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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`______________________
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
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`v.
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`ALMIRALL, LLC.,
`Patent Owner.
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`U.S. Patent No. 9,517,219 to Warner et al.
`Issue Date: December 13, 2016
`Title: Topical dapsone and dapsone/adapalene compositions and methods for use
`thereof
`Inter Partes Review No.: IPR2019-01095
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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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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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
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`Contents
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`INTRODUCTION .................................................................................................................. 1
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`III.
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`INSTITUTION SHOULD NOT BE DENIED BASED ON §314(A).................................... 2
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`IV. The General Plastic Factors Do Not Support Denial of Institution Under §314(A). ............. 3
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`A. General Plastic Factor 1 ..................................................................................................... 4
`B. General Plastic Factors 2-5 ................................................................................................ 5
`C. General Plastic Factors 6-7 ................................................................................................. 7
`V. CONCLUSION ....................................................................................................................... 8
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`TABLE OF AUTHORITIES
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`
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`Page(s)
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`Cases
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`Abiomed, Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02134, Paper 7 (P.T.A.B. Apr. 16, 2018) ...................................................................6
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`Amneal Pharmaceuticals LLC et al v. Almirall, LLC et al.,
`IPR2019-00207, Paper 13 (P.T.A.B. Nov. 6, 2018) ..................................................................1
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`General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017) ........................................................ passim
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`Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GMBH,
`IPR2018-01680, Paper 22 (P.T.A.B. Apr. 3, 2019) ...............................................................2, 3
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`Sawai USA, Inc. v. Biogen MA, Inc.,
`IPR2019-00789, Paper 17 (P.T.A.B. Sept. 12, 2019) ...................................................... passim
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`Valve Corp. v. Electronic Scripting Prods., Inc.,
`IPR2019-00062, -00063, -00084, Paper 11 (P.T.A.B. Apr. 2, 2019) ........................................5
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`Statutes
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`35 U.S.C. § 314(a) .......................................................................................................................1, 2
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`35 U.S.C. § 316(a)(11) .....................................................................................................................4
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`Regulations
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`37 C.F.R. § 42.22 .............................................................................................................................6
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`37 C.F.R. § 42.122(b) ......................................................................................................................6
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`ii
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`II.
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`INTRODUCTION
`Mylan Pharmaceuticals Inc. (“Mylan” or “Petitioner”) filed a “me-too” or
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`“copycat” petition seeking joinder with Amneal Pharmaceuticals LLC et al v.
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`Almirall, LLC et al., IPR2019-00207, filed November 6, 2018 and instituted May
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`10, 2019 (“the Amneal IPR”). See IPR2019-00207, Paper 13. There is no dispute
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`that Mylan’s Petition is a “me-too” or “copycat” petition. In fact, Almirall, LLC
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`(“Almirall” or “Patent Owner”) freely admits that Mylan’s Petition is a “me-too”
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`Petition. Prelim. Resp. at 10 (“Mylan’s petition, copying Amneal’s petition word-
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`for-word”); id. (“identical petition”); id. at 1 (“The Petitioner challenges the same
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`claims of the same patent previously challenged by Amneal . . . in IPR2019-00207,
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`asserting the same prior art references.”). Moreover, Patent Owner filed no
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`Opposition against Mylan’s Motion for Joinder.
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`In its Preliminary Patent Owner Response and without citing any credible
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`authority, Patent Owner argues that 35 U.S.C. § 314(a) and its related PTAB case
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`law preventing a Patent Owner from being exposed to serial petitions should
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`somehow apply to a “me-too” joinder petition. The PTAB recently rejected this very
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`argument explaining that “there is no abuse of process where . . . a different
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`petitioner files a ‘me-too’ or ‘copycat’” petition in conjunction with a timely motion
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`to join an inter partes review based upon the (essentially) copied petition filed by
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`different petitioner.” Sawai USA, Inc. v. Biogen MA, Inc., IPR2019-00789, Paper 17
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`at 10 (P.T.A.B. Sept. 12, 2019).
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`III.
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`INSTITUTION SHOULD NOT BE DENIED BASED ON §314(A)
`When deciding to exercise its discretion under §314(a) and the General
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`Plastic factors, the Board typically does so in the case of “follow-on” petitions that
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`“abuse [the] review process by repeated attacks on patents.” General Plastic
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`Industrial Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 17
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`(P.T.A.B. Sept. 6, 2017) (precedential); Mylan Pharmaceuticals Inc. v. Sanofi-
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`Aventis Deutschland GMBH, IPR2018-01680, Paper 22 at 17 (P.T.A.B. Apr. 3,
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`2019) (“the General Plastic factors were articulated in the context of follow-on
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`petitions.”).
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`The instant petition is not a follow-on petition; it is a “me-too” or “copycat”
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`petition filed concurrently with a Motion for Joinder with the Amneal IPR. Mylan’s
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`Petition: (1) is identical in substance to the Amneal IPR; (2) challenges the same
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`claims of the ’219 patent on the same grounds, (3) relies on substantively the same
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`expert testimony, and (4) has no impact on the Amneal IPR schedule. See generally,
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`IPR2019-01095, Paper 1; IPR2019-00789 at 11 (“[The joinder] Petition does not
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`present any substantive ground or matter not already at issue”). And as stated in its
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`Motion for Joinder, Mylan has also requested to serve as an understudy to Amneal.
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`See IPR2019-01095, Paper 2.
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`Patent Owner does not dispute any of these facts. Prelim. Resp. at 10
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`(“Mylan’s petition, copying Amneal’s petition word-for-word”); id. (“identical
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`petition”). As stated in Sawai USA, Inc. —a case that is exactly on point—under
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`these circumstances, filing a “me-too” petition “effectively obviates any concerns of
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`serial harassment and unnecessary expenditure of resources that the General Plastic
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`factors and the Trial Practice Guide July 2019 Update are meant to address.” Sawai,
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`IPR2019-00789 at 11.
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`IV. The General Plastic Factors Do Not Support Denial of Institution Under
`§314(A).
`As mentioned above, General Plastic Industrial Co., Ltd. v. Canon Kabushiki
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`Kaisha, cited by Patent Owner, addresses follow-on, serial petition situations where
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`the PTAB has determined that the repeated nature of the filings constitutes an abuse
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`of the Patent Owner. IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017); Mylan
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`Pharmaceuticals Inc., IPR2018-01680 at 17. The instant petition is not a follow-on
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`petition, but a joinder petition.
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`In General Plastic, the Board set out seven nonexclusive factors to be weighed
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`in deciding whether to exercise its denial discretion. These factors are:
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`1. whether the same petitioner previously filed a petition directed to the
`same claims of the same patent;
`2. whether at the time of filing of the first petition the petitioner knew of
`the prior art asserted in the second petition or should have known of it;
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`4.
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`3. whether at the time of filing of the second petition the petitioner already
`received the patent owner’s preliminary response to the first petition or
`received the Board’s decision on whether to institute review in the first
`petition;
`the length of time that elapsed between the time the petitioner learned
`of the prior art asserted in the second petition and the filing of the
`second petition;
`5. whether the petitioner provides adequate explanation for the time
`elapsed between the filings of multiple petitions directed to the same
`claims of the same patent;
`the finite resources of the Board; and
`the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the Director
`notices institution of review.
`General Plastic, IPR2016-01357, Paper 19 at 15-16.
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`6.
`7.
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`The Patent Owner’s own arguments provide support for why the General
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`Plastic factors are not satisfied here. It is undisputed that the Petition is directed to
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`the same claims of the same patent as the Amneal IPR and does not raise any
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`substantively different grounds or matters. See generally IPR2019-01095, Paper 2.
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`Mylan is willing to participate as a “silent understudy” in the Amneal IPR and as
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`such, institution and joinder should have no impact on the schedule.
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`General Plastic Factor 1
`A.
`Patent Owner focuses its General Plastic Factor 1 analysis on a supposed
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`“relationship between Petitioner Mylan and Amneal.” Prelim. Resp. at 5. Patent
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`Owner incorrectly applies Valve Corp. v. Electronic Scripting Prods., Inc., in
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`support of its assertion that Mylan is similarly situated to Amneal. IPR2019-00062,
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`-00063, -00084, Paper 11 at 9 (P.T.A.B. Apr. 2, 2019). In Valve Corp., among other
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`things, Valve Corp. and HTC were co-defendants in district court litigation.
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`IPR2019-00062, Paper 11 at 9-10 (“Valve represented that ‘HTC’s VIVE devices
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`incorporate certain Valve technologies . . . .’ and ‘Valve employees did provide HTC
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`with technical assistance during development of the accused VIVE devices.’”).
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`Mylan and Amneal do not have any relationship with each other—they are
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`independent companies, each filing a separate ANDA with the FDA for separate
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`products. Prelim. Resp. at 6 (“Here, although Mylan and Amneal are not co-
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`defendants in a district court case regarding the ʼ219 patent . . . ”). They provide no
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`assistance to each other. Cf. Valve Corp., IPR2019-00062, Paper 11 at 9-10 (“Valve
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`represented that ‘HTC’s VIVE devices incorporate certain Valve technologies . . . .’
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`and ‘Valve employees did provide HTC with technical assistance during
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`development of the accused VIVE devices.’”). Mylan and Amneal are, in fact,
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`industry competitors. Patent Owner cannot allege otherwise. Moreover, Mylan and
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`Amneal are not co-defendants in district court litigation involving the ’219 patent.
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`Accordingly, General Plastic Factor 1 does not weigh in favor of denying institution.
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`B.
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`General Plastic Factors 2-5
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`General Plastic Factors 2-5 focus on the similarity between the Amneal IPR
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`and the “me-too” Mylan IPR, and the timing of Mylan’s IPR filing. Prelim. Resp.
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`at 7-9. As the PTAB explained in the context of joinder, the concerns raised by
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`General Plastic Factors 2-5 are abated:
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`By its very nature, such a “me-too” or “copycat” petition
`necessarily relies on substantially the same prior art and
`arguments previously considered by the Office, and is
`timely, even though such a petition is filed after our
`institution decision in the earlier proceeding. See 37 C.F.R.
`§ 42.122(b) (“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.”). Patent Owner’s arguments directed to the
`other earlier filed petitions lose force when we consider that
`we have already instituted trial in the Mylan IPR, Patent
`Owner has filed its Response in the Mylan IPR addressing
`the same patentability challenges, and the case is actively
`proceeding to a Final Written Decision.
`Sawai, Paper 17 at 10.
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`For its part, Patent Owner cites to Abiomed, Inc. v. Maquet Cardiovascular,
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`LLC where the Board denied institution based on the abuse created by serially filed
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`petitions. IPR2017-02134, Paper 7 at 8 (P.T.A.B. Apr. 16, 2018) (“[T]his Petition is
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`the last of twenty petitions to be addressed by the Board, filed by Petitioner against
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`six related patents held by Patent Owner . . . . [and] [w]e declined to institute inter
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`partes review in each of the previous nineteen cases.”) (emphasis added). The
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`instant petition is a “me-too” or “copycat” joinder petition and any arguments “in
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`favor of discretionary denial do not persuade us that there is abuse of process where,
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`as here, a different petitioner files a ‘me-too’ or ‘copycat’ petition in conjunction
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`with a timely motion to join an inter partes review based upon the (essentially)
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`copied petition filed by different petitioner.” Sawai USA Inc., IPR2019-00789, Paper
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`17 at 10. Under these circumstances, institution of the instant IPR will “not result
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`in undue prejudice to Patent Owner.” Id. at 12. Accordingly, General Plastic Factors
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`2-5 do not weigh in favor of denying institution.
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`General Plastic Factors 6-7
`C.
`General Plastic Factors 6-7 focus on the finite resources of the Board and the
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`related timing requirement for the Board to issue its Final Written Decision. Given
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`Mylan will adhere to all applicable deadlines set in the Scheduling Order for the
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`Amneal IPR and has asked to participate as a silent understudy, there is “little, if
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`any, waste of Board resources in allowing Petitioner to join an ongoing inter partes
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`review proceeding.” Sawai USA, Inc., IPR2019-00789, Paper 17 at 11. Accordingly,
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`General Plastic Factors 6-7 do not weigh in favor of denying institution.
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`V.
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`CONCLUSION
`Petitioner respectfully requests that the Board institute the Petition.
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`RESPECTFULLY SUBMITTED,
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`Katten Muchin Rosenman LLP
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`Date: October 14, 2019
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`/ Jitendra Malik /
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`Jitendra Malik (Reg. No. 55823)
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`Lead Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
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`Petitioner’s Reply to Patent Owner’s Preliminary Response
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`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
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`certifies that on October 14, 2019, a complete copy of the foregoing Petitioner’s
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`Reply to Patent Owner’s Preliminary Response was served via email to the Patent
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`Owner’s counsel at:
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`jtrainor@fenwick.com
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`ehagan@fenwick.com
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`jbush@fenwick.com
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`Respectfully submitted,
`Katten Muchin Rosenman LLP
`By: /Jitendra Malik/
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