Filed: November 13, 2014
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`Filed on behalf of:
`Mylan Pharmaceuticals Inc.
`Joseph M. Reisman
`Jay R. Deshmukh
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`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. TBD
`Patent 6,335,031
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`MOTION FOR JOINDER UNDER 35 U.S.C §§ 315(C),
`37 C.F.R. §§ 42.22 AND 42.122(B)
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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. TBD
`Patent 6,335,031
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`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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`Mylan v. Novartis
`Motion for Joinder - U.S. Pat. 6,335,031
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`
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`I.
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`INTRODUCTION
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`Mylan Pharmaceuticals Inc. (“Mylan”) submits concurrently herewith a
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`Petition for Inter Partes Review of U.S. Patent No. 6,335,031 (“the ’031
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`Patent”) based on identical grounds that form the basis for pending IPR
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`proceeding, Case No. IPR2014-00550 (“the Noven IPR”). Pursuant to 35
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`U.S.C. § 315(c), Mylan respectfully moves that (1) this Petition be instituted
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`based on the same grounds, and (2) the present IPR be joined with the Noven
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`IPR. Mylan’s petition asserts identical grounds as asserted in the Noven IPR
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`petition, but Mylan seeks institution only on the three grounds of invalidity
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`instituted by the Board in the Noven IPR. See IPR2014-00550, Paper No. 10 at
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`28.
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`II. BACKGROUND AND RELATED PROCEEDINGS
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`Novartis AG and LTS Lohmann Therapie-Systeme AG (“Patent Owners”) are
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`the owners of the ’031 Patent. On June 19, 2014, Patent Owners filed suit against
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`Mylan Inc. and Mylan Pharmaceuticals, Inc. for infringement of the ’031 Patent in
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`Delaware, 1:14-cv-00777 (D. Del.); and on June 20, 2014, Patent Owners also filed suit
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`against Mylan Inc. and Mylan Pharmaceuticals, Inc. for infringement of the ’031 Patent
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`in West Virginia, 1:14-cv-00106 (N.D. W.Va.) (collectively, “the Mylan Litigation”).
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`
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`Mylan v. Novartis
`Motion for Joinder - U.S. Pat. 6,335,031
`
`
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`Patent Owners have filed two suits against Noven for infringement of the ’031
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`Patent: Novartis Pharm. Corp. et al. v. Noven Pharm. Inc., 1:13-cv-00527 (D. Del.); and
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`Novartis Pharm. Corp. et al. v. Noven Pharm. Inc., 1:14-cv-00111 (D. Del.)
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`(collectively, “the Noven Litigation”).
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`The ’031 Patent is also being asserted in the following patent infringement
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`lawsuits: Novartis Pharm. Corp. et al. v. Par Pharm. Inc. et al., 1:11-cv-01077 (D. Del.);
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`Novartis Pharm. Corp. et al. v. Watson Labs. Inc. et al., 1:11-cv-01112 (D. Del.);
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`Novartis Pharm. Corp. et al. v. Alvogen Pine Brook Inc. et al., 1:13-cv-00052 (D. Del.);
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`Novartis Pharm. Corp. et al. v. Alvogen Pine Brook Inc. et al., 1:13-cv-00370 (D. Del.);
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`Novartis Pharm. Corp. et al. v. Actavis, Inc. et al., No. 1:13-cv-00371 (D. Del.);
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`Novartis Pharm. Corp. et al. v. Par Pharm. Inc. et al., No. 1:13-cv-01467 (D. Del.);
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`Novartis Pharm. Corp. et al. v. Zydus Noveltech Inc. et al., No. 1:14-cv-05405 (D.
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`N.J.); Novartis Pharm. Corp. et al. v. Zydus Noveltech Inc. et al., No. 1:14-cv-01104
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`(D. Del.); Par Pharm. Inc. et al. v. Novartis Pharm. Corp. et al., 1:14-cv-00843 (D.
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`Del.); Watson Labs Inc. v. Novartis Pharm. Corp et al., 14-1799 (C.A.F.C.); Novartis
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`Pharm. Corp et al. v. Par Pharm. Inc. et al, 15-1061 (C.A.F.C.); Novartis Pharm. Corp
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`et al. v. Par Pharm. Inc. et al, 15-1062 (C.A.F.C.); Par Pharm. Inc. v. Novartis Pharm
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`Corp. et al., 15-1120 (C.A.F.C.); and Par Pharm. Inc. v. Novartis Pharm Corp. et al., 15-
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`1121 (C.A.F.C.).
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`3
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`
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`Mylan v. Novartis
`Motion for Joinder - U.S. Pat. 6,335,031
`
`
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`Noven filed its petition for Inter Partes Review of the ’031 Patent in the Noven
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`IPR on April 2, 2014. On October 14, 2014, the Board instituted trial on three of the
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`five proposed grounds of invalidity. See IPR2014-00550, Paper No. 10 at 28. Under
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`Rule 42.122, this Motion is timely as it is filed within one month of the institution of the
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`Noven IPR.
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`III. THE REQUIREMENTS FOR MOTION FOR JOINDER ARE MET
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`In accordance with the Board’s Representative Order identifying matters
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`to be addressed in a motion for joinder (IPR2013-00004, Paper No. 15, April 24,
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`2013), Mylan submits that joinder is appropriate because: (1) joinder will
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`promote efficient determination of the validity of the ’031 Patent without
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`prejudice to Patent Owners or Noven; (2) Mylan’s petition raises the same
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`grounds of unpatentability as the Noven IPR; (3) joinder will not affect the
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`pending schedule in the Noven IPR nor increase the complexity of that
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`proceeding in any way; and (4) Mylan will agree to consolidated filings with
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`Noven to minimize burden and schedule impact.
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`a.
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`Joinder Will Promote the Efficient Determination of
`Validity Without Prejudice to the Patent Owners or Noven
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`Granting joinder and allowing a consolidated IPR will not prejudice Patent
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`Owners. Mylan raises no issues that are not already before the Board, such that
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`joinder would not affect the timing of the IPR or the content of Patent Owners’
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`4
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`Mylan v. Novartis
`Motion for Joinder - U.S. Pat. 6,335,031
`
`
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`responses. Indeed, Mylan’s Petition challenges the same claims and is based on
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`the same grounds and same combinations of prior art considered by the Board in
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`instituting trial in the Noven IPR. Since Mylan’s Petition does not raise any new
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`issues beyond those already considered by Patent Owners, Mylan does not
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`anticipate that Patent Owners will need a substantial amount of time to complete
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`its Preliminary Response, should it choose to file one. Likewise, as Mylan agrees
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`to consolidated filings with Noven, Patent Owners will not need to coordinate
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`with or respond to arguments by more parties than they already do.
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`Noven also will not be prejudiced by the Board’s grant of this Motion and
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`consolidation of Mylan’s IPR with the Noven IPR. Mylan agrees to act in a
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`limited “understudy” role, and will assume an active lead role only in the event
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`that Noven settles with the Patent Owners or otherwise ceases to participate.
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`Moreover, a final written decision on the validity of the ’031 Patent will
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`minimize issues in the Mylan Litigation, the Noven Litigation, and potentially
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`resolve the litigation of the ’031 Patent altogether thereby promoting the efficient
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`determination of validity. If the Board permits Mylan to join the Noven IPR, and
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`the ’031 Patent is upheld in a final decision, Mylan will be estopped from further
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`challenging the validity of the patent on these grounds, avoiding duplication of
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`Patent Owner’s efforts at least as to Mylan and Noven. See 35 U.S.C.
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`5
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`Mylan v. Novartis
`Motion for Joinder - U.S. Pat. 6,335,031
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`
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`§ 315(e)(1). Accordingly, to avoid duplicate efforts and promote efficiency,
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`joinder is appropriate.
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`b. Mylan’s Petition Raises the Same Grounds of Unpatentability as
`the Noven IPR
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`Mylan’s Petition asserts, verbatim, the arguments that the Board has
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`already instituted in the Noven IPR. Thus, there are no new arguments for the
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`Board to consider or to which the Patent Owners need to respond. Although
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`Mylan has submitted a verbatim copy of the Noven petition, including the
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`grounds not instituted by the Board, Mylan seeks institution only as to the three
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`grounds of invalidity already instituted by the Board in the Noven IPR. Further,
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`Mylan’s Petition relies on the same expert declarations—of Drs. Kydonieus and
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`Schöneich—that were submitted in support of the Noven IPR petition. Thus,
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`Mylan does not anticipate the need for new expert depositions following joinder.
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`Joinder Will Not Affect the Pending Schedule in the Noven IPR
`c.
`nor Increase the Complexity of that Proceeding
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`Joinder in this case will not impact the Board’s ability to complete its
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`review in a timely manner. Section 316(a)(11) provides that IPR proceedings
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`should be completed, and the Board’s final decision issued, within one year of
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`institution of the review. See also 37 C.F.R. § 42.100(c). Here, joinder will not
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`affect the Board’s ability to issue its final determination within one year because
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`Mylan does not raise any issues that are not already before the Board. Indeed, the
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`6
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`
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`Mylan v. Novartis
`Motion for Joinder - U.S. Pat. 6,335,031
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`
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`Petition includes only verbatim copies of those grounds previously asserted in
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`Noven’s Petition, and Mylan only seeks institution as to the grounds on which the
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`Noven IPR was instituted. Mylan also agrees to consolidated filings with Noven.
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`Thus, Mylan does not anticipate that its presence will introduce any additional
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`arguments, briefing, or need for discovery.
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`Furthermore, Noven and Patent Owners recently submitted a Joint
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`Stipulation to Modify the Scheduling Order (IPR2014-00550, Paper No. 16, Nov.
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`4, 2014) to extend each of Due Date 1 and Due Date 2 by four weeks, and to
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`eliminate Due Date 3. In view of the parties’ extension of these early dates,
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`joinder of Mylan’s IPR with the Noven IPR should have no impact on the
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`schedule.
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`d. Mylan Will Agree to Consolidated Filings With Noven to
`Minimize Burden and Schedule Impact
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`As long as Noven remains an active participant in the IPR, Mylan agrees to
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`assume a limited “understudy” role. As discussed above, Mylan offers no new
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`grounds for invalidity and Mylan does not anticipate that its presence will
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`introduce any additional arguments, briefing, or need for discovery. If Noven
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`ceases to participate in the IPR, Mylan will assume the primary role of petitioner.
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`Mylan is willing to agree to consolidated filings on the existing briefing
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`schedule, for which Noven will maintain responsibility. (IPR2013-00256, Paper
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`7
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`
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`Mylan v. Novartis
`Motion for Joinder - U.S. Pat. 6,335,031
`
`
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`No. 10 at 9, June 20, 2013.) Similar to the procedures ordered by the Board in
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`IPR2013-00256, Mylan is willing to be limited to separate filings, if any, of no
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`more than seven pages directed only to points of disagreement with Noven, with
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`the understanding that Mylan will not be permitted any separate arguments in
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`furtherance of those advanced in Noven’s consolidated filings. (Id.) “This
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`approach should avoid introducing delay that could arise from lengthy briefing by
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`each party, while providing the parties an opportunity to address all issues that
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`may arise.” (Id.) Mylan notes that in numerous joined IPRs, such as IPR2013-
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`00385 (Paper No. 17) and IPR2014-00306 (Paper No. 13), the Board has
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`similarly permitted separate filings from the joined petitioner of no more than
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`seven pages, directed only to points of disagreement with the first petitioner.
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`Mylan requests that the Board do likewise in this matter.
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`IV.
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`CONCLUSION
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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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`8
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`4
`Mylan v. Novartis
`Motion for Joinder — U.S. Pat. 6,335,031
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`Respectfully submitted,
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`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
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`Dated: November 13 2014
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`By:
`
`.
`Jo ph M. Reisman
`Reg. No. 43,878
`Customer No. 20,995
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`Attorneys for Petitioner
`MYLAN PHARMACEUTICALS INC.
`
`(949) 760-0404
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`
`
`Mylan V. Novartis
`Motion for Joinder — U.S. Pat. 6,335,031
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`CERTIFICATE OF SERVICE
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`I hereby certify that a true and correct copy of the foregoing MOTION
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`FOR JOINDER is being served on November 13, 2014, via FedEx Priority
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`Overnight on counsel of record at the U.S. Patent and Trademark Office for U.S.
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`Pat. 6,316,031, at:
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`Novartis Pharmaceutical Corporation
`Intellectual Property Department
`One Health Plaza 433/2
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`East Hanover, NJ 07936-1080
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`The Motion is also being served on November 13, 2014, via FedEx Priority
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`Overnight, on Patent Owner counsel of record in IPR2014—00550 at:
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`Raymond R. Mandra
`Fitzpatrick Cella, Harper & Scinto
`1290 Avenue of the Americas
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`New York, NY 10104
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`Telephone: (212) 218-2100
`Facsimile: (212) 218-2200
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`Dated: November 13 2014
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`
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`
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`seph M. Reisman
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`s
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`Attorneys for Petitioner
`Mylan Pharmaceuticals Inc.
`
`19251204
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