throbber
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.1
`Patent Owners.
`
`
`
`
`Case IPR2016-01127 (U.S. Patent No. 8,685,930)
`Case IPR2016-01128 (U.S. Patent No. 8,629,111)
`Case IPR2016-01129 (U.S. Patent No. 8,642,556)
`Case IPR2016-01130 (U.S. Patent No. 8,633,162)
`Case IPR2106-01131 (U.S. Patent No. 8,648,048)
`Case IPR2016-01132 (U.S. Patent No. 9,248,191)2
`_____________
`
`PATENT OWNER’S SUPPLEMENTAL BRIEFING ON COLLATERAL
`ESTOPEL AUTHORIZED BY PAPER 142
`
`
`
` 1
`
` The caption used in this Notice of Appeal was intended only to comply with the
`Board’s Order that the “caption for these proceedings shall reflect both Allergan’s
`and the Tribe’s status as ‘Patent Owners.’” Saint Regis Mohawk Tribe is the Patent
`Owner. By using this caption, neither Saint Regis Mohawk Tribe nor Allergan
`concede that Allergan is a “Patent Owner.”
`2 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. have been joined with
`this proceeding. The identical brief is being filed in each proceeding in the caption.
`
`
`
`
`

`

`EXHIBIT LIST
`
`EX. 2002
`EX. 2003
`
`EX. 2004
`EX. 2005
`EX. 2006
`EX. 2007
`EX. 2008
`EX. 2009
`
`EX. 2010
`EX. 2011
`
`EX. 2012
`
`EX. 2013
`
`Exhibit No. Description
`EX. 2001
`NDA 21-023 Cyclosporine Ophthalmic Emulsion 0.05%, Original
`NDA Filing, Vol. 1 (Feb. 24, 1999)
`U.S. Pat. No. 4,839,342
`Said et al., Investigative Ophthalmology & Visual Science, vol. 48,
`No. 11 (Nov. 2007):5000-5006
`Alba et al., Folia Ophthalmol. Jpn. 40:902-908 (1989)
`Stedman’s Medical Dictionary, definition of therapeutic
`Dorland’s Illustrated Medical Dictionary, definition of therapeutic
`Stedman’s Medical Dictionary, definition of palliative
`RESTASIS® label
`Murphy, R., “The Once and Future Treatment of Dry Eye,” Review
`of Optometry, pp. 73-75 (Feb. 15, 2000)
`RESERVED
`Agarwal, Priyanka and Ilva D. Rupenthal, “Modern Approaches to
`the Ocular Delivery of Cyclosporine A,” Drug Discovery Today, vol.
`21, no. 6 (June 2016)
`Damato et al., “Senile Atrophy of the Human Lacrimal Gland: The
`Contribution of Chronic Inflammatory Disease,” British Journal of
`Ophthalmology (1984)
`Higuchi, “Physical Chemical Analysis of Percutaneous Absorption
`Process From Creams and Ointments,” Seminar, New York City
`(1959)
`Lallemand et al., “Cyclosporine a Delivery to the Eye: A
`Pharmaceutical Challenge,” European Journal of Pharmaceutics and
`Biopharmaceutics (2003)
`das Neves et al., “ Mucosal Delivery of Biopharmaceuticals: Biology,
`Challenges and Strategies,” Springer Science (2014)
`
`EX. 2014
`
`EX. 2015
`
`
`
`i
`
`

`

`EX. 2016
`
`EX. 2017
`EX. 2018
`
`EX. 2019
`
`EX. 2020
`
`EX. 2021
`
`EX. 2022
`
`EX. 2023
`EX. 2024
`EX. 2025
`EX. 2026
`EX. 2027
`EX. 2028
`EX. 2029
`
`EX. 2030
`EX. 2031
`
`Power et al., “Effect of Topical Cyclosporin A on Conjunctival T
`Cells in Patients with Secondary Sjögren’s Syndrome,” Cornea 12(6):
`507-511 (1993)
`Schaefer et al., “Skin Permeability,” Springer-Verlag (1982)
`Stern et al., “The Pathology of Dry Eye: The Interaction Between the
`Ocular Surface and Lacrimal Glands,” Cornea 17(6): 584-589 (1998)
`Wepierre, Jacques and Jean-Paul Marty, “Percutaneous Absorption of
`Drugs,” Elsvier/North-Holland Biomedical Press (1970)
`Williamson et al., “Histology f the Lacrimal Gland in
`Keratoconjunctivitis Sicca,” Brit. F. Ophthal /91973)
`“Approved Drug Products with Therapeutic Equivalence
`Evaluations,” U.S. Department of Health and Huma Services, 37th
`Edition (2017)
`Lemp, Michael A., “ Report of the National Eye Institute/Industry
`Workshop on Clinical Trials in Dry Eyes,” CLAO Journal, vol. 21,
`no. 4 (October 1995)
`Deposition transcript of Mansoor Amiji, Ph.D
`Declaration of John D. Sheppard, M.D., M.M.Sc.
`Declaration of Dr. Thorsteinn Loftsson, Ph.D.
`Declaration of Eric Rubinson
`Allergan PK-98-074 Report
`Declaration of Robert S. Maness, Ph.D.
`DiMasi, “Risks in New Drug Development: Approval Success Rates
`for Investigational Drugs,” Clinical Pharmacology and Therapeutics,
`May 2001
`FDA Review, “The Drug Development and Approval Process”
`Allergan – NYSE: AGN – Company Profile
`
`
`
`ii
`
`

`

`EX. 2032
`
`EX. 2033
`
`EX. 2034
`
`EX. 2035
`EX. 2036
`
`EX. 2037
`
`EX. 2038
`EX. 2039
`
`EX. 2040
`
`EX. 2041
`EX. 2042
`
`EX. 2043
`EX. 2044
`EX. 2045
`EX. 2046
`EX. 2047
`
`Drugs@FDA: FDA Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=021023
`Drugs@FDA: FDA Approved Drug Products, Restasis Approved,
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-
`023_Restasis_Approv.PDF
`Drugs@FDA: FDA Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=050790
`Facts About Dry Eye, https://nei.nih.gov/health/dryeye/dryeye
`Christopher Glenn, “New Thinking Spurs New Products,” Review of
`Ophthalmology, February 15, 2003
`Mark B. Abelson, MD and Jason Casavant, “Give Dry Eye a One-
`two Punch,” Review of Ophthalmology, March 15, 2003
`Deposition of David LeCause, February 17, 2017
`Joan-Marie Stiglich ELS, “Restasis: the road to approval,” Ocular
`Surgery News, March 1, 2003
`Lynda Charters, “Increased Tear Production,” Ophthalmology Times,
`February 1, 2003
`RESERVED
`Jonathan R. Pirnazar, MD, “Taking a Custom Approach to Dry Eye
`Treatment,” Ophthalmology Management, February 1, 2004
`RESERVED
`FDA label for Xiidra®
`RESERVED
`Restasis Strategic Plan Forecast 2009-2013
`Allergan Inc., Credit Suisse First Boston Equity Research Report, Jan
`30, 2003
`
`
`
`iii
`
`

`

`EX. 2048
`
`EX. 2049
`
`EX. 2050
`EX. 2051
`EX. 2052
`EX. 2053
`EX. 2054
`EX. 2055
`EX. 2056
`EX. 2057
`
`EX. 2058
`EX. 2059
`EX. 2060
`
`EX. 2061
`EX. 2062
`
`EX. 2063
`
`EX. 2064
`
`EX. 2065
`EX. 2066
`
`
`
`Allergan Inc., Buckingham Research Group Equity Research Report,
`Feb 5, 2003
`Allergan Inc., SalomonSmithBarney Equity Research Report, Feb 12,
`2003
`Allergan Inc., Morgan Stanley Equity Research Report, Jan 30, 2003
`Restasis P&L (US Only excl. Canada and Puerto Rico)
`Allergan Inc., Morgan Stanley Equity Research Report, Apr 30, 2004
`Allergan Inc., JP Morgan Equity Research Report, Nov 1, 2005
`RESERVED
`“commercial Restasis Formulary June 2006.xls”
`“NOVEMBER 2006 input MHC Report Restasis Playbook data.ppt”
`Restasis® 2013 Managed Markets Tactics & Preliminary Budget,
`August 8, 2012
`RESERVED
`RESERVED
`“Allergan Inc. (AGN) - Q4 2002 Financial Release Conference Call
`Wednesday, January 29, 2003 11:00 am” Fair Disclosure Financial
`Network
`Restasis Launch Marketing Plan, dated February 12-13, 2003
`Allergan Dry Eye, “Dry Eye Franchise 2014 Business Plan,” 2014
`U.S. Eye Care Sales & Marketing Plan, September 9, 2013
`Allergan Eye Care, “US Dry Eye Strat Plan Narrative: Summary
`Version,” April 16, 2011
`Kline, Kate, “Restasis Professional Critical Issues,” Allergan Dry
`Eye, 2010
`Allergan Dry Eye, “Restasis Business Update,” August 16, 2010
`“Sales-Units_2011-2016_AllData_NSP_Feb-19-
`2017_RESTASIS.xlsx”
`
`iv
`
`

`

`EX. 2067
`EX. 2068
`
`EX. 2069
`
`EX. 2070
`
`EX. 2071
`
`EX. 2072
`EX. 2073
`EX. 2074
`EX. 2075
`
`EX. 2076
`
`EX. 2077
`
`EX. 2078
`EX. 2079
`
`EX. 2080
`EX. 2081
`
`
`
`RESERVED
`Iazuka and Jin, “The Effect of Prescription Drug Advertising on
`Doctor Visits,” Journal of Economics and Management Strategy,
`2007
`Bradford, Kleit, Nietert, et al, “How Direct-to-Consumer Television
`Advertising for Osteoarthritis Drugs Affect Physicians’ Prescribing
`Behavior,” Health Affairs, 2006
`Calfee, Winston, and Stempski, “Direct-to-Consumer Advertising
`and the Demand for Cholesterol Reducing Drugs,” Journal of Law
`and Economics, 2002
`Bradford, Kleit, Nietert, et al, “Effects of Direct-to-Consumer
`Advertising of Hydroxymethylglutaryl Coenzyme A Reductase
`Inhibitors or Attainment of LDL-C Goals,” Clinical Therapeutics,
`2006
`Restasis NPA Monthly
`Restasis Projects, Global R&D Cost
`Refresh Endura Lubricant Eye Drops (Allergan), Theodora
`Declaration of Jonathan Singer in support of Petitioner’s Motion for
`Pro Hac Vice Admission
`Memorandum Opinion and Order, Allergan, Inc. v. Teva
`Pharmaceuticals USA, Inc., et al., Case No. 2:15-cv-1455-WCB
`Nussenblatt, R. et al. Local Cyclosporine Therapy for Experimental
`Autoimmune Uveitis in Rats. Arch Ophthalmology, Volume 103,
`October 1985.
`Medical Officer’s Review of NDA 21-023
`Correction to Sall article (Ex. 1007), Opthalmology, Vol. 107, No. 7,
`July 2000.
`GraphPad Calculation of Bloch Table 2 – 3 mo. B vs A.
`GraphPad Calculation of Bloch Table 2 – 3 mo. C vs A.
`
`v
`
`

`

`EX. 2082
`EX. 2083
`EX. 2084
`EX. 2085
`EX. 2086
`EX. 2087
`EX. 2088
`
`EX. 2089
`
`EX. 2090
`EX. 2091
`EX. 2092
`EX. 2093
`EX. 2094
`EX. 2095
`
`EX. 2096
`
`EX. 2097
`
`EX. 2098
`
`EX. 2099
`
`EX. 2100
`
`
`
`Deposition transcript of Andrew F. Calman, M.D., Ph.D.
`Deposition transcript of Daniel A. Bloch, Ph.D.
`Deposition transcript of Ivan T. Hofmann
`Assignment
`Patent Assignment Agreement
`Patent License Agreement
`Declaration of Christopher Evans in support of Motion for pro hac
`vice Admission
`Declaration of Michael Shore in support of Motion for pro hac vice
`Admission
`Transcript of Conference Call held on 09/11/17
`Federal Register, Vol. 82, No. 10, January 17, 2017
`Treaty with the Seven Nations of Canada, 1776
`Executive Order 13647
`TCR-2017-36
`Covidien LP v. Univ. of Fla. Research Found. Inc., Case IPR 2016-
`01274, Paper 21 (Jan. 25, 2017)
`Neochord, Inc. v. Univ. of Md., et al, Case IPR2016-00208, Paper 28
`(May 23, 2017)
`Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., Case IPR2016-
`01914, Paper 36 (July 13, 2017)
`Order, Allergan, Inc. v. Teva Pharmas USA, Inc. et al, No. 2:15-
`cv1455 (E.D. Tex.), Docket No. 478 (September 8, 2017)
`Joint Pre-Trial Order in Allergan, Inc. v. Teva Pharmas USA, Inc. et
`al, No. 2:15-cv-1455 (E.D. Tex.), Docket No. 379 (July 25, 2017)
`National Congress of American Indians, Current Tax Needs in Indian
`Country
`
`vi
`
`

`

`EX. 2101
`EX. 2102
`EX. 2103
`EX. 2104
`
`EX. 2105
`EX. 2106
`
`EX. 2107
`
`EX. 2108
`
`EX. 2109
`
`EX. 2110
`
`EX. 2111
`
`EX. 2112
`
`EX. 2113
`
`EX. 2114
`
`EX. 2115
`
`National Congress of American Indians, Securing Our Futures
`National Congress of American Indians, Taxation
`Recorded Assignment
`Declaration of Marsha K. Schmidt in Support of Motion for Pro Hac
`Vice Admission
`Intellectual Property and the U.S. Economy: 2016 Update
`Richard Baker, American Invents Act Cost the U.S. Economy over $1
`Trillion, PatentlyO (June 8, 2015),
`https://patentlyo.com/patent/2015/06/america-invents-trillion.html
`The Roots of Innovation, U.S. Chamber International IP Index (Fifth
`Ed. February 2017)
`Ryan Davis, PTAB’s ‘Death Squad’ Label Not Totally Off-Base Chief
`Says, Law360 (Aug. 14, 2014)
`Letter from Saint Regis Mohawk Tribal Counsel to Senator Charles
`Grassley sent on Oct. 12, 2017`
`Adam Perlman et al, ‘Reverse’ Patent Trolling: Nontraditional
`Participants in the Inter Partes Review Process, 33 Westlaw Journal
`Pharmaceutical 9 (2017).
`Imprimis Pharmaceuticals to Offer Compounded Cyclosporine
`Alternative to Restasis®, Cision PR Newswire (Oct. 19, 2017)
`Declaration of Dale White in Support of Patent Owner’s Motion to
`Sea
`Excerpts of Chief Judge David Rushke’s Testimony at 11/09/17
`PPAC Quarterly Meeting
`Michelle Stephenson; The Latest Use for Restatis, Review of
`Ophthalmology (Dec. 30, 2005)
`Eric Donnenfeld, MD and Stephen Pflugfelder, MD; Topical
`Ophthalmic Cyclosporine: Pharmacology and Clinical Uses, Survey
`of Ophthalmology, Vol. 54, Number 3 (May-June 2009)
`
`
`
`vii
`
`

`

`EX. 2116
`EX. 2117
`
`EX. 2118
`
`EX. 2119
`
`12/27/17 email string regarding discovery
`January 26, 2017 Memorandum Opinion and Order regarding
`reduction of asserted claims (E.D. Tex., C.A. No. 2:15-cv-01455-
`WCB, Dkt. 265)
`Allergan’s Brief on Representative Claims, July 28, 2017 (E.D.
`Tex., C.A. No. 2:15-cv-01455-WCB, Dkt. 385)
`Docket from CRESPE LLC v. Silicon Laboratories Inc., No 17-
`1072 (Fed. Cir.)
`
`
`
`
`
`viii
`
`

`

`I. INTRODUCTION
`Petitioners have cited no authority applying collateral estoppel in the current
`
`
`
`posture of this IPR Proceeding, and the Board need not do so here. As an initial
`
`matter, this issue is premature because the Federal Circuit has not issued its mandate
`
`in the appeal from the underlying district court case, the case on which Petitioners’
`
`estoppel argument rests, and therefore, that judgment is not final. Moreover, with
`
`respect to the four patents that were “actually litigated” at the district court, there is
`
`no need to go through the exercise of determining estoppel—if the Federal Circuit
`
`denies the petition for rehearing and issues its mandate, those claims are adjudged
`
`invalid, and the Board may simply dismiss the IPRs on them as moot. Facebook,
`
`Inc. v. EveryMD.com, IPR2017-02027, Paper No. 24 (PTAB Oct. 9, 2018). While
`
`Allergan and the Tribe recognize that the Board has found that there is “no legal
`
`reason” to stay this case until the mandate, respectfully, that is not correct. As
`
`demonstrated below, the issuance of the mandate directly impacts the judgment’s
`
`finality and work required of the parties and the Board.
`
`And as to the claims of the two patents that were not part of the district court
`
`trial, Petitioners make no effort to show that those claims, and any different issues
`
`
`
`1
`
`

`

`that they present, were actually litigated in district court. That is because they were
`
`not, as Allergan and the Tribe3 lay out below, so collateral estoppel does not apply.
`
`
`
`
`3 The Saint Regis Mohawk Tribe (the “Tribe”) is the Patent Owner, and
`
`Allergan, Inc. (“Allergan”) is an exclusive field-of-use licensee. Neither the Saint
`
`Regis Mohawk Tribe nor Allergan concede that Allergan is a “Patent Owner,” but
`
`recognize the Board’s order to the contrary. (Paper 130.) The Tribe also objects to
`
`the Board’s assertion of jurisdiction over it and its appearance in this briefing
`
`should not be construed in any way as a waiver of immunity or an agreement that
`
`the Board has jurisdiction. That question will be presented to the Supreme Court.
`
`Until then, the courts have been clear that the Tribe should not be subject to
`
`unnecessary harm. Once a sovereign entity is compelled to participate in an
`
`administrative adjudication, a core element of sovereign immunity is irrevocably
`
`lost. “[T]ribal sovereign immunity ‘is an immunity from suit rather than a mere
`
`defense to liability; and . . . it is effectively lost if a case is erroneously permitted to
`
`go to trial.’” Burlington N. and Santa Fe Ry. Co. v. Vaughn, 509 F.3d 1085, 1090
`
`(9th Cir. 2007) (quoting Mitchell v. Forsyth, 472 U.S. 511, 526 (1985)). The
`
`Supreme Court has explained, sovereign immunity “is for the most part lost as
`
`
`
`2
`
`

`

`For all of these reasons, the Board should wait until the mandate issues in the
`
`underlying case. And when, or if, a mandate issues with no change in the Federal
`
`Circuit’s judgment, the Board should decline Petitioners’ invitation to apply
`
`collateral estoppel to claims that were not actually litigated at the district court.
`
`
`
`litigation proceeds past motion practice.” P.R. Aqueduct & Sewer Auth. v. Metcalf
`
`& Eddy, Inc., 506 U.S. 139, 145 (1993); see also Osage Tribal Council ex rel.
`
`Osage Tribe of Indians v. U.S. Dept. of Labor, 187 F.3d 1174, 1180 (10th Cir.
`
`1999) (“Were this case erroneously permitted to proceed further, the [tribal
`
`council’s] absolute entitlement to immunity from suit would still be effectively
`
`lost.”); Tamiami Partners By & Through Tamiami Dev. Corp. v. Miccosukee Tribe
`
`of Indians of Fla., 63 F.3d 1030, 1050 (11th Cir. 1995) (“Tribal sovereign
`
`immunity would be rendered meaningless if a suit against a tribe asserting its
`
`immunity were allowed to proceed to trial.”).
`
`Since this Board has concluded it will continue with the case, the Tribe
`
`believes it is necessary to make clear for the record its continuing objection to this
`
`case going forward. The only other option is for the Tribe to not appear and
`
`potentially have its patents declared invalid in its absence.
`
`
`
`3
`
`

`

`II. BACKGROUND
`These IPRs concern six patents covering Allergan’s groundbreaking drug,
`
`Restasis®—U.S. Patent Nos. 8,629,111 (the “’111 patent”), 8,633,162 (the “’162
`
`patent”), 8,642,556 (the “’556 patent”), 8,648,048 (the “’048 patent”), 8,685,930
`
`(the “’930 patent”), and 9,248,191 (the “’191 patent”). Four of those six patents—
`
`the ’111, ’048, ’930, and ’191 patents—were also at issue in the district court trial.
`
`During discovery, the district court urged Allergan to reduce the number of total
`
`claims it would be asserting at trial, for purposes of streamlining the case. (EX.
`
`2117.) Despite Allergan’s stated concerns about due process, and based on the
`
`district court’s urgings, Allergan agreed that thirteen claims in those patents would
`
`be treated as “representative” of those four patents only. (EX. 2118; EX1164 at 29-
`
`30 (“Allergan selected 13 claims from four of the Restasis patents to be litigated at
`
`trial.”).) Allergan selected the thirteen claims for trial based on its assessment of all
`
`of the issues to be tried, which included infringement, inventorship, enablement,
`
`anticipation, and obviousness. (See, e.g., EX1164 at 109, 112, 117, and 126.)
`
`When making its agreement regarding the representative claims, Allergan
`
`made clear that those claims were not properly treated as “representative” of the ’162
`
`and ’556 patents. Indeed, when asked that question at the Pretrial Conference,
`
`Allergan’s counsel explained to the district court that the thirteen claims were not
`
`
`
`4
`
`

`

`representative of the ’162 and ’556 patents, and that those patents were no longer at
`
`issue because Allergan had granted Petitioners a covenant not to sue on them:
`
`THE COURT: Okay. Now, there was one -- maybe this isn’t an
`ambiguity but it is one fill up that I wanted to tie down. And there’s a
`reference I think in maybe your paper to the two patents as to which
`there are no representative claims among the 13. Those patents, if I
`understand it, are covered by the representative claims as well; is that
`correct?
`MS. BROOKS: Actually, your Honor, what we’ve done is we’ve
`dropped them completely, including the claims that were asserted, and
`we’re giving a covenant not to sue.
`(EX1173 at 8:5-13l; see also EX1164 at 29-30 (“For purposes of simplifying the
`
`issues to be decided at trial, Allergan gave the defendants a covenant not to sue with
`
`respect to the claims in the two patents that are no longer asserted (the ’162 patent
`
`and the ’556 patent).”).) As a result, the validity of the claims of the ’162 and ’556
`
`patents was never “actually litigated.”
`
`After a bench trial, the district court found that the thirteen representative
`
`claims were invalid as obvious. (EX1164 at 108-132; see also EX1165.) The
`
`Federal Circuit affirmed by Rule 36 judgment on November 13, 2018. (EX1172.)
`
`Allergan and the Tribe’s rehearing petition is due December 21, 2018, the same day
`
`as this brief is being filed, and thus the Federal Circuit has not yet issued a mandate
`
`on its judgment from the district court case.
`
`On December 13, the Board held a telephonic hearing on the requests made
`
`by Allergan and the Tribe to stay proceedings before the Board. Despite the fact
`
`
`
`5
`
`

`

`that all parties agreed that a stay at least pending the issuance of the mandate in the
`
`district court was appropriate, the Board on December 20 denied the motion to stay,
`
`before Allergan and the Tribe’s deadline to submit this responsive supplemental
`
`brief on the impact of the Federal Circuit’s affirmance, and without allowing any
`
`briefing requested by Allergan and the Tribe to support their motion to stay.
`
`III. ARGUMENT
`Petitioners have not cited a single case that applies collateral estoppel to the
`
`fact pattern present here. The Board should deny Petitioners’ request as to the ’111,
`
`’048, ’930, and ’191 patents because it is premature and unnecessary; if the mandate
`
`issues on the decision as it stands, the Board can dismiss the institution decision as
`
`moot for the same reasons that the Board did in the Facebook IPR (IPR2017-02027,
`
`Paper No. 24 (PTAB Oct. 9, 2018)). As to the ’162 and ’556 patents, which have
`
`not been litigated and are not subject to a final judgment, collateral estoppel does not
`
`apply. For these reasons, the Board should deny Petitioners’ request in its entirety.
`
`A. A Decision on the Patents from the District Court Case is Premature,
`because the Federal Circuit Has Not Yet Issued a Mandate
`The Federal Circuit affirmed the district court’s decision invalidating the
`
`asserted claims of the ’111, ’048, ’930, and ’191 patents as obvious on November
`
`13, 2018. But the mandate has not yet issued on that judgment, and Allergan and
`
`the Tribe will be filing a petition for en banc and/or panel rehearing from that
`
`judgment on December 21, 2018. That petition will be raising substantial questions
`
`
`
`6
`
`

`

`about the application of the blocking patent doctrine to ignore objective indicia of
`
`non-obviousness, a controversial issue at the Federal Circuit that has been the subject
`
`of a number of dissenting opinions and an issue on which a similar rehearing petition
`
`is pending in another, unrelated case. Acorda Therapeutics, Inc. v. Alkermes
`
`Pharma Ireland Ltd., 903 F.3d 1310 (Fed. Cir. 2018) (Newman, dissenting) (rehearing
`
`petition pending at Nos. 17-2078, 17-2134, Dkt. 145); Merck & Co., Inc. v. Teva
`
`Pharmaceuticals USA, Inc., 395 F.3d 1364, 1377-81 (Fed. Cir. 2005) (Rader,
`
`dissenting); Galderma Laboratories, LP v. Tolmar, Inc., 737 F.3d 731, 741-750
`
`(Fed. Cir. 2013) (Newman, dissenting). The mandate for this case will not issue
`
`until the Federal Circuit reviews and acts on Allergan and the Tribe’s petition. And
`
`until the mandate issues, the Federal Circuit’s judgment is not final. The Advisory
`
`Committee Notes to Federal Rule of Appellate Procedure 41, which governs
`
`appellate mandates, specifically notes that “[a] court of appeals judgment or order is
`
`not final until issuance of the mandate; at that time the parties’ obligations become
`
`fixed.” (Fed. R. App. P. 41, Adv. Comm. Notes to 1998 Amendments, Subdivision
`
`(c) (emphasis added).) It is thus premature and improper for the Board to apply the
`
`Federal Circuit’s judgment here before issuance of the mandate. Indeed, all parties
`
`informed the Board on the December 13 telephone conference that they agreed it
`
`was proper to stay further action in these IPRs until the mandate had issued. As a
`
`
`
`7
`
`

`

`result, the Board’s determination that there is “no legal reason” to stay these
`
`proceedings until the issuance of the mandate is not correct.
`
`There also is no reason for the Board to rush to a decision here. The patents
`
`in this IPR are not preventing Petitioners from entering the market with their generic
`
`versions of Restasis®. Once the district court issued its decision, FDA was free to
`
`approve Petitioners’ ANDAs for their generic versions of Restasis®. FDA has not
`
`yet issued final approval for any of the generic products, but the patents at issue here
`
`are not preventing it from doing so. If FDA finds Petitioners’ ANDAs to be in
`
`condition for final approval, there is nothing to prevent it from issuing that approval.
`
`Moreover, waiting for the Federal Circuit mandate from the district court
`
`action would actually promote the “just, speedy, and inexpensive resolution” of this
`
`proceeding, a policy expressly set forth in the regulations governing proceedings
`
`before the Board. 37 C.F.R. § 42.1(b). As the parties have agreed, the mandate will
`
`provide clarity, and may, as discussed in the section below, remove issues from the
`
`Board’s consideration, conserving resources of both the parties and the Board. For
`
`example, an oral hearing before the mandate issues would necessarily cover all six
`
`patents even though four of the IPRs would become moot, as described below, if the
`
`Federal Circuit denies the rehearing petition.
`
`
`
`8
`
`

`

`B. Once the Mandate Issues, the IPRs on the ’111, ’048, ’930, and ’191
`Patents Are Moot
`Once the Federal Circuit’s judgment in the litigation is final, assuming that
`
`there has been no change in that judgment, the Board can dismiss the IPRs on the
`
`’111, ’048, ’930, and ’191 patents as moot, similar to what it has done in previous
`
`cases.
`
`Because Allergan agreed to treat the thirteen litigated claims as representative
`
`of all claims of the ’111, ’048, ’930, and ’191 patents at the district court’s request
`
`for purposes of streamlining the litigation, as the district court recognized (EX1164
`
`at 29-30), the judgment as to those thirteen claims can be properly applied to all
`
`claims of those four patents. Thus, if the Federal Circuit denies Allergan’s petition
`
`for rehearing and that judgment becomes final, there will be nothing left for the
`
`Board to do on those patents, rendering the IPRs on those patents moot.
`
`This is similar to the situation in Facebook, Inc. v. EveryMD.com, IPR2017-
`
`02027, Paper No. 24 (PTAB Oct. 9, 2018). In that case, the Federal Circuit had
`
`issued a final judgment, i.e., mandate, that all claims of a patent at issue in an IPR
`
`were unpatentable before the Board held a hearing or issued a written decision. The
`
`Petitioner sought to have the Board terminate the IPR proceeding and dismiss a
`
`pending motion to amend by the Petitioner. The Board agreed and issued a decision
`
`vacating its institution the decision, dismissing the petition, and terminating the case.
`
`Id. at 10. The Board reasoned that “[t]he courts have determined, with finality, that
`9
`
`
`
`

`

`all existing claims of the ’192 Patent are unpatentable. As a result, every ground on
`
`unpatentability set forth in the Petition is now moot.” Id. at 6. See also Asghari-
`
`Kamrani v. United Servs. Auto. Ass’n, No. 2018-1040, 2018 WL 4334150, at *1
`
`(Fed. Cir. Sept. 11, 2018) (dismissing IPR appeals as moot and vacating decisions
`
`after affirming district court decision that all claims were unpatentable). Notably,
`
`the Board did not dismiss based on collateral estoppel.
`
`If the Federal Circuit denies the rehearing petition here, its judgment will be
`
`final by issuance of the mandate. The courts will have finally determined that the
`
`claims of the ’111, ’048, ’930, and ’191 patents are unpatentable, rendering the
`
`grounds in the Petitions, and the entire IPR proceedings on those four patents, moot.
`
`C. There Is No Collateral Estoppel on the ’162 and ’556 Patents
`Petitioners vastly oversimplify the question of collateral estoppel. Petitioners
`
`appear to assume that collateral estoppel would apply to the claims of the ’162 and
`
`’556 patents that were not at issue in the district court, and to which the
`
`representative claims do not apply. But Petitioners do not specifically address many
`
`of the claim limitations, particularly for the dependent claims, and merely make
`
`conclusory assertions that collateral estoppel applies without showing why or how
`
`it should, under the proper legal standards. It is Petitioners’ burden to show that
`
`
`
`10
`
`

`

`collateral estoppel applies,4 and their supplemental briefing does not come close to
`
`meeting that burden.
`
`Application of collateral estoppel is only appropriate where “the identical
`
`issue was ‘actually litigated, that is, contested by the parties and submitted for
`
`determination by the court,’ where the issue was ‘actually and necessarily
`
`determined by a court of competent jurisdiction,’ and where preclusion does not
`
`work an unfairness in the second trial.” SunTiger, Inc. v. Scientific Research
`
`Funding Grp., 189 F.3d 1327, 1332-33 (Fed. Cir. 1999) (quoting Swentek v. USAir,
`
`830 F.2d 552, 561 (4th Cir. 1987)).
`
`
`
` 4
`
` While the Federal Circuit has not spoken directly on this question in the context of
`
`proceedings before the PTAB, that Court generally applies the law of the regional
`
`circuit with respect to collateral estoppel. In so doing the Federal Circuit has
`
`consistently held it is the burden of the party asserting estoppel to show that estoppel
`
`applies. See Mallinckrodt, Inc. v. Masimo Corp., 147 F. App’x 158, 168 (Fed. Cir.
`
`2005) (applying 9th Circuit case law); RF Delaware, Inc. v. Pac. Keystone Techs.,
`
`Inc., 326 F.3d 1255, 1261 (Fed. Cir. 2003) (applying 11th Circuit case law); Novartis
`
`Pharm. Corp. v. Abbott Labs., 375 F.3d 1328, 1333 (Fed. Cir. 2004) (applying 3rd
`
`Circuit case law).
`
`
`
`11
`
`

`

`That a patent may be related to a previously-litigated patent does not mean
`
`that collateral estoppel applies. See SunTiger, 189 F.3d at 1332-33 (rejecting
`
`collateral estoppel on different patent than one previously litigated because issue
`
`was not identical). Instead, “separate patents describe ‘separate and distinct
`
`[inventions],’ and it cannot be presumed that related patents rise and fall together.”
`
`Comair Rotron, Inc. v. Nippon Densan Corp., 49 F.3d 1535, 1539 (Fed. Cir. 1995)
`
`(citations omitted).
`
`When a party invokes collateral estoppel against patent claims that have not
`
`previously been litigated, a court must consider whether those claims raise issues of
`
`validity that are not identical to the ones that were considered before. Interconnect
`
`Planning Corp. v. Feil, 774 F.2d 1132, 1136 (Fed. Cir. 1985). “Where obviousness
`
`is the basis for the prior invalidity holding, inquiry into the identity of the validity
`
`issue is more properly phrased in terms of the factual inquiries mandated by Graham
`
`v. John Deere Co., 383 U.S. 1, 17 (1966), as a prerequisite to such a validity
`
`determination.” Id.
`
`Petitioners’ brief does not even address these standards, and instead cites only
`
`to MaxLinear, Inc. v. CF CRESPE LLC, 880 F.3d 1373 (Fed. Cir. 2018), a case that
`
`is factually distinct and thus inapposite. First, MaxLinear does not address the
`
`collateral estoppel effect of a district court decision on further proceedings in an IPR;
`
`Allergan and the Tribe are aware of no case that addresses that specific issue.
`
`
`
`12
`
`

`

`Instead, in MaxLinear, the petitioner, MaxLinear, appealed from a final written
`
`decision finding two independent claims of CRESPE’s patent patentable over the
`
`prior art. MaxLinear, 880 F.3d at 1374-75. During the pendency of MaxLinear’s
`
`IPR, another IPR, filed by petitioner Silicon Labs (the “Silicon Labs IPR”), had held
`
`the same two independent claims unpatentable over different prior art, and the
`
`Federal Circuit affirmed. Id. The mandate issued in the Silicon Labs IPR on January
`
`16, 2018, nine days before the Federal Circuit’s decision in MaxLinear. See CF
`
`CRESPE LLC v. Silicon Laboratories Inc., No 17-1072 (Fed. Cir. Docket.)
`
`(EX2119).
`
`Therefore, MaxLinear addresses whether collateral estoppel applies after a
`
`mandate issues from one IPR proceeding in a second IPR. MaxLinear, 880 F.3d at
`
`1377. MaxLinear says nothing about applying collateral estoppel before the
`
`mandate issues, as is the case here. This is yet another reason that the Board should
`
`stay further proceedings in this IPR until after the mandate issues from the Federal
`
`Circuit. Moreover, the Federal Circuit in MaxLinear remanded the case to the PTAB
`
`for further proceedings on dependent claims that had not been decided by the earlier
`
`IPR, and did not find those claims to be collaterally estopped. Id. For the same
`
`reason, this Court should not apply collateral estoppel to the claims of the ’162 and
`
`’556 patents, which the district court did not rule on, but should instead wait and
`
`address them on their merits.
`
`
`
`13
`
`

`

`Petitioners fail to acknowledge any of the other cases cited above, which show
`
`that the thirteen representative claims were the only claims “actually litigated” for
`
`purposes of collateral estoppel. And here, the claims at issue in the ’162 and ’556
`
`patents present issues of validity that are not identical to the ones that were
`
`considered by the district court. As just one example of those differences

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