Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`_____________________
`
`Case IPR: IPR2016-01029
`_____________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`WOCKHARDT BIO AG
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`Patent Owner
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`_____________________
`
`Case IPR: IPR2016-01029
`_____________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`WOCKHARDT BIO AG
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`Patent Owner
`
`
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`TABLE OF CONTENTS
`
`I.
`Statement of precise relief requested ............................................................... 1
`Governing law, rules and precedent ................................................................ 2
`II.
`Statement of material facts .............................................................................. 4
`III.
`IV. Argument ......................................................................................................... 7
`A. No new grounds of unpatentability are asserted in this Petition ............ 7
`B.
`Joinder is appropriate under the governing law, rules, and
`precedent ................................................................................................ 7
`Joinder will have at most a minimal impact on the trial schedule
`and costs for the existing IPR ................................................................. 9
`Procedures to simplify briefing and discovery..................................... 11
`D.
`Conclusion ..................................................................................................... 13
`
`
`V.
`
`C.
`
`ii
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`Wockhardt Bio AG (“Wockhardt”) moves for joinder of the accompanying
`
`Inter Partes Review (“IPR”) Petition filed today, Wockhardt Bio AG v.
`
`AstraZeneca AB, Case No. IPR2016-01029, with Mylan Pharms., Inc. v.
`
`AstraZeneca AB, Case No. IPR2015-01340, for at least the following reasons: (1)
`
`joinder is appropriate under the governing law, rules, and precedent of this Board;
`
`(2) this Motion for Joinder is timely filed; (3) the two proceedings concern the
`
`same parties, same patent, and same prior art; (4) Wockhardt relies in whole on the
`
`same evidence and same declaration testimony in both proceedings; (5) joinder
`
`would neither complicate the issues nor unduly delay the existing schedule of
`
`IPR2015-01340; (6) joinder would significantly simplify briefing and discovery in
`
`the two IPRs, and will have no impact on the existing schedule; and (7) joinder
`
`will not prejudice any party. Finally, joinder here will secure a just, speedy, and
`
`inexpensive resolution in both proceedings, more so than in the absence of joinder,
`
`by avoiding having the Board preside over two separate proceedings involving
`
`identical and duplicative filings and reviews of the same issues.
`
`I.
`
`Statement of precise relief requested
`
`Wockhardt requests joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§
`
`42.22 and 42.122(b) of the concurrently-filed petition for IPR of claims 1, 2, 4, 6-
`
`22, 25-30, 32-37, and 39-42 of U.S. Patent No. RE44,186 (“the ’186 patent”) with
`
`the related and instituted IPR, Mylan Pharms., Inc. v. AstraZeneca AB, Case No.
`
`1
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`IPR2015-01340 (“the Mylan IPR”).
`
`Wockhardt notified counsel for Petitioner Mylan Pharmaceuticals, Inc.
`
`(“Mylan”) and Patent Owner AstraZeneca AB (“AstraZeneca”) in the Mylan IPR
`
`of this Motion, requesting their consent for Joinder, but to date neither party has
`
`provided consent.
`
`II. Governing law, rules and precedent
`
`Title 35 U.S.C. § 315(c) states:
`
`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.
`
`
`
`Title 37 C.F.R. § 42.122(b) states:
`
`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.
`
`
`
`The Board has repeatedly allowed joinder of IPR proceedings when a second
`
`petition raises the same ground(s) of unpatentability as those instituted in a first
`
`2
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`proceeding. See, e.g., Wockhardt Bio AG v. Jazz Pharms., Inc., IPR2015-01813,
`
`Paper 10 (PTAB Oct. 30, 2015); Mylan Pharms. Inc. v. Novartis AG, et al.,
`
`IPR2015-00268, Paper 17 (PTAB Apr. 10, 2015); Apple, Inc. v. Smartflash LLC,
`
`CBM2015-00119, Paper 11 (PTAB Aug. 6, 2015); LG Elec., Inc. v. Innovative
`
`Display Techs. LLC, IPR2015-00493, Paper 10 (July 15, 2015); Cisco Sys., Inc., et
`
`al. v. Straight Path IP Grp., Inc., IPR2015-01006, Paper 12 (PTAB June 5, 2015).
`
`Indeed, there is a “policy preference for joining a party that does not present
`
`new issues that might complicate or delay an existing proceeding.” See Dell Inc. v.
`
`Network-1 Sec. Solutions, Inc., IPR2013-00385, Paper 17 at 10 (PTAB July 29,
`
`2013) (citing 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen.
`
`Kyl) (“The Office anticipates that joinder will be allowed as of right – if an inter
`
`partes review is instituted on the basis of a petition, for example, a party that files
`
`an identical petition will be joined to that proceeding, and thus allowed to file its
`
`own briefs and make its own arguments.”) (emphasis added)).
`
`
`
`That is precisely the situation here. In accordance with the Board’s
`
`governing law and rules, each of the factors supporting joinder are present in this
`
`Motion for Joinder: (1) reasons why joinder is appropriate; (2) the lack of any new
`
`grounds of unpatentability being raised in the subsequent petition; (3) what impact
`
`(if any) there will be on the trial schedule for the existing review; and (4) how
`
`briefing and/or discovery may be simplified to minimize schedule impact. Kyocera
`
`3
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB April 24, 2013); see
`
`also Samsung Elecs. Co. Ltd. v. Unifi Sci. Batteries, LLC, IPR2013-00236, Paper
`
`22 at 3 (PTAB Oct. 17, 2013).
`
`Each of these factors is addressed below.
`
`III. Statement of material facts
` On May 23, 2014,1 AstraZeneca sued Wockhardt Bio AG and Wockhardt
`
`USA LLC for infringement of the ’186 patent in the United States
`
`District Court for the District of Delaware;
`
` On October 8, 2014, AstraZeneca’s case against Wockhardt Bio AG and
`
`Wockhardt USA LLC was consolidated with AstraZeneca’s cases
`
`asserting infringement of the ’186 patent against Mylan and three other
`
`defendants;
`
` On June 4, 2015, Mylan requested IPR of claims 1, 2, 4, 6-22, 25-30, 32-
`
`37 and 39-42 of the ’186 patent under four grounds of unpatentability.
`
`See IPR2015-01340, Paper 3;
`
`
`1 Wockhardt is not barred from filing its Petition, even though it was served with a
`
`complaint asserting infringement of the ’186 patent more than one year before
`
`filing the Petition, because Wockhardt seeks joinder with IPR2015-01340. See 35
`
`U.S.C. § 315(b)-(c).
`
`4
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
` On September 25, 2015, AstraZeneca filed its Patent Owner Preliminary
`
`Response. See id., Paper 7;
`
` On October 27, 2015, the Board authorized Mylan to file a Reply to the
`
`Patent Owner Preliminary Response in order to respond to AstraZeneca’s
`
`(1) “contentions that one of ordinary skill in the art would not have
`
`chosen Ashford compound 25 as a lead compound” (see id., Paper 10 at 2
`
`(citing Paper 7 at 31-35) and (2) “contentions that one of ordinary skill in
`
`the art would not have been motivated to add a cylopropyl ring to
`
`Ashworth compound 25” (see id., Paper 10 at 3 (citing Paper 7 at 36-40);
`
` On November 6, 2015, Mylan filed its Reply to the Patent Owner
`
`Preliminary Response. See id., Paper 11;
`
` On December 9, 2015, the Board denied institution of the Mylan IPR.
`
`See id., Paper 12;
`
` On January 8, 2016, Mylan filed a Request for Rehearing;
`
` On May 2, 2016, the Board granted Mylan’s Request for Rehearing and
`
`instituted the Mylan IPR on each of the four grounds asserting that claims
`
`1, 2, 4, 6-22, 25-30, 32-37, and 39-42 of the ’186 patent would have been
`
`obvious over the prior art pursuant to 35 U.S.C. § 103. See id., Papers 15
`
`and 16. These grounds are:
`o Claims 1, 2, 4, 6-11, 25-28, 32-35, 39, and 40 would have been
`
`5
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`obvious over Ashworth I, Villhauer, Raag, and Hanessian I;
`o Claims 12–16, 29, 30, 36, 37, 41, and 42 would have been obvious
`
`over Ashworth I, Villhauer, Raag, Hanessian I, Bachovchin, and
`
`GLUCOPHAGE Label;
`o Claims 12, 17, 18, and 22 would have been obvious over Ashworth
`
`I, Villhauer, Raag, Hanessian I, Bachovchin, and XENICAL
`
`Label; and
`o Claims 12, 19, 20, and 21 would have been obvious over Ashworth
`
`I, Villhauer, Raag, Hanessian I, Bachovchin, and MEVACOR
`
`Label;
`
` Wockhardt’s Petition that accompanies the present Motion for Joinder
`
`was filed within one month of the May 2, 2016 decision to institute the
`
`Mylan IPR, and includes only the same grounds of unpatentability that
`
`were instituted in the Mylan IPR; and
`
` Wockhardt’s Petition that accompanies the present Motion for Joinder
`
`and accompanying evidence are the same as the instituted Mylan IPR
`
`Petition and Petitioner’s Reply to the Patent Owner Response, aside from
`
`procedural sections that, for example, identify Wockhardt, any real
`
`parties in interest, and its standing, etc.
`
`6
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`
`IV. Argument
`This Motion for Joinder addresses the criteria identified by the Board in
`
`Kyocera Corp., IPR2013-00004, Paper 15. Each factor is addressed below and all
`
`compel granting the instant motion.
`
`A. No new grounds of unpatentability are asserted in this Petition
`Wockhardt’s Petition does not assert any grounds of unpatentability
`
`additional to those asserted in the Mylan IPR. It challenges the same ’186 patent
`
`claims based on the same arguments, evidence, and ground of unpatentability on
`
`which the Board instituted review in the Mylan IPR.
`
`B.
`
`Joinder is appropriate under the governing law, rules, and
`precedent
`
`The Board has authority to join a properly-filed IPR petition to an instituted
`
`IPR proceeding. See 35 U.S.C. § 315(c). Wockhardt’s Petition is properly filed
`
`under 35 U.S.C. § 311 and timely under 37 C.F.R. § 42.122(b), that is, within one
`
`month of the Board’s May 2, 2016 decision to institute Mylan IPR. See IPR2015-
`
`01340, Paper 16.
`
`Further, joinder is appropriate according to the Board’s rationale applied in
`
`previous cases. As discussed above, the Board has granted numerous requests for
`
`joinder of IPR proceedings under circumstances similar to the instant proceeding.
`
`For example, in LG Elec., the Board granted joinder of a second petition
`
`challenging the same claims on the same Grounds as that instituted in the first
`
`7
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`proceeding. See LG Elec., IPR2015-00493, Paper 10. This rationale has been
`
`applied by the Board in other cases. See, e.g., ION Geophysical, et al. v.
`
`WesternGeco LLC, IPR2015-00565, Paper 14 at 4-5 (PTAB Apr. 23, 2015)
`
`(granting joinder when both patent owner and previous petitioner opposed because
`
`it “facilitates scheduling of the joined actions and minimizes delay”); Wockhardt
`
`Bio AG, IPR2015-01813, Paper 10; Mylan Pharms., IPR2015-00268, Paper 17;
`
`Apple, Inc., CBM2015-00119, Paper 11; Cisco Sys., IPR2015-01006, Paper 12.
`
`And the Board’s consistent reasoning is equally applicable here:
`
`Wockhardt’s Petition challenges the same claims at issue in the existing trial; relies
`
`on the same prior art as the existing trial; and relies on the same testimony from the
`
`same expert witness as in the existing trial. Thus, in accordance with the Board’s
`
`previously applied rationale, joinder of these proceedings is appropriate and will
`
`“secure the just, speedy, and inexpensive resolution in every proceeding.” 37
`
`C.F.R. § 42.1(b).
`
`Further, AstraZeneca has asserted the ’186 patent against Wockhardt in
`
`concurrent district court litigation, and Wockhardt is in the same consolidate suit as
`
`Mylan (AstraZeneca AB v. Aurobinda Pharma, Ltd. et al., 1:14-cv-00664 (D.
`
`Del.)). As such, allowing Wockhardt to participate in the Mylan IPR will allow
`
`Wockhardt and AstraZeneca to resolve the underlying litigation between the
`
`parties in a cost effective, expeditious manner should Mylan seek to terminate its
`
`8
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`participation in the Mylan IPR based on settlement or other factors.
`
`Moreover, any opposition by AstraZeneca and/or Mylan, to the extent they
`
`file any, cannot dispute the overwhelming efficiencies that will be promoted by
`
`joinder. In fact, these parties have not to date articulated any reason why joinder is
`
`not appropriate or would otherwise present any undue burden. Indeed, without
`
`joinder, it will be the Board that will be burdened by having needlessly to
`
`adjudicate and preside over two proceedings involving the same patent, same
`
`issues, same patent owner, same evidence, and same expert declarations.
`
`Therefore, granting joinder will avoid wasteful duplicative filings and reviews of
`
`the same issues across multiple proceedings. See, e.g., Wockhardt Bio AG,
`
`IPR2015-01813, Paper 10 at 4.
`
`C.
`
`Joinder will have at most a minimal impact on the trial schedule
`and costs for the existing IPR
`
`Joinder will have minimal—indeed, likely no—impact on the trial schedule
`
`and costs for the existing Mylan IPR because of the substantial overlap between
`
`the two petitions. Based on Wockhardt’s review of the papers Mylan has submitted
`
`to date in the instant IPR, Wockhardt’s substantive interests completely align with
`
`Mylan’s, and Wockhardt foresees no substantive issues or arguments on which it
`
`would depart from Mylan’s submissions going forward.
`
`Accordingly, Wockhardt is prepared to adopt any papers submitted by
`
`Mylan in the joined IPR proceeding. Thus, even though Mylan has not yet agreed
`
`9
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`to coordinate with Wockhardt on joint submissions, their agreement is not
`
`necessary because any filing will be public and Wockhardt is willing to agree to
`
`adopt Mylan’s filings, including the testimony from the same expert witness(es) as
`
`in the instituted trial. See ION Geophysical, IPR2015-00565, Paper 14 at 4-5; See
`
`Wockhardt Bio AG, IPR2015-01813, Paper 10 at 3.
`
`To the extent that a modest adjustment might be required—and Wockhardt
`
`foresees no such need—Title 35 U.S.C. § 316(a)(11) allows the Director to “adjust
`
`the time periods … in the case of joinder.” See also, 37 C.F.R. § 42.100(c).
`
`Accordingly, the Board has granted extensions in other trial schedules to
`
`accommodate joinder. See Ariosa Diagnostics v. Isis Innovation Ltd., IPR2013-
`
`00250, Paper 24 at 5 (PTAB Sept. 3, 2013) (“while some adjustments to the
`
`schedule have been necessary, there is not undue delay.”); see also Microsoft Corp.
`
`v. Proxyconn, Inc., IPR2013-00109, Paper 15 at 4-5 (PTAB Feb. 25, 2013);
`
`Samsung Elec. Co., Ltd. v. Virginia Innovation Sci., Inc., IPR2014-00557, Paper 10
`
`at 18 (PTAB June 13, 2014).
`
`And any “alleged” prejudice or burden to AstraZeneca and Mylan—if not
`
`entirely nonexistent—is outweighed by the public interest in obtaining a speedy
`
`and efficient resolution of all the patentability issues of the ’186 patent in a single
`
`proceeding, with minimal burden on this Board.
`
`10
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`Procedures to simplify briefing and discovery
`
`D.
`Briefing and discovery in the joined proceeding can be simplified to
`
`minimize any impact to the schedule or the volume of materials submitted to the
`
`Board. Given that Wockhardt and Mylan will rely upon the same prior art and the
`
`same bases for rejection of the same claims using the same expert(s), Wockhardt
`
`envisions few, if any, differences in position.
`
`In the unlikely event that there might be a procedural issue or statement by
`
`Mylan in the joined IPR with which Wockhardt disagrees—and to be sure
`
`Wockhardt foresees none at this time—Wockhardt will request a conference call to
`
`seek permission and explain its reasons to submit a short separate filing, if needed,
`
`of no more than 3-5 pages directed to points of procedural disagreement with the
`
`other petitioners, at the Board’s discretion. Cf. Apple, Inc., CBM2015-00119,
`
`Paper 11 at 5-6. And Wockhardt accepts that it will not be permitted any separate
`
`arguments in furtherance of those advanced in Mylan’s filings. See, e.g., Motorola
`
`Mobility LLC v. Softview LLC, IPR2013-00256, Paper 10 at 9 (PTAB June 20,
`
`2013). The Board can also allow the patent owner a corresponding number of
`
`pages to respond to any separate filings. See Dell Inc., IPR2013-00385, Paper 17 at
`
`8; Motorola Mobility, IPR2013-00256, Paper 10 at 8-9.
`
`Additionally, Wockhardt will not seek to submit any new expert declarations
`
`from those entered by Mylan, except to the extent that for some unlikely reason
`
`11
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`Wockhardt is precluded from relying on Mylan’s experts’ declarations, e.g., if
`
`Mylan settles with AstraZeneca and contractually bind their experts from
`
`continuing in the IPR with Wockhardt. Further, Wockhardt agrees that it will not
`
`seek additional time at any deposition and that Mylan will be permitted to ask
`
`questions before Wockhardt. And Wockhardt agrees that it will not seek any
`
`additional time at any oral argument. Indeed, Wockhardt intends to maintain a
`
`secondary role in the joined proceeding. Wockhardt will assume a primary role
`
`only if Mylan ceases to participate in the IPR, or to the extent Mylan willingly
`
`seeks more prominent participation from Wockhardt’s counsel. These concessions
`
`by Wockhardt remove any alleged “complication or delay” caused by joinder,
`
`while providing the parties an opportunity to address all issues that may arise and
`
`avoiding any undue burden on AstraZeneca, Mylan, and the Board. See, e.g.,
`
`Motorola Mobility, IPR2013-00256, Paper 10 at 9.
`
`
`
`
`
`12
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`
`V. Conclusion
`For the foregoing reasons, Wockhardt requests that its Petition for IPR of the
`
`’186 patent be granted, and that the Board grant this Motion and join this
`
`proceeding with the Mylan IPR. Joinder will ensure a just, speedy, and inexpensive
`
`resolution in both proceedings, and it will promote efficiency by avoiding
`
`duplicative filings and reviews of the same issues.
`
`Respectfully submitted,
`
`DUANE MORRIS LLP
`
`
`
` /s/ Patrick Gallagher f
`Patrick C. Gallagher
`Registration No. 63,407
`Attorney for Petitioner
`
`
`
`
`
`Date: May 11, 2016
`190 South LaSalle Street
`Suite 3700
`Chicago, IL 60603
`(312) 499-6700
`
`13
`
`
`
`Motion for Joinder
`Inter Partes Review of U.S. Patent No. RE44,186 E
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Motion for
`
`Joinder Under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22 and 42.122(b)” was
`
`served in its entirety on May 11, 2016, upon the following parties via Express
`
`Charles E. Lipsey
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`11955 Freedom Drive
`Reston, VA 20190
`Additional address known to
`Petitioner as likely to effect service
`
`mail:
`
`
`
`BAKER & HOSTETLER LLP
`Cira Centre 12th Floor
`2929 Arch Street
`Philadelphia, PA 19104-2891
`
`Patent owner’s correspondence
`address of record for U.S. Patent No.
`RE44,186 E
`
`
`
`DUANE MORRIS LLP
`
`
`
` /s/ Patrick Gallagher f
`Patrick C. Gallagher
`Registration No. 63,407
`Attorney for Petitioner
`
`
`
`Date: May 11, 2016
`190 South LaSalle Street
`Suite 3700
`Chicago, IL 60603
`(312) 499-6700
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