UNITED STATES PATENT AND TRADEMARK OFFICE
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`————————————————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
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`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners.
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`————————————————
`
`Case IPR2016-00710
`Patent 6,331,415
`
`————————————————
`
`PETITIONER’S REPLY IN SUPPORT OF MOTION FOR JOINDER
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`
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`
`
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`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners.
`
`————————————————
`
`Case IPR2016-00710
`Patent 6,331,415
`
`————————————————
`
`PETITIONER’S REPLY IN SUPPORT OF MOTION FOR JOINDER
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`
`
`
`
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`
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`
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`I.
`
`II.
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`
`
`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
`
`SUBSTANTIVE SIMILARITIES WEIGH HEAVILY IN FAVOR
`OF JOINDER ................................................................................................... 1
`
`III.
`
`JOINDER WILL NOT PREJUDICE SANOFI ............................................... 2
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`A. No Interference from Mylan ................................................................. 2
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`B.
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`C.
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`Sanofi’s Cited Board Decisions Are Distinguishable ........................... 3
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`Consideration of Joinder Will Not Slow the Proceedings
`in the Sanofi IPR ................................................................................... 3
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`IV.
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`JOINDER WILL NOT PREJUDICE PATENT OWNERS ............................ 4
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`A. Mylan’s Joinder Will Not Disrupt the Sanofi IPR ................................ 4
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`B.
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`Patent Owners’ Proposed Conditions for Joinder ................................. 4
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`C. Mylan Is Amenable to a Telephone Conference ................................... 5
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`V.
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`CONCLUSION ................................................................................................ 5
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`
`
`
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`
`
`TABLE OF AUTHORITIES
`
`Cases
`Dell, Inc. v. Network-1 Sec. Solutions, Inc.,
`IPR2013-00385 ....................................................................................................... 2
`
`Samsung Electronics Co. v. Arendi S.A.R.L.,
`IPR2014-01142 ....................................................................................................... 3
`
`Teva Pharmaceuticals USA Inc. v. ViiV Healthcare Co.,
`IPR2015-00550 ....................................................................................................... 3
`
`Statutes
`
`35 U.S.C. § 315(b) ..................................................................................................... 3
`
`Regulations
`
`37 C.F.R. § 42.23(a) ................................................................................................... 1
`
`
`
`
`ii
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`
`
`Pursuant to 37 C.F.R. § 42.23(a), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Mylan”) hereby submits this Reply to Patent Owners’ Opposition to Motion for
`
`Joinder (IPR2016-00710, Paper No. 8 (P.T.A.B. Apr. 4, 2016) (“PO Opp’n”)) and
`
`Petitioners’ Opposition to Motion for Joinder Filed by Mylan Pharmaceuticals Inc.
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`in IPR2016-00710 (IPR2015-01624, Paper No. 25 (P.T.A.B. Apr. 4, 2016)
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`(“Sanofi Opp’n”)).
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`I.
`
`INTRODUCTION
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`Mylan’s Petition contains the exact grounds on which the Sanofi IPR was
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`instituted. For this reason alone, joinder is warranted. Moreover, the procedural
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`concessions set forth in Mylan’s Motion for Joinder, and reaffirmed here, ensure
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`that there will be no prejudice to Sanofi or Patent Owners should joinder be
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`granted. Further, these procedural concessions—including Mylan’s additional
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`concession (as proposed by Patent Owners) that Dr. Foote’s deposition testimony
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`be entered into the record and cited in the parties’ respective filings irrespective of
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`termination of the Sanofi IPR—eliminate any prejudice to Sanofi or Patent Owners
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`and minimize the burden on the Board. For the reasons set forth below and in its
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`Motion, Mylan respectfully requests that joinder be granted.
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`II.
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`SUBSTANTIVE SIMILARITIES WEIGH HEAVILY IN FAVOR OF
`JOINDER
`
`Genentech and Sanofi take no issue with joinder of the Mylan IPR on
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`substantive grounds—nor could they—given the utter lack of substantive
`
`
`
`1
`
`
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`differences between the Mylan IPR and the grounds of unpatentability the Board
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`instituted in the Sanofi IPR. Indeed, the Mylan IPR seeks institution of inter
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`partes review on the exact grounds instituted in the Sanofi IPR. Considering “the
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`policy preference for joining a party that does not present new issues that might
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`complicate or delay an existing proceeding,” the Board should exercise its
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`discretion to grant joinder here. Dell, Inc. v. Network-1 Sec. Solutions, Inc.,
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`IPR2013-00385, Paper No. 17, at 10 (P.T.A.B. July 29, 2013).
`
`III. JOINDER WILL NOT PREJUDICE SANOFI
`
`A. No Interference from Mylan
`
`Sanofi asserts that “interference from Mylan” and “having to seek Mylan’s
`
`cooperation” on consolidated filings and discovery will cause prejudice to Sanofi.
`
`(Sanofi Opp’n, at 1). Not so. As stated in Mylan’s Motion, Mylan agrees to
`
`significant procedural concessions should joinder be granted. (Petitioner’s Motion for
`
`Joinder, IPR2016-00710, Paper No. 3, at 5-6, 8-9 (P.T.A.B. Mar. 3, 2016) (“Mot.”)).
`
`To be clear, Mylan has no (and never had any) intention to “interfere” with
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`any of Sanofi’s filings or discovery. Instead, Mylan seeks to minimize any burden
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`on the Board by coordinating on filings and discovery should joinder be granted,
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`while at the same time seeking no additional pages or deposition time. Further,
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`Sanofi’s counsel has been made aware that Mylan is willing to consider any
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`reasonable procedural concessions in order to facilitate joinder and cooperation of
`
`
`
`2
`
`
`
`the parties should joinder be granted. As a result, there will be no “interference
`
`from Mylan.”
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`B.
`
`Sanofi’s Cited Board Decisions Are Distinguishable
`
`Sanofi cites Teva Pharmaceuticals USA Inc. v. ViiV Healthcare Co.,
`
`IPR2015-00550, and Samsung Electronics Co. v. Arendi S.A.R.L., IPR2014-01142,
`
`to support its Opposition. The Board denied joinder in each of these proceedings;
`
`however, in each of these proceedings, the party seeking joinder had been served a
`
`complaint more than one year before the filing of the petition and motion for
`
`joinder. Thus, absent joinder, the petitions would have been barred under 35
`
`U.S.C. § 315(b). Here, Mylan has not been served a complaint relating to U.S.
`
`Patent No. 6,331,415, the patent challenged in Mylan’s petition and in the Sanofi
`
`IPR.
`
`Furthermore, in each of the cited proceedings, the party seeking joinder
`
`requested seven additional pages. However, as stated in its motion for joinder,
`
`Mylan has agreed “not to be permitted any arguments separate from those
`
`advanced by Sanofi . . . in the consolidated filings.” (Mot. at 6). Thus, the present
`
`case is clearly distinguishable from the cited proceedings.
`
`C. Consideration of Joinder Will Not Slow the Proceedings in the
`Sanofi IPR
`
`Sanofi opposes joinder because the “Sanofi IPR is now in the Patent
`
`Owners’ discovery period, with the deposition of Dr. Foote already scheduled for
`
`
`
`3
`
`
`
`April 21, 2016—before Mylan’s reply papers would be due and before the Board
`
`will likely rule on the joinder motion.” (Sanofi Opp’n, at 3). That the Sanofi IPR
`
`is currently in discovery cannot be a valid basis to deny joinder, particularly where
`
`Mylan has agreed to allow Sanofi to conduct discovery as it sees fit. Moreover,
`
`consistent with Mylan’s goal to minimize the burden on the Board, Mylan is
`
`submitting this Reply before the scheduled deposition of Dr. Foote, and well
`
`before the due date. Thus, consideration of joinder will not slow the proceedings.
`
`IV. JOINDER WILL NOT PREJUDICE PATENT OWNERS
`
`A. Mylan’s Joinder Will Not Disrupt the Sanofi IPR
`
`Mylan submits that any concerns related to any purported disruption of the
`
`Sanofi IPR have been addressed above. See (III)(A), supra.
`
`B.
`
`Patent Owners’ Proposed Conditions for Joinder
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`As an initial matter, in order to facilitate joinder, Mylan agrees to abide by
`
`the conditions set forth in its Motion for Joinder. (See PO Opp’n, at 2-4).
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`Patent Owners additionally propose that “any deposition testimony of Dr.
`
`Foote taken in this proceeding may be entered into the record and cited in the
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`parties’ filings irrespective of whether the Sanofi IPR is terminated.” (PO Opp’n,
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`at 4-5). Mylan agrees that Patent Owners’ proposal would facilitate joinder and
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`minimize the burden on the Board.
`
`
`
`4
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`
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`Mylan cannot agree, however, with Patent Owners’ second proposal, that
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`“once Dr. Foote is deposed in this proceeding, Mylan may not rely on Dr. Calame
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`as a declarant supporting the Petition,” because such a limitation may unilaterally
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`restrict Mylan’s ability to rebut new issues raised in Patent Owners’ Response in
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`the event of a settlement before submission of Petitioner’s Reply. (PO Opp’n, at
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`5). As made clear in its opening papers, Mylan intends to rely solely on the
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`testimony of Sanofi’s expert, Dr. Foote, unless the Sanofi IPR is terminated prior
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`to a final written decision. (Mot. at 7). Viewed as a whole, Mylan’s proposed
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`procedural concessions weigh heavily in favor of joinder, and the Board would
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`benefit significantly even if the Sanofi IPR were to settle prior to a final written
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`decision.
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`C. Mylan Is Amenable to a Telephone Conference
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`Patent Owners state that “Patent Owners’ counsel are available for a
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`telephone conference with the Board should the Board consider the issues related
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`to Joinder amenable to be addressed by a conference call.” (PO Opp’n, at 5).
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`Mylan is also amenable to a telephone conference.
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`V. CONCLUSION
`For the foregoing reasons, Mylan respectfully requests that its Petition for
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`inter partes review of U.S. Patent No. 6,331,415 be instituted and that the
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`proceeding be joined with the Sanofi IPR.
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`
`
`5
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`
`
`Respectfully submitted,
`
` /Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
`
`
`
`Dated: April 19, 2016
`
`
`
`6
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`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that true and correct copies of the
`
`foregoing Petitioner’s Reply in Support of Motion for Joinder were served on April
`
`19, 2016, via electronic mail to counsel for Patent Owners at the following
`
`addresses:
`
`David L. Cavanaugh
`(David.Cavanaugh@wilmerhale.com)
`Heather M. Petruzzi
`(Heather.Petruzzi@wilmerhale.com)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Avenue, NW
`Washington, DC 20006
`
`Daralyn J. Durie
`(ddurie@durietangri.com)
`Adam R. Brausa
`(abrausa@durietangri.com)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`Jeffrey P. Kushan
`(jkushan@sidley.com)
`SIDLEY AUSTIN LLP
`1501 K Street, N.W.
`Washington, D.C. 20005
`
`
`Robert J. Gunther, Jr.
`(Robert.Gunther@wilmerhale.com)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, New York 10007
`
`
`
`Additionally, the undersigned hereby certifies that true and correct copies of
`
`the foregoing Petitioner’s Reply in Support of Motion for Joinder were served on
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`April 19, 2016, via electronic mail to counsel for Petitioners Sanofi-Aventis U.S.
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`LLC and Regeneron Pharmaceuticals
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`in IPR2015-01624 at MB-Cabilly-
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`IPR@mayerbrown.com.
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`
`
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`
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`Dated: April 19, 2016
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`
`
`Respectfully submitted,
`
`
`
` /Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
`
`2
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