Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 134
`Entered: March 22, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., and AKORN INC.
`Petitioners,
`
`v.
`
`SAINT REGIS MOHAWK TRIBE and ALLERGAN, INC.,
`Patent Owners.
`____________
`
`Case IPR2016-01127 (8,685,930 B2); Case IPR2016-01128 (8,629,111 B2);
`Case IPR2016-01129 (8,642,556 B2); Case IPR2016-01130 (8,633,162 B2);
`Case IPR2016-01131 (8,648,048 B2); Case IPR2016-01132 (9,248,191 B2)1
`_______________
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PER CURIAM.
`
`
`
`
`ORDER
`Denying Patent Owners’ Motion Concerning Board’s Divested Jurisdiction
`or, in the Alternative, for a Stay Pending the Appeal
`37 C.F.R. § 42.5
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-
`00599, IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and
`IPR2017-00601, have respectively been joined with the captioned
`proceedings. This Order addresses issues that are the same in the identified
`cases. Paper numbers and exhibits cited in this Order refer to those
`documents filed in IPR2016-01127.
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`I.
`
`INTRODUCTION
`Pursuant to our authorization, Patent Owners Saint Regis Mohawk
`Tribe (“Tribe”) and Allergan, Inc. (“Allergan”) filed a “Joint Motion by
`[Patent Owners] Concerning Board’s Divested Jurisdiction or, in the
`Alternative, for a Stay Pending the Appeal.” Paper 134 (“Joint Motion” or
`“Joint Mot.”). Petitioners filed an opposition to Patent Owners’ Joint
`Motion. Paper 136 (“Opposition” or “Opp’n”).
`After considering the respective positions of the parties, and for the
`reasons discussed below, we determine that the collateral order doctrine does
`not apply to our findings regarding patent ownership and denial of
`Allergan’s motion to withdraw. Furthermore, for the reasons discussed
`below, we deny Patent Owners’ request for a stay.
`II. BACKGROUND
`On February 28, 2018, Allergan and the Tribe filed a combined notice
`of appeal to the United States Court of Appeals for the Federal Circuit.
`Paper 133 (“Combined Notice”). The Tribe appeals our Decision Denying
`the Tribe’s Motion to Terminate (Paper 130; “Decision”) and “any other
`orders factually intertwined with the Order denying the Tribe’s Motion to
`Dismiss.” Id. at 2. Allergan appeals our order denying Allergan’s Motion to
`Withdraw (Paper 126) and “any other orders factually intertwined with the
`Order denying Allergan’s Motion to Withdraw, including but not limited to
`the Orders appealed by the Tribe.” Id. As stated in the Combined Notice,
`Allergan anticipates that the issues on appeal may include the following:
`• Whether the Board erred in finding that Allergan obtained all
`substantial rights in the patents at issue in these Proceedings.
`
` 2
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`• Whether the Board erred in finding that Allergan “remains an
`effective ‘patent owner’ of the challenged patents in these
`proceedings” and erred in denying Allergan’s requests and
`motion to withdraw from the Proceedings.
`Combined Notice, 6.
`In its Joint Motion, Patent Owners argue that the Tribe is entitled to
`immediate appellate review under the collateral order doctrine of our
`Decision denying its assertion that tribal sovereign immunity should be
`applied to inter partes review. Joint Mot. 1–3. Patent Owners further argue
`that the Combined Notice divests the Board of jurisdiction in these
`proceedings. Id. at 3–6. In the alternative, Patent Owners request that we
`stay these proceedings pending the appeal. Id. at 7–10.
`In its Opposition, Petitioners assert “Movants forfeited any claim to
`collateral order review through their ongoing ‘sham,’ ‘dilatory,’ and
`‘manipulative’ immunity claims.” Opp’n 3. Moreover, Petitioners argue
`“the [Joint Motion] never explains how Allergan’s appeal could
`independently qualify for collateral order review.” Id. Petitioners further
`note, “the Board has [] determined that the Tribe is not an indispensable
`party and that Allergan can sufficiently represent patent owner interests.”
`Id. at 4. Addressing Patent Owners’ alternative request for a stay,
`Petitioners argue that a “stay would [] significantly undermine the public’s
`interest in the orderly conduct of these proceedings.” Id. at 9 (noting the
`strong public interest in securing just and speedy resolution of inter partes
`reviews (citing H.R. REP. 112-98, 45, 47 (2011) (stating inter partes review
`statutory deadline is an improvement over inter partes reexaminations that
`can last “several years”)).
`
` 3
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`III. ANALYSIS
`A. Application of the Collateral Order Doctrine
`We recognize the possibility that the Tribe may be entitled under the
`collateral order doctrine to immediate appellate review of our decision
`denying its assertion that tribal sovereign immunity applies to inter partes
`review. See Joint Mot. 1–3 (citing Osage Tribal Council ex rel. Osage Tribe
`of Indians v. U.S. Dep't of Labor, 187 F.3d 1174, 1179 (10th Cir. 1999)).
`Ultimately, that is a question for the Federal Circuit to decide. Given the
`facts of these cases, however, we are not persuaded that the interlocutory
`appeal of our Decision necessarily divests the Board of jurisdiction to
`continue to final written decision with Allergan, as Patent Owners assert.
`See id. at 3–7. We have previously determined that the Tribe is not an
`indispensable party and that Allergan is a true owner of the challenged
`patents in these proceedings. Decision 35–40; see also id. at 32–33
`(recognizing that the Tribe can only participate if permitted by Allergan
`(citing Ex. 2087 § 5.3 (“Allergan shall retain control of the defense . . . .”))).
`The issues raised in the Combined Notice by the Tribe concerning tribal
`immunity are collateral issues separate from the merits of these inter partes
`reviews. As set forth in our prior Decision Denying the Tribe’s Motion to
`Terminate, we have already determined that these proceedings sensibly can
`proceed without the Tribe. Id. at 35–39; Opp’n 7–8; see Bradford-Scott
`Data Corp. v. Physician Comput. Network, Inc., 128 F.3d 504, 506–07 (7th
`Cir. 1997) (acknowledging that a collateral order appeal by some parties
`does not stop the tribunal from continuing if the case “sensibly can proceed
`without” the absent parties).
`
` 4
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`We are not persuaded by Patent Owners that the issues raised by
`Allergan in the Combined Notice—that is, our findings regarding patent
`ownership and denial of Allergan’s motion to withdraw—fall into any
`recognized exception to normal finality rules. A collateral order amounts to
`an immediately appealable final decision if “the order ‘[1] conclusively
`determine[s] the disputed question, [2] resolve[s] an important issue
`completely separate from the merits of the action, and [3] [will] be
`effectively unreviewable on appeal from the final judgment.’” Johnson v.
`Jones, 515 U.S. 304, 310–11 (1995) (quoting Puerto Rico Aqueduct &
`Sewer Auth. V. Metcalf & Eddy, Inc., 506 U.S. 139, 144 (1993) (numbered
`brackets in original)). The requirement that the issue underlying the order be
`“‘effectively unreviewable’ . . . means that failure to review immediately
`may well cause significant harm.” Id. at 311 (citing 15A C. Wright, A.
`Miller, & E. Cooper, Federal Practice and Procedure § 3911, pp. 334–335
`(1992)).
`With regard to Allergan’s appeal, Patent Owners have not established
`that our findings regarding patent ownership and denial of Allergan’s motion
`to withdraw will cause immediate significant harm. Proceeding to final
`written decision in these proceedings can only affect the status of the
`challenged patent claims and, if we determine certain claims are
`unpatentable, no claims are cancelled until after any appellate review of our
`final written decisions. 35 U.S.C. § 318(b); cf. Mitchell v. Forsyth, 472 U.S.
`511, 525–26 (1985) (stating “the ‘consequences’ with which we were
`concerned . . . are not limited to liability for money damages; they also
`include ‘the general costs of subjecting officials to the risks of trial—
`
` 5
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`distraction of officials from their governmental duties, inhibition of
`discretionary action, and deterrence of able people from public service’”)
`(citation omitted). Accordingly, any unpatentability determination that may
`be rendered in our final written decision would not cause irreparable harm,
`because the status of each of the challenged patent claims remains
`unchanged until after any appellate review of our decisions.
`We consider also “the competing considerations underlying all
`questions of finality—‘the inconvenience and costs of piecemeal review on
`the one hand and the danger of denying justice by delay on the other.’”
`Johnson, 515 U.S. at 315 (quoting Eisen v. Carlisle & Jacquelin, 417 U.S.
`156, 171 (1974)). We further consider the comparative expertise of trial and
`appellate courts and the wise use of appellate resources. Johnson, 515 U.S.
`at 316–17. Specific to these proceedings, we consider that we are in the late
`stages of the trial, after the close of evidence, where oral argument, which
`the parties have affirmatively requested, is the only remaining task for the
`parties to perform. See 37 C.F.R. § 42.70 (“A party may request oral
`argument on an issue raised in a paper at a time set by the Board.”).
`Although an oral argument may allow each party to present its case to the
`panel, it is not a requirement for a “trial” in an inter partes review
`proceeding, as oral hearing is a right that can be waived. See 35 U.S.C.
`§ 316(a)(10); 37 C.F.R. § 42.70(a). Nor is it an opportunity for the parties to
`supplement the record with new evidence or arguments. As set forth in our
`order granting the parties’ request for oral argument, no new evidence or
`arguments may be presented at oral argument; rather, each party must rest its
`case on the arguments and evidence already of record. Paper 56; see also
`
` 6
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14,
`2012).
`Upon weighing the considerations summarized above, we are
`persuaded by Petitioners’ argument that the collateral order doctrine does
`not apply to our conclusions concerning Allergan’s ownership, because
`those findings “may be effectively reviewed after final judgment.” See
`Opp’n 4; Crowe & Dunlevy, P.C. v. Stidham, 640 F.3d 1140, 1148 (10th Cir.
`2011) (finding collateral order doctrine does not justify interlocutory review
`of determination regarding “required party” under Fed. R. Civ. P. 19); see
`also Alto v. Black, 738 F.3d 1111, 1130 (9th Cir. 2013) (same); MasterCard
`Int’l Inc. v. Visa Int’l Serv. Assoc., 471 F.3d 377, 383–84 (2d Cir. 2006)
`(finding interlocutory appeal of denial of motion to dismiss for lack of
`indispensable party “does not fit within the exception created by the
`collateral order doctrine”).
`Finally, we are unpersuaded by Patent Owners’ argument that the
`issue of ownership is a “pend[e]nt appellate claim” that is inextricably tied
`to the Tribe’s immunity assertion. Joint Mot. 6. Pendent appellate
`jurisdiction “allows an appellate court, in its discretion, to exercise
`jurisdiction over issues that are not independently appealable.” Bates v.
`Dura Auto. Sys., Inc., 625 F.3d 283, 286–87 (6th Cir. 2010) (emphasis
`added). Here, we note that the Federal Circuit has not yet decided to
`exercise jurisdiction over the issues identified by Allergan in the Combined
`Notice. As such, we are persuaded by Petitioners’ argument that “the Board
`does not somehow lose jurisdiction here simply because the Federal Circuit
`might in its discretion decide to consider the ownership issue.” Opp’n 6
`
` 7
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`(citing Courtright v. City of Battle Creek, No. 1:14-CV-1297, 2015 WL
`13173470, at *3 (W.D. Mich. Aug. 20, 2015) (holding notice of appeal
`requesting exercise of pendent jurisdiction does not divest lower tribunal
`jurisdiction over pendent issue). Because we do not find that our conclusion
`regarding Allegan’s ownership is a proper “appealable decision,” we do not
`find that the filing of the Combined Notice has divested the Board of
`jurisdiction to proceed to a final written decision. See In re Graves, 69 F.3d
`1147, 1150 (Fed. Cir. 1995) (stating the subject matter of an appeal is
`transferred to the Federal Circuit upon the filing of a notice of appeal from
`an appealable decision); Joint Mot. 4–5.
`
`B. Patent Owners’ Request for a Stay
`Patent Owners also move to stay these proceedings pending appellate
`review of the issues set forth in the Combined Notice. Joint Mot. 7–10.
`Patent Owners contend, inter alia, that our rules provide the Board with
`authority to suspend the current June 6, 2018, deadline set for final written
`decision and that “[t]he sovereign immunity issues in this case are precisely
`the type of ‘situation not specifically covered’ by the statutory scheme that
`warrants extraordinary relief under 37 C.F.R. § 42.5(a).” Id. at 8.
`Petitioners argue the following:
`The scheduled oral argument will not harm the Tribe
`because its participation is unnecessary and depends on
`Allergan’s authorization. The Board correctly concluded that the
`Tribe’s involvement is unnecessary as the [final written
`decisions] will “be the same regardless of whether Allergan or
`the Tribe continues to participate.” Paper 130 at 38-39. The
`Board also correctly recognized that the Tribe can only
`participate if permitted by Allergan. Id. at 32–33 (citing
`
` 8
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`retain control of
`
`the
`
`(“Allergan shall
`EX2087, §5.3
`defense….”)). . . .
`The [final written decisions] will not irreparably harm the
`Tribe in any way because it will be fully and immediately
`reviewable. No claims are cancelled until after any appellate
`review of the [final written decisions], 35 U.S.C. § 318(b), and
`Allergan’s contractual payments continue “until all claims of the
`Licensed Patents are rendered invalid in a nonappealable final
`judgment.” EX2087 § 9.1.1. Movants thus face no cognizable
`harm from the Board’s issuance of the [final written decisions].
`On the other hand, a stay would cause substantial harm to
`all other interested parties, to the public, and to the rule of law.
`Movants’ suggestion that Petitioners will not be harmed by delay
`because no generic product has yet received FDA approval
`ignores movants’ assertion that they intend to pursue their
`interlocutory appeal, “if necessary, [to] the Supreme Court.”
`EX1168 at 13:3–7, 14:12–16, 19:5–11. A stay could thus delay
`ultimate resolution for years, which would significantly impede
`Petitioners’ efforts to lower consumer costs by offering effective,
`lower cost alternatives to Restasis. . . .
`
`A stay would also significantly undermine the public’s
`interest in the orderly conduct of these proceedings. In addition
`to the statutory deadline of § 316(a)(11), various Board rules
`reflect the strong public interest in securing just and speedy
`resolution of IPRs. See 37 C.F.R. §§ 42.1(b), 42.5(c)(1).
`Congress viewed the statutory deadline as an important tool for
`ensuring IPRs serve the public interest in prompt review of
`issued patents. H.R. REP. 112-98, 45, 47 (2011) (IPR statutory
`deadline an improvement over inter partes reexaminations that
`can last “several years”). EX1171.
`Opp’n 7–9.
`After considering the respective positions of the parties, we agree with
`Petitioners that a stay delaying our decision on the merits until a resolution
`
` 9
`
`
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`of Patent Owners’ appeal is not warranted in these proceedings. Board rules
`“shall be construed to secure the just, speedy, and inexpensive resolution of
`every proceeding.” 37 C.F.R. § 42.1(b). As noted above, the issues raised
`in the Combined Notice by the Tribe concerning tribal immunity are
`collateral issues—separate from the merits of these inter partes reviews—
`and we sensibly can proceed without the Tribe to final written decision
`without risk of immediate significant harm to any party. Moreover, our June
`6, 2018, deadline by which to render final judgment already includes a 6-
`month extension of time over the one year deadline set forth in 35 U.S.C.
`§ 316(a)(11). Patent Owners direct us to no prior proceeding—joinder or
`otherwise—where we have extended our final determination in an inter
`partes review beyond 18 months. For the reasons stated above, we decline
`to be the first do so here.
`
`IV. ORDER
`Accordingly, based on the foregoing, it is:
`ORDERED that Patent Owners’ joint motion concerning the Board’s
`divested jurisdiction or, in the alternative, for a stay pending appeal is
`denied.
`
`
`10
`
`
`
`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`PETITIONER MYLAN:
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`PETITIONER TEVA:
`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURH,
`LINDQUIST & SCHUMAN, P.A.
`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`
`PETITIONER AKORN:
`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`SUGHRUE MION, PLLC
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
`
`PATENT OWNER:
`
`Dorothy P. Whelan
`Michael Kane
`Susan Coletti
`Robert Oakes
`FISH & RICHARDSON P.C.
`whelan@fr.com
`PTABInbound@fr.com
`coletti@fr.com
`oakes@fr.com
`
`
`
`
`11
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`

`

`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`Alfonso Chan
`Michael Shore
`Christopher Evans
`SHORE CHAN DEPUMPO LLP
`achan@shorechan.com
`mshore@shorechan.com
`cevans@shorechan.com
`
`Marsha Schmidt
`marsha@mkschmidtlaw.com
`
`
`
`
`
`12
`
`
`
`