`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________
`
`MYLAN PHARMACEUTICALS INC.,
`TEVA PHARMACEUTICALS USA, INC. and AKORN INC.,1
`Petitioners,
`
`v .
`
`ST. REGIS MOHAWK TRIBE and ALLERGAN, INC.,
`Patent Owners.
`
`___________________________
`
`Case IPR2016-01127 (US 8,685,930 B2) Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2) Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2) Case IPR2016-01132 (US 9,248,191 B2)
`___________________________
`
`
`PETITIONERS’ OPPOSITION TO MOTION TO STAY
`
`
`1Cases 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. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10). Paper numbers and exhibits cited in this
`Opposition refer to those documents filed in IPR2016-01127.
`
`
`
`
`
`
`
`I.
`
`Precise Statement of Relief
`
`Movants claim their “Combined Notice of Appeal” (Paper 133) has
`
`“divested” the Board’s jurisdiction to complete these proceedings and issue final
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`written decisions (“FWDs”). They claim in the alternative to be equitably entitled to
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`a stay pending resolution of their appeal. Movants fail on both counts.
`
`The timing of movants’ latest filing (two days before the Board’s deadline
`
`for submitting hearing conflicts) is reminiscent of the timing of their agreement
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`“transferring” the patents from Allergan to the Tribe last year. That earlier
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`maneuver occurred just one week before the original hearing date, long after the
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`case had been “allowed to proceed to trial” (Paper 134), and well after the close of
`
`evidence. Movants repeatedly admitted (even boasted) that the purpose of their
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`agreement was to prevent the Board from issuing FWDs. Movants’ appeal is just
`
`another exercise in manipulation and delay. The Board should deny the motion
`
`based on the determinations it has already made in its decisions on the motions to
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`terminate and withdraw.
`
`II. The Board Has Discretion to Continue
`
`Congress restricted the right to appeal from IPR proceedings to parties
`
`“dissatisfied with the final written decision” of the Board. 35 U.S.C. § 141(c)
`
`(emphasis added); see also § 314(d) (no appeal from institution decisions). The
`
`collateral order doctrine allows for an appeal before a final judgment is entered for
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`- 1 -
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`
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`
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`a “small class” of issues that are separable from the underlying action and
`
`effectively unreviewable after the final decision. See Mitchell v. Forsyth, 472 U.S.
`
`511, 524 (1985); Amgen Inc. v. Hospira, Inc., 866 F.3d 1355, 1358-59 (Fed. Cir.
`
`2017).
`
`While Forsyth-type collateral order appeals are available under some
`
`circumstances, the mere filing of such an appeal does not automatically divest the
`
`trial tribunal of jurisdiction. Movants’ own cases emphasize that tribunals “are not
`
`helpless in the face of manipulation” and may proceed when the appeal is a “sham,”
`
`“frivolous,” “waive[d] or forfeit[ed],” or used “in a manipulative fashion.” Apostol
`
`v. Gallion, 870 F.2d 1335, 1338-39 (7th Cir. 1989); see also Rivera-Torres v. Ortiz
`
`Velez, 341 F.3d 86, 94-96 (1st Cir. 2003) (jurisdiction not lost where collateral
`
`order appeal constitutes a transparently frivolous attempt to impede the progress of
`
`the case). Courts need only explain why they are proceeding. Bancpass, Inc. v.
`
`Highway Toll Admin., LLC, 863 F.3d 391, 399 (5th Cir. 2017) (“[a]ll circuits to
`
`reach the issue have uniformly…recognize[ed] similar procedures whereby [lower
`
`tribunals] may retain jurisdiction despite the filing of an interlocutory appeal”);
`
`Rivera-Torres, 341 F.3d at 94-96; 15A C. Wright et al., Federal Practice & Proc.
`
`Juris. § 3914.10 n. 71 (2d ed.) (collecting additional authorities). EX1169.
`
`A. Allergan’s Collateral Order Appeal Is Frivolous
`
`Allergan claims it is entitled to an immediate appeal “via the Collateral Order
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`- 2 -
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`
`
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`Doctrine, which applies to agency adjudications rejecting sovereign immunity
`
`claims.” Appeal notice at 3. But Allergan is not a sovereign and has no colorable
`
`claim to sovereign immunity. The other issues identified by Allergan in the notice
`
`of appeal—i.e., the Board’s findings regarding patent ownership and denial of
`
`Allergan’s motion to withdraw, id. at 6—do not fall into any recognized exception
`
`to normal finality rules, let alone “divest” jurisdiction. See 15B C. Wright et al.,
`
`Federal Practice & Proc. Juris. § 3914.18 (2d ed.) (collecting cases holding that
`
`decisions on joinder and substitution are ineligible for collateral order review).
`
`EX1170. Indeed, the motion never explains how Allergan’s appeal could
`
`independently qualify for collateral order review. Paper 134 at 3-7. Allergan’s
`
`appeal is frivolous and does not affect the Board’s ability to proceed.
`
`B. The Tribe’s Appeal Does Not Divest the Board’s Jurisdiction
`
`This appeal is just the latest example of the movants misusing tribal
`
`sovereign immunity as if it were a “monetizable commodity that can be purchased
`
`by private entities as part of a scheme to evade their legal responsibilities.”
`
`Allergan, Inc. v. Teva Pharm. USA, Inc., (E.D. Tex. Oct. 16, 2017). EX1163 at 5.
`
`Movants forfeited any claim to collateral order review through their ongoing
`
`“sham,” “dilatory,” and “manipulative” immunity claims. See pp. 1-2, supra; Paper
`
`86 at 1-2, 10-13; Paper 125 at 1-2.
`
`The Board has already determined that it can proceed without any patent
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`
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`owner. Paper 130, 16-18. The Board determined that an IPR is not a private “suit”
`
`for tribal immunity purposes but rather a federal agency’s reconsideration of its
`
`own prior decision. Paper 130, 11-18. Appeal of these determinations is premature
`
`and does not divest the Board’s jurisdiction.
`
`Movants’ procedural manipulations aside, the Board has also determined that
`
`the Tribe is not an indispensable party and that Allergan can sufficiently represent
`
`patent owner interests. Paper 130 at 35-40. The collateral order doctrine does not
`
`apply to decisions to proceed without an allegedly indispensable party, since such
`
`decisions “may be effectively reviewed after final judgment.” Crowe & Dunlevy,
`
`P.C. v. Stidham, 640 F.3d 1140, 1148 (10th Cir. 2011); see also Alto v. Black, 738
`
`F.3d 1111, 1130 (9th Cir. 2013); MasterCard Int'l Inc. v. Visa Int'l Serv. Assoc.,
`
`471 F.3d 377, 383-84 (2d Cir. 2006) (denial of motion to dismiss for lack of
`
`indispensable party “does not fit within the exception created by the collateral order
`
`doctrine”). Appeal of these determinations is thus premature—if the Federal Circuit
`
`determines the Board cannot reconsider the patents without the Tribe’s
`
`acquiescence, then the Tribe will have lost nothing because the claims will not be
`
`cancelled.
`
`Not one of the many decisions cited by Movants holds that a collateral order
`
`appeal by one party divests the tribunal of jurisdiction over all other parties and all
`
`other issues. To the contrary, one of movants’ cases (Paper 134 at 4) acknowledges
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`
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`that a collateral order appeal by some defendants does not stop the tribunal from
`
`continuing if the case “sensibly can proceed without” the absent parties. Bradford-
`
`Scott Data Corp. v. Physician Computer Network, Inc., 128 F.3d 504, 506-07 (7th
`
`Cir. 1997). That is precisely what the Board has concluded here, a conclusion that
`
`can be reviewed on appeal from the Board’s FWDs.
`
`Movants also argue that the “ownership” issue is immediately appealable as a
`
`“pend[e]nt appellate claim” since it is “inextricably intertwined” with the immunity
`
`claim. Paper 134 at 6. This argument fundamentally misapprehends pendent
`
`jurisdiction, which “allows an appellate court, in its discretion, to exercise
`
`jurisdiction over issues that are not independently appealable” if “inextricably
`
`intertwined” with an immediately appealable issue. Bates v. Dura Auto Sys., Inc.,
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`625 F.3d 283, 286-87 (6th Cir. 2010) (emphasis added). As shown by movants’
`
`own cases, “the ‘inextricably intertwined’ requirement is not meant to be loosely
`
`applied as a matter of discretion” and “is satisfied only if the resolution of the
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`properly appealable issue ‘necessarily and unavoidably’ decides the non-appealable
`
`issue.” Turi v. Main St. Adoption Servs., 633 F.3d 496, 502 (6th Cir. 2011) (internal
`
`quotation omitted); see also Poulos v. Caesars World, Inc., 379 F.3d 654, 669 (9th
`
`Cir. 2004) (issues involving different legal standards not “inextricably
`
`intertwined”). That is plainly not the case here. The Federal Circuit can evaluate a
`
`ruling that tribal immunity does not apply in IPR proceedings separate and apart
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`- 5 -
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`
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`from patent ownership questions, which turn on distinct legal standards and factual
`
`considerations. In any event, the Board does not somehow lose jurisdiction here
`
`simply because the Federal Circuit might in its discretion decide to consider the
`
`ownership issue. Courtright v. City of Battle Creek, 2015 WL 13173470, at *3
`
`(W.D. Mich. Aug. 20, 2015) (notice of appeal requesting exercise of pendent
`
`jurisdiction does not divest lower tribunal jurisdiction over pendent issue).
`
`Movants further insist that an immediate appeal is necessary because the
`
`Board has allegedly exceeded the scope of its authority and violated its precedents.
`
`See Paper 134 at 6-7, 9-10. But, such challenges do not qualify for interlocutory
`
`review and can await appeal of the FWDs. See, e.g., Wi-fi One, LLC v. Broadcom
`
`Corp., 878 F.3d 1364, 1370-71 (Fed. Cir. 2018) (en banc); Versata Dev. Grp., Inc.
`
`v. SAP Am., Inc., 793 F.3d 1306, 1310 (Fed. Cir. 2015); Benefit Funding Sys. v.
`
`Advance Am. Cash Advance Ctrs. Inc., 767 F.3d 1383, 1386 (Fed. Cir. 2014).
`
`III. The Board Should Not Stay Its Decision on the Merits
`
`In exercising its discretion whether to stay pending appeal, the Board must
`
`“assess[] the movant[s’] chances of success on the merits and weigh[] the equities
`
`as they affect the parties and the public.” E.I. DuPont de Nemours & Co. v. Phillips
`
`Petroleum Co., 835 F.2d 277, 278 (Fed. Cir. 1987). Petitioners have already
`
`demonstrated why the movants are unlikely to succeed since they are not entitled to
`
`immediate appeal under the collateral order doctrine and, regardless, fail on the
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`
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`merits. The weight of the equities is also overwhelmingly against movants.
`
`To begin, the Tribe “has no legitimate interest in selling an opportunity to
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`evade [the] law” to a non-Indian company like Allergan, Otoe-Missouria Tribe v.
`
`NY DFS, 769 F.3d 105, 114, 116 (2d Cir. 2014), and Allergan has no legitimate
`
`interest in misappropriating tribal sovereign immunity to circumvent the law and
`
`“reap a windfall at the public’s expense.” Barona Band of Mission Indians v. Yee,
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`528 F.3d 1184, 1187, 1190 (9th Cir. 2008). Movants identify no harm to Allergan
`
`from having to wait to appeal until the FWDs, and only two potential harms to the
`
`Tribe: the “final hearing” and the Board’s eventual “ruling” itself. Paper 134 at 3.
`
`Neither is a cognizable injury to the Tribe, “irreparable” or otherwise.
`
`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 FWDs 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 EX2087, §5.3 (“Allergan
`
`shall retain control of the defense….”)). Moreover, the Tribe is not “compelled” to
`
`participate, merely permitted to if it desires. Mylan even expressed a willingness to
`
`revisit its request for oral argument and proceed immediately to FWDs if movants
`
`agree not to participate as well. EX1168 at 27:24-28:6. The Tribe is not harmed by
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`- 7 -
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`
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`a Board hearing that the Tribe need not attend, the outcome of which does not
`
`depend on its participation, and in which its participation is possible only by
`
`Allergan’s consent.
`
`The FWDs 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 FWDs, 35 U.S.C. § 318(b), and Allergan’s contractual payments
`
`continue “until all claims of the Licensed Patents are rendered invalid in a non-
`
`appealable final judgment.” EX2087 § 9.1.1. Movants thus face no cognizable harm
`
`from the Board’s issuance of the FWDs.
`
`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. Movants’ scheme is designed to extend Allergan’s
`
`monopoly pricing by injecting a full appeal and the Supreme Court certiorari
`
`process before the Board can even issue its FWDs, which in turn will no doubt
`
`engender another round of appellate review.
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`- 8 -
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`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.
`
`Movants attempt to trivialize the public interest in timely issuance of FWDs
`
`by mischaracterizing the relevant statutes, regulations, and case law. Incredibly,
`
`they insist that missing the deadline “would not run afoul of any statutory or
`
`regulatory requirement.” Paper 134 at 8. Similarly, movants claim Brock v. Pierce
`
`County, 476 U.S. 253 (1986), holds that statutes are not mandatory if they do not
`
`list explicit penalties for missing a deadline. To the contrary, Brock recognizes that
`
`such deadlines are enforceable at least by actions under 5 U.S.C. § 706(1). 476 U.S.
`
`at 260 n.7; see also H.R. REP. 112-98, 47 (2011) (IPRs “must be completed” by
`
`statutory deadline). EX1171. Furthermore, failure to heed statutory and regulatory
`
`requirements also invites supervisory and institutional consequences as well as
`
`Congressional oversight.
`
`Movants motion to stay poses a greater harm than just running afoul of the
`
`- 9 -
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`
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`statutory deadlines. Validating movants’ strategic, unfounded interlocutory appeal
`
`with a stay that further delays resolution of this proceeding would invite others to
`
`recreate the same tactics in future Board proceedings, undermining not just this
`
`proceeding but IPRs as a whole. IPRs would be rendered toothless if patent owners
`
`could unilaterally derail and delay proceedings via sham assignments and
`
`procedural gimmicks whenever a patent seemed to be at risk. Judge Bryson recently
`
`underscored the grave risks that movants’ tactics pose to IPRs and the AIA:
`
`If that ploy succeeds, any patentee facing IPR proceedings would
`
`presumably be able to defeat those proceedings by employing the same
`
`artifice. In short, Allergan’s tactic, if successful, could spell the end of
`
`the PTO’s IPR program, which was a central component of the
`
`America Invents Act of 2011.
`
`EX1163 at 4. There can be no doubt that rewarding movants’ manipulative tactics
`
`and misappropriation of tribal sovereign immunity would significantly undermine
`
`the integrity of IPRs and the AIA.
`
`IV. Conclusion
`
`Petitioners respectfully request that the Board deny the motion to stay.
`
`
`
`Dated: March 14, 2018
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
`Steven W. Parmelee
`Reg. No. 31,990
`
`
`
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`- 10 -
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`
`
`Exhibit
`No.
`
`1001
`
`LIST OF EXHIBITS
`
`
`Description
`
`The Patent (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 – IPR2016-01132, respectively)
`
`1002
`
`Declaration of Dr. Mansoor Amiji
`
`1003
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`1004
`
`1005
`
`File History (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 –01132, respectively)
`
`File history of U.S. Patent Application No. 10/927,857, filed on
`August 27, 2010 to Acheampong et al.
`
`1006
`
`U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994
`
`1007
`
`1008
`
`Sall, K., et al., Two Multicenter, Randomized Studies of the
`Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in
`Moderate to Severe Dry Eye Disease, 107 OPHTHALMOL. 631
`(2000)
`
`Acheampong, A., et al., Cyclosporine distribution into the
`conjunctiva, cornea, lacrimal gland, and systemic blood
`following topical dosing of cyclosporine to rabbit, dog, and
`human eyes, 2 LACRIMAL GLAND, TEAR FILM, AND DRY EYE
`SYNDROMES 1001 (1998)
`
`1009
`
`U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`
`1010
`
`U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998
`
`1011
`
`Kaswan, R., Intraocular Penetration of Topically Applied
`Cyclosporine 20 TRANSPL. PROC. 650 (1988)
`
`11
`
`
`
`
`
`1012
`
`Kunert, K., et al., Analysis of Topical Cyclosporine Treatment of
`Patients with Dry Eye Syndrome 118 ARCH OPHTHALMOL 1489
`(2000)
`
`1013
`
`Physicians’ Desk Reference for Ophthalmic Medicines (1999)
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`Turner, K., et al., Interleukin-6 Levels in the Conjunctival
`Epithelium of Patients with Dry Eye Disease Treated with
`Cyclosporine Ophthalmic Emulsion 19 CORNEA 492 (2000)
`
`Stevenson, D., et al. Efficacy and Safety of Cyclosporin A
`Ophthalmic Emulsion in the Treatment of Moderate-to-Severe
`Dry Eye Disease 107 OPHTHALMOL. 967 (2000)
`
`Remington’s 20th Edition: The Science and Practice of Pharmacy
`(A. Gennaro ed. 2003)
`
`Goto, E., et al. Low-Concentration Homogenized Castor Oil Eye
`Drops for Noninflamed Obstructive Meibomian Gland
`Dysfunction 109 OPHTHALMOL. 2030 (2002)
`
`Kanpolat, A., et al., Penetration of Cyclosporin A into the Rabbit
`Cornea and Aqueous Humor after Topical Drop and Collagen
`Shield Administration 20 CLAO J. 119 (1994)
`
`Vieira, A., et al., Effect of ricinoleic acid in acute and subchronic
`experimental models of inflammation, 9 MED. INFLAMM. 223
`(2000)
`
`Murphy, R., The Once and Future Treatment of Dry Eye, REVIEW
`OF OPTOMETRY 1 (2000)
`
`Small, D., et al., Blood concentrations of Cyclosporin A During
`Long-Term Treatment with Cyclosporin A Ophthalmic
`Emulsions in Patients with Moderate to Severe Dry Eye Disease
`18 J. OC. PHARM. THERAP. 411 (2002)
`
`1022
`
`Stedman’s Medical Dictionary 27th Edition (M.B. Pugh ed. 2000)
`
`12
`
`
`
`
`
`1023
`
`1024
`
`1025
`
`(IPR2016-
`01127)
`
`1025
`
`(IPR2016-
`01132)
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., and Mylan Inc., No.
`2:15-cv-01455
`
`Approved Drug Products with Therapeutic Equivalence
`Evaluations (34th Ed.) (2014) (Excerpts)
`
`File history of U.S. Patent No. 8,629,111 to Acheampong et al.
`(Exhibit Number Reserved in IPR2016-01128, -01129, -01130,
`& -01131)
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., No. 2:15-cv-01455
`(Exhibit Number Reserved in IPR2016-01128, -01129, -01130,
`& -01131)
`
`1026
`
`Reserved
`
`Allergan Department of Pharmacokinetics and Drug Metabolism
`Departmental Research Report, Report No: PK-00-163,
`Concentrations of Cyclosporin A in Cornea and Conjunctiva
`After a Single Ophthalmic Dose to New Zealand White Rabbits:
`Evaluation of 7 Ophthalmic Emulsion Formulations
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7626
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-1998-5709
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-1998-5707
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7726
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Orange Book 29th Edition (2009) (excerpts)
`
`1033 Mayssa Attar Professional Linkedin Profile
`
`13
`
`
`
`
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1038
`
`1039
`
`1040
`
`1041
`
`PROTECTIVE ORDER MATERIAL - Transcript of May 31, 2017
`Deposition of Robert S. Maness, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 1, 2017
`Deposition of Rhett Schiffman, M.D., M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 7, 2017
`Deposition of Thorsteinn Loftsson, Ph.D.
`
`Transcript of June 20, 2017 Deposition of John D. Sheppard, M.D.,
`M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 22, 2017
`Deposition of Mayssa Attar, Ph.D.
`
`REDACTED - Transcript of June 22, 2017 Deposition of Mayssa
`Attar, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Andrew F.
`Calman, M.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Daniel A.
`Bloch, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Ivan T.
`Hofmann
`
`1042
`
`Curriculum Vitae of Andrew F. Calman, M.D.
`
`1043
`
`Curriculum Vitae of Daniel A. Bloch, Ph.D.
`
`1044
`
`Curriculum Vitae of Ivan T. Hofmann
`
`1045
`
`1046
`
`Facts About Dry Eye, NATIONAL EYE INSTITUTE OFFICE OF SCIENCE
`COMMUNICATIONS, PUBLIC LIAISON, AND EDUCATION, 2013,
`https://nei.nih.gov/health/dryeye/dryeye (accessed June 26,
`2017)
`
`Niederkorn, et al., Desiccating Stress Induces T Cell-Mediated
`Sjögren’s Syndrome-Like Lacrimal Keratoconjunctivitis, 176 J.
`IMMUNOL. 3950 (2006)
`
`14
`
`
`
`
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern,
`AMERICAN ACADEMY OF OPHTHALMOLOGY (2013)
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern Limited
`Revision, AMERICAN ACADEMY OF OPHTHALMOLOGY (2011)
`
`A real tear-jerker: Team creates device to alleviate dry eye,
`STANFORD MEDICINE NEWS CENTER,
`https://med.stanford.edu/news/all-news/2015/01/a- real-tear-
`jerker-team-creates-device-to-alleviate-dry-eye.html (accessed
`June 26, 2017)
`
`Allergan Granted Marketing Authorization by the FDA for
`TrueTearTM, the First Intranasal Neurostimulating Device
`Proven to Temporarily Increase Tear Production,
`https://www.allergan.com/News/News/Thomson-
`Reuters/Allergan-Granted-Marketing-Authorization-by-the-FD
`(accessed June 26, 2017)
`
`Dalton, M., Novel neurostimulator device uses nasal cavities to
`stimulate tears, OPHTHALMOLOGY TIMES,
`http://ophthalmologytimes.modernmedicine.com/ophthalmology
`times/news/novel- neurostimulator-device-uses-nasal-cavities-
`stimulate-tears?page=0,1 (accessed June 26, 2017)
`
`Marsh, P. and Pflugfelder S., Topical Nonpreserved
`Methylprednisolone Therapy for Keratoconjunctivitis Sicca in
`Sjörgen Syndrome, 106 OPHTHALMOL. 811 (1999)
`
`PubMed Abstract: Sainz de la Maza Serra, et al., Nonpreserved
`Topical Steroids and Punctal Occlusion for Severe
`Keratoconjunctivitis Sicca, 10 ARCH. SOC. ESP. OFTALMOL. 751
`(2000)
`
`Eadie, S., et al., Kerato-Conjunctivitis Sicca Treated With
`Cortisone and ACTH, 39 BRIT. J. OPHTHAL. 90 (1955)
`
`Gaulhofer, W. K., The Effect of Cortisone on Sjögren’s Syndrome,
`CXLIX, ACTA MEDICA SCANDINAVICA (1954)
`
`15
`
`
`
`
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`Rolando, M., et al., Topical Non-Preserved Diclofenac Therapy for
`Keratoconjunctivitis Sicca, 506 ADV. EXP. MED. BIO.
`(LACRIMAL GLAND, TEAR FILM & DRY EYE SYNDROMES 3) 1237
`(2002)
`
`Glenn, C., New Thinking Spurs New Products, 1 REV.
`OPHTHALMOL. (FEB. 2003)
`
`Oellerich, et al., Lake Louise Consensus Conference on
`Cyclosporin Monitoring in Organ Transplantation: Report of
`the Consensus Panel, 17 THER. DRUG MONIT. 642 (1995)
`
`Foulks, G.N., et al., 2007 Report of the International Dry Eye
`Workshop (DEWS) 5 OCULAR SURF. 65 (2007)
`
`Avunduk, et al., The Comparison of Efficacies of Topical
`Corticosteroids and Nonsteroidal Anti-inflammatory Drops on
`Dry Eye Patients: A Clinical and Immunocytochemical Study,
`136 AM. J. OPHTHAL.593 (2003)
`
`Lamberts, D.W., Clinical Diseases of the Tear Film, THE CORNEA,
`3rd Ed., (eds. Smolin & Thoft (1994))
`
`Akpek, et al., Ocular Rosacea: Patient Characteristics and Follow-
`up, 104 OPHTHALMOL. 1863 (1997)
`
`1063
`
`Allergan Form 10-K for the year ended December 31, 2015
`
`1064
`
`FDA Approved Drug Products, New Drug Application No. 050790,
`DRUGS@FDA, https://www.accessdata.fda.gov/scripts/cder/daf
`/index.cfm?event=overview.process&ApplNo=050790
`(accessed June 20, 2017)
`
`1065
`
`Allergan Form 10-K for the year ended December 31, 2009
`
`16
`
`
`
`
`
`1066
`
`Allergan Introduces RESTASIS MULTIDOSE (Cyclosporine
`Ophthalmic Emulsion) 0.05 %, a New Delivery System for the
`One and Only FDA Approved Treatment to Help Patients
`Produce More of Their Own Tears, CISION PR NEWSWIRE,
`http://www.prnewswire.com/news-releases/allergan-introduces-
`restasis-multidose-cyclosporine-ophthalmic-emulsion-005-a-
`new-delivery-system-for-the-one-and-only-fda-approved-
`treatment-to-help-patients-produce-more-of-their-own-tears-
`300353429.html# (accessed June 20, 2017)
`
`1067
`
`FDA Label for Restasis MultiDose™
`
`1068
`
`Allergan Form 10-K for the year ended December 31, 1993
`
`1069
`
`1070
`
`1071
`
`Patent and Exclusivity for: N050790, ORANGE BOOK,
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm
`?Product_No=001&Appl_No=050790&Appl_type=N (accessed
`June 21, 2017)
`
`Kymionis, G.D., et al., Treatment of chronic dry eye: focus on
`cyclosporine, 2 CLIN. OPTHALMOL., 829 (2008)
`
`Chronic Dry Eye Disease, https://www.restasis.com/What-Is-
`Chronic-Dry-Eye-Disease (accessed June 21, 2017)
`
`1072
`
`Allergan Form 10-K for the year ended December 31, 2002
`
`1073
`
`1074
`
`Keratoconjunctivitis Sicca, MERCK MANUAL,
`http://www.merckmanuals.com/home/eye-disorders/corneal-
`disorders/keratoconjunctivitis-sicca (accessed June 21, 2017)
`
`Abelson and Smith, A Stepwise Approach to Acute Dry Eye,
`REVIEW OF OPHTHALMOLOGY,
`https://www.reviewofophthalmology.com/article/a-stepwise-
`approach-to-acute-dry-eye (accessed June 22, 2017)
`
`1075
`
`Javadi and Feizi, Dry Eye Syndrome, 6 J. OPHTHALMIC VIS. RES.
`192 (2011)
`
`1076
`
`Xiidra, https://www.xiidra.com/ (accessed June 22, 2017)
`
`17
`
`
`
`
`
`1077
`
`1078
`
`1079
`
`1080
`
`1081
`
`1082
`
`1083
`
`FDA approves new medication for dry eye disease, FDA NEWS
`RELEASE,
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnounceme
`nts/ucm510720.htm (accessed June 22, 2017)
`
`Bailey, G., Shire gets FDA nod for Xiidra (lifitegrast) for dry eye,
`OPTOMETRY TIMES OPTOMETRY ALCON,
`http://optometrytimes.modernmedicine.com/optometrytimes/ne
`ws/shire-gets-fda-nod-xiidra-lifitegrast-dry-eye (accessed June
`22, 2017)
`
`Dry eyes, MAYO CLINIC, http://www.mayoclinic.org/diseases-
`conditions/dry-eyes/basics/treatment/con-20024129 (accessed
`June 22, 2017)
`
`Scleral Lenses, CONTACT LENS MANUFACTURERS ASSOCIATION,
`http://www.contactlenses.org/scleral.htm (accessed June 22,
`2017)
`
`Jedlicka, J., Scleral Contact Lenses, ALLABOUTVISION.COM,
`http://www.allaboutvision.com/contacts/scleral-lenses.htm
`(accessed June 22, 2017)
`
`Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364,
`1376-77 (Fed. Cir. 2005)
`
`New Patents Could Sustain Allergan Restasis Franchise Until
`2024, SEEKING ALPHA,
`http://seekingalpha.com/article/1945551-new-patents-could-
`sustain-allergan-restasis-franchise-until-2024 (accessed June 22,
`2017)
`
`1084
`
`FDA Label for Lacrisert®
`
`1085
`
`1086
`
`Stephenson, M., OTC Drops: Telling the Tears Apart, REV.
`OPHTHALMOL., https://www.reviewofophthalmology.com/
`article/otc-drops-telling-the-tears-apart (accessed June 20, 2017)
`
`Narayanan, S., Which Drop for Dry Eye?, REV. OPTOM., 2009,
`https://www.reviewofoptometry.com/article/which-drop-for-
`dry-eye (accessed June 20, 2017)
`
`18
`
`
`
`
`
`1087
`
`1088
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
`1095
`
`1096
`
`Schachet, J., The Golden Age of Dry Eye Management, REVIEW OF
`OPTOMETRY, 2008, https://www.reviewofoptometry.com/ce/the-
`golden-age-of-dry-eye-management (accessed June 20, 2017)
`
`Refresh Products, http://www.refreshbrand.com/Products (accessed
`June 23, 2017)
`
`Alrex (loteprednol etabonate ophthalmic suspension) 0.2%,
`BAUSCH + LOMB, http://www.bausch.com/ecp/our-products/rx-
`pharmaceuticals/rx-pharmaceuticals/alrex-loteprednol-
`etabonate-ophthalmic-suspension-02 (accessed June 23, 2017)
`
`Lotemax (loteprednol etabonate ophthalmic suspension) 0.5%,
`BAUSCH + LOMB, http://www.bausch.com/ecp/our-products/rx-
`pharmaceuticals/rx-pharmaceuticals/lotemax-ecp (accessed June
`23, 2017)
`
`Fluorometholone Suspension – Ophthalmic, MEDICINENET.COM,
`http://www.medicinenet.com/fluorometholone-
`ophthalmic_suspension/article.htm (accessed June 23, 2017)
`
`Rimexolone Suspension – Ophthalmic, MEDICINENET.COM,
`http://www.medicinenet.com/rimexolone-
`ophthalmic/article.htm (accessed June 23, 2017)
`
`Methylprednisolone (Oral Route), Mayo Clinic,
`http://www.mayoclinic.org/drugs-supplements/
`methylprednisolone-oral-route/description/drg-20075237
`(accessed June 23, 2017)
`
`Hessen, M. and Akpek, E., Dry Eye: an Inflammatory Ocular
`Disease, 9 J. OPHTHALMIC VIS. RES. 240 (2014)
`
`Dry Eye Syndrome, E MEDICINE HEALTH,
`http://www.emedicinehealth.com/dry_eye_syndrome-
`health/article_em.htm (accessed June 23, 2017)
`
`PubMed Abstract: Mrukwa-Kominek, et al., Effect of anti-
`inflammatory therapy on the treatment of dry eye syndrome, 109
`KLIN OCZNA 79 (2007)
`
`19
`
`
`
`
`
`1097
`
`1098
`
`1099
`
`Adler, R., Dry Eye Treatment: Getting Relief From Dry Eyes,
`ALLABOUTVISION.COM, http://www.allaboutvision.com/
`conditions/dryeye.htm (accessed June 23, 2017)
`
`Ramsey, L., How Allergan went from a tiny Los Angeles eye care
`company to the biggest takeover target of 2015, BUSINESS
`INSIDER, 2015, http://www.businessinsider.com/allergan-
`history-since-1948-founding-2015-11 (accessed June 22, 2017)
`
`Allergan Product Information,
`https://www.allerganoptometry.com/ Product-Information/
`(accessed June 23, 2017)
`
`1100
`
`Allergan Third Quarter 2016 Earnings Call Transcript
`
`1101
`
`Allergan Second Quarter 2016 Earnings Call Transcript
`
`1102
`
`Allergan Form 10-K for the year ended December 31, 2005
`
`1103
`
`Allergan Form 10-K for the year ended December 31, 2014
`
`1104
`
`Allergan Third Quarter 2015 Earnings Call Transcript
`
`1105
`
`Allergan Third Quarter 2013 Earnings Call Transcript
`
`1106
`
`Allergan Fourth Quarter 2007 Earnings Call Transcript
`
`1107
`
`Allergan First Quarter 2009 Earnings Call Transcript
`
`1108
`
`Allergan Third Quarter 2009 Earnings Call Transcript
`
`1109
`
`1110
`
`Weintraub, A., Allergan: Smoothing the Wrinkles,
`BLOOMBERG.COM, 2006,
`https://www.bloomberg.com/news/articles/2006-02-08/allergan-
`smoothing-the-wrinkles (accessed June 21, 2017)
`
`Restasis commercial among most memorable as of 2013, PMLIVE,
`http://www.pmlive.com/pharma_news/restasis_ad_among_most
`_memorable_of_2013_531999 (accessed June 21, 2017)
`
`20
`
`
`
`
`
`1111
`
`Actress Marisa Tomei Partners with Allergan to Raise Awareness
`of Chronis Dry Eye, CISION PR NEWSWIRE, 2016,
`http://www.prnewswire.com/news-releases/actress-marisa-
`tomei-partners-with-allergan-to-raise-awareness-of-chronic-dry-
`eye-300301221.html# (accessed on June 22, 2017)
`
`1112
`
`Allergan Form 10-K for the year ended December 31, 2011
`
`1113
`
`1114
`
`Bihari, M., Understanding Your Health Plan Drug Formulary,
`https://www.verywell.com/understanding-your-health-plan-
`drug-formulary-1738897 (accessed June 22, 2017)
`
`Copayment Tier Definitions, BLUE CROSS AND BLUE SHIELD OF
`NORTH CAROLINA, 2017,
`http://www.bcbsnc.com/content/services/ formulary/rxdef.htm
`(accessed June 22, 2017)
`
`1115
`
`Allergan Fourth Quarter 2015 Earnings Call Transcript
`
`1116
`
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