Paper 17
`Trials@uspto.gov
`571-272-7822 Entered: April 10, 2015
`
`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 IPR2015-00268
`Patent 6,335,031 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)
`
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
`571-272-7822 Entered: April 10, 2015
`
`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 IPR2015-00268
`Patent 6,335,031 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)
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2015-00268
`Patent 6,335,031 B1
`
`
`
`
`INTRODUCTION
`I.
`Mylan Pharmaceuticals Inc. (“Petitioner” or “Mylan”) filed a Petition
`
`(Paper 1, “Pet.”) requesting an inter partes review of claims 1–3, 7, 15, 16,
`and 18 of U.S. Patent No. 6,335,031 B1 (Ex. 1001, “the ’031 patent”). On
`February 18, 2015, Novartis AG and LTS Lohmann Therapie-Systeme AG
`(collectively, “Patent Owner”) filed a Preliminary Response. Paper 13.
`
`At the same time that Petitioner filed its Petition, Petitioner also filed
`a Motion for Joinder to join this proceeding with Noven Pharmaceuticals,
`Inc. v. Novartis AG, IPR2014-00550. Paper 3 (“Joinder Motion”).
`IPR2014-00550 concerns the same patent at issue here. We instituted trial in
`IPR2014-00550 on October 14, 2014. We have not yet instituted trial in
`IPR2015-00268. 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
`
`in IPR2015-00268, and (2) grant Petitioner’s Motion for Joinder, subject to
`the conditions detailed herein.
`
`
`INSTITUTION OF INTER PARTES REVIEW
`II.
`The Petition in IPR2015-00268 challenges the same claims, and is
`
`based on the same grounds and declaration testimony as those asserted in
`IPR2014-00550. Compare Pet. 19–52, with IPR2014-00550, Paper 1, 19–
`52. In IPR2014-00550, we instituted trial on three of the five grounds
`asserted, as follows:
`
`2
`
`
`
`
`IPR2015-00268
`Patent 6,335,031 B1
`
`
`
`
`Claims 1, 2, 7, 15, and 18 under 35 U.S.C. § 103(a) as
`1.
`obvious over Enz,1 the Handbook,2 Rosin,3 Elmalem,4 and
`Ebert;5
`2.
`Claims 3 and 16 under 35 U.S.C. § 103(a) as obvious
`over Enz, the Handbook, Rosin and Ebert; and
`3. Claims 1–3, 7, 15, 16, and 18 under 35 U.S.C. § 103(a)
`as obvious over Enz and Sasaki.6
`
`IPR2014-00550, Paper 10, 29. Patent Owner notes correctly in its
`Preliminary Response, that Petitioner asserts in its Joinder Motion that it
`“seeks institution only as to the three grounds of invalidity already
`instituted by the Board in the Noven IPR.” Paper 13, 2 (quoting Paper 3,
`2). Patent Owner has not raised additional arguments or evidence other than
`what we considered in the course of instituting trial in IPR2014-00550.
`Therefore, our consideration of the Petition in IPR2015-00268 is based upon
`consideration of the same issues, arguments, and oppositions raised with
`respect to IPR2014-00550.
`
`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 IPR2014-00550.
`
`
`
`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 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 JP Patent Application 59-184121, published Oct. 19, 1984 (Ex. 1005).
`3
`
`
`
`
`
`
`IPR2015-00268
`Patent 6,335,031 B1
`
`
`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.
`
`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-
`00550 trial institution, as required by 37 C.F.R. § 42.122(b).
`As noted above, in IPR2015-00268, Petitioner limited the grounds of
`unpatentability asserted in the Petition to those previously raised in
`IPR2014-00550. Significantly, as discussed above, Petitioner seeks
`institution only as to the three grounds of unpatentability previously
`instituted by the Board in IPR2014-00550. Paper 3, 2. Additionally,
`
`4
`
`
`
`
`
`
`IPR2015-00268
`Patent 6,335,031 B1
`
`Petitioner relies on the same experts as Noven Pharmaceuticals, Inc.
`(“Noven”) relies on in IPR2014-00550. Id. at 6.
`Petitioner asserts that joinder will not affect the pending schedule in
`IPR2014-00550, 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.
`
`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.
`
`5
`
`
`
`
`IPR2015-00268
`Patent 6,335,031 B1
`
`Those limitations are consistent with the “understudy” role that Petitioner
`agrees to assume, as well as Petitioner’s assertion that its presence would not
`require introducing any additional arguments, briefing or discovery.
`Accordingly, based on the record before us, grant Petitioner’s motion to join
`IPR2015-00268 with IPR2014-00550, subject to the conditions of the
`following order.
`
`
`
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that trial is instituted in IPR2015-00268 as to claims 1–3,
`7, 15, 16, and 18 of the ’031 patent on the following grounds only:
`1. Claims 1, 2, 7, 15, and 18 under 35 U.S.C. § 103(a) as obvious
`over Enz, the Handbook, Rosin, Elmalem, and Ebert;
`2. Claims 3 and 16 under 35 U.S.C. § 103(a) as obvious over Enz,
`the Handbook, Rosin and Ebert; and
`3. Claims 1–3, 7, 15, 16, and 18 under 35 U.S.C. § 103(a) as
`obvious over Enz and Sasaki;
`
`FURTHER ORDERED that the Petitioner’s Motion for Joinder is
`granted;
`FURTHER ORDERED that IPR2015-00268 is terminated under
`37 C.F.R. § 42.72 and all further filings in the joined proceeding are to be
`made in IPR2014-00550;
`FURTHER ORDERED that the Scheduling Order in IPR2014-00550
`remains unchanged by this Decision and applies to the joined proceeding;
`FURTHER ORDERED that Noven will file all papers in the joined
`proceeding jointly on behalf of Noven and Petitioner Mylan, except in the
`case of motions that do not involve the other party;
`
`6
`
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`
`
`IPR2015-00268
`Patent 6,335,031 B1
`
`
`
`
`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 IPR2014-00550 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 IPR2014-00550.
`
`
`PETITIONER:
`
`Joseph Reisman
`2jmr@knobbe.com
`
`Jay Deshmukh
`2jrd@knobbe.com
`
`
`PATENT OWNER:
`
`Raymond Mandra
`rmandra@fchs.com
`
`Nicholas Kallas
`nkallas@fchs.com
`
`
`
`
`
`
`7
`
`
`
`
`
`
`IPR2015-00268
`Patent 6,335,031 B1
`
`
`Example Case Caption
`
`
`
`
`
`
`
`
`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 IPR2014-005501
`Patent 6,335,031 B1
`
`
`
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`8
`
`
`
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