UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS, INC.
`Petitioner,
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`v.
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`BAYER INTELLECTUAL PROPERTY, GMBH,
`Patent Owner.
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`Case No. IPR2018-01143
`Patent No. 9,539,218
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`PATENT OWNER’S AUTHORIZED SUR-REPLY
`IN SUPPORT OF ITS PRELIMINARY RESPONSE
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`[PUBLICLY FILED VERSION]
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
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`MYLAN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
`BAYER INTELLECTUAL PROPERTY, GMBH,
`Patent Owner.
`
`
`
`Case No. IPR2018-01143
`Patent No. 9,539,218
`
`
`
`PATENT OWNER’S AUTHORIZED SUR-REPLY
`IN SUPPORT OF ITS PRELIMINARY RESPONSE
`
`
`[PUBLICLY FILED VERSION]
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`TABLE OF CONTENTS
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`I. MYLAN’S CLAIM CONSTRUCTION IS UNSUPPORTED ........................... 1
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`II. MYLAN’S § 325(d) ARGUMENTS DO NOT SAVE THE PETITION ........... 2
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`III. MYLAN’S § 312(a)(3) ARGUMENTS DO NOT SAVE THE PETITION ... 5
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`i
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`Case IPR2018-01 I43
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`Patent No. 9, 539, 218
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`Nothing in Petitioner Mylan’s Reply (Paper 8) warrants institution.
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`I.
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`lVIYLAN’S CLAIM CONSTRUCTION IS UNSUPPORTED
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`Contrary to Mylan’s assertion, the proceedings before the District Court do
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`nothing to support the Petition. The District Court construed “rapid-release tablet”
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`as the Board did, i.e., a tablet “which, according to the USP release method using
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`apparatus 2 (paddle). has a Q value (30 minutes) of 75%.” Patent Owner Prelim.
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`Resp. (Paper 6) (“POPR”) at 8-9. Because that construction is based on the
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`express lexicography in the ’2 l 8 patent. it applies irrespective of which claim
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`construction standard is used. Id. at 8 n. 1.
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`As reflected in exhibits filed with the Reply, after Alarlmmn in the District
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`Court. Mylan asserted—for the first time—
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`Patent No. 9,539,218
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`Bayer therefore informed the District Court that the parties disputed what the
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`District Court’s construction meant. Ex. 1066 at 2. Any alleged ambiguity in the
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`District Court’s construction was a result of Mylan’s belated and inconsistent
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`positions, not any action by Bayer. Cf. Reply at 1-2.
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`In response, the District Court ultimately indicated that the parties’
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`disagreement was not a Markman question, but rather appeared to be a “fact
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`decision [for] trial” based on evidence as to what, “as a matter of fact, meets the
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`lexicographic definition.” Ex. 1069 at 1; see also Ex. 1067 at 3.
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`In short, nothing from the District Court supports Mylan’s claim
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`construction arguments in this proceeding. Indeed, Mylan’s proposed
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`interpretation of “rapid-release tablet” in the District Court is
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` than
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`both the construction it proposes for Ground 1, and the construction it employs for
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`Ground 2 as applied in the Petition. See Pet. at 47. Worse still,
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`II. MYLAN’S § 325(d) ARGUMENTS DO NOT SAVE THE PETITION
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`The Reply’s arguments under § 325(d) are misplaced. The issue on remand
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`2
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`from the Board was not the abstract question of “whether the prior art rendered
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`obvious the use of a tablet having a Q value (30 minutes) of 75% in place of a
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`rapid-release liquid that achieved maximum plasma concentrations within 30
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`minutes.” Reply at 4. Rather, in the words of the Examiner, it was whether prior
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`art rendered obvious “a method of treating the claimed thromboembolic disorders
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`comprising administering rivaroxaban” when “a rapid-release tablet is utilized.”
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`Ex. 1004 at 0055 (emphasis added).1 However, Mylan’s Reply (at 3) concedes that
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`Forsman (Ex. 1007), at best, merely “disclos[es] a tablet with the requisite Q value
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`and teaching its use for thromboembolic disorders”—i.e., totally divorced from
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`rivaroxaban. That rapid release tablets were known in other contexts does not
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`explain why such a tablet should be used with rivaroxaban.
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`Moreover, while Bayer disagrees that the Petition provides “new art and
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`evidence” that fills the “gap” identified by the Board, Reply at 3-4, Mylan’s
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`reliance on that allegedly “new art and evidence”—in particular, the declarations
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`of Drs. Benet and Doherty and the Forsman reference—warrants denial given the
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`1 Bayer did not “concede[] Forsman satisfies the rapid-release limitation of
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`claim 1” in the District Court. Cf. Reply at 2. Bayer merely explained that the
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`Petition’s reading of Forsman supports Bayer’s view as to what qualifies as “a Q
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`value (30 minutes) of 75%,”
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` Ex. 1066.
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`3
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`Patent No. 9,539,218
`advanced stage of the District Court case (as reflected in the letters submitted with
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`the Reply). The District Court trial is set for April 1, 2019. Also, Mylan on
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`October 12, 2018 served reports in the District Court from the same experts who
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`submitted declarations here (Drs. Benet and Doherty) and which allegedly fill the
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`“gap” at issue. Those reports rely on the very ’610 Publication, Kubitza Abstracts,
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`and Forsman reference cited in the grounds for the Petition’s § 103 challenges (as
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`well as other references). Further, the same construction of “rapid-release tablet”
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`applies in both forums. Supra at 1. This case is thus on all fours with NHK Spring
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`Co., Ltd. v. Intri-Plex Techs. Inc., IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018),
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`which issued after Bayer filed its POPR. In NHK, the Board agreed that it “would
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`be inefficient” to institute “given the status of the district court proceeding between
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`the parties,” id. at 19, and denied the petition.2 The district court trial in NHK
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`would have taken place well before the IPR could be decided, the same validity
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`issues and art were raised in both forums, and the same claim construction applied
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`2 While this part of NHK was decided in the context of § 314(a), the
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`rationale applies to § 325(d) as well based on the facts here, especially given the
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`issues involved in the prior Board appeal, “the interest of the patent owner in
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`avoiding duplicative challenges,” and the need for “efficient administration of the
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`office.” See Aug. 2018 Trial Practice Guide Update at 11-12 (analyzing § 325(d)).
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`4
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`(because the patent would have expired). Id. at 19-20. That logic applies squarely
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`to this case, as even if trial were instituted, it would not conclude until December
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`2019, well after the district court trial addressing the validity issues raised here.
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`III. MYLAN’S § 312(a)(3) ARGUMENTS DO NOT SAVE THE PETITION
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`The Reply’s arguments under § 312(a)(3) are unavailing. That the Kubitza
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`Abstracts are part of the same volume of abstracts does not cure the Petition’s
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`flaws. Cf. Reply 4-5. Nor do Mylan’s efforts to distinguish various cases cited in
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`the POPR. Id. What Mylan cannot refute is the basic principle of those cases: a
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`petition cannot ambiguously refer to multiple references in the aggregate, as Mylan
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`does, and leave the Board and the patent owner to guess what particular
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`combination of references is intended for each limitation. Indeed, Mylan’s efforts
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`to distinguish Google, CBM2016-00021, Paper 11, and Enovate, IPR2015-00300,
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`Paper 12, ring especially hollow. While Mylan asserts that it did not combine
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`separate documents into a single exhibit in violation of 37 C.F.R. § 42.6(a)(3),
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`neither the POPR nor those cases rely on that regulation. Cf. Reply 5. Rather, by
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`treating multiple references as if they were one, the petitioners in those cases failed
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`to sufficiently articulate their challenges. Finally, Mylan’s affirmative reliance on
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`Ford, IPR2015-00800, Paper 12, is unfounded. The Ford petitioner was allowed
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`to proceed on certain references because the teachings of the first four were
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`“adopted for use” in the fifth. Id. at 12-17. No such circumstance is present here.
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`5
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`Dated: October 29, 2018
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`Case IPR2018-01143
`Patent No. 9,539,218
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`Respectfully submitted,
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`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for Patent Owner
`Williams & Connolly LLP
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`725 Twelfth St. NW
`Washington, DC 20005
`Telephone: 202-434-5812
`Facsimile: 202-434-5029
`Email: dgrossman@wc.com
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`6
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`Case IPR2018-01143
`Patent No. 9,539,218
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`CERTIFICATE OF SERVICE
`(37 C.F.R. § 42.6(e))
`The undersigned hereby certifies that the document above was served on
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`this 29th day of November, 2018, on Petitioner by delivering a copy via electronic
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`mail to the following individuals at the email addresses below:
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`Steven W. Parmelee
`Reg No. 31,990
`sparmelee@wsgr.com
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`Michael T. Rosato
`Reg. No. 52,182
`mrosato@wsgr.com
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`Jad A. Mills
`Reg. No. 63,344
`jmills@wsgr.com
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`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue
`Suite 5100
`Seattle, WA 98104-7036
`P: 206-883-2542
`F: 206-883-2699
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`Date: November 29, 2018
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`/Dov P. Grossman/
`Dov P. Grossman
`Registration No. 72,525
`Lead Counsel for Patent Owner
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