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
`
`U.S. Patent No. 9,517,219
`________________________
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`
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`
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`PETITIONERS’ REPLY TO PATENT OWNER’S
`PRELIMINARY RESPONSE
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`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313–1450
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`

`

`
`
`I. 
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`TABLE OF CONTENTS
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`The co-pending IPR on the ’926 patent is not grounds to
`deny institution of this IPR under §314(a). ................................................. 2
`
`A.
`
` 
`
`B.
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` 
`
`The General Plastic factors are not satisfied here. ............................... 2 
`
`Strong public policy weighs against denial of
`institution. .............................................................................................. 7 
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`II. 
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`Section 325(d) does not provide a basis to deny institution. .......................... 7 
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`III.  Conclusion .................................................................................................... 10 
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`
`i
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`TABLE OF AUTHORITIES
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`CASES
`Abiomed, Inc. v. Maquet Cardiovascular, LLC, IPR2017-02134, Paper 7
` (PTAB April 16, 2018) ........................................................................................... 4
`
`Abiomed, Inc. v. Maquet Cardiovascular, LLC, IPR2017-02150, Paper 11
`
` (PTAB Mar. 12, 2018) ........................................................................................... 4
`
`Almirall LLC v. Taro Pharmaceutical Industries Ltd.,
` 17-cv-00663-JFB-SRF, Dkt. No. 26 (D. Del.) ....................................................... 5
`
`Apple Inc. v. Immersion Corp., IPR2017-01371, Paper 7 (Nov. 21, 2017) .............. 4
`
`Arris Grp, Inc. v. Cirrex Sys. LLC, IPR2015-00530, Paper 12 (Jul. 27,
`2015) ....................................................................................................................... 4
`
`
`Conopco, Inc.dba Unilever v. Proctor & Gamble Co.,
` IPR2014-00628, Paper 21 (October 20, 2014) ....................................................... 5
`
`Conopco, Inc.dba Unilever v. Proctor & Gamble Co.,
` IPR2014-00506, Paper 25 (Dec. 10, 2014) ............................................................ 2
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.,
` IPR2017-01301, Paper 7 (Oct. 13, 2017) ............................................................... 4
`
`General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha,
` IPR2016-01357, Paper 19 (Sept. 6, 2017) .............................................................. 2
`
`In re Power Integrations, Inc., 884 F.3d 1370 (Fed. Cir. 2018) ............................... 3
`
`NetApp Inc. v. Realtime Data LLC, IPR2017-01195, Paper 9 (Oct. 12,
`2017) ....................................................................................................................... 4
`
`
`Power Integrations, Inc. v. Lee, 797 F.3d 1318 (Fed. Cir. 2015) .............................. 5
`
`Samsung Elecs. Co., Ltd. v. Immersion Corp., IPR2018-01499, Paper 11
` (Mar. 6, 2019) ........................................................................................................ 9
`
`Samsung Elecs. Co., Ltd. v. Rembrandt Wireless Techs., LP, IPR2015-
`00555, Paper 20 (June 19, 2015) ............................................................................ 4
`
`
`
`ii
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`

`

`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`
`Toyota Motor Corp. v. Cellport Sys., Inc., IPR2015-01423, Paper 7
` (Oct. 28, 2015) ........................................................................................................ 4
`
`Wirtgen Am., Inc. v. Caterpillar Paving Prods. Inc., IPR2018-01201,
` Paper 13 (Jan. 8, 2019). .......................................................................................... 9
`
`STATUTES
`35 U.S.C. § 121 ........................................................................................................ 1
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`35 U.S.C. § 314(a) ..................................................................................................... 1
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`35 U.S.C. § 325(d) ..................................................................................................... 1
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`
`
`
`iii
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`Amneal’s Petition demonstrated that inter partes review (“IPR”) should be
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`instituted for all claims of U.S. Patent No. 9,517,219 (“the ’219 patent”).
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`Tellingly, Patent Owner Almirall, LLC (“Almirall”) did not dispute the
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`substantive merits of Amneal’s grounds. Instead, Almirall limits its Preliminary
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`Response (“POPR,” Paper 8) to misleading and unavailing § 314(a) and § 325(d)
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`arguments, both of which the Board should soundly reject.
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`First, Almirall seeks institution denial under 35 U.S.C. § 314(a) and the
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`General Plastic factors in view of co-pending IPR2018-00608, which has been
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`instituted, challenging U.S. Patent No. 9,161,926 (“the ’926 patent”). The
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`’219 patent is a divisional of the ’926 patent. Almirall has failed to establish
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`the General Plastic factors, and its arguments misstate facts and misapply the
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`law. For example, this Petition is the first filed against the ’219 patent, so it is
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`not a follow-on of the sort governed by the General Plastic factors. Almirall
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`tries to create the illusion that the ’219 and ’926 patents are the same, but
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`cannot dispute that the ’219 patent is a divisional patent, which means it is
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`“independent and distinct” from the ’926 patent. See 35 U.S.C. § 121.
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`Second, Almirall seeks denial of institution under 35 U.S.C. § 325(d).
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`Remarkably, Almirall’s argument essentially is that if an examiner applies a
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`reference for a limitation during prosecution, then any other reference for that
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`limitation would be per se cumulative. Almirall’s untenable reading of § 325(d)
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`1
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`

`

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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`would effectively insulate from IPR nearly any patent that emerged from
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`prosecution. This is wrong. Moreover, Almirall’s arguments raise material factual
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`disputes as to whether Amneal’s cited art overcomes Almirall’s alleged unexpected
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`results evidence, further compelling institution of the IPR.
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`I.
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`The co-pending IPR on the ’926 patent is not grounds to deny
`institution of this IPR under §314(a).
`The Board typically exercises its discretion under § 314(a) and the General
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`Plastic factors to deny institution of “follow-on” IPRs that are duplicative of
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`earlier-filed petitions on the same patent, to avoid offending notions of res
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`judicata, judicial economy, and petitioner diligence. See 35 U.S.C. §314(a);
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`General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357,
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`Paper 19, at 10-11 (Sept. 6, 2017); Conopco, Inc. dba Unilever v. Proctor &
`
`Gamble Co., IPR2014-00506, Paper 25, at 4 (Dec. 10, 2014). But this Petition is
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`not a follow-on to the earlier-filed (and instituted) petition challenging the related-
`
`but-distinct ’926 patent. Section 314(a) does not warrant denial of institution.
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` The General Plastic factors are not satisfied here.
`A.
`Factor 1 weighs in Amneal’s favor. By Almirall’s own admission, the ’219
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`patent is a divisional, which by definition claims an “independent and distinct”
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`invention from the ’926 patent challenged in the earlier IPR. Amneal has not “filed
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`a petition directed to the same claims of the same patent,” as required by this
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`General Plastic factor. Betraying its prior representation that the ’219 and ’926
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`2
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`patents are distinct inventions (AMN1017, 283), Almirall now argues that those
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`patents are essentially the same to escape institution.
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`Seizing on an out-of-context statement in the Petition, Almirall goes to great
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`lengths to argue that Amneal allegedly “admitted” the two patents are essentially
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`the same. POPR, 6. Not so. That statement from the Petition was simply observing
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`that the same commercial product (ACZONE® Gel 7.5%) is an embodiment of
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`both the ’219 and ’926 patents. Amneal was not suggesting that the claims of each
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`patent were the same, as Almirall disingenuously states. Moreover, Almirall, for its
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`part, does not say that the two patents are the same, defeating its own argument.
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`Rather, Almirall hopes to rely solely on an alleged “admission” that it
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`manufactured out of whole cloth.
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`That’s because the claims are materially different, as evidenced by
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`Almirall’s own claim-comparison chart in its POPR. Id., 6-8. Not only do the
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`preambles substantially differ, but so do the claimed polymeric viscosity builder
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`limitations. The “polymeric viscosity builder” of the ’219 patent is “comprising”
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`acrylamide/sodium acryloyldimethyl taurate copolymer, while in the ’926 patent it
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`is “consisting of” the same. Almirall cannot seriously contend that Amneal
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`somehow “admitted” that large chunks of claim language in the ’219 patent are
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`superfluous. In re Power Integrations, Inc., 884 F.3d 1370, 1376 (Fed. Cir. 2018)
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`(rejecting Board’s construction which “renders claim language meaningless.”).
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`3
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`Almirall tenuously argues that “non-identical claims do[] not automatically
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`weigh in favor of institution.” POPR, 8. But its cited cases are inapposite because
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`they involve (1) follow-on petitions to the same claims that were previously
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`challenged in a prior petition1 or (2) second challenges to different claim sets of the
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`same patents.2 Almirall has cited no case where a petition was denied under
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`§314(a) in view of an earlier-filed petition on a separate patent.
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`Factors 2, 4, and 5 weigh in Amneal’s favor. These factors discourage
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`1 Abiomed, Inc. v. Maquet Cardiovascular, LLC, IPR2017-02134, Paper 7, at 8
`
`(PTAB April 16, 2018); Abiomed, Inc. v. Maquet Cardiovascular, LLC, IPR2017-
`
`02150, Paper 11, at 7-8 (PTAB Mar. 12, 2018); NetApp Inc. v. Realtime Data LLC,
`
`IPR2017-01195, Paper 9, at 2, 11-12 (Oct. 12, 2017); Conopco, Inc. dba Unilever
`
`v. Procter & Gamble Co., IPR2014-00506, Paper 25, at 3 (Dec. 10, 2014); Toyota
`
`Motor Corp. v. Cellport Sys., Inc., IPR2015-01423, Paper 7, at 6-7 (Oct. 28, 2015);
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc., IPR2017-01301,
`
`Paper 7, at 10 (Oct. 13, 2017); Samsung Elecs. Co., Ltd. v. Rembrandt Wireless
`
`Techs., LP, IPR2015-00555, Paper 20, at 7 (June 19, 2015); Samsung Elecs. Co.,
`
`Ltd. v. Elm 3DS Innovations, LLC, IPR2017-01305, Paper 11, at 8 (Oct. 17, 2017).
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`2 Apple Inc. v. Immersion Corp., IPR2017-01371, Paper 7, at 11 (Nov. 21, 2017);
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`Arris Grp, Inc. v. Cirrex Sys. LLC, IPR2015-00530, Paper 12, at 3 (Jul. 27, 2015).
`
`4
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`

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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`filing a first petition that withholds prior art, without justification, for use in
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`successive attacks if the first petition is denied. See General Plastic, IPR2016-
`
`01357, Paper 19, at 10-11 (Sept. 6, 2015); Conopco, IPR2014-00506, Paper 25, at
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`3; Conopco, Inc. dba Unilever v. Proctor & Gamble Co., IPR2014-00628, Paper
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`21, at 11 (Oct. 20, 2014). This is not a successive attack to the ’219 patent.
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`Almirall also ignores that in a parallel district court litigation over the ’219
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`patent—where Amneal was not a party—claim construction of the term
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`“polymeric viscosity builder” was outstanding prior to this Petition. See Almirall
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`LLC v. Taro Pharmaceutical Industries Ltd., 17-cv-00663-JFB-SRF, Dkt. No. 26
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`(D. Del.) (“Taro Dkt.”). The court’s August 23, 2018 claim construction decision
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`was sealed, so Amneal filed its Petition about two months later, after awaiting a
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`redacted version of the court’s construction decision and rationale, as both would
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`be relevant to this Petition. See Power Integrations, Inc. v. Lee, 797 F.3d 1318,
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`1327 (Fed. Cir. 2015) (explaining that the board should consider parallel district
`
`court claim constructions). Additionally, Allergan announced that it was selling the
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`patents after Amneal filed the ’926 patent IPR. See, e.g., ’926 IPR, Paper 13 (Oct.
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`12, 2018). That this transaction could have obviated the need to file the ’219 patent
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`IPR is another factor that explains any alleged “delay” that Almirall complains of.
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`Factor 3 supports institution because Amneal is not using any prior denials
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`of institution as a “roadmap” to gain any advantage. Rather, Amneal’s IPR on the
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`5
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`

`

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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`’926 patent was instituted so there were no critical deficiencies in its positions that
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`needed to be “refined” or corrected in a subsequent petition. POPR, 13. Nor has
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`Almirall demonstrated that it would suffer any unfair prejudice if the instant IPR
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`was instituted, so its cries of alleged unfair “advantages” to Amneal ring hollow.
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`First, Almirall complains that Amneal, after addressing Almirall’s evidentiary
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`objections in the ’926 patent IPR, used that cured evidence in this Petition. Id, 12-
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`13. But there is no advantage toward institution as these evidentiary issues would
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`be relevant only after institution. Also, any alleged “advantages” or “benefits”
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`would equally inure to Almirall as it no longer would need to expend resources
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`disputing now-authenticated exhibits. Almirall’s second complaint—that Amneal
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`construes the term “acne vulgaris” in the instant Petition but did not do so in the
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`prior IPR—is even more flimsy. The term “acne vulgaris” only appears in the ’219
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`patent, not the ’926 patent. So Amneal had no reason—indeed no ability—to
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`construe that term in the prior petition.
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`Factors 6 and 7 also do not warrant denying institution because the Petition
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`is not a serial attack on the same patent that imposes any inefficient and
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`uneconomical “tax” on the Board. Conopco, IPR2014-00506, Paper 25, at 4-5;
`
`Edwards Lifesciences, IPR2017-01301, Paper 7, at 10; Rembrandt, IPR2015-
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`00555, Paper 20, at 7. This is not a follow-on Petition to the ’219 patent. Nor
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`would instituting review of the ’219 patent jeopardize the Board’s one-year final
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`6
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`

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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`decision requirement, which Almirall fails to even address. POPR, 17-18.
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`B.
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`Strong public policy weighs against denial of institution.
`
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`Two public policy considerations also counsel against denying institution
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`here. First, extending § 314(a), as Almirall requests, would obligate petitioners to
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`challenge every related patent in a family at the same time. This would be a
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`needless drain on the Board’s resources, and serve to create needless disputes.
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`Second, Almirall’s position would promote gamesmanship, encouraging
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`patent owners to keep patent families open and strategically issue essentially
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`indistinguishable patents when disputes arise. Any unchallenged patents under
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`Almirall’s reading would be insulated from IPR, allowing patent owners to shield
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`one bad patent with another merely because they are challenged at different times.
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`Almirall’s § 314(a) arguments fail for at least these reasons.
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`Section 325(d) does not provide a basis to deny institution.
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`The asserted art is not the same or cumulative of the art considered during
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`II.
`
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`prosecution; therefore, Becton factors (a)-(c) are resolved in Amneal’s favor. The
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`Garrett reference in this Petition is not “cumulative” of the “Garrett 2” reference
`
`considered during prosecution. Garrett 2 offers a scattershot description of multiple
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`embodiments from which some of the ’219 patent’s limitations can be found,
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`leading the examiner to cite eight pages of Garrett 2 in order to support an
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`obviousness rejection. AMN1017, 60. In contrast, the Garrett reference in this
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`7
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`

`

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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`Petition teaches a key feature of the claims missing from Garrett 2: a “preferred”
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`embodiment having all claimed excipients (except the claimed thickening agent) in
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`ranges encompassing the amounts claimed. AMN1004, 4:2-5. Almirall argued that
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`Garrett 2 was not invalidating because the cited disclosures were not preferred—a
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`defect not present in the Garrett reference in this Petition. AMN1017, 283 n.1.
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`Similarly, the Nadau-Fourcade and Bonacucina references are not
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`duplicative of the Hani reference considered during prosecution. As Almirall
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`argued to the examiner, Hani teaches the claimed acrylamide/sodium
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`acryloyldimethyl taurate copolymer (1) as part of a “laundry list” and (2) as a
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`second thickening agent (not the sole thickener). Id. Nadau-Fourcade and
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`Bonacucina, in contrast, are not “laundry lists,” and instead specifically direct a
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`POSA to the claimed acrylamide/sodium acryloyldimethyl taurate copolymer
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`(Sepineo P 600) and disclose its use as the sole thickening agent. AMN1005, 48:5-
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`9); AMN1015, Abstract, 7. Bonacucina also discloses a range of amounts of the
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`claimed acrylamide/sodium acryloyldimethyl taurate copolymer that encompass
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`the claimed amounts—a disclosure not shown in Hani. AMN1017, 7.
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`As explained in the Petition, Nadau-Fourcade and Bonacucina were not
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`previously considered. Garrett was considered, but only for certain dependent
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`claims and only to show the use of topical dapsone to treat acne vulgaris. Id., 62-
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`63. The ’219 patent was not tested against the “preferred” disclosure of Garrett’s
`
`8
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`

`

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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`topical composition containing “about 5% to 10% dapsone,” “about 10% to 30%
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`ethoxydiglycol,” a thickening agent, water, and methyl paraben (see AMN1004,
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`14:3-14) in combination with either Nadau-Fourcade or Bonacucina.
`
`Almirall’s extreme reading of § 325(d) appears to be that if a reference was
`
`applied to a limitation during prosecution, then any other reference used for that
`
`limitation is somehow per se cumulative. That reading has no basis in law and
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`Almirall makes no attempt to support it. See Wirtgen Am., Inc. v. Caterpillar
`
`Paving Prods. Inc., IPR2018-01201, Paper 13, at 12-15 (Jan. 8, 2019). Two days
`
`ago, the Board rejected a similar argument: “[a]ny similarity of the art in this
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`proceeding to art previously applied to [the claim] is due to the fact that any
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`ground applied to [the claim] must address the subject matter of [that claim].”
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`Samsung Elecs. Co. Ltd. v. Immersion Corp., IPR2018-01499, Paper 11, at 12-13
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`(Mar. 6, 2019).
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`Similarly, Almirall appears to argue that simply because the examiner and
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`Amneal both apply the law of obviousness of ranges, then Amneal’s arguments are
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`now all of a sudden “cumulative.” That is nonsensical, and has no basis in law. The
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`Petition explains specific motivations to combine different art so that the law of
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`obviousness of ranges is applied to the ’219 patent in a different context. For
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`example, Amneal’s Ground 1 asks the Board to assess obviousness in view of
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`Garrett’s “preferred” topical dapsone disclosure in combination with Nadau-
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`9
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`Fourcade’s disclosure of a small and finite group of “preferred” thickening agents:
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`“carbomers, for instance Carbopol 980® or 981®, polyacrylamides, for instance
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`Sepineo P 600® or Simulgel 600 PHA®, and polysaccharides, for instance
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`xanthan gum.” AMN1005, 48:5-7. Amneal’s Ground 2 provides multiple explicit
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`motivations for using Sepineo, unlike the dearth of motivations offered by the
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`examiner. Petition, 46-50. Accordingly, Becton factor (d) favors Amneal.
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`Becton factors (e)-(f) also favor Amneal. As previously explained, the
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`Examiner erred by not assessing patentability in view of Garrett’s “preferred”
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`topical dapsone disclosure and by relying upon Hani’s “laundry list.” The Petition
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`also explains that the alleged unexpected results evidence would have actually
`
`been expected—an issue not raised during prosecution. At bottom, Almirall’s
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`analysis of Becton factor (f) asks this Board to make factual findings as to whether
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`the Petition “warrant[s] reconsideration” of alleged unexpected results. Such a
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`request is improper at the institution stage.
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`Finally, Garrett, Nadau-Fourcade, and Bonacucina are already before the
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`Board in the co-pending ’926 patent IPR. Few resources will be saved by denying
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`institution here. For at least these reasons, the Board should reject Almirall’s
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`§325(d) arguments.
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`III. Conclusion
`The Board should institute IPR on the ’219 patent.
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`10
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: March 8, 2019
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`11
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`Petitioners’ Reply to Patent Owner’s Preliminary Response
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
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`I certify that the above-captioned “Petitioners’ Reply to Patent Owner
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`Preliminary Response” was served in its entirety on March 8, 2019, upon the
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`following parties via electronic mail:
`
`
`James Trainor: jtrainor@fenwick.com
`Ewa Davidson: edavidson@fenwick.com
`Elizabeth Hagan: ehagan@fenwick.com
`Jennifer Bush: jbush@fenwick.com
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`
`
`
`
`
`
`
`Date: March 8, 2019
`1100 New York Avenue, N.W.
`Washington, DC 20005
`(202) 371-2600
`
`10070511.8
`
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`