`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`MYLAN LABORATORIES LTD.
`Petitioner
`
`v.
`
`JANSSEN PHARMACEUTICA NV
`Patent Owner
`____________________
`
`Case IPR2020-00440
`Patent 9,439,906
`____________________
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`

`

`TABLE OF CONTENTS
`
`IPR2020-00440
`
`I.
`II.
`
`2.
`
`Page
`
`INTRODUCTION ........................................................................................... 1
`THE BOARD SHOULD EXERCISE ITS DISCRETION UNDER 35
`U.S.C. § 314(a) TO DENY MYLAN’S PETITION ....................................... 6
`A.
`The Timing of Mylan’s Petition Supports Discretionary Denial .......... 7
`B.
`Co-Pending Litigation Involving the 906 Patent ................................ 11
`1.
`Apple Factors 1 and 2: The Absence of a Stay and Proximity of
`Trial Date .................................................................................. 12
`Apple Factor 3: The Court’s and Parties’ Investment in the
`Parallel Proceedings .................................................................. 13
`Apple Factor 4: Overlapping Issues ......................................... 14
`3.
`Apple Factor 5: Same Parties in Parallel Proceeding ............... 16
`4.
`Apple Factor 6: Other Circumstances Including the Merits .... 16
`5.
`Apple: Other Considerations .................................................... 17
`6.
`III. GROUNDS 1 AND 2 OF MYLAN’S PETITION RELY ON
`REFERENCES THAT ARE NOT PRIOR ART .......................................... 20
`IV. MYLAN’S PETITION AND ACCOMPANYING EXPERT TESTIMONY
`ARE CONCLUSORY, HINDSIGHT-DRIVEN, AND UNSUPPORTED OR
`CONTRADICTED BY THE RECORD ....................................................... 25
`A.
`Failure to Address Obviousness of the Unique Combination of
`Elements .............................................................................................. 28
`No Motivation to Administer Two Loading Doses in the Deltoid
`Muscle Only ........................................................................................ 30
`1.
`Grounds 1 and 2 ........................................................................ 30
`2.
`Grounds 3 and 4 ........................................................................ 34
`No Motivation to Use a 150 mg-eq. First Loading Dose .................... 38
`1.
`Citrome ...................................................................................... 39
`2.
`PI-74 and PI-75 ......................................................................... 43
`3.
`Alleged Overlapping Ranges .................................................... 46
`D. No Motivation to Use a Lower 100 mg-eq. Second Loading Dose
`Following the 150 mg-eq. First Loading Dose ................................... 48
`
`B.
`
`C.
`
`
`
`i
`
`

`

`
`
`E.
`
`No Motivation to Arrive at Claimed Lower Dose Amounts for Renally
`Impaired Patients ................................................................................. 53
`No Reasonable Expectation of Success .............................................. 55
`F.
`V. MYLAN FAILS TO PROVIDE EVIDENTIARY FOUNDATIONS FOR
`ITS OBVIOUSNESS GROUNDS ................................................................ 61
`A.
`Failure to Address Site of Administration of Maintenance Doses ..... 61
`B.
`Failure to Address Maintenance Dose Monthly Dosing Windows .... 63
`C.
`Failure to Address Motivation to Combine PI-74 and PI-75 .............. 63
`VI. CONCLUSION .............................................................................................. 65
`
`
`TABLE OF CONTENTS
`(continued)
`
`Page
`
`
`ii
`
`

`

`
`
`
`TABLE OF AUTHORITIES
`
`IPR2020-00440
`
` Page(s)
`
`Cases
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
`GmbH,
`IPR2019-01469, Paper 6 (Feb. 13, 2020) ............................................... 17, 18, 19
`Alcon Research Ltd. v. Barr Labs., Inc.,
`837 F. Supp. 2d 364 (D. Del. 2011), aff’d in part, rev’d in part on
`other grounds, 745 F.3d 1180 (Fed. Cir. 2014) ............................................ 21, 22
`Alliance Indus. Corp. v. Gebo Cermex USA, Inc.,
`IPR2019-01647, Paper 9 (PTAB Mar. 24, 2020) ............................................... 26
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ......................................passim
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 15 (PTAB May 13, 2020) ............................................. 11
`Arris Solutions, Inc. v. Realtime Adaptive Streaming LLC,
`IPR2019-01586, Paper 7 (PTAB Mar. 16, 2020) ............................................... 40
`Ex Parte Bayer,
`No. 2012-006699, 2013 WL 3972367 (PTAB July 31, 2013) ..................... 21, 22
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ............................................... 17
`Belden, Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) .......................................................................... 40
`Dr. Reddy’s Laboratories, Ltd. v. Monosol RX, LLC,
`IPR2016-01111, Paper 14 (PTAB Dec. 5, 2016) ............................................... 60
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .......................................................................... 20
`
`
`
`iii
`
`

`

`IPR2020-00440
`
`
`
`E.I. duPont de Nemours & Co. v. Synvina C.V.,
`904 F.3d 996 (Fed. Cir. 2018) ...................................................................... 46, 48
`Eisai Co. v. Dr. Reddy’s Labs., Ltd.,
`533 F.3d 1353 (Fed. Cir. 2008) .......................................................................... 36
`Eli Lilly & Co. v. Sicor Pharm., Inc.,
`705 F. Supp. 2d 971 (S.D. Ind. 2010) ................................................................. 21
`Enovate Medical, LLC, v. Intermetro Indus. Corp.,
`IPR2015-00300, Paper 12 (PTAB May 20, 2015) ............................................. 64
`Ericsson, Inc. v. Intellectual Ventures I LLC,
`890 F.3d 1336 (Fed. Cir. 2018) ........................................................ 34, 37, 45, 51
`Gen. Elec. Co. v. United Tech. Corp.,
`IPR2017-00428, Paper No. 38 (PTAB June 22, 2018) ...................................... 29
`Gillette Co. v. S.C. Johnson & Son, Inc.,
`919 F.2d 720 (Fed. Cir. 1990) ............................................................................ 29
`Harmonic, Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .......................................................................... 25
`Hulu, LLC v. Sound View Innovations, LLC,
`IPR2018-01039, Paper 29 (PTAB Dec. 20, 2019) ............................................. 35
`Hybritech, Inc. v. Monoclonal Antibodies, Inc.,
`802 F.2d 1367 (Fed. Cir. 1986) .................................................................... 28, 29
`InfoBionic, Inc. v. Braemar Mfg., LLC,
`IPR2015-01704, Paper 11 (PTAB Feb. 16, 2016) ............................ 26, 38, 40, 50
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 61
`Intelligent Bio-Systems v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .......................................................................... 55
`Ioxus, Inc. v. CAP-XX, Ltd.,
`IPR2019-01179, Paper 77 (PTAB Dec. 4, 2019) ............................................... 63
`iv
`
`
`
`

`

`IPR2020-00440
`
`
`
`IpDataTel, LLC v. ICN Acquisition, LLC,
`IPR2018-01822, Paper 19 (PTAB Apr. 22, 2019) ....................................... 62, 63
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................ 26
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`KVK-Tech, Inc. v. Shire PLC,
`IPR2018-00290, Paper 58 (PTAB July 3, 2019) .......................................... 36, 37
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .................................................................... 26, 59
`Metalcraft of Mayville, Inc. v. The Toro Company,
`848 F.3d 1358 (Fed. Cir. 2017) .......................................................................... 64
`Mylan Labs. Ltd. v. Aventis Pharma S.A.,
`IPR2016-00712, Paper 112 (PTAB Oct. 22, 2019) ...................................... 42, 57
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ............................................. 7, 8
`Otsuka Pharm. Co. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) .......................................................................... 36
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .................................................................... 46, 48
`Pfizer, Inc. v. Genentech, Inc.,
`IPR2017-01488, Paper 87 (PTAB Nov. 29, 2018) ............................................. 21
`Pfizer, Inc. v. Teva Pharm. USA, Inc.,
`No. 04-754 (JCL), 2006 U.S. Dist. LEXIS 98765 (D.N.J. Oct. 25,
`2006) ............................................................................................................. 21, 22
`RPX Corp. v. Chanbond LLC,
`IPR2016-00234, Paper 28 (PTAB May 25, 2017) ............................................. 41
`
`
`
`v
`
`

`

`IPR2020-00440
`
`
`
`Samsung Elecs. Am., Inc. v. Uniloc 2017 LLC,
`IPR2020-00117, Paper 11 (PTAB May 28, 2020) ............................................. 11
`Sanofi v. Glenmark Pharm., Inc., USA,
`204 F. Supp. 3d 665, 691-92 (D. Del. 2016), aff’d sub nom., Sanofi
`v. Watson Labs., Inc., 975 F.3d 636 (Fed. Cir. 2017) .................................. 42, 57
`Sanofi-Synthelabo v. Apotex, Inc.,
`550 F.3d 1075 (Fed. Cir. 2008) .................................................................... 28, 47
`Ex Parte Schreiner,
`No. 2012-006692, 2013 WL 5866489 (PTAB Oct. 29, 2013) ..................... 21, 22
`Securenet Techs., LLC v. Icontrol Networks, Inc.,
`IPR2016-01911, Paper 9 (PTAB Mar. 31, 2017) ........................................passim
`SFC Co. v. LG Chem. Ltd.,
`IPR2020-00178, Paper 16 (PTAB May 29, 2020) ............................................. 26
`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) ...................................................................... 21, 22
`In re Stryker,
`435 F.2d 1340 (C.C.P.A. 1971) .......................................................................... 23
`In re Tanczyn,
`347 F.2d 830 (C.C.P.A. 1965) .......................................................... 21, 22, 23, 24
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d 1352 (Fed. Cir. 2019) .......................................................................... 26
`Vanguard Prods. Grp. v. InVue Sec. Prods., Inc.,
`IPR2020-00014, Paper 8 (PTAB Apr. 1, 2020) ........................................... 48, 52
`W.L. Gore & Assocs. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) .......................................................................... 52
`Warner Chilcott Co., LLC v. Teva Pharm. USA, Inc.,
`642 F. App’x 996 (Fed. Cir. 2016) ..................................................................... 46
`
`
`
`vi
`
`

`

`IPR2020-00440
`
`
`
`Wilson Elec., LLC v. Cellphone-Mate, Inc.,
`IPR2018-01779, Paper 10 (PTAB Apr. 23, 2019) ....................................... 43, 52
`Statutes
`35 U.S.C. § 102(a) ............................................................................................. 20, 24
`35 U.S.C. § 119(e) ................................................................................................... 20
`35 U.S.C. § 314(a) ............................................................................................passim
`35 U.S.C. § 325(d) ............................................................................................. 17, 19
`Other Authorities
`37 C.F.R. § 42.104(b)(4) .................................................................................... 62, 63
`MPEP § 715.02 .................................................................................................. 23, 24
`
`
`
`
`
`vii
`
`

`

`IPR2020-00440
`
`Description
`
`Complaint, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-
`16484 (CCC) (MF) (D.N.J. Aug. 8, 2019) (Dkt. No. 1)
`Excerpts of Janssen’s Preliminary Responses to Mylan’s Initial
`Invalidity Contentions with Respect to U.S. Patent No. 9,439,906,
`Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484
`(CCC) (MF) (D.N.J. Feb. 7, 2020)
`Order, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-
`16484 (CCC) (MF) (D.N.J. Dec. 13, 2019) (Dkt. No. 43)
`Joint Proposed Discovery Plan, Janssen Pharm., Inc. v. Mylan
`Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Nov. 8, 2019)
`(Dkt. No. 34-1)
`Scheduling Order, Janssen Pharm., Inc. v. Teva Pharm. USA, Inc.,
`No. 2:18-cv-734 (CCC) (MF) (D.N.J. June. 11, 2020) (Dkt. No. 90)
`Stipulation and Order Regarding Infringement of Claims 1-21 of
`U.S. Patent No. 9,439,906, Janssen Pharm., Inc. v. Teva Pharm.
`USA, Inc., No. 2:18-cv-734 (CCC) (MF) (D.N.J. June. 8, 2020)
`(Dkt. No. 88)
`Excerpts of Teva’s Preliminary Invalidity Contentions with
`Respect to U.S. Patent No. 9,439,906, Janssen Pharm., Inc. v. Teva
`Pharm. USA, Inc., No. 2:18-cv-734 (CCC) (MF) (D.N.J. June. 25,
`2018)
`Excerpts of Mylan’s Initial Invalidity Contentions, Janssen
`Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF)
`(D.N.J. Dec. 20, 2019)
`Comparison of Examples 2 and 3 of U.S. Provisional Application
`No. 61/014,918 with PI-75 and PI-74 (Ex. 1003)
`
`viii
`
`
`
`Exhibit
`No.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`
`
`

`

`
`
`
`2010
`
`2011
`
`2012
`
`IPR2020-00440
`
`Search results from FDA website
`(https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) for FDA-
`approved drugs containing paliperidone palmitate
`FDA Summary Review for Invega Trinza® (available at
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Ori
`g1s000SumR.pdf)
`Declaration of Joong Youn (Jay) Cho
`
`
`
`ix
`
`

`

`IPR2020-00440
`
`I.
`
`INTRODUCTION
`Patent Owner Janssen Pharmaceutica, NV (“Janssen”) submits this
`
`Preliminary Response to the Petition for Inter Partes Review of U.S. Patent No.
`
`9,439,906 (“the 906 Patent”) filed by Mylan Laboratories Ltd. (“Mylan”). The 906
`
`Patent is directed, inter alia, to dosing regimens for treating psychotic disorders
`
`using a long-acting injectable formulation of the antipsychotic medication
`
`paliperidone palmitate. The inventors discovered, and the claims recite, a unique
`
`combination of dosing schedules, amounts, and injection sites that provides both
`
`rapid and long-term efficacy without the need for oral run-in or supplementation.
`
`The invention paved the way for the approval of Invega Sustenna®, a
`
`groundbreaking therapy that solved a significant compliance challenge facing this
`
`patient population. The blockbuster success of this product attracted several
`
`generic competitors, including Mylan, seeking to market a copy of Janssen’s
`
`medicine prior to the expiration of the 906 Patent.
`
`The path to the patented dosing regimens was not straightforward. As
`
`reflected in the references Mylan relies upon, Janssen conducted multiple clinical
`
`trials using paliperidone palmitate formulations with a “fixed-dose” initiation
`
`regimen (i.e., patients received the same dose of medication on each scheduled day
`
`of treatment). In these trials, injection sites were also fixed; all patients received
`
`injections in the same muscle (i.e., deltoid or gluteal).
`1
`
`
`
`

`

`
`
`
`Mylan relies on publications that refer to these fixed-dose clinical trials—but
`
`IPR2020-00440
`
`which present no efficacy data—to assert that the claims of the 906 Patent would
`
`have obvious. But these publications provide no insight into crucial subsequent
`
`breakthroughs that led to the inventions of the 906 Patent.
`
`After examining the unpublished data from these fixed-dose trials (data that
`
`are not in the prior art), the 906 Patent inventors determined that they would need
`
`to abandon the concept of fixed initiation doses. They modified the dosing
`
`regimen to provide a high initial dose of 150 mg-eq. of paliperidone palmitate on
`
`day one, followed by a second loading dose of 100 mg-eq. (a reduced but still high
`
`loading dose) around the second week of treatment. The inventors also perceived
`
`that this approach worked only if these two loading dose injections, of different
`
`amounts, were given exclusively in the deltoid muscle. After the two initial
`
`loading doses, this regimen called for maintenance doses of 25 mg-eq. to 150 mg-
`
`eq., which the inventors discerned could be given in the deltoid or gluteal muscle
`
`monthly ±7 days.1 No dosing regimen with these features is found or suggested in
`
`the prior art.
`
`1 Claims 1 and 2 of the 906 Patent exemplify these concepts. Other claims of the
`
`patent add additional limitations, including specifying the composition and
`
`physical properties of the formulation of paliperidone palmitate (claims 17-21) and
`
`
`
`2
`
`

`

`
`
`
`Mylan contends that the claims of the 906 Patent would have been obvious
`
`IPR2020-00440
`
`because a person of ordinary skill in the art (“POSA”) could have found each of
`
`the elements of the claims—in isolation—in the prior art. But none of the
`
`references relied upon by Mylan discloses anything other than dosing regimens
`
`with fixed initial doses (or single doses) of paliperidone palmitate. None of the
`
`references provides any reason for a POSA to modify the disclosed doses, abandon
`
`the fixed-dose concept, require the deltoid injection site for the two loading doses
`
`of different amounts (but not require deltoid injection of the maintenance doses),
`
`and select the unique combination of elements that comprise the claimed dosing
`
`regimens. Furthermore, none of the references contains efficacy data on which to
`
`base a reasonable expectation of success. Mylan’s analysis is factually deficient
`
`and the approach of its expert (Dr. Amiji)—lacking any identified motivation to
`
`select the various fragments of references relied upon by Mylan to cobble together
`
`the claimed dosing regimens—is unapologetic hindsight.
`
`
`providing dosing regimens for patients with renal impairment (claims 8-14 and
`
`16).
`
`
`
`3
`
`

`

`
`
`
`For these reasons, set forth in greater detail below, Mylan’s Petition fails on
`
`IPR2020-00440
`
`the merits. But the Board need not delve into the merits, because Mylan’s Petition
`
`should be denied at the threshold under 35 U.S.C. § 314(a) (Section II).
`
`Two parallel litigations involving alleged obviousness of the 906 Patent
`
`warrant denial under § 314(a). In the case involving Mylan—commenced six
`
`months before it filed this Petition—the obviousness issues Mylan raised are nearly
`
`identical to those presented by its Petition. In an earlier case against Teva, set for
`
`trial in September 2020, validity of the 906 Patent is the only issue, obviousness is
`
`the central issue, and Teva’s obviousness theories substantially overlap with those
`
`presented by the Petition. Granting this Petition would be an inefficient use of
`
`Board resources.
`
`Mylan’s tactics in timing this Petition also warrant denial under § 314(a).
`
`Mylan developed its obviousness position in the first half of 2019, when it
`
`prepared and provided to Janssen a detailed statement required by the Hatch-
`
`Waxman statute in a Paragraph IV notice letter dated June 28, 2019. Nevertheless,
`
`Mylan waited until February 2020 to file its Petition, allowing the Hatch-Waxman
`
`litigation triggered by that letter to advance to the binding contentions stage. Then,
`
`having inexplicably delayed, Mylan raced to file its Petition mere hours before
`
`
`
`4
`
`

`

`
`
`receiving Janssen’s responsive contentions setting forth objective evidence of non-
`
`IPR2020-00440
`
`obviousness, apparently to avoid addressing that evidence in its Petition.
`
`Should the Board reach the merits, it should deny Mylan’s Petition. Mylan’s
`
`obviousness arguments suffer from multiple substantive defects, each of which
`
`warrants denial of institution.2
`
`First, as detailed in Section III, the two Cleton abstracts—which are not
`
`one, but two distinct references, PI-74 and PI-75—on which Mylan relies in its
`
`principal obviousness grounds (and that the Examiner found were not prior art) are,
`
`in fact, not prior art.3 The inventors were in possession of the information in them,
`
`and included that information in their patent filing leading to the 906 Patent, prior
`
`to the alleged publication date of the two abstracts.
`
`Most fundamentally, as detailed in Section IV, Mylan’s obviousness
`
`grounds rely almost exclusively on conclusory assertions and equally conclusory
`
`
`2 For purposes of this Preliminary Response only, Janssen agrees with Mylan that
`
`no claim construction is necessary. Petition 8-9.
`
`3 Mylan uses the name “Cleton” to collectively refer to the two separate and
`
`distinct abstracts identified in Ex. 1003 as “PI-74” and “PI-75.” See infra Section
`
`V.C.
`
`
`
`5
`
`

`

`
`
`expert testimony that are either unsupported, or contradicted, by the references
`
`IPR2020-00440
`
`accompanying Mylan’s Petition. Crucially, these conclusory assertions entirely
`
`fail to address the alleged obviousness of the combination of elements that make
`
`up the claimed dosing regimen: the unique combination of dose amounts, schedule,
`
`and sites of administration that allowed these regimens to work. Instead, with
`
`hindsight only, using the 906 Patent as a roadmap, Mylan finds each element of the
`
`claims in the prior art and argues that they are, in isolation, obvious. Not only does
`
`Mylan fail to meet its burden as to the isolated elements, but the Petition does not
`
`even attempt to show that the elements in combination—the patented dosing
`
`regimens “as a whole”—would have been obvious. That is a fundamental failing.
`
`Finally, as detailed in Section V, Mylan’s Petition fails entirely to: (a)
`
`address the element of all claims requiring that the first maintenance dose be
`
`“administer[ed] intramuscularly in the deltoid or gluteal muscle”; (b) address the
`
`flexibility around the timing of maintenance dosing that the claims provide; and (c)
`
`provide evidence of a motivation to combine PI-74 and PI-75.
`
`II. THE BOARD SHOULD EXERCISE ITS DISCRETION UNDER 35
`U.S.C. § 314(a) TO DENY MYLAN’S PETITION
`Under § 314(a), the Board considers whether Mylan gained “any tactical
`
`advantage, or opportunity for tactical advantage . . . by waiting to file the Petition,”
`
`and whether the nature of co-pending district court litigation on the same patent is
`6
`
`
`
`

`

`
`
`such that instituting trial “would be an efficient use of the Board’s resources.” See
`
`IPR2020-00440
`
`NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8, at 19-20
`
`(PTAB Sept. 12, 2018) (precedential). Mylan’s Petition barely addresses the issue
`
`of discretionary denial. Petition 65. It makes no attempt to explain the timing of
`
`the Petition or address the status of the parallel litigations involving the 906 Patent.
`
`Both factors establish that the Petition should be denied under § 314(a).
`
`A. The Timing of Mylan’s Petition Supports Discretionary Denial
`First, the timing of Mylan’s Petition reveals that it was intended to provide
`
`Mylan with an “opportunity for tactical advantage” in this proceeding. See NHK,
`
`at 19-20. As discussed below, the validity of the 906 Patent is the subject of co-
`
`pending Hatch-Waxman litigation between Mylan and Patent Owner. That case
`
`was filed on August 8, 2019, six months before Mylan filed this Petition. Prior to
`
`that litigation, Mylan had fully considered the validity of the 906 Patent, laying out
`
`its obviousness position in a statutorily-required detailed statement in support of its
`
`Paragraph IV certification dated June 28, 2019. Ex. 2001 ¶¶ 50-52. Despite
`
`working out its obviousness position at that time—and knowing that its Paragraph
`
`IV notice letter would trigger litigation—Mylan inexplicably delayed over seven
`
`months before starting this proceeding, delaying resolution in the Patent Office and
`
`allowing the parallel district court proceeding to advance. See infra Section II.B.
`
`
`
`7
`
`

`

`
`
`
`Indeed, Mylan waited until the very day it was scheduled to receive
`
`IPR2020-00440
`
`Janssen’s response to its invalidity contentions to file this Petition, when it could
`
`have filed well earlier. As precedential Board authority holds:
`
`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. If, however, the
`evidence shows that the petitioner did not file expeditiously,
`such as at or around the same time that the patent owner
`responds to the petitioner’s invalidity contentions, or even if
`petitioner cannot explain the delay in filing its petition, these
`facts have favored denial.
`
`Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11, at 11-12 (PTAB Mar. 20,
`
`2020) (precedential);4 see infra Section II.B.2. Apple is on all fours; Mylan’s
`
`inexplicable delay warrants denial.
`
`To make matters worse, when Mylan finally decided to file the IPR, it
`
`engaged in tactical gamesmanship. Mylan raced to the Patent Office on February
`
`7, 2020, literally hours before receiving Janssen’s response to Mylan’s obviousness
`
`contentions (served in December 2019). Janssen’s response included evidence of
`
`
`4 All emphases added unless stated otherwise.
`
`
`
`8
`
`

`

`
`
`secondary considerations rebutting Mylan’s obviousness contentions. See
`
`IPR2020-00440
`
`generally Ex. 2002. Mylan knew Janssen’s contentions detailing secondary
`
`considerations were coming; the scheduling order setting that deadline was agreed
`
`to on November 8, 2019 and court-ordered on December 13, 2019. Ex. 2003 ¶ 5;
`
`Ex. 2004 at 4. Nevertheless, in a transparent effort to avoid addressing secondary
`
`considerations in its Petition, Mylan filed that very day.
`
`The obvious purpose of Mylan’s decision to file on February 7 was to
`
`preserve its ability to feign ignorance about secondary considerations in the
`
`Petition. See Petition 64 (“To the extent Patent Owner does assert any secondary
`
`considerations . . . detailed consideration of Patent Owner’s evidence should not be
`
`undertaken until Petitioner has had an opportunity to respond to it.”); Ex. 1002
`
`(“Amiji Dec.”) ¶ 216 (“At this time, I am not aware of any evidence of non-
`
`obviousness with regard to the claims of the 906 Patent, including failure of others,
`
`copying, perception in the industry, commercial success, or long-felt but unmet
`
`
`
`9
`
`

`

`
`
`need.”).5 This purported unawareness is a direct consequence of Mylan filing
`
`IPR2020-00440
`
`when it did, rather than waiting a few hours to see what secondary considerations
`
`were actually in play.
`
`Moreover, Mylan’s purported ignorance of any secondary considerations is
`
`not credible. As a sophisticated generic pharmaceutical company seeking to
`
`market a copy of Janssen’s successful Invega Sustenna product, Mylan would have
`
`been aware of, and able to address in the Petition, the dramatic commercial success
`
`of the claimed dosing regimens and Mylan’s own efforts to copy them. Likewise,
`
`Mylan’s expert—offered “in the field of pharmaceutical science and
`
`pharmacokinetics” having significant academic and industry experience “with the
`
`design, development and considerations involved with depot formulations” who
`
`“was familiar with risperidone and reviewed a significant amount of literature on
`
`paliperidone,” Amiji Dec. ¶¶ 8, 16, 18—should have been able to address Invega
`
`
`5 Although the contentions included some Janssen confidential information, as is
`
`customary in litigation, Mylan could have asked Janssen’s permission to use the
`
`information—the vast majority of which is not confidential—in connection with its
`
`Petition.
`
`
`
`10
`
`

`

`
`
`Sustenna’s perception in the pharmaceutical industry, as well as the long-felt need
`
`IPR2020-00440
`
`it addressed.
`
`Mylan’s gamesmanship is one reason to deny its Petition under § 314(a).
`
`B. Co-Pending Litigation Involving the 906 Patent
`Another reason to deny Mylan’s Petition is the advanced state of the co-
`
`pending Hatch-Waxman litigations involving the 906 Patent. Under the
`
`precedential Apple decision, 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 considers a variety of factors, addressed
`
`below, and, in evaluating these factors, “takes a holistic view of whether efficiency
`
`and integrity of the system are best served.” IPR2020-00019, Paper 11, at 5-6; see
`
`also Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 15, at 12-17 (PTAB May 13,
`
`2020) (denying institution after applying precedential multi-factor test); Samsung
`
`Elecs. Am., Inc. v. Uniloc 2017 LLC, IPR2020-00117, Paper 11, at 7-11 (PTAB
`
`May 28, 2020) (same). Granting this Petition would be an inefficient use of Board
`
`resources.
`
`The projected statutory deadline for the Board’s final written decision in this
`
`IPR is approximately September 2021. In the Mylan case, No. 2:19-cv-16484
`
`(D.N.J. filed Aug. 8, 2019), involving only the 906 Patent and pending before
`
`
`
`11
`
`

`

`
`
`Judge Cecchi, fact discovery is ongoing (due to conclude in November), and a
`
`IPR2020-00440
`
`bench trial is anticipated in the summer of 2021 (Ex. 2004 at 5)—before a final
`
`decision from the Board will issue. As explained below (Section II.B.3), the
`
`obviousness issues in Mylan overlap substantially with those presented here.
`
`In the Teva case, No. 2:18-cv-00734 (D.N.J. filed Jan. 17, 2018), also
`
`involving only the 906 Patent and pending before Judge Cecchi, fact and expert
`
`discovery concluded in early 2020, and trial is set for September 28, 2020. See Ex.
`
`2005 ¶ 4. In Teva, validity is the only issue to be tried (Ex. 2006), and all claims
`
`are challenged as obvious for reasons overlapping with Mylan’s Grounds here. See
`
`Ex. 2007 at 40-41. The court’s obviousness decision in Teva is anticipated well
`
`before the deadline for final decision in this IPR.
`
`Under Apple, these parallel proceedings weigh in favor of denial under §
`
`314(a).
`
`1.
`
`Apple Factors 1 and 2: The Absence of a Stay and
`Proximity of Trial Date
`As mentioned above, both the Mylan and Teva trials are anticipated before a
`
`final decision in this IPR, and a ruling in Teva is expected well before. Neither
`
`case is stayed. These factors therefore support denial.
`
`
`
`12
`
`

`

`
`
`
`IPR2020-00440
`
`2.
`
`Apple Factor 3: The Court’s and Parties’ Investment in the
`Parallel Proceedings
`The significant investment by Judge Cecchi and the parties in the parallel
`
`proceedings also supports denial under Apple.
`
`The Teva case is trial-ready; the parties have completed fact and expert
`
`discovery (including the exchange of detailed expert reports on obviousness).
`
`Trial is looming. In Mylan, the parties have exchanged binding validity
`
`contentions (nearly 400 pages worth), and fact discovery is ongoing.6 “[M]ore
`
`work completed by the parties and the court in the parallel proceedings 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.” Apple, at 10. Indeed,
`
`under Apple, filing “at or around the same time that patent owner respond[ed] to
`
`the petitioner’s invalidity contentions,” as Mylan did here, suggests the
`
`proceedings are advanced, favoring denial. See id. at 11-12. The significant
`
`investments in the district court proceedings favors denial.
`
`
`6 Neither Mylan nor Teva sought any claim construction rulings in the parallel
`
`proceedings and the court made none.
`
`
`
`13
`
`

`

`
`
`
`IPR2020-00440
`
`3.
`Apple Factor 4: Overlapping Issues
`“[I]f 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.” Id. at 12. This factor supports denial “[e]ven when a
`
`petitioner