`Date filed: December 15, 2014
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2015-00265
`
`U.S. Patent 6,316,023
`
`PATENT OWNERS’ OPPOSITION TO PETITIONER’S
`MOTION FOR JOINDER
`
`
`
`Patent Owners Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`(collectively “Novartis”) respectfully oppose the Motion For Joinder (“Motion”)
`
`by Mylan Pharmaceuticals Inc. (“Mylan”) to join this inter partes review
`
`proceeding, IPR 2015-00265, with that brought by Noven Pharmaceuticals Inc.
`
`(“Noven”), Noven Pharmaceuticals Inc. v. Novartis AG and LTS Lohmann
`
`Therapie-Systeme AG, IPR2014-00549 (“the Noven IPR”) on the terms proposed
`
`by Mylan. However, Novartis would not oppose joinder if the Board were to order
`
`that (a) all filings by Mylan in the joined proceeding be consolidated with
`
`Noven’s, unless a filing solely concerns issues that do not involve Noven; (b)
`
`Mylan shall not be permitted to raise any new grounds not already instituted by the
`
`Board in the Noven IPR, or introduce any argument or discovery not already
`
`introduced by Noven; (c) Mylan shall be bound by any agreement between
`
`Novartis and Noven concerning discovery and/or depositions; and (d) Mylan at
`
`deposition shall not receive any direct, cross-examination or redirect time beyond
`
`that permitted for Noven alone under either 37 C.F.R. § 42.53 or any agreement
`
`between Novartis and Noven. As set forth below, Novartis’s requests in this regard
`
`are consistent with the Board’s prior orders on motions for joinder.
`
`I.
`
`THE NOVEN IPR
`
`On April 2, 2014, Noven filed a petition to institute inter partes review of
`
`U.S. Patent No. 6,316,023 (“the ’023 Patent”). Noven Pharmaceuticals Inc. v.
`
`1
`
`
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG, IPR2014-00549 (Apr. 2,
`
`2014) (Paper 1). The Board instituted review of the ’023 Patent on October 14,
`
`2014. Noven Pharmaceuticals, IPR2014-00549 (Oct. 14, 2014) (Paper 10).
`
`Novartis’s response to Noven’s petition is due on January 20, 2015. Noven
`
`Pharmaceuticals, IPR2014-00549 (Nov. 4, 2014) (Paper 16). Novartis and
`
`Noven have stipulated that the cross-examination of Noven’s declarants will occur
`
`no earlier than January 2, 2015. Id.
`
`II.
`
`ARGUMENT
`
`The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`
`(2011) permits joinder of like review proceedings. The Board, acting on behalf of
`
`the Director, has the discretion to join an inter partes review with another inter
`
`partes review when warranted. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. The
`
`Board has indicated that it will determine whether to grant joinder on a case-by-
`
`case basis, taking into account the particular facts of each case, substantive and
`
`procedural issues, and other considerations. See 157 CONG. REC. S1376 (daily ed.
`
`Mar. 8, 2011) (statement of Sen. Kyl). In the exercise of this discretion, the Board
`
`should consider that patent trial regulations, including the rules for joinder, must be
`
`construed to secure the just, speedy, and inexpensive resolution of every
`
`proceeding. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b).
`
`2
`
`
`
`As the moving party, Mylan has the burden of proving that it is entitled to
`
`join its IPR to the Noven IPR. 37 C.F.R. §§ 42.20(c), 42.122(b). Mylan’s Motion
`
`for joinder should have: (1) set forth the reasons why joinder is appropriate; (2)
`
`identified any new ground of unpatentability asserted in Mylan’s petition; (3)
`
`explained what impact (if any) joinder would have on the trial schedule for the
`
`Noven IPR; and (4) addressed specifically how briefing and discovery may be
`
`simplified. See Kyocera Corp. v. SoftView LLC, IPR2013-00004 (Apr. 24, 2013)
`
`(Paper 15 at 4). Mylan has failed to meet this burden.
`
`First, Mylan has failed to explain clearly how joinder would simplify
`
`briefing. Although Mylan in its Motion “agree[s] to consolidated filings on the
`
`existing briefing schedule, for which Noven will maintain responsibility” (Motion
`
`at 7), Mylan has provided no assurance that it will refrain from introducing
`
`additional, unconsolidated filings that are not on the existing briefing schedule. If
`
`Mylan is not required to consolidate all of its filings with Noven’s upon joinder,
`
`Mylan potentially may force Novartis and the Board to respond to numerous
`
`additional papers. However, Novartis would not oppose joinder if the Board were
`
`to order that all filings by Mylan in the joined proceeding be consolidated with
`
`Noven’s, unless a filing solely concerns issues that do not involve Noven.
`
`Novartis’s request in this regard is consistent with the Board’s order in SAP
`
`3
`
`
`
`America Inc. v. Clouding IP, LLP, IPR2014-00306 (May 19, 2014) (Paper 13 at 5),
`
`cited by Mylan in support of its motion. (Motion at 8.)
`
`Second, Mylan has failed to explain clearly how joinder would simplify
`
`discovery. For example, although Mylan states that it “does not anticipate the
`
`need for new expert depositions following joinder” (Motion at 6) and does not
`
`“anticipate” that it will introduce new argument or discovery (id.), Mylan has
`
`provided no assurance that it will not, in fact, introduce new experts, argument or
`
`discovery in any joined proceeding. However, Novartis would not oppose joinder
`
`if the Board were to order that (1) Mylan shall not be permitted to introduce any
`
`experts, argument or discovery not already introduced by Noven; (2) Mylan shall
`
`be bound by any agreement between Novartis and Noven concerning discovery
`
`and/or depositions; and (3) Mylan at deposition shall not receive any direct, cross-
`
`examination or redirect time beyond that permitted for Noven alone under either
`
`37 C.F.R. § 42.53 or any agreement between Novartis and Noven. Novartis’s
`
`requested limitation on Mylan’s deposition time is consistent with the Board’s
`
`order in SAP America Inc., IPR2014-00306 (Paper 13 at 6).
`
`Third, Mylan has proposed that in a joined proceeding, Mylan should be
`
`permitted “separate filings” of no more than seven pages directed to points of
`
`disagreement with Noven’s asserted positions in any consolidated filing. (Motion
`
`at 7.) Mylan’s proposal, however, does not give Novartis an opportunity to
`
`4
`
`
`
`respond to these “separate filings.” In the event that the Board permits Mylan such
`
`“separate filings,” which Novartis opposes, Novartis respectfully requests that in
`
`addition to having the opportunity to respond to any consolidated filing, Novartis
`
`should be permitted to respond concurrently to any “separate filing” by Mylan in a
`
`responsive paper of up to seven pages. Novartis’s request in this regard again is
`
`consistent with the Board’s order in SAP America Inc., IPR2014-00306 (Paper 13
`
`at 5).
`
`Finally, although Mylan’s motion represents that “Mylan’s Petition asserts,
`
`verbatim, the arguments that the Board has already instituted in the Noven IPR,”
`
`(Motion at 6), Mylan has not expressly confirmed that it will not create new issues
`
`for the Board and Novartis to address. Novartis therefore respectfully requests that
`
`the Board expressly prohibit Mylan from raising any new grounds or arguments
`
`beyond those already instituted by the Board in the Noven IPR. Noven
`
`Pharmaceuticals, IPR2014-00549 (Oct. 14, 2014) (Paper 10).
`
`III. CONCLUSION
`
`For the foregoing reasons, Novartis opposes Mylan’s Motion to join its inter
`
`partes review proceeding 2015-00265 with Noven’s inter partes review
`
`proceeding 2014-00549.
`
`Respectfully submitted,
`
`5
`
`
`
`Dated: December 15, 2014
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`Lead Counsel for Patent Owners
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the Patent Owners’ Opposition To Petitioner’s
`
`Motion For Joinder was served on December 15, 2014 by causing it to be sent by
`
`email to counsel for Petitioner at the following email address:
`
`BoxMylan@knobbe.com
`
`Dated: December 15, 2014
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`7
`
`