IPR2018-01183
`Patent No. 6,943,166
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`______________________
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`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner
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`v.
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`ICOS CORPORATION,
`Patent Owner.
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`______________________
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`IPR2018-01183
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`Patent No. 6,943,166
`______________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`Patent No. 6,943,166
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
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`
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`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner
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`v.
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`ICOS CORPORATION,
`Patent Owner.
`
`______________________
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`
`IPR2018-01183
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`Patent No. 6,943,166
`______________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`TABLE OF CONTENTS
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`IPR2018-01183
`Patent No. 6,943,166
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`TABLE OF AUTHORITIES .................................................................................... ii
`TABLE OF ABBREVIATIONS ............................................................................. iv
`I.
`Introduction and Summary .............................................................................. 1
`II.
`Aquestive’s 18-Months Later Follow-On Petition Should Be Denied
`under 35 U.S.C. § 314(a) ................................................................................. 5
`1.
`Aquestive Unsuccessfully Challenged All Claims in the First IPR ...... 5
`2.
`Aquestive Knew or Should Have Known of the Asserted
`References Before Filing the First Petition ........................................... 6
`Aquestive Used the First IPR As A Roadmap ...................................... 9
`Aquestive Delayed Twice as Long as in General Plastic ................... 13
`Aquestive Failed to Explain Its Delay ................................................ 14
`A.
`Panduit Fails to Justify Aquestive’s Delay............................... 15
`B.
`Ruberg Fails to Justify Aquestive’s Delay ............................... 16
`C. Mylan IPR Fails to Justify Aquestive’s Delay ......................... 17
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`3.
`4.
`5.
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`Aquestive Did Not “Adopt” the Mylan Petition ................................. 19
`6.
`III. The Board Should Deny the Second Petition under § 325(d) ....................... 21
`IV. Conclusion ..................................................................................................... 26
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`i
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`TABLE OF AUTHORITIES
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`IPR2018-01183
`Patent No. 6,943,166
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`Page(s)
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`Federal Cases
`PGS Geophysical AS v. Iancu,
`891 F.3d 1354 (Fed. Cir. 2018) .......................................................................... 19
`SAS Institute, Inc. v. Iancu,
`138 S. Ct. 1348 (2018) ........................................................................................ 19
`Patent Trial and Appeal Board Cases
`Adva Optical Networking, Inc., v. Rad Data Comms. Ltd.,
`IPR2016-01848, Paper 6 (PTAB March 9, 2017) .............................................. 22
`Alcatel-Lucent USA Inc. v. Oyster Optics, LLC,
`IPR2018-00257, Paper 14 (PTAB June 4, 2018) .......................................... 9, 17
`Alere Inc. v. Rembrandt Diagnostics, LP,
`IPR2017-01130, Paper 10 (PTAB Sept. 28, 2017) ............................................... 8
`Becton Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (informative) ......................... 26
`Conopco, Inc. v. Proctor & Gamble Co.,
`IPR2014-00628, Paper 21 (PTAB Oct. 20, 2014) .............................................. 12
`Cultec, Inc. v. StormTech LLC,
`IPR2017-00777, Paper 7 (PTAB Aug. 22, 2017) (informative) ................... 4, 26
`FedEx Corp. v. Intellectual Ventures II LLC,
`IPR2017-02039, Paper 9 (PTAB Feb. 21, 2018) ................................. 6, 9, 12, 14
`Fisher & Paykel Healthcare Ltd. v. Resemed Ltd.,
`IPR2017-02003, Paper 8 (PTAB March 12, 2018) .............................................. 6
`General Plastic Industrial Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) (§ II.B.4.i.
`Precedential) ............................................................................................... passim
`
`
`
`ii
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`IPR2018-01183
`Patent No. 6,943,166
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`LG Elecs. Inc. v. Core Wireless Licensing S.A.R.L.,
`IPR2016-00986, Paper 12 (PTAB Aug. 22, 2016) ...................................... 19, 21
`Neil Ziegmann, N.P.Z., Inc. v. Stephens,
`IPR2015-01860, Paper 11 (PTAB Feb. 24, 2016) .............................................. 25
`NetApp Inc. v. Realtime Data LLC,
`IPR2017-01195, Paper 9 (PTAB Oct. 12, 2017) .................................................. 8
`NVIDIA Corp. v. Samsung Elecs. Co., Ltd.,
`IPR2016-00134, Paper 9 (PTAB May 4, 2016) ................................................. 14
`Omron Oilfield & Marine, Inc. v. MD/TOTCO,
`IPR2013-00265, Paper 11 (PTAB Oct. 31, 2013) .............................................. 25
`Panduit Corp. v. CCS Technology, Inc.,
`IPR2017-01375, Paper 8 (PTAB Nov. 8, 2017) .......................................... 15, 16
`Toyota Motor Corp. v. Am. Vehicular Sciences LLC,
`IPR2015-00261, Paper 10 (PTAB Jan. 29, 2015) .............................................. 20
`Toyota Motor Corp. v. Cellport Sys. Inc.,
`IPR2015-01423, Paper 7 (PTAB Oct. 28, 2015) ........................................ passim
`Unified Patents Inc. v. Berman,
`IPR2016-01571, Paper 10 (PTAB Dec. 14, 2016) (informative) ................ 25, 26
`ZTE Corp. v. Adaptix, Inc.,
`IPR2015-01184, Paper 10 (PTAB July 24, 2015) .............................................. 20
`ZTE Corp. v. ContentGuard Holdings Inc.,
`IPR2013-00454, Paper 12 (PTAB Aug. 25, 2013) (informative) ................. 4, 21
`Federal Statutes
`35 U.S.C. § 314(a) ........................................................................................... passim
`35 U.S.C. § 316(a)(11) ............................................................................................. 18
`35 U.S.C. § 325(d) ........................................................................................... passim
`Regulations
`37 C.F.R. § 42.122(b) .............................................................................................. 18
`iii
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`IPR2018-01183
`Patent No. 6,943,166
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`TABLE OF ABBREVIATIONS
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`Explanation
`Ex. 1016
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`refers collectively to Daugan ’329 and ’675
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`Ex. 1003
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`Ex. 1005
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`Ex. 1014
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`Abbreviation
`Cutler
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`Daugan
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`Daugan ’329
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`Daugan ’675
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`FDA Guideline
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`First Institution Decision
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`First IPR
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`First Petition
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`IPR2017-00412, Paper 11
`IPR2017-00412
`IPR2017-00412, Paper 4
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`First Preliminary Response
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`IPR2017-00412, Paper 9
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`First Rehearing Request
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`IPR2017-00412, Paper 12
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`First Rehearing Decision
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`IPR2017-00412, Paper 18
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`First Williams Declaration
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`IPR2017-00412, Ex. 1010
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`Ruberg
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`Second Petition
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`SNDA
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`Ex. 1018
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`Paper 1
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`Ex. 1011
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`iv
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`I.
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`IPR2018-01183
`Patent No. 6,943,166
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`Introduction and Summary
`This is Petitioner’s (“Aquestive”) second petition against U.S. Patent No.
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`6,943,166 (“’166 patent”). (Paper 1 (“Second Petition”) at 1-2.) Its first petition
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`was filed eighteen months earlier, under Petitioner’s former name “MonoSol.” (Id.;
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`IPR2017-00412 (“First IPR”), Paper 4 (“First Petition”).) Following a detailed
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`Patent Owner’s Preliminary Response, the First Petition was denied on the merits
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`because “Petitioner ha[d] not established a reasonable likelihood that it would
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`prevail in showing the unpatentability of at least one challenged claim.” (IPR2017-
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`00412, Paper 9 (“First Preliminary Response”); IPR2017-00412, Paper 11 (“First
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`Institution Decision”) at 2, 9-11.) Aquestive’s Second Petition should likewise be
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`denied, this time under 35 U.S.C. §§ 314(a) and 325(d).
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` “[T]he potential for abuse of the review process by repeated attacks on
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`patents,” such as Aquestive’s Second Petition here, was addressed in General Plastic
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`Industrial Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 15-19
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`(PTAB Sept. 6, 2017) (§ II.B.4.i. Precedential) (“General Plastic”). As explained,
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`denying institution of a follow-on petition under § 314(a) may be warranted because
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`“[m]ultiple, staggered petitions challenging the same patent and same claims raise
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`the potential for abuse . . . this is unfair to patent owners and is an inefficient use of
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`the inter partes review process and other post-grant review processes.” Id. at 17-18.
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`Here, Aquestive’s eighteen-month delay is even more egregious and unjustified than
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`1
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`the comparatively short nine-month delay in General Plastic. Id. at 10.
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`IPR2018-01183
`Patent No. 6,943,166
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`One of the recognized abuses of follow-on petitions is that they “allow
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`petitioners the opportunity to strategically stage their prior art and arguments in
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`multiple petitions, using [the Board’s] decisions as a roadmap, until a ground is
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`found that results in the grant of review.” Id. at 17. This improper roadmapping is
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`clear in Aquestive’s Second Petition.
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`For instance, in denying institution of the First Petition, the Board explained
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`that Aquestive could not rely on alleged “common sense” to teach the claimed
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`tadalafil “maximum daily dosage” and that Aquestive did “not point to any other
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`persuasive evidence to account for the claimed limitation.” (First Institution
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`Decision at 9.) Rejecting Aquestive’s contention that it had overlooked evidence
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`and misapprehended the prior art (IPR2017-00412, Paper 12 (“First Rehearing
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`Request”) at i, 3, 10), the Board further explained that the First Petition lacked
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`evidence “provid[ing] [a] detailed analysis of the tadalafil dosage” as claimed in the
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`’166 patent (IPR2017-00412, Paper 18 (“First Rehearing Decision”) at 5-6).
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`Aquestive relied on this guidance, newly asserting in the Second Petition, for
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`example, a hypothesized 15 mg daily dose of tadalafil to “satisf[y] each of the
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`limitations of claim 1.” (Second Petition at 42-43.)
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`Aquestive provides no meaningful explanation for its eighteen-month delay.
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`Although ultimately found insufficient, the petitioner in General Plastic at least
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`explained that “it had found new prior art as a result of two later searches.” General
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`Plastic at 10. By contrast, Aquestive merely asserts that “the Ruberg reference [Ex.
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`1018] was not previously known to Aquestive (or MonoSol) until a few weeks ago.”
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`(Second Petition at 5.) This does not even purport to explain how or why Aquestive
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`became aware of Ruberg or “explain why a reasonably diligent search could not
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`have uncovered the newly applied prior art” (General Plastic at 20). Notably,
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`Ruberg had been available for two decades, including one decade online for
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`immediate download, prior to the First Petition. (Ex. 1018 at 1018-0001.)
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`Aquestive’s assertion that joinder with an earlier filed IPR was “legally impossible”
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`(Second Petition at 5) is both inaccurate and irrelevant to explaining Aquestive’s
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`long delay.
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`Aquestive’s Second Petition presents an additional reason for denial,
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`specifically under § 325(d), that goes beyond General Plastic. In that case, the
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`grounds asserted in the follow-on petitions were principally based on entirely new
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`references, repeating the previously asserted “Matsuoka” only as a secondary
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`reference in some grounds. General Plastic at 6-8. The consideration under
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`§ 325(d) as to whether “the same or substantially the same prior art or arguments
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`previously were presented to the Office” did not apply. See id. at 19 (rejecting
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`petitioner’s argument that § 325(d) is “the sole factor in the exercise of discretion
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`under § 314(a)”).
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`3
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`Here, by contrast, the Second Petition is based on “the same or substantially
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`IPR2018-01183
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`the same prior art or arguments [that] previously were presented to the Office”
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`(§ 325(d)) during prosecution and in the denied First Petition. Denial of institution
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`under § 325(d) is appropriate for such recycled arguments. Cultec, Inc. v. StormTech
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`LLC, IPR2017-00777, Paper 7 at 12-13 (PTAB Aug. 22, 2017) (informative)
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`(denying institution under § 325(d) where cited references were cumulative of prior
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`art considered during examination); see also ZTE Corp. v. ContentGuard Holdings
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`Inc., IPR2013-00454, Paper 12 at 5, 7-8 (PTAB Aug. 25, 2013) (informative)
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`(denying institution under § 325(d) of a second-filed petition that “present[ed] the
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`same or substantially the same prior art or arguments” as a previously-denied, first-
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`filed petition).
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`Although Aquestive recycles the primary Daugan1 reference from prosecution
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`and the First Petition, Aquestive does not even mention the § 325(d) standard, much
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`less dispute its applicability here as an independent reason to deny institution. The
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`only new reference in the Second Petition—Ruberg—is used in just one ground
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`(Ground 3) and is cumulative of references used in the First Petition for the generic
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`concept of dose optimization. (E.g., Second Petition at 53-54; First Petition at 11.)
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`1 “Daugan” refers collectively to Daugan ’675 (Ex. 1005) and Daugan ’329 (Ex.
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`1003), the U.S. equivalent of Daugan ’675 addressed during prosecution.
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`4
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`Petitioner’s eighteen-month-delayed attempt at a second bite thus violates the
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`IPR2018-01183
`Patent No. 6,943,166
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`intents of both 35 U.S.C. § 314(a) and 35 U.S.C. § 325(d). For the reasons explained
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`further below, Aquestive’s Second Petition should be denied.
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`II. Aquestive’s 18-Months Later Follow-On Petition Should Be
`Denied under 35 U.S.C. § 314(a)
`In General Plastic, the expanded panel enumerated seven non-exhaustive
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`factors for denying institution of follow-on petitions under § 314(a). General Plastic
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`at 15-19. These factors consider the potential for abuse, undue prejudice to patent
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`owners, and waste of resources that follow-on petitions may engender. Id. at 16-17.
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`Here, all seven General Plastic factors strongly favor denying institution of
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`Aquestive’s Second Petition. Although Aquestive acknowledges these factors, it
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`addresses none directly. (Second Petition at 3-5.)
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`Aquestive Unsuccessfully Challenged All Claims in the First IPR
`1.
`Factor 1 concerns “whether the same petitioner previously filed a petition
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`directed to the claims of the same patent.” General Plastic at 16. This factor points
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`directly to denying institution here, as Aquestive filed a previous petition—eighteen
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`months before its petition in this IPR—directed to the same claims of the ’166 patent.
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`Specifically, Aquestive filed its First Petition on December 6, 2016, seeking
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`inter partes review of all claims of the ’166 patent. Patent Owner filed its First
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`Preliminary Response on April 6, 2017 and the Board denied institution on July 3,
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`5
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`2017. That decision was on the merits, as “Petitioner ha[d] not established a
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`IPR2018-01183
`Patent No. 6,943,166
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`reasonable likelihood that it would prevail in showing the unpatentability of at least
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`one challenged claim.” (First Institution Decision at 2, 11 (“In sum, based on the
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`current record, we conclude Petitioner has not established a reasonable likelihood it
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`would prevail in showing that any challenged claim would have been obvious over
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`Daugan, (1) alone, (2) in combination with the Guideline for Industry, or (3) in
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`combination with the FDA Petition.”).)
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`Because “[e]ach of the claims Petitioner challenges now was challenged
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`previously by Petitioner in the [First IPR] . . . this factor weighs against institution.”
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`FedEx Corp. v. Intellectual Ventures II LLC, IPR2017-02039, Paper 9 at 8 (PTAB
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`Feb. 21, 2018); Fisher & Paykel Healthcare Ltd. v. Resemed Ltd., IPR2017-02003,
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`Paper 8 at 13 (PTAB March 12, 2018).
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`2.
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`Aquestive Knew or Should Have Known of the Asserted
`References Before Filing the First Petition
`Factor 2 concerns “whether at the time of filing of the first petition the
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`petitioner knew of the prior art asserted in the second petition or should have known
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`of it” and also favors denial of the Second Petition. General Plastic at 16, 19-20.
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`Aquestive demonstrably knew of four of the references asserted in the Second
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`Petition—Daugan ’675 (Ex. 1005), SNDA (Ex. 1011), the FDA Guideline (Ex.
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`6
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`1014), and Cutler (Ex. 1016)—having cited all of these in the First Petition.2
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`IPR2018-01183
`Patent No. 6,943,166
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`Aquestive’s unexplained assertion that the cumulative fifth reference, Ruberg (Ex.
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`1018), “was not previously known to Aquestive (or MonoSol) until a few weeks
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`ago” and that Aquestive “filed the current petition soon after learning of and
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`reviewing [Ruberg]” (Second Petition at 5) is insufficient to tip Factor 2 in
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`Aquestive’s favor. Instead, the facts here point strongly in favor of denying
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`institution.
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`First, as held in General Plastic, Factor 2 favors denial even where, as here,
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`the petitioner asserts that a reference has been newly discovered but “provide[s] no
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`meaningful explanation for the delay in filing the follow-on petition[].” General
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`Plastic at 10-11, 19-20. Aquestive’s failure to present any evidence that it could not
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`have located Ruberg earlier is sufficient to find that Factor 2 weighs in favor of
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`2 (1) Daugan ’675 (First Petition at i-ii, 6-7); (2) SNDA (First Petition at ii
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`(identifying Ex. 1011 as “Excerpt from Viagra Approval Pkg”): IPR2017-00412,
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`Ex. 1010 (“First Williams Declaration”) ¶ 71 (citing “Ex. 1011, Excerpt from
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`Sildenafil Approval Package, Table 1”); see also First Rehearing Request at 13
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`(“Petitioner MonoSol also submitted and relied upon the exact same evidence [as
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`the Mylan Petition]: . . . (2) the SNDA (submitted as Petitioner’s Ex. 1011)”)); (3)
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`FDA Guideline (First Petition at i-ii, 6-7); and (4) Cutler (First Petition at ii, 11).
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`7
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`denial. Id.; see also NetApp Inc. v. Realtime Data LLC, IPR2017-01195, Paper 9 at
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`IPR2018-01183
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`12 (PTAB Oct. 12, 2017) (denying institution where “[t]he record also contains no
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`evidence that NetApp could not have located Kitagawa (a U.S. patent) at an earlier
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`date”); Toyota Motor Corp. v. Cellport Sys. Inc., IPR2015-01423, Paper 7 at 8
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`(PTAB Oct. 28, 2015) (“Petitioner presents no argument or evidence that CAN was
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`not known or available to Petitioner at the time of filing of the Petition in IPR2015-
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`00634.”).
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`Second, Aquestive could have found Ruberg prior to the First Petition if it had
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`exercised reasonable diligence. Ruberg was published online and available for
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`immediate download in 2007, and originally published in the Journal of
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`Biopharmaceutical Statistics in 1995, i.e., one and two decades before the First
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`Petition. (Ex. 1018 at 1018-0001.) See Alere Inc. v. Rembrandt Diagnostics, LP,
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`IPR2017-01130, Paper 10 at 8 (PTAB Sept. 28, 2017) (denying a follow-on petition
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`where the newly relied upon references “were published at least 14 and 22 years,
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`respectively,” before the first petition).
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`Finally, as discussed below, Aquestive has not explained how or why Ruberg
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`is substantively and meaningfully different from the other references it presented to
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`the Office in the First Petition, including, for example, the FDA Guideline. (Infra,
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`§ III.) To the contrary, it is clearly cumulative, such that Aquestive’s failure to
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`discover Ruberg previously is irrelevant. See Alcatel-Lucent USA Inc. v. Oyster
`8
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`Optics, LLC, IPR2018-00257, Paper 14 at 21, 25 (PTAB June 4, 2018) (“Further,
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`IPR2018-01183
`Patent No. 6,943,166
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`Petitioner has also not explained why Corke is not merely cumulative of Corke ’917,
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`in which case a later discovery of Corke would not justify another filing.”).
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`Aquestive Used the First IPR As A Roadmap
`3.
`Factor 3 considers “whether at the time of filing of the second petition the
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`petitioner already received the patent owner’s preliminary response to the first
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`petition or received the Board’s decision on whether to institute review in the first
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`petition.” General Plastic at 16-18 & n.14. Here, Aquestive not only filed its
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`Second Petition after receiving the First Preliminary Response, the First Institution
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`Decision, and the First Rehearing Decision, it used those papers as a roadmap to
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`modify the art and arguments asserted in its Second Petition. Instituting such a
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`strategically-delayed follow-on petition would be unfair to Patent Owner and an
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`inefficient use of inter partes review proceedings. See id. at 17-18 & n.14 (collecting
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`cases); FedEx Corp., IPR2017-02039, Paper 9 at 9-10.
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`Aquestive’s improper use of the First IPR as a roadmap is clear. Specifically,
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`in its First Petition, Aquestive argued that the higher potency of tadalafil as
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`compared to sildenafil generally motivated towards “lower doses” of tadalafil. (First
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`Petition at 15-16; First Williams Declaration ¶ 187 (citing SNDA).) In response,
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`Patent Owner:
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`9
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`IPR2018-01183
`Patent No. 6,943,166
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`1) demonstrated that “[n]othing ties [Aquestive’s] vague assertion of a
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`‘lower dose’ to a reasonable expectation that 20 mg would be the
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`maximum tadalafil dose,” as claimed (First Preliminary Response at 28,
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`38-39);
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`2) showed that the FDA Guideline provides only “general guidance” that
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`“is not specific to any particular drug, any particular dose, or any
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`particular treatment” and “therefore provides no more reasonable
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`expectation of success in achieving the claimed dosing regimen than
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`Daugan alone” (id. at 29); and
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`3) noted that Aquestive failed to address the level of ordinary skill in the
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`art (id. at 10) and failed to submit SNDA as an exhibit (id. at 26 n.8
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`(noting that Exhibit 1011 in IPR2017-00412 is a second copy of the
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`First Williams Declaration)).
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`The Board agreed with Patent Owner, finding that:
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`[t]he teachings of the asserted prior art, at best, provide
`“general guidance” to identify a maximum daily dosage of
`tadalafil. Petitioner does not point to any other persuasive
`evidence to account for the claimed limitation. Instead,
`Petitioner relies on “common sense.” See, e.g., Pet. 9, 21,
`36. Common sense, however, “cannot be used as a
`wholesale substitute for reasoned analysis and evidentiary
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`10
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`IPR2018-01183
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`support, especially when dealing with a limitation missing
`from the prior art references specified.
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`(First Institution Decision at 9-11.) On this basis, the Board was “not persuaded
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`that the challenged claims would have been obvious over Daugan, in combination
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`with either the Guideline for Industry, or the FDA Petition.” (Id. at 10; see also
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`First Rehearing Decision at 4-6.)
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`Having had the benefit of these analyses, Aquestive seeks to cure the
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`previously identified deficiencies of its First Petition. For example, Aquestive now
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`asserts an argument—albeit hindsight-driven and contradictory3—for a
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`hypothesized 15 mg maximum tadalafil dose. (Compare First Petition at 15-16 and
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`First Williams Decl. ¶ 187, with Second Petition at 39-40, 42-43.) Aquestive’s
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`creation of a hypothetical 15 mg maximum dose not taught or suggested in the art is
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`3 According to Aquestive’s overly-simplistic scaling theory (see Second Petition at
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`41; Ex. 1010 ¶¶ 115-116, 164), the maximum dose of tadalafil actually would be 60
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`mg/day—i.e., three-fifths of the FDA approved maximum sildenafil dose of 100
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`mg—and outside the claims, rather than 15 mg based on Aquestive’s hindsight-
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`driven selection of sildenafil’s lowest approved dose of 25 mg (see Ex. 1010 ¶¶ 20
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`(citing Ex. 1006), 115-116, 120, 127, 130, 134-136, 164, 166-167, 169).
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`11
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`clearly an attempt to address the Board’s finding that “[t]he teachings of the asserted
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`IPR2018-01183
`Patent No. 6,943,166
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`prior art, at best, provide ‘general guidance’ to identify a maximum daily dosage of
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`tadalafil.” (First Institution Decision at 9-10; First Rehearing Decision at 4-5.)
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`Furthermore, Aquestive made the strategic decision to not include SNDA in
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`its proposed grounds in the First Petition. (Supra, § II.2.) Now, attempting to fill
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`holes in its First Petition, Aquestive includes SNDA in all three of its proposed
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`grounds. (Second Petition at 32.) Aquestive should not be permitted to revisit its
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`prior strategic decision based on guidance from the First IPR. See Conopco, Inc. v.
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`Proctor & Gamble Co., IPR2014-00628, Paper 21 at 11 (PTAB Oct. 20, 2014)
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`(discouraging filing a first petition that holds back prior art for use in later attacks
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`against the same patent if the first petition is denied); FedEx Corp., IPR2017-02039,
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`Paper 9 at 9-10 (finding that factor three weighed against institution because the
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`petitioner “used both the prior preliminary response and our Institution Decision as
`
`a roadmap for selecting references for the present Petition”).
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`As another example of Aquestive’s reliance on the First IPR, Aquestive now
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`attempts to address the level of ordinary skill in the art, which it failed to do in the
`
`First Petition. (See First Petition; First Preliminary Response at 10.) Leaving aside
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`Aquestive’s failure to properly articulate and support its definition of the level of
`
`
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`12
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`
`
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`ordinary skill in the art,4 this, too, is a belated attempt by Aquestive to cure the
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`IPR2018-01183
`Patent No. 6,943,166
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`deficiencies of its First Petition identified by Patent Owner. (See First Preliminary
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`Response at 10.)
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`In sum, Factor 3 weighs strongly in favor of denying institution because (i)
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`Aquestive willfully delayed filing the Second Petition until after it received the First
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`Preliminary Response, the First Institution Decision, and the First Rehearing
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`Decision, and (ii) Aquestive used those papers as a roadmap to modify its asserted
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`art and arguments.
`
`Aquestive Delayed Twice as Long as in General Plastic
`4.
`Factor 4 concerns “the length of time that elapsed between the time the
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`petitioner learned of the prior art asserted in the second petition and the filing of the
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`second petition.” General Plastic at 16-17.
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`Here, as discussed above, Aquestive knew of Daugan ’675, SNDA, the FDA
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`Guideline, and Cutler when it filed the First Petition and should have known of
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`
`4 Aquestive partially copies Mylan’s definition of the level of ordinary skill, which
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`was based on the testimony of Mylan’s declarants, but cites its own declarant, Dr.
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`Williams, who provides a completely different definition. (Compare Second Petition
`
`at 23 (citing Ex. 1010 ¶¶ 90-91), with IPR2017-00323 Paper 2 at 15-16 (citing
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`IPR2017-00323, Ex. 1002 ¶¶ 38-39 and IPR2017-00323, Ex. 1004 ¶¶ 24-25.)
`
`
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`13
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`
`
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`Ruberg as well. (Supra, § II.2.) Nevertheless, Aquestive delayed eighteen months—
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`IPR2018-01183
`Patent No. 6,943,166
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`from December 6, 2016 until June 6, 2018—before filing the Second Petition. This
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`is twice as long as the delay in General Plastic and more than three times longer
`
`than in other cases where the Board denied institution under § 314(a). See, e.g.,
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`General Plastic at 10-11 (9-month delay); FedEx Corp., IPR2017-02039, Paper 9 at
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`10 (5.5-month delay); NVIDIA Corp. v. Samsung Elecs. Co., Ltd., IPR2016-00134,
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`Paper 9 at 8-9, 11-12 (PTAB May 4, 2016) (5-month delay). Petitioner does not
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`cite, and Patent Owner is unaware of, any case instituting a follow-on petition
`
`delayed as long as Aquestive’s Second Petition (i.e., eighteen months).
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`Further, even assuming, counterfactually, that joinder with the Mylan petition
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`became “legally impossible” as of the parties’ July 7, 2017, motion to terminate, as
`
`Aquestive asserts (Second Petition at 5), that does not explain why Aquestive
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`delayed another eleven months before filing the Second Petition, which purports to
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`“adopt” Mylan’s arguments and evidence. (Infra, §§ II.5.C, II.6.) Indeed, if the
`
`Second Petition merely “adopted” Mylan’s arguments and evidence, there is no
`
`reason why Aquestive could not have filed it as a standalone petition in July 2017.
`
`Factor 4 thus weighs strongly in favor of denying institution.
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`Aquestive Failed to Explain Its Delay
`5.
`Factor 5 considers “whether the petitioner provides adequate explanation for
`
`the time elapsed between the filings of multiple petitions directed to the same claims
`
`
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`14
`
`
`
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`of the same patent.” General Plastic at 16-17. Although it failed to specifically
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`IPR2018-01183
`Patent No. 6,943,166
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`address this factor, none of Aquestive’s purported justifications withstands scrutiny.
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`Panduit Fails to Justify Aquestive’s Delay
`A.
`Rather than addressing the General Plastic factors, Aquestive attempts an
`
`inapt analogy with Panduit Corp. v. CCS Technology, Inc., IPR2017-01375, Paper
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`8 (PTAB Nov. 8, 2017) (“Panduit”). But the two “particular circumstances” in
`
`Panduit (id. at 9-10) that justified a follow-on petition directed to previously non-
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`instituted claims (6 and 11) weigh against institution of Aquestive’s Second Petition.
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`First, Panduit noted that “the particular facts of this case,” where the Board
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`had not addressed the merits of claims 6 and 11 when previously denying institution
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`on evidentiary grounds, “do not present a situation in which Petitioner is ‘using our
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`decisions as a roadmap.’” Id. Here, by contrast, the First Institution Decision and
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`the First Rehearing Decision addressed the merits and Aquestive used them as a
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`roadmap for the Second Petition. (Supra, § II.3.)
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`Second, as an apparent mitigating factor, Panduit held that “Petitioner’s
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`reliance on TIA Technical in its first petition [as art against claims 6 and 11] was not
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`unreasonable” even though the Board ultimately held its public accessibility had not
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`been established. Panduit at 9-10. Here, opposite of Panduit, the Board found that
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`Aquestive’s reliance on certain references in the First Petition was unreasonable:
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`“[o]n its face, neither Exhibit 1018 nor Exhibit 1019 appears to [have been] in
`
`
`
`15
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`
`
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`existence before the [April 30, 1999,] priority date of the ’166 patent.” (First
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`IPR2018-01183
`Patent No. 6,943,166
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`Institution Decision at 10-11 (emphasis added) (further noting, inter alia, that Ex.
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`1018 “refers, in the past tense, to studies conducted in 2000 and 2001, and to meeting
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`minutes dated in 2002”).)
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`Additionally, Panduit cannot justify Aquestive’s eighteen-month delay in
`
`filing the Second Petition. To the contrary, whereas the petitioner in Panduit filed
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`its follow-on petition three months after receiving the Board’s partially-adverse
`
`institution decision in the first-filed IPR (see IPR2016-01648, Paper 8 (Feb 8, 2017);
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`IPR2017-01375, Paper 2 (May 5, 2017)), Aquestive delayed more than three times
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`longer. Thus, even if the two “particular circumstances” considered in Panduit
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`weighed in Aquestive’s favor—they do not—Aquestive’s unexplained delay
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`remains unreasonable.
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`B. Ruberg Fails to Justify Aquestive’s Delay
`The Second Petition next asserts that Ruberg “was not previously known to
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`Aquestive (or MonoSol) until a few weeks ago” and that “[Aquestive] filed the
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`current petition soon after learning of and reviewing [Ruberg].” (Second Petition at
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`5.) These vague assertions provide no meaningful explanation for Aquestive’s
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`eighteen-month delay. See General Plastic at 10-11, 19-20; Toyota v. Cellport,
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`IPR2015-01423, Paper 7 at 7-8.
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`16
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`
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`First, as discussed above, Aquestive failed to explain why it could not have
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`IPR2018-01183
`Patent No. 6,943,166
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`
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`found Ruberg sooner through the exercise of reasonable diligence. (Supra, § II.2.)
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`Second, as noted above and discussed below, Aquestive failed to explain how or
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`why Ruberg is substantively and meaningfully different from the other references it
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`previously presented to the Office in the First Petition, including, for example, the
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`FDA Guideline. (Supra, § II.2.; Infra, § III.) See Alcatel-Lucent, IPR2018-00257,
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`Paper 14 at 21, 25. Third, Aquestive also failed to explain why it could not have
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`presented grounds 1 and 2—neither of which includes Ruberg—sooner. See id. at
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`23 (“Petitioner has not provided any explanation for why it waited until this Petition
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`to assert the three grounds that do not involve Moulton (Grounds 2a, 2b, 2c).”).
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`Giving Aquestive a second bite at the apple under these circumstances would
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`be unfair to Patent Owner and a waste of the Board’s resources. See Toyota v.
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`Cellport, IPR2015-01423, Paper 7 at 7-8 (“Without explanation, Petition[er] seeks
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`another opportunity to challenge the same claims on essentially the same grounds,
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`albeit not based on the identical set of prior art references. Such a second bite at the
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`apple wastes the Board’s limited resources and imposes undue burden on the Patent
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`Owner.”).
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