1) proceeded only on the ground
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`instituted by the Board in the earlier IPR; (2) relied on its own expert, who adopted
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`the original expert’s analysis and rationale; (3) worked with the original petitioner
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`3 Exs. 1079–80 address whether prednisone has an anti-tumor effect, an issue
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`raised in Janssen’s now-denied motion for rehearing. The exhibits offer no basis to
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`deny joinder after the Board refused to narrow its construction, as Janssen urged.
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`- 3 -
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`to manage deposition questioning and hearing presentations to avoid redundancy;
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`and (4) filed a petition not time-barred in the absence of joinder, so joinder
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`increased both efficiency and consistency. Further, as here, Mylan and the
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`petitioner agreed that they would make joint filings and not allow joinder to unduly
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`delay the resolution of the proceeding.
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`After the Board joined Mylan’s petition to Torrent’s, the final written
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`decision issued 2 months early even with joinder and different experts. Torrent,
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`Paper 112 (PTAB Sept. 24, 2015); see also Microsoft Corp. v. VirnetX Inc.,
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`IPR2014-00404 (Board joined two trials, with two experts, on its initiative and
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`over objection; final written decision issued within 12 months of institution and 11
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`months of joinder). The only real difference between Torrent and this case is that,
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`here, Janssen, unlike the Torrent patent owner, rejected steps to implement joinder
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`effectively; after discussing the timing and procedure of joinder with Mylan,
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`Argentum, and Amerigen, Janssen then opposed only Mylan’s joinder. This
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`suggests that Janssen’s reasons for opposing are strategic rather than substantive.
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`III. THE CASES JANSSEN CITED ARE DISTINGUISHABLE
`Janssen cites several Board decisions denying joinder, suggesting that each
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`relied on some determinative factor. Opp. 4-5. But Janssen’s arguments ignore that
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`the joinder decision is multifactorial, and each cited case is distinguished easily.
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`See Opp. 4, 10 (citing ZTE Corp. v. Adaptix, Inc., IPR2015-01184) (patent owner
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`- 4 -
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`had filed its preliminary response and deposed petitioner’s expert, and a time bar
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`applied without joinder, so denial did not yield duplication of effort); Opp. 5-7
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`(citing Samsung Elecs. Co., Ltd. v. Arendi S.A.R.L., IPR2014-01144) (petitioner
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`filed two IPRs on the same patent, was time-barred without joinder, and failed to
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`support its claim that it couldn’t raise its invalidity arguments in district court);
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`Opp. 8–9 (citing Sony Corp. v. Network-1 Sec. Solutions, Inc., IPR2013-00386)
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`(petitioner challenged new claim and added four grounds); Opp. 5 (citing NetApp,
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`Inc. v. PersonalWeb Techs., LLC, IPR2013-00319) (petitioner added new claim,
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`claim construction issues, and § 112 arguments, and pending IPR was coordinated
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`with five others); and Opp. 4 (citing Toyota Motor Corp. v. Am. Vehicular Scis.
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`LLC, IPR2015-00261) (petition untimely without joinder, and petitioner sought to
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`join terminated IPR, challenged more claims than the IPR it sought to join, and did
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`not include asserted grounds in earlier petition). None of these cases support denial
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`of joinder here.
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`* * *
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`For the foregoing reasons, Mylan respectfully requests that the Board
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`institute trial on Mylan’s petition for inter partes review of the ’438 patent and join
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`the proceeding with the Amerigen IPR. To ensure prompt resolution of the
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`proceeding, the Board should shorten the time for Janssen’s preliminary response.
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`See, e.g., Toyota Motor Corp., IPR2015-00261 (Paper 4).
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`- 5 -
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`August 9, 2016
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`Respectfully submitted,
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`/Brandon M. White/
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`Brandon M. White, Esq.
`Reg. No. 52,354
`Perkins Coie LLP
`700 Thirteenth Street, N.W.
`Suite 600
`Washington, DC 20005-3960
`bmwhite@perkinscoie.com
`Tel: 202-654-6206
`Fax: 202-654-9681
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`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
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`- 6 -
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
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`correct copy of the foregoing: REPLY IN SUPPORT OF MYLAN’S MOTION
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`FOR JOINDER PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
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`by email to the electronic service addresses for Patent Owner:
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`JANS-ZYTIGA@akingump.com
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`ZytigaIPRTeam@sidley.com
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`Dated: August 9, 2016
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`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
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`Counsel for Petitioner Mylan Pharmaceuticals Inc.
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