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` Paper No. 17
`Filed: March 17, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ACTAVIS LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, LTD., SUN PHARMACEUTICALS
`INDUSTRIES, INC., TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC
`
`Petitioners
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner
`
`
`
`U.S. Patent No. 8,822,438 to Auerbach et al.
`
`
`
`Inter Partes Review IPR2017-00853
`
`
`
`REPLY IN SUPPORT OF PETITIONERS’ MOTION FOR JOINDER
`WITH RELATED INSTITUTED INTER PARTES REVIEW OF U.S.
`PATENT NO. 8,822,438 PURSUANT TO 35 U.S.C. § 315(c), 37 C.F.R. 42.22
`AND 42.112(b)
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`Petitioners’ joinder request is timely. .............................................................. 1
`
`II.
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`Joinder will neither delay nor complicate the Mylan IPR. .............................. 4
`
`III.
`
`Petitioners agree with Patent Owner’s “safeguards.” ...................................... 5
`
`IV. Conclusion ....................................................................................................... 5
`
`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Achates Reference Publishing, Inc. v. Apple, Inc.
`803 F.3d 652 (Fed. Cir. 2015) .............................................................................. 1
`
`Innopharma Licensing v. Senju Pharmaceutical Co.,
`IPR2016-00089, Paper 13 (P.T.A.B., Feb. 25, 2016) ....................................... 4, 5
`
`Wockhardt Bio AG v. AstraZeneca AB,
`IPR2016-01029, Paper 15 (P.T.A.B., Aug. 23, 2016) .................................. 1, 2, 3
`
`Statutes
`
`35 U.S.C. § 315(b) ..................................................................................................... 3
`
`Other Authorities
`
`37 C.F.R. § 42.101(b) ................................................................................................ 1
`
`37 C.F.R. § 42.122(b) ............................................................................................ 1, 3
`
`
`
`
`
`IPR2017-00853
`U.S. Patent No. 8,822,438
`
`Far from being the “gang tackling” of the ’438 patent alleged by Patent
`
`Owner, the Petitioners’ request for joinder to the trial instituted in Mylan
`
`Pharmaceuticals Inc., v. Janssen Oncology, Inc., IPR2015-01332 (“Mylan IPR”) is
`
`expressly permitted and encouraged by both 37 C.F.R. § 42.122(b) and relevant
`
`prior Board decisions. Petitioners have taken all necessary steps to ensure that their
`
`request will neither disrupt ongoing proceedings nor prejudice Patent Owner. For at
`
`least the following reasons, the Board should institute Petitioners’ IPR and join it to
`
`the Mylan IPR.
`
`I.
`
`Petitioners’ joinder request is timely.
`
`Petitioner’s IPR is timely pursuant to 37 C.F.R. § 42.122(b) because the
`
`Petition was filed within one month of the Mylan IPR’s institution. See 37 C.F.R. §
`
`42.122(b) (“The time period set forth in § 42.101(b) shall not apply when the petition
`
`is accompanied by a request for joinder.”). Section 42.122(b) is agnostic to district
`
`court-related time bars, and joinder is liberally granted under this regulation. See
`
`Wockhardt Bio AG v. AstraZeneca AB, IPR2016-01029, Paper 15 (P.T.A.B., Aug.
`
`23, 2016) (granting joinder irrespective of the one-year time bar); see also Achates
`
`Reference Publishing, Inc. v. Apple, Inc. 803 F.3d 652, 657 (Fed. Cir. 2015) (“[A]n
`
`otherwise time-barred party may nonetheless participate in an inter partes review
`
`proceeding if another party files a proper petition.”). Thus, the law is clear that
`
`1
`
`
`
`IPR2017-00853
`U.S. Patent No. 8,822,438
`
`Petitioners’ Motion for Joinder is timely, and Patent Owner’s argument to the
`
`contrary runs afoul of statute, regulations, and the related case law.
`
`Patent Owner characterizes this Petition as a “gang tackling” of the ʼ438
`
`patent and argues that Petitioners are “manipulating the IPR process” by requesting
`
`joinder. Patent Owner’s Opposition at 7. This is not the case. As stated throughout
`
`this Reply and opening Motion for Joinder, Petitioners have agreed to play a
`
`secondary role in the Mylan IPR. See, e.g., Petitioners’ Motion for Joinder, Paper 9
`
`at 8. There are no new experts or arguments in Petitioners’ Petition. And Petitioners
`
`have agreed to be bound by all proceedings that have already occurred in the Mylan
`
`IPR. There will be no prejudice to Patent Owner because it can continue to defend
`
`against the Mylan IPR just as it would before joinder while still allowing Petitioners
`
`to take part in an “efficient, streamlined, and cost-effective alternative to district
`
`court litigation.” Patent Owner’s Opposition at 7.
`
`Patent Owner argues that, because Petitioners’ ability to independently file a
`
`petition is time-barred, Petitioners’ joinder request should be denied because there
`
`would otherwise “be no parallel proceeding and no threat of duplicative briefs,
`
`expert discovery, or trial testimony.” Patent Owner’s Opposition at 9. But this
`
`argument has already been rejected by other boards. For example, in Wockhardt Bio
`
`AG v. AstraZeneca AB, petitioner filed a petition and motion for joinder over a year
`
`after it was served in the district court. Wockhardt, paper 15 at p. 7. Patent owner
`
`2
`
`
`
`IPR2017-00853
`U.S. Patent No. 8,822,438
`
`argued that “joinder will not enhance efficiencies because [petitioner’s] petition has
`
`no independent right to seek an IPR given its petition is time-barred pursuant to 35
`
`U.S.C. § 315(b).” Id. The board nonetheless granted joinder in part because the
`
`regulations clearly state that the one-year time limit “shall not apply when the
`
`petition is accompanied by a request for joinder.” Id. at p. 8; see also 37 C.F.R.
`
`§ 42.122(b). Further, and just as Petitioners here, the Wockhardt petitioner agreed
`
`to adhere to the joined IPR’s existing schedule and to participate in consolidated
`
`filings, discovery, and testimony. Id. at 8-9. Thus, the Board should use its
`
`discretion to grant Petitioners’ joinder request, which is indistinguishable from the
`
`request in Wockhardt.
`
`Relatedly, granting joinder will not “encourage petitioners to file multiple,
`
`staggered challenges—well after the one-year time bar—without any fear that their
`
`delay in filing might have adverse consequences.” Id. This type of coordinated
`
`conduct is addressed by the rules barring real parties in interest to file multiple
`
`proceedings. Moreover, the one-year time bar joinder exception allows petitioners
`
`to efficiently wait and see if a petition is instituted before deciding to join a
`
`proceeding. Petitioners here waited to see if the Mylan IPR would be instituted and
`
`properly filed its Petition and Motion for Joinder to participate in the proceedings
`
`after institution was confirmed.
`
`3
`
`
`
`IPR2017-00853
`U.S. Patent No. 8,822,438
`
`II.
`
`Joinder will neither delay nor complicate the Mylan IPR.
`
`Joinder will not delay or complicate the Mylan IPR because Petitioners will
`
`only play a passive, secondary role in the proceedings. Petitioners have repeatedly
`
`informed Patent Owners of the same, and Patent Owners offer no evidence to the
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`contrary. See, e.g., JSN 2012, 02/08/2017 Email from Wong to Donovan
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`(suggesting the same secondary role to Patent Owner). Petitioners will not request
`
`any change to the current schedule in the Mylan IPR, and Petitioners agree to be
`
`bound to all proceedings that have already occurred.
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`This joinder request is indistinguishable from Innopharma Licensing v. Senju
`
`Pharmaceutical Co., IPR2016-00089, Paper 13 (P.T.A.B., Feb. 25, 2016). There,
`
`petitioners timely filed their motion for joinder one month from the related IPR’s
`
`institution. Innopharma, Paper 13 at 6. The Innopharma patent owner argued that
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`it would be prejudiced because joinder would “unduly complicate the case and
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`issues,” even though petitioners had accepted to take an “understudy” role. Id. But
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`the board found the Innopharma patent owner’s bare prejudice allegations
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`unconvincing because petitioner “accept[ed] a back-seat, understudy role” that
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`“would essentially only add petitioners to the related IPR.” Id. at 6-7. In granting
`
`joinder, the board further reasoned that “joinder . . . will have little to no impact on
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`the timing, cost, or presentation of the trial on the instituted ground.” Id. at 7.
`
`4
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`
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`IPR2017-00853
`U.S. Patent No. 8,822,438
`
`As in Innopharma, Petitioners here have accepted a “back-seat” role and
`
`joinder “would essentially only add petitioners” to the Mylan IPR. Joinder will have
`
`“no impact on the timing” of the Mylan IPR because Petitioners have represented
`
`that they will be bound to all proceedings that have already occurred and will accept
`
`the Mylan IPR’s condensed schedule going forward. Therefore, the Board should
`
`grant joinder for the same reasons as the board did in Innopharma.
`
`III. Petitioners agree with Patent Owner’s “safeguards.”
`
`In its opposition, Patent Owner lays out “strict safeguards” that the Board
`
`should implement if it grants joinder. Patent Owner’s Opposition at 10-11. Notably,
`
`most of these safeguards are quoted directly from the measures Petitioners listed in
`
`its Motion for Joinder. As such, to simplify the proceedings, Petitioners reiterate
`
`their intention only to play a secondary role in the Mylan IPR and agree to all of
`
`Patent Owner’s “safeguards.”
`
`IV. Conclusion
`
`Petitioners’ joinder request is proper and will neither complicate nor delay the
`
`Mylan IPR. Therefore, the Board should join this IPR with Mylan Pharmaceuticals
`
`Inc., v. Janssen Oncology, Inc., IPR2015-01332.
`
`Dated: March 17, 2017
`
`
`
`Respectfully submitted,
`
`/Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`
`
`5
`
`
`
`IPR2017-00853
`U.S. Patent No. 8,822,438
`
`Lead Counsel for Petitioners
`
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`E-mail: spark@winston.com
`
`
`
`
`
`6
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: Reply in Support of Petitioners’ Motion for Joinder
`
`with Related Instituted Inter Partes Review of U.S. Patent 8,822,438 Pursuant to
`
`35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.112(b) by email to the service
`
`addresses for Patent Owner:
`
`JANS-ZYTIGA@akingump.com
`ZytigaIPRTeam@sidley.com
`
`
`
`Date: March 17, 2017
`
`/Samuel S. Park/
`Samuel S. Park
`
`Lead Counsel for Petitioners
`
`
`
`
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