UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`Patent Owner
`
`_____________________
`
`Case No.: IPR2016-01104
`Patent No.: RE44,186
`_____________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`Patent Owner
`
`_____________________
`
`Case No.: IPR2016-01104
`Patent No.: RE44,186
`_____________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`Page
`
`TABLE OF CONTENTS
`
`
`I. STATEMENT OF PRECISE RELIEF REQUESTED ....................................... 2
`II. GOVERNING LAW, RULES AND PRECEDENT .......................................... 2
`III. STATEMENT OF MATERIAL FACTS ........................................................ 4
`IV. ARGUMENT ................................................................................................... 7
`A. No New Grounds of Unpatentability Are Asserted in the Petition ....... 7
`B.
`Joinder is Appropriate Under the Governing Law, Rules, and
`Precedent ............................................................................................... 7
`Joinder Will Have Minimal Impact on the Trial Schedule and Costs
`for the Existing IPR ............................................................................... 9
`Procedures to Simplify Briefing and Discovery ................................. 10
`D.
`V. CONCLUSION ................................................................................................. 12
`
`C.
`
`i
`
`
`
`
`
`
`
`Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd. (together,
`
`“Sun”), and Amneal Pharmaceuticals LLC (“Amneal”) (collectively, “Petitioner”)
`
`move for joinder of the accompanying Inter Partes Review (“IPR”) Petition filed
`
`today, Sun Pharma Global FZE, Sun Pharmaceutical Industries, Ltd., and Amneal
`
`Pharmaceuticals LLC v. AstraZeneca AB, Case No. IPR2016-01104, 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)
`
`Petitioner relies in whole on the same evidence and the 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.
`
`1
`
`
`
`
`
`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Petitioner 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.
`
`IPR2015-01340 (“the Mylan IPR”).
`
`Petitioner has notified counsel for Mylan Pharmaceuticals, Inc. (“Mylan”),
`
`petitioner in the Mylan IPR, of this Motion. Mylan has indicated that it does not
`
`oppose Petitioner’s request for joinder. Further, Mylan and Petitioner have agreed
`
`to coordinate in discovery should joinder be granted, with Mylan leading in all
`
`discovery matters and hearings before the Board.
`
`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:
`
`2
`
`
`
`
`
`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
`
`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
`
`3
`
`
`
`
`
`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 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 June 2, 2014,1 AstraZeneca sued Sun and Amneal, in separate
`
`proceedings, for infringement of the ’186 patent before the United States
`
`District Court for the District of Delaware;
`
`1 Petitioner is not barred from filing their Petition, even though Sun and Amneal
`
`were each served with a complaint asserting infringement of the ’186 patent more
`
`than one year before filing the Petition, because Petitioner seeks joinder with
`
`IPR2015-01340. See 35 U.S.C. § 315(b)-(c).
`
`4
`
`
`
`
`
`• On October 8, 2014, AstraZeneca’s respective cases against Sun and
`
`Amneal were 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;
`
`• 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 Ashworth 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;
`
`5
`
`
`
`
`
`• On January 8, 2016, Mylan filed a Request for Rehearing. See id., Paper
`
`13;
`
`• 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
`
`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;
`
`• The 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
`
`6
`
`
`
`
`
`• The Petition that accompanies the present Motion for Joinder is
`
`substantially identical to the instituted Mylan IPR Petition, and the
`
`accompanying evidence is the same as that relied upon in the Mylan IPR
`
`Petition and Petitioner’s Reply to the Patent Owner Response.
`
`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 the Petition
`The 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 grounds 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). Sun and Amneal’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 the Mylan IPR. See
`
`IPR2015- 01340, Paper 16.
`
`7
`
`
`
`
`
`Further, joinder is appropriate under the Board’s rationale for permitting
`
`joinder 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 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: the Petition
`
`that accompanies the present Motion for Joinder 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).
`
`8
`
`
`
`
`
`Further, AstraZeneca has asserted the ’186 patent against Petitioner in
`
`concurrent district court litigation, and Petitioner is in the same consolidated suit as
`
`Mylan (AstraZeneca AB v. Aurobinda Pharma, Ltd. et al., 1:14-cv-00664 (D.
`
`Del.)). As such, allowing Petitioner to participate in the Mylan IPR may allow
`
`Petitioner and AstraZeneca to resolve the underlying litigation between the parties
`
`in a cost-effective, expeditious manner even if Mylan seeks to terminate its
`
`participation in the Mylan IPR based on settlement or other factors.
`
`C.
`
`Joinder Will Have Minimal Impact on the Trial Schedule and
`Costs for the Existing IPR
`
`Joinder will have no impact on the trial schedule and costs for the existing
`
`Mylan IPR by agreement between Mylan and Petitioner, as well as because of the
`
`substantial overlap between the two petitions. Based on Petitioner’s review of the
`
`papers Mylan has submitted to date in the instant IPR, Petitioner’s substantive
`
`interests completely align with Mylan’s, and Petitioner foresees no substantive
`
`issues or arguments on which it would depart from Mylan’s submissions going
`
`forward. Further, Petitioner has agreed to adopt any papers submitted by Mylan in
`
`the joined IPR proceeding and to rely on the testimony from the same expert
`
`witness(es) as Mylan in the instituted trial for as long as Mylan is a party.
`
`To the extent that a modest schedule adjustment might be required—and
`
`Petitioner 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. §
`
`9
`
`
`
`
`
`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).
`
`Finally, any alleged prejudice or burden to AstraZeneca and Mylan—to the
`
`extent any exists at all—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.
`
`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.
`
`Petitioner and Mylan have agreed that Petitioner is to maintain a secondary
`
`role in any joined proceeding for as long as Mylan is a party to such proceeding.
`
`Specifically, Petitioner has agreed not to seek additional time at any deposition,
`
`and also that cross-examinations will occur within the timeframe normally allotted
`
`by the Board rules to one party and will not need to be extended in light of the
`
`10
`
`
`
`
`
`joinder. Petitioner has further agreed to consolidated filings for all substantive
`
`papers in the proceeding, except for motions that do not involve Mylan. Petitioner
`
`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 Petitioner’s
`
`counsel. These agreements remove any potential “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.
`
`In the unlikely event that there might be a procedural issue or statement by
`
`Mylan in the joined IPR with which Petitioner disagree—and to be sure, Petitioner
`
`foresees none—Petitioner 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
`
`Petitioner 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.
`
`11
`
`
`
`
`
`V.
`
`CONCLUSION
`
`For the foregoing reasons, Petitioner requests that the 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,
`
`/s/ Samuel S. Park
`Samuel S. Park
`Registration No. 59,656
`
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`Email: spark@winston.com
`
`Lead Counsel for Petitioner
`Sun Pharmaceutical Industries, Ltd.,
`Sun Pharma Global FZE, and Amneal
`Pharmaceuticals LLC
`
`
`
`
`
`
`
`12
`
`
`
`Dated: June 1, 2016
`
`
`
`
`
`
`
`
`
`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 June 1, 2016, upon the following parties via Express
`
`mail:
`
`Patent Owner’s
`correspondence
`address of record for U.S.
`Patent No. RE44,186 E
`Lead Counsel for Patent
`Owner:
`
`Back-Up Counsel for
`Patent Owner:
`
`Back-Up Counsel for
`Patent Owner:
`
`Back-Up Counsel for
`Patent Owner:
`
`
`
`Baker & Hostetler LLP
`Cira Centre 12th Floor
`2929 Arch Street
`Philadelphia, PA 19104-2891
`Charles E. Lipsey
`Reg. No. 28,165
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`11955 Freedom Drive
`Reston, VA 20190
`Email: charles.lipsey@finnegan.com
`Eric E. Grondahl
`Reg. No. 46,741
`McCarter & English LLP
`CityPlace I
`185 Asylum St.
`Hartford, CT 06103
`Email: egrondahl@mccarter.com
`John D. Livingstone
`Reg. No. 59,613
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`3500 SunTrust Plaza
`303 Peachtree Street, N.E.
`Atlanta, GA 30308
`Email:
`john.livingstone@finnegan.com
`Anthony A. Hartmann
`Reg. No. 43,662
`
`
`
`
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Email:
`anthony.hartmann@finnegan.com
`M. David Weingarten
`Reg. No. 54,533
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`3500 SunTrust Plaza
`303 Peachtree Street, N.E.
`Atlanta, GA 30308
`Email:
`david.weingarten@finnegan.com
`
`
`
`/Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`Email: spark@winston.com
`
`Lead Counsel for Petitioner
`Sun Pharmaceutical Industries, Ltd.,
`Sun Pharma Global FZE, and Amneal
`Pharmaceuticals LLC
`
`Back-Up Counsel for
`Patent Owner:
`
`
`
`Dated: June 1, 2016
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