`
`
`Filed on behalf of:
`Mylan Pharmaceuticals Inc.
`Joseph M. Reisman
`Jay R. Deshmukh
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Fax: (949) 760-9502
`Ph.: (949) 760-0404
`E-mail: BoxMylan@knobbe.com
`
`By:
`
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2015-00265
`Patent 6,316,023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER REPLY IN SUPPORT OF MOTION FOR JOINDER UNDER
`35 U.S.C §§ 315(C), 37 C.F.R. §§ 42.22 AND 42.122(B)
`
`
`
`
`
`I.
`
`Introduction
`
`Novartis’s Opposition (Paper No. 10, Dec. 15, 2014) to Mylan’s Joinder
`
`Motion asks the Board to impose four conditions before Novartis will agree to
`
`joinder, and raises objections that are unrelated to the Board’s guidelines on
`
`joinder. Obtaining Novartis’s agreement is unnecessary, its proposed conditions
`
`are moot or unwarranted, and its objections are meritless.
`
`Joinder is appropriate in this case. The Mylan IPR is substantively identical
`
`to the corresponding Noven IPR and, thus, will avoid multiplication of issues
`
`before the Board. If joinder is denied, Mylan’s petition on these substantively
`
`identical issues would proceed independently from Noven’s earlier-filed IPR,
`
`doubling the Board’s burden. Mylan has agreed to procedural concessions, such
`
`as consolidated filings and discovery, thereby preventing prejudice to Novartis.
`
`Thus, Mylan has born its burden to show that joinder is appropriate. See Kyocera
`
`Corp. v. SoftView LLC, IPR2013-00004 (Apr. 24, 2013) (Paper 15 at 4).
`
`II. Novartis’s Conditions are Moot or Unwarranted
`
`Novartis asks the Board to impose four conditions before Novartis will
`
`agree to joinder. Paper 10 at 1. First, Novartis asks that Mylan’s filings be
`
`consolidated with Noven’s. This is moot because Mylan has already agreed to
`
`this. Paper 3 at 7-8. Second, Novartis asks that Mylan not raise new grounds. This
`
`also is moot because Mylan has already agreed to this. Paper 3 at 6. Third,
`
`-1-
`
`
`
`IPR2015-00265
`Mylan v. Novartis
`
`Novartis asks that Mylan be bound by any agreement between Novartis and
`
`Noven. This is unwarranted; Novartis could agree with Noven to settle the IPR
`
`with Noven and conduct no discovery, thereby prejudicing Mylan. Fourth,
`
`Novartis requires that the timing for deposition be subject to 37 C.F.R. §42.53.
`
`Mylan agrees and has no intention of proceeding contrary to the Rules.
`
`III. Novartis’s Objections Are Meritless
`
`Novartis raises four objections that are irrelevant, as they are not
`
`appropriate considerations for joinder motions under Kyocera Corp. v. SoftView
`
`LLC, IPR2013-00004 (Apr. 24, 2013) (Paper 15 at 4). None of the objections is
`
`relevant because none would help ensure a just, speedy, and inexpensive resolution to
`
`the IPRs. See 35 U.S.C. §316(b); 37 C.F.R. §42.1(b).
`
`Novartis first objects that Mylan has not promised to refrain from filing
`
`papers that it has not been authorized to file. Paper 10 at 3. Novartis concedes, as it must,
`
`that Mylan has agreed to consolidated filings in order to simplify briefings. Id. However,
`
`Novartis would require that joinder motions must also promise to “refrain from
`
`introducing additional, unconsolidated filings that are not on the existing briefing
`
`schedule.” Id. (emphasis in original). Mylan has agreed to consolidated filings. Paper 3 at
`
`7. Any paper not on the briefing schedule is subject to prior Board authorization. Thus,
`
`Novartis’s proposed requirement (that Mylan promise not to do something not permitted
`
`under the rules) is pointless. Mylan reserves the right to request relief from the
`
`-2-
`
`
`
`IPR2015-00265
`Mylan v. Novartis
`
`Board in the event Noven pursues the joined IPR in a manner that is harmful to
`
`Mylan (for example, if Noven chooses not to depose any expert testifying on
`
`behalf of Novartis).
`
`Novartis’s second objection is that “Mylan has failed to explain clearly how
`
`joinder would simplify discovery.” Paper 10 at 4. Novartis concedes, as it must, that
`
`Mylan has stated it “‘does not anticipate the need for new expert depositions following
`
`joinder’ [] and does not ‘anticipate’ that it will introduce new argument or discovery.” Id.
`
`However, Novartis implies that Mylan is contemplating the exact opposite: “Mylan has
`
`provided no assurance that it will not, in fact, introduce new experts, argument or
`
`discovery in any joined proceeding.” Given the possibility of settlement between Novartis
`
`and Noven, Mylan cannot agree to this requirement. Nonetheless, subject to the
`
`conditions that Novartis and Noven have not settled and Noven is actively pursuing the
`
`IPR in a manner that does not disadvantage Mylan, Mylan agrees to Novartis’s provisions
`
`(1)-(3) of Paper 10, page 4.
`
`Novartis states that its requested limitation on Mylan’s deposition time is consistent
`
`with the Board’s order in SAP America Inc. v. Clouding IP, LLC, IPR2014-00306 (Paper
`
`13 at 6), but Novartis seeks to further restrict deposition time based on “any agreement
`
`between Novartis and Noven.” Paper 10 at 4. The joinder order in SAP required only that
`
`witness examination occur “within the time frame normally allotted by the rules for one
`
`party,” and did not restrict deposition time based on any agreement between the original
`
`-3-
`
`
`
`IPR2015-00265
`Mylan v. Novartis
`
`parties, as urged by Novartis. SAP America Inc., IPR-2014-00306 (Paper 13 at 6). This
`
`additional restriction is not warranted.
`
`Novartis’s third objection is that Mylan’s proposal for separate filings
`
`“does not give Novartis an opportunity to respond to these ‘separate filings.’”
`
`Paper 10 at 4-5. Novartis again cites SAP America Inc., IPR-2014-00306 (Paper 13 at 5)
`
`and in so doing concedes that Mylan’s request is consistent with standard Board practice.
`
`Allowing separate filings in joined IPRs is consistent with Board orders in other joined
`
`IPRs. See Paper 10 at 8. As the Board may provide Novartis the customary responsive
`
`paper (of a corresponding number of pages) in the event it grants Mylan’s request for
`
`separate filings, Mylan would not oppose Novartis’s request, provided such papers would
`
`not exceed the number of pages in the Mylan filing and would be limited to issues raised
`
`in the Mylan filing. See SAP America Inc., IPR2014-00306 (Paper 13 at 5).
`
`Novartis’s final objection is that “Mylan has not expressly confirmed that it
`
`will not create new issues for the Board and Novartis to address.” Paper 10 at 5.
`
`Again, Novartis is requiring Mylan to confirm it will not act impermissibly in the joined
`
`IPR. Mylan has already filed its petition; Mylan is now prohibited from raising new issues
`
`or presenting belated evidence in its Reply to Patent Owner’s Response. See Office Patent
`
`Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012); 37 C.F.R. § 42.23(b).
`
`Thus, while Novartis asks the Board to expressly prohibit Mylan from doing so, Novartis
`
`-4-
`
`
`
`IPR2015-00265
`Mylan v. Novartis
`
`can be assured that Mylan will not file any papers prohibited by the rules and regulations
`
`nor file any paper not authorized by the Board.
`
`IV. Conclusion
`
`The Mylan and Noven IPR petitions are substantively
`
`identical—
`
`challenging the same claims on the same grounds, submitting the same claim
`
`constructions, and relying upon the same declarations. Furthermore, Mylan has
`
`proposed procedural protections that allow Noven to retain control over the joined
`
`proceeding. Joining the IPRs will not alter the Scheduling Order in the Noven IPR.
`
`Procedurally, the impact of joinder will be minimal.
`
`For the foregoing reasons, Mylan respectfully requests that its Petition for
`
`Inter Partes Review of the ’023 Patent be granted and that the proceedings of the
`
`present IPR be joined with IPR2014-00549.
`
`
`
`
`Respectfully submitted,
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`Dated: January 14, 2015
`
`
`
`By: /Joseph M. Reisman/
`Joseph M. Reisman
`Reg. No. 43,878
`Customer No. 20,995
`Attorneys for Petitioner
`MYLAN PHARMACEUTICALS INC.
`(949) 760-0404
`
`-5-
`
`
`
`IPR2015-00265
`Mylan v. Novartis
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that a true and correct copy of the foregoing PETITIONER
`
`REPLY IN SUPPORT OF MOTION FOR JOINDER is being served on
`
`January 15, 2015, via email pursuant to 37 C.F.R. § 42.6(e) per agreement of the
`
`parties, to counsel for Novartis AG and LTS Lohmann Therapie-Systeme AG at
`
`the address below:
`
`ExelonPatchIPR@fchs.com
`
`Raymond R. Mandra
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104
`
`Dated: _January 14, 2015 ____
`
`
`19671541
`
`
`
` /Joseph M. Reisman/
`Joseph M. Reisman, Reg. No. 43,878
`Attorney for Petitioner
`Mylan Pharmaceuticals Inc.
`
`
`
`-1-
`
`