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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners
`
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`Case IPR2019-00207
`Patent 9,517,219
`
`PATENT OWNER ALMIRALL, LLC’S SUR-REPLY
`PURSUANT TO ORDER [PAPER 9]
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`
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`
`TABLE OF CONTENTS
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`Institution Should Be Denied Under § 314(a) ..................................................... 2
`I.
`II. Institution Should Be Denied Under § 325(d) ..................................................... 4
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`Page
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`i
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
`Abiomed, Inc. et al. v. Maquet Cariovascula, LLC (Abiomed 2),
`IPR2017-02134, Paper 7 ....................................................................................... 3
`Becton, Dickenson and Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 ....................................................................................... 5
`Hologic, Inc. v. Biomerieux, Inc.,
`IPR2018-00566, Paper 9 ....................................................................................... 5
`NetApp Inc. v. Realtime Data LLC,
`IPR2017-01195, Paper 9 ................................................................................... 1, 3
`OTHER AUTHORITIES
`77 Fed. Reg. 48,680, 48,689 (Aug. 14, 2012) ........................................................... 2
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`ii
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`PATENT OWNER’S EXHIBIT LIST
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`Exhibit No.
`2001
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`2002
`
`2003
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`2004
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`2005
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`2006
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`
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`Description
`International Patent Application Publication No. WO 2009/108147
`(“Garrett 2”)
`International Patent Application Publication No. WO 2010/105052
`(“Hani”)
`Redline Comparison of Petitions in IPR2018-00608 and
`IPR2019-00207
`Redline Comparison of Michniak-Kohn Declarations in
`IPR2018-00608 and IPR2019-00207
`Redline Comparison of Gilmore Declarations in IPR2018-00608
`and IPR2019-00207
`Petitioner’s Notice of Paragraph IV Certification to PO
`(February 22, 2019) (truncated)
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`iii
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`
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`IPR2019-00207
`Patent Owner’s Sur-Reply
`
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`The issue before the Board remains whether it should exercise its denial
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`discretion under §§ 314(a) and/or 325(d). This Petition presents the opportunity for
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`the Board to clarify that AIA proceedings are not test-vehicles to be gamed or
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`gimmicked – not least by Petitioners, as here, maintaining parallel validity
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`challenges under the Hatch-Waxman scheme.
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`Two paramount questions remain unmeaningfully answered by Petitioner:
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`(1) what explains its delay in bringing this Petition relative to the earlier-instituted,
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`virtually identical IPR of its ’926 parent?; and (2) where does the Reply “correct”
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`any “admissions in the Petition that Petitioners’ duty of candor [so] obligates”–i.e.,
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`the very premise represented to the Board as justifying its extended briefing request?
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`Where made at all, Petitioner’s unresonant responses to these questions solidify the
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`most reasonable inference: that Petitioner purposefully staggered the two petitions–
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`identical in Grounds, extensively verbatim in supporting argument and evidence, and
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`targeting claims asserted as reciting “identical” compositions. Petitioner clearly did
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`so to gain a tactical advantage at the expense of, and without regard for, the
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`resources or convenience of Patent Owner (“PO”), not to mention the Board (Factor
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`6). Instituting this IPR “would require the Board to conduct an entirely separate
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`proceeding involving numerous issues that have been considered already…The
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`result would be a significant waste of the Board’s resources.” NetApp Inc. v.
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`Realtime Data LLC, IPR2017-01195, Paper 9, p. 13 (October 12, 2017).
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`1
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`With these two related patents–one to compositions, the other to a method of
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`treatment administering what the Petition itself termed “identical” compositions–
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`Petitioner was poised for two bites at the apple from the filing of the initial ’926
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`Petition, a position reinforced upon its institution. Had the Board declined to
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`institute the ’926 Petition, Petitioner likely would either have forgone a second
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`’219 petition, or brought one on different Grounds. It follows that this was
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`precisely Petitioner’s calculus in filing this IPR two months after institution of the
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`’926 IPR. Worse, Petitioner has now certified to the FDA that both the ’219 and
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`’926 patents are invalid on grounds identical to Grounds I and II of both this and
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`the ‘926 Petition (Ex. 2006), triggering a third bite at the apple in Article III
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`courts–as a hedge against failure at trial of the ’926 IPR or of this institution.
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`It is hardly “telling,” as Petitioner alleges, that PO did not dispute the Petition
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`on the merits in its POPR. Reply 1. To the contrary, no inference or prejudice is
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`imputed to a PO even when no POPR is filed. 77 Fed. Reg. 48,680, 48,689 (Aug.
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`14, 2012). As such, and where neither the spirit of the AIA nor any public policy
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`would be served in sanctioning Petitioner’s test-and-see challenge paradigm, the
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`Board is well within its discretion to deny institution on–but limited to–the facts of
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`this Petition. This result is even more reasonable with fair §325(d) consideration of
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`the cumulativeness of the references.
`I.
`Institution Should Be Denied Under § 314(a)
`PO maintains that the General Plastic Factors collectively weigh in favor of
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`
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`2
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`denying institution based on the incontrovertible facts set forth in its POPR. E.g.,
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`Factors 2-4 factually favor denial (Petitioner knew of the identical art when the
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`’926 petition was filed, the POPR and Institution Decision had been received, and
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`nearly nine months elapsed between petitions). The Reply did not substantively
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`address Factors 2 and 4. Only new/revised arguments raised in the Reply are
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`addressed below.
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`For Factor 1, Petitioner takes no subtle pains to obscure the reversal of its
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`own position in the Petition–that it alone deliberately framed, that “[t]he specific
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`compositions recited in these [’219] claims are identical to those recited in the ’926
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`patent, which is the subject of a related IPR that the Board has recently ordered
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`instituted.” Reply 2-4. Curiously, this was not among the “admissions” Petitioner
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`represented to the Board in seeking a Reply that its duty of candor ‘obliged it’ to
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`make. Petitioner now recharacterizes this representation as “out of context” and
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`“misleading,” but PO submits the verbatim quote from the Petition is plain and
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`unambiguous on its face, and Petitioner’s arguments otherwise are indeed the
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`pretexts they seem. Petitioner inaccurately distinguishes relevant Factor 1 authority
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`as concerning “follow on petitions to the same claims.” Reply 4 n2. In fact, two of
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`the cases addressed non-identical claims. See Abiomed, Inc. et al. v. Maquet
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`Cariovascula, LLC (Abiomed 2), IPR2017-02134, Paper 7, p. 11 (April 16, 2018);
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`NetApp, IPR2017-01195, Paper 9, p. 13.
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`3
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`IPR2019-00207
`Patent Owner’s Sur-Reply
`
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`Factor 5 goes to the essence of the issue. Petitioner offers two incredible
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`explanations for the delay between the filings of the initial ’926 and instant
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`Petitions. First, the fact that claim construction in parallel litigation was not
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`decided until six months after filing of the ’926 Petition has no plausible bearing
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`on the timeliness of this Petition. Petitioner was not a party to that litigation and
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`has never suggested that the term construed there (“polymeric viscosity builder”)
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`requires construction in this or the initial ’926 Petition; it could be of no
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`consequence anyway because the term, however any tribunal might construe it, is
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`recited in both patents. Petitioner suggests next that Allergan’s previously-
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`unannounced sale of the ’219 patent to PO in October 2018–already eight months
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`into Petitioner’s delay–might have “obviated” the need to file the instant Petition.
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`This argument went from unsupported to absurd following the revelation that
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`Petitioner is seeking FDA approval to market an embodiment of the ’219 patent
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`before its expiration. Ex. 2006. Under Hatch-Waxman, a precondition of any such
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`approval is the successful challenge of all Orange Book-listed patents, which, as
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`Petitioner undeniably knew at the time of the first petition, meant both patents. Id.
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`Ownership of these patent rights is irrelevant to any Factor.
`II.
`Institution Should Be Denied Under § 325(d)
`Petitioner argues that Garrett (Ex. 1004) differs “materially” from Garrett 2
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`(Ex. 2001) in that the limitations on which the Examiner relied from Garrett 2 are
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`found within the “preferred embodiment” in Garrett. Reply 7-9. Regardless, it is
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`4
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`beside the point: Garrett 2 discloses as “one preferred embodiment” exactly what
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`Petitioner relies on in Garrett to argue it is not cumulative of Garrett 2. Compare
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`Reply 7-9 with Ex. 2001, 4. Petitioner merely disagrees with the examiner’s
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`assessment that Garrett 2 is the closer prior art. Ex. 1017, p. 468. Petitioner argues
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`that the content of secondary references Nadau-Fourcade and Bonacina differ from
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`that of the Hani reference relied upon during examination. But that is always the
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`case when “new” references are advanced. The Board nonetheless often has found
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`new references cumulative, including under similar circumstances. See, e.g.,
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`IPR2017-0156, Paper 8, pp. 21-22; IPR2016-00379, Paper 16, pp. 1-2.
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`Additionally, in arguing the Examiner incorrectly relied on the Warner
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`Declaration evidence of unexpected results, Petitioner improperly asks the Board
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`to reweigh this already-considered evidence. Hologic, Inc. v. Biomerieux, Inc.,
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`IPR2018-00566, Paper 9, p. 25 (August 24, 2018). And while Petitioner posits that
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`such examiner findings cannot “warrant consideration” at the institution stage, that
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`proposition is contrary to the explicit authority of this Board (see Becton,
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`Dickenson and Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, p. 18
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`(December 15, 2017)), and its precedent denying institution of just such a request
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`to reweigh Declaration evidence. Hologic, IPR2018-00566, Paper 9, pp. 18-21.
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`For the foregoing, additional reasons supporting the POPR, institution
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`should be denied.
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`5
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`Respectfully submitted,
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`
`/James Trainor /
`
`JAMES TRAINOR
`Reg. No. 52,297
`Counsel for Almirall, LLC
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`Dated: March 15, 2019
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`6
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`IPR2019-00207
`Patent Owner’s Sur-Reply
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent Owner
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`Updated Mandatory Notices Under 37 C.F.R. § 42.8 was served on March 15,
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`2019, by filing this document through the Patent Trial and Appeal Board End to
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`End system as well as delivering a copy via electronic mail upon the following
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`attorneys of record for the Petitioner:
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`
`
`Dennies Carughese, Reg. No. 61,868
`dvarughe-ptab@sternekessler.com
`Adam LaRock, Reg. No. 64,681
`alarock-ptab@sternekessler.com
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
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`
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`Dated: March 15, 2019
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`Fenwick & West LLP
`902 Broadway, Suite 14
`New York, NY 10010
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`
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`FENWICK & WEST LLP
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`
`/James Trainor /
`JAMES TRAINOR
`Reg. No. 52,297
`Attorney for Patent Owner
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`7
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