`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
`
`_________________
`
`IPR2019-01505 (Patent 8,450,475)
`IPR2019-01506 (Patent 8,357,795)
`IPR2019-01508 (Patent 9,238,013)
`IPR2019-01509 (Patent 9,358,322)
`IPR2019-01617 (Patent 8,822,676)
`IPR2019-01632 (Patent 8,357,795)
`IPR2020-00084 (Patent 9,089,519)
`
`_________________
`
`PETITIONER’S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE1
`
`
`1 Authorization for the use of a joint caption page was received on April 27, 2020.
`Neither party opposes the use of a joint caption page. An identical, consolidated
`Reply to the Motion to Exclude has been filed in each case recited in the
`consolidated caption, as authorized by the Board via e-mail on December 8, 2020.
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`TABLE OF CONTENTS
`
`I.
`EXHIBITS 2059 AND 2060 (THE MICHEELS ARTICLES) ....................... 1
`EXHIBITS 2083 AND 2084 (THE VIVACY REPORTS) .............................. 2
`II.
`III. THE CITED PORTIONS OF PRESTWICH DEPOSITION .......................... 6
`
`i
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`TABLE OF ABBREVIATIONS
`
`Abbreviation
`BDDE
`HA
`POSITA
`Response
`
`Pet. MTE
`
`PO Opp. MTE
`
`
`
`
`
`Term
`butanediol diglycidyl ether
`hyaluronic acid
`Person of Ordinary Skill in the Art
`Patent Owner Response, IPR2019-01617, Paper 40 (cited as
`exemplary of citations for the remaining proceedings)
`Petitioner’s Motion to Exclude, IPR2019-01617, Paper 54
`(cited as exemplary of citations for the remaining
`proceedings)
`Patent Owner’s Opposition to Petitioner’s Motion to
`Exclude, IPR2019-01617, Paper 57 (cited as exemplary of
`citations for the remaining proceedings)
`
`ii
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`Prollenium US Inc. (“Prollenium”) respectfully replies to its Motion to
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`Exclude (MTE) certain information under the Federal Rules of Evidence (FRE).
`
`I.
`
`EXHIBITS 2059 AND 2060 (THE MICHEELS ARTICLES)
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`The parties agree post-filing documents can be used as evidence of the state
`
`of the art at the relevant time. But those documents must relate to or show the
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`knowledge or skill of the POSITA at the time; they cannot be used to contradict the
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`POSITA’s knowledge at the relevant time. See PO Opp. MTE 4 (agreeing). The
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`only way Allergan can paint its post-dated exhibits as representing the “state of the
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`art” is by misconstruing what the documents actually say.
`
`The two “Micheels” papers (EX2059, EX2060), published 8-10 years post-
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`filing, do not show “unpredictability” in formulating HA fillers or “that creating
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`crosslinked HA fillers was an uncertain endeavor” as Allergan argues. PO Opp.
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`MTE 4. Rather, they show “[a]t least 7 different types of crosslinking technology
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`are used in the production of current HA gels,” all of which are available with
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`lidocaine introduced during manufacturing. EX2059, 601.
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`While Micheels 2016 contains one sentence speculating that added lidocaine
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`“may modify” rheological properties, the authors explained that “differences in the
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`behavior” of the tested gels came from the “different crosslinking technologies”
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`used. EX2059, 604, 606. Indeed, Micheels noted that a 2008 test found that
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`“cohesivity … results were the same for all gels, whether or not they contained
`
`1
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`added lidocaine.” EX2059, 604.2 Micheels 2018 likewise found some rheological
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`differences when comparing gels with and without lidocaine, but the differences
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`were “to a variable extent.” EX2060, Abstract, 954. Specifically, both Restylane
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`and Juvéderm gels were found to have “similar viscoelastic characteristics”
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`between the tested versions. Id.
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`The Micheels articles thus show a variety of crosslinking technologies were
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`successfully used in BDDE-crosslinked gels with lidocaine, and even where there
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`are some rheological differences from their non-lidocaine iterations, the overall
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`characteristics for Restylane and Juvéderm were “similar,” “comparable,” or
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`“equivalent.” These articles do not comment on, and are thus irrelevant to, the
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`POSITA’s expectations for making a gel with lidocaine as of the priority date.
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`II. EXHIBITS 2083 AND 2084 (THE VIVACY REPORTS)
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`Allergan asserts that the Vivacy Reports are offered to show “skepticism that
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`a lidocaine-HA-gel could be heat-sterilized without degradation” and the fact that
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`testing was performed at all shows “scientists were ‘concerned’ about lidocaine
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`degradation and ‘in disbelief’ of Molliard’s alleged discovery.” PO Opp. MTE 6.
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`First, Allergan cannot sidestep the hearsay problems by arguing a non-
`
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`2 Micheels 2016 also reports the CPM gel “remains perfectly cohesive with or
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`without … lidocaine.” Id.
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`2
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`
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`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`hearsay purpose because whether “the fact that testing was performed at all” is
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`itself true depends on the statements in the documents. Second, Allergan’s
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`Responses relied not on the fact of the testing but on the “data submitted” within
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`them to “corroborate [the] concern of lidocaine degradation.” Response 32-33
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`(quoting EX2084 for discussion of supposed “detrimental effects”). Again, such a
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`conclusion is only found within the 2014 test report. The earlier Molliard document
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`described, to the contrary, how “addition of a polyol and of lidocaine” together
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`gave “improvement[s] to rheology and “counter[ed] the “three main types of
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`degradation” already known. EX2067, 2:30-53. Instead of indicating the alleged
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`detrimental effect of lidocaine, Molliard “assumed that the lidocaine considerably
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`increases the ability of a polyol to protect a [HA]-based gel.” EX2067, 3:28-32.3
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`Thus, the truth of the “skepticism” about lidocaine versus concern of degradation
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`depends on statements within the reports. These exhibits are hearsay.4
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`3 Notably, none of the Molliard or the Vivacy Reports discuss gels with lidocaine
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`but lacking a polyol; the two are always in conjunction.
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`4 Additionally, even as argued by Allergan, the simple “fact” of testing by a third
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`party during adversarial proceedings does not prove Allergan’s assertion of
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`“disbelief.” The Vivacy Reports and Berkland’s statements lose all weight if not
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`
`
`3
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`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`None of Allergan’s asserted hearsay exceptions justify admission of the
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`Vivacy Reports. First, Allergan merely guesses that the scientists compiled present-
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`sense impressions of instrument data, PO Opp. MTE 7, because the reports contain
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`no indication as to when the tests ran or when the authors “compiled” the results.
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`Moreover, the asserted “skepticism,” “concern,” or “disbelief” that Allergan infers
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`from the authors’ conclusions about the data originated from the speaker—not any
`
`testing instrument. Thus, without knowing when these statements were made,
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`relative to the observed event, FRE 803(1) is no basis for admission.5
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`The state of mind exception also does not apply. Allergan again speculates
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`about “doubt” the authors may have had and the purpose of the test. PO Opp. MTE
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`7-8. But the statements do not show, and are not offered to show, the authors’ state
`
`of mind within the meaning of the rule, such as “motive, intent, or plan” (FRE
`
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`offered for the results and conclusions described in them. And they would
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`contradict the earlier evidence expressing no concerns about lidocaine degradation,
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`and thus cannot be used as evidence of skill in the art. The reports should also be
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`excluded under FRE 402. See Section I, above; Pet. MTE 3 n.4.
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`5 Prollenium doesn’t dispute the documents are authentic copies of what was filed
`
`in the European opposition. See PO Opp. MTE 9 n.4. Prollenium only noted the
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`unidentified authors to show that none are declarants in these IPRs. Pet. MTE 2.
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`4
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`
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`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`803(3)); rather, they state test results and the authors’ conclusions about the results.
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`To the extent the reports could be considered statements of belief, the exception
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`does not apply because those cannot be used, as Allergan submits, “to prove the
`
`fact … believed.” Cf. id. at 7. As explained above, Allergan offers the Vivacy
`
`Reports for the results themselves—not to show why the testing was performed
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`(motive, intent, or plan) as required by FRE 803(3).
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`Last, without citing any hearsay exception, Allergan asserts the Vivacy
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`Reports are admissible “because both parties have cited filings” from the
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`Oppositions, so there is “no prejudice” to Prollenium to admit them. PO Opp. MTE
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`8. But Prollenium’s use of Allergan statements characterizing the state of the art,6
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`which did not refer or relate to Vivacy’s supposed testing, is irrelevant to whether
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`the non-party Vivacy reports are admitted. And the hearsay exceptions concern
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`guarantees of trustworthiness, not “prejudice.”
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`As for Allergan’s argument that paragraph 182 of Berkland’s declaration is
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`admissible even if the Vivacy Reports are not, as noted in Section I above, the later
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`(e.g., 2014) statements purporting to contradict the earlier evidence and
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`assumptions in Molliard are not relevant of the level of skill around 2008. Thus the
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`Vivacy Reports’ probative value cannot “substantially outweigh” anything. And
`
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`6 Allergan doesn’t not dispute these non-hearsay party admissions. FRE 801(d)(2).
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`5
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`
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`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
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`Berkland’s “opinion” simply recites the hearsay evidence about the testing.
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`EX2013 ¶ 182. Allergan cannot simply have Berkland restate another’s
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`conclusions and call it an expert opinion to get around the rule against hearsay.
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`III. THE CITED PORTIONS OF PRESTWICH DEPOSITION
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`Prollenium moves to exclude three portions of Prestwich’s deposition
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`because Allergan’s questions probed topics on which Prestwich did not offer
`
`opinions. Allergan contends these exchanges are admissible because Prestwich
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`“offered opinions in all of these areas.” PO Opp. MTE 11. But Allergan fails to cite
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`anything within Prestwich’s declaration where these “offered opinions” might be
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`found. Instead, Allergan (again) retreads its arguments that Prestwich’s Declaration
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`should be struck or excluded entirely. Id. at 11-12. As to Allergan’s questions about
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`the Grounds in general, Allergan argues these “call[] into question his reliability.”
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`PO Opp. MTE 12. But the cited testimony reflects that Prestwich focused on the
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`necessary technical information to respond to technical issues raised by
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`Berkland/Allergan, not his “reliability.” Likewise, as to the line of questions about
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`the ’519 patent Petition, they were not “germane” to his declaration because it is
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`undisputed (and plain without Allergan “confirm[ing],” PO Opp. MTE 13)
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`Prestwich offered no testimony on those documents or priority dates. The question
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`is not whether the cross-examination was related to the “Grounds” but whether it
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`related to Prestwich’s direct testimony. It was not, so it should not be considered.
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`6
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`
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`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`Respectfully submitted,
`
`/Warren Thomas/
`Warren J. Thomas
`Reg. No. 70,581
`
`
`
`7
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`
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`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. § 42.6(e)(4) and consent of the Patent Owner, I certify
`that on December 22, 2020, a copy of Petitioner’s Reply in Support of Its Motion
`to Exclude was served on the counsel of record by email to:
`aminsogna@jonesday.com
`tweisser@jonesday.com
`cplatt@jonesday.com
`sgeers@jonesday.com
`jhartjes@jonesday.com
`
`
`
`
`
`/Laura Heidt/
`Laura Heidt
`Meunier Carlin & Curfman, LLC
`999 Peachtree St. NE
`Suite 1300
`Atlanta, GA 30309
`
`
`8
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`