`Trials@uspto.gov
`571-272-7822 Entered: April 10, 2015
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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 Owner.
`____________
`
`Case IPR2015-00265
`Patent 6,316,023 B1
`
`____________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`SCOTT E. KAMHOLZ, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F.R. § 42.122(b)
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`IPR2015-00265
`Patent 6,316,023 B1
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`INTRODUCTION
`I.
`Mylan Pharmaceuticals Inc., (“Petitioner” or “Mylan”) filed a Petition
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`(Paper 1, “Pet.”) requesting an inter partes review of claims 1, 2, 4, 5, 7, and
`8 of U.S. Patent No. 6,316,023 B1 (Ex. 1001, “the ’023 patent”). On
`February 18, 2015, Novartis AG and LTS Lohmann Therapie-Systeme AG
`(collectively, “Patent Owner”) waived their opportunity to file a preliminary
`response. Paper 13.
`
`At the same time it filed its Petition, Petitioner also filed a Motion for
`Joinder to join this proceeding with Noven Pharmaceuticals, Inc. v. Novartis
`AG, IPR2014-00549. Paper 3 (“Joinder Motion”). IPR2014-00549
`concerns the same patent at issue here. We instituted trial in IPR2014-00549
`on October 14, 2014. We have not yet instituted trial in IPR2015-00265.
`Patent Owner filed an Opposition to Petitioner’s Joinder Motion. Paper 10
`(“Opposition Motion”). Petitioner filed a Reply in Support of Motion for
`Joinder. Paper 12.
`For the reasons set forth below, we (1) institute an inter partes review
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`in IPR2015-00265, and (2) grant Petitioner’s Motion for Joinder, subject to
`the conditions detailed herein.
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`INSTITUTION OF INTER PARTES REVIEW
`II.
`The Petition in IPR2015-00265 challenges the same claims, and is
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`based on the same grounds and declaration testimony as those asserted in
`IPR2014-00549. Compare Pet. 22–48, with IPR2014-00549, Paper 1, 21–
`45. In IPR2014-00549, we instituted trial on the following grounds:
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`IPR2015-00265
`Patent 6,316,023 B1
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`Claims 1 and 7 under 35 U.S.C. § 103(a) as obvious over
`1.
`Enz,1 the Handbook,2 Rosin,3 Elmalem,4 and Ebert;5
`2.
`Claim 2 under 35 U.S.C. § 103(a) as obvious over Enz,
`the Handbook, Rosin, and Ebert;
`3. Claims 4 and 5 under 35 U.S.C. § 103(a) as obvious over
`Enz, the Handbook, and Ebert;
`4.
`Claim 8 under 35 U.S.C. § 103(a) as obvious over Enz,
`the Handbook, and Ebert or Kissel;6
`5. Claims 1, 2, 4, 5, and 7 under 35 U.S.C. § 103(a) as
`obvious over Enz and Sasaki;7 and
`6.
`Claim 8 under 35 U.S.C. § 103(a) as obvious over Enz,
`Sasaki, and Ebert or Kissel.
`
`IPR2014-00549, Paper 10, 26. As Patent Owner waived filing a preliminary
`response in IPR2015-00265, Patent Owner has not raised additional
`arguments or evidence other than what we considered in the course of
`instituting trial in IPR2014-00549. Therefore, our consideration of the
`Petition in IPR2015-00265 is based upon consideration of the same issues,
`arguments, and oppositions raised with respect to IPR2014-00549.
`
`In view of the similarity of the challenges in the two Petitions, we
`institute an inter partes review in this proceeding on the same grounds as
`those on which we instituted trial in IPR2014-00549.
`
`
`1 UK Patent Application GB 2,203,040 A, published Oct. 12, 1988
`(Ex. 1002).
`2 HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (A. Wade & P.J. Weller eds.,
`2d ed. 1994) (Ex. 1003).
`3 US 4,948,807, issued Aug. 14, 1990 (Ex. 1008).
`4 Esther Elmalem et al., Antagonism of Morphine-Induced Respiratory
`Depression by Novel Anticholinesterase Agents, 30 NEUROPHARMACOLOGY
`1059–1064 (1991) (Ex. 1009).
`5 WO 95/24172, published Sept. 14, 1995 (Ex. 1006).
`6 EP Patent Application 0155229A2, published Sept. 18, 1985 (Ex. 1007).
`7 JP Patent Application 59-184121, published Oct. 19, 1984 (Ex. 1005).
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`IPR2015-00265
`Patent 6,316,023 B1
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`JOINDER OF INTER PARTES REVIEWS
`III.
`An inter partes review may be joined with another inter partes
`review, subject to the provisions 35 U.S.C. § 315(c), which governs joinder
`of inter partes review proceedings:
`(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.
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`As the moving party, Petitioner bears the burden of proving that it is
`entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder
`should: (1) set forth the reasons joinder is appropriate; (2) identify any new
`grounds of unpatentability asserted in the petition; and (3) explain what
`impact (if any) joinder would have on the trial schedule for the existing
`review. See Kyocera Corp. v. Softview, LLC, Case IPR2013-00004, slip op.
`at 4 (PTAB Apr. 24, 2013) (Paper 15) (Order Authorizing Motion for
`Joinder); Frequently Asked Questions H5,
`http://www.uspto.gov/ip/boards/bpai/prps.jsp.
`Petitioner filed its Joinder Motion within one month of the IPR2014-
`00549 trial institution, as required by 37 C.F.R. § 42.122(b).
`As noted above, in IPR2015-00265, Petitioner limited the grounds of
`unpatentability asserted in the Petition to those previously raised in
`IPR2014-00549. Additionally, Petitioner relies on the same experts as
`Noven Pharmaceuticals, Inc. (“Noven”) relies on in IPR2014-00549. Paper
`3, 6.
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`IPR2015-00265
`Patent 6,316,023 B1
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`Petitioner asserts that joinder will not affect the pending schedule in
`IPR2014-00549, nor will it increase the complexity of that proceeding. Id.
`Specifically, Petitioner agrees to consolidated filings with Noven, for which
`Noven will maintain responsibility. Id. at 6–7. Petitioner does not anticipate
`introducing “any additional arguments, briefing, or need for discovery.” Id.
`at 7. Petitioner explains that “[a]s long as Noven remains an active
`participant in the IPR, Mylan agrees to assume a limited ‘understudy’ role.”
`Id. Petitioner will assume the primary role only if Noven ceases to
`participate in the IPR. Id.
`Patent Owner does not oppose the Joinder Motion if, in the joined
`proceedings,
`(a) all filings by Mylan
`joined proceeding be
`the
`in
`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.
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`Paper 10, 1.
`We agree with Petitioner that joinder is appropriate under the
`circumstances. We also find that the limitations on joinder requested by
`Patent Owner, and quoted above, are appropriate under the circumstances.
`Those limitations are consistent with the “understudy” role that Petitioner
`agrees to assume, as well as Petitioner’s assertion that its presence would not
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`IPR2015-00265
`Patent 6,316,023 B1
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`require introducing any additional arguments, briefing or discovery.
`Accordingly, based on the record before us, we grant Petitioner’s motion to
`join IPR2015-00265 with IPR2014-00549, subject to the conditions of the
`following order.
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`IV. ORDER
`
`Accordingly, it is
`ORDERED that trial is instituted in IPR2015-00265 as to claims 1, 2,
`4, 5, 7, and 8 of the ’023 patent on the following grounds only:
`1.
`Claims 1 and 7 under 35 U.S.C. § 103(a) as obvious over
`Enz, the Handbook, Rosin, Elmalem, and Ebert;
`2.
`Claim 2 under 35 U.S.C. § 103(a) as obvious over Enz,
`the Handbook, Rosin, and Ebert;
`3. Claims 4 and 5 under 35 U.S.C. § 103(a) as obvious over
`Enz, the Handbook, and Ebert;
`4.
`Claim 8 under 35 U.S.C. § 103(a) as obvious over Enz,
`the Handbook, and Ebert or Kissel;
`5. Claims 1, 2, 4, 5, and 7 under 35 U.S.C. § 103(a) as
`obvious over Enz and Sasaki; and
`6.
`Claim 8 under 35 U.S.C. § 103(a) as obvious over Enz,
`Sasaki, and Ebert or Kissel;
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`FURTHER ORDERED that the Petitioner’s Motion for Joinder is
`granted;
`FURTHER ORDERED that IPR2015-00265 is terminated under
`37 C.F.R. § 42.72, and all further filings in the joined proceeding are to be
`made in IPR2014-00549;
`FURTHER ORDERED that the Scheduling Order in IPR2014-00549
`remains unchanged by this Decision and applies to the joined proceeding;
`FURTHER ORDERED that Noven will file all papers in the joined
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`IPR2015-00265
`Patent 6,316,023 B1
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`proceeding jointly on behalf of Noven and Petitioner Mylan, except in the
`case of motions that do not involve the other party;
`FURTHER ORDERED that Mylan shall be bound by any agreement
`between Novartis and Noven concerning discovery and/or depositions;
`FURTHER ORDERED that Mylan shall not receive any direct, cross-
`examination or redirect time at deposition beyond that permitted for Noven
`alone under either 37 C.F.R. § 42.53 or any agreement between Novartis and
`Noven;
`FURTHER ORDERED that the case caption in IPR2014-00549 shall
`be changed to reflect joinder in accordance with the attached example; and
`FURTHER ORDERED that a copy of this Decision be entered into
`the file of IPR2014-00549.
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`PETITIONER:
`
`Joseph Reisman
`2jmr@knobbe.com
`
`Jay Deshmukh
`2jrd@knobbe.com
`
`
`PATENT OWNER:
`
`Raymond Mandra
`rmandra@fchs.com
`
`Nicholas Kallas
`nkallas@fchs.com
`
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`IPR2015-00265
`Patent 6,316,023 B1
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`Example Case Caption
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
` NOVEN PHARMACEUTICALS, INC.
`and MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`NOVARTIS AG and LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owner.
`____________
`
`Case IPR2014-005491
`Patent 6,316,023 B1
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`1 Case IPR2015-00265 has been joined with this proceeding.
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