UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED
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`Petitioner
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`v.
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`NOVARTIS PHARMACEUTICALS CORPORATION
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`Patent Owner
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`Case IPR2018-
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`U.S. Patent No. 8,410,131
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`PETITIONER'S MOTION FOR JOINDER PURSUANT TO 35 U.S.C.
`§ 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED
`
`Petitioner
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`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION
`
`Patent Owner
`
`Case IPR2018-
`
`U.S. Patent No. 8,410,131
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`PETITIONER'S MOTION FOR JOINDER PURSUANT TO 35 U.S.C.
`§ 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`TABLE OF CONTENTS
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`Table of Authorities .................................................................................................. ii
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`I.
`
`II.
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`Statement of Relief Requested ........................................................................ 1
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`Statement of Material Facts ............................................................................. 2
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`III. Argument ......................................................................................................... 3
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`A.
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`B.
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`Legal Standards ..................................................................................... 3
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`Joinder Is Appropriate ........................................................................... 4
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`i.
`
`ii.
`
`No New Grounds of Unpatentability in the Petition .................. 6
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`Joinder Will Not Impact the Board’s Ability to Complete the
`Review in a Timely Manner ....................................................... 7
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`iii. Briefing and Discovery Will Be Simplified ............................... 9
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`iv. No Prejudice to Patent Owner...................................................10
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`IV. Conclusion .....................................................................................................10
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`i
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`
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`
`Dell Inc. v. Network-1 Sec. Solutions, Inc.,
`
`IPR2013-00385, Paper No. 17 (July 29, 2013) .................................................... 3
`
`Enzymotec Ltd. v. Neptune Techs & Bioresources, Inc.,
`
`IPR2014-00556, Paper No. 19 (July 9, 2014) ...................................................... 4
`
`MediaTek Inc., et al. v. Bandspeed, Inc.,
`
`IPR2015-00314, Paper No. 20 (Sept. 17, 2015) ................................................... 6
`
`SAP America Inc. v. Clouding IP, LLC,
`IPR2014-00306, Paper No. 13 (May 19, 2014) .................................................. 8
`
`Statutes
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`35 U.S.C. § 315(b) ..................................................................................................... 6
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`35 U.S.C. § 315(c) ............................................................................................. 1, 2, 3
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`35 U.S.C. § 316(a)(11) ........................................................................................... 7, 9
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`35 U.S.C. § 317(a) ................................................................................................. 5, 6
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`Rules
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`37 C.F.R. § 42.22 ....................................................................................................... 1
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`37 C.F.R. § 42.100(c) ............................................................................................. 7, 9
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`37 C.F.R. § 42.101(b) ................................................................................................ 2
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`37 C.F.R. § 42.122 ................................................................................................. 2, 3
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`37 C.F.R. § 42.122(b) ............................................................................................ 1, 6
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`Other Authorities
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`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) .................................................... 5
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`
`ii
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`
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`I.
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`STATEMENT OF RELIEF REQUESTED
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`West-Ward Pharmaceuticals International Limited (“West-Ward” or
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`“Petitioner”) respectfully submits this Motion for Joinder, together with a Petition
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`for Inter Partes Review (“the West-Ward Petition”) of claims 1-3 and 5-9 of U.S.
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`Patent No. 8,410,131 (“the ’131 patent”). Pursuant to 35 U.S.C. § 315(c) and 37
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`C.F.R. § 42.122(b), Petitioner requests inter partes review and joinder with
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`Breckenridge Pharmaceutical, Inc. v. Novartis Pharmaceuticals Corporation,
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`IPR2017-01592 (the “Breckenridge IPR”), which was instituted on January 3,
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`2018. Joinder is appropriate because it will promote efficient and consistent
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`resolution of the unpatentability grounds at issue and will not prejudice any of the
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`parties to the Breckenridge IPR. Petitioner has requested consent from
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`Breckenridge Pharmaceutical, Inc. (“Breckenridge”) to file this motion for joinder.
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`To date, Breckenridge has not indicated its position regarding Petitioner’s request.
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`Absent joinder, West-Ward will be prejudiced because its interests may not be
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`adequately represented in the Breckenridge IPR.
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`This Motion for Joinder and accompanying Petition are being filed within
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`one month of the decision instituting trial in the Breckenridge IPR, and are
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`therefore timely. 37 C.F.R. §§ 42.22, 42.122(b).
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`1
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`
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`II.
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`STATEMENT OF MATERIAL FACTS
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`1.
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`Novartis Pharmaceuticals Corporation (“Novartis” or “Patent Owner”)
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`owns the ’131 patent. Novartis sued West-Ward (previously Roxane Laboratories,
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`Inc.), in the United States District Court for the District of Delaware, for
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`infringement of the ’131 patent in 2015 and final judgment was entered in favor of
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`Novartis in December 2017.
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`2.
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`On June 12, 2017, Breckenridge filed a petition for inter partes
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`review of claims 1-3 and 5-9 of the ’131 patent. See IPR2017-01592, Paper No. 1.
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`3.
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`On January 3, 2018, the Board instituted an inter partes review of
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`claims 1-3 and 5-9 of the ’131 patent. See IPR2017-01592, Paper No. 12.
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`4. West-Ward’s Petition that accompanies the present Motion for Joinder
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`is filed within one month of the January 3, 2018 decision to institute the
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`Breckenridge IPR, and includes only the same grounds of unpatentability that were
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`instituted in the Breckenridge IPR. West-Ward’s Petition is timely under 37
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`C.F.R. § 42.122, which provides that the time period set forth in 37 C.F.R.
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`§ 42.101(b) shall not apply when the petition is accompanied by a request for
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`joinder.
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`2
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`III. ARGUMENT
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`A. Legal Standards
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`The Board has authority under 35 U.S.C. § 315(c) to join a party who files a
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`proper inter partes review petition to a previously instituted inter partes review
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`proceeding. This authority is discretionary. 35 U.S.C. § 315(c); 37 C.F.R.
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`§ 42.122.
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`In exercising its discretion to grant joinder, the Board considers the impact
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`of substantive and procedural issues on the proceedings, as well as other
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`considerations, while being “mindful that patent trial regulations, including the
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`rules for joinder, must be construed to secure the just, speedy, and inexpensive
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`resolution of every proceeding.” Dell Inc. v. Network-1 Sec. Solutions, Inc.,
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`IPR2013-00385, Paper No. 17 at 3 (July 29, 2013). The Board should consider
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`“the policy preference for joining a party that does not present new issues that
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`might complicate or delay an existing proceeding.” Id. at 10. Under this
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`framework, joinder of the present Petition with the Breckenridge IPR is
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`appropriate.
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`The moving party has the burden of proof and “should: (1) set forth the
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`reasons why joinder is appropriate; (2) identify any new grounds of unpatentability
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`asserted in the petition; (3) explain what impact (if any) joinder would have on the
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`trial schedule for the existing review; and (4) address specifically how briefing and
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`3
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`discovery may be simplified.” Dell, IPR2013-00385, Paper No. 17 at 4. Each of
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`these is addressed fully below.
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`B.
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`Joinder Is Appropriate
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`Although joinder is discretionary, it is appropriate here because the present
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`Petition “does not present issues that might complicate or delay” the existing
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`Breckenridge IPR. See Enzymotec Ltd. v. Neptune Techs & Bioresources, Inc.,
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`IPR2014-00556, Paper No. 19 at 6 (July 9, 2014) (“we are mindful of a policy
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`preference for joining a party that does not present new issues that might
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`complicate or delay an existing proceeding”). In fact, because the present Petition
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`contains the identical grounds on which the Breckenridge IPR was instituted,
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`joinder would secure the just, speedy, and inexpensive resolution of related
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`proceedings. In such circumstances, the PTO anticipated that joinder would be
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`granted as a matter of right. See CONG. REC. S1376 (daily ed. Mar. 8, 2011)
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`(statement of Sen. Kyl) (“The Office anticipates that joinder will be allowed as of
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`right – if an inter partes review is instituted on the basis of a petition, for example,
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`a party that files an identical petition will be joined to that proceeding, and thus
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`allowed to file its own briefs and make its own arguments.”).
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`Because joining Petitioner’s proceeding will not complicate the substantive
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`issues already pending in the Breckenridge IPR, Petitioner respectfully submits
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`that the Patent Owner would thus not be prejudiced by the joinder.
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`4
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`In contrast, Petitioner would be prejudiced if joinder is denied. In order to
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`permit Petitioner to protect its interests related to the validity and interpretation of
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`the ’131 patent claims, Petitioner should be permitted to participate in the
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`Breckenridge IPR. For example, allowing a joined inter partes review would
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`avoid prejudice to Petitioner in the event that Breckenridge and Novartis resolve
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`their disputes during the pendency of the Breckenridge IPR. 35 U.S.C. § 317(a)
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`provides that an inter partes review “shall be terminated with respect to any
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`petitioner upon the joint request of the petitioner and the patent owner” unless the
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`Board has already reached its decision on the merits. The Board, at its discretion,
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`“may terminate the review” if no petitioner remains. Id. In previous proceedings,
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`the Board has exercised its discretion not to terminate a review after dismissing
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`petitioner because of a pending joinder motion in a related proceeding. See
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`MediaTek Inc., et al. v. Bandspeed, Inc., IPR2015-00314, Paper No. 20 at 3 (Sept.
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`17, 2015) (“We exercise the discretion afforded under 35 U.S.C. § 317(a) to
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`decline, at this time, to terminate these proceedings with respect to Patent Owner”).
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`Specifically, in MediaTek, the Board, after noting that the Motion for Joinder was
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`filed before the Motion to Terminate, chose to wait until after ruling on the Motion
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`for Joinder to consider whether to terminate the review entirely. Id. at 2-3.
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`Here, if Novartis and Breckenridge settled, the Breckenridge IPR could
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`terminate without proceeding to a final written decision, prejudicing Petitioner. At
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`5
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`this stage, to challenge Novartis’s claims in an inter partes review, the only option
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`available to Petitioner is to file its petition and simultaneously request to join
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`Breckenridge’s IPR pursuant to 37 C.F.R. § 42.122(b), because Petitioner is
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`otherwise time-barred from filing an inter partes review petition under 37 C.F.R.
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`§ 315(b). Petitioner would be prejudiced if the Board refuses joinder, as their
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`interests may not be adequately represented in the Breckenridge IPR.
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`Accordingly, for the reasons discussed below, joinder is appropriate because
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`it will not delay the Breckenridge IPR and ensures a just, speedy, and inexpensive
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`resolution of these proceedings.
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`i.
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`No New Grounds of Unpatentability in the Petition
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`West-Ward’s Petition is substantively identical to the petition in the
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`Breckenridge IPR. In particular, the present Petition challenges the same instituted
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`claims on the same grounds, and is supported by the same prior art, prior art
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`combinations, and arguments as relied upon in Breckenridge’s IPR petition and
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`considered by the Board in instituting review in the Breckenridge IPR. Petitioner
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`also intends to rely on the same expert as Breckenridge (discussed further below).
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`As such, Petitioner raises no issues that are not already before the Board in the
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`Breckenridge IPR. Accordingly, no new claims and no new grounds will be added
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`to the Breckenridge IPR as a result of the Board allowing joinder.
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`6
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`ii.
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`Joinder Will Not Impact the Board’s Ability to Complete
`the Review in a Timely Manner
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`Joinder in this case will not impact the Board’s ability to complete its review
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`in a timely manner. 35 U.S.C. § 316(a)(11) and associated rule 37 C.F.R.
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`§ 42.100(c) provide that inter partes review proceedings should be completed and
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`the Board’s final decision issued within one year of institution of the review. In
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`this case, joinder will not affect the Board’s ability to issue the decision within this
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`required one-year timeframe because the Petition filed in the present IPR contains
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`the identical ground on which the Breckenridge IPR was instituted.
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`Moreover, to further simplify the proceeding, Petitioner intends to rely on
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`the same expert as Breckenridge, Dr. Pantuck. If Petitioner is able to retain
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`Dr. Pantuck, then Petitioner will withdraw its expert declaration of Dr. Cho and
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`rely solely on Dr. Pantuck’s declaration and testimony.1
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`1
`Petitioner has submitted an expert declaration of its own expert, Dr. Cho.
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`Dr. Cho has reviewed and adopted the opinions set forth in Dr. Pantuck’s
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`declaration. To the extent that Petitioner is not able to retain Dr. Pantuck, and the
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`Board determines that it would not be able to complete these proceedings within
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`the one-year timeframe as a result of having to provide the Patent Owner with the
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`opportunity to additionally depose Petitioner’s expert, Dr. Cho, West-Ward would
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`agree to withdraw Dr. Cho’s declaration and instead rely solely on any
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`7
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`Even if, through no fault of its own, Petitioner was required to proceed with
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`its own expert, there would be no impact on the Board’s ability to complete its
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`review in a timely manner, in light of the fact that Petitioner’s expert has adopted
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`the opinions set forth in Breckenridge’s expert declaration. Moreover, there would
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`be only a modest impact on the Patent Owner, given that little additional
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`preparation would be needed for the deposition of Petitioner’s expert beyond that
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`required for the deposition of Breckenridge’s expert (assuming Patent Owner must
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`depose both experts).
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`In addition, and as discussed further below, if joined, Petitioner respectfully
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`proposes procedures to simplify any further briefing and discovery, which will
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`minimize any potential impact on the schedule or the volume of materials to be
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`submitted to the Board. Effectively, Petitioner will act as a “silent understudy”
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`unless, and until such time as, Breckenridge drops out of the proceedings for any
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`reason. If the Breckenridge IPR is terminated with respect to the Breckenridge,
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`Petitioner intends to “step into the shoes” of Breckenridge and materially
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`declaration(s) of Dr. Pantuck submitted in IPR2017-01592, if Dr. Pantuck had
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`already been deposed based on any such declaration(s), and the deposition
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`transcript(s) have been made of record.
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`8
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`participate in the remainder of the proceedings. Only if Breckenridge drops out of
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`the proceedings for any reason, will Petitioner cease its understudy role.
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`The Board has previously acknowledged that such concessions that West-
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`Ward proposes are sufficient to minimize the impact on the original proceeding.
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`See SAP America Inc. v. Clouding IP, LLC, IPR2014-00306, Paper 13, page 4.
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`Accordingly, for the reasons set forth above, joinder of Petitioner to the
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`Breckenridge IPR will not affect the Board’s ability to complete its review and
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`issue a final decision within the statutory time limits under 35 U.S.C. § 316(a)(11)
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`and 37 C.F.R. § 42.100(c).
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`iii. Briefing and Discovery Will Be Simplified
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`Given that the positions in the Petition are identical to those presented in the
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`instituted Breckenridge IPR, Petitioner agrees to consolidated filings for all
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`substantive papers and to consolidated discovery in the joined proceeding. With
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`respect to consolidated filings, any papers jointly submitted by Petitioner will not
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`exceed the normal word count or page limits for a single party as set forth in the
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`rules. Petitioner will not file, or request to file, any separate briefs beyond the
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`consolidated filings. Petitioner will not request additional cross-examination or
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`redirect time. Further, with respect to any oral hearing, unless the Breckenridge
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`IPR has been terminated with respect to Breckenridge, Breckenridge will be
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`responsible for the presentation before the Board. Petitioner will not request any
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`
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`9
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`additional time to independently argue before the Board or attempt to submit its
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`own demonstratives.2
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`Accordingly, if joinder is granted, briefing and discovery and hearing in the
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`joined proceeding will be no more complex than if Petitioner had never been
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`joined. Consolidated briefing and discovery will ensure a simplified and efficient
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`joined proceeding.
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`iv. No Prejudice to Patent Owner
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`Joining Petitioner to the Breckenridge IPR will not create any additional
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`burden on the Patent Owner. The Patent Owner need not expend any additional
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`resources above and beyond those required in the current Breckenridge IPR. By
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`allowing the identical grounds of unpatentability to be addressed in a single
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`proceeding, the interests of all parties and the Board will be well served.
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`IV. CONCLUSION
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`Joining Petitioner to the Breckenridge IPR would ensure protection of the
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`parties’ interests and would not negatively impact the Breckenridge IPR schedule.
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`For the foregoing reasons, West-Ward respectfully requests that the Board institute
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`2 While Petitioner will not materially participate in calls with the Board,
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`depositions, or hearings, Petitioner anticipates that its counsel will attend such
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`events.
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`10
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`
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`its Petition for Inter Partes Review of U.S. Patent 8,410,131 and join this
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`proceeding with Breckenridge Pharmaceutical, Inc. v. Novartis Pharmaceuticals
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`Corp., Case IPR2017-01592.
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`Although West-Ward believes that no fee is required for this Motion, the
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`Commissioner may charge any additional fees which may be required for this
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`Motion to Deposit Account No. 50-6989.
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`11
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`Dated: January 17, 2018
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`Respectfully submitted,
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`
`
`/Keith A. Zullow/
`Keith A. Zullow (Reg. No. 37,975)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Tel.: 212-813-8846
`Fax: 646-558-4226
`kzullow@goodwinprocter.com
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`Counsel for Petitioner West-Ward
`Pharmaceuticals International
`Limited
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`12
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`
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that this “MOTION FOR JOINDER
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`
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`PURSUANT TO 35 U.S.C. § 315(C) AND 37 C.F.R. §§ 42.22 AND 42.122(B)”
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`was served in its entirety on this 17th day of January 2018 by FedEx First
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`Overnight on Patent Owner and counsel of record for Novartis in Breckenridge
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`Pharmaceutical, Inc. v. Novartis Pharmaceutical Corporation, IPR2017-01592 at
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`their correspondence addresses as follows:
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`Novartis Pharmaceutical Corporation
`Intellectual Property Department
`Attn: Peter J. Waibel, Esq. (Head of Patent Litigation)
`One Health Plaza 433/2
`East Hanover, NJ 07936-1080
`
`Novartis Pharmaceutical Corporation
`Intellectual Property Department
`Attn: Thomas Savitsky, Esq.
`One Health Plaza 433/2
`East Hanover, NJ 07936-1080
`
`Nicholas Kallas, Esq.
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`
`
`
`
`13
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`
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`In addition, Novartis AG was served via FedEx International Priority at the
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`following address:
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`Novartis International AG
`Novartis Campus
`Attn: Alisa A. Harbin, Esq.
`Head, Group Litigation and Intellectual Property
`Forum 1-1.20
`Basel, CH-4002
`SWITZERLAND
`
`
`
`Courtesy copies of the foregoing were also served by FedEx First Overnight
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`to counsel of record for the Petitioner in Breckenridge Pharmaceutical, Inc. v.
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`Novartis Pharmaceutical Corporation, IPR2017-01592 as follows:
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`Breckenridge Pharmaceutical, Inc.
`
`Daniel R. Evans, Esq.
`MERCHANT & GOULD P.C.
`191 Peachtree Street, NE
`Suite 3800
`Atlanta, GA 30303
`
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`January 17, 2018
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`
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`
`
` /Keith A. Zullow/
`Keith A. Zullow (Reg. No. 37,975)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-813-8846
`Fax: 646-558-4226
`kzullow@goodwinprocter.com
`
`Counsel for Petitioner West-Ward
`Pharmaceuticals International Limited
`
`14
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`
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