throbber
Paper No. __
`Filed: January 27, 2015
`
`
`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
`
` jonathan.stroud@finnegan.com
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`METRICS, INC., MAYNE PHARMA, and
`JOHNSON MATTHEY, INC.
`Petitioner
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`
`
`
`
`
`
`
`
`Case IPR2014-01043
`Patent 8,669,290
`
`
`
`
`
`
`
`
`Patent Owner’s Reply Brief
`to Petitioner’s Opposition Brief Addressing
`Real Party-in-Interest Issues Raised in Patent Owner’s Preliminary Response
`
`
`
`
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`
`Table of Contents
`
`I. 
`
`II. 
`
`Introduction ..................................................................................................... ii 
`
`Coastal is a real party-in-interest that Metrics was required to disclose
`under the AIA statute and regulations. .............................................................. 2 
`
`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 
`
`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 
`
`Conclusion ...................................................................................................... 10 
`
`i
`
`V. 
`
`
`
`
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`
`
`
`TABLE OF AUTHORITIES
`
`
`FEDERAL CASES
`Snowden v. Checkpoint Check Cashing,
`290 F.3d 631 (4th Cir. 2002) ............................................................................ 4, 5
`
`Page(s)
`
`STATE CASES
`Baker v. Rushing,
`104 N.C. App. 240 (N.C. Ct. App. 1991) ............................................................. 7
`
`La Familia Cosmovision, Inc. v. The Inspiration Networks,
`No. 13-CVS-1079, 2014 WL 5342583 (N.C. Super. Oct. 20, 2014) ................... 5
`
`Pinkerton’s, Inc. v. Superior Court,
`57 Cal. Rptr. 2d 356 (Cal. Ct. App. 1996) ............................................................ 5
`
`BOARD DECISIONS
`Conopco, Inc. d/b/a Unilever v. Procter & Gamble Co.,
`IPR2013-00505, IPR2013-00509 (Aug. 14, 2013) .............................................. 1
`
`Nat’l Envtl. Prods. Ltd. & N.E.P., Inc., d/b/a Neptronic v. Dri-Steem Corp.,
`IPR2014-01503 (Sept. 9, 2014) ............................................................................ 1
`
`Paramount Home Entm’t Inc. v. Nissim Corp.,
`IPR2014-00961 (Dec. 29, 2014) ............................................................... 1, 4, 7, 9
`
`Wavemarket Inc. d/b/a Location Labs v. LocationNet Sys. Ltd.,
`IPR2014-00199, Paper 24 (June 11, 2014) ........................................................... 1
`
`Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp.,
`IPR2013-00606, Paper 13 (Mar. 20, 2014) .......................................................... 6
`
`FEDERAL STATUTES
`
`35 U.S.C. § 271(e)(2) ................................................................................................. 3
`
`35 U.S.C. § 312(a)(2) ............................................................................................. 1, 2
`ii
`
`
`
`

`

`REGULATIONS
`
`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`
`37 C.F.R. § 42.8 ......................................................................................................... 2
`
`37 C.F.R. § 42.104 ..................................................................................................... 2
`
`37 C.F.R. § 42.106(b) ........................................................................................ 1, 2, 9
`
`Trial Practice Guide, 77 Fed. Reg. at 48,759 ............................................................. 6
`
`
`
`
`
`iii
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`
`Introduction
`
`“Where a party files an incomplete petition, no filing date will be accorded, and
`
`the Office will dismiss the petition if the deficiency in the petition is not corrected
`
`within one month . . . .” 37 C.F.R. § 42.106(b); see Paramount Home Entm’t Inc. v. Nissim
`
`Corp., IPR2014-00961, at 8 (Dec. 29, 2014) (denying petition for failing to name real
`
`party in interest (“RPI”)). Metrics filed an incomplete petition by failing to name an
`
`RPI, Coastal, and its petition should be likewise dismissed under 35 U.S.C. § 312(a)(2).
`
`The test for an RPI is not driven by corporate labels. It is a factual inquiry into
`
`a party’s actions. Coastal, the disputed entity, is said to be a corporate “d/b/a,” and
`
`thus, according to Metrics, not a real party in interest.1 Coastal, however, committed
`
`most of the salient acts. It filed the Abbreviated New Drug Application (“ANDA”)
`
`with the U.S. Food and Drug Administration (“FDA”) seeking to copy a patented
`
`drug. Coastal likewise filed a Paragraph IV Certification, a statutory act of patent
`
`
`1 Board petitions frequently disclose d/b/a entities as real parties-in-interest. See, e.g.,
`
`Wavemarket Inc. d/b/a Location Labs v. LocationNet Sys. Ltd., IPR2014-00199, Paper 24,
`
`at 1 (June 11, 2014) (“Wavemarket, Inc. d/b/a Location Labs (collectively
`
`ʻPetitioner’)”); see also Conopco, Inc. d/b/a Unilever v. Procter & Gamble Co., IPR2013-
`
`00505, IPR2013-00509 (Aug. 14, 2013) (informative); Nat’l Envtl. Prods. Ltd. &
`
`N.E.P., Inc., d/b/a Neptronic v. Dri-Steem Corp., IPR2014-01503 (Sept. 9, 2014).
`
`
`
`1
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`infringement, initiating district court litigation. The petition carbon copied Coastal’s
`
`Paragraph IV Notice Letter to Senju. And contrary to Metrics’ assertion, Metrics’
`
`admission in district court that Metrics and Coastal are in privity with one another
`
`does not eliminate Coastal as an RPI but rather confirms it.
`
`Senju respectfully requests that the Board deny the IPR petition for failure to
`
`name the necessary parties.2 Metrics and Coastal both stand to benefit from the
`
`ANDA and this petition; therefore, both needed to be named.
`
`I.
`
`Coastal is a real party-in-interest that Metrics had to disclose under the
`AIA statute and regulations.
`
`Under the AIA statute, a petition for inter partes review “may be considered
`
`only if” it meets distinct requirements. 35 U.S.C. § 312(a) (emphases added). The
`
`statute requires that petitions identify “all real parties in interest.” 35 U.S.C.
`
`§ 312(a)(2). The regulations likewise require that a petitioner identify “each real party-
`
`in-interest for the party.” 37 C.F.R. § 42.8(a)(1), (b)(1), (b)(2); see also 37 C.F.R.
`
`§ 42.104 (indicating that a petition for inter partes review must include “the
`
`requirements of” § 42.8). When a petition fails to identify an RPI, “no filing date will
`
`be accorded, and the Office will dismiss the petition” after a one-month grace period
`
`expires. 37 C.F.R. § 42.106(b).
`
`2 An incomplete RPI is but one of the many defects in Metrics’ petition requiring
`
`dismissal, as set forth in Patent Owner’s Preliminary Response.
`
`
`
`2
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`The centerpiece of Metrics’ argument is that Coastal is “solely a business name
`
`for Metrics—nothing more.” Opp. Br. at 1. The extension of this argument is that
`
`having a corporate designation of “d/b/a” somehow eliminates any need to further
`
`determine whether its actions relative to the patents challenged by the petition also
`
`make it a real party in interest as required by statute. Metrics’ bright-line argument—
`
`besides being inappropriate—in no way excuses Metrics’ failure to initially name
`
`Coastal as an RPI. Here, Coastal is a “real party” with an undeniable interest.
`
`Coastal is enough of a real party to have filed an ANDA with the FDA seeking
`
`to place a generic copy of a patented prescription drug into the U.S. marketplace.
`
`EX2001. The ANDA contained a Paragraph IV Certification challenge by Coastal on
`
`the validity of the same patent as the petition. Id. By doing so, Coastal committed a
`
`statutory act of infringement, significantly harming Patent Owner Senju. 35 U.S.C.
`
`§ 271(e)(2).3
`
`
`3 This is not an isolated event. Coastal has made a business of these infringing acts,
`
`having filed for at least nine generic versions of patented approved products. See
`
`EX2023 (FDA Orange Book). Coastal owns approved ANDAs for the following
`
`generic drugs: A090177 (Oxycodone and Acetaminophen); A091670 (asprin and
`
`oxycodone hydrochloride); A201211 (bromfenac sodium); A090097 (liothyronine
`
`
`
`
`
`3
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`Coastal’s interest reaches into this proceeding. Coastal, not Metrics, sent its
`
`Paragraph IV Notice Letter to Senju on the same day this petition was filed by the
`
`same counsel. That Letter makes the same validity arguments as those asserted here
`
`on Metrics’ behalf, and relies on the same references. Compare EX2001 with Second
`
`Corrected Petition, IPR2014-01043, Paper 9, at 1–50 (Aug. 20, 2014). Metrics could
`
`not deny that it and Coastal are privies—in the district court litigation triggered by
`
`Coastal, counsel for Metrics candidly conceded that the two entities are privies and
`
`that any judgment binding one would bind the other. EX2004 at 30–31.
`
`Metrics should not be permitted to use Coastal to harm Senju by infringing
`
`Senju’s patents, and then to attack Senju’s same patents in this IPR proceeding
`
`without naming Coastal. Metrics’ failure to name Coastal dictates denial of its
`
`petition. See, e.g., Paramount Home Entm’t Inc. v. Nissim Corp., IPR2014-00961, at 8
`
`(denying petition for failing to name RPI involved in license negotiations and related
`
`district court litigation).
`
`Metrics cites three cases for the proposition that “Coastal cannot be a RPI
`
`because it is nothing more than a d/b/a trade name of Metrics.” Opp. Br. at 8–9.
`
`None of these cases is directly relevant to an RPI inquiry or binds this Panel. The
`
`
`sodium); A091189 (methamphetamine hydrochloride); A065203 (nystatin); A203107
`
`(oxycodone hydrochloride); A204092 (same, Jun. 25, 2014); A091313 (same).
`
`
`
`4
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`first case, Snowden v. Checkpoint Check Cashing, 290 F.3d 631, 634–35, n.2 (4th Cir.
`
`2002), cites only to a footnote for support, and Pinkerton’s, Inc. v. Superior Court, 57 Cal.
`
`Rptr 2d 356, 360 n.1 (Cal. Ct. App. 1996), a non-precedential California state court
`
`decision, mentions a d/b/a but provides no insight into whether a d/b/a constitutes a
`
`real party in interest before the PTAB. And Metrics cites La Familia Cosmovision, Inc. v.
`
`The Inspiration Networks, an unpublished district court opinion, for the proposition that
`
`a district court action cannot be maintained against both a legal entity and its assumed
`
`name. No. 13-CVS-1079, 2014 WL 5342583, at *5 (N.C. Super. Oct. 20, 2014).
`
`There the Court amended the case caption to read The Inspirational Network, Inc.
`
`d/b/a The Inspirational Networks, satisfying the notice function and recognizing the
`
`import of appropriately named parties. Id. Even so, La Familia did not address
`
`whether a d/b/a could be a real party in interest for a petition before this Board.
`
`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.
`
`Metrics repeatedly argues that Coastal allegedly cannot be an RPI because it is
`
`not a “separate legal entity” from Metrics. Opp. Br. at 1–3, 5, 7–10. That is not alone
`
`dispositive, for even as Metrics acknowledges, the RPI inquiry is “highly fact-
`
`dependent,” Opp. Br. at 2, and delves into a party’s actions and legal benefits.
`
`Naming RPIs acts to “assist members of the Board in identifying potential
`
`conflicts, and to assure proper application of the statutory estoppel provisions[,
`
`
`
`5
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`which,] in turn, seek[] to protect patent owners from harassment via successive
`
`petitions by the same or related parties, to prevent parties from having a ‘second bite
`
`at the apple,’ and to protect the integrity of both the USPTO and Federal Courts by
`
`assuring that all issues are promptly raised and vetted.” Trial Practice Guide (“TPG”),
`
`77 Fed. Reg. at 48,759; see also Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-
`
`00606, Paper 13, at 7–8 (Mar. 20, 2014).
`
`By failing to disclose Coastal at the time of this petition’s filing, Metrics
`
`prevented the Board judges from checking conflicts and to recuse themselves if they
`
`had engaged in legal work for or against Coastal. Metrics prevented the Board from
`
`searching for statements made by Coastal in other proceedings (e.g., other IPR
`
`petitions, reexaminations, and/or litigations) that could bear on the issues and/or
`
`credibility of evidence in this proceeding. TPG, 77 Fed. Reg. at 48,759; see also Zoll
`
`Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-00606, Paper 13, at 7–8 (Mar. 20,
`
`2014). And Metrics prevented the Board from properly applying the statutory
`
`estoppel provisions within the PTO. Metrics’ failure to name Coastal as an RPI at the
`
`time of filing thwarted these requirements, ultimately compromising the Board’s
`
`ability to objectively and fairly administer justice.
`
`Metrics argues that naming Coastal would not serve the purpose of the RPI
`
`rule, for Coastal would not file a future IPR petition or appear in court without
`
`Metrics. Opp. Br. at 3. Yet Coastal filed, on its own, an ANDA with a Paragraph IV
`
`
`
`6
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`challenge against the patent in this proceeding and committed an independent act of
`
`infringement.4 The threat therefore looms that Coastal could file future IPR petitions.
`
`Indeed, had Senju not identified Coastal’s involvement with Metrics’ petition, the
`
`Board would not have known about the relationship between Coastal and Metrics and
`
`the impact of Coastal on Metrics’ petition. Moreover, the Board would not have
`
`known about Coastal’s infringing ANDA Paragraph IV Certification, Coastal’s and
`
`Metrics’ copying of validity arguments by the same counsel, and Coastal’s and Metrics’
`
`pursuit of two parallel statutory schemes, as discussed in the POPR. See Paramount
`
`Home Entm't. Inc. v. Nissim Corp., IPR2014-00961 (denying institution where same
`
`counsel copied arguments in DJ action). Metrics has shown no intention of disclosing
`
`this relationship, and the Board should not countenance Metrics’ failure to do so.
`
`At the heart of Metrics’ position is an effort to claim “no harm, no foul”
`
`because Senju allegedly has since raised related issues in the district court action. That
`
`mischaracterizes the court’s actions, and suggests Metrics is gaming the system. Senju
`
`
`4 Corporate records reveal that Coastal Pharmaceuticals, Inc. registered as a domestic
`
`business incorporated in North Carolina on December 22, 2003. EX2024. The
`
`North Carolina law of corporations holds that “dissolution does not terminate the
`
`corporation’s existence; a dissolved corporation continues in existence indefinitely.”
`
`Baker v. Rushing, 104 N.C. App. 240, at 250 (N.C. Ct. App. 1991).
`
`
`
`7
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`sued the necessary parties to the district court litigation, as statute requires. Senju
`
`forced Metrics to reveal its relationship with Coastal only after Metrics filed its
`
`petition. In district court, Senju agreed to dismiss without prejudice as to Coastal, but
`
`only after Metrics’ counsel admitted the parties were privies and after Senju secured
`
`an order from the district court binding Coastal, as if it were a named party, to full
`
`discovery and to any judgment against Metrics. Raising and addressing issues in one
`
`forum does not negate the need to adhere to the requirements of another. Timely
`
`addressing them was entirely within Metrics’ control, and any blame for the delay
`
`belongs to Metrics. As in the district court, Coastal is a necessary party. It committed
`
`a statutory act of infringement regarding the patent in this proceeding and has an
`
`undeniable interest in the outcome. Coastal should have been named at filing so the
`
`important purposes of the RPI rule could be fulfilled.
`
`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.
`
`In volunteering to amend the caption with a bold caveat that no negative
`
`repercussions befall it, Metrics seeks to sidestep the consequences of not meeting its
`
`filing obligations.5 Metrics is far too late to control that decision. Seven months after
`
`
`5 Metrics’ stipulation to amendment without consequence amounts to an improper
`
`request for an advisory opinion from the Board.
`
`
`
`8
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`Metrics filed its original petition and half a year after the one-month grace period set
`
`forth in 37 C.F.R. § 42.106(b) expired, Metrics should not be permitted to evade the
`
`consequences of its failure to comply with the statute and regulations. The Board
`
`should reject Metrics’ request and deny its petition.
`
`The panel has already Metrics multiple opportunities, three petitions, and seven
`
`months to come forward with their relationship with Coastal and its related ANDA
`
`filings. Metrics filed the first round of petitions June 26, 2014, the same day that
`
`Coastal provided nearly identical invalidity arguments in its Paragraph IV Notice
`
`Letter. Compare Pet., EX2001 with Paramount, IPR2014-00961, at 4–5 (dismissing
`
`petition where declaratory judgments were “virtually a carbon copy” filed by the same
`
`counsel). After the Board found Metrics’ filings defective, Metrics filed a first
`
`Corrected Petition. Paper 6 (July 26). After Senju pointed to further defects, the
`
`Board allowed Metrics to file a Second Corrected Petition. Paper 9 (Aug. 20). It was
`
`not until two months after Senju highlighted Metrics’ deficiency in its POPR (Nov.
`
`20) that Metrics finally contacted the Board in January.
`
`Now—on the eve of a panel decision on institution and long after Coastal’s
`
`harmful acts of infringement in derogation of Senju’s patent rights—Metrics asks to
`
`amend the caption and keep its original filing date. If granted, Metrics’ request would
`
`let it maintain a filing date to which it is not entitled and continue its race to the
`
`Federal Circuit with IPRs Metrics filed after using Coastal to initiate parallel Hatch-
`
`
`
`9
`
`

`

`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`Waxman litigation in federal court. The Board should not permit them such
`
`gamesmanship. For at least these reasons, the Board should reject Metrics’ belated
`
`request to amend its petition and deny it.
`
`IV. Conclusion
`Metrics’ petition did not identify Coastal as an RPI. Senju requests that the
`
`panel not institute IPR for this and any of the reasons already presented in the POPR.
`
`
`
`Dated: January 27, 2015
`
`
`
`Respectfully submitted,
`
`
`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
`
`
`
`10
`
`

`

`
`
`IPR2014-01043
`Patent Owner’s Preinstitution Reply Brief
`Patent 8,669,290
`
`CERTIFICATE OF SERVICE
`
`I certify that on this 27 January 2015, a copy of Patent Owner’s
`
`Preinstitution Reply Brief in Inter Partes Review of U.S. Patent No. 8,669,290
`
`and supporting materials were served by electronic mail, as agreed by the parties, upon
`
`the following:
`
`
`
`Patrick D. McPherson
`PDMcPherson@duanemorris.com
`
`Vincent L. Capuano
`VCapuano@duanemorris.com
`
`
`Dated: January 27, 2015
`
`Respectfully submitted,
`
`
`
`
`
`
` /Ashley Cheung/
`Ashley Cheung
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`
`
`
`
`
`
`
`11
`
`

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