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`IPR2017-02032
`Patent Owner’s Request For Rehearing
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`Filed on behalf of Patent Owner Genentech, Inc. by:
`
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`David L. Cavanaugh (Reg. No. 36,476)
`Lauren V. Blakely (Reg. No. 70,247)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
`Kevin S. Prussia (Pro Hac Vice)
`Andrew J. Danford (Pro Hac Vice)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`Adam R. Brausa (Reg. No. 60,287)
`Daralyn J. Durie (Pro Hac Vice)
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________________________________
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`BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2017-02032
`Patent No. 6,407,213
`____________________________________________
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`PATENT OWNER’S REQUEST FOR REHEARING
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 2
`BACKGROUND ............................................................................................. 4
`A.
`The Eight Prior IPR Petitions Challenging The ’213 Patent ................ 4
`B.
`The Boehringer Follow-On Petitions .................................................... 6
` ARGUMENT ................................................................................................... 8
`A.
`Legal Standard ....................................................................................... 8
`B.
`The Board Abused Its Discretion By Overturning Its Earlier
`Institution Decision In Order To Institute Review Of Boehringer’s
`Improper Copycat Challenges. .............................................................. 8
` CONCLUSION .............................................................................................. 13
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`i
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Blue Coat Sys., Inc. v. Finjan, Inc.,
`IPR2016-01444, Paper 11 (P.T.A.B. July 18, 2017) ............................................ 8
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .................................................................................... 9, 11
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00739, Paper 16 (P.T.A.B. July 27, 2017) ............................................ 9
`Neil Ziegman, N.P.Z., Inc. v. Stephens,
`IPR2015-01860, Paper 11 (P.T.A.B. Feb. 24, 2016) ............................................ 3
`Personal Web Techs., LLC v. Apple. Inc.,
`848 F.3d 987 (Fed. Cir. 2018) ............................................................................ 10
`SAS Institute Inc. v. Iancu,
`138 S. Ct. 1348 (2018) ............................................................................ 1, 3, 7, 11
`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005) ............................................................................ 8
`Statutes and Regulations
`5 U.S.C. § 706 .......................................................................................................... 10
`35 U.S.C. § 314(a) ............................................................................................... 9, 11
`35 U.S.C. § 325(d) ..................................................................................................... 9
`37 C.F.R. § 42.71(c) ................................................................................................... 8
`37 C.F.R. § 42.71(d) .................................................................................................. 1
`Other Authorities
`Guidance on the Impact of SAS on AIA Trial Proceedings,
`Patent Trial and Appeal Board (Apr. 26, 2018) ................................................... 7
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`i
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`Genentech, Inc. (“Genentech”) respectfully requests, pursuant to 37 C.F.R.
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`
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`
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`§ 42.71(d), that the Board reconsider its May 8, 2018 decision (“May Institution
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`Decision”) instituting inter partes review of previously-denied grounds in light of
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`the Supreme Court’s decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348
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`(2018).
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`Genentech recognizes the extremely high burden placed on movants seeking
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`reconsideration and does not take this step lightly. Indeed, in the over 30 IPRs that
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`have been filed by parties seeking to invalidate patents in Genentech’s Herceptin
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`portfolio, this is the first motion for reconsideration that Genentech has filed.
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`Genentech requests rehearing because, based on the unique facts presented by this
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`and the numerous prior IPRs which have been instituted regarding U.S. Patent No.
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`6,407,213 (“the ’213 patent”), Genentech believes that the institution of Petitioner
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`Boehringer Ingelheim Pharmaceuticals, Inc.’s (“Boehringer’s”) non-meritorious,
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`previously-denied grounds rises to the level of an abuse of discretion that unfairly
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`prejudices Genentech and does not comply with the Administrative Procedure Act
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`(“APA”). Upon rehearing, Genentech requests that the Board vacate the May
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`Institution Decision and deny Boehringer’s request for inter partes review of the
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`’213 patent in its entirety.
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`1
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`INTRODUCTION
`On August 31, 2017, Boehringer filed two IPR petitions challenging
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`numerous claims of the ’213 patent: IPR2017-02032 (i.e., the present petition) and
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`IPR2017-02031. These two petitions were the ninth and tenth IPR petitions filed
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`against the ’213 patent.1
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`Boehringer copied four grounds in its IPR2018-02031 petition from
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`IPR2016-01693 (Mylan), IPR2017-01374 (Celltrion), and IPR2017-01488 (Pfizer),
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`and copied five grounds in its IPR2017-02032 petition from IPR2017-01694
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`(Mylan), IPR2017-01373 (Celltrion) and IPR2017-01489 (Pfizer)—yet Boehringer
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`strategically chose not to seek joinder with those earlier-filed proceedings.2
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`1
`The previous petitions include: IPR2016-01693 and IPR2016-01694, filed
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`by Mylan Pharmaceuticals, Inc. (“Mylan”); IPR2017-01373 and IPR2017-01374,
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`filed by Celltrion, Inc. (“Celltrion”); IPR2017-01488 and IPR2017-01489, filed by
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`Pfizer, Inc. (“Pfizer”); and IPR2017-02139 and IPR2017-02140, filed by Samsung
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`Bioepis Co., Ltd. (“Samsung”).
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`2
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`After Boehringer filed its two petitions challenging the ’213 patent,
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`Samsung filed two petitions (IPR2017-02139 and IPR2017-02140), which copied
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`the grounds in Pfizer’s petitions (IPR2017-01488 and IPR2017-01489). Unlike
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`Boehringer, Samsung sought joinder to Pfizer’s previously-filed petitions, which
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`the Board granted. (IPR2017-02139 (Paper 11); IPR2017-02140 (Paper 11).)
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`2
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`Patent Owner’s Request For Rehearing
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`Boehringer thus asked the Board to institute its IPRs on the exact same grounds
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`already instituted in the earlier proceedings, but on a schedule trailing those
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`proceedings by several months.
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`As the Board correctly recognized in its original decisions on institution
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`(“March Institution Decisions”), allowing Boehringer to raise these duplicative
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`arguments in a new IPR proceeding would waste the Board’s and Genentech’s
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`resources, and would unfairly allow Boehringer to preview Genentech’s arguments
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`and evidence before having to address them itself. Thus, the Board properly
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`denied institution of Boehringer’s nine “copycat” grounds.3
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`However, after the Supreme Court issued its decision in SAS Institute Inc. v.
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`Iancu, 138 S. Ct. 1348 (2018), the Board reversed course and instituted the nine
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`previously-denied grounds. Respectfully, Genentech believes that this action
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`amounted to an abuse of discretion that violated the APA. The Board did not
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`articulate any reason why Boehringer’s purported interest in having its petitions
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`instituted outweighed Genentech’s
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`interest
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`in “avoid[ing] harassment and
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`enjoy[ing] quiet title to [its] rights.” Neil Ziegman, N.P.Z., Inc. v. Stephens,
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`IPR2015-01860, Paper 11 at 12-13 (P.T.A.B. Feb. 24, 2016). The Board also
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`3
`The Board instituted review of three grounds that were not raised in prior
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`petitions.
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`3
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`failed to address the Board’s original reasons for denial, most notably that
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`instituting review of the copycat grounds on a delayed track would result in
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`proceedings that were unfairly prejudicial to Genentech. (See IPR2017-02031
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`(Paper 19 at 12); IPR2017-02032 (Paper 17 at 8).)
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`To the extent that the Board believes that it cannot deny Boehringer’s nine
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`copycat grounds without also denying the three originally-instituted grounds (i.e.,
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`that it is limited to an “all or nothing” approach), the correct course is to deny
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`Boehringer’s petitions entirely rather than subject Genentech to administrative
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`proceedings that the Board has already determined would be unfair. Genentech
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`therefore respectfully requests that the Board vacate the May Institution Decision
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`and deny Boehringer’s request for inter partes review the ’213 patent in its
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`entirety.
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` BACKGROUND
`A. The Eight Prior IPR Petitions Challenging The ’213 Patent
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`In August 2016, Mylan Pharmaceuticals, Inc. (“Mylan”) challenged the ’213
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`patent in two separate IPRs (IPR2016-01693 and IPR2016-01694). The Board
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`terminated these petitions after settlement in March 2017. (IPR2016-01693 (Paper
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`24); IPR2016-01694 (Paper 23).)
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`In May 2017, Celltrion, Inc. (“Celltrion”) and Pfizer, Inc. (“Pfizer”) each
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`filed copycat petitions of the two original Mylan petitions. (IPR2017-01373
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`4
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`Patent Owner’s Request For Rehearing
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`(Celltrion); IPR2017-01374 (Celltrion); IPR2017-01488 (Pfizer); IPR2017-01489
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`(Pfizer).) In September 2017, Samsung Bioepis Co., Ltd. (“Samsung”) also filed
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`copycat petitions of the Mylan/Celltrion/Pfizer petitions (IPR2017-02139 and
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`IPR2017-02140).
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`On December 1, 2017, the Board instituted IPRs on all grounds recited in the
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`four Celltrion and Pfizer petitions. (IPR2017-01373 (Paper 16); IPR2017-01374
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`(Paper 15); IPR2017-01488 (Paper 27); IPR2017-01489 (Paper 27).) On February
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`22, 2018, the Board similarly instituted IPRs on all grounds recited in the Samsung
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`petitions and granted Samsung’s motions to join each of its petitions to a
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`corresponding Pfizer petition. (IPR2017-02139 (Paper 11); IPR2017-02140 (Paper
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`11).)
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`Genentech deposed the petitioners’ four experts and filed its Patent Owner
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`Response in each of the four IPRs on March 8, 2018. (IPR2017-01373 (Paper 38);
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`IPR2017-01374 (Paper 38); IPR2017-01488 (Paper 45); IPR2017-01489 (Paper
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`42).) The petitioners are expected to file their respective petitioner replies on May
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`25, 2018. The oral hearing in each of the four IPRs is scheduled for July 16, 2018.
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`(IPR2017-01373 (Paper 33); IPR2017-01374 (Paper 32); IPR2017-01488 (Paper
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`39); IPR2017-01489 (Paper 37).)
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`5
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`B.
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`The Boehringer Follow-On Petitions
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`Boehringer filed its two IPR petitions on August 31, 2017—i.e., over seven
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`months after Genentech filed its December 2016 Patent Owner’s Preliminary
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`Response in the original Mylan proceedings, over three months after Celltrion and
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`Pfizer filed their petitions, and without any explanation as to why it could not have
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`filed its petitions earlier.
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`Boehringer’s follow-on petitions were largely duplicative of the earlier-filed
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`petitions. In IPR2017-02031, four of the six asserted grounds were identical to
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`those already instituted in IPR2017-01374 and IPR2017-01488, and in IPR2017-
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`02032, five of the six asserted grounds were identical to those already instituted in
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`IPR2017-01373 and IPR2017-01489. (IPR2017-02031 (Paper 19 at 13); IPR2017-
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`02032 (Paper 17 at 8).) Boehringer could have sought to join its petitions to the
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`pending IPRs raising the same grounds, yet it chose not to. (See, e.g., id.)
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`On March 29, 2019, the Board issued its decisions on institution. The Board
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`instituted review of the three grounds not asserted in prior petitions and denied
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`review of the nine copycat grounds. (IPR2017-02031 (Paper 19); IPR2017-02032
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`(Paper 17).) The Board explained that it would waste both the Board’s and
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`Genentech’s resources if it were to institute review of the exact same grounds that
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`were already being considered in previously-instituted proceedings. (IPR2017-
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`02031 (Paper 19 at 13); IPR2017-02032 (Paper 17 at 8).) The Board also found
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`6
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`Patent Owner’s Request For Rehearing
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`that it would unfairly prejudice Genentech if Boehringer were allowed to preview
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`the parties’ arguments and evidence before having to address them itself. (See,
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`e.g., id.) The Board gave particular weight to the fact that Boehringer strategically
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`chose not to request joinder and thereby place its petitions on a delayed track as
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`compared to the earlier petitions addressing identical grounds. (See, e.g., id.)
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`In response to the Board’s institution decisions, Boehringer filed motions for
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`rehearing (IPR2017-02031 (Paper 23); IPR2017-02032 (Paper 21)) requesting that
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`the Board institute review of the denied copycat grounds. On April 24, 2018,
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`while Boehringer’s motions were pending, the Supreme Court issued its decision
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`in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018). Shortly thereafter, the Board
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`issued a Guidance on the Impact of SAS on AIA Trial Proceedings (“SAS
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`Guidance”), which stated that “for pending trials in which a panel has instituted
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`trial only on some of the challenges raised in the petition (as opposed to all
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`challenges raised in the petition), the panel may issue an order supplementing the
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`institution decision to institute on all challenges raised in the petition.”4
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`4
`Guidance on the Impact of SAS on AIA Trial Proceedings (Apr. 26, 2018),
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`https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-
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`board/trials/guidance-impact-sas-aia-trial.
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`7
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`On May 8, 2018, the Board issued its decisions on Boehringer’s motions and
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`
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`instituted review of the nine previously-denied copycat grounds. (IPR2017-02031
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`(Paper 25); IPR2017-02032 (Paper 23).) The Board did not perform a case-
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`specific assessment of the parties’ competing interests in having the additional
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`grounds granted or denied, nor did the Board address the “persuasive” reasons that
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`originally led the Board to deny institution of the copycat grounds.
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` ARGUMENT
`A. Legal Standard
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`“When rehearing a decision on petition, a panel will review the decision for
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`an abuse of discretion.” 37 C.F.R. § 42.71(c). The Board abuses its discretion
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`when a decision is based on an erroneous interpretation of law, a factual finding
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`not supported by substantial evidence, or an unreasonable judgment in weighing
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`relevant factors. Blue Coat Sys., Inc. v. Finjan, Inc., IPR2016-01444, Paper 11 at 2
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`(P.T.A.B. July 18, 2017) (citing Star Fruits S.N.C. v. United States, 393 F.3d 1277,
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`1281 (Fed. Cir. 2005)).
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`B.
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`The Board Abused Its Discretion By Overturning Its Earlier
`Institution Decision In Order To Institute Review Of Boehringer’s
`Improper Copycat Challenges.
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`In view of the unique situation presented by this case, in which Boehringer’s
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`copycat IPR grounds trail four active IPRs challenging the same claims of the same
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`patent on identical grounds, the Board’s decision to institute review of
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`8
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`Boehringer’s copycat grounds rises to the level of an abuse of discretion. Under
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`
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`Section 314(a) and Section 325(d), the Board has discretion whether to institute or
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`deny a petition for inter partes review. That discretion, however, is not
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`unbounded—it must comply with the governing statutory framework, including the
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`APA. See, e.g., Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2141 (2016)
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`(explaining that the APA “enables reviewing courts to set aside agency action that
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`is contrary to constitutional right, in excess of statutory jurisdiction, or arbitrary
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`and capricious” (internal quotation marks and alterations omitted)); Hospira, Inc.
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`v. Genentech, Inc., IPR2017-00739, Paper 16 at 18 (P.T.A.B. July 27, 2017)
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`(informative) (“Our discretion under § 325(d) involves a balance between several
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`competing interests [such as] the interests in conserving the resources of the Office
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`and granting patent owners repose on issues and prior art that have been considered
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`previously.” (internal quotation marks and citations omitted)).
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`The Board has already determined—correctly—that it would be “unfair[]” to
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`institute review based on Boehringer’s nine copycat grounds. (IPR2017-02031
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`(Paper 19 at 12); IPR2017-02032 (Paper 17 at 8).) These grounds are identical to
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`those at issue in the previously-instituted Celltrion, Pfizer, and Samsung petitions,
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`yet Boehringer made the tactical decision not to seek joinder so that its petitions
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`could proceed on a delayed track. (See, e.g., id.) As a result, if Boehringer were
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`permitted to proceed on these grounds, as the Board has already found, Boehringer
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`9
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`would unfairly get a second opportunity to present the grounds with the benefit of
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`seeing the briefing and evidence presented by Genentech as well the Board’s
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`assessment of their weaknesses (for example, at the oral hearings scheduled for
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`July 16, 2018). Thus, as Genentech explained in its Patent Owner’s Preliminary
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`Response, the Board should not allow Boehringer to engage in this sort of
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`prejudicial gamesmanship, particularly when coupled with
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`the
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`inherent
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`inefficiency that would result from proceeding on the same grounds already
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`instituted in the Celltrion, Pfizer, and Samsung IPRs. (IPR2017-02031 (Paper 11
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`at 13-14); IPR2017-02032 (Paper 9 at 13-14).)). In its March Institution Decision,
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`the Board explained that it found Genentech’s arguments “persuasive” and denied
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`institution of Boehringer’s copycat grounds. (IPR2017-02031 (Paper 19 at 12);
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`IPR2017-02032 (Paper 17 at 8).)
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`The May Institution Decision fails to provide a proper basis for overturning
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`the denial of the copycat grounds. See, e.g., 5 U.S.C. § 706; Personal Web Techs.,
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`LLC v. Apple. Inc., 848 F.3d 987, 992 (Fed. Cir. 2018) (“The Board, as an
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`administrative agency, must articulate logical and rational reasons for its decision.”
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`(internal quotation marks omitted)). The Board stated that, in light of the Supreme
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`Court’s SAS decision and the Board’s subsequently issued guidance on that
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`decision, it was instituting review on all grounds presented in Boehringer’s
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`petitions. Yet the Board performed no analysis of the unique circumstances of this
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`Patent Owner’s Request For Rehearing
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`case, let alone the “persuasive” reasons that originally led the Board to deny
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`institution of the copycat grounds. The Board’s decision to institute review of
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`Boehringer’s copycat grounds, despite its prior finding that such proceedings
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`would be “unfair[]” to Genentech, thus constitutes an abuse of discretion and fails
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`to comply with the APA.
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`Nor does the Supreme Court’s SAS decision permit the Board to disregard its
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`statutory obligations. In SAS, the Court simply held that if the Board institutes
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`inter partes review, it must decide the patentability of every claim challenged in
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`the underlying petition. SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1354 (2018)
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`(explaining that its decision was compelled by the plain language of Section 318(a)
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`stating that the Board “shall issue a final written decision with respect to the
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`patentability of any patent claim challenged by the petitioner”).
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`Nothing in SAS requires that the Board institute review in cases where it has
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`found that the vast majority of grounds asserted in a petition do not merit review.
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`SAS Institute, 138 S. Ct. at 1356 (explaining that Ҥ 314(a) invests the Director
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`with discretion on the question whether to institute review”); see also Cuozzo, 136
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`S. Ct. at 2140 (explaining that there is “no mandate to institute review”). Indeed,
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`as explained in the Board’s recent “Chat with the Chief” regarding SAS, the Board
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`may deny a petition (even retroactively) in cases where the majority of grounds do
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`11
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`not merit review.5 This is such a case. Across Boehringer’s two petitions, the
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`Board instituted only three grounds while denying the nine copycat grounds. To
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`the extent the Board is adopting an “all or nothing” approach with respect to the
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`grounds raised in an IPR petition, the proper result here is to deny the petition in its
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`entirety rather than creating an unfair and prejudicial proceeding by adding the
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`previously-denied grounds.
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`There is also no prejudice to Boehringer in denying institution of its
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`petitions in their entirety. It was Boehringer’s strategic choice to make the
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`overwhelming majority of its petitions copycat grounds and yet not to seek joinder
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`with the earlier-filed petitions. Having positioned itself so that Boehringer’s
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`petitions would proceed on a later schedule that would allow Boehringer to adjust
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`its positions with the benefit of the briefing and argument from the earlier-filed
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`proceedings, Boehringer cannot complain if that strategy results in the denial of its
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`5 Matthew Bultman, PTAB Will Address All Challenger Arguments Post-SAS,
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`Law360 (Apr. 30, 2018), at https://www.law360.com/articles/1037398/ptab-will-
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`address-all-challenger-arguments-post-sas (“Judge Weidenfeller said the PTAB
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`could also deny review retroactively in certain cases where the board already
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`agreed to partial institution. He used the example of a petition that challenged 20
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`claims in a patent and review was instituted on just one claim.”).
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`12
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`petitions in their entirety. Boehringer was free to file a petition addressing only the
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`three new grounds and thus far has chosen not to do so. Genentech should not
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`suffer the consequence of institution of nine prejudicial grounds to permit review
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`of Boehringer’s three new grounds in these proceedings.
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` CONCLUSION
`The Board should vacate
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`the May Institution Decision and deny
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`Boehringer’s request for inter partes review of the ’213 patent in its entirety.
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`Date: May 22, 2018
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` IPR2017-02032
`Patent Owner’s Request For Rehearing
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`Respectfully submitted,
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`
`
`/David L. Cavanaugh/
`David L. Cavanaugh
`Registration No. 36,476
`Counsel for Patent Owner
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`
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`WILMER CUTLER PICKERING HALE AND DORR LLP
`1875 PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20006
`TEL: 202-663-6000
`FAX: 202-663-6363
`EMAIL: david.cavanaugh@wilmerhale.com
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`IPR2017-02032
`Patent Owner’s Request For Rehearing
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`CERTIFICATE OF SERVICE
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`I hereby certify that on May 22, 2018, I caused a true and correct copy of the
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`following materials:
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` Patent Owner’s Request For Rehearing
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`to be served electronically via electronic mail, as previously agreed by the parties,
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`on the following attorneys of record:
`
`Ira J. Levy
`GOODWIN PROCTER LLP
`620 Eighth Avenue, New York, NY 10018
`ILevy@goodwinlaw.com
`
`Brian A. Fairchild
`GOODWIN PROCTER LLP
`100 Northern Avenue Boston, MA 02210
`bfairchild@goodwinlaw.com
`
`DG-BI213@goodwinlaw.com
`
`
`/Lauren V. Blakely/
`Lauren V. Blakely
`Reg. No. 70,247
`WILMER CUTLER PICKERING HALE
`AND DORR LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`(650) 600-5039
`
`
`15
`
`
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