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`
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`_____________________
`
`Case IPR: IPR2015-01818
`_____________________
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`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`
`
`
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`WOCKHARDT BIO AG
`Petitioner
`
`v.
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`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`TABLE OF CONTENTS
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`I.
`Statement of precise relief requested ............................................................... 1
`Governing law, rules and precedent ................................................................ 2
`II.
`Statement of material facts .............................................................................. 4
`III.
`IV. Argument ......................................................................................................... 5
`A. No new grounds of unpatentability are asserted in this Petition ............ 5
`B.
`Joinder is appropriate under the governing law, rules, and
`precedent ................................................................................................ 6
`Joinder will have at most a minimal impact on the trial schedule
`and costs for the existing IPR ................................................................. 8
`Procedures to simplify briefing and discovery....................................... 9
`D.
`Conclusion ..................................................................................................... 11
`
`
`V.
`
`C.
`
`ii
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`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`Wockhardt Bio AG (“Wockhardt”) moves for joinder of the accompanying
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`Inter Partes Review (“IPR”) Petition filed today, Wockhardt Bio AG v. Jazz
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`Pharms., Inc., Case No. IPR2015-01818, with Amneal Pharms., LLC, et al. v. Jazz
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`Pharms., Inc., Case No. IPR2015-00554, for at least the following reasons: (1)
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`joinder is appropriate under the governing law, rules, and precedent of this Board;
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`(2) this Motion for Joinder is timely filed; (3) the two proceedings concern the
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`same parties, same patent, and same prior art; (4) Wockhardt relies in whole on the
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`same evidence and same declaration testimony in both proceedings; (5) joinder
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`would neither complicate the issues nor unduly delay the existing schedule of
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`IPR2015-00554; (6) joinder would significantly simplify briefing and discovery in
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`the two IPRs, and will have no impact on the existing schedule; and (7) joinder
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`will not prejudice any party. Finally, joinder here will secure a just, speedy, and
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`inexpensive resolution in both proceedings, more so than in the absence of joinder,
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`by avoiding having the Board preside over two separate proceedings involving
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`identical and duplicative filings and reviews of the same issues.
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`I.
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`Statement of precise relief requested
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`Wockhardt requests joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§
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`42.22 and 42.122(b) of the concurrently-filed petition for IPR of claims 1-11 of
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`U.S. Patent No. 7,668,730 (“the ’730 patent”) with the related and instituted IPR,
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`Amneal Pharms., LLC, et al. v. Jazz Pharms., Inc., Case No. IPR2015-00547 (“the
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`1
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`
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
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`Amneal/Par IPR”).1
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`Wockhardt notified counsel for each of Petitioners Amneal Pharmaceuticals,
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`LLC (“Amneal”) and Par Pharmaceutical, Inc. (“Par”) and Patent Owner Jazz
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`Pharmaceuticals, Inc. (“Jazz”) in the earlier Amneal/Par IPR of this Motion,
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`requesting their consent for Joinder, but to date all three parties have refused
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`consent and did not provide any reasons for their refusal.
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`II. Governing law, rules and precedent
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`Title 35 U.S.C. § 315(c) states:
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`If the Director institutes an inter partes review, the Director, in
`his or her discretion, may join as a party to that inter partes
`review any person who properly files a petition under section
`311 that the Director, after receiving a preliminary response
`under section 313 or the expiration of the time for filing such a
`response, determines warrants the institution of an inter partes
`review under section 314.
`
`1 Wockhardt is concurrently filing similar motions for joinder along with
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`five other petitions for IPR of U.S. Patent Nos. 7,765,106; 7,765,107; 7,895,059;
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`8,457,988; and 8,589,182, which are related to the ’730 patent and for which IPR
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`was instituted based on the same prior art presented in the Amneal/Par IPR
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`Petition. As such, granting joinder will simplify the issues across multiple
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`proceedings.
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`2
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`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`Title 37 C.F.R. § 42.122(b) states:
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`
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`Joinder may be requested by a patent owner or petitioner. Any
`request for joinder must be filed, as a motion under §42.22, no
`later than one month after the institution date of any inter partes
`review for which joinder is requested. The time period set forth
`in §42.101(b) shall not apply when the petition is accompanied
`by a request for joinder.
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`
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`The Board has repeatedly allowed joinder of IPR proceedings when a second
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`petition raises the same ground(s) of unpatentability as those instituted in a first
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`proceeding. See, e.g., Mylan Pharms. Inc. v. Novartis AG, et al., IPR2015-00268,
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`Paper 17 (PTAB Apr. 10, 2015); Apple, Inc. v. Smartflash LLC, CBM2015-00119,
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`Paper 11 (PTAB Aug. 6, 2015); LG Elec., Inc. v. Innovative Display Techs. LLC,
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`IPR2015-00493, Paper 10 (July 15, 2015); Cisco Sys., Inc., et al. v. Straight Path
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`IP Grp., Inc., IPR2015-01006, Paper 12 (PTAB June 5, 2015).
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`Indeed, there is a “policy preference for joining a party that does not present
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`new issues that might complicate or delay an existing proceeding.” See Dell Inc. v.
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`Network-1 Sec. Solutions, Inc., IPR2013-00385, Paper 17 at 10 (PTAB July 29,
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`2013) (citing 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen.
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`Kyl) (“The Office anticipates that joinder will be allowed as of right – if an inter
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`partes review is instituted on the basis of a petition, for example, a party that files
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`an identical petition will be joined to that proceeding, and thus allowed to file its
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`3
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`own briefs and make its own arguments.”) (emphasis added)).
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`
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`That is precisely the situation here. In accordance with the Board’s
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`governing law and rules, each of the factors supporting joinder are present in this
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`Motion for Joinder: (1) reasons why joinder is appropriate; (2) the lack of any new
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`grounds of unpatentability being raised in the subsequent petition; (3) what impact
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`(if any) there will be on the trial schedule for the existing review; and (4) how
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`briefing and/or discovery may be simplified to minimize schedule impact. Kyocera
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`Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB April 24, 2013); see
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`also Samsung Elecs. Co. Ltd. v. Unifi Sci. Batteries, LLC, IPR2013-00236, Paper
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`22 at 3 (PTAB Oct. 17, 2013).
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`Each of these factors is addressed below.
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`III. Statement of material facts
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` On January 8, 2015, Amneal and Par requested IPR of claims 1-11 of
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`the ’730 patent under two grounds of unpatentability. See IPR2015-
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`00554, Paper 1;
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` On July 17, 2015, Jazz sued Wockhardt Bio AG, Wockhardt Limited,
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`and Wockhardt USA LLC for infringement of the ’730 patent and
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`related patents in the United States District Court for the District of
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`New Jersey;
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` On July 28, 2015, the Board instituted the Amneal/Par IPR on one of
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`4
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`the two requested grounds that claims 1-11 of the ’730 patent would
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`have been obvious over the Advisory Committee Art pursuant to 35
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`U.S.C. § 103. See id., Paper 20;
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` The Wockhardt Petition that accompanies the present Motion for
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`Joinder was filed within one month of the decision noted above in the
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`Amneal/Par
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`IPR, and
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`includes only
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`the same ground of
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`unpatentability that was instituted in the Amneal/Par IPR; and
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` The Wockhardt Petition that accompanies the present Motion for
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`Joinder and accompanying evidence are identical to the instituted
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`Amneal/Par IPR Petition, aside from procedural sections that, for
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`example, identify Wockhardt, any real parties in interest, and its
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`standing, etc.
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`IV. Argument
`This Motion for Joinder addresses the criteria identified by the Board in
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`Kyocera Corp., IPR2013-00004, Paper 15. Each factor is addressed below and all
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`compel granting the instant motion.
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`A. No new grounds of unpatentability are asserted in this Petition
`The Wockhardt Petition does not assert any new grounds of unpatentability.
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`It challenges the same ’730 patent claims based on the same arguments, evidence,
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`and ground of unpatentability on which the Board instituted review in the
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`5
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
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`Amneal/Par IPR.
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`B.
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`Joinder is appropriate under the governing law, rules, and
`precedent
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`The Board has authority to join a properly-filed IPR petition to an instituted
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`IPR proceeding. See 35 U.S.C. § 315(c). Wockhardt’s Petition is properly filed
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`under 35 U.S.C. § 311 and timely under 37 C.F.R. § 42.122(b), that is, within one
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`month of the Board’s July 28, 2015 decision to institute the Amneal/Par IPR. See
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`IPR2015-00554, Paper 20.
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`Further, joinder is appropriate according to the Board’s rationale applied in
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`previous cases. As discussed above, the Board has granted numerous requests for
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`joinder of IPR proceedings under circumstances similar to the instant proceeding.
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`For example, in LG Elec., the Board granted joinder of a second petition
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`challenging the same claims on the same Grounds as that instituted in the first
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`proceeding. See LG Elec., IPR2015-00493, Paper 10. This rationale has been
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`applied by the Board in other cases. See, e.g., ION Geophysical, et al. v.
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`WesternGeco LLC, IPR2015-00565, Paper 14 at 4-5 (PTAB Apr. 23, 2015)
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`(granting joinder when both patent owner and previous petitioner opposed because
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`it “facilitates scheduling of the joined actions and minimizes delay”); Mylan
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`Pharms., IPR2015-00268, Paper 17; Apple, Inc., CBM2015-00119, Paper 11;
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`Cisco Sys., IPR2015-01006, Paper 12.
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`And
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`the Board’s consistent reasoning
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`is equally applicable here:
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`6
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`
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`Wockhardt’s Petition challenges the same claims at issue in the existing trial; relies
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`on the same prior art as the existing trial; and relies on the same testimony from the
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`same expert witness(es) as in the existing trial. Thus, in accordance with the
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`Board’s previously applied rationale, joinder of these proceedings is appropriate
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`and will “secure the just, speedy, and inexpensive resolution in every proceeding.”
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`37 C.F.R. § 42.1(b).
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`Further, Jazz has recently asserted the ’730 patent and related patents against
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`Wockhardt in concurrent district court litigation, and in the same court and before
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`the same Judge that Jazz has similar pending suits against Amneal and Par (Jazz
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`Pharms., Inc., et al. v. Wockhardt Bio AG, et al., 2:15-cv-05619 (D.N.J. July 17,
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`2015)). As such, allowing Wockhardt to participate in the Amneal/Par IPR will
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`allow Wockhardt and Jazz to resolve the underlying litigation between the parties
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`in a cost effective, expeditious manner should Amneal and Par seek to terminate
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`their participation in the Amneal/Par IPR based on settlement or other factors.
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`Moreover, any opposition by Jazz, Amneal, and/or Par, to the extent they
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`file any, cannot dispute the overwhelming efficiencies that will be promoted by
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`joinder. In fact, other than stating that they do not consent to joinder, these parties
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`have not to date articulated any reason why joinder is not appropriate or would
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`otherwise present any undue burden. Indeed, without joinder, it will be the Board
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`that will be burdened by having needlessly to adjudicate and preside over two
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`7
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`proceedings involving the same patent, same issues, same patent owner, same
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`evidence, and same expert declarations. Therefore, granting joinder will avoid
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`wasteful duplicative filings and reviews of the same issues across multiple
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`proceedings.
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`C.
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`Joinder will have at most a minimal impact on the trial schedule
`and costs for the existing IPR
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`Joinder will have minimal—indeed, likely no—impact on the trial schedule
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`and costs for the existing Amneal/Par IPR because of the substantial overlap
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`between the two petitions. Based on Wockhardt’s review of the papers Amneal and
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`Par have submitted to date in the instant IPR, and submitted in related portions of
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`the previously-filed CBM petition involving the ’730 patent, Wockhardt’s
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`substantive interests completely align with Amneal and Par’s, and Wockhardt
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`foresees no substantive issues or arguments on which it would depart from Amneal
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`and Par’s submissions going forward.
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`Accordingly, Wockhardt is prepared to adopt any papers submitted by
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`Amneal and Par in the joined IPR proceeding. Thus, even though Amneal and Par
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`have not yet agreed to coordinate with Wockhardt on joint submissions, their
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`agreement is not necessary because any filing will be public and Wockhardt is
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`willing to agree to adopt them, including the testimony from the same expert
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`witness(es) as in the instituted trial. See ION Geophysical, IPR2015-00565, Paper
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`14 at 4-5.
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`8
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`To the extent that a modest adjustment might be required—and Wockhardt
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`foresees no such need—Title 35 U.S.C. § 316(a)(11) allows the Director to “adjust
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`the time periods … in the case of joinder.” See also, 37 C.F.R. § 42.100(c).
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`Accordingly, the Board has granted extensions in other trial schedules to
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`accommodate joinder. See Ariosa Diagnostics v. Isis Innovation Ltd., IPR2013-
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`00250, Paper 24 at 5 (PTAB Sept. 3, 2013) (“while some adjustments to the
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`schedule have been necessary, there is not undue delay.”); see also Microsoft Corp.
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`v. Proxyconn, Inc., IPR2013-00109, Paper 15 at 4-5 (PTAB Feb. 25, 2013);
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`Samsung Elec. Co., Ltd. v. Virginia Innovation Sci., Inc., IPR2014-00557, Paper 10
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`at 18 (PTAB June 13, 2014).
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`And any “alleged” prejudice or burden to Jazz, Amneal, and Par—if not
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`entirely nonexistent—is outweighed by the public interest in obtaining a speedy
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`and efficient resolution of all the patentability issues of the ’730 patent in a single
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`proceeding, with minimal burden on this Board.
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`Procedures to simplify briefing and discovery
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`D.
`Briefing and discovery in the joined proceeding can be simplified to
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`minimize any impact to the schedule or the volume of materials submitted to the
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`Board. Given that Wockhardt, Amneal, and Par will rely upon the same prior art
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`and the same bases for rejection of the same claims using the same expert(s),
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`Wockhardt envisions few, if any, differences in position.
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`9
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`
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`Motion for Joinder
`Inter Partes Review of U.S. Patent No. 7,668,730
`In the unlikely event that there might be a procedural issue or statement by
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`Amneal or Par in the joined IPR with which Wockhardt disagrees—and to be sure
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`Wockhardt foresees none at this time—Wockhardt will request a conference call to
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`seek permission and explain its reasons to submit a short separate filing, if needed,
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`of no more than 3-5 pages directed to points of procedural disagreement with the
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`other petitioners, at the Board’s discretion. Cf. Apple, Inc., CBM2015-00119,
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`Paper 11 at 5-6. And Wockhardt accepts that it will not be permitted any separate
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`arguments in furtherance of those advanced in Amneal and Par’s filings. See, e.g.,
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`Motorola Mobility LLC v. Softview LLC, IPR2013-00256, Paper 10 at 9 (PTAB
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`June 20, 2013). The Board can also allow the patent owner a corresponding
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`number of pages to respond to any separate filings. See Dell Inc., IPR2013-00385,
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`Paper 17 at 8; Motorola Mobility, IPR2013-00256, Paper 10 at 8-9.
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`Additionally, Wockhardt will not seek to submit any new expert declarations
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`from those entered by Amneal and Par, except to the extent that for some unlikely
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`reason Wockhardt is precluded from relying on Amneal and Par’s experts’
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`declarations, e.g., if Amneal and Par settle with Jazz and contractually bind their
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`experts from continuing in the IPR with Wockhardt. Further, Wockhardt agrees
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`that it will not seek additional time at any deposition and that Amneal and Par will
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`be permitted to ask questions before Wockhardt. And Wockhardt agrees that it will
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`not seek any additional time at any oral argument. Indeed, Wockhardt intends to
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`10
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`
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`maintain a secondary role in the joined proceeding. Wockhardt will assume a
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`Motion for Joinder
`Inter Partes Review of US. Patent No. 7,668, 730
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`primary role only if Amneal and Par cease to participate in the IPR, or to the extent
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`Amneal and Par willingly seek more prominent participation from Wockhardt’s
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`counsel. These concessions by Wockhardt remove any alleged “complication or
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`delay” caused by joinder, While providing the parties an opportunity to address all
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`issues that may arise and avoiding any undue burden on Jazz, Amneal, Par, and the
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`Board. See, e. g., IPR20l3—00256, Paper 10 at 9.
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`Conclusion
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`For the foregoing reasons, Wockhardt requests that its Petition for IPR of the
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`’730 patent be granted, and that
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`the Board grant
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`this Motion and join this
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`proceeding with the Amneal/Par IPR. Joinder Will ensure a just, speedy, and
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`inexpensive resolution in both proceedings, and it will promote efficiency by
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`avoiding duplicative filings and reviews of the same issues.
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`Date: August27, 2015
`
`100 High Street, Suite 2400
`Boston, MA 021 10
`(857) 488-4200
`
`Respectfully submitted,
`DUANE MORRIS LLP
`
`K1,;g [9
`
`Laura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner
`
`
`
`Motion for Joinder
`Inter Partes Review of US. Patent No. 7,668, 730
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`CERTIFICATION OF SERVICE 137 C.F.R. §§ 42.616”
`
`The undersigned hereby certifies that
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`the aboVe—captioned “Motion for
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`Joinder Under 35 U.S.C. § 3l5(c) and 37 C.F.R. §§ 42.22 and 42.122(b)” was
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`served in its entirety on August 27, 2015, upon the following parties Via Express
`
`mail:
`
`Schwegman Lundberg &
`Woessner/Jazz Pharmaceutical
`
`F. Dominic Cerrito
`Eric C. Stops
`Gabriel P. Brier
`
`P.O. Box 2938
`Minneapolis, MN 55402
`
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`
`Patent owner ’s correspondence
`address ofrecordfor US. Patent No.
`7, 668, 730
`
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`
`Additional address known to
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`Petitioner as likely to eflect service
`
`Respectfully submitted,
`DUANE MORRIS LLP
`
`Date: August27, 2015
`
`100 High Street, Suite 2400
`Boston, MA 02110
`(857) 488-4200
`
`(
`
`5 QAQ
`
`&[O3»g.@
`
`Laura A. Vogel
`Registration No. 55,702
`Attorney for Petitioner
`
`