Filed: January 15, 2015
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`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: BoxMylan2@knobbe.com
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`By:
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
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`Case No. IPR2015-00268
`Patent 6,335,031
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`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)
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`
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`
`
`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: BoxMylan2@knobbe.com
`
`By:
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`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
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`Case No. IPR2015-00268
`Patent 6,335,031
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`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)
`
`
`
`
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`IPR2015-00268
`Mylan v. Novartis
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`I.
`
`Introduction
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`Novartis’s Opposition (Paper No. 10, Dec. 15, 2014) to Mylan’s Joinder
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`Motion asks the Board to impose four conditions before Novartis will agree to
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`joinder, and raises objections that are unrelated to the Board’s guidelines on
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`joinder. Obtaining Novartis’s agreement is unnecessary, its proposed conditions
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`are moot or unwarranted, and its objections are meritless.
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`Joinder is appropriate in this case. The Mylan IPR is substantively identical
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`to the corresponding Noven IPR and, thus, will avoid multiplication of issues
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`before the Board. If joinder is denied, Mylan’s petition on these substantively
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`identical issues would proceed independently from Noven’s earlier-filed IPR,
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`doubling the Board’s burden. Mylan has agreed to procedural concessions, such
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`as consolidated filings and discovery, thereby preventing prejudice to Novartis.
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`Thus, Mylan has born its burden to show that joinder is appropriate. See Kyocera
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`Corp. v. SoftView LLC, IPR2013-00004 (Apr. 24, 2013) (Paper 15 at 4).
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`II. Novartis’s Conditions are Moot or Unwarranted
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`Novartis asks the Board to impose four conditions before Novartis will
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`agree to joinder. Paper 10 at 1. First, Novartis asks that Mylan’s filings be
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`consolidated with Noven’s. This is moot because Mylan has already agreed to
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`this. Paper 3 at 7-8. Second, Novartis asks that Mylan not raise new grounds. This
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`also is moot because Mylan has already agreed to this. Paper 3 at 6. Third,
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`-1-
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`
`
`IPR2015-00268
`Mylan v. Novartis
`
`Novartis asks that Mylan be bound by any agreement between Novartis and
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`Noven. This is unwarranted; Novartis could agree with Noven to settle the IPR
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`with Noven and conduct no discovery, thereby prejudicing Mylan. Fourth,
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`Novartis requires that the timing for deposition be subject to 37 C.F.R. §42.53.
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`Mylan agrees and has no intention of proceeding contrary to the Rules.
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`III. Novartis’s Objections Are Meritless
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`Novartis raises four objections that are irrelevant, as they are not
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`appropriate considerations for joinder motions under Kyocera Corp. v. SoftView
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`LLC, IPR2013-00004 (Apr. 24, 2013) (Paper 15 at 4). None of the objections is
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`relevant because none would help ensure a just, speedy, and inexpensive resolution to
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`the IPRs. See 35 U.S.C. §316(b); 37 C.F.R. §42.1(b).
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`Novartis first objects that Mylan has not promised to refrain from filing
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`papers that it has not been authorized to file. Paper 10 at 3. Novartis concedes, as
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`it must, that Mylan has agreed to consolidated filings in order to simplify
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`briefings. Id. However, Novartis would require that joinder motions must also
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`promise to “refrain from introducing additional, unconsolidated filings that are
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`not on the existing briefing schedule.” Id. (emphasis in original). Mylan has
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`agreed to consolidated filings. Paper 3 at 7. Any paper not on the briefing
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`schedule is subject to prior Board authorization. Thus, Novartis’s proposed
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`requirement (that Mylan promise not to do something not permitted under the
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`-2-
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`
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`IPR2015-00268
`Mylan v. Novartis
`
`rules) is pointless. Mylan reserves the right to request relief from the Board in the
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`event Noven pursues the joined IPR in a manner that is harmful to Mylan (for
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`example, if Noven chooses not to depose any expert testifying on behalf of
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`Novartis).
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`Novartis’s second objection is that “Mylan has failed to explain clearly how
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`joinder would simplify discovery.” Paper 10 at 4. Novartis concedes, as it must,
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`that Mylan has stated it “‘does not anticipate the need for new expert depositions
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`following joinder’ [] and does not ‘anticipate’ that it will introduce new argument
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`or discovery.” Id. However, Novartis implies that Mylan is contemplating the
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`exact opposite: “Mylan has provided no assurance that it will not, in fact,
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`introduce new experts, argument or discovery in any joined proceeding.” Given
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`the possibility of settlement between Novartis and Noven, Mylan cannot agree to
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`this requirement. Nonetheless, subject to the conditions that Novartis and Noven
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`have not settled and Noven is actively pursuing the IPR in a manner that does not
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`disadvantage Mylan, Mylan agrees to Novartis’s provisions (1)-(3) of Paper 10,
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`page 4.
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`Novartis states that its requested limitation on Mylan’s deposition time is
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`consistent with the Board’s order in SAP America Inc. v. Clouding IP, LLC,
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`IPR2014-00306 (Paper 13 at 6), but Novartis seeks to further restrict deposition
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`time based on “any agreement between Novartis and Noven.” Paper 10 at 4. The
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`-3-
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`
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`IPR2015-00268
`Mylan v. Novartis
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`joinder order in SAP required only that witness examination occur “within the
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`time frame normally allotted by the rules for one party,” and did not restrict
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`deposition time based on any agreement between the original parties, as urged by
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`Novartis. SAP America Inc., IPR-2014-00306 (Paper 13 at 6). This additional
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`restriction is not warranted.
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`Novartis’s third objection is that Mylan’s proposal for separate filings
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`“does not give Novartis an opportunity to respond to these ‘separate filings.’”
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`Paper 10 at 4-5. Novartis again cites SAP America Inc., IPR-2014-00306 (Paper
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`13 at 5) and in so doing concedes that Mylan’s request is consistent with standard
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`Board practice. Allowing separate filings in joined IPRs is consistent with Board
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`orders in other joined IPRs. See Paper 10 at 8. As the Board may provide Novartis
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`the customary responsive paper (of a corresponding number of pages) in the event
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`it grants Mylan’s request for separate filings, Mylan would not oppose Novartis’s
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`request, provided such papers would not exceed the number of pages in the Mylan
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`filing and would be limited to issues raised in the Mylan filing. See SAP America
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`Inc., IPR2014-00306 (Paper 13 at 5).
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`Novartis’s final objection is that “Mylan has not expressly confirmed that it
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`will not create new issues for the Board and Novartis to address.” Paper 10 at 5.
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`Again, Novartis is requiring Mylan to confirm it will not act impermissibly in the
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`joined IPR. Mylan has already filed its petition; Mylan is now prohibited from
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`-4-
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`
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`IPR2015-00268
`Mylan v. Novartis
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`raising new issues or presenting belated evidence in its Reply to Patent Owner’s
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`Response. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767
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`(Aug. 14, 2012); 37 C.F.R. § 42.23(b). Also, Novartis’s concern that Mylan’s
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`petition contains grounds that were denied in the Noven IPR (Paper 10 at 5) is
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`unwarranted, as Mylan has expressly stated it “seeks institution only as to the
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`three grounds of invalidity already instituted by the Board in the Noven IPR.”
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`Paper 3 at 6. Thus, while Novartis asks the Board to expressly prohibit Mylan
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`from doing so, Novartis can be assured that Mylan will not file any papers
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`prohibited by the rules and regulations nor file any paper not authorized by the
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`Board.
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`IV. Conclusion
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`The Mylan and Noven IPR petitions are substantively
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`identical—
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`challenging the same claims on the same grounds, submitting the same claim
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`constructions, and relying upon the same declarations. Furthermore, Mylan has
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`proposed procedural protections that allow Noven to retain control over the joined
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`proceeding. Joining the IPRs will not alter the Scheduling Order in the Noven IPR.
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`Procedurally, the impact of joinder will be minimal.
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`For the foregoing reasons, Mylan respectfully requests that its Petition for
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`Inter Partes Review of the ’031 Patent be granted and that the proceedings of the
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`present IPR be joined with IPR2014-00550.
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`-5-
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`
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`IPR2015-00268
`Mylan v. Novartis
`
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`
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`Dated: January 14, 2015
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`
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`Respectfully submitted,
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`
`
`By: /Joseph M. Reisman/
`Joseph M. Reisman
`Reg. No. 43,878
`Customer No. 20,995
`Attorneys for Petitioner
`MYLAN PHARMACEUTICALS INC.
`(949) 760-0404
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`-6-
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`
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`IPR2015-00268
`Mylan v. Novartis
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that a true and correct copy of the foregoing PETITIONER
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`REPLY IN SUPPORT OF MOTION FOR JOINDER is being served on
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`January 15, 2015, via email pursuant to 37 C.F.R. § 42.6(e) per agreement of the
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`parties, to counsel for Novartis AG and LTS Lohmann Therapie-Systeme AG at
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`the address below:
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`ExelonPatchIPR@fchs.com
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`Raymond R. Mandra
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104
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`Dated: _January 14, 2015___
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`
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`19612193
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`
` /Joseph M. Reisman/
`Joseph M. Reisman, Reg. No. 43,878
`Attorney for Petitioner
`Mylan Pharmaceuticals Inc.
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`-1-
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