Trials@uspto.gov
`571-272-7822
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`
`
`Paper 17
`Date: September 16, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN LABORATORIES LTD.
`Petitioner,
`
`v.
`
`JANSSEN PHARMACEUTICA NV,
`Patent Owner.
`
`IPR2020-00440
`Patent 9,439,906 B2
`
`
`
`Before JOHN G. NEW, KRISTINA M. KALAN, and ROBERT A.
`POLLOCK, Administrative Patent Judges.
`
`NEW, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`Paper 17
`Date: September 16, 2020
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN LABORATORIES LTD.
`Petitioner,
`
`v.
`
`JANSSEN PHARMACEUTICA NV,
`Patent Owner.
`
`IPR2020-00440
`Patent 9,439,906 B2
`
`
`
`Before JOHN G. NEW, KRISTINA M. KALAN, and ROBERT A.
`POLLOCK, Administrative Patent Judges.
`
`NEW, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`IPR2020-00440
`Patent 9,439,906 B2
`
`
`I. INTRODUCTION
`Petitioner Mylan Laboratories Ltd. (“Petitioner”) has filed a Petition
`(Paper 3, “Petition” or “Pet.”) requesting inter partes review of claims 1–21
`of US Patent 9,439,906 B2 (Ex. 1001, “the ’906 patent”). Patent Owner
`Janssen Pharmaceutica NV (“Patent Owner”) has filed a Preliminary
`Response (Paper 8, “Preliminary Response” or “Prelim. Resp.”). On July 2,
`2020, the panel issued an order authorizing Petitioner to file a Reply to the
`Preliminary Response and further authorizing Patent Owner to file a Sure-
`Reply (Papers 12 and 14, “Reply” and “Sur-Reply,” respectively.
`Under 35 U.S.C. § 314, the Board “may not authorize an inter partes
`review to be instituted unless … the information presented in the petition …
`and any response … shows that there is a reasonable likelihood that
`Petitioner would prevail with respect to at least one of the claims challenged
`in the petition.” Upon consideration of the Petition, and of the supporting
`evidence, we exercise our discretion under § 314(a) to deny institution.
`
`
`A.
`
`II. BACKGROUND
`Real Parties-in-Interest
`The real parties-in-interest for Petitioner are Mylan Laboratories Ltd.,
`Mylan Institutional LLC, Mylan Pharmaceuticals Inc., Mylan Inc., and
`Mylan N.V. Pet. 4. Patent Owner’s Mandatory Notices identify Janssen
`Pharmaceutica NV and Janssen Pharmaceuticals, Inc., which are wholly-
`owned subsidiaries of Johnson & Johnson (“J&J”), as the real parties-in-
`interest for Patent Owner. Paper 6, 1.
`
`
`
`
`
`
`2
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`IPR2020-00440
`Patent 9,439,906 B2
`
`B.
`
`Related Matters
`Petitioner identifies the following district court actions involving the
`’906 patent: (1) Janssen Pharmaceuticals, Inc. et al. v. Teva
`Pharmaceuticals USA, Inc. et al., 2-18-cv-00734 (D.N.J.); (2) Janssen
`Pharmaceuticals, Inc. et al. v. Mylan Laboratories Ltd., 2-19-cv-16484
`(D.N.J.); (3) Janssen Pharmaceuticals, Inc. et al. v. Mylan Laboratories
`Ltd., 1-19-cv-00153 (N.D. W. Va.); (4) Janssen Pharmaceuticals, Inc. et al.
`v. Mylan Laboratories Ltd., 1-19-cv-01488 (D. Del.); (5) Janssen
`Pharmaceuticals, Inc. et al. v. Pharmascience Inc. et al., Case No. 2-19-cv-
`21590 (D.N.J.); (6) Janssen Pharmaceuticals, Inc. et al. v. Pharmascience
`Inc. et al., 1-19- cv-02313 (D. Del.). Pet. 5. The Patent Owner similarly
`identifies these actions as involving the ’906 patent. Paper 6, 1.
`
`
`
`3
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`IPR2020-00440
`Patent 9,439,906 B2
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` C.
`
`The Asserted Grounds of Unpatentability
`Petitioner contends that the ’906 patent is unpatentable based on the
`following grounds:
`
`
`Claim Challenged
`1–7, 15, 17–21
`8–14, 16
`
`35 U.S.C. §
`1031
`103
`
`1–7, 15, 17–21
`8–14, 16
`
`103
`103
`
`Reference(s)/Basis
`Citrome2, Cleton3, ’544 patent4
`Citrone, Cleton, Palperidone
`Formulary5, ’544 patent
`Citrome, ’544 patent
`Citrone, Palperidone Formulary,
`’544 patent
`
`
`1 Because the patent at issue has an effective filing date before March 16,
`2013, the effective date of the applicable provisions of the Leahy Smith
`America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”),
`we apply the pre-AIA version of 35 U.S.C. §103(a) in this decision.
`
` 2
`
` 3
`
` L. Citrome, Paliperidone: Quo Vadis? 61(4) INT. J. CLIN. PRACT. 653–62
`(2007) (“Citrome”) (Ex. 1004).
`
` The Cleton reference is collectively constituted of: (1) A. Cleton et al.,
`Assessment of the Dose Proportionality of Palperidone Palmitate 25, 50,
`100 And 150 mg eq., A New Long-Acting Injectable Antipsychotic
`Following Administration in the Deltoid or Gluteal Muscles (Abstract PI-
`74); and (2) A. Cleton et al., Evaluation of the Pharmacokinetic Profile of
`Gluteal Versus Deltoid Intramuscular Injections of Palperidone Palmitate
`100 Mg Equivalent in Patients with Schizophrenia (Abstract PI-75), in
`83(Supp. 1) CLIN. PHARMACOL. & THERAPS. S31 (2008) (“Cleton”) (Ex.
`1003). The Patent Owner routinely refers to these references as “PI-74”
`and “PI-75.”
`
` 4
`
` US 6,555,544 B2, April 29, 2003 (the “’544 patent”) (Ex. 1005).
`
`5 D.J. Cada et al., Formulary Drug Review: Palperidone, 42(7) HOSP.
`PHARM. 637–47 (2007).
`
`
`
`4
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`IPR2020-00440
`Patent 9,439,906 B2
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`
`D.
`
`E.
`
`Petitioner also relies upon the Declaration of its expert, Dr. Mansoor
`M. Amiji (the “Amiji Declaration”) (Ex. 1002).
`
`The ’906 Patent
`The ’906 patent is directed to a method of treating patients in need of
`treatment with long acting injectable paliperidone palmitate formulations.
`
`Illustrative Claims
`Independent claim 1 is representative of the claims of the ’906 patent
`and recites:
`for administering paliperidone
`regimen
`1. A dosing
`palmitate to a psychiatric patient in need of treatment for
`schizophrenia, schizoaffective disorder, or schizophreniform
`disorder comprising
`
`(1) administering intramuscularly in the deltoid of a patient in
`need of treatment a first loading dose of about 150 mg-eq.
`of paliperidone as paliperidone palmitate formulated in a
`sustained release formulation on the first day of treatment;
`
`
`(2) administering intramuscularly in the deltoid muscle of the
`patient in need of treatment a second loading dose of about
`100 mg-eq. of paliperidone as paliperidone palmitate
`formulated in a sustained release formulation on the 6th to
`about 10th day of treatment; and
`
`
`(3) administering intramuscularly in the deltoid or gluteal
`muscle of the patient in need of treatment a first
`maintenance dose of about 25 mg-eq. to about 150 mg-eq.
`of paliperidone as paliperidone palmitate in a sustained
`release formulation a month (± 7 days) after the second
`loading dose.
`
`
`
`
`
`5
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`IPR2020-00440
`Patent 9,439,906 B2
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`Ex. 1001 col. 32, ll. 11–30. Independent claim 8 is similar to claim 1, and is
`directed to the treatment of renally-impaired patients:
`8. A dosing
`regimen
`for administering paliperidone
`palmitate to a renally impaired psychiatric patient in need of
`treatment for schizophrenia, schizoaffective disorder, or
`schizophreniform disorder comprising
`
`
`(a) administering intramuscularly in the deltoid of a
`renally impaired psychiatric patient in need of
`treatment a first loading dose of from about 75 mg-
`eq. of paliperidone as paliperidone palmitate
`formulated in a sustained release formulation on the
`first day of treatment;
`
`
`(b) administering intramuscularly in the deltoid muscle
`of the patient in need of treatment a second loading
`dose of from about 75 mg-eq. of paliperidone as
`paliperidone palmitate formulated in a sustained
`release formulation on the 6th to about 10th day of
`treatment; and
`
`
`(c) administering intramuscularly in the deltoid or
`gluteal muscle of the patient in need of treatment a
`first maintenance dose of about 25 mg-eq. to about 75
`mg-eq. of paliperidone as paliperidone palmitate in a
`sustained release formulation a month (±7 days) after
`the second loading dose.
`
`
`Id. at cols. 32–33, ll. 66–20.
`
`
`III. ANALYSIS
`
`A.
`
`Claim Construction
`In an inter partes review for a petition filed on or after November 13,
`2018, the “[claims] of a patent … shall be construed using the same claim
`construction standard that would be used to construe the [claims] in a civil
`
`
`
`6
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`Patent 9,439,906 B2
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`action under 35 U.S.C. § 282(b), including construing the [claims] in
`accordance with the ordinary and customary meaning of such claims as
`understood by one of ordinary skill in the art and the prosecution history
`pertaining to the patent.” See 37 C.F.R. § 42.100(b) (2019); see also
`Phillips v. AWH Corp., 415 F.3d 1303, 1312–14 (Fed. Cir. 2005) (en banc).
`Only those terms that are in controversy need be construed, and only to the
`extent necessary to resolve the controversy. See Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(citing Vivid Techs., Inc. v. America Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999)).
`Petitioner asserts that it is unaware of prior claim construction
`determination concerning the ’906 patent in any of the related proceedings
`listed in II.B. supra. Pet. 9. Petitioner therefore argues that no claim
`construction is necessary and the challenged claims should be afforded a
`meaning “in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the prosecution
`history pertaining to the patent.” Id. (quoting 37 C.F.R. § 42.100(b)). Patent
`Owner does not dispute the Petitioner’s assertions.
`We consequently conclude that resolving whether we should institute
`inter partes review does not require any express claim construction.
`
`B. A Person of Ordinary Skill in the Art
`
`The Petitioner asserts that, with respect to the ’906 patent, a person of
`ordinary skill in the art would have had: (1) several years’ experience in
`designing and formulating drug delivery systems including parenteral
`systems based on analyzing pharmacokinetic data such as blood serum or
`
`
`
`7
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`IPR2020-00440
`Patent 9,439,906 B2
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`drug plasma levels and clearance rates and familiarity with depot
`formulations; (2) an advanced degree (M.S. and/or Ph.D.) in pharmaceutical
`sciences, and/or pharmaceutics or a related degree; and (3) experience with
`the formulation of therapeutic agents, their dosing, and the literature
`concerning drug developmental study and design. Pet. 13–14. The
`Petitioner also asserts that a skilled artisan might consult with individuals
`having specialized expertise, for example, a physician with experience in the
`administration, dosing, and efficacy of drugs, and/or a regulatory affairs
`specialist. Id. at 14 (citing Ex. 1002 ¶¶ 33–37).
`
`Absent any objection by Patent Owner, we adopt Petitioner’s
`proposed definition of a person of ordinary skill in the art as of the date of
`invention because it is consistent with the level of skill in the art at the time
`of the invention as reflected by the prior art and the Specification of the ’906
`patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)
`(explaining that specific findings regarding ordinary skill level are not
`required “where the prior art itself reflects an appropriate level and a need
`for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State
`Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
`
`The Board’s Discretion to Deny Institution under 35 U.S.C. § 314(a)
`C.
`The Patent Owner urges the Board to exercise its discretion under 35
`
`U.S.C. § 314(a) and deny institution of the proposed inter partes review.
`Prelim. Resp. 6. The Patent Owner argues that, under § 314(a), the Board
`must consider whether the nature of co-pending district court litigation on
`the same patent is such that instituting trial “would be an efficient use of the
`Board’s resources.” Id. at 6–7 (quoting NHK Spring Co. v. Intri-Plex
`
`
`
`8
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`IPR2020-00440
`Patent 9,439,906 B2
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`Techs., Inc., IPR2018-00752, Paper 8 at 19–20 (PTAB Sept. 12, 2018)
`(precedential)).
`
`Patent Owner contends that, under our precedential decision in Apple
`Inc. v. Fintiv, Inc., IPR2020-00019, Paper 15 at 12–17 (PTAB May 13,
`2020), in deciding “whether efficiency, fairness, and the merits support the
`exercise of authority to deny institution in view of an earlier trial date in the
`parallel proceeding,” the Board should consider a variety of factors, and, in
`evaluating these factors, “takes a holistic view of whether efficiency and
`integrity of the system are best served.” Prelim Resp. 11 (quoting Fintiv,
`Paper 11 at 5–6; also citing Samsung Elecs. Am., Inc. v. Uniloc 2017 LLC,
`IPR2020-00117, Paper 11 at 7–11 (PTAB May 28, 2020) (same).
`According to Patent Owner, granting the Petition for inter partes review
`would be an inefficient use of Board resources. Id.
`Specifically, Patent Owner points to two of the related litigations cited
`in Section II.B. supra: (1) Janssen Pharmaceuticals, Inc. et al v. Teva
`Pharmaceuticals USA, Inc. et al., 2-18-cv-00734 (D.N.J.) (the “Teva
`litigation”); and (2) Janssen Pharmaceuticals, Inc. et al. v. Mylan
`Laboratories Ltd., 2-19-cv-16484 (D.N.J.) (the “Mylan litigation”). Patent
`Owner contends that the procedural postures of each of these cases is such
`that institution by the Board of an inter partes review would be an inefficient
`use of Board resources.
`
`The Teva litigation
`1.
`
`In the Teva litigation, the validity of claims 1–21 of the ’906 patent is
`
`the only issue to be resolved at trial, and all claims are challenged as being
`obvious for reasons overlapping those of the instant Petition. Exs. 2006;
`
`
`
`9
`
`
`
`
`
`
`
`
`
`3.
`
`4.
`
`
`5.
`
`6.
`
`7.
`
`Cleton, the ’548 Trial, the ’544 patent and, optionally, in
`view of DOFA 2006 and Vieta 2001
`
`Cleton, the ’548 Trial, and/or the ’544 patent, with the WO
`’312 application and the WO ’384 application, in view of
`Cleton 2007 and paliperidone ER 2006
`
`Cleton, the ’548 trial, and the ’544 patent, in view
`of Ereshefsky 1990, Ereshefsky 1993 and paliperidone ER
`2006
`
`Cleton, the ’548 trial, and the ’544 patent, in view
`of Gibaldi or Goodman & Gilman
`
`Cleton, the ’548 trial, and the ’544 patent, in view of
`Ereshesky 1990, Ereshefsky 1993, paliperidone ER 2006
`and Gibaldi or Goodman & Gilma
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`IPR2020-00440
`Patent 9,439,906 B2
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`2007 at 40–41. In that litigation, Teva asserts that the ’906 patent is invalid
`under 35 U.S.C. § 103(a) as being obvious over:
`1. Cleton, the ’548 Trial6, and the ’544 patent
`
`2.
`
`Cleton, the ’548 Trial, and the ’544 patent, in view of
`Cleton 2007 and Paliperidone ER 2006
`
`
`Ex. 2007 at 41.
`Fact and expert discovery in the Teva litigation were completed in
`early 2020, and trial is set for September 28, 2020, ten days after the
`
`
`6 The “’548 Trial” refers to Clinicaltrials.gov, NCT00210548 A Study to
`Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate
`in Treating Subjects With Schizophrenia, available at
`https://clinicaltrials.gov/ct2/history/ NCT00210548?V_11
`=View#StudyPageTop (last visited September 3, 2020) (Ex. 1032). The
`’548 Trial is summarized in Table 1 of Citrome, and, in the Petition, the
`Petitioner relies on Citrome as teaching these summarized aspects of the
`’548 Trial. See, e.g., Pet. 36.
`
`
`
`10
`
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`IPR2020-00440
`Patent 9,439,906 B2
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`mandatory date for institution of this proposed inter partes review. Ex. 2005
`¶ 5.
`
`The Mylan litigation
`2.
`
`In the Mylan litigation, the validity of claims 1–21 of the ’906 patent
`
`is also a central issue to be determined at trial. Exs. 2001; 2007. In that
`litigation, Mylan asserts that the ’906 patent is invalid under 35 U.S.C.
`§ 103(a) on the following grounds:
`1.
`Claims 1-7, 15, and 17-21 as being obvious over the
`combination of NCT 5487, Cleton [PI-]758, and/or the
`’544 patent
`
`
`2.
`
`Claims 8-14, and 16 as being obvious over NCT 548,
`Cleton [PI-]75, the Paliperidone Formulary and/or the
`’544 patent
`
`
`Ex. 2008 at 41, 53.
`In this action, brought pursuant to the Hatch-Waxman Act, 21 U.S.C.
`§ 355, all fact discovery is scheduled to be completed by November 13,
`2020, and all expert discovery is due to be completed by February 19, 2021.
`Ex. 2003. A tentative trial date sometime in June 2021 has been proposed,
`but dates for the pretrial conference and the trial itself have yet to be
`determined. Exs. 2004, 2003. The statutory thirty-month stay imposed by
`21 U.S.C. § 355(j)(5)(B)(iii) is due to expire on January 2, 2022. Ex. 2004
`at 5.
`
`
`7 This reference appears to be the same as the ’548 Trial, summarized in
`Citrome. See fn.6.
`
` See fn.3.
`
` 8
`
`
`
`11
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`IPR2020-00440
`Patent 9,439,906 B2
`
`The Fintiv Factors
`3.
`
`In NHK, the Board held that, in the event there exists a parallel district
`
`court proceeding, in which the Petitioner asserted the same prior art and
`arguments, then instituting inter partes review “would not be consistent with
`‘an objective of the AIA . . . to provide an effective and efficient alternative
`to district court litigation.’” NHK at 20 (quoting General Plastic Ind. Co.,
`Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 16–17 (PTAB
`Sept. 6, 2017). The parallel district court litigation in NHK was in its latter
`stages, with expert discovery ending two months after the mandatory date
`for the proposed institution of the inter partes review. Id. A jury trial was
`also set to begin six months afterward, concluding six months prior to the
`mandatory date for the Final Written Decision in the proposed inter partes
`review. Id. The Board therefore exercised its discretion under § 314(a) and
`declined to institute trial.
`Our precedential decision in Apple v. Fintiv held that, as with other
`non-dispositive factors considered for institution under 35 U.S.C. § 314(a),
`an early trial date should be weighed as part of a “balanced assessment of all
`relevant circumstances of the case, including the merits.” Fintiv, 5 (citing
`the Consolidated Trial Practice Guide, November 2019 (“TPG”) at 58; also
`citing Abbott Vascular, Inc. v. FlexStent, LLC, IPR2019-00882, Paper 11 at
`31 (PTAB Oct. 7, 2019) (declining to adopt a bright-line rule that an early
`trial date alone requires denial in every case)).
`In Fintiv, the Board set forth six factors relating to whether efficiency,
`fairness, and the merits support the exercise of authority to deny institution
`in view of an earlier trial date in the parallel proceeding:
`1. whether the court granted a stay or evidence exists that one
`may be granted if a proceeding is instituted;
`12
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`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline for a final written decision;
`
`
`3. investment in the parallel proceeding by the court and the
`parties;
`
`
`4. overlap between issues raised in the petition and in the
`parallel proceeding;
`
`
`5. whether the petitioner and the defendant in the parallel
`proceeding are the same party; and
`
`
`6. other circumstances that impact the Board’s exercise of
`discretion, including the merits.
`
`
`Fintiv at 21. We consider these interrelated factors, as they apply to the
`facts of the Petition, as follows.
`
`
`a.
`
`Fintiv Factor #1: Whether the court granted a stay or
`evidence exists that one may be granted if a proceeding is
`instituted.
`
`
`
`“A district court stay of the litigation pending resolution of the PTAB
`
`trial allays concerns about inefficiency and duplication of efforts. This fact
`has strongly weighed against exercising the authority to deny institution
`under NHK.” Fintiv at 6 (citing Precision Planting, LLC v. Deere & Co.,
`IPR2019-01052, Paper 19 at 10 (PTAB Jan. 7, 2020)).
`
`In neither the Teva litigation nor the Mylan litigation has a stay been
`entered. Furthermore, neither Petitioner nor Patent Owner has indicated that
`a motion for a stay has been filed, that there is an intention to file, or that
`filing has even been contemplated in either litigation. At this stage of the
`Teva litigation, with trial set to commence on September 28, 2020 (see Ex.
`13
`
`
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`IPR2020-00440
`Patent 9,439,906 B2
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`2005 ¶ 5), it seems highly unlikely that the district court, at this late stage of
`the proceeding, would enter a stay of the litigation pending the year-long
`duration of an inter partes review. Prelim. Resp. 12; Sur-Reply 1.
`
`In the Mylan litigation, discovery is ongoing and all discovery is
`scheduled to be completed in February 2021. Although the court has not yet
`set a date for trial, a trial in June of 2021 has been proposed by both parties
`(see Ex. 2004), and with the 30-month limit provided for by 21 U.S.C. §
`355(j)(5)(B)(iii) expiring on January 2, 2022, we think it unlikely that a stay
`will be granted in the Mylan litigation, either. Id; see also Prelim. Resp. 12;
`Sur-Reply 1.
`We consequently conclude that the balance of facts in the two
`litigations indicate that no stay is likely to be entered in either, and therefore
`Fintiv factor 1 leans towards denial of institution.
`
`
`b.
`
`Fintiv Factor #2: Proximity of the court’s trial date
`to the Board’s projected statutory deadline for a
`final written decision.
`
`
`If the trial dates in the parallel litigations are earlier than the projected
`
`statutory deadline, this weighs in favor of exercising authority to deny
`institution under NHK. Fintiv at 9. But if the court’s trial date is at or
`around the same time as the projected statutory deadline, or even
`significantly after the projected statutory deadline, the decision whether to
`institute will likely implicate the other Fintiv factors, such as the resources
`that have been invested in the parallel proceeding. Id.
`
`The Teva litigation is scheduled to begin trial later this month, ten
`days after the mandatory decision date for institution of this inter partes
`review and almost a year prior to the deadline for a final written decision in
`14
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`IPR2020-00440
`Patent 9,439,906 B2
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`this inter partes review. Ex. 2005 ¶ 5. A trial date has not been set for the
`Mylan litigation, although both parties, in their Joint Proposed Discovery
`Plan, have proposed a trial date sometime in June 2021. Ex. 2004 at 5. The
`district court has, however, adopted the schedule set in the parties’ Joint
`Proposed Discovery Plan for fact and expert discovery, with the former
`closing in November 2020 and the latter in February 2021. Ex. 2003 at 3. A
`trial date set in the summer of 2021, before the mandatory deadline for the
`Final Written Decision in this proposed inter partes review, therefore seems
`likely. We therefore find that this factor weighs strongly in favor of denying
`institution. Fintiv, 9.
`
`
`c.
`
`Fintiv Factor #3: Investment in the parallel
`proceeding by the court and the parties.
`
`
`Under Fintiv factor #3, we consider the amount and type of work
`already completed in the parallel litigation by the court and the parties at the
`time of the institution decision. Fintiv, 9. Specifically, if, at the time of the
`institution decision, the district court has issued substantive orders related to
`the patent at issue in the petition, this fact favors denial. Id. at 9–10 (citing
`E-One, Inc. v. Oshkosh Corp., IPR2019-00162, Paper 16 at 8, 13, 20 (PTAB
`June 5, 2019)). Similarly, district court claim construction orders may
`indicate that the court and parties have invested sufficient time in the parallel
`proceeding to favor denial. Id. at 10 (citing Next Caller, Inc. v. TRUSTID,
`Inc., IPR2019-00963, Paper 8 at 13 (PTAB Oct. 28, 2019)).
`However, if the district court has not issued orders related to the
`patent at issue in the petition, prior to the mandatory date for institution, this
`fact weighs against exercising discretion to deny institution under NHK. Id.
`
`
`
`15
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`
`IPR2020-00440
`Patent 9,439,906 B2
`
`(citing Facebook, Inc. v. Search and Social Media Partners, LLC, IPR2018-
`01620, Paper 8 at 24 (PTAB Mar. 1, 2019) (district court proceeding in its
`early stages, with no claim constructions having been determined);
`Amazon.com, Inc. v. CustomPlay, LLC, IPR2018-01496, Paper 12 at 8‒9
`(PTAB Mar. 7, 2019).
`Fintiv factor #3 is thus related to Fintiv factor #2, insofar as that more
`work completed by the parties and court in the parallel proceeding tends to
`support the arguments that the parallel proceeding is more advanced, a stay
`may be less likely, and instituting would lead to duplicative costs. Id.
`
`Furthermore, under Fintiv factor #3, if the evidence shows that the
`petitioner filed the petition expeditiously, such as promptly after becoming
`aware of the claims being asserted, this fact has weighed against exercising
`the authority to deny institution under NHK. Fintiv at 11 (citing, e.g., Intel
`Corp. v. VLSI Technology LLC, IPR2019-01192, Paper 15 at 12‒13 (January
`9, 2020)). If, however, the evidence shows that the petitioner did not file the
`petition expeditiously, such as at or around the same time that the patent
`owner responded to the petitioner’s invalidity contentions, or even if the
`petitioner cannot explain the delay in filing its petition, these facts have
`favored denial. Id. at 12 (citing Next Caller, Inc. v. TRUSTID, Inc.,
`IPR2019-00961, Paper 10 at 16 (PTAB Oct. 16, 2019)).
`
`The Teva litigation is trial-ready, representing a very considerable
`investment by both parties. See Ex. 2005 ¶ 5. Furthermore, the Patent
`Owner contends, in the Mylan litigation, the parties have exchanged binding
`validity contentions, and fact discovery is presently ongoing. Prelim. Resp.
`13. The Patent Owner also asserts that Petitioner did not file its Petition
`with the Board until the day it was scheduled to receive Janssen’s response
`
`
`
`16
`
`
`
`IPR2020-00440
`Patent 9,439,906 B2
`
`to its invalidity contentions to file this Petition, which, the Petitioner asserts,
`weighs in favor of denial under Fintiv factor #3. Id. at 8, 13 (citing Fintiv at
`12).
`The Petitioner replies that the Petition was filed prior to receiving
`
`Janssen’s responsive contentions. Reply at 2 (citing Prelim. Resp. 4–5).
`The Petitioner also argues that the Patent Owner admits that Mylan filed its
`Petition six months before the statutory deadline and without the benefit of
`Janssen’s responsive validity contentions. Reply 3 (citing Prelim. Resp. 7,
`8). The Petitioner points to Oticon Medical AB et al. v. Cochlear Ltd,
`IPR2019-00975, Paper 15 at 22–23 (October 16, 2019) (precedential) as
`demonstrating that this time of filing avoids any prejudice to Janssen. Id.
`(also citing Apple Inc. v. Seven Networks LLC, IPR2020-00156, Paper 10 at
`11 (PTAB Jun. 15, 2020)).
`Petitioner argues further that the Petition in this proceeding was filed
`six weeks after serving its invalidity contentions in the Mylan litigation. Id.
`at 4 (citing Ex. 2003 at 1). Petitioner points to Seven Networks, at 11, in
`which the Board declined to exercise §314(a) discretion when Petition filed
`“fourteen weeks after its initial invalidity contentions.” Id. Petitioner
`asserts that it was reasonable for Mylan to avoid incurring any IPR expenses
`until litigation ensued and Janssen identified the asserted claims. Id. (citing
`Fintiv at 11) (holding that it was “reasonable for a petitioner to wait to file
`its petition until it learns which claims are being asserted against it”).
`
`We find that the balance of facts in evidence weigh in favor of denial.
`As we have explained, the Teva litigation is poised to go to trial within the
`next few weeks. See Ex. 2005 ¶ 5. In the Mylan litigation, Mylan has
`served Janssen with its initial invalidity contentions, and Janssen has served
`
`
`
`17
`
`
`
`IPR2020-00440
`Patent 9,439,906 B2
`
`Mylan with its responses to the invalidity contentions. See Exs. 2008, 2002.
`The court in the Mylan litigation has entered its scheduling order, with fact
`discovery to be completed in November, 2020 and expert discovery in
`February, 2021. Neither party has acknowledged any potential issues of
`claim construction that need to be resolved. See, e.g., Pet. 9. It is therefore
`reasonably likely that the Mylan litigation will go to trial sometime in June
`2021, or shortly thereafter, as proposed by the parties in their Joint Proposed
`Discovery Plan. Ex. 2004 at 5. Consequently, in both the Teva and Mylan
`litigations, we find that the district court has issued substantive orders
`related to the patent at issue in the petition regarding scheduling of discovery
`and trial (the latter in the case of the Teva litigation), and claim construction
`is not likely to be at issue. See Fintiv at 9–10. These facts favor denial. Id.
`
`Furthermore, Fintiv states, with respect to factor #3, that
`“notwithstanding that a defendant has one year to file a petition, it may
`impose unfair costs to a patent owner if the petitioner, faced with the
`prospect of a looming trial date, waits until the district court trial has
`progressed significantly before filing a petition at the Office.” Fintiv at 11.
`Fintiv continues in this vein:
`If, however, the evidence shows that the petitioner did not file
`the petition expeditiously, such as at or around the same time
`that the patent owner responds to the petitioner’s invalidity
`contentions, or even if the petitioner cannot explain the delay in
`filing its petition, these facts have favored denial.
`
`Fintiv at 11–12 (emphasis added) (citing Next Caller, Inc. v. TRUSTID, Inc.,
`IPR2019-00961, Paper 10 at 16 (PTAB Oct. 16, 2019) (finding that “Had
`[the Petitioner] filed this Petition … around the same time as the service of
`the initial invalidity contentions, the proceeding in this case may have
`
`
`
`18
`
`
`
`IPR2020-00440
`Patent 9,439,906 B2
`
`resolved the issues prior to the Parallel District Court Proceeding” and
`concluding that this delay favored denial). In this instance, Petitioner did
`not file the Petition at or about the time (December 20, 2019) Mylan served
`its initial invalidity contentions in the Mylan litigation. See Prelim. Resp. 8
`(indicating that the Petition was filed when Janssen served Mylan with its
`response to Mylan’s initial invalidity contentions on February 7, 2020).
`Because we therefore find that: (1) there is a near certainty that trial
`will be completed in the Teva litigation imminently, so that the district court
`will have invested significant resources in assessing the validity of the
`challenged patent well before the Board would issue a Final Written
`Decision should we institute inter partes review; (2) there is a reasonable
`likelihood that, given the current investment of time and resources by the
`parties and the court in the Mylan litigation and the fact that a stay is
`unlikely, the district court and the parties will have invested significant
`resources in assessing the validity of the challenged patent well before the
`Board would issue a Final Written Decision; and (3) the timing of the
`Petitioner’s filing its Petition for inter partes review, we conclude that Fintiv
`factor #3 favors denial.
`
`
`d.
`
`Fintiv Factor #4: overlap between issues raised in the
`petition and in the parallel proceeding.
`
`
`With respect to factor #4, Fintiv informs us that:
`If the petition includes the same or substantially the same claims,
`grounds, arguments, and evidence as presented in the parallel
`proceeding, this fact has favored denial. Conversely, if the
`petition includes materially different grounds, arguments and/or
`evidence than those presented in the district court, this fact has
`
`19
`
`
`
`
`
`
`
`IPR2020-00440
`Patent 9,439,906 B2
`
`
`tended to weigh against exercising discretion to deny institution
`under NHK.
`
`Fintiv at 12–13 (internal references omitted). In this instance, the validity of
`claims 1–21 of the ’906 patent is a principal (and in the Teva litigation, the
`only) issue to be determined at trial. In the Petition, claims 1–7, 15, 17–21
`are alleged to be invalid over the combined teachings of Cleton, Citrome,
`and the ’544 patent, and claims 8–14 and 16 are alleged to be invalid over
`Citrone, Cleton, the ’544 patent, and the Palperidone Formulary. Pet. 14–15.
`In the Teva litigation, claims 1–21 are alleged to be invalid over the
`combination principally of Cleton, the ’548 Trial, and the ’544 patent, and
`optionally with, or in view of, certain other references. Ex. 2007 at 41. In
`the Mylan litigation, claims 1–7, 15, 17–21 are alleged to be invalid over the
`combination of NCT 548, Cleton [PI-]75, and/or the ’544 patent, and claims
`8–14 and 16 are alleged to be invalid over NCT 548, Cleton [PI-]75, and/or
`the ’544 patent, and the Palperidone Formulary. Ex. 2008 at 41, 53.
`
`As we have explained supra, both the ’548 Trial in the Teva litigation,
`and NCT 548 in the Mylan litigation, refer to NCT00210548, a Phase III
`clinical palperidone palmitate trial in patients diagnosed with schizophrenia.
`See fn.6 supra. The pertinent details of the ’548 Trial (
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