IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`ALMIRALL, LLC.,
`Patent Owner.
`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
`
`
`
`PETITIONER’S MOTION FOR JOINDER
`UNDER 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
`
`
`
`US_139654252v1_391026-00295
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`ALMIRALL, LLC.,
`Patent Owner.
`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
`
`
`
`PETITIONER’S MOTION FOR JOINDER
`UNDER 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
`
`
`
`US_139654252v1_391026-00295
`
`
`
`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`
`Table of Contents
`
`I. STATEMENT OF RELIEF REQUESTED ........................................................ 3
`
`II.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ......................... 4
`
`A. Legal Standards ............................................................................................. 4
`
`B. Mylan’s Motion is Timely ............................................................................. 5
`
`C.
`
`Joinder is Appropriate ................................................................................... 5
`
`1. No New Grounds of Unpatentability in the Petition .................................. 7
`
`2. No Impact on the Schedule for the Existing IPR Proceeding .................... 8
`
`3. Briefing and Discovery Will be Simplified ............................................... 9
`
`4. No Prejudice to Patent Owner ..................................................................10
`
`III. CONCLUSION ..............................................................................................11
`
`
`
`
`
`
`
`
`2
`
`
`
`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`
`
`I.
`STATEMENT OF RELIEF REQUESTED
`Petitioner Mylan Pharmaceuticals Inc. (hereinafter “Mylan” or “Petitioner”)
`
`respectfully requests joinder of the concurrently filed petition for inter partes
`
`review of U.S. Patent No. 9,517,219 (“the ’219 patent”) (IPR2019-01095) with
`
`Amneal Pharmaceuticals LLC et al v. Almirall, LLC et al., IPR2019-00207, filed
`
`November 6, 2018 and instituted May 10, 2019 (hereinafter, “the Amneal IPR”).
`
`See IPR2019-00207, Paper 13. The instant Petition is the same as the Amneal IPR:
`
`it involves the same patent, same claims, same grounds of unpatentability, and the
`
`same evidence (including the same prior art combinations) as the Amneal IPR. If
`
`joined, as discussed further below, Mylan will assume a “silent understudy” role
`
`and will not take an active role in the inter partes review proceeding unless the
`
`Amneal Petitioner ceases to participate in the instituted IPR.
`
`While the instant Petition includes the declarations of Dr. Serota and Dr.
`
`Stinchcomb (“Mylan Declarants”), these declarations present identical expert
`
`testimony to that put forth by Dr. Gilmore and Dr. Michniak-Kohn (“Amneal
`
`Declarants”) in the Amneal IPR. If Amneal allows Mylan to use the Amneal
`
`Declarants, then Mylan will withdraw the Mylan Declarants, and rely only the
`
`Amneal Declarants. The PTAB has acknowledged that such concessions are
`
`sufficient to minimize the impact on the original proceeding. SAP America Inc. v.
`
`Clouding IP, LLC, IPR2014-00306, Paper 13 at 4 (May 19, 2014). Thus, the
`
`
`
`3
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`proposed joinder will neither unduly complicate the Amneal IPR nor delay its
`
`schedule. As such, the joinder will promote judicial efficiency in determining the
`
`patentability of the Amneal IPR without prejudice to Patent Owner.
`
`Although Mylan is not otherwise time barred pursuant to 37 C.F.R. §
`
`42.101(b), this Motion for Joinder, and accompanying Petition, are timely because
`
`it is filed less than one month after a decision instituting trial in the Amneal IPR.
`
`37 C.F.R. § 42.122(b) (“no later than one month after the institution date of any
`
`inter partes review for which joinder is requested.”). Accordingly, Mylan
`
`respectfully requests that the Board grant this Motion for Joinder.
`
`II.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`A. Legal Standards
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review (IPR) proceedings. Joinder is governed by 35 U.S.C. § 315(c), which states:
`
`(c) JOINDER. – 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.
`
`
`
`4
`
`
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`A motion for joinder should “(1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the
`
`petition; (3) explain what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) address specifically how briefing and discovery
`
`may be simplified.” Dell Inc. v. Network-1 Sec. Solutions, Inc., IPR2013-00385,
`
`Paper 17 (PTAB July 29, 2013); Hyundai Motor Co. v. Am. Vehicular Sciences
`
`LLC, IPR2014-01543, Paper No. 11 at 3 (Oct. 24, 2014); Macronix Int’l Co. v.
`
`Spansion, IPR2014-00898, Paper 15 at 4 (Aug. 13, 2014) (quoting Kyocera
`
`Corporation v. Softview LLC, IPR2013-00004, Paper 15 at 4 (April 24, 2013)).
`
`B. Mylan’s Motion is Timely
`A Motion for Joinder is timely if the moving party files within one month of
`
`
`
`institution of the inter partes review for which joinder is requested. 37 C.F.R. §
`
`42.122(b). Because Mylan files this motion less than one month after a decision on
`
`the institution of the Amneal IPR, this motion is timely.
`
`C.
`Joinder is Appropriate
`Joinder is appropriate because Mylan’s Petition does not raise any new
`
`grounds of unpatentability and does “not present issues that might complicate or
`
`delay” the Amneal IPR. See Enzymotec Ltd. v. Neptune Techs & Bioresources,
`
`Inc., IPR2014-00556, Paper 19 (PTAB July 9, 2014). Mylan’s Petition is identical
`
`to the petition in the Amneal IPR, challenging the same claims of the ’219 patent
`
`
`
`5
`
`
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`on the same grounds and relying on identical expert testimony. The primary
`
`difference between Mylan’s Petition and the petition filed in the Amneal IPR are
`
`the sections on Real Party-In-Interest, Related Matters, and Counsel, which have
`
`been appropriately updated.
`
`To simplify this proceeding, Mylan will rely on the Amneal Declarants,
`
`should Amneal permit it. If Amneal allows Mylan to do so, Mylan will withdraw
`
`the Mylan Declarants and rely on the declarations and testimonies of the Amneal
`
`Declarants. Mylan’s proposal is identical to the procedure proposed by other
`
`petitioners when they sought joinder. Teva Pharmaceutical USA, Inc. et al. v. Eli
`
`Lilly & Co., IPR2016-01343, Motion for Joinder, Paper 3 at 8 (Jul. 1, 2016)
`
`(offering same procedure); Argentum Pharmaceuticals LLC, v. Janssen Oncology,
`
`Inc., IPR2016-01317, Motion for Joinder, Paper 3 at 6-7 (Jun. 29, 2016) (same);
`
`Argentum Pharmaceuticals LLC, v. Cosmo Technologies, Ltd.., IPR2016-01317,
`
`Motion for Joinder, Paper 3 at 4-5 (Oct. 20, 2017) (same). Such concessions on
`
`the part of a joining party are sufficient to minimize the impact on the original
`
`proceeding. SAP America Inc., IPR2014-00306, Paper 13 at 4.
`
`Even if, despite its best efforts with Amneal, Mylan were required to
`
`proceed with its own Declarants, there would be no impact on the Board’s ability
`
`to complete its review in a timely manner, in light of the identical testimony
`
`between the Mylan Declarants and the Amneal Declarants. In such a situation, at
`
`
`
`6
`
`
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`best, there would be a modest impact on the Patent Owner given that little
`
`additional preparation would be needed for the deposition of the Mylan Declarants
`
`beyond that required for the deposition of the Amneal Declarants. Still further, in
`
`the event that Amneal does not agree to allow Mylan to retain its Declarants,
`
`Mylan would agree to withdraw the Mylan Declarants if the Amneal Declarants
`
`have already been deposed based on their declarations in the Amneal IPR and the
`
`deposition transcripts have been made of record. In that case, Mylan would rely on
`
`the declarations and testimonies of the Amneal Declarants. Teva Pharmaceutical
`
`USA, Inc., IPR 2016-01343, Motion for Joinder, Paper 3 at 9 & fn. 2 (offering the
`
`same concessions).
`
`Joinder would, therefore, have little, if any, impact on the Amneal IPR, the
`
`schedule would not be affected, no additional briefing or discovery would be
`
`required, and no additional burdens would be placed on any party or the PTAB, as
`
`detailed below.
`
`1.
`No New Grounds of Unpatentability in the Petition
`Mylan’s Petition does not assert any new grounds of unpatentability. It
`
`challenges the same claims (1-8) of the ’219 patent based on the same arguments
`
`and analysis, evidence, and two grounds of unpatentability as the Amneal IPR.
`
`See, e.g., Hyundai, IPR2014-01543, Paper No. 11 at 2-4; Dell Inc. v. Network-1
`
`Solutions, Inc., IPR2013-00385, Paper No. 17, at 6-10 (Jul. 29, 2013).
`
`
`
`7
`
`
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`
`No Impact on the Schedule for the Existing IPR
`
`2.
`Proceeding
`Because Mylan’s Petition raises no new grounds of unpatentability, and
`
`because a Scheduling Order has been established for the Amneal IPR less than one
`
`month ago, joinder should have no impact on the schedule of the Amneal IPR. See
`
`LG v. Memory Integrity, LLC., IPR2015-01353, Paper No. 11 at 6 (Oct. 5, 2015)
`
`(granting IPR and motion for joinder where “joinder should not necessitate any
`
`additional briefing or discovery from Patent Owner beyond that already required in
`
`[the original IPR]”). Mylan will adhere to all applicable deadlines set in the
`
`Scheduling Order for the Amneal IPR.
`
`As discussed further below, Mylan is willing to limit its participation in this
`
`proceedings to a “silent understudy”. In the event that the Amneal IPR is
`
`terminated with respect to the Amneal Petitioner, only then does Mylan intend to
`
`“step into the shoes” of the dismissed petitioner and materially participate in the
`
`joined proceedings. Accordingly, for the reasons stated above, joinder of Mylan to
`
`the Amneal IPR will not affect the Board’s ability to complete its review and final
`
`decision within the statutory time limits under 35 U.S.C. § 316(a)(11) and 37
`
`C.F.R. § 42.100(c).
`
`
`
`8
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`
`3.
`Briefing and Discovery Will be Simplified
`As a “silent understudy”, Mylan agrees that, if joined, the following
`
`conditions will apply so long as Amneal remains an active party, as previously
`
`approved by the Board in other joinder circumstances:
`
`(a) all filings by Mylan in the joined proceeding be consolidated with the
`
`filings of Amneal, unless a filing solely concerns issues that do not involve
`
`Amneal;1
`
`(b) Mylan shall not be permitted to raise any new grounds not instituted by
`
`the Board in the Amneal IPR, or introduce any argument or discovery not already
`
`introduced by Amneal;
`
`(c) Mylan shall be bound by any agreement between the Patent Owner and
`
`Amneal concerning discovery and/or depositions; and
`
`(d) Mylan at deposition shall not receive any direct, cross examination or
`
`redirect time beyond that permitted for Amneal in this proceeding alone under
`
`either 37 C.F.R. § 42.53 or any agreement between the Patent Owner and Amneal.
`
` See Mylan Pharms. Inc. v. Novartis AG, IPR2015-00268, Paper 17 at 5-6 (PTAB
`
`Apr. 10, 2015) (finding the same proposed limitations “are consistent with the
`
`‘understudy’ role that Petitioner agrees to assume, as well as Petitioner’s assertion
`
`1 If a filing is necessary concerning an issue that does not involve Amneal, Mylan
`
`will seek prior authorization from the PTAB before filing any paper.
`
`
`
`9
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`
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`that its presence would not require introducing any additional arguments, briefing,
`
`or discovery.”). Mylan also is willing to abide by any additional conditions the
`
`Board deems appropriate.
`
`4.
`No Prejudice to Patent Owner
`Joinder of Petitioner to the Amneal IPR will not create any additional burden
`
`on the Patent Owner. The Patent Owner need not expend any additional resources
`
`above and beyond those required in the current Amneal IPR. Moreover, joinder
`
`eliminates the need for the Patent Owner to participate in multiple, staggered inter
`
`partes review proceedings instituted upon identical grounds of unpatentability.2
`
`Indeed, in the very inter partes review Mylan seeks to join, this very Patent Owner
`
`told the PTAB that staggered proceedings with different schedules presents a
`
`burden to it. Patent Owner’s Preliminary Response, IPR2019-0027, Paper 8 at 17-
`
`18 (February 14, 2019). In light of Patent Owner’s own statements to the PTAB,
`
`because joinder would eliminate the need to dealing with staggered proceedings,
`
`
`2 The argument that joinder may metaphysically frustrate settlement between
`
`Amneal and Patent Owner is not a basis deny joinder because that same possibility
`
`exists in every joinder situation. Global Foundries U.S. Inc. v. Godo Kaisha IP
`
`Bridge 1, IPR2017-00925 and IPR2017-00926, Paper 13 at 10 (June 9, 2017).
`
`
`
`10
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`
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`even Patent Owner would have to concede there would be no prejudice to Patent
`
`Owner.
`
`III. CONCLUSION
`For the foregoing reasons, Mylan respectfully requests that its Petition for
`
`Inter Partes Review of the ’219 patent be granted and that the proceedings be
`
`joined with IPR2019-00207.
`
`
`
`
`
`
`Respectfully submitted,
`KATTEN MUCHIN ROSENMAN LLP
`
`Date: June 7, 2019
`
`
`_/Jitendra Malik/______________________
`Jitendra Malik, Ph.D. (Reg. No. 55,823)
`Attorney for Petitioner
`
`
`
`11
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`
`
`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on June 7, 2019, I caused a true and correct copy of the
`
`foregoing PETITIONER’S MOTION FOR JOINDER UNDER 37 C.F.R. §§ 42.22
`
`AND 42.122(b) to be served via express mail on the counsel of record for Patent
`
`Owner at the following addresses for counsel of record listed in Patent Owner’s
`
`Updated Mandatory Notices for the pending IPR, IPR2019-00207:
`
`Allergan, Inc.
`2525 Dupont Drive, T2-7H
`Irvine, California 92612-1599
`
`Almirall, LLC
`707 Eagleview Blvd. Suite 200
`Exton, PA 19341
`
`
`
`
`
`
`
`James S. Trainor, Jr.
`Vanessa Park-Thompson
`FENWICK & WEST LLP,
`902 Broadway, Suite 14,
`New York, NY 10010
`Elizabeth B. Hagan
`FENWICK & WEST LLP,
`1191 Second Avenue, 10th Floor,
`Seattle, Washington 98101
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`
`12
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`
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`U.S. Patent No. 9,517,219
`IPR No. 2019-01095
`
`In addition, a courtesy copy of the motion was served upon counsel of
`
`record for Petitioner Amneal in IPR2019-00207 at the following addresses:
`
`Dennies Varughese, Pharm.D.,
`Adam C. LaRock
`STERNE, KESSLER, GOLDSTEIN & FOX,
`1100 New York Avenue, N.W.,
`Washington, D.C., 20005
`
`
`
`
`KATTEN MUCHIN ROSENMAN LLP
`
`Date: June 7, 2019
`
`
`_/Jitendra Malik/______________________
`Jitendra Malik, Ph.D. (Reg. No. 55,823)
`Attorney for Petitioner
`
`
`
`13
`
`
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