`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner
`_______________
`
`Case: IPR2016-01111
`
`Patent 8,603,514
`_______________
`
`PATENT OWNER MONOSOL RX, LLC’S
`MOTION FOR ADDITIONAL DISCOVERY1
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`
`
`
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`
`
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`1 Corresponding motions are being filed in IPR2016-01112 and IPR2016-01113.
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`
`
`
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`
`
`I.
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`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
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`IPR2016-01111
`
`II.
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`FACTUAL BACKGROUND .......................................................................... 3
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`III. REASONS FOR ORDERING ADDITIONAL DISCOVERY ...................... 6
`
`A.
`
`B.
`
`C.
`
`D.
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`E.
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`
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`
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`First Garmin Factor: It is highly likely that the requested additional
`discovery will uncover relevant and useful information. .................... 10
`
`Second Garmin Factor: The requested discovery does not seek Teva’s
`or Petitioner’s litigation positions. ...................................................... 13
`
`Third Garmin Factor: Patent Owner can only obtain the requested
`discovery through Petitioner. .............................................................. 13
`
`Fourth Garmin Factor: The instructions are easily understandable. ... 14
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`Fifth Garmin Factor: The requests are narrowly tailored and not
`burdensome. ........................................................................................ 15
`
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`IV. CONCLUSION .............................................................................................. 15
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`
`
`
`
`i
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`
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`
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`TABLE OF AUTHORITIES
`
`IPR2016-01111
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` Page(s)
`
`Cases
`Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc.,
`IPR2014-01288, Paper 13 (Aruze) .................................................................. 8, 11
`
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper 26 ................................................................................... 10
`
`Greenway Ctr. Inc. v. Essex Ins. Co.,
`475 F.3d 139 (3d Cir. 2007) ................................................................................. 8
`
`Johnson Health Tech Co. v. Icon Health & Fitness, Inc.,
`IPR2014-01242, 2015 WL 996358 (Feb. 11, 2015) ......................................... 3, 6
`
`Litchfield v. Crane,
`123 U.S. 549 (1887) .............................................................................................. 8
`
`Murphy v. Jefferson Pilot Commc’ns Co.,
`657 F. Supp. 2d 683 (D.S.C. 2008) ...................................................................... 8
`
`Reckitt Benckiser Pharmaceuticals Inc. et al. v. Teva Pharaceuticals
`USA, Inc.,
`Civil Case No. 1:14-01451 (D. Del. filed December 2, 2014) ............................. 3
`
`Strauser v. Westfield Ins. Co.,
`827 N.E.2d 1181 (Ind. Ct. App. 2005) ................................................................. 9
`
`Synopsys, Inc. v. Mentor Graphics Corp.,
`814 F.3d 1309 (Fed. Cir. 2016) .................................................................... 12, 13
`
`Synopsys, Inc. v. Mentor Graphics Corp.,
`IPR2012-00042, Paper 60 (Feb. 19, 2014) ......................................................... 12
`
`Taylor v. Sturgell,
`553 U.S. 880 (2008) .......................................................................................... 2, 8
`
`VMware, Inc. v. Good Tech. Software, Inc.,
`IPR2015-00027, Paper 11 (Mar. 6, 2015) .......................................................... 12
`
`ii
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`
`
`
`
`Statutes
`35 U.S.C. § 315(b) ............................................................................................passim
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`IPR2016-01111
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`Other Authorities
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`37 C.F.R. § 42.51(b) (2) ............................................................................................. 1
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`37 C.F.R. § 42.101(b) ................................................................................................ 6
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`77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012) ........................................................... 2
`
`77 Fed. Reg. at 48,759 ............................................................................................... 7
`
`H.R. Rep. No. 112-98 (2011) ................................................................................. 7, 8
`
`Restatement (Second) of Judgments § 43 (1982) ...................................................... 8
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`
`
`
`
`iii
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`
`
`EXHIBIT
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`
`
`
`2001
`2002
`
`2003
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`2004
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`2005
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`2006
`2007
`2008
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`IPR2016-01111
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`PATENT OWNER’S EXHIBIT LIST
`
`
`DESCRIPTION
`
`Transcript of Conference Call of August 1, 2015
`Redline comparison of Teva petition in IPR2016-00281
`and Dr. Reddy’s petition in IPR2016-01111
`Redline comparison of Dr. Panyam declaration in Teva
`IPR2016-00281 and Dr. Celik declaration in Dr.
`Reddy’s IPR2016-01111
`“Dr. Reddy’s to acquire product portfolio from TEVA
`for US Market,” Press Release, June 11, 2016
`Email from Dr. Reddy’s counsel summarizing meet and
`confer teleconference conducted July 6, 2016
`Teva/Allergan Divestiture Products Table
`FTC Complaint with list of products
`“Teva Pharm finalizing asset sales to clear Allergan
`deal: source,” Reuters, May 5, 2016
`
`iv
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`
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`Pursuant to the Board’s Order (Paper 6), Patent Owner, MonoSol Rx, LLC
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`IPR2016-01111
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`moves under 37 C.F.R. § 42.51(b) (2) for additional discovery related to entities in
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`privity with Petitioners Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc. (“Petitioner” or “Dr. Reddy’s”).
`
`I.
`
`INTRODUCTION
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`Teva Pharmaceuticals USA, Inc. (“Teva”) filed two Abbreviated New Drug
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`Applications (“ANDAs”) with the FDA to market generic versions of Suboxone®
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`Film, a branded drug for the treatment of opioid addiction covered by numerous
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`patents. After Patent Owner sued Teva for infringement under the Hatch-Waxman
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`Act, Teva filed several petitions for inter partes review (“IPR”) challenging three
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`patents covering Suboxone® Film. The Board denied institution for several
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`reasons, including because Teva did not file two of its petitions within the one-year
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`time bar under 35 U.S.C. § 315(b).
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`Eight days after the Board determined that Teva’s petitions were time-
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`barred, Dr. Reddy’s—a drug company that was not a defendant in the underlying
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`lawsuit and that had not filed its own ANDAs pertaining to Suboxone® Film—
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`filed IPR petitions that are substantially identical to the failed Teva petitions.
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`Shortly after filing the petitions, Dr. Reddy’s announced that it had entered into an
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`agreement with Teva to acquire a number of ANDAs for $350 million. Patent
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`Owner has since learned that the acquired ANDAs include the Suboxone® Film
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`1
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`
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`ANDAs. Litigation counsel for Patent Owner has also learned from litigation
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`IPR2016-01111
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`counsel for Teva that Dr. Reddy’s will likely be moving to substitute itself for
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`Teva in the ongoing litigation, and that Dr. Reddy’s will provide more information
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`once the acquisition is completed within a few days.
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`Accordingly, the information available without discovery suggests that
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`Teva, as a predecessor in interest to the Suboxone® Film ANDAs, is in privity
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`with Petitioner. See Taylor v. Sturgell, 553 U.S. 880, 892–93 (2008) (legal
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`relationships, such as those between “preceding and succeeding owners of
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`property” or between “assignee and assignor,” can support nonparty preclusion due
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`to privity). Patent Owner brings this motion to obtain further discovery regarding
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`privity as the question of “[w]hether a party who is not a named participant in a
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`given proceeding nonetheless constitutes a . . . ‘privy’ to that proceeding is a
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`highly fact-dependent question.” Office Patent Trial Practice Guide, 77 Fed. Reg.
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`48,756, 48,759 (Aug. 14, 2012) (emphasis added) (hereinafter “Trial Guide”).
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`In an attempt to avoid discovery, Petitioner espouses a narrow concept of
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`privity that is contrary to both Congressional and Board guidance. Were
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`Petitioner’s notion of privity to become law, it would enable any accused infringer
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`to circumvent the statutory time limit in § 315(b) after failing to timely file an IPR
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`petition by selling its accused asset to a third party, which would then be able to
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`take over the infringement litigation and file an otherwise time-barred IPR petition.
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`2
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`
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`Petitioner’s approach unlawfully contravenes the purpose of the one-year deadline
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`IPR2016-01111
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`of § 315(b), which “helps to ensure that inter partes review provides a quick and
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`cost effective alternative to litigation, and is not used as a tool for harassment or
`
`litigation gamesmanship.” Johnson Health Tech Co. v. Icon Health & Fitness,
`
`Inc., IPR2014-01242, 2015 WL 996358, at *2 (Feb. 11, 2015) (citing H.R. Rep.
`
`No. 112-98, at 48, as reprinted in 2011 U.S.C.C.A.N. at 78). To prevent abuse of
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`the IPR process by efforts at gamesmanship, this Board should permit the
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`discovery requested in this motion to ensure appropriate resolution of this highly
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`fact-dependent privity issue.
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`II.
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`FACTUAL BACKGROUND
`
`The three patents challenged by Petitioner in these proceedings (IPR2016-
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`01111, -01112 and -01113), the ’514, ’150 and ’832 Patents, respectively, are all
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`listed in the FDA’s Orange Book for Suboxone® Film, a treatment for opioid
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`dependence that is the first sublingual pharmaceutical film ever approved by the
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`FDA. MonoSol Rx, LLC (“MonoSol”) owns the ’514 and ’150 patents, and
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`Indivior UK Limited (“Indivior”) owns the ’832 patent (these three patents will be
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`collectively referred to as the “Suboxone® Film Patents”). The Suboxone® Film
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`Patents have been asserted in Hatch-Waxman litigation against several defendants,
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`including Teva, related to potential generic versions of Suboxone® Film. See, e.g.,
`
`Reckitt Benckiser Pharmaceuticals Inc. et al. v. Teva Pharaceuticals USA, Inc.,
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`3
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`
`
`
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`Civil Case No. 1:14-01451 (D. Del. filed December 2, 2014).
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`IPR2016-01111
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`Specifically, Teva filed two ANDAs for a generic version of Suboxone®
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`Film. Patent Owners MonoSol and Indivior (collectively, “Patent Owners”) then
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`served Teva with an infringement complaint on December 3, 2014, asserting
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`infringement of the Suboxone® Film Patents. Teva filed petitions for inter partes
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`review of certain claims of the Suboxone® Film Patents. See IPR2016-00280, -
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`00281, and -00282 (“Teva IPRs”). The Board denied institution in two of the Teva
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`IPRs because Teva did not file its petitions within one year of service of the
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`complaint as required by 35 U.S.C. § 315(b). See IPR2016-00281, Paper 21;
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`IPR2016-00282, Paper 19. The Board denied institution in the third IPR after
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`finding Teva had failed to establish a reasonable likelihood that the challenged
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`claims were unpatentable. IPR2016-00280, Paper 23.
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`Eight days after the Board determined that Teva’s petitions were time-
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`barred, Petitioner filed these proceedings on May 31, 2016 challenging the
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`Suboxone® Film Patents. IPR2016-01111, -01112 and -01113. With few
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`exceptions, the petitions are virtually identical to the petitions filed in the Teva
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`IPRs. The petitions seek review of the same claims of the same patents, rely on the
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`same arguments and prior art, contain substantially identical text, and rely on
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`substantially identical expert declarations. See, e.g., Exs. 2002 & 2003 (redline
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`comparisons of petitions and declarations, respectively).
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`4
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`IPR2016-01111
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`A mere eleven days after filing the petitions, Petitioner announced that it had
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`“entered into a definitive agreement” with Teva Pharmaceutical Industries Ltd.
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`Ex. 2004 (June 11, 2016 Press Release). Specifically, Petitioner announced that it
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`had agreed “to acquire a portfolio of eight Abbreviated New Drug Applications
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`(ANDAs) in the U.S. for $350 million in cash at closing.” Id. But Petitioner’s
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`press release did not specify when negotiations pertaining to that definitive
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`agreement began or when the agreement was reached.
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`Based on that press release, Patent Owners sought discovery from Petitioner.
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`Patent Owners emailed Petitioner on June 27, 2016 seeking to meet and confer,
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`and the parties conducted a telephonic conference on July 6, 2016 to discuss the
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`timing and nature of Petitioner’s “definitive agreement” with Teva. Ex. 2005. But
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`Petitioner’s counsel was unwilling to answer the threshold question regarding
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`whether the Suboxone® Film ANDAs were included among the ANDAs to be
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`transferred by the agreement. Id. Patent Owners propounded specific written
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`requests to Petitioner on July 14, 2016, but Petitioner has refused to provide the
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`requested discovery. On July 27, 2016, the FTC released a table of Teva/Allergan
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`Divestiture Products (Ex. 2006),2 which included a disclosure of the acquisition by
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`Dr. Reddy’s of Teva’s ANDAs for buprenorphine HCl/naloxone HCl oral film,
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`2 Teva has agreed to divest various ANDAs in order to receive FTC approval of its
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`acquisition of Allergan Plc. Ex. 2007.
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`5
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`
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`i.e., generic Suboxone® Film. But Petitioner has not changed its position
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`IPR2016-01111
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`regarding Patent Owners’ requests. Ex. 2001, 23:22–26:23.
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`Based at least on the foregoing, Patent Owners seek the Requests for
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`Production in four categories as set forth in the Appendix (see Paper 6, p. 3): (1)
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`documents pertaining to the agreement to acquire ANDAs described in Petitioner’s
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`June 11, 2016 press release (the “Agreement”), including any drafts, term sheets,
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`or other acquisition documents; (2) communications relating to the Agreement or
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`the Suboxone® Film-related ANDAs; (3) communications between Teva and
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`Petitioner (or their respective counsel) regarding IPR petitions; and (4) documents
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`showing when acquisition discussions relating to these ANDAs started.
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`III. REASONS FOR ORDERING ADDITIONAL DISCOVERY
`A petition for inter partes review of a patent may not be granted if the
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`petition is filed more than one year after the date that a privy of the petitioner is
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`served with a complaint alleging infringement of the patent. 35 U.S.C. § 315(b);
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`see also 37 C.F.R. § 42.101(b). This Board has recognized that the “one-year
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`deadline [of § 315(b)] helps to ensure that inter partes review provides a quick and
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`cost effective alternative to litigation, and is not used as a tool for harassment or
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`litigation gamesmanship.” Johnson Health, 2015 WL 996358, at *2 (citing H.R.
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`REP. NO. 112-98 at 48). When creating the IPR process, Congress decried the use
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`of IPRs “as tools for harassment or . . . repeated litigation and administrative
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`6
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`
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`
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`attacks on the validity of a patent” because it “recognize[d] the importance of quiet
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`IPR2016-01111
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`title to patent owners to ensure continued investment resources.” H.R. Rep. No.
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`112-98, at 45–48 (2011). To deter such harassment, Congress explained that it
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`“intends for the USPTO to address potential abuses . . . under its expanded
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`procedural authority.” Id.
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`This case provides a perfect example of the abuse of the IPR process that
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`Congress has denounced. These proceedings represent a third attempt to invalidate
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`patents in order to gain an advantage in a single ongoing patent infringement
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`action. If patent owners can be subject to such repeated validity attacks, they will
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`be deprived of the “quiet title” in their patents that Congress recognized as so
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`important to the incentives undergirding the patent system.
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`Given the “highly fact-dependent” nature of the privity inquiry, additional
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`discovery is appropriate to show whether Teva is Petitioner’s privy. See Trial
`
`Guide, 77 Fed. Reg. at 48,759 (Privity “questions will be handled by the Office on
`
`a case-by-case basis taking into consideration how courts have viewed the terms
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`‘real party-in-interest’ and ‘privy.’”). Because Teva is time-barred, this discovery
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`may be dispositive of these proceedings as Petitioner would also be time-barred,
`
`through privity, from seeking IPR.
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`Privity is a “flexible and equitable” doctrine rooted in common law. Id.
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`Although privity inquiries often focus on the ability to control a proceeding, the
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`7
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`
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`Patent Office has recognized that privity “‘can apply even in the absence of such
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`IPR2016-01111
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`control.’” Id. at 48,760 (quoting Cal. Physicians’ Serv. v. Aoki Diabetes Research
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`Inst., 163 Cal. App. 4th 1506, 1523–25 (Cal. App. 2008)). The privity issue in this
`
`proceeding is similar to the numerous cases where privity arose when distinct
`
`parties held successive interests in the same property. See, e.g., Litchfield v.
`
`Crane, 123 U.S. 549, 551 (1887) (defining privity to include a “mutual or
`
`successive relationship to the same rights of property”); Greenway Ctr. Inc. v.
`
`Essex Ins. Co., 475 F.3d 139 (3d Cir. 2007) (same). Thus, a judgment with respect
`
`to a particular property interest may be binding on a third party based on a transfer
`
`of the property in issue to the third party after judgment. See Taylor, 128 S. Ct. at
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`2172–73; see also Restatement (Second) of Judgments § 43 (1982) (“A judgment
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`in an action that determines interests in real or personal property ... [h]as preclusive
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`effects upon a person who succeeds to the interest of a party to the same extent as
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`upon the party himself.”). The Board has also found that privity can exist between
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`“preceding and succeeding owners of property” or where a nonparty “assumed
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`control over the litigation.” Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc.,
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`IPR2014-01288, Paper 13 at 8–9 (Aruze) (citing Taylor, 128 S. Ct. at 2172–73).
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`And courts have repeatedly held that parties cannot circumvent a time limit,
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`such as a statute of limitations, through assignment. See, e.g., Murphy v. Jefferson
`
`Pilot Commc’ns Co., 657 F. Supp. 2d 683, 692 n.2 (D.S.C. 2008) (holding that the
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`8
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`
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`claim accrued based on the assignor’s knowledge because “if any assignment of a
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`IPR2016-01111
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`claim served to reset the statute of limitations, anyone could assign or sell a claim
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`for which the statute of limitations had long expired so long as the assignee did not
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`know about the basis for claim.”); Strauser v. Westfield Ins. Co., 827 N.E.2d 1181,
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`1185 (Ind. Ct. App. 2005) (“A cause of action brought by an assignee of another’s
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`claims accrues at the same time that the assignor’s claims accrued.”).
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`In this case, Teva’s ANDAs were the cause and have been the subject of
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`litigation for more than one year before Petitioner acquired the ANDAs. Petitioner
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`entered into a $350 million agreement with Teva to acquire the very same ANDAs,
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`but Petitioner has refused to disclose when acquisition discussions relating to those
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`ANDAs first occurred. Discovery may show, for example, that Petitioner reached
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`a binding legal agreement before filing its petitions. Indeed, news reports state that
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`Teva was “finalizing” its ANDA sales nearly one month before Dr. Reddy’s filed
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`its petitions. E.g., Ex. 2008 (Reuters report dated May 5, 2016). If mere
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`finalization was happening a month before Dr. Reddy’s filed its petitions,
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`discovery may show that the parties reached an agreement on terms with respect to
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`the Suboxone Film® ANDAs prior to the filing date of Dr. Reddy’s IPRs and
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`merely waited to formally execute the agreement in an effort to circumvent the
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`§ 315(b) bar.
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`Petitioner is likely in possession of documents, such as draft agreements and
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`9
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`
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`communications with Teva, that will provide important evidence regarding
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`IPR2016-01111
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`whether there is a privity relationship between Teva and Petitioner. Petitioner
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`notably has not denied the existence of draft agreements or communications. Ex.
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`2001, 23:22-24:13. Accordingly, Patent Owner seeks discovery of such evidence
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`in the interests of justice, and outline the five factors (“the Garmin Factors”) for
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`determining whether additional discovery is in the interests of justice below. See
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`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 26 at 6–7.
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`A.
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`First Garmin Factor: It is highly likely that the requested
`additional discovery will uncover relevant and useful information.
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`The requested discovery is highly likely to lead to evidence regarding privity
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`between Teva and Petitioner. Patent Owner has presented evidence such as press
`
`releases and news reports showing that (a) Teva has assigned the Suboxone® Film-
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`related ANDAs to Petitioner (Exs. 2006 & 2007), (b) Teva was “finalizing” its
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`ANDA divestures nearly a month before the petition was filed (Ex. 2008), and (c)
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`Teva and Petitioner reached a “definitive agreement” regarding the assignment no
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`more than eleven days after Dr. Reddy’s filed its petitions and potentially much
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`earlier (Ex. 2004). The requested discovery is therefore highly likely to show
`
`whether Petitioner is in privity with Teva and thus time-barred from seeking IPR.
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`In opposition, Petitioner asserted that (1) some of the requested documents
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`do not exist and (2) others of the requested documents are not relevant to privity.
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`Ex. 2001, 23:22-25:9, 30:24-31:2. The first assertion is a non sequitur at best and
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`10
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`
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`not credible at worst. After failing to provide any written response to Patent
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`IPR2016-01111
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`Owners’ discovery requests for weeks, Petitioner claimed for the first time during
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`the teleconference before the Board that certain types of documents (e.g., term
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`sheets and letters of intent) concerning the ANDA sale do not exist. Ex. 2001,
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`24:14–26:23. But Petitioner has never represented that there are no preliminary
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`documents (e.g., drafts and communications) pertaining to the ANDA sale.
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`Regardless, such a representation would not be credible because $350 million
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`dollar deals generally do not happen overnight, without related correspondence,
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`and without draft agreements. Similarly, Petitioner has never represented that
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`there were no communications concerning either Teva’s or Dr. Reddy’s IPRs
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`between Teva or its counsel and Dr. Reddy’s or its counsel (which might include
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`acquisition counsel other than Cantor Colburn, which is serving as IPR counsel).
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`Petitioner’s relevance objection is based on its mistaken attempt to draw
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`bright lines around when (i.e., at the time the complaint was served) and how (i.e.,
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`only consider finalized agreements) the issue of privity should be assessed. Ex.
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`2001, 13:7–17:4, 29:12–30:23. But as the Board has repeatedly explained, “privity
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`is based on flexible and equitable considerations,” and there is no “bright line test
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`for when privity exists.” E.g., Aruze, IPR2014-01288, Paper 13 at 15. Were
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`petitioners allowed to choose an arbitrary date for “closing” merely for the purpose
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`of first filing an IPR petition, then the flood gates would be open for failed
`
`11
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`
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`petitioners like Teva to transfer ANDAs and reset the one-year bar with impunity.
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`IPR2016-01111
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`Regardless, Petitioner’s cabined notion of privity should not preclude discovery
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`because Petitioner can seek that interpretation of privity after the relevant facts
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`have been disclosed.
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`During the teleconference with the Board, Petitioner cited Synopsys, Inc. v.
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`Mentor Graphics Corp., 814 F.3d 1309 (Fed. Cir. 2016), in support of its position
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`that privity should be assessed at the time the complaint was served. Ex. 2001,
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`30:6–23. But that Federal Circuit opinion does not provide any guidance regarding
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`privity, and merely holds that “the PTO’s decisions concerning the § 315(b) time
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`bar . . . are non-appealable.” Synopsys, 814 F.3d at 23–24. And the Board
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`decision in Synopsys relies on a wholly distinguishable situation, where there was
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`no already-pending litigation, no substitution of litigants, and no previous failed
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`IPR attempt. See IPR2012-00042, Paper 60, at 7 (Final Written Decision, Feb. 19,
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`2014) (explaining that the purposes behind § 315(b) are not implicated where the
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`petition does not affect “already-pending litigation”). By contrast, the purposes
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`behind § 315(b) of preventing gamesmanship and wasted effort are clearly
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`implicated by Petitioner’s strategy of filing a second set of IPRs and taking over
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`Teva’s role in the underlying litigation. Moreover, other Board decisions have
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`expressly acknowledged that the panel’s Synopsys decision “is not binding
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`precedent.” See, e.g., VMware, Inc. v. Good Tech. Software, Inc., IPR2015-00027,
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`12
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`
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`
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`Paper 11, at 3–4 (Mar. 6, 2015). Indeed, the Synopsis panel itself issued three
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`IPR2016-01111
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`different decisions on the § 315(b) issue, Papers 16, 23, and 60, each with a
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`different rationale. Patent Owners respectfully submit that, in addition to being
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`factually distinguishable, the Synopsys decisions wrongly decided several legal
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`issues beyond the scope of this discovery motion as part of the process of
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`“reconsider[ing its decision] during the merits phase of proceedings and restat[ing
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`it] as part of the Board’s final written decision.” Synopsis, 814 F.3d at 1314 n.4
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`(internal quotations omitted). Patent Owners respectfully request the opportunity
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`to brief those issues after pertinent discovery has been taken.
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`B.
`
`Second Garmin Factor: The requested discovery does not seek
`Teva’s or Petitioner’s litigation positions.
`
`Patent Owner does not seek any discovery concerning litigation positions.
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`Further, Patent Owners’ requests do not attempt to alter the Board’s trial
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`procedures under the pretext of discovery. Rather, Patent Owners’ requests are
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`narrowly targeted to the privity issue. Petitioner did not argue otherwise on the
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`teleconference with the Board regarding authorization for the present motion.
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`C. Third Garmin Factor: Patent Owner can only obtain the
`requested discovery through Petitioner.
`
`To date, Patent Owners have been able to discover publicly available
`
`information suggesting that Teva is a privy of Petitioner due to Petitioner’s
`
`acquisition of the Suboxone® Film ANDAs. But Patent Owners cannot obtain the
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`13
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`
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`requested discovery from publicly available sources. Indeed, Petitioner’s counsel
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`IPR2016-01111
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`has repeatedly represented that the requested discovery is highly confidential. Ex.
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`2001, 15:3–10, 17:18–23, 28:22–29:10, 31:10–22. Petitioner asserted on the
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`teleconference with the Board that Patent Owners can obtain the requested
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`discovery from Teva in the underlying litigation. Ex. 2001, 16:24–17:4. But that
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`assertion is incorrect because (a) counsel for Teva reported that it will soon cease
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`to be a party to the litigation and (b) the district court may not grant the discovery
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`requests, especially because fact discovery in that proceeding is now formally
`
`closed. Moreover, any district court discovery would be useless in this proceeding
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`because the Protective Order in that litigation does not permit the use of designated
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`materials outside of that litigation.
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`D.
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`Fourth Garmin Factor: The
`understandable.
`
`instructions
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`are
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`easily
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`Patent Owner seeks limited and straightforward discovery from Petitioner.
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`The proposed discovery does not include complex instructions, or any specific
`
`instructions, but rather relies on good faith that opposing counsel and Petitioner
`
`will reasonably interpret the requests. Patent Owners have only proposed four
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`requests to date, which are set forth in the Appendix. The requests themselves are
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`easily understandable. Petitioner did not argue otherwise on the teleconference
`
`with the Board regarding authorization for the present motion.
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`14
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`IPR2016-01111
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`E.
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`Fifth Garmin Factor: The requests are narrowly tailored and not
`burdensome.
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`Patent Owners propose only four requests
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`that seek
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`limited and
`
`straightforward discovery from Petitioner with regard to the issue of privity. The
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`requests do not seek large volumes of documents. And, they are limited to the
`
`facts and circumstances surrounding Dr. Reddy’s acquisition of the Suboxone®
`
`Film-related ANDAs. The requested discovery likely resides with a small number
`
`of Petitioner’s personnel. As such, there is little risk of financial burden, burden on
`
`human resources or IT, or jeopardizing the schedule of these proceedings.
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`On the teleconference with the Board, Petitioner vaguely alleged that it
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`would be burdened by producing the requested information. Ex. 2001, 31:10–18.
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`But Petitioner provided no detail or explanation regarding the alleged burden.
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`Given that Petitioner acquired ANDAs subject to ongoing litigation and initiated
`
`the present proceedings, it can hardly claim surprise that it may be subject to
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`relevant discovery. Further, Petitioner asserted concerns about protecting the
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`confidentiality of Petitioner’s information, but Patent Owners have indicated that
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`they would not be opposed to the entering of a protective order. Id. at 37:2–9.
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`Accordingly, this factor weighs in favor of granting the motion.
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`IV. CONCLUSION
`For the foregoing reasons, Patent Owner respectfully requests that the Board
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`grant this motion for additional discovery.
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`15
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`Date: August 11, 2016
`
`Steptoe & Johnson LLP
`1330 Connecticut Avenue, N.W.
`Washington, DC 20036-1795
`Telephone: (202) 429-3000
`Facsimile: (202) 429-3902
`
`IPR2016-01111
`
`Respectfully submitted,
`
`/Harold H. Fox/
`
`
`
`
`
`Harold H. Fox
`Reg. No. 41,498
`Counsel for MonoSol Rx, LLC
`
`16
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`
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`APPENDIX
`
`Patent Owner submits the following Requests for Production from
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`Petitioner:
`
`(1) The “definitive agreement” referenced in Petitioner’s June 11,
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`2016 press release (the “Agreement”), any drafts of the
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`Agreement, any term sheets or letter of intent related to the
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`Agreement, and any common interest or other agreement
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`related to the Agreement.
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`(2) Correspondence or communications
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`related
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`to
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`(a)
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`the
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`agreements or term sheets identified in category (1) above or
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`(b) the Suboxone® Film-related ANDAs.
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`(3) Correspondence or communications between Teva or its
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`counsel and Petitioners or their counsel regarding either Teva’s
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`or Petitioner’s IPR petitions.
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`(4) Documents sufficient to show the date on or about which Teva
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`and Petitioner initiated discussions relating to the Suboxone®
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`Film-related ANDAs.
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing PATENT
`OWNER MONOSOL RX, LLC’S MOTION FOR ADDITIONAL DISCOVERY,
`APPENDIX and EXHIBITS were served on August 11, 2016 by filing this
`document through the Patent Review Processing System as well as by delivering a
`copy via electronic email to the attorneys of record for the Patent Owner’s as
`follows:
`
`Jeffery B. Arnold
`Peter R. Hagerty
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`jarnold@cantorcolburn.com
`phagerty@cantorcolburn.com
`
`Leslie-Anne Maxwell, Ph.D.
`Andrew C. Ryan
`Cantor Colburn LLP
`20 Church Street, 22nd Floor
`Hartford, Connecticut 06103
`amaxwell@cantorcolburn.com
`ryan@cantorcolburn.com
`
`August 11, 2016 By
`
`
`
`
`/Harold H. Fox/
`
`
`
`
`
`Harold H. Fox
`Reg. No. 41,498
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036-1795
`Tel: (202) 429-3000
`Fax: (202) 429-3902
`
`Counsel for MonoSol Rx, LLC