Filed: September 26, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`SAWAI USA, INC., AND
`SAWAI PHARMACEUTICAL CO., LTD.,
`Petitioner,
`
`
`v.
`
`
`BIOGEN MA INC.,
`Patent Owner.
`____________________________________________
`
`IPR2018-01403*
`Patent No. 8,399,514
`____________________________________________
`
`
`PATENT OWNER’S REHEARING REQUEST ON INSTITUTION AND
`JOINDER OF SAWAI PETITION IN IPR2019-00789
`
`
`
`
`
`
`
`
` 
`* Case IPR2019-00789 has been joined with this proceeding and the Board
`instructed that “all further filings shall be made only in IPR2018-01403.”
`IPR2019-00789, Paper 17, 21.
`
`

`

`TABLE OF CONTENTS
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Page(s)
`
`Introduction ................................................................................................................ 1 
`
`I.  Real Party in Interest Requirement for Institution .............................................. 3 
`
`A.  The Board Improperly Applied the RPI Burdens Framework ......................... 4 
`
`B.  The Decision Failed to Properly Consider Sumitomo’s Undisputed “Strategic
`Alliance” with Sawai .............................................................................................. 6 
`
`C.  The Decision Violates Due Process by Preventing Patent Owner from Cross-
`Examining and Being Heard on the RPI Issue ..................................................... 10 
`
`II.  Joinder of Otherwise Time-Barred Sawai Was Improperly Granted ................ 10 
`
`III.  Improper Exercise of Discretion ........................................................................ 14 
`
`Conclusion ............................................................................................................... 15 
`
`
`
`
`
`
`
`

`

` 
`
`TABLE OF AUTHORITIES
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Page(s)
`
`Federal Cases
`Applications in Internet Time, LLC v. RPX Corp.,
`897 F.3d 1336 (Fed. Cir. 2018) ...................................................................passim
`Facebook, Inc. v. Windy City Innovations, LLC,
`IPR2016-01156, Paper 39 (PTAB Aug. 14, 2017) ......................................... 3, 13
`General Plastics Indus. Co. v. Canon Kabushiki,
`IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) ........................................... 3, 15
`Goldberg v. Kelly,
`397 U.S. 254 (1970) .................................................................................... 2, 3, 13
`Greene v McElroy,
`360 U.S. 474 (1959) ............................................................................................ 13
`Icon Health & Fitness, Inc. v. Strava, Inc.,
`849 F.3d 1034 (Fed. Cir. 2017) ............................................................................ 5
`Lumentum Holdings, Inc. v. Capella Photonics, Inc.,
`No. IPR2015-00739, Paper 38 (PTAB Mar. 4, 2016) .......................................... 9
`Medtronic, Inc. v. Robert Bosch Healthcare Sys., Inc.,
`IPR2014-00488, Paper 61 (PTAB May 22, 2015) ............................................... 5
`Proppant Express Investments, LLC v. Oren Technologies, LLC,
`IPR2018-00914, Paper 38 (PTAB Mar. 13, 2019) ......................................... 2, 11
`Stride Rite Children’s v. Shoes by Firebug,
`IPR2017-01809, Paper 64 (PTAB Jan. 16, 2019) .............................................. 14
`Unified Patents, Inc. v. Personalized Media Comm’n, LLC,
`IPR2015-00521, Paper 13 (PTAB Jun. 8, 2015) ................................................ 11
`Valve Corp. v. Electronic Scripting Prods., Inc.,
`IPR2019-00062, Paper 11 at 14 (PTAB Apr. 2, 2019) ....................................... 14
`
` 
`
`iii 
`
`

`

`U.S. Patent No. 8,399,514
`IPR2018-01403
`
` 
`Worlds Inc. v. Bungie, Inc.,
`903 F.3d 1237 (Fed. Cir. 2018) ...................................................................passim
`ZTE Corp. v. Adaptix, Inc.,
`IPR2015-01184, Paper 10 (PTAB July 24, 2015) .......................................... 3, 12
`ZTE (USA) Inc. v. Fundamental Innovation Systems Int’l LLC,
`IPR2018-01076, Paper 14 at 12 (PTAB Dec. 3, 2018) ........................................ 5
`Federal Statutes
`5 U.S.C. § 554 .................................................................................................... 2, 3, 8
`5 U.S.C. § 556 .................................................................................................. 2, 3, 13
`35 U.S.C. § 312 .................................................................................................... 1, 10
`35 U.S.C. § 313 ........................................................................................................ 14
`35 U.S.C. § 314 .......................................................................................................... 3
`35 U.S.C. § 315 .............................................................................................. 3, 7, 8, 9
`35 U.S.C. § 316 ........................................................................................................ 13
`35 U.S.C. § 317 ........................................................................................................ 15
`35 U.S.C. § 325 .......................................................................................................... 3
`Regulations
`37 C.F.R. § 42.51 ................................................................................................. 3, 13
`37 C.F.R. § 42.71 ....................................................................................................... 1
`37 C.F.R. § 42.108 ..................................................................................................... 3
`Other Authorities
`PTAB Standard Operating Procedure 2 (Rev. 10) ................................................... 11
`Restatement (Third) of Agency § 1.01, comment c
`(Am. Law Inst. 2006) ............................................................................................ 8
`
` 
`
`iv 
`
`

`

` 
` 
`Introduction
`Patent Owner respectfully requests rehearing of the Board’s decision of
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`September 12, 2019 (IPR2019-00789, Paper 17) (“Decision” or “Dec.”), which
`
`instituted inter partes review on Sawai’s petition (IPR2019-00789, Paper 1) and
`
`granted the joinder motion (IPR2019-00789, Paper 2). Dec., 2. Rehearing should
`
`be granted pursuant to 37 C.F.R. § 42.71(d), and institution and joinder denied.
`
`First, the Decision improperly granted institution by “misapprehend[ing] or
`
`overlook[ing],” id., whether the Real Party in Interest (“RPI”) was properly named
`
`in the petition. 35 U.S.C. § 312(a)(2). The Board found that Biogen “reasonably
`
`br[ought] into question the accuracy of a petitioner’s identification of RPIs . . . .”
`
`See Dec., 13. After finding that Biogen had satisfied its burden of production,
`
`however, the Decision erred by holding that Patent Owner had “not persuaded” the
`
`Board that there were unnamed RPIs. See id., 13, 17. This was contrary to the
`
`established framework that petitioner always bears the burden of persuasion to
`
`establish compliance with the statutory requirement to identify all RPIs. Worlds
`
`Inc. v. Bungie, Inc., 903 F.3d 1237, 1242-46 (Fed. Cir. 2018).
`
`The Decision’s RPI analysis also overlooked the evidence and argument that
`
`Sumitomo Corporation and SCOA (collectively “Sumitomo”) are unnamed RPIs
`
`via an “attorney-in-fact” or “implied litigating agent” relationship with Sawai.
`
`IPR2019-00789, Paper 15, 7-9, 12-13; Applications in Internet Time, LLC v. RPX
`
` 
`
`1 
`
`

`

` 
`Corp., 897 F.3d 1336, 1351, 1354-58 (Fed. Cir. 2018) (“AIT”). Rather than
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`assessing this argument and applying the RPI analysis of AIT, the Decision only
`
`addressed whether “Sumitomo or SCOA exercise[d] control of this proceeding or
`
`otherwise ‘desires review’ of the patent.’” Dec., 17. The Decision thus
`
`misapprehends legal authority on the “full range of relationships” that establish an
`
`RPI. AIT, 897 F.3d at 1354-58. The Decision compounded these errors by
`
`apparently foreclosing RPI discovery, including cross-examination on the
`
`Hiramatsu Declaration (IPR2019-00789, Ex. 1060, “Hiramatsu Declaration”), by
`
`granting Sawai’s motion for joinder with the Mylan IPR and terminating Sawai’s
`
`petition. The Decision thus deprived Patent Owner of due process rights and
`
`protections under the Administrative Procedures Act (“APA”). E.g., Goldberg v.
`
`Kelly, 397 U.S. 254, 269 (1970); 5 U.S.C. §§ 554-556.
`
`Second, the Decision misapprehended, overlooked, and improperly decided
`
`the issue of joinder for otherwise time-barred Sawai. Contrary to the Decision’s
`
`findings (Dec., 10-11, 19-21), Sawai’s was not a true “copycat” petition because it
`
`relied upon new declarants. See Dec., 5. The Decision is inconsistent with other
`
`panels and a Precedential Opinion Panel (“POP”) decision establishing that joinder
`
`is inappropriate where, as here, different experts are relied on and no justification
`
`exists for the late filing of the petition. See, e.g., Proppant Express Investments,
`
`LLC et al. v. Oren Techs., LLC, IPR2018-00914, Paper 38 at 19 (PTAB Mar. 13,
`
` 
`
`2 
`
`

`

` 
`2019) (precedential); ZTE Corp. et al. v. Adaptix, Inc., IPR2015-01184, Paper 10 at
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`5 (PTAB July 24, 2015). Further, as a result of the joinder decision and termination
`
`of Sawai’s IPR, Patent Owner has been denied the opportunity to be heard on and
`
`cross-examine the Sawai declarants, including technical experts, relied upon by
`
`Sawai in its petition. IPR2019-00789, Paper 14, 2-3, 23-24; 5 U.S.C. § 554. This
`
`violates the APA, due process norms, relevant decisional law, and applicable
`
`statutes and regulations that uniformly provide for the opportunity to cross-
`
`examine. E.g., Goldberg, 397 U.S. at 269; Facebook, Inc. v. Windy City
`
`Innovations, LLC, IPR2016-01156, Paper 39 (PTAB Aug. 14, 2017); 5 U.S.C.
`
`§§ 554-556; 37 C.F.R. § 42.51(b)(1)(ii).
`
`Third, inasmuch as institution is discretionary, e.g., 35 U.S.C. §§ 314(a),
`
`315(c), 325(d); 37 C.F.R. § 42.108(a), the Decision overlooked and
`
`misapprehended considerations raised by Patent Owner under which institution
`
`should have been denied. See IPR2019-00789, Paper 15, 17-24. Several General
`
`Plastics factors addressed by Patent Owner but not analyzed in the Decision
`
`militate against institution, including the unexplained and prejudicial timing of the
`
`filing by Sawai. Id.; Gen. Plastics Indus. Co. v. Canon Kabushiki, IPR2016-01357,
`
`Paper 19 (PTAB Sept. 6, 2017) (precedential) (e.g., factors 4-7).
`
`I. Real Party in Interest Requirement for Institution
`
`The Decision misapprehended, overlooked, and improperly decided RPI
`
` 
`
`3 
`
`

`

` 
`issues relevant to institution for at least three reasons: (A) Patent Owner was
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`erroneously required to bear the burden of persuasion on the RPI issue, contrary to
`
`precedent (Worlds, 903 F.3d at 1242-46); (B) the Decision failed to address and
`
`credit Patent Owner’s evidence and arguments that Sawai served as “attorney-in-
`
`fact” in filing IPR for unnamed RPIs (AIT, 897 F.3d at 1354-58); and (C) the error
`
`on RPI was compounded by the Decision instituting, joining, and then sua sponte
`
`terminating the Sawai IPR, thereby eliminating the ability to be heard on the RPI
`
`issue in violation of due process and statutory rights. Dec., 12-18.
`
`A. The Board Improperly Applied the RPI Burdens Framework
`1.
`Biogen Successfully Disputed RPI Identification: “[A]n IPR
`
`petitioner’s initial identification of the real parties in interest should be accepted
`
`unless and until disputed by a patent owner.” Worlds, 903 F.3d at 1242 (emphasis
`
`added). Patent Owner presented undisputed evidence and argued that Petitioner
`
`had failed to identify all RPIs in the petition pursuant to statute, and pointed to the
`
`admission of Sumitomo’s “strategic alliance” with Sawai and ownership-stake in
`
`Upsher-Smith as evidence that Sumitomo should have been named. IPR2019-
`
`00789, Paper 15, 8, 12-13 (citing Exs. 2001, 2011). Even with Petitioner’s
`
`Hiramatsu Declaration before it, the Board found that Patent Owner produced
`
`sufficient evidence to dispute the Petitioner’s identification of all RPIs: “We
`
`determine Patent Owner has presented evidence to overcome that low hurdle” to
`
` 
`
`4 
`
`

`

` 
`show that Sumitomo should have been named an RPI. Dec., 13. Because Biogen
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`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`carried its burden of production, it was Petitioner’s burden of persuasion to
`
`establish that Sumitomo was not an RPI. E.g., Medtronic, Inc. v. Robert Bosch
`
`Healthcare Sys., Inc., IPR2014-00488, Paper 61 at 21 (PTAB May 22, 2015)
`
`(“Bosch has provided sufficient evidence to reasonably bring into question the
`
`accuracy of Medtronic’s representation in the Petitions that it is the sole real party-
`
`in-interest, and Medtronic has not proved that it is the sole real party-in-interest.”).
`
`2.
`
`Petitioner Did Not Rebut Patent Owner Evidence: “[I]n this
`
`circumstance, the Board could no longer merely rely upon [Sawai]’s initial
`
`identification of the real parties in interest,” and erred by “merely cit[ing] attorney
`
`argument from [Sawai]’s briefing,” which is insufficient to carry the burden on
`
`RPI. Worlds, 903 F.3d at 1246 (citing Icon Health & Fitness, Inc. v. Strava, Inc.,
`
`849 F.3d 1034, 1043 (Fed. Cir. 2017) (“Attorney argument is not evidence.”)); see
`
`Dec., 16 (citing only “Reply 4”). The Decision did not rely on anything that can be
`
`given weight to dispute Patent Owner’s unrebutted evidence. See Dec., 15-18.
`
`3.
`
`The Burden Was Improperly Placed On Biogen: Despite
`
`express recognition that Patent Owner had met its burden of production to question
`
`the accuracy of Petitioner’s initial identification of RPIs, the Decision improperly
`
`faulted the Patent Owner for “not persuad[ing]” the Board, Dec., 17, “that a
`
`particular third party should be named a real party in interest,” Worlds, 903 F.3d at
`
` 
`
`5 
`
`

`

` 
`1242, 1243-46. Shifting the burden of persuasion to Biogen was improper, as it
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`was Petitioner’s burden to prove that Sumitomo was not an RPI, id., under the
`
`legal theories reasonably raised by Biogen and supported with evidence. E.g.,
`
`IPR2019-00789, Paper 15, 12-17. The untested Hiramatsu Declaration did not
`
`rebut Biogen’s evidence, and did not even address Biogen’s “attorney-in-fact”
`
`evidence and arguments, see AIT, 897 F.3d at 1354-58. Compare, e.g., IPR2019-
`
`00789, Paper 15, 12-13 (citing IPR2019-00789, Ex. 2011, 79), with IPR2019-
`
`00789, Ex. 1060, ¶¶ 1-26. And Sawai introduced no other evidence to overcome
`
`the Biogen RPI challenge. Cross-examination of the Hiramatsu Declaration,
`
`moreover, could have exposed this lack of evidence to “contradict” that Sumitomo
`
`was an RPI—a burden always Sawai’s to bear. AIT, 897 F.3 at 1356 (“[N]othing in
`
`these paragraphs, or anything else in Chuang’s declaration . . . ‘contradicts’ AIT’s
`
`theory that RPX filed IPR petitions . . . to benefit Salesforce. . . . RPX bore the
`
`burden of persuasion on this issue, as the Board itself recognized.”). Patent Owner,
`
`however, was prejudicially prevented from pursuing this discovery, leaving the
`
`Hiramatsu Declaration untested in every respect. See infra § I.C.
`
`B.
`
`The Decision Failed to Properly Consider Sumitomo’s Undisputed
`“Strategic Alliance” with Sawai
`While the Decision briefly addressed the undisputed evidence of
`
`Sumitomo’s “strategic alliance” with Sawai, it evaluated only whether the evidence
`
`was “sufficient to establish that either Sumitomo or SCOA exercises control of this
`6 
`
` 
`
`

`

` 
`proceeding or otherwise ‘desires review’ of the patent.” Dec., 17 (emphasis
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`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`added). The Decision overlooked Patent Owner’s evidence and argument regarding
`
`“Sumitomo’s own public statements demonstrat[ing] that Sawai Japan is
`
`Sumitomo’s attorney-in-fact or its express or implied litigating agent for IP
`
`strategies,” which makes Sumitomo an RPI for the reasons articulated in AIT, 897
`
`F.3d at 1354-58. See IPR2019-00789, Paper 15, 12-13 (citing IPR2019-00789, Ex.
`
`2011, 79) (emphasis added). For example, unaddressed by the Decision was Patent
`
`Owner’s undisputed evidence that Petitioner was responsible for the “Intellectual
`
`property strategy” on behalf of itself and Sumitomo, strategy that, like this IPR,
`
`ultimately benefits unnamed Sumitomo. See IPR2019-00789, Paper 15, 13
`
`(quoting IPR2019-00789, Ex. 2011, 79 (“Sawai Pharmaceutical[:] Intellectual
`
`property strategy…—>…Value for Sumitomo Corporation”)).
`
`AIT is directly on point, as Biogen argued (see IPR2019-00789, Paper 15, 2,
`
`4, 12-17). There, AIT contended unsuccessfully before the Board that unnamed
`
`Salesforce was an RPI required to be named in the petition. AIT, 897 F.3d at 1338,
`
`1343-44, 1356-57. AIT offered evidence that petitioner RPX was an “attorney-in-
`
`fact” for unnamed principal Salesforce with “apparent authority” to file IPR
`
`petitions to benefit Salesforce. Id. at 1357. The court vacated the RPI
`
`determination because, inter alia, “[t]he Board did not consider critical evidence
`
`proffered by AIT[,] [n]or did it adequately explain why it rejected certain of AIT’s
`
` 
`
`7 
`
`

`

` 
`common law theories [e.g., ‘attorney-in-fact’], particularly where RPX bore the
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`burden of proving its petitions were not time-barred under § 315(b).” Id. at 1356.
`
`The Decision improperly suggests in a footnote that AIT supports finding
`
`that Sumitomo is not an RPI. Dec., 16 n.5. The footnote’s quotation from AIT,
`
`however, only teaches that an agent (e.g., Petitioner Sawai) is not necessarily an
`
`RPI when filing an IPR on behalf of its principal (e.g., Sumitomo). That does not
`
`support finding the inverse, i.e., that the principal (Sumitomo) on whose behalf the
`
`agent acts need not be named. See id. AIT’s holding, in fact, confirms Biogen’s
`
`position: “[A]n entity can serve as an agent to a principal and file an IPR on the
`
`principal’s behalf even without the two formally agreeing that the agent will do
`
`so.” 897 F.3d at 1357 (citing Restatement (Third) of Agency § 1.01, cmt c (2006)).
`
`Just as the Federal Circuit vacated the RPI determination in AIT, here, too,
`
`“it was error for the Board not to have considered [‘attorney-in-fact’ or ‘litigating
`
`agent’] theories, particularly because [Patent Owner] raised arguments that directly
`
`implicate them.” 897 F.3d 1356-57; see id. at 1358 (“The Board also failed to
`
`comply with its obligations under the APA to consider the evidence that justifies
`
`and detracts from its conclusions and to explain sufficiently its rationale for
`
`rejecting [Patent Owner]’s arguments and theories.”); see 5 U.S.C. §§ 554-56. Like
`
`Salesforce in AIT, Sumitomo should have been named as an RPI—the Decision’s
`
`contrary conclusion rests on a reading of the standard that ignores the “full range
`
` 
`
`8 
`
`

`

` 
`of relationships under § 315(b) and the common law” that makes an RPI. AIT, 897
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`F.3d at 1358. In addition, it contravenes instructions to apply “a flexible approach
`
`[to identifying RPIs] that takes into account both equitable and practical
`
`considerations, with an eye toward determining whether the non-party is a clear
`
`beneficiary that has a preexisting, established relationship with the petitioner.” Id.
`
`at 1354; see, e.g., IPR2019-00789, Paper 15, 12-17.
`
`Accordingly, given the undisputed evidence that Sumitomo is an unnamed
`
`RPI, rehearing should be granted, and institution should be denied for the reasons
`
`explained. See AIT, 897 F.3d at 1356 (“In sum, we believe that the Board’s
`
`determination that Salesforce was not a real party in interest under § 315(b) relied
`
`[1] on an impermissibly narrow understanding of the common-law meaning of the
`
`term, [2] was not based on consideration of the entirety of the administrative
`
`record, and seemingly [3] misallocated the burden of proof. Any one of these
`
`errors might warrant vacatur—together, they compel it.”).
`
`The Board states that even if Sumitomo was deemed an RPI, “denial of
`
`institution is not the appropriate remedy,” Dec., 13 n.4 (citing Lumentum Holdings,
`
`Inc. v. Capella Photonics, Inc., IPR2015-00739, Paper 38 at 5 (PTAB Mar. 4,
`
`2016)). But Lumentum’s context was about not correcting RPI within the 21 days
`
`allowed for updating a mandatory notice in the event of a change in RPI under 37
`
`C.F.R. § 42.8(a)(3). That holding is not relevant here. The statutory requirement at
`
` 
`
`9 
`
`

`

` 
`35 U.S.C. § 312(a) specifying that petitions “may be considered only if” the RPIs
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`are named may not be redefined or overlooked by PTO decision or rulemaking.
`
`C. The Decision Violates Due Process by Preventing Patent Owner
`from Cross-Examining and Being Heard on the RPI Issue
`The Decision’s errors were compounded by due process and APA violations
`
`foreclosing the opportunity for Biogen to seek discovery and be fully heard on RPI
`
`issues. The Board’s decision to institute, join, and sua sponte terminate the Sawai
`
`IPR now apparently shields the Hiramatsu Declaration from cross-examination
`
`because it is not of record in the Mylan IPR. See Dec., 20. Despite earlier
`
`indications, cf. IPR2019-00789, Ex. 2006, the Decision effectively precludes RPI
`
`discovery by excluding the Sawai record and retaining the Mylan IPR schedule
`
`wherein Patent Owner has already filed its Patent Owner Response, has no
`
`opportunity to address RPI, and cannot submit new evidence. See, e.g., Dec., 12,
`
`20. To the extent that the Board would allow RPI discovery and the opportunity to
`
`be heard, this would be inconsistent with the Board’s rationale for joinder, i.e., that
`
`it will “create no additional burden for the parties or the Board, will not add
`
`additional complexity to the Mylan IPR, will not impact the trial schedule of the
`
`Mylan IPR,” Dec., 20; see also IPR2019-00789, Paper 9, 2-14 (addressing reasons
`
`why joinder should be denied in view of prejudice and additional discovery). 
`
`Joinder of Otherwise Time-Barred Sawai Was Improperly Granted
`The Decision misapprehended, overlooked, and improperly decided joinder.
`
`10 
`
`II.
`
`
` 
`
`

`

` 
`See Dec., 19-21. Patent Owner had argued that joinder of otherwise time-barred
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Sawai should not be permitted under the Board’s discretion and settled precedent,
`
`including due to Sawai’s introduction of new declarants. IPR2019-00789, Paper 9,
`
`3-14; Unified Patents, Inc. v. Personalized Media Comm’n, LLC, IPR2015-00521,
`
`Paper 13 at 7-8 (PTAB Jun. 8, 2015) (exercising discretion to deny petition).
`
`No equitable facts or circumstances were relied upon in the Decision to
`
`justify joining Sawai. See Dec., 19-21. This is inconsistent with the POP’s
`
`directive that “the Board [] exercise this discretion [to join the otherwise time-
`
`barred petitioner] only in limited circumstances—namely, where fairness requires
`
`it and to avoid undue prejudice to a party.” Proppant, IPR2018-00914, Paper 38 at
`
`19 (emphasis added). Proppant is “binding agency authority.” PTAB Standard
`
`Operating Procedure 2 (Rev. 10), 1.
`
`Notably, because Sawai used different experts than Mylan, the Sawai IPR
`
`petition was not, in fact, a true “copy-cat.” See Dec., 5 (“In addition, Petitioner
`
`submits declarations of Robert Walter Baumhefner, M.D. (Ex. 1056), Jacquelyn
`
`Bainbridge, Pharm.D. (Ex. 1057), Ronald G. Marks, Ph.D. (Ex. 1058), and
`
`Jennifer Rock (Ex. 1059). Pet. 5.”). The Decision is thus inconsistent with prior
`
`denials of joinder where, as here, Petitioner presents different experts and there
`
`was no justification for the petition’s late filing. See ZTE Corp., IPR2015-01184,
`
`Paper 10 at 4-5 (denying joinder because, inter alia, “Petitioner has not filed an
`
` 
`
`11 
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`

`

` 
`‘identical petition’…. [and patent owner] should have the opportunity to cross-
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`U.S. Patent No. 8,399,514
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`
`examine Petitioner’s proffered expert . . . [and] the new issues raised by reliance on
`
`the different declarant in the instant Petition would adversely impact the” earlier
`
`IPR).
`
`In addition, the Decision violates Patent Owner’s due process and APA
`
`rights. Patent Owner had argued that joinder should be denied as additional
`
`briefing and discovery necessitated by Sawai’s new issues and declarants will
`
`interfere with the Mylan IPR. See IPR2019-00789, Paper 9, 4-10. The Decision,
`
`however, sua sponte terminated the Sawai IPR and held that declarations relied
`
`upon by Sawai in its Petition are not in the Mylan IPR record and that Biogen is
`
`not entitled to take related discovery:
`
`Upon entry of this decision, however, the present case is terminated
`and the declarations referred to by Patent Owner are not of record in
`the Mylan IPR. . . . [T]hese declarations will have no effect on the
`discovery or briefing schedule in the Mylan IPR and cause no
`prejudice to Patent Owner in that proceeding.
`Dec., 20 (emphasis added). Joinder under these circumstances was improper, as it
`
`denies Biogen the opportunity to examine inconsistent statements going to
`
`patentability. For example, Sawai asserted in the petition that post hoc analyses of
`
`Biogen’s phase 2 data “shows likley [sic] efficacy [of the 360 mg/day dose of
`
`DMF] in treating MS” to support its obviousness challenge. IPR2019-00789, Paper
`
`1, 55. But Sawai’s expert Dr. Marks previously testified that “you don’t give the
`
` 
`
`12 
`
`

`

` 
`same weight [to post hoc analysis] as pre-planned analyses.” IPR2019-00789, Ex.
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`2017, 173:10-11.
`
`The joinder of Sawai to the Mylan IPR at this stage—with the
`
`accompanying sua sponte termination and lack of Biogen discovery from Sawai
`
`and its declarants—violates Patent Owner’s due process rights. Indeed, the
`
`Supreme Court has held that “[i]n almost every setting where important decisions
`
`turn on questions of fact, due process requires an opportunity to confront and
`
`cross-examine adverse witnesses.” Goldberg, 397 U.S. at 269; Greene v. McElroy,
`
`360 U.S. 474, 497 (1959). The APA further provides that “[a] party is entitled . . .
`
`to conduct such cross-examination as may be required for a full and true disclosure
`
`of the facts.” 5 U.S.C. § 556(d); see also 37 C.F.R. § 42.51(b)(1)(ii) (“[c]ross
`
`examination of affidavit testimony prepared for th[e] proceeding”). In this context,
`
`Biogen’s right to cross-examine declarants in the instituted IPR holds even if the
`
`Board did not rely on the Sawai declarants, because Biogen is affirmatively
`
`entitled “to respond, introduce evidence of its own, and challenge [joined]
`
`Petitioner’s new evidence.” Facebook, Inc., IPR2016-01156, Paper 39 at 5 (“the
`
`new testimonial evidence Petitioner advances is similar, but not the same”) (citing
`
`35 U.S.C. § 316(a)(8) (“The Director shall prescribe regulations . . . providing for
`
`the filing by the patent owner of a response to the petition under section 313 after
`
`an inter partes review has been instituted . . . [including] any additional factual
`
` 
`
`13 
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`

`

` 
`evidence and expert opinions on which the patent owner relies in support of the
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`response”)); Stride Rite Children’s v. Shoes by Firebug, IPR2017-01809, Paper 64
`
`(PTAB Jan. 16, 2019) (“The right to cross-examine an adversarial witness is a
`
`long-standing and vital feature of the law in all cases including administrative
`
`actions.”). Rehearing should be granted and the motion to join denied.
`
`III.
`
`Improper Exercise of Discretion
`The Decision misapprehended, overlooked, and improperly assessed whether
`
`the Board should exercise its discretion to institute. See Dec., 7-12. Patent Owner
`
`argued that it was not an appropriate exercise of discretion to institute because
`
`Sawai could have filed its petition—but did not—long before it did, IPR2019-
`
`00789, Paper 15, 17-24. Sawai never provided an explanation for filing on March
`
`5, 2019, despite the fact it could have found all the references cited in the petition
`
`at least by the time that Mylan filed on July 13, 2018. Id. at 19-20. Other panels
`
`have held that such a delay “does not excuse” a prejudicial follow-on petition, even
`
`if otherwise within the statutory timing requirements. Valve Corp. v. Elec.
`
`Scripting Prods., Inc., IPR2019-00062, Paper 11 at 14 (PTAB Apr. 2, 2019)
`
`(denying institution of petition delayed five months after first petition). And while
`
`“it was incumbent upon Petitioner to identify those circumstances” in the first
`
`instance, ZTE (USA) Inc. v. Fundamental Innov. Sys. Int’l LLC, IPR2018-01076,
`
`Paper 14 at 12 (PTAB Dec. 3, 2018), the Decision points to no “adequate
`
` 
`
`14 
`
`

`

` 
`explanation” for this lateness, ignoring General Plastics factors 4 and 5. See Dec.,
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`7-12. Further, the Decision did not properly consider factors 6 and 7 (see IPR2019-
`
`00789, Paper 15, 22-24), thereby failing to assess and address the prejudicial
`
`delays and timing complications created by Petitioner’s additional declarants—
`
`eight months after Mylan’s, 20 months after service in district court, and nearly
`
`two years after seeking ANDA certification with the FDA. Dec., 22-24. The
`
`Decision’s reliance on authority for the Board to “proceed to a final written
`
`decision” under 35 U.S.C. § 317(a) (Dec., 11-12), in no way mitigates the
`
`prejudice of instituting and joining Sawai as an adversarial petitioner while
`
`briefing and motion practice are ongoing and the hearing has yet to occur. See
`
`IPR2019-00789, Paper 9, 2, 14.
`
`Conclusion
`Once properly considered, the overlooked and misapprehended evidence and
`
`arguments merit reconsideration and denial of the institution and joinder decisions.
`
`
`
`
`
` 
`
` By: / Barbara C. McCurdy /
`Barbara C. McCurdy, Reg. No. 32,120
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4047
`
`Counsel for Patent Owner Biogen MA Inc.
`
`15 
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`

`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`
` 
`
`
`
`
`REHEARING REQUEST ON INSTITUTION AND JOINDER OF SAWAI
`
`PETITION IN IPR2019-00789 was served electronically via e-mail on
`
`September 26, 2019, in its entirety on the following:
`
`Brandon M. White
`Shannon M. Bloodworth
`Michael A. Chajon
`Maria A. Stubbings
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`Email: bmwhite@perkinscoie.com
`Email: sbloodworth@perkinscoie.com
`Email: mchajon@perkinscoie.com
`Email: mstubbings@perkinscoie.com
`
`David L. Anstaett
`Emily J. Greb
`Perkins Coie LLP
`33 East Main St., Suite 201
`Madison, WI 53703
`Telephone: (608) 663-7494
`Email: egreb@perkinscoie.com
`Email: danstaett@perkinscoie.com
`
`Courtney M. Prochnow
`Perkins Coie LLP
`633 W. 5th St., Suite 5850
`Los Angeles, CA 90071
`Telephone: (310) 788-3284
`Email: cprochnow@perkinscoie.com
`
` 
`
`16 
`
`

`

`U.S. Patent No. 8,399,514
`IPR2018-01403
`
` 
`Brian Sodikoff
`Katten Muchin Rosenman LLP
`525 West Monroe Street Chicago, IL 60661-3693
`Telephone: (312) 902-5462
`E-mail: brian.sodikoff@kattenlaw.com
`
`Christopher B. Ferenc
`Katten Muchin Rosenman LLP 2900 K Street NW
`North Tower - Suite 200
`Washington, DC 20007
`Telephone: (202) 625-3647
`E-mail: Christopher.ferenc@kattenlaw.com
`
`Petitioners have agreed to electronic service.
`
`Dated: September 26, 2019
`
`By: / Catherine A. Sadler /
`Catherine Sadler
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
` 
`
`17 
`
`