`571-272-7822
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`Paper 9 (IPR2016-01111)
`Paper 9 (IPR2016-01112)
`Entered: September 1, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`
`Petitioner,
`v.
`MONOSOL RX, LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01111 (Patent 8,603,514 B2)
` Case IPR2016-01112 (Patent 8,017,150 B2)
`____________
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Denying Patent Owner’s Motions for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
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`
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`IPR2016-01111 (8,603,514 B2)
`IPR2016-01112 (8,017,150 B2)
`
`
`INTRODUCTION
`I.
`With authorization of the Board, Paper 6,1 MonoSol RX, LLC
`(“Patent Owner”) filed a motion for additional discovery in each captioned
`proceeding relating to the issue of privity between Dr. Reddy’s Laboratories,
`Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Petitioner”) and Teva
`Pharmaceuticals USA, Inc. (“Teva”). Paper 7 (“Mot.” or “Motion”).
`Previously, Teva filed Petitions directed to the same patents and challenging
`the same claims as in the instant Petitions. See Case IPR2016-00281, Paper
`1 and Case IPR2016-00282, Paper 1. Those Teva Petitions were denied
`because we determined that Teva did not file its Petitions within one year
`from the time it was served with a complaint in district court by Patent
`Owner. Case IPR2016-00281, Paper 21; Case IPR2016-00282, Paper 19; 35
`U.S.C. § 315(b). In addition, Teva previously filed a Petition directed to a
`related patent, owned by a different entity, Indivior UK Limited, and
`involving substantially similar subject matter. See Case IPR2016-00280,
`Paper 1. The Petition in IPR2016-00280 was denied primarily because Teva
`failed to make a threshold showing that certain references, critical to the
`grounds asserted, were sufficiently publicly accessible to qualify as “printed
`publications” under 35 U.S.C. § 102(b). See Case IPR2016-00280, Paper
`23.
`
`In its Motions now, Patent Owner seeks to serve four Requests for
`Production of documents relating to agreements and communications
`between Petitioner and Teva concerning Petitioner’s acquisition from Teva
`
`
`
` 1
`
` Papers and Exhibits cited in this decision are numbered the same in each
`proceeding.
`
`
`
`
`2
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`IPR2016-01111 (8,603,514 B2)
`IPR2016-01112 (8,017,150 B2)
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`of a portfolio of Abbreviated New Drug Applications (“ANDAs”) for
`buprenorphine HCl/naloxone HCl oral film, i.e., a generic version of
`Suboxone® Film. Mot. 6, Appendix. Petitioner opposes the Motion. Paper
`8 (“Opp.” or “Opposition”). For the reasons that follow, we deny Patent
`Owner’s Motion.
`
`II. ANALYSIS
`A party seeking discovery beyond what is expressly permitted by our
`rules must establish that such additional discovery is “necessary in the
`interest of justice.” 35 U.S.C. § 316(a)(5); see also 37 C.F.R. § 42.51(b)(2)
`(“The moving party must show that such additional discovery is in the
`interest of justice.”). Discovery in an inter partes review proceeding is more
`limited than in district court patent litigation, as Congress intended our
`proceedings to provide a more efficient and cost-effective alternative to such
`litigation. H. Rep. No. 112-98 at 45–48 (2011). Thus, we take a
`conservative approach to granting additional discovery. 154 Cong. Rec.
`S9988-89 (daily ed. Sept. 27, 2008) (statement of Sen. Kyl).
`The Board has identified five factors (the “Garmin factors”) to be
`considered in determining whether additional discovery is in the interest of
`justice. See Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, Case IPR2012-
`00001, slip op. at 6–7 (PTAB Mar. 5, 2013) (Paper 26) (precedential)
`(“Garmin”). In particular, the first Garmin factor requires essentially that
`the party seeking additional discovery establish that it already is in
`possession of a threshold amount of evidence or reasoning tending to show
`beyond speculation that something useful will be uncovered. Garmin at 7.
`In support of its assertion that its Requests for Production will
`uncover documents favorable to its position, Patent Owner offers the
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`IPR2016-01111 (8,603,514 B2)
`IPR2016-01112 (8,017,150 B2)
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`following as evidence tending to show beyond speculation that “Teva, as a
`predecessor in interest of the Suboxone® Film ANDAs, is in privity with
`Petitioner,” and therefore, like Teva, is now time-barred under § 315(b).
`Mot. 2. In particular, Patent Owner notes that Teva filed two ANDAs to
`market generic versions of Suboxone® Film. Id. at 1. Patent Owner asserts
`also that Teva’s denied Petitions were directed to patents covering
`Suboxone® Film. Id. Moreover, according to Patent Owner, the present
`Petitions, as well as the concurrently filed Petition in IPR2016-01113, with
`few exceptions, are virtually identical to Teva’s Petitions in IPR2016-00280,
`IPR2016-00281, and IPR2016-00282. Id. at 4.
`Patent Owner asserts also that after filing the Petitions in IPR2016-
`01111, 01112, and 01113, Petitioner issued a press release announcing that it
`had entered into an agreement to acquire a number of Teva’s ANDAs.
`Patent Owner represents that it “has since learned that the acquired ANDA’s
`include the Suboxone® Film ANDAs.” Id. at 1–2. Patent Owner further
`represents that it has been informed that Petitioner will likely be moving to
`substitute itself for Teva in ongoing district court litigation. Id. at 2.
`In an effort to determine the “timing and nature” of the agreement,
`Patent Owner initiated a telephone conference on July 6, 2016, with
`Petitioner. Id. at 5. Patent Owner asserts that Petitioner’s counsel was
`unwilling to answer questions during the conference regarding the ANDAs
`to be transferred by the agreement. Id. Thereafter, Patent Owner
`“propounded specific written requests to Petitioner on July 14, 2016,” but
`asserts that “Petitioner has refused to provide the requested discovery.” Id.
`Patent Owner contends that “Petitioner is likely in possession of
`documents, such as draft agreements and communications with Teva, that
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`will provide important evidence regarding whether there is a privity
`relationship between Teva and Petitioner.” Mot. 9–10. According to Patent
`Owner, Petitioner “notably has not denied the existence of draft agreements
`or communications.” Id. at 10.
`Patent Owner’s Requests for Production are set forth in an Appendix
`to its Motion. Patent Owner’s first proposed Request for Production is
`directed to the “definitive agreement” between Petitioner and Teva
`referenced in Petitioner’s June 11, 2016 press release (“the Agreement”),
`along with “any term sheets or letter of intent related to the Agreement, and
`any common interest or other related agreements.” Mot. Appendix 1. The
`second proposed Request for Production is directed to correspondence or
`communications related to the Agreement or other agreements or term sheets
`related to the Agreement, or the Suboxone® Film-related ANDAs. Id. The
`third proposed Request for Production is directed to correspondence or
`communications between Teva or its counsel and Petitioner or its counsel
`regarding either Teva’s or Petitioner’s Petitions for inter partes review. Id.
`Finally, the fourth proposed Request for Production is directed to documents
`“sufficient to show the date on or about which Teva and Petitioner initiated
`discussions relating to the Suboxone® Film-related ANDAs.” Id.
`In its Opposition, Petitioner has provided responses to each of Patent
`Owner’s Requests for Production. Opp. 17–18 (Appendix). In response to
`the first request, Petitioner initially “objects to the use of ‘related to’ in this
`request as vague.” Opp. 17. Nevertheless, Petitioner represents that:
`No “definitive agreement,” common interest agreements or
`drafts thereof or other agreements related to the ‘definitive
`agreement’ or drafts thereof executed on or before May 31, 2016
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`IPR2016-01111 (8,603,514 B2)
`IPR2016-01112 (8,017,150 B2)
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`exist. No terms sheets or drafts thereof exist. No letters of intent
`or drafts thereof exist.
`Id. (emphasis added).
`In that regard, Petitioner contends that the evidence proffered by
`Patent Owner “establishes that Petitioner’s acquisition of the ANDAs from
`Teva occurred after the petition was filed on May 31, 2016” and “[a]ny
`suggestion by Patent Owner to the contrary is based on nothing but pure
`speculation.” Id. at 4. Specifically, Petitioner contends that its June 11,
`2016 press release “shows that Petitioner’s acquisition of the ANDAs was
`not complete even as of that date. Rather, the press release states that ‘The
`acquisition of these ANDAs is also contingent on the closing of the
`Teva/Allergan generics transaction and approval by the U.S. Federal Trade
`Commission of Dr. Reddy’s as a buyer.’” Id. (citing Ex. 2004). Moreover,
`Petitioner contends that “the FTC’s press release of July 27, 2016 . . . shows
`that the acquisition was not even finalized as of that date, but rather that
`‘Teva and Allergan must divest the drug products no later than 10 days after
`the acquisition is complete.’” Id. at 4-5 (citing Ex. 1041, 2).
`Petitioner argues essentially that “it is only privity relationships up
`until the time a petition is filed that matter; any later-acquired privies are
`irrelevant.” Opp. at 4 (quoting Synopsys, Inc. v. Mentor Graphics Corp.,
`Case IPR2012-00042, slip op. at 12 (PTAB Feb. 19, 2014) (Paper 60)
`(“Synopsys”). Petitioner contends that Patent Owner has failed to show how
`documents described in the first Request—none of which were executed on
`or before May 31, 2016, the filing date of the present Petition—are relevant
`to show privity at any time prior to the filing of the present Petition. Id.
`
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`IPR2016-01111 (8,603,514 B2)
`IPR2016-01112 (8,017,150 B2)
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`We agree with Petitioner that Patent Owner’s evidence and argument
`in support of its discovery requests fail to demonstrate more than a mere
`possibility or mere allegation that something useful will be found.
`Generally, the Board has considered the relationship between entities
`alleged to be in privity at the time of service of the complaint. See, e.g.,
`Synopsys, Paper 60, at 13 (“A person who was not a party to a suit generally
`has not had a ‘full and fair opportunity to litigate’ the claims and issues
`settled in that suit.”). Patent Owner has not alleged that privity existed
`between Petitioner and Teva when Patent Owner served Teva with a
`complaint on December 3, 2014. Even accepting arguendo that Petitioner’s
`acquisition of Teva’s ANDAs (as opposed to acquisition of Teva as a wholly
`owned subsidiary2) established privity between Petitioner and Teva, Patent
`Owner has not proffered persuasive evidence that indicia of privity existed at
`any time prior to the filing of the present Petition—e.g., a pre-existing
`substantive legal relationship between Teva and Petitioner; Teva’s control
`of, or opportunity to control the present proceeding; or Petitioner’s control
`of any previous proceeding involving the present patent. See Taylor v.
`Sturgell, 553 U.S. 880, 893–95 (2008). Finally, to the extent Petitioner
`contends that the present Petition is virtually identical to Teva’s Petition in
`IPR2016-00280 (Mot. 4), we do not view this as evidence of control on
`Teva’s part. Teva’s prior Petitions are, and previously were, publically
`available.
`
`
` 2
`
` Cf. VMware, Inc. v. Good Tech. Software, Inc., Case IPR2014-01324
`(PTAB Feb. 20, 2015) (Paper 28, Decision Denying Institution of Inter
`Partes Review) (finding the parties in privity after service of a complaint
`where one party acquired the other as a wholly-owned subsidiary).
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`IPR2016-01111 (8,603,514 B2)
`IPR2016-01112 (8,017,150 B2)
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`With respect to Patent Owner’s second and third Requests for
`Production, Petitioner represents that no responsive documents exist. Opp.
`18. Accordingly, authorizing the second and third Requests would be
`unproductive. Regarding the fourth request, Patent Owner has not
`demonstrated anything more than the mere possibility that documents
`showing the date on which Teva and Petitioner initiated discussions relating
`to the Teva ANDAs, even if extant, would not be relevant to the issue of
`privity at the relevant time.
`Thus, the first Garmin factor weighs heavily against granting Patent
`Owner’s request for additional discovery. We note that Patent Owner also
`addresses the remaining factors set forth in Garmin. Mot. 13–15. Even if
`we considered those factors to weigh in favor of Patent Owner, however,
`Patent Owner still has not met its burden to show that the additional
`discovery would serve the interest of justice, for the reasons provided above.
`Having considered the evidence and arguments proffered in support of
`the Requests for Production, together with Petitioner’s responses, we are not
`persuaded that granting Patent Owner’s Motions would uncover something
`useful in support of Patent Owner’s contention that Petitioner and Teva were
`in privity at the relevant time.
`III. CONCLUSION
`For the reasons discussed above, and in consideration of our
`
`conservative approach to granting additional discovery, we conclude that
`Patent Owner has not met its burden to show that the additional discovery
`sought is necessary in the interest of justice.
`
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`IPR2016-01111 (8,603,514 B2)
`IPR2016-01112 (8,017,150 B2)
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`IV. ORDER
`In accordance with the foregoing, it is hereby:
`
`ORDERED that Patent Owner’s Motions for additional discovery are
`
`denied.
`
`
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`
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`PETITIONER:
`
`Jeffery B. Arnold
`Peter R. Hagerty
`Leslei-Anne Maxwell
`Andrew C. Ryan
`CANTOR COLBURN LLP
`jarnold@cantorcolburn.com
`phagerty@cantorcolburn.com
`amaxwell@cantorcolburn.com
`ryan@cantorcolburn.com
`
`
`PATENT OWNER:
`
`Harold Fox
`John L. Abramic
`STEPTOE & JOHNSON LLP
`hfox@steptoe.com
`jabramic@steptoe.com
`
`
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`9
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