Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 17
`Entered: September 12, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`SAWAI USA, INC. AND
`SAWAI PHARMACEUTICAL CO., LTD.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`_______________
`
`Case IPR2019-00789
`Patent No. 8,399,514
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, JENNIFER MEYER CHAGNON, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`Granting of Motion for Joinder
`37 C.F.R. § 42.122(b)
`
`
`
`

`

`IPR2019-00789
`Patent No. 8,399,514 B2
`
`I.
`
`INTRODUCTION
`Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd. (collectively
`“Sawai” or “Petitioner”) filed a Petition to institute an inter partes review of
`claims 1–20 (“the challenged claims”) of U.S. Patent No. 8,399,514 B2 (the
`“’514 patent”). Paper 1 (“Pet.”). Biogen MA Inc. (“Patent Owner”) filed a
`Preliminary Response to the Petition. Paper 15 (“Prelim. Resp.”).
`Concurrently with its Petition, Petitioner filed a Motion for Joinder
`seeking to join Petitioner as a party to the following instituted proceeding:
`Mylan Pharmaceuticals Inc. v. Biogen MA Inc., Case IPR2018-01403
`(PTAB) (“the Mylan IPR”). Paper 2 (“Mot.”). Patent Owner filed an
`Opposition to Petitioner’s Motion for Joinder. Paper 9 (“Opp.”). Petitioner
`filed a Reply to Patent Owner’s Opposition. Paper 10 (“Reply”). Patent
`Owner filed a Sur-Reply to Petitioner’s Reply. Paper 14 (“Sur-Reply”).
`For the reasons discussed below, we institute inter partes review of all
`challenged claims, and grant Petitioner’s Motion for Joinder.
`
`A. Related Matters
`Petitioner identifies the following litigation between the parties
`involving the ’514 patent: Biogen Int’l GmbH v. Sawai USA, Inc., C.A. No.
`17-cv-00875 (D. Del.). Pet. 2. The parties also identify several other
`litigations involving the ’514 patent. See Pet. 2–3; Paper 7, 2.
`In addition to the Mylan IPR, the ’514 patent also has been involved
`in the following proceedings before the Patent Trial and Appeal Board
`(“PTAB” or “Board”): Coalition for Affordable Drugs V LLC v. Biogen MA
`Inc., IPR2015-01993; Coalition for Affordable Drugs V LLC v. Biogen MA
`
`2
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`IPR2019-00789
`Patent No. 8,399,514 B2
`
`Inc., IPR2015-01136; and Biogen MA Inc. v. Forward Pharma A/S, Patent
`Interference No, 106,023. See Pet. 3; Paper 7, 2–3.
`
`B. The ’514 patent
`The subject matter claimed in the ’514 patent is directed to methods of
`treating patients needing treatment for Multiple Sclerosis or MS. Ex. 1001,
`27:59–30:27. The heart of the treatment, and a requirement of every claim,
`is administering about 480 milligrams (mg) per day of certain fumarates. Id.
`The fumarates are limited to dimethyl fumarate (DMF), monomethyl
`fumarate (MMF), or their combination. Id. Biogen markets dimethyl
`fumarate under the tradename Tecfidera®. Prelim. Resp. 1–2.
`
`C. Illustrative Claims
`Independent claims 1, 11, 15, and 20, reproduced below, are
`illustrative of the challenged claims:
`
`1. A method of treating a subject in need of treatment for
`multiple sclerosis comprising orally administering to the subject
`in need thereof a pharmaceutical composition consisting
`essentially of
`(a) a therapeutically effective amount of dimethyl
`fumarate, monomethyl fumarate, or a combination thereof, and
`(b) one or more pharmaceutically acceptable excipients,
`wherein the therapeutically effective amount of dimethyl
`fumarate, monomethyl fumarate, or a combination thereof is
`about 480 mg per day.
`11. A method of treating a subject in need of treatment for
`multiple sclerosis consisting essentially of orally administering
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
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`
`to the subject about 480 mg per day of dimethyl fumarate,
`monomethyl fumarate, or a combination thereof.
`15. A method of treating a subject in need of treatment for
`multiple sclerosis comprising orally administering to the subject
`pharmaceutical composition consisting essentially of
`(a) a therapeutically effective amount of dimethyl
`fumarate and
`(b) one or more pharmaceutically acceptable excipients,
`wherein the therapeutically effective amount of dimethyl
`fumarate is about 480 mg per day.
`20. A method of treating a subject in need of treatment for
`multiple sclerosis comprising treating the subject in need thereof
`with a therapeutically effective amount of dimethyl fumarate,
`monomethyl fumarate, or a combination thereof, wherein the
`therapeutically effective amount of dimethyl
`fumarate,
`monomethyl fumarate, or a combination thereof is about 480 mg
`per day.
`
`D. Evidence Relied Upon
`Petitioner relies upon the following prior art references:
`Ex. 1005, Biogen News Release, Phase II Study of Oral Compound BG-12
`Meets Primary Endpoint in Multiple Sclerosis (Jan. 9, 2006) (“Biogen Press
`Release”).
`Ex. 1006, S. Schimrigk et al., A Prospective, Open-Label, Phase II Study of
`Oral Fumarate Therapy for the Treatment of Relapsing-Remitting Multiple
`Sclerosis, 10 (Suppl. 2) MULTIPLE SCLEROSIS CLIN. & LAB. RES. S258,
`Abstract P642 (2004) (“Schimrigk 2004”).
`Ex. 1007, L. Kappos et al., Efficacy of a Novel Oral Single-Agent Fumarate,
`BG00012, in Patients with Relapsing-Remitting Multiple Sclerosis: Results
`of a Phase 2 Study, 253 (Suppl. 2) J. NEUROL. II27, O108 (2006)
`(“Kappos 2006”).
`Ex. 1008, International Publication No. WO 2006/0037342 A2 (published
`Apr. 13, 2006) (“WO ’342”).
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
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`Ex. 1009, R. K. Joshi et al., U.S. Patent No. 7,320,999, issued Jan. 22, 2008
`(“Joshi ʼ999”).
`Ex. 1010, NCT00168701, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/archive/NCT00168701/2005_09_14
`(“Clinical Trials”).
`Ex. 1011, ICH Harmonised Tripartite Guideline - Dose-Response
`Information to Support Drug Registration E4 (Mar. 10, 1994)
`(“ICH Guideline”).
`Petitioner also relies upon the Declarations of Dr. John R. Corboy
`(Ex. 1002), Dr. Leslie Z. Benet (Ex. 1003), Dr. Ian McKeague (Ex. 1004),
`and Jennifer Rock (Ex. 1055) to support its contentions. Pet. 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. Petitioner explains
`that “Dr. Baumhefner’s (Ex. 1056), Dr. Bainbridge’s (Ex. 1057), and Dr.
`Marks’ (Ex. 1058) declarations . . . [are] substantively identical to that of Dr.
`John R. Corboy’s (Ex. 1002), Dr. Leslie Z. Benet’s (Ex. 1003), and Dr. Ian
`McKeague’s (Ex. 1004) expert declarations, respectively, in the Mylan
`IPR.” Pet. 6 n.1. In its Motion for Joinder, Petitioner explains the purpose
`of the additional set of expert declarations submitted with the Petition as
`follows:
`
`In order to further simplify the proceeding, Sawai will rely
`on the same declarants as Mylan, Dr. John R. Corboy, Dr. Leslie
`Z. Benet, Ms. Rock, and Dr. Ian McKeague, should Mylan
`permit it. If Mylan allows Sawai to use the same declarants, then
`Sawai will withdraw the declarations of Dr. Baumhefner,
`Dr. Bainbridge, Ms. Rock, and Dr. Marks, and rely solely on the
`declarations and testimonies of Mylan’s declarants: Dr. John R.
`Corboy, Dr. Leslie Z. Benet, Ms. Rock and Dr. Ian McKeague.
`Mot. 4–5.
`
`5
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`IPR2019-00789
`Patent No. 8,399,514 B2
`
`
`E. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability (Pet. 5):
`
`Ground Claims
`
`1
`
`2
`3
`4
`
`1–20
`
`1–20
`1–20
`1–20
`
`References
`Basis
`§ 103(a) Biogen Press Release and
`Schimrigk 2004
`§ 103(a) Kappos 2006 and
`Schimrigk 2004
`§ 103(a) Kappos 2006 and WO ’342
`§ 103(a) Kappos 2006, Clinical Trials,
`Joshi ʼ999, and ICH Guideline
`
`II.
`
`INSTITUTION OF INTER PARTES REVIEW
`Petitioner can be joined as a petitioner in the Mylan IPR only if we
`determine the present Petition warrants institution under 35 U.S.C. § 314.
`35 U.S.C. § 315(c). We first discuss whether the Petition warrants
`institution on the merits. We then address Patent Owner’s contentions that
`we should exercise our discretion to deny the Petition under 35 U.S.C.
`§ 314(a) (Prelim. Resp. 17–24), and the allegation that Petitioner has failed
`to name all real parties-in-interest pursuant to 35 U.S.C. § 312(a)(2) (id. at
`3–17).
`
`A. Petitioner’s Asserted Grounds
`We instituted trial in the Mylan IPR with respect to all challenged
`claims and on all the grounds set forth in Mylan’s Petition (IPR2018-01403,
`Paper 2). See IPR2018-01403, Paper 12 (“Mylan IPR Institution Decision”).
`Petitioner represents that the current Petition is substantially identical
`to Mylan’s Petition. See Mot. 4 (“[T]he Petition raises grounds identical to
`those raised in the IPR2018-01403 petition, and does not include any new
`grounds not raised in that petition.”). Patent Owner does not dispute that the
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
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`current Petition is substantively identical to Mylan’s Petition.1 See generally
`Prelim. Resp. Moreover, we conducted our own review and determine that
`the Petition in this case is substantively identical to the one in the Mylan
`IPR. Accordingly, given that Sawai’s Petition is substantively the same as
`Mylan’s Petition, we determine, for the same reasons stated in the Mylan
`IPR Institution Decision, that Petitioner has demonstrated a reasonable
`likelihood that it would prevail in showing the challenged claims are
`unpatentable based upon the same grounds.
`
`B. Discretionary Denial under 35 U.S.C. § 314(a) and
`35 U.S.C. § 325(d)
`Patent Owner contends that we should “exercise [our] discretion
`under [35 U.S.C.] § 314(a) and deny Sawai’s follow-on petition under the
`General Plastic factors.” Prelim. Resp. 17–18 (citing Gen. Plastic Indus.
`Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357 (PTAB Sept. 6, 2017)
`(Paper 19) (Section II.B.4.i. designated as precedential) (“General Plastic”);
`also citing Valve Corp. v. Elec. Scripting Prods., Inc., Case IPR2019-00062
`(PTAB Apr. 2, 2019) (Paper 11) (precedential) (holding that the General
`Plastic factors can apply also to different petitioners)). Patent Owner further
`contends that we should “deny institution under § 325(d), as the grounds on
`
`1 We recognize Patent Owner’s argument that “Sawai’s petition adds new
`declarants, each of whom will need to be cross-examined.” Opp. 3. We
`note, however, that Petitioner concurrently relies on the same expert
`declarations submitted in the Mylan IPR (see Pet. 5) and the “substantively
`identical” new declarations submitted in the event that Mylan would
`somehow not permit Sawai access to Mylan’s chosen experts (see Mot. 4–5).
`Patent Owner’s concern regarding the new declarants is discussed in more
`detail below in the context of Petitioner’s Motion for Joinder. See Section
`III.
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
`
`which Sawai relies are fully addressed in the Mylan IPR.” Id. at 18. We
`address Patent Owner’s discretionary denial arguments together.
`In General Plastic, the Board identified seven nonexclusive factors
`that bear on the issue of whether the Board should invoke its discretion to
`deny institution of an inter partes review, based on a follow-on petition on
`the same patent, under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a). These
`factors are:
`1. whether the same petitioner previously filed a petition
`directed to the same claims of the same patent;
`2. whether at the time of filing of the first petition the petitioner
`knew of the prior art asserted in the second petition or should
`have known of it;
`3. whether at the time of filing of the second petition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision
`on whether to institute review in the first petition;
`4. the length of time that elapsed between the time the petitioner
`learned of the prior art asserted in the second petition and the
`filing of the second petition;
`5. whether the petitioner provides adequate explanation for the
`time elapsed between the filings of multiple petitions directed
`to the same claims of the same patent;
`6. the finite resources of the Board; and
`7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the
`Director notices institution of review.
`General Plastic, slip op. at 15–16 (citing NVIDIA Corp. v. Samsung Elec.
`Co., Case IPR2016-00134, slip op. at 6–7 (PTAB May 4, 2016) (Paper 9)).
`“The General Plastic factors, alone or in combination, are not dispositive,
`but part of a balanced assessment of all relevant circumstances in the case,
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
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`including the merits.” Trial Practice Guide August 2018 Update2,
`referenced at 83 Fed. Reg. 39,989 (Aug. 13, 2018), at 10. We also have
`considered the posture of related district court proceedings under § 314(a),
`as Patent Owner requests here. See Prelim. Resp. 22–23; see also NHK
`Spring Co. v. Intri-Plex Techs., Inc., Case IPR2018-00752, slip op. at 19–20
`(PTAB Sept. 12, 2018) (Paper 8) (precedential) (“NHK”) (finding that “the
`advanced state of the district court proceeding is an additional factor that
`weighs in favor of denying the Petition under § 314(a)”); Trial Practice
`Guide July 2019 Update3, referenced at 84 Fed. Reg. 33,925 (July 16, 2019)
`(“Trial Practice Guide July 2019 Update”).
`Applying the General Plastic factors, Patent Owner points to
`previously filed petitions challenging the ’514 patent, identified in Section
`I.A hereinabove. Prelim. Resp. 17–23. In particular, Patent Owner contends
`that (a) “Sawai knew of or could have found with reasonable diligence all of
`the references cited in its Petition long before it filed this proceeding” (id. at
`19); (b) “Sawai had the benefit of not only Mylan’s Petition that it is
`attempting to join, but also it has the benefit of three prior unsuccessful
`Board proceedings against the ’514 patent, as well as the Board’s Institution
`Decision in the Mylan IPR” (id. at 20); (c) “Sawai knew of or could have
`reasonably identified the asserted references long before it filed its Petition,
`and it has provided no adequate explanation for its delay” (id. at 21);
`(d) “Sawai’s belated IPR is an unwarranted and unreasonable waste of the
`
`
`2 Available at https://go.usa.gov/xU7GP.
`3 Available at https://www.uspto.gov/sites/default/files/documents/trial-
`practice-guide-update3.pdf. All citations made herein to the Trial Practice
`Guide July 2019 Update refer to this version of the document.
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`IPR2019-00789
`Patent No. 8,399,514 B2
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`Board resources for multiple reasons” (id. at 22); and (e) that “[t]he Sawai
`district court trial in the pending infringement action will occur before the
`Board reaches a Final Written Decision” (id. at 22–23, citing NHK, slip. op.
`at 20).
`We “recognize the potential for abuse of the review process by
`repeated attacks on patents.” General Plastic, slip op. at 17. Nevertheless,
`“[t]here is no per se rule precluding the filing of follow-on petitions after the
`Board’s denial of one or more first-filed petitions on the same patent.” Id. at
`15. In this case, Patent Owner’s arguments in favor of discretionary denial
`do not persuade us that there is abuse of process where, as here, a different
`petitioner files a “me-too” or “copycat” petition in conjunction with a timely
`motion to join an inter partes review based upon the (essentially) copied
`petition filed by different petitioner. We also are not persuaded that this
`circumstance warrants denial under § 325(d). By its very nature, such a
`“me-too” or “copycat” petition necessarily relies on substantially the same
`prior art and arguments previously considered by the Office, and is timely,
`even though such a petition is filed after our institution decision in the earlier
`proceeding. See 37 C.F.R. § 42.122(b) (“Any request for joinder must be
`filed, as a motion under § 42.22, no later than one month after the institution
`date of any inter partes review for which joinder is requested.”). Patent
`Owner’s arguments directed to the other earlier filed petitions lose force
`when we consider that we have already instituted trial in the Mylan IPR,
`Patent Owner has filed its Response in the Mylan IPR addressing the same
`patentability challenges, and the case is actively proceeding to a Final
`Written Decision. See also Mylan IPR Institution Decision, slip op at 35–43
`(declining to exercise our discretion under § 325(d) in the Mylan IPR). The
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
`
`instant Petition does not present any substantive ground or matter not
`already at issue in the Mylan IPR and Petitioner agrees that it “is willing to
`participate in the proceeding as an understudy to Mylan.” Mot. 1. Thus,
`under these circumstances, the concurrently filed motion to join the Mylan
`IPR effectively obviates any concerns of serial harassment and unnecessary
`expenditure of resources that the General Plastic factors and the Trial
`Practice Guide July 2019 Update are meant to address. Cf. General Plastic,
`slip op. at 18 (“[T]here may be circumstances where multiple petitions by
`the same petitioner against the same claims of a patent should be permitted,
`and . . . such a determination is dependent on the facts at issue in the case.”);
`Trial Practice Guide July 2019 Update, 25 (stating that the PTAB will
`consider “events in other proceedings related to the same patent, either at the
`Office [or] in district courts. . . .”).
`We recognize that there is a trial in the related district court litigation
`which may occur before a Final Written Decision is issued in the Mylan
`IPR, but perceive limited prejudice to Patent Owner and little, if any, waste
`of Board resources in allowing Petitioner to join an ongoing inter partes
`review proceeding. We are mindful of the possibility that Mylan and Patent
`Owner may settle their dispute and seek a termination of the Mylan IPR.
`Even under that potential circumstance, however, instituting trial here would
`not result in undue prejudice against Patent Owner. First, the statute
`explicitly states that even “[i]f no petitioner remains in the inter partes
`review, the Office may . . . proceed to a final written decision.” 35 U.S.C.
`§ 317(a). The Federal Circuit also recognizes that the “Board may enter
`decision even after petitioner settles and drops out of the proceeding.”
`Progressive Cas. Ins. Co. v. Liberty Mut. Ins. Co., 625 Fed. Appx. 552, 556
`
`11
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`IPR2019-00789
`Patent No. 8,399,514 B2
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`(Fed. Cir. 2015). Second, once joined, this case assumes the schedule of the
`Mylan IPR for all the filings and for the oral hearing, with Petitioner Sawai
`playing an understudy role; Petitioner Sawai therefore cannot, for example,
`“strategically stage their prior art and arguments in multiple petitions, using
`our decisions [in the Mylan IPR] as a roadmap.” See General Plastic, slip
`op. at 17.
`Based on these circumstances and our consideration of the General
`Plastic factors, we determine that instituting inter partes review in this case
`would not result in undue prejudice to Patent Owner. See General Plastic,
`slip op. at 17 (“Our intent in formulating the factors was to take undue
`inequities and prejudices to Patent Owner into account.”). We, therefore,
`decline to exercise our discretion under 35 U.S.C. § 314(a) to deny
`institution. We also do not exercise our discretion under 35 U.S.C. § 325(d).
`
`C. Real Party-in-Interest
`The statute governing inter partes review proceedings sets forth
`certain requirements for a petition, including that “the petition identif[y] all
`real parties in interest.” 35 U.S.C. § 312(a)(2); see also 37 C.F.R.
`§ 42.8(b)(1) (requirement to identify real parties-in-interest in mandatory
`notices). Pursuant to 35 U.S.C. § 312(a)(2) and 37 C.F.R. § 42.8(b)(1),
`Petitioners state that real parties-in-interest (“RPIs”) for Petitioners are
`Sawai USA, Inc., Sawai Pharmaceutical Co., Ltd., Sawai America Holdings
`Inc., Sawai America, LLC, Upsher-Smith Laboratories LLC, and Stason
`Pharmaceuticals, Inc. Pet. 1.
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
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`
`Patent Owner argues, however, that the Petition should be denied
`because Petitioner has failed to identify all RPIs.4 Prelim. Resp. 2. In
`particular, Patent Owner contends “does not identify Sumitomo Corporation
`or its wholly-owned subsidiary SCOA [(Sumitomo Corporation of
`Americas)] which, along with RPI Sawai America Holdings, is a joint owner
`of RPI Upsher-Smith.” Id. at 5 (citing Ex. 1060 ¶¶ 9, 19, 21). As noted, a
`petition for inter partes review “may be considered only if . . . the petition
`identifies all real parties in interest.” 35 U.S.C. § 312(a)(2). When a patent
`owner provides sufficient evidence prior to institution that reasonably brings
`into question the accuracy of a petitioner’s identification of RPIs, the overall
`burden remains with the petitioner to establish that it has complied with the
`statutory requirement to identify all RPIs. Worlds Inc. v. Bungie, Inc.,
`903 F.3d 1237, 1242–45 (Fed. Cir. 2018) (also finding that the petitioner’s
`initial identification of RPIs cannot be treated as a “rebuttable
`presumption.”). We determine Patent Owner has presented evidence to
`overcome that low hurdle, and we discuss that evidence and associated
`arguments below.
`1. Patent Owner’s Contentions
`Patent Owner contends that the evidence of record shows that
`(a) “multiple entities have a direct interest in the Sawai generic DMF
`
`
`4 We note that denial of institution is not the appropriate remedy even if
`Petitioner failed to identify certain RPIs. See Lumentum Holdings, Inc. v.
`Capella Photonics, Inc., Case IPR2015-00739, slip op. at 5 (PTAB Mar. 4,
`2016) (Paper 38) (precedential) (holding that “a lapse in compliance with”
`the requirements of 35 U.S.C. § 312(a) “does not deprive the Board of
`jurisdiction over the proceeding, or preclude the Board from permitting such
`lapse to be rectified”).
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`product accused of infringing the ’514 patent in the district court litigation,”
`including Sumitomo Corporation and SCOA (Prelim. Resp. 6–7, citing
`Ex. 1060 ¶¶ 10, 21); and (b) Sumitomo and Sawai Japan formed a “strategic
`alliance,” which according to Patent Owner “divides responsibility for
`Upsher-Smith’s business of making and selling generic drugs in the U.S.
`between unnamed RPI Sumitomo and Petitioner Sawai Japan” (id. at 8,
`citing Exs. 2001, 2011).
`Patent Owner additionally directs our attention to the following
`diagram. Prelim. Resp. 9.
`
`
`
`
`The above diagram is provided by Petitioner in its Reply to Patent Owner’s
`Opposition to Petitioner’s Motion for Joinder to show the corporate
`relationship among the named RPIs and allegedly unnamed RPIs, Sumitomo
`and SCOA. Reply 3 (citing Ex. 1060). According to Patent Owner,
`Sumitomo’s 20% stake in Sawai America represents a “substantial
`ownership-stake in Upsher-Smith” and therefore Sumitomo “‘will benefit
`from having [the ’514 patent] claims canceled or invalidated’ and should
`have been named as an RPI.” Prelim. Resp. 13–14 (quoting Applications in
`
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`Internet Time, LLC v. RPX Corp., 897 F.3d 1336, 1348 (Fed. Cir. 2018)
`(“AIT”)). Thus, according to Patent Owner, Sumitomo and SCOA are RPIs
`in this inter partes review. Id.
`2. Discussion
`“Whether a party who is not a named participant in a given
`proceeding nonetheless constitutes a ‘real party-in-interest’ . . . to that
`proceeding is a highly fact dependent question” with no “bright line test,”
`and is assessed “on a case-by-case basis.” Trial Practice Guide, 77 Fed.
`Reg. 48,756, 48,759 (Aug. 14, 2012) (“Trial Practice Guide”) (citing Taylor
`v. Sturgell, 553 U.S. 880, 893–95 (2008)). AIT, relied on by Patent Owner,
`repeatedly cites the Trial Practice Guide with approval. AIT, 897 F.3d at
`1344 n.2 (stating that “the Trial Practice Guide is a thoughtful and useful
`resource to which individual Board members and the public might turn for
`guidance” and noting “that many of the statements in the Trial Practice
`Guide concerning § 315(b) are consistent with the language, structure, and
`purpose of the statutory provision it addresses and with its common-law
`predicates”); see also id. at 1344–45, 1348–49, 1351. The Trial Practice
`Guide explains that, “at a general level, the ‘real party-in-interest’ is the
`party that desires review of the patent. Thus, the ‘real party-in-interest’ may
`be the petitioner itself, and/or it may be the party or parties at whose behest
`the petition has been filed.” Trial Practice Guide, 77 Fed. Reg. at 48,759.
`Relevant considerations include, but are not limited to: (1) “whether
`the non-party exercised or could have exercised control over the proceeding”
`(Trial Practice Guide, 48,759 (citing Taylor, 533 U.S. at 895; Charles Alan
`Wright, Arthur R. Miller & Edward H. Cooper, FEDERAL PRACTICE &
`PROCEDURE (“Wright & Miller”) § 4451)); (2) whether the non-party funded
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`IPR2019-00789
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`the proceeding (id. at 48,760); (3) the non-party’s relationship with the
`petition (id.); (4) “the nature of the entity filing the petition” (id.); and
`(5) the non-party’s relationship with the petitioner (id.).5 The concept of
`control generally means that “the nonparty has the actual measure of control
`or opportunity to control that might reasonably be expected between two
`formal coparties.” Id. at 48,759 (citing Wright & Miller § 4451).
`In discussing the issue of whether a party is a real party in interest for
`purposes of an inter partes review, the Trial Practice Guide cites Gonzalez v.
`Banco Cent. Corp., 27 F.3d 751 (1st Cir. 1994). Trial Practice Guide,
`77 Fed. Reg. at 48,759. As explained in Gonzalez, “the concept of
`substantial control can be illustrated better by examples than by linguistic
`constructs.” Gonzalez, 27 F.3d at 759; see also Daifuku Co. v. Murata
`Machinery, Ltd., Case IPR2015-01538, slip op. at 11 (PTAB Jan. 19, 2016)
`(Paper 11) (“Theoretical, hypothetical, or speculative assertions about
`effective control, unsupported by evidence, are neither probative nor
`persuasive.”); Reply 4. For instance, substantial control has been found
`where a liability insurer assumes the insured’s defense; where an indemnitor
`participates in defending an action brought against the indemnitee; and
`where the owner of a close corporation assumes control of litigation brought
`
`
`5 For example, “an attorney-in-fact or an agent solely for the purpose of
`bringing suit is viewed as a nominal rather than a real party in interest and
`will be required to litigate in the name of the principal rather than the agent’s
`own name.” AIT, 897 F.3d at 1349 (citing Wright & Miller § 1553). As
`another example, “if Trade Association X files an IPR petition, Party A does
`not become a ‘real party-in-interest’ or a ‘privy’ of the Association simply
`based on its membership in the Association.” Trial Practice Guide at
`48,760. However, Party A’s membership in Trade Association X may still
`be relevant to determining whether Party A is an RPI. Id.
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
`
`against the firm. Gonzelez, 27 F.3d at 759 (citations omitted); Daifuku, slip
`op. at 11–12. Conversely, courts have refused to find substantial control
`merely because a nonparty retained the attorney who represented a party to
`the earlier action; the nonparty assisted in financing the earlier action; the
`nonparty testified as a witness in the earlier action; the nonparty procured
`witnesses or evidence; or the nonparty furnished its attorney’s assistance.
`Gonzelez, 27 F.3d at 759 (citations omitted); Daifuku, slip op. at 12.
`Patent Owner points to Sumitomo’s “strategic alliance” with Sawai
`corporate entities and minority ownership-stake in Upsher-Smith as
`evidence that Sumitomo and SCOA should have been named as RPIs. See
`Prelim. Resp. 13. While this relationship may have important business
`significance to Sumitomo (and may be sufficient to make Sumitomo a privy
`of Petitioner6), we are not persuaded that such a relationship establishes
`either Sumitomo or SCOA as an RPI. The evidence presented merely
`establishes a minority ownership-stake in Upsher-Smith and a small
`Sumitomo presence on the Upshur-Smith Board, which by itself, is not
`sufficient to establish that either Sumitomo or SCOA exercises control of
`this proceeding or otherwise “desires review” of the patent. “[M]erely
`
`6 “Privity is a well-recognized common law concept that is primarily based
`on the legal relationship between parties.” AIT, 897 F.3d at 1359 (Reyna, J.,
`concurring). We need not resolve the issue of whether Sumitomo a privy of
`Petitioner, because Patent Owner does not allege that a privity relationship
`bars this proceeding. See 35 U.S.C. § 315(b) (“An inter partes review may
`not be instituted if the petition requesting the proceeding is filed more than 1
`year after the date on which the petitioner, real party in interest, or privy of
`the petitioner is served with a complaint alleging infringement of the
`patent.” Further, any possible time-bar under § 315(b) “shall not apply to a
`request for joinder under subsection (c)” (35 U.S.C. § 315(b)), as is the case
`here.
`
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`IPR2019-00789
`Patent No. 8,399,514 B2
`
`having a pre-existing, established relationship with Petitioner does not make
`a party an RPI, even if the party may enjoy certain benefits from a favorable
`result in the proceeding, because it invests in Petitioner and has members on
`Petitioner’s Board.” Bowtech, Inc., v. MCP IP, LLC, Case IPR2019-00379,
`slip op. at 25 (PTAB July 3, 2019) (Paper 14) (internal citations omitted). In
`other words, “to be an RPI, a party must be more than merely one ‘who will
`benefit’ from a favorable result in an inter partes review.” Id. (citing AIT,
`897 F.3d at 1348).
`By way of comparison, the facts herein are substantively
`distinguishable from those in Galderma S.A. v. Allergan Industrie, SAS,
`Case IPR2014-01422 (PTAB Mar. 5, 2015) (Paper 14) (quoting Gonzalez,
`27 F.3d at 759), where the Board determined that the Petition did not
`identify each real party-in-interest. In Galderama, the Board found a parent
`company to be an RPI where the same person was President and CEO of
`both companies and there was a “pattern of control” by the parent over the
`subsidiary. Galderma, slip op. at 12–13. The evidence on this record does
`not demonstrate similar effective, de facto control by either Sumitomo or
`SCOA over Petitioner.
`In view of the above, on the present record, we determine that
`Sumitomo or SCOA are not RPIs in this proceeding. We therefore decline
`to deny institution for Petitioner’s alleged failure to identify either
`Sumitomo or SCOA as RPIs.
`
`D. Conclusion
`For the reasons discussed, we determine that the Petition warrants
`institution under 35 U.S.C. § 314.
`
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`IPR2019-00789
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`III. MOTION FOR JOINDER
`As noted above, Petitioner requests that we join the present
`proceeding with IPR2018-01403. Mot. 1. Joinder is governed by 35 U.S.C.
`§ 315(c), which recites:
`
`(c) JOINDER. —If the Director institutes an inter partes review,
`the Director, in his or her discretion, may join as a party to that
`inter partes review any person who properly files a petition under
`section 311 that the Director, after receiving a preliminary
`response under section 313 or the expiration of the time for filing
`such a response, determines warrants the institution of an inter
`partes review under section 314.
`When determining whether to grant a motion for joinder, we consider factors
`such as timing and impact of joinder on the trial schedule, cost, discovery,
`and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC,
`Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013) (Paper 15).
`As noted in Section II.A. above, the Petition asserts the same
`unpatentability grounds on which we instituted review in the Mylan IPR.
`Mot. 1; Prelim. Resp. 1