UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _______________
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
` _______________
`IPR2019-01505 (Patent 8,450,475 B2)
`IPR2019-01506 (Patent 8,357,795 B2)
`IPR2019-01508 (Patent 9,238,013 B2)
`IPR2019-01509 (Patent 9,358,322 B2)
`IPR2019-01617 (Patent 8,822,676 B2)
`IPR2019-01632 (Patent 8,357,795 B2)
`IPR2020-00084 (Patent 9,089,519 B2)
` _______________
`PATENT OWNER’S REPLY
`TO PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE1
`
`
`
`1 Authorization for Allergan to file a single reply to Petitioner’s Opposition
`
`to Allergan’s Motion to Exclude, not to exceed 6 pages, was received on December
`
`8, 2020. The Board previously authorized use of a joint caption page on April 27,
`
`2020. An identical paper has been filed in each case recited in the joint caption.
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _______________
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
` _______________
`IPR2019-01505 (Patent 8,450,475 B2)
`IPR2019-01506 (Patent 8,357,795 B2)
`IPR2019-01508 (Patent 9,238,013 B2)
`IPR2019-01509 (Patent 9,358,322 B2)
`IPR2019-01617 (Patent 8,822,676 B2)
`IPR2019-01632 (Patent 8,357,795 B2)
`IPR2020-00084 (Patent 9,089,519 B2)
` _______________
`PATENT OWNER’S REPLY
`TO PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE1
`
`
`
`1 Authorization for Allergan to file a single reply to Petitioner’s Opposition
`
`to Allergan’s Motion to Exclude, not to exceed 6 pages, was received on December
`
`8, 2020. The Board previously authorized use of a joint caption page on April 27,
`
`2020. An identical paper has been filed in each case recited in the joint caption.
`
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF ABBREVIATIONS
`
`BDDE
`CTPG
`DEO
`HA
`MTE
`
`Term
`Abbreviation
`Allergan Opp. Patent Owner’s Opposition to Petitioner’s Motion to Exclude,
`IPR2019-01617, Paper 57
`(identical paper filed in all proceedings)
`butanediol diglycidyl ether
`Consolidated Trial Practice Guide (Nov. 2019)
`1,2,7,8-diepoxyoctane
`hyaluronic acid
`Patent Owner’s Motion to Exclude, IPR2019-01617, Paper 55
`(identical paper filed in all proceedings)
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude,
`IPR2019-01617, Paper 58
`(identical paper filed in all proceedings)
`p-phenylene-bis(ethylcarbodiimide)
`pBCDI
`Patent Owner Response
`POR
`Person of Ordinary Skill in the Art
`POSA
`Petitioner’s Reply, Paper 44
`Reply
`Common citations are to documents filed in the -01617 IPR.
`Unless otherwise noted, all internal citations are omitted and emphasis is added.
`
`Opp.
`
`
`
`TABLE OF CONTENTS
`
`
`Page
`
`
`I.
`
`II.
`
`INTRODUCTION .......................................................................................... 1
`
`BOTH DR. DEVORE’S AND DR. PRESTWICH’S
`DECLARATIONS ARE UNRELIABLE AND SHOULD BE
`EXCLUDED ................................................................................................... 1
`
`III. DR. PRESTWICH’S DECLARATION IS UNFAIRLY
`PREJUDICIAL AND VIOLATES ALLERGAN’S RIGHTS UNDER
`THE APA ........................................................................................................ 2
`
`IV. THE BOARD SHOULD EXCLUDE THE OTHER EXHIBITS
`IDENTIFIED IN ALLERGAN’S MOTION .................................................. 5
`
`V.
`
`CONCLUSION ............................................................................................... 6
`
`
`
`
`
`
`
`I.
`
`
`INTRODUCTION
`Petitioner’s experts and exhibits should be excluded. Petitioner entirely
`
`avoids Dr. DeVore’s discredited and unreliable testimony. See MTE 3-5; POR 26-
`
`31. And it fails to justify its submission of Dr. Prestwich’s declaration to present
`
`new, scientifically-unsound arguments and evidence on Reply. Allergan’s
`
`objections are not about the “weight” of the evidence (Opp. 1-3), but about its
`
`scientific unreliability and the fundamental unfairness of Petitioner relying on
`
`unsubstantiated evidence and then taking a mulligan, refashioning its case in the
`
`Replies with new expert opinions. For both reasons, both expert declarations and
`
`Petitioner’s additional new evidence should be excluded.
`
`II. BOTH DR. DEVORE’S AND DR. PRESTWICH’S DECLARATIONS
`ARE UNRELIABLE AND SHOULD BE EXCLUDED
`Petitioner urges the Board to abdicate its gatekeeping role and instead
`
`
`
`address the unreliable expert testimony “when weighing the evidence.” Opp. 2-3.
`
`But Fed. R. Evid. 702 and 703 cannot be discarded: “The Daubert standards of
`
`relevance and reliability must nevertheless be met” in IPRs. Edmund Optics, Inc.
`
`v. Semrock, Inc., IPR2014-00599, Paper 72 at 49 (PTAB, Sept. 16, 2015).
`
`
`
`Petitioner does not address Dr. DeVore’s unreliability at all, Opp. 2-3, and it
`
`brushes aside Dr. Prestwich’s strategic omissions from his prior testimony that
`
`render his opinions unreliable. Opp. 5. For instance, Petitioner ignores Dr.
`
`Prestwich’s previous testimony that acidic destabilization of a lidocaine-containing
`
`
`
`1
`
`
`
`
`
`HA gel “may be more pronounced” during autoclaving. EX2200G, ¶ 181.
`
`Likewise, Dr. Prestwich’s generic acknowledgement that the crosslinkers are
`
`“chemically different,” EX1105, ¶ 98, does not justify his excluding differences he
`
`previously acknowledged between BDDE and DEO in their hydrophilicity and
`
`reactivity. MTE 7-8; EX2200FF (Prestwich article conceding “chemical nature of
`
`linker” affects filler properties). Petitioner declines to explain the deletion of Dr.
`
`Prestwich stating that “a solution of lidocaine HCl will become even more acidic at
`
`an elevated temperature for autoclaving.” MTE 7. Petitioner’s claim about the
`
`cherry-picked lidocaine solubility value (from EX2200FFF) lacks merit: he could
`
`“not recall if there were other solubility numbers,” EX2200, 331:17-18. Dr.
`
`Prestwich’s conflation of “free release” with “sustained release,” see infra, is
`
`contradicted by numerous scientific publications—including his own. MTE 5-6.
`
`Both declarations should be excluded under Fed. R. Evid. 702 and 703.
`
`III. DR. PRESTWICH’S DECLARATION IS UNFAIRLY PREJUDICIAL
`AND VIOLATES ALLERGAN’S RIGHTS UNDER THE APA
`Petitioner’s cavalier attitude toward the Board’s procedural obligations to
`
`
`
`patent owners is far out of step with IPR precedent, and its portrayal of Dr.
`
`Prestwich’s declaration as merely “responsive” is false. See Opp. 6-9, 10-12.
`
`While Paper 50 identifies improper evidence and arguments that should be
`
`stricken, Allergan’s MTE sets forth reasons for exclusion per the Federal Rules of
`
`Evidence. MTE 2 n.4. Dr. Prestwich’s declaration must be excluded per Rule 403.
`
`
`
`2
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`
`
`
`
`
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`A new declarant with new arguments and evidence on Reply is not, as
`
`Petitioner claims, just a “wrinkle.” Opp. 6. Prejudice cannot be mitigated because
`
`Allergan has “possessed and been able to consider [Dr. Prestwich’s] testimony
`
`since at least 2014.” Opp. 7. The Petitions must make Petitioner’s prima facie
`
`case—motivation to combine and reasonable expectation included. Intelligent Bio-
`
`Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016)
`
`(barring new theory of motivation to combine because “[Petitioner] chose which
`
`grounds of invalidity to assert in its petition and it chose not to assert this new
`
`one”). Petitioner cannot present its prima facie case on Reply under the guise of a
`
`“response” to Dr. Berkland. Opp. 7; see CTPG 73. A patent owner must be given
`
`“notice of and a fair opportunity to meet the grounds of rejection.” Belden Inc. v.
`
`Berk-Tek, LLC, 805 F.3d 1064, 1080 (Fed. Cir. 2015). Allergan had no notice of
`
`Dr. Prestwich’s testimony, and it lacks a fair opportunity to respond because it was
`
`precluded from presenting expert testimony and other evidence in its Sur-Reply.
`
`
`
`First, for Lebreton in view of Sadozai, Petitioner’s assertion that Dr.
`
`Prestwich did not offer “any new claim construction” for “freely released” is
`
`contrary to its Replies and his declaration. Dr. Prestwich superficially agrees the
`
`term should take its “ordinary meaning,” EX1105, ¶ 37, but when analyzing the
`
`grounds, Dr. Prestwich stretches “freely released” to fit Sadozai, so far that it
`
`actually encompasses sustained release, ¶ 82. Neither the Petitions nor Dr. DeVore
`
`
`
`3
`
`
`
`
`
`adopted this construction. While Petitioner tries to justify this as simply evaluating
`
`Sadozai, that interpretation of Sadozai was not offered either. Dr. Prestwich also
`
`improperly relies on EX2067 to support a motivation to add lidocaine to an HA
`
`gel. EX1105, ¶ 163. Petitioner’s claim that Dr. Prestwich cites EX1216 (allegedly
`
`showing Elevess’ pBCDI crosslinker) only for the state of the art rings hollow. He
`
`and Petitioner unveiled EX1216 in Reply to fill a major gap in Dr. DeVore’s
`
`reasonable expectation of success analysis. Reply 30; EX1105, ¶ 63. Dr. DeVore
`
`never identified a reference showing that CTA/Elevess used a pBCDI crosslinker,
`
`EX1002, ¶¶ 115, 138-40, let alone showed how that knowledge would allegedly
`
`suggest success in combining Sadozai and Lebreton. See POR 41-42.
`
`
`
`Second, Petitioner’s arguments on Kinney and Zhao are similarly wrong. It
`
`argues that Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir.
`
`2015), does not forbid Dr. Prestwich’s reliance on new EX1112 and previously-
`
`uncited portions of Zhao since they allegedly do not disclose a new embodiment.
`
`Opp. 10-11. But Ariosa was not limited to embodiments; the petitioner was
`
`improperly “mak[ing] a meaningfully distinct contention” using previously-cited
`
`references. 805 F.3d at 1367. And Dr. Prestwich similarly cites new EX1114 and
`
`EX1115 to try to show motivation to combine with an expectation of success in a
`
`way Petitioner did not attempt in its Petitions. EX1105, ¶ 75.
`
`Third, Petitioner’s excuse that Dr. Prestwich is not citing new “EX1210
`
`4
`
`
`
`
`
`
`
`
`
`instead, but in addition to” its other evidence, is a distinction without a difference.
`
`Opp. 13. And Petitioner fails to rebut that Dr. Prestwich’s reliance on EX1210 to
`
`show “it was [allegedly] conventional to include free HA in a dermal filler” is
`
`improper new evidence of motivation to combine. MTE 13-14.
`
`
`
`Fourth, Petitioner does not dispute that EX1107 is new. Opp. 11. It cannot
`
`be used to bolster Dr. DeVore’s unsupported testimony.
`
`
`
`Petitioner’s attempts to distinguish precedent also fail. Opp. 6, 8. NuVasive
`
`broadly explained that a patent owner, as here, does not have a fair opportunity to
`
`respond when it lacks “a vehicle for submitting new evidence, including new
`
`expert declarations” in response to the petitioner changing “the thrust” of its
`
`arguments, “even when the new ground involved the same prior art as earlier
`
`asserted grounds.” 841 F.3d 966, 972-73 (Fed. Cir. 2016). It was not, as
`
`Petitioner argues, limited to finding “observations” an insufficient opportunity to
`
`respond to new arguments on Reply. And Belden’s affirmance of “new reply
`
`testimony” (Opp. 6) concerned a declaration that fairly responded to the patent
`
`owner’s response. 805 F.3d at 1078. That is not the situation here, and Dr.
`
`Prestwich’s declaration should be excluded under Fed. R. Evid. 403.
`
`IV. THE BOARD SHOULD EXCLUDE THE OTHER EXHIBITS
`IDENTIFIED IN ALLERGAN’S MOTION
`Allergan moved to exclude several exhibits as irrelevant and unfairly
`
`
`
`prejudicial post-filing art. MTE, V.A. Unlike Allergan’s post-filing art (see
`
`
`
`5
`
`
`
`
`
`Allergan Opp. 3-4), which is relevant because it shows uncertainty at the priority
`
`date that continued for years, Petitioner’s post-filing art does not reflect the state of
`
`the art at the time of the invention. Plant Genetic Sys., N.V. v. DeKalb Genetics
`
`Corp., 315 F.3d 1335 (Fed. Cir. 2003) (barring “impermissible application of later
`
`knowledge about later art-related facts”). Instead, Petitioner violates this rule. See
`
`Reply 36 (citing EX1102 to meet the “free HA” limitation in combination with
`
`Lebreton and Sadozai), 26 (citing EX1103, from 2013, for unsupported argument
`
`that 0.3% lidocaine was “well-established” in 2008); EX1105, ¶ 63.
`
`
`
`Petitioner ignores the argument that EX1104 (the inventor’s emails), which
`
`it uses for motivation to combine, should be excluded as unfairly prejudicial.
`
`MTE, V.B; see Reply 26 n.9. Petitioner’s argument that EX1104 is not hearsay
`
`because it shows “monitoring and sharing information” about competing products
`
`(Opp. 16) is unpersuasive; Petitioner alleges the truth of that information supports
`
`its overbroad POSA definition and alleged motivation to combine. Reply 26 n.9.
`
`
`
`Finally, Petitioner misses the point on its improper incorporation by
`
`reference (MTE, V.C), asserting Kaz USA has to do with nexus. Opp. 7 n.14.
`
`Regardless of the legal issue in dispute there, the Board declined to consider
`
`exhibits uncited in the party’s brief just because they were cited in a declaration.
`
`V. CONCLUSION
`
`Allergan respectfully requests that the Board grant its motion to exclude.
`
`6
`
`
`
`
`
`
`
`
`
`
`
`Dated: December 22, 2020
`
`
`
`Respectfully submitted,
`
`
`
`/s/ Anthony M. Insogna
`Anthony M. Insogna (Reg. No. 35,203)
`Tamera M. Weisser (Reg. No. 47,856)
`S. Christian Platt (Reg. No. 46,998)
`aminsogna@jonesday.com
`tweisser@jonesday.com
`cplatt@jonesday.com
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`Telephone: 858-314-1200
`Fax: 844-345-3178
`
`Sarah A. Geers (Reg. No. 69,123)
`sgeers@jonesday.com
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`Telephone: 212-326-3939
`Fax: 212-755-7306
`
`Jennifer M. Hartjes (Reg. No. 77,687)
`jhartjes@jonesday.com
`JONES DAY
`90 South Seventh Street, Suite 4950
`Minneapolis, MN 55402
`Telephone: 612-217-8800
`Fax: 844-345-3178
`
`Attorneys for Patent Owner Allergan Industrie,
`SAS
`
`
`
`
`
`
`
`
`
`
`7
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on December
`
`22, 2020, a true and correct copy of PATENT OWNER’S REPLY TO
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`
`EXCLUDE has been served in its entirety by e-mail on the following counsel of
`
`record for Petitioner:
`
`Lead Counsel:
`Christopher L. Curfman, Ph.D.
`(Reg. No. 52,787)
`MEUNIER CARLIN & CURFMAN LLC
`999 Peachtree Street NE, Suite 1300
`Atlanta, GA 30309
`ccurfman@mcciplaw.com
`
`Dated: December 22, 2020
`
`
`Backup Counsel:
`William W. Cutchins (Reg. No. 63,451)
`Warren J. Thomas (Reg. No. 70,581)
`John Harbin (pro hac vice motion filed)
`MEUNIER CARLIN & CURFMAN LLC
`999 Peachtree Street NE, Suite 1300
`Atlanta, GA 30309
`wcutchins@mcciplaw.com
`wthomas@mcciplaw.com
`mcc.Petitioner.ipr@mcciplaw.com
`
`/s/ Anthony M. Insogna
`Anthony M. Insogna (Reg. No. 35,203)
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`Telephone: 858-314-1200
`Fax: 844-345-3178
`
`Attorney for Patent Owner Allergan
`Industrie, SAS
`
`
`
`8
`
`
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