IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`IPR2020-00440
`Authorized Reply to Patent Owner’s Preliminary Response
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Mylan Laboratories Ltd.
`Petitioner,
`
`v .
`
`Janssen Pharmaceutica NV
`Patent Owner.
`
`U.S. Patent No. 9,439,906 to Vermeulen et al.
`Issue Date: September 13, 2016
`Title: Dosing Regimen Associated with Long
`Acting Injectable Paliperidone Esters
`
`Inter Partes Review No.: IPR2020-00440
`
`AUTHORIZED REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`145116331v2
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`IPR2020-00440
`Authorized Reply to Patent Owner’s Preliminary Response
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Mylan Laboratories Ltd.
`Petitioner,
`
`v .
`
`Janssen Pharmaceutica NV
`Patent Owner.
`
`U.S. Patent No. 9,439,906 to Vermeulen et al.
`Issue Date: September 13, 2016
`Title: Dosing Regimen Associated with Long
`Acting Injectable Paliperidone Esters
`
`Inter Partes Review No.: IPR2020-00440
`
`AUTHORIZED REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`145116331v2
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`
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`IPR2020-00440
`Authorized Reply to Patent Owner’s Preliminary Response
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`TABLE OF CONTENTS
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`Page
`1. The Apple Factors Favor Institution .................................................................... 1
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`2.
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`Janssen Has Failed to Remove PI-74 and PI-75 .................................................. 7
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`1. The Apple Factors Favor Institution
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`Apple Factor 1: As various panels have explained since Apple, if neither
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`side presents evidence of a stay and “the record lacks any evidence to suggest that
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`a stay has been granted, or may be granted in the future,” Factor #1 is “neutral.”
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`Supercell Oy v. Gree, IPR2020-00513, Paper 21 at 8 (PTAB June 24, 2020); Apple
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`Inc. v. Seven Networks LLC, IPR2020-00156, Paper 10 at 7 (PTAB June 15, 2020);
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`Intel Corp. v. VLSI Technology LLC, IPR2020-00142, Paper 17 at 10 (PTAB June
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`4, 2020).
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`Apple Factor 2: The FWD is due approximately September 2021. POPR at
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`11. Trial in the district court is not scheduled. While in the Joint Proposed
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`Discovery Plan the parties proposed a trial date of “June 2021 or at the Court’s
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`convenience” (EX2004, p. 5 of 12), the District Court declined to set a trial date.
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`EX2003. “Patent Owner has not provided the Board with any procedural schedule
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`from the District Court showing a trial date.” Oticon Medical AB et al. v.
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`Cochlear Ltd., IPR2019-00975, Paper 15 at 22-24 (PTAB Oct. 16, 2019)
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`(precedential). Under precedential PTAB authority, the parties’ intentions are
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`irrelevant. To prevail on this factor, Janssen must provide concrete evidence “from
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`the District Court showing a trial date” (id.), which Janssen cannot do because the
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`District Court expressly declined to set a trial date. Like Oticon, Factor #2 favors
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`Petitioner and trial should be instituted. Id. at 24.
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`Apple Factor 3: Factor #3 addresses prior investment by the Court and the
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`parties “at the time of the institution.” Apple, 9. At best, Janssen argues that “[i]n
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`Mylan, the parties have exchanged binding validity contentions (nearly 400 pages
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`worth), and fact discovery is ongoing.” POPR at 13. Not a single deposition has
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`occurred and Janssen points to no activity by the District Court in Mylan. Further,
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`the Petition was filed prior to receiving Janssen’s responsive contentions. POPR at
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`4-5. And, little will have occurred “at the time of the institution.” (EX2004). Under
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`similar facts, the PTAB has instituted the review. Oticon, IPR2019-00975 at 23
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`(“Patent Owner simply informs us that ‘discovery is well underway.’”); Apple, 9-
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`10 (lack of activity by District Court weighs against denial); Mylan Pharms. Inc. v.
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`Merck Sharpe & Dohme Corp., IPR2020-00040, Paper 21 at 33-34 (PTAB May
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`11, 2020) (“Merck”). Instead, Janssen focuses on the Teva litigation—an unrelated
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`defendant in another proceeding. POPR at 13. “Mylan should not, however, be
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`foreclosed from petitioning the Board to hear its challenge based on choices of the
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`other drug manufacturers.” Merck, IPR2020-00040 at 29.
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`Apple does state that when a petitioner is unrelated to a defendant (i.e.,
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`Teva), a Petitioner should still explain “why addressing the same or substantially
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`the same issues would not be duplicative of the prior case.” Apple, 14. Janssen
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`provided an excerpt of Teva’s invalidity contentions. EX2007 at 40-41; POPR at
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`16. Other than stating in a conclusory manner that “all claims are challenged as
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`obvious for reasons overlapping with Mylan’s Grounds here” (POPR at 12),
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`Janssen offers no further explanation. Each of Teva’s positions rely on Cleton
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`2008 as the primary reference. EX2007, p.41. “Cleton 2008 refers collectively to
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`PI-74 and PI-75.” POPR at fn. 9. Thus, Teva’s entire case is premised on the same
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`§102(a) art that Janssen is seeking to antedate in this IPR. POPR at 20-24. But
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`Mylan is not using Cleton 2008 as its primary reference; Citrome is Mylan’s
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`primary reference—a reference not even used by Teva. Petition at 14-15; EX2007
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`at 40-41. Citrome is §102(b) art that cannot be antedated, and no antedation
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`challenge has been made against Ground 3 or 4 because they only rely on §102(b)
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`art. The Cleton 2008 threshold issue will presumably cut across Teva’s entire case
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`whereas it will not cut across all Grounds in this IPR. Citrome’s unchallenged prior
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`art status makes Mylan’s challenge substantially different.
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`There is more. Apple Factor 3 also considers the timing of the Petition.
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`Apple, 11. Janssen admits Mylan filed its Petition six months before the statutory
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`deadline and without the benefit of Janssen’s responsive validity contentions
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`(POPR at 7, 8) which, as explained by Oticon, avoids any prejudice to Janssen.
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`IPR2019-00975 at 22-23; Seven Networks, IPR2020-00156 at 11 (declining to
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`exercise §314(a) discretion when the Petition was filed four months in advance of
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`bar). Janssen complains that Mylan had on hand its positions at the time it served
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`its notice letter as required by the Hatch-Waxman statute but then delayed filing.
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`POPR at 4. Such a position finds no support in the PTAB’s decisions. Mylan filed
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`its IPR six weeks after serving its invalidity contentions. EX2003 at p. 1 of 5.
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`Seven Networks, IPR2020-00156 at 11 (declining to exercise §314(a) discretion
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`when Petition filed “fourteen weeks after its initial invalidity contentions”). It was
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`reasonable for Mylan to avoid any IPR expenses until litigation ensued and Janssen
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`identified the asserted claims. Apple, 11 (“reasonable for a petitioner to wait to file
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`its petition until it learns which claims are being asserted against it”). Janssen next
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`complains Mylan remained blind to its secondary considerations (POPR at 8-9)
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`even though Janssen never provided any objective indicia evidence in its POPR.
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`Even with knowledge, Mylan did not have to address secondary considerations in
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`its Petition. Petition at 64 (citing cases). Factor #3 favors institution.
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`Apple Factor 4: As shown in Janssen’s own table, the primary reference in
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`Mylan’s IPR is Citrome. POPR at 15. Citrome is never mentioned in Janssen’s
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`corresponding district court table; the primary reference there is NCT 548, which
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`“is a clinicaltrials.gov protocol.” Id. at fn. 7. Janssen’s table is also missing IPR
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`Grounds 3 and 4. And, Janssen admits that these Grounds are not before the
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`District Court. Oticon, IPR2019-00975 at 23 (“Patent Owner seems to
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`acknowledge that the Board proceeding would not be directly duplicative of the
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`District Court consideration of validity.”).
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`Janssen next alleges that the single clinical trial described in NCT 548
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`(EX1032) and Citrome, which tabulates information from multiple clinical trials,
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`including NCT 548 (EX1004 at 656), have the “same content.” POPR at fn. 7. But
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`the Petition relies on multiple trials described in Citrome. Petition at 25 (NCT 548,
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`NCT 717, NCT 756, and NCT 634); id at 27, 29, 32. NCT 548 is not duplicative of
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`Citrome’s other clinical trials. The different challenged grounds “might produce a
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`different outcome without the [the district court and IPR] trials necessarily yielding
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`inconsistent results.” Seven Networks, IPR2020-00156 at 19. Even where the IPR
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`and the district court prior position positions overlap, the PTAB has still instituted
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`IPRs. Merck, IPR2020-00040 at 34. Factor #4 favors institution.
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`Apple Factor 5: The District Court and the IPR actions involve the same
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`parties. Already at least one other panel has questioned the relevance of this factor.
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`Seven Networks, IPR2020-00156 at 20, fn.12 (not disagreeing that Factor #5 could
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`appear “contrary to the goal of providing district court litigants an alternative
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`venue to resolve questions of patentability.”); see also Cisco Sys., Inc. v. Ramot at
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`Tel Aviv Univ. Ltd., IPR2020-00122, Paper 15 at 10 (PTAB May 15, 2020) (APJ
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`Crumbley, dissenting). According to 35 U.S.C. §315(b), the defendant who was
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`“served with a complaint alleging infringement of the patent” has one year to file
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`its Petition. And Congress has mandated that the defendant file the IPR, or be
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`subject to the one year bar. Chevron v. Natural Resources Defense Council Inc.,
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`467 US 837, 842-843 (1984) (“First, always, is the question whether Congress has
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`directly spoken to the precise question at issue.”). Thus, Factor #5 is neutral.
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`Apple Factor 6: “Fairness strongly favors Petitioner here, as this is
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`Petitioner’s only (indeed, the only) IPR challenge to the validity of the [’906]
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`patent’s claims.” Merck, IPR2020-00040 at 36. Moreover, the primary reference in
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`all four grounds is Citrome, thereby reducing the draw on Board resources. Id. at
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`27 (Petitioner “raises six grounds, each of which relies substantially on WO ’498
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`(or its counterpart, the ’871 patent).”) With an unopposed expert and only attorney
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`argument in response, Mylan’s arguments are “particularly strong on the
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`preliminary record.” Apple, 14, 15 n.29; Apotex, IPR2019-00400 at 18-19 (noting
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`the absence of countervailing expert testimony). Janssen does not argue that the
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`IPR would burden the district court, “[i]f anything, there are possibilities for
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`streamlining [district court’s work].” Merck, IPR2020-00040 at fn. 22.
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`Janssen conflates a §325(d) analysis with a §314(a) analysis. POPR at 17-18.
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`Under the two-part test of Advanced Bionics, LLC v. Med-El Electromedizinishe
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`Gerӓte GMBH, IPR2019-01469, Paper 6 at 8-10 (Feb. 13, 2020) (precedential)
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`(“Bionics”), the first part asks whether the same or substantially the same art
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`previously was presented to the Office, or whether the same or substantially the
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`same arguments previously were presented to the Office. Citrome—Mylan’s
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`primary reference—was not disclosed to the Examiner. EX1001. Janssen does not
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`claim Citrome is duplicative of any art that was before the Office. Whether
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`Citrome is duplicative of anything in the Teva litigation (which as explained
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`above, it is not) is not the issue. Under Bionics, the issue is what art was presented
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`“to the Office.” Janssen also argues the “Examiner made an express finding that
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`[the Cleton] references were ‘not applicable as prior art’ because ‘the instant
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`claims are fully supported by [the ’918 provisional].” POPR at 18. But as Janssen
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`admits, this has no bearing on Grounds 3 and 4. Id. Further, there is no evidence
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`the Examiner considered the specific priority issue discussed in the Petition. In any
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`event, Janssen’s antedation argument fails for multiple reasons. Infra. Factor #6
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`favors institution. Thus, balancing all six Apple factors favors institution.
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`2. Janssen Has Failed to Remove PI-74 and PI-75
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`Janssen bears the burden on its attempt to antedate PI-74 and PI-75.
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`Medtronic, Inc. et al v. Teleflex Medical Devices SARL f/k/a Teleflex Innovations
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`SARL et al., IPR2020-00135, Paper 22 at 11 (PTAB June 8, 2020). Although
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`antedating questions are typically reserved for trial – in order to ensure the
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`Petitioner has had a full and fair opportunity to challenge the evidence – Janssen
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`does not wait to provide such an opportunity. Mylan Pharms. Inc. v. Boehringer
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`Ingelheim Pharms. Inc., IPR2016-01563, Paper 14 at 4 (PTAB Dec. 7, 2016).
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`Instead, it charges ahead with two antedating arguments, both of which fail.
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` Janssen primarily alleges that a 1957 case, In re Stempel, 241 F.2d 755, 759
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`(C.C.P.A. 1957), mandates disqualification of PI-74 and PI-75 as prior art. But,
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`Janssen expands Stempel well beyond its ultimate holding, and fails to account for
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`the facts of this case. Janssen ignores that the CCPA later narrowed the application
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`of Stempel, explaining that “in retrospect” it was “necessary . . . to restrict
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`somewhat certain broad language in Stempel” and relegated it “as applied to the
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`facts.” In re Tanczyn, 347 F.2d 830, 832-33 (C.C.P.A. 1965). In restricting the
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`application of Stempel to its facts, the CCPA noted: (1) that Stempel dealt with an
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`anticipation challenge; and (2) “the reference showed a species of the generic
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`invention being claimed.” Id. at 833. Neither of those facts are present here.
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` First, this IPR relates to obviousness, not anticipation. The CCPA expressly
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`noted that “[a] different situation may prevail when the [challenge] is based upon
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`35 U.S.C. § 103.” Tanczyn, 347 F.2d at 833. That is not surprising as Tancyzn
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`makes clear that a reference used in a § 103 analysis cannot be antedated merely by
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`showing possession of the prior art. Id. (Rule 131 affidavit found ineffective to
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`overcome the prior art used in a § 103 rejection). Second, Janssen does not even
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`argue that PI-74 and PI-75 by themselves disclose a species of the claimed dosing
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`regimen. To the contrary, Janssen notes that they each disclose specific fixed
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`dosage regimens. POPR at 47 (“[PI-74 and PI-75] disclose fixed-dose regimens, in
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`which the amount in each injection is the same for a given patient.”) (emphasis
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`original). Given Stempel’s limited application and the stark factual differences
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`between it and the present case, Janssen’s reliance on Stempel is misplaced.
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` Perhaps recognizing the fallacy of their primary argument, Janssen
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`alternatively asserts that Tanczyn stands for the proposition that “[p]rior possession
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`of something falling within the claims suffices to remove a later reference as prior
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`art.” POPR at 22-23. Janssen alleges that the protocol for clinical trial “PSY-
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`3006”—which is referenced in the ’918 provisional—discloses “what the inventors
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`considered to be an ‘optimized loading dose regimen[],’ namely ‘150 [mg] deltoid
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`(day 1), 100 mg deltoid (day 8), then every 4 weeks maintenance (gluteal or
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`deltoid).’” POPR at 24 (citing ’918 provisional (EX1016) at 28:13-14). Simply put:
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`that is not enough to succeed on its antedation claim. Janssen must demonstrate
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`that the ’918 provisional provides both written description and enablement support
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`for the claimed invention. Frazer v. Schlegel, 498 F.3d 1283, 1287 (Fed. Cir.
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`2007). Janssen has not met that burden. For example, during prosecution, the
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`Examiner stated in the Notice of Allowance, “Applicant has enabled the present
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`treatment [regimens] at least by Example 8 in the specification.” EX1019 at p.
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`295. Example 8 is the only example that provides any efficacy data. Yet, Example
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`8 is not present in the ’918 provisional. EX1012, 30-42 (underline indicates new
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`matter added to the ’276 provisional). That alone undermines reliance on the ’918
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`provisional for antedating purposes.
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` Janssen’s reliance on PSY-3006 fares no better. PSY-3006 was not
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`completed until June 2009, well after the December 2007 ’918 provisional filing
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`date. (EX1049 at 2; see also id. at 6 (identifying PSY-3006)). Thus, PSY-3006
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`cannot provide § 112 support for the claimed invention. Further, Janssen is
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`foreclosed from arguing that Examples 2 and 3 (which are the equivalents of PI-75
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`and PI-74, respectively) provide § 112 support for the claimed invention in light of
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`express statements made in Janssen’s very own POPR. POPR at 45 (the claimed
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`regimen “is not remotely suggested by PI-74 and PI-75”); id. at 59 (“the single-
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`dose Phase I study [of PI-74] provides no information about any dosing regimen,
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`let alone the claimed dosing regimens”); id. at 32 (“nothing in PI-75 indicates that
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`achieving a higher median Cmax, and doing so through deltoid injection, is
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`‘better.’”) Janssen should be held to its word.
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`Finally, it is axiomatic that if Janssen believes the ’918 provisional provides
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`sufficient § 112 support to antedate PI-74 and PI-75, it should have provided an
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`expert declaration with its POPR—written description and enablement are
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`considered from the perspective of the skilled artisan. MPEP §2163 (written
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`description); id. §2164 (enablement). Simply providing attorney argument does
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`nothing to carry Janssen’s burden. Medtronic, IPR2020-00135 at 11; Merck,
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`IPR2020-00040 at 53 (“[A]ttorney argument is not evidence.”).
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`Respectfully submitted,
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`Katten Muchin Rosenman LLP
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`/s/ Jitendra Malik
`Jitendra Malik, Ph.D. (Reg. No. 55823)
`Lead Counsel for Petitioner
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`Date: July 10, 2020
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`CERTIFICATION OF SERVICE ON PATENT OWNER
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`The undersigned certifies that a copy of the foregoing AUTHORIZED
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`REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE, the updated
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`exhibit list and with any associated exhibits was filed and served electronically via
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`the PTAB electronic filing system on July 10, 2020, in its entirety on the
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`following:
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`JANS-INVEGAIPR@akingump.com
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`JanssenInvegaIPR@pbwt.com
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`bmullin@pbwt.com
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`jcho@pbwt.com
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`acohen@pbwt.com
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`Respectfully submitted,
`Katten Muchin Rosenman LLP
`/s/ Jitendra Malik
`Jitendra Malik, Ph.D. (Reg. No. 55823)
`Lead Counsel for Petitioner
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