`Trials@uspto.gov
`571-272-7822 IPR2017-01078, Paper No. 9
`
` Entered: September 25, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`____________
`
`Case IPR2017-01063
`Patent 9,006,224 B2
`____________
`
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED,
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`____________
`
`Cases IPR2017-01078
`Patent 9,006,224 B2
`__________
`
`
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`CRUMBLEY, Administrative Patent Judge.
`
`
`
`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`
`
`DECISION
`Granting Motions for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122(b)
`
`INTRODUCTION
`
`I.
`On February 15, 2017, the Board instituted an inter partes review trial
`of claims 1–3 of U.S. Patent No. 9,006,224 B2 (Ex. 1001,1 “the ’224 patent”).
`Par Pharm. v. Novartis AG, Case IPR2016-01479 (PTAB Feb. 15, 2017)
`(Paper 8) (“the Par IPR”). Trial in that matter is pending on the following
`grounds of unpatentability:
`1. Whether claims 1–3 are unpatentable under 35 U.S.C. § 103(a) as
`having been obvious over the combined disclosures of Öberg
`2004,2 Boulay 2004,3 and O’Donnell;4
`
`
`1 Unless otherwise indicated, when substantively identical documents have
`been filed in both cases we will cite only to the docket of IPR2017-01063.
`2 K. Öberg, Treatment of neuroendocrine tumors of the gastrointestinal tract,
`27(4) ONCOLOGÍA 57–61 (2004) (Ex. 1027).
`3 A. Boulay et al., Antitumor efficacy of intermittent treatment schedules with
`the rapamycin derivative RAD001 correlates with Prolonged Inactivation of
`Ribosomal Protein S6 Kinase 1 in Peripheral Blood Mononuclear Cells, 64
`CANCER RES. 252–261 (2004) (Ex. 1005).
`4 A. O’Donnell et al., A phase I study of the oral mTOR inhibitor RAD001 as
`a monotherapy to identify the optimal biologically effective dose using
`toxicity, pharmacokinetic (PK) and pharmacodynamics (PD) endpoints in
`patients with solid tumors, 22 PROC. AM. SOC’Y OF CLINICAL ONCOLOGY
`200(803 ab.) (2003) (Ex. 1029).
`
`
`
`2
`
`
`
`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`
`2. Whether claim 2 is unpatentable under 35 U.S.C. § 103(a) as
`having been obvious over the combined disclosures of Öberg
`2004, Boulay 2004, O’Donnell, and Tabernero;5
`
`3. Whether claims 1–3 are unpatentable under 35 U.S.C. § 103(a) as
`having been obvious over the combined disclosures of Boulay
`2004, O’Donnell, and Duran;6 and
`
`4. Whether claim 2 is unpatentable under 35 U.S.C. § 103(a) as
`having been obvious over the combined disclosures of Boulay
`2004, O’Donnell, Duran, and Tabernero.
`
`Two additional petitions have now been filed with the Board, each
`seeking joinder with the Par IPR. In IPR2017-01063, Argentum
`Pharmaceuticals LLC filed a Petition requesting inter partes review of claims
`1–3 of the ’224 patent. IPR2017-01063, Paper 1. Concurrently with its
`Petition, Argentum filed a Motion for Joinder (Paper 3), seeking joinder with
`the Par IPR. The owner of the ’224 patent, Novartis AG, filed a Response to
`the Motion for Joinder (Paper 9) but waived the filing of a preliminary
`response (Paper 10).
`In IPR2017-01078, West-Ward Pharmaceuticals International Limited
`filed a Petition requesting inter partes review of claims 1–3 of the ’224 patent.
`IPR2017-01078, Paper 1. Concurrently with its Petition, West-Ward filed a
`Motion for Joinder (Paper 3), seeking joinder with the Par IPR. Novartis filed
`
`
`5 J. Tabernero et al., A phase I study with tumor molecular pharmacodynamics
`(MPD) evaluation of dose and schedule of the oral mTOR-inhibitor
`Everolimus (RAD001) in patients (pts) with advanced solid tumors, 23(16S) J.
`CLINICAL ONCOLOGY 3007 (2005) (Ex. 1038).
`6 I. Duran et al., A phase II trial of temsirolimus in metastatic Neuroendocrine
`Carcinomas (NECs), 23(16S) SUPPLEMENT TO J. CLINICAL ONCOLOGY 3096
`(ab.) (2005) (Ex. 1011).
`
`
`
`3
`
`
`
`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`a Response to the Motion for Joinder (Paper 6) but waived the filing of a
`preliminary response (Paper 8).
`Both newly-filed Petitions assert the same grounds of unpatentability as
`those on which trial was instituted in the Par IPR. IPR2017-01063, Paper 1,
`1; IPR2017-01078, Paper 1, 1.
`As a threshold matter, we determine that the Motions for Joinder were
`timely. Our Rules provide that a request for joinder must be filed “no later
`than one month after the institution date of any inter partes review for which
`joinder is requested.” 37 C.F.R. § 42.122(b). The Motions were filed on or
`before March 15, 2017, less than one month after the February 15, 2017
`institution date of the Par I inter partes review, and are thus timely.
`For the reasons explained below, we grant both Motions.
`
`II. THE PETITIONS WARRANT INSTITUTION
`The controlling statute regarding joinder of a party to an inter partes
`review is 35 U.S.C. § 315(c), which reads as follows:
`(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.
`The statute makes clear that joinder of a party to an instituted inter
`partes review is within the Board’s7 discretion. That discretion may only be
`
`
`7 By regulation, the Director’s discretion has been delegated to the Board. 37
`C.F.R. § 42.4(a).
`
`
`
`4
`
`
`
`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`exercised, however, if the party seeking joinder “files a petition . . . that the
`Director . . . determines warrants the institution of an inter partes review.”
`35 U.S.C. § 315(c). As a threshold issue, therefore, we must first determine
`whether the instant Petitions warrant institution of an inter partes review.
`The grounds of unpatentability asserted in the instant Petitions are
`identical to those instituted in the Par IPR. Argentum and West-Ward state
`that their Petitions include the same grounds and arguments as those in the Par
`IPR, and note that the parties rely on the same expert witness, Mark J. Ratain,
`M.D., as Par does. IPR2017-01063, Paper 3, 4; IPR2017-01078, Paper 3, 7–8.
`We previously determined, upon consideration of the Petition and
`Novartis’ Preliminary Response in the Par IPR, that the record in that
`proceeding established a reasonable likelihood that Par would prevail with
`respect to claims 1–3. IPR2016-01479, Paper 8, 18. Furthermore, Novartis
`waived any preliminary response to the Petitions, so we are not presented with
`any arguments against institution of trial that were not previously considered
`in the Par IPR. Given the identical grounds and evidence presented in the
`present proceedings, we likewise determine that the instant Petitions warrant
`institution on all presented grounds. We rely on, and hereby incorporate by
`reference, the reasoning set forth in our Decision on Institution in the Par IPR.
`See id. at 5–18.
`
`III. DISCRETION TO GRANT JOINDER
`
`Having determined that the instant Petitions warrant institution, we
`must determine whether to exercise our discretion to join Argentum and West-
`Ward as parties to the Par IPR. As the moving parties, Argentum and West-
`Ward bear the burden of showing that joinder is appropriate. 37 C.F.R. §§
`
`
`
`5
`
`
`
`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`42.20(c), 42.122(b). A motion for joinder should: (1) set forth the reasons
`why joinder is appropriate; (2) identify any new grounds of unpatentability;
`(3) explain what impact (if any) joinder would have on the trial schedule; and
`(4) address specifically how briefing and discovery may be simplified. See
`Frequently Asked Question (“FAQ”) H5 on the Board’s website at
`https://go.usa.gov/xRHCf.
`As discussed above, the instant Petitions assert the same grounds of
`unpatentability as those instituted in the Par IPR and do not present any
`argument beyond those already at issue in the Par IPR. Furthermore, if
`joinder is granted, both Argentum and West-Ward propose to take an
`“understudy” role in the joined proceeding so long as Par remains an active
`party, and will consolidate filings and discovery. IPR2017-01063, Paper 3, 5;
`IPR2017-01078, Paper 3, 8. In its Response to the Motions, Novartis states
`that it does not oppose joinder, but asks that the Board order Argentum and
`West-Ward:
`(i) to rely solely on the petition and the evidence filed by Par in
`IPR2016-01479; (ii) to consolidate all briefing under the page
`limits of 37 C.F.R. § 42.24 and to share the pages that are allotted
`for written work product to Par in IPR2016-01479; and (iii) to
`share with Par the time that is or will be allotted for cross and
`redirect examination to Par in the IPR2016-01479.
`IPR2017-01063, Paper 9, 1 (citing Bungie, Inc. v. Acceleration Bay, LLC,
`IPR2016-00934 at 13–14 (PTAB Jul. 8, 2016) (Paper 11); ZTE USA, Inc. v.
`Evolved Wireless LLC, IPR2016-01280 at 4 (PTAB Dec. 21, 2016) (Paper 8).
`Upon review, the Motions for Joinder demonstrate that joinder of
`Argentum and West-Ward as parties to the Par IPR is appropriate, and will
`lead to the more efficient resolution of the proceedings. The instant Petitions
`
`
`
`6
`
`
`
`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`do not assert any new ground of unpatentability that is not already being
`considered in the Par IPR, rely on the same arguments and evidence, and do
`not require any modification to the existing schedule. We, therefore,
`determine that joinder will not unduly complicate or delay the proceedings,
`and exercise our discretion to join Argentum and West-Ward as parties to the
`Par IPR.
`With respect to Novartis’ proposed requirements that the Petitioners act
`in concert, we consider them appropriate and in keeping with procedures
`followed by the Board in other cases of joinder where the joining parties filed
`identical Petitions with identical evidence. We do not consider it necessary at
`this time to permit Argentum and West-Ward additional briefing beyond that
`already permitted Par. The Petitioners should work together to present
`consolidated briefing in the Par IPR, with Par as the lead Petitioner. If some
`disagreement arises which prevents a unified position, the Petitioners may
`request a conference call with the Board.
`
`IV. ORDER
`
`Accordingly, it is:
`ORDERED that Argentum’s Motion for Joinder (IPR2017-01063,
`Paper 3) is granted;
`FURTHER ORDERED that West-Ward’s Motion for Joinder
`(IPR2017-01078, Paper 3) is granted;
`FURTHER ORDERED that Argentum and West-Ward are joined as
`Petitioners to IPR2016-01479;
`FURTHER ORDERED that the grounds on which IPR2016-01479 was
`instituted are unchanged;
`
`
`
`7
`
`
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`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`
`FURTHER ORDERED that, within one week of this Decision, any
`party may request a conference call with the Board to discuss changes to the
`Scheduling Order; in the absence of such changes, the Scheduling Order in
`place for IPR2016-01479, as modified by any stipulation agreed to by the
`parties, shall continue to govern the joined proceeding;
`FURTHER ORDERED that, throughout IPR2016-01479, any paper,
`except for a motion that does not involve the other Petitioners, shall be filed
`by Par as a single, consolidated filing on behalf of Par, Argentum, and West-
`Ward, pursuant to the page limits set forth in 37 C.F.R. § 42.24, and Par will
`identify each such filing as a consolidated filing;
`FURTHER ORDERED that except as otherwise agreed by the
`Petitioners, counsel for Par will conduct cross-examination and other
`discovery on behalf of Par, Argentum, and West-Ward, and that Novartis is
`not required to provide separate discovery responses or additional deposition
`time as a result of the joinder;
`FURTHER ORDERED that Par, Argentum, and West-Ward
`collectively will designate attorneys to present at the oral hearing (if requested
`and granted) as a consolidated presentation;
`FURTHER ORDERED that IPR2017-01063 and IPR2017-01078 are
`terminated under 37 C.F.R. § 42.72, and all further filings for these
`proceedings are to be made in IPR2016-01479;
`FURTHER ORDERED that a copy of this Decision will be entered into
`the record of IPR2016-01479; and
`FURTHER ORDERED that the case caption in IPR2016-01479 shall be
`changed to reflect the joinder, in accordance with the attached example.
`
`
`
`8
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`
`
`IPR2017-01063 and IPR2017-01078
`Patent 9,006,224 B2
`
`
`
`FOR PETITIONER:
`Kevin Laurence
`Matthew Phillips
`LAURENCE & PHILLIPS IP LAW LLP
`klaurence@lpiplaw.com
`mphillips@lpiplaw.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
`
`Keith A. Zullow
`Marta E. Delsignore
`GOODWIN PROCTER LLP
`kzullow@goodwinprocter.com
`mdelsignore@goodwinprocter.com
`
`Daniel G. Brown
`Jonathan M. Strang
`LATHAM & WATKINS LLP
`daniel.brown@lw.com
`jonathan.strang@lw.com
`
`FOR PATENT OWNER:
`Nicholas N. Kallas
`Laura K. Fishwick
`Raymond Mandra
`FITZPATRICK, CELLA, HARPER & SCINTO
`nkallas@fchs.com
`lfishwick@fchs.com
`rmandra@fchs.com
`
`
`
`9
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PAR PHARMACEUTICAL, INC.,
`ARGENTUM PHARMACEUTICAL LLC, AND
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`____________
`
`Case IPR2016-014791
`Patent 9,006,224 B2
`____________
`
`
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`1 Argentum Pharmaceutical LLC was joined as a party to this proceeding via
`a Motion for Joinder in IPR2017-01063; West-Ward Pharmaceuticals
`International Limited was joined as a party via a Motion for Joinder in
`IPR2017-01078.
`
`