IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`METRICS, INC.
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`_____________________
`
`U.S. Patent No. 8,129,431 to Sawa et al.
`Issue Date: March 6, 2012
`Title: Aqueous Liquid Preparation Containing 2-Amino-3-(4-bromobenzoyl)
`Phenylacetic Acid
`_____________________
`
`Inter Partes Review No.: IPR2014-01041
` _____________________
`
`PETITIONER’S OPPOSITION TO INNOPHARMA’S MOTION FOR
`JOINDER AND PROPOSED SCHEDULING ORDER FILED
`IN IPR2015-00903
`
`
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`
`
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`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`METRICS, INC.
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`_____________________
`
`U.S. Patent No. 8,129,431 to Sawa et al.
`Issue Date: March 6, 2012
`Title: Aqueous Liquid Preparation Containing 2-Amino-3-(4-bromobenzoyl)
`Phenylacetic Acid
`_____________________
`
`Inter Partes Review No.: IPR2014-01041
` _____________________
`
`PETITIONER’S OPPOSITION TO INNOPHARMA’S MOTION FOR
`JOINDER AND PROPOSED SCHEDULING ORDER FILED
`IN IPR2015-00903
`
`
`
`
`
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`I.
`
`RELIEF REQUESTED
`Pursuant to the Board’s Order of April 17, 2015 (see Paper 31), Petitioner
`
`Metrics, Inc. (“Metrics”) submits this Opposition to InnoPharma Licensing Inc.,
`
`InnoPharma Licensing LLC, InnoPharma Inc., InnoPharma LLC, Mylan
`
`Pharmaceuticals Inc., and Mylan Inc.’s (collectively, “InnoPharma”) Motion for
`
`Joinder (see IPR2015-00903, Paper 0) (“Motion for Joinder”) and Proposed
`
`Scheduling Order (see IPR2015-00903, Paper 9) (“Proposed Scheduling Order”).
`
`InnoPharma requests that the Board grant joinder of IPR2015-00903 with
`
`the currently instituted proceeding, and submits its Proposed Scheduling Order
`
`extending the current trial schedule. For the reasons set forth below, the Board
`
`should reject InnoPharma’s Motion for Joinder because joining the schedules and
`
`granting joinder will unduly delay Metrics’ already progressing instant proceeding
`
`and unduly prejudice Metrics. To the extent that the Board is inclined to grant
`
`InnoPharma’s Motion for Joinder, either in whole or in-part, Metrics requests that
`
`the Board adjust and adopt the schedule proposed below in order to minimize the
`
`disruption to the instant proceeding and maintain the scheduled oral hearing in this
`
`instituted trial proceeding.
`
`II.
`
`PROCEDURAL BACKGROUND
`
`On June 26, 2014, Metrics filed an Abbreviated New Drug Application
`
`(“ANDA”) with the Food and Drug Administration, including a Paragraph IV
`
`
`
`
`
`Certification asserting, inter alia, that the claims of U.S. Patent No. 8,129,431
`
`(“the ’431 Patent) are invalid. The ’431 Patent is currently the subject of a patent
`
`infringement suit pending in the U.S. District Court for the District of New Jersey
`
`against Metrics which was filed by Patent Owner in response to Metrics’ ANDA
`
`filing. (See Senju Pharmaceutical Co., Ltd., et al. v. Metrics, Inc., et al., C.A. No.
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`1:14-cv-03962-JBS-KMW (D.N.J.)). Metrics can receive final approval for its
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`ANDA by showing that the ’431 Patent is invalid. In order to prove invalidity and
`
`secure final approval of its ANDA, Metrics filed its Petition for Inter Partes
`
`Review challenging each of the claims of the ’431 Patent on June 26, 2014. (See
`
`Papers 1, 6, and 9). On November 20, 2014, Patent Owner filed its Preliminary
`
`Response. (See Paper 13). The Board instituted trial in its Decision of February
`
`19, 2015 (see Paper 19) and issued its Scheduling Order on the same day (see
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`Paper 20) (“Scheduling Order”).
`
`On March 19, 2015, InnoPharma filed its Petition for Inter Partes Review of
`
`the ’431 Patent in IPR2015-00903 (see IPR2015-00903, Paper 2), which was
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`accompanied by its Motion for Joinder. By Order, Patent Owner’s Preliminary
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`Response in InnoPharma’s proceeding is due May 26, 2015. (See Paper 31, 3). On
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`May 19, 2015, InnoPharma, based on its request for joinder, filed its Proposed
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`Scheduling Order to amend the current schedule in the instant proceeding,
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`including delaying the oral hearing date from November 12, 2015 to January 21,
`
`2
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`
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`2016. (See IPR2015-00903, Paper 9, 4). Based on the current trial schedule,1
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`Patent Owner’s Response (Due Date 1) is due on June 26, 2015. The Parties are
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`currently working on scheduling the deposition of Metrics’ expert in the next three
`
`(3) weeks.
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`III. DISCUSSION
`A. Metrics Will Be Prejudiced If The Board Grants Joinder Because
`Additional Expert Discovery Will Be Required
`
`The instant proceeding is sufficiently advanced that permitting joinder with
`
`IPR2015-00903 proceeding will cause undue delay to Metrics because additional
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`discovery will be required which will result in delaying the current trial schedule
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`by at least two months, as shown in the Proposed Scheduling Order.2 (See
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`IPR2015-00903, Paper 9, 2-4). The additional discovery is necessitated because
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`InnoPharma is relying on a different expert than the expert used by Metrics in the
`
`current proceeding. If joinder is granted, Patent Owner will seek to depose
`
`InnoPharma’s expert as well as Metric’s expert. The delay caused by this
`
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`1 On April 23, 2015, the Parties filed a Notice of Stipulation Adjusting Due Dates
`
`1 through 3 in the instant proceeding. (See Paper 33).
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`2 At the hearing held on April 15, 2015, Patent Owner indicated its intention to
`
`seek a longer delay of the oral hearing date if the Board was inclined to grant
`
`joinder. (See Exhibit 2026, 16:14-21).
`
`3
`
`
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`additional expert discovery will delay the ultimate resolution of the invalidity of
`
`the ‘431 Patent and thereby unduly delay the final approval of Metrics’ ANDA and
`
`subsequent ability to enter the market. Because joinder of IPR2015-00903 with the
`
`current proceeding will not help “secure the just, speedy, and inexpensive
`
`resolution” of the issues in the current proceeding, the Board should exercise its
`
`discretion and deny InnoPharma’s Motion for Joinder. (See 37 C.F.R. § 42.1(b)).
`
`B.
`
`Innopharma Filed Its IPR Within One-Year Of Being Sued For
`Infringement And Thus Is Not Time-Barred And Will Therefore
`Not Be Prejudice If Joinder Is Denied. In The Event That The
`Board Grants The Motion For Joinder, The Schedule Should Be
`Modified
`
`A request for joinder pursuant to 35 U.S.C. § 315 affects certain deadlines
`
`under the AIA. Normally, a petitioner is barred from filing a petition for inter
`
`partes review more than one year after the petitioner is served with a complaint
`
`alleging infringement of a patent. (35 U.S.C. § 315(b); 37 C.F.R. § 42.101(b)).
`
`Here, InnoPharma is not time-barred as its Petition for Inter Partes Review was
`
`filed well within the one-year statutory bar date. Accordingly, InnoPharma will
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`not be prejudice if joinder is denied. To the extent that the Board is inclined to
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`grant InnoPharma’s Motion for Joinder, Metrics requests that the Board adjust the
`
`current schedule and adopt the schedule below in all four proceedings (IPR2014-
`
`01041, IPR2014-01043, IPR2015-00902, and IPR2015-00903). This schedule
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`maintains the current oral argument date of November 26, 2015, avoiding ultimate
`
`4
`
`
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`prejudice to Metrics, and allows for modest adjustments of Due Dates 1 and 4,
`
`accounting for additional expert discovery should joinder be granted.
`
`Current Trial Schedule in IPR2014-
`01041, IPR2014-01043
`
`DUE DATE 1 – June 26, 2015
`Patent owner’s response to the petition
`
`Patent owner’s motion to amend the
`patent
`DUE DATE 2 – September 18, 2015
`Petitioner’s reply to patent owner’s
`response to petition
`
`Petitioner’s opposition to motion to
`amend
`DUE DATE 3 – October 8, 2015
`Patent owner’s reply to petitioner’s
`opposition to motion to amend
`DUE DATE 4 – October 8, 2015
`Motion for observation regarding cross-
`examination of reply witness
`
`Motion to exclude evidence
`Request for oral argument
`DUE DATE 5 – October 22, 2015
`Response to observation
`
`Opposition to motion to exclude
`DUE DATE 6 – October 29 2015
`Reply to opposition to motion to
`exclude
`DUE DATE 7 – November 12, 2015
`Oral argument (if requested)
`
`
`
`
`Metrics’ Proposed Consolidated Trial
`Schedule in IPR2014-01041, IPR2014-
`01043, IPR2015-00902, and IPR2015-
`00903
`July 27, 2015 (extending deadline by
`one month from June 26, 2015)
`
`September 18, 2015 (unchanged)
`
`October 8, 2015 (unchanged)
`
`October 15, 2015 (extending deadline
`by one week from October 8, 2015)
`
`October 22, 2015 (unchanged)
`
`October 29, 2015 (unchanged)
`
`November 12, 2015 (unchanged)
`
`5
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`RESPECTFULLY SUBMITTED,
`DUANE MORRIS LLP
`
`Date: May 26, 2015
`
`
`
`
`
`
`
`/Patrick D. McPherson/
`Patrick D. McPherson
`Registration No. 46,255
`Duane Morris LLP
`505 9th Street, Suite 1000
`Washington, DC 2004
`(202) 776-7800
`
`Vincent L. Capuano
`Registration No. 42,385
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`Attorneys for Petitioner Metrics, Inc.
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`6
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`
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`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on the 26th day
`
`of May 2015, a complete copy of the foregoing was served via e-mail on counsel
`
`for Patent Owner at:
`
`Bryan C. Diner
`Bryan.Diner@finnegan.com
`M. Andrew Holtman
`Andy.Holtman@finnegan.com
`Justin J. Hasford
`Justin.Hasford@finnegan.com
`Jonathan R.K. Stroud
`Jonathan.Stroud@finnegan.com
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`
`A courtesy copy of the foregoing was also served via e-mail on counsel of
`
`
`
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`record for the Petitioner in InnoPharma, Licensing, Inc. et al., v. Senju
`
`Pharmaceutical Co., Ltd., et al, Case No. IPR2015-00903, as follows:
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`Jitendra Malik, Ph.D.
`jitty.malik@alston.com
`Bryan Skelton, Ph.D.
`bryan.skelton@alston.com
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`Alston & Bird LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016-1387
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`RESPECTFULLY SUBMITTED,
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`DUANE MORRIS LLP
`
`
`
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`By: /Patrick D. McPherson/
`Patrick D. McPherson, Esq.
`Registration No. 46,255
`505 9th Street, Suite 1000
`Washington, DC 2004
`
`Lead Counsel for Petitioner Metrics, Inc.
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`2
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