`Filed: January 27, 2015
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`
`Filed on behalf of: Senju Pharmaceuticals Ltd., Co.
`By: M. Andrew Holtman, Ph.D.
`
`Jonathan R.K. Stroud
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Telephone: 202-408-4000
`Facsimile: 202-408-4400
`E-mail: andy.holtman@finnegan.com
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` jonathan.stroud@finnegan.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`METRICS, INC., MAYNE PHARMA, and
`JOHNSON MATTHEY, INC.
`Petitioner
`v.
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`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
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`Case IPR2014-01043
`Patent 8,669,290
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`Patent Owner’s Reply Brief
`to Petitioner’s Opposition Brief Addressing
`Real Party-in-Interest Issues Raised in Patent Owner’s Preliminary Response
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`IPR2014-01043
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`Table of Contents
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`I.
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`II.
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`Introduction ..................................................................................................... ii
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`Coastal is a real party-in-interest that Metrics was required to disclose
`under the AIA statute and regulations. .............................................................. 2
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`III. Metrics’ argument that Coastal allegedly cannot be an RPI because it is
`not a “separate legal entity” ignores the standard and purpose behind the
`RPI requirement, which Metrics has improperly attempted to evade. ............... 5
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`IV. Metrics’ belated request to amend its petition and identify Coastal, which
`confirms that Coastal in fact is an RPI, should be rejected as untimely
`and prejudicial to Senju. .................................................................................... 8
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`Conclusion ...................................................................................................... 10
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`i
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`V.
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`TABLE OF AUTHORITIES
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`FEDERAL CASES
`Snowden v. Checkpoint Check Cashing,
`290 F.3d 631 (4th Cir. 2002) ............................................................................ 4, 5
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`Page(s)
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`STATE CASES
`Baker v. Rushing,
`104 N.C. App. 240 (N.C. Ct. App. 1991) ............................................................. 7
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`La Familia Cosmovision, Inc. v. The Inspiration Networks,
`No. 13-CVS-1079, 2014 WL 5342583 (N.C. Super. Oct. 20, 2014) ................... 5
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`Pinkerton’s, Inc. v. Superior Court,
`57 Cal. Rptr. 2d 356 (Cal. Ct. App. 1996) ............................................................ 5
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`BOARD DECISIONS
`Conopco, Inc. d/b/a Unilever v. Procter & Gamble Co.,
`IPR2013-00505, IPR2013-00509 (Aug. 14, 2013) .............................................. 1
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`Nat’l Envtl. Prods. Ltd. & N.E.P., Inc., d/b/a Neptronic v. Dri-Steem Corp.,
`IPR2014-01503 (Sept. 9, 2014) ............................................................................ 1
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`Paramount Home Entm’t Inc. v. Nissim Corp.,
`IPR2014-00961 (Dec. 29, 2014) ............................................................... 1, 4, 7, 9
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`Wavemarket Inc. d/b/a Location Labs v. LocationNet Sys. Ltd.,
`IPR2014-00199, Paper 24 (June 11, 2014) ........................................................... 1
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`Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp.,
`IPR2013-00606, Paper 13 (Mar. 20, 2014) .......................................................... 6
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`FEDERAL STATUTES
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`35 U.S.C. § 271(e)(2) ................................................................................................. 3
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`35 U.S.C. § 312(a)(2) ............................................................................................. 1, 2
`ii
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`REGULATIONS
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`37 C.F.R. § 42.8 ......................................................................................................... 2
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`37 C.F.R. § 42.104 ..................................................................................................... 2
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`37 C.F.R. § 42.106(b) ........................................................................................ 1, 2, 9
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`Trial Practice Guide, 77 Fed. Reg. at 48,759 ............................................................. 6
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`iii
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`Introduction
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`“Where a party files an incomplete petition, no filing date will be accorded, and
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`the Office will dismiss the petition if the deficiency in the petition is not corrected
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`within one month . . . .” 37 C.F.R. § 42.106(b); see Paramount Home Entm’t Inc. v. Nissim
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`Corp., IPR2014-00961, at 8 (Dec. 29, 2014) (denying petition for failing to name real
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`party in interest (“RPI”)). Metrics filed an incomplete petition by failing to name an
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`RPI, Coastal, and its petition should be likewise dismissed under 35 U.S.C. § 312(a)(2).
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`The test for an RPI is not driven by corporate labels. It is a factual inquiry into
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`a party’s actions. Coastal, the disputed entity, is said to be a corporate “d/b/a,” and
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`thus, according to Metrics, not a real party in interest.1 Coastal, however, committed
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`most of the salient acts. It filed the Abbreviated New Drug Application (“ANDA”)
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`with the U.S. Food and Drug Administration (“FDA”) seeking to copy a patented
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`drug. Coastal likewise filed a Paragraph IV Certification, a statutory act of patent
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`1 Board petitions frequently disclose d/b/a entities as real parties-in-interest. See, e.g.,
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`Wavemarket Inc. d/b/a Location Labs v. LocationNet Sys. Ltd., IPR2014-00199, Paper 24,
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`at 1 (June 11, 2014) (“Wavemarket, Inc. d/b/a Location Labs (collectively
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`ʻPetitioner’)”); see also Conopco, Inc. d/b/a Unilever v. Procter & Gamble Co., IPR2013-
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`00505, IPR2013-00509 (Aug. 14, 2013) (informative); Nat’l Envtl. Prods. Ltd. &
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`N.E.P., Inc., d/b/a Neptronic v. Dri-Steem Corp., IPR2014-01503 (Sept. 9, 2014).
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`1
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`infringement, initiating district court litigation. The petition carbon copied Coastal’s
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`Paragraph IV Notice Letter to Senju. And contrary to Metrics’ assertion, Metrics’
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`admission in district court that Metrics and Coastal are in privity with one another
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`does not eliminate Coastal as an RPI but rather confirms it.
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`Senju respectfully requests that the Board deny the IPR petition for failure to
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`name the necessary parties.2 Metrics and Coastal both stand to benefit from the
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`ANDA and this petition; therefore, both needed to be named.
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`I.
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`Coastal is a real party-in-interest that Metrics had to disclose under the
`AIA statute and regulations.
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`Under the AIA statute, a petition for inter partes review “may be considered
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`only if” it meets distinct requirements. 35 U.S.C. § 312(a) (emphases added). The
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`statute requires that petitions identify “all real parties in interest.” 35 U.S.C.
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`§ 312(a)(2). The regulations likewise require that a petitioner identify “each real party-
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`in-interest for the party.” 37 C.F.R. § 42.8(a)(1), (b)(1), (b)(2); see also 37 C.F.R.
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`§ 42.104 (indicating that a petition for inter partes review must include “the
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`requirements of” § 42.8). When a petition fails to identify an RPI, “no filing date will
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`be accorded, and the Office will dismiss the petition” after a one-month grace period
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`expires. 37 C.F.R. § 42.106(b).
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`2 An incomplete RPI is but one of the many defects in Metrics’ petition requiring
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`dismissal, as set forth in Patent Owner’s Preliminary Response.
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`2
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`The centerpiece of Metrics’ argument is that Coastal is “solely a business name
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`for Metrics—nothing more.” Opp. Br. at 1. The extension of this argument is that
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`having a corporate designation of “d/b/a” somehow eliminates any need to further
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`determine whether its actions relative to the patents challenged by the petition also
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`make it a real party in interest as required by statute. Metrics’ bright-line argument—
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`besides being inappropriate—in no way excuses Metrics’ failure to initially name
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`Coastal as an RPI. Here, Coastal is a “real party” with an undeniable interest.
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`Coastal is enough of a real party to have filed an ANDA with the FDA seeking
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`to place a generic copy of a patented prescription drug into the U.S. marketplace.
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`EX2001. The ANDA contained a Paragraph IV Certification challenge by Coastal on
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`the validity of the same patent as the petition. Id. By doing so, Coastal committed a
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`statutory act of infringement, significantly harming Patent Owner Senju. 35 U.S.C.
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`§ 271(e)(2).3
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`3 This is not an isolated event. Coastal has made a business of these infringing acts,
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`having filed for at least nine generic versions of patented approved products. See
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`EX2023 (FDA Orange Book). Coastal owns approved ANDAs for the following
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`generic drugs: A090177 (Oxycodone and Acetaminophen); A091670 (asprin and
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`oxycodone hydrochloride); A201211 (bromfenac sodium); A090097 (liothyronine
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`3
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`Coastal’s interest reaches into this proceeding. Coastal, not Metrics, sent its
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`Paragraph IV Notice Letter to Senju on the same day this petition was filed by the
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`same counsel. That Letter makes the same validity arguments as those asserted here
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`on Metrics’ behalf, and relies on the same references. Compare EX2001 with Second
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`Corrected Petition, IPR2014-01043, Paper 9, at 1–50 (Aug. 20, 2014). Metrics could
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`not deny that it and Coastal are privies—in the district court litigation triggered by
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`Coastal, counsel for Metrics candidly conceded that the two entities are privies and
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`that any judgment binding one would bind the other. EX2004 at 30–31.
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`Metrics should not be permitted to use Coastal to harm Senju by infringing
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`Senju’s patents, and then to attack Senju’s same patents in this IPR proceeding
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`without naming Coastal. Metrics’ failure to name Coastal dictates denial of its
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`petition. See, e.g., Paramount Home Entm’t Inc. v. Nissim Corp., IPR2014-00961, at 8
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`(denying petition for failing to name RPI involved in license negotiations and related
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`district court litigation).
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`Metrics cites three cases for the proposition that “Coastal cannot be a RPI
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`because it is nothing more than a d/b/a trade name of Metrics.” Opp. Br. at 8–9.
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`None of these cases is directly relevant to an RPI inquiry or binds this Panel. The
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`sodium); A091189 (methamphetamine hydrochloride); A065203 (nystatin); A203107
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`(oxycodone hydrochloride); A204092 (same, Jun. 25, 2014); A091313 (same).
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`4
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`first case, Snowden v. Checkpoint Check Cashing, 290 F.3d 631, 634–35, n.2 (4th Cir.
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`2002), cites only to a footnote for support, and Pinkerton’s, Inc. v. Superior Court, 57 Cal.
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`Rptr 2d 356, 360 n.1 (Cal. Ct. App. 1996), a non-precedential California state court
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`decision, mentions a d/b/a but provides no insight into whether a d/b/a constitutes a
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`real party in interest before the PTAB. And Metrics cites La Familia Cosmovision, Inc. v.
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`The Inspiration Networks, an unpublished district court opinion, for the proposition that
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`a district court action cannot be maintained against both a legal entity and its assumed
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`name. No. 13-CVS-1079, 2014 WL 5342583, at *5 (N.C. Super. Oct. 20, 2014).
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`There the Court amended the case caption to read The Inspirational Network, Inc.
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`d/b/a The Inspirational Networks, satisfying the notice function and recognizing the
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`import of appropriately named parties. Id. Even so, La Familia did not address
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`whether a d/b/a could be a real party in interest for a petition before this Board.
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`II. Metrics’ argument that Coastal allegedly cannot be an RPI because it is
`not a “separate legal entity” ignores the standard and purpose behind
`the RPI requirement, which Metrics has improperly attempted to evade.
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`Metrics repeatedly argues that Coastal allegedly cannot be an RPI because it is
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`not a “separate legal entity” from Metrics. Opp. Br. at 1–3, 5, 7–10. That is not alone
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`dispositive, for even as Metrics acknowledges, the RPI inquiry is “highly fact-
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`dependent,” Opp. Br. at 2, and delves into a party’s actions and legal benefits.
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`Naming RPIs acts to “assist members of the Board in identifying potential
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`conflicts, and to assure proper application of the statutory estoppel provisions[,
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`5
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`which,] in turn, seek[] to protect patent owners from harassment via successive
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`petitions by the same or related parties, to prevent parties from having a ‘second bite
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`at the apple,’ and to protect the integrity of both the USPTO and Federal Courts by
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`assuring that all issues are promptly raised and vetted.” Trial Practice Guide (“TPG”),
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`77 Fed. Reg. at 48,759; see also Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-
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`00606, Paper 13, at 7–8 (Mar. 20, 2014).
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`By failing to disclose Coastal at the time of this petition’s filing, Metrics
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`prevented the Board judges from checking conflicts and to recuse themselves if they
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`had engaged in legal work for or against Coastal. Metrics prevented the Board from
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`searching for statements made by Coastal in other proceedings (e.g., other IPR
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`petitions, reexaminations, and/or litigations) that could bear on the issues and/or
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`credibility of evidence in this proceeding. TPG, 77 Fed. Reg. at 48,759; see also Zoll
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`Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-00606, Paper 13, at 7–8 (Mar. 20,
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`2014). And Metrics prevented the Board from properly applying the statutory
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`estoppel provisions within the PTO. Metrics’ failure to name Coastal as an RPI at the
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`time of filing thwarted these requirements, ultimately compromising the Board’s
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`ability to objectively and fairly administer justice.
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`Metrics argues that naming Coastal would not serve the purpose of the RPI
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`rule, for Coastal would not file a future IPR petition or appear in court without
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`Metrics. Opp. Br. at 3. Yet Coastal filed, on its own, an ANDA with a Paragraph IV
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`challenge against the patent in this proceeding and committed an independent act of
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`infringement.4 The threat therefore looms that Coastal could file future IPR petitions.
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`Indeed, had Senju not identified Coastal’s involvement with Metrics’ petition, the
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`Board would not have known about the relationship between Coastal and Metrics and
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`the impact of Coastal on Metrics’ petition. Moreover, the Board would not have
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`known about Coastal’s infringing ANDA Paragraph IV Certification, Coastal’s and
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`Metrics’ copying of validity arguments by the same counsel, and Coastal’s and Metrics’
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`pursuit of two parallel statutory schemes, as discussed in the POPR. See Paramount
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`Home Entm't. Inc. v. Nissim Corp., IPR2014-00961 (denying institution where same
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`counsel copied arguments in DJ action). Metrics has shown no intention of disclosing
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`this relationship, and the Board should not countenance Metrics’ failure to do so.
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`At the heart of Metrics’ position is an effort to claim “no harm, no foul”
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`because Senju allegedly has since raised related issues in the district court action. That
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`mischaracterizes the court’s actions, and suggests Metrics is gaming the system. Senju
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`4 Corporate records reveal that Coastal Pharmaceuticals, Inc. registered as a domestic
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`business incorporated in North Carolina on December 22, 2003. EX2024. The
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`North Carolina law of corporations holds that “dissolution does not terminate the
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`corporation’s existence; a dissolved corporation continues in existence indefinitely.”
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`Baker v. Rushing, 104 N.C. App. 240, at 250 (N.C. Ct. App. 1991).
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`7
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`sued the necessary parties to the district court litigation, as statute requires. Senju
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`forced Metrics to reveal its relationship with Coastal only after Metrics filed its
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`petition. In district court, Senju agreed to dismiss without prejudice as to Coastal, but
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`only after Metrics’ counsel admitted the parties were privies and after Senju secured
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`an order from the district court binding Coastal, as if it were a named party, to full
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`discovery and to any judgment against Metrics. Raising and addressing issues in one
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`forum does not negate the need to adhere to the requirements of another. Timely
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`addressing them was entirely within Metrics’ control, and any blame for the delay
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`belongs to Metrics. As in the district court, Coastal is a necessary party. It committed
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`a statutory act of infringement regarding the patent in this proceeding and has an
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`undeniable interest in the outcome. Coastal should have been named at filing so the
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`important purposes of the RPI rule could be fulfilled.
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`III. Metrics’ belated request to amend its petition and identify Coastal,
`which confirms that Coastal is an RPI, should be rejected as untimely
`and prejudicial to Senju.
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`In volunteering to amend the caption with a bold caveat that no negative
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`repercussions befall it, Metrics seeks to sidestep the consequences of not meeting its
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`filing obligations.5 Metrics is far too late to control that decision. Seven months after
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`5 Metrics’ stipulation to amendment without consequence amounts to an improper
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`request for an advisory opinion from the Board.
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`8
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`IPR2014-01043
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`Metrics filed its original petition and half a year after the one-month grace period set
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`forth in 37 C.F.R. § 42.106(b) expired, Metrics should not be permitted to evade the
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`consequences of its failure to comply with the statute and regulations. The Board
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`should reject Metrics’ request and deny its petition.
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`The panel has already Metrics multiple opportunities, three petitions, and seven
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`months to come forward with their relationship with Coastal and its related ANDA
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`filings. Metrics filed the first round of petitions June 26, 2014, the same day that
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`Coastal provided nearly identical invalidity arguments in its Paragraph IV Notice
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`Letter. Compare Pet., EX2001 with Paramount, IPR2014-00961, at 4–5 (dismissing
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`petition where declaratory judgments were “virtually a carbon copy” filed by the same
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`counsel). After the Board found Metrics’ filings defective, Metrics filed a first
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`Corrected Petition. Paper 6 (July 26). After Senju pointed to further defects, the
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`Board allowed Metrics to file a Second Corrected Petition. Paper 9 (Aug. 20). It was
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`not until two months after Senju highlighted Metrics’ deficiency in its POPR (Nov.
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`20) that Metrics finally contacted the Board in January.
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`Now—on the eve of a panel decision on institution and long after Coastal’s
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`harmful acts of infringement in derogation of Senju’s patent rights—Metrics asks to
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`amend the caption and keep its original filing date. If granted, Metrics’ request would
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`let it maintain a filing date to which it is not entitled and continue its race to the
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`Federal Circuit with IPRs Metrics filed after using Coastal to initiate parallel Hatch-
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`Waxman litigation in federal court. The Board should not permit them such
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`gamesmanship. For at least these reasons, the Board should reject Metrics’ belated
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`request to amend its petition and deny it.
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`IV. Conclusion
`Metrics’ petition did not identify Coastal as an RPI. Senju requests that the
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`panel not institute IPR for this and any of the reasons already presented in the POPR.
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`Dated: January 27, 2015
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`Respectfully submitted,
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`
`By: /M. Andrew Holtman/
`M. Andrew Holtman, Reg. No. 53,032
`Jonathan R.K. Stroud, Reg. No. 72,518
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
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`10
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`CERTIFICATE OF SERVICE
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`I certify that on this 27 January 2015, a copy of Patent Owner’s
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`Preinstitution Reply Brief in Inter Partes Review of U.S. Patent No. 8,669,290
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`and supporting materials were served by electronic mail, as agreed by the parties, upon
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`the following:
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`
`
`Patrick D. McPherson
`PDMcPherson@duanemorris.com
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`Vincent L. Capuano
`VCapuano@duanemorris.com
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`Dated: January 27, 2015
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`Respectfully submitted,
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`
`
`
`
`
` /Ashley Cheung/
`Ashley Cheung
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
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`11
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