Filed: December 22, 2020
`
`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)
`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.
`
`
`
`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)
`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
`
`Exclude (MTE) certain information under the Federal Rules of Evidence (FRE).
`
`I.
`
`EXHIBITS 2059 AND 2060 (THE MICHEELS ARTICLES)
`
`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
`
`knowledge or skill of the POSITA at the time; they cannot be used to contradict the
`
`POSITA’s knowledge at the relevant time. See PO Opp. MTE 4 (agreeing). The
`
`only way Allergan can paint its post-dated exhibits as representing the “state of the
`
`art” is by misconstruing what the documents actually say.
`
`The two “Micheels” papers (EX2059, EX2060), published 8-10 years post-
`
`filing, do not show “unpredictability” in formulating HA fillers or “that creating
`
`crosslinked HA fillers was an uncertain endeavor” as Allergan argues. PO Opp.
`
`MTE 4. Rather, they show “[a]t least 7 different types of crosslinking technology
`
`are used in the production of current HA gels,” all of which are available with
`
`lidocaine introduced during manufacturing. EX2059, 601.
`
`While Micheels 2016 contains one sentence speculating that added lidocaine
`
`“may modify” rheological properties, the authors explained that “differences in the
`
`behavior” of the tested gels came from the “different crosslinking technologies”
`
`used. EX2059, 604, 606. Indeed, Micheels noted that a 2008 test found that
`
`“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
`
`differences when comparing gels with and without lidocaine, but the differences
`
`were “to a variable extent.” EX2060, Abstract, 954. Specifically, both Restylane
`
`and Juvéderm gels were found to have “similar viscoelastic characteristics”
`
`between the tested versions. Id.
`
`The Micheels articles thus show a variety of crosslinking technologies were
`
`successfully used in BDDE-crosslinked gels with lidocaine, and even where there
`
`are some rheological differences from their non-lidocaine iterations, the overall
`
`characteristics for Restylane and Juvéderm were “similar,” “comparable,” or
`
`“equivalent.” These articles do not comment on, and are thus irrelevant to, the
`
`POSITA’s expectations for making a gel with lidocaine as of the priority date.
`
`II. EXHIBITS 2083 AND 2084 (THE VIVACY REPORTS)
`
`Allergan asserts that the Vivacy Reports are offered to show “skepticism that
`
`a lidocaine-HA-gel could be heat-sterilized without degradation” and the fact that
`
`testing was performed at all shows “scientists were ‘concerned’ about lidocaine
`
`degradation and ‘in disbelief’ of Molliard’s alleged discovery.” PO Opp. MTE 6.
`
`First, Allergan cannot sidestep the hearsay problems by arguing a non-
`
`
`2 Micheels 2016 also reports the CPM gel “remains perfectly cohesive with or
`
`without … lidocaine.” Id.
`
`2
`
`
`
`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
`
`itself true depends on the statements in the documents. Second, Allergan’s
`
`Responses relied not on the fact of the testing but on the “data submitted” within
`
`them to “corroborate [the] concern of lidocaine degradation.” Response 32-33
`
`(quoting EX2084 for discussion of supposed “detrimental effects”). Again, such a
`
`conclusion is only found within the 2014 test report. The earlier Molliard document
`
`described, to the contrary, how “addition of a polyol and of lidocaine” together
`
`gave “improvement[s] to rheology and “counter[ed] the “three main types of
`
`degradation” already known. EX2067, 2:30-53. Instead of indicating the alleged
`
`detrimental effect of lidocaine, Molliard “assumed that the lidocaine considerably
`
`increases the ability of a polyol to protect a [HA]-based gel.” EX2067, 3:28-32.3
`
`Thus, the truth of the “skepticism” about lidocaine versus concern of degradation
`
`depends on statements within the reports. These exhibits are hearsay.4
`
`
`3 Notably, none of the Molliard or the Vivacy Reports discuss gels with lidocaine
`
`but lacking a polyol; the two are always in conjunction.
`
`4 Additionally, even as argued by Allergan, the simple “fact” of testing by a third
`
`party during adversarial proceedings does not prove Allergan’s assertion of
`
`“disbelief.” The Vivacy Reports and Berkland’s statements lose all weight if not
`
`
`
`3
`
`
`
`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
`
`Vivacy Reports. First, Allergan merely guesses that the scientists compiled present-
`
`sense impressions of instrument data, PO Opp. MTE 7, because the reports contain
`
`no indication as to when the tests ran or when the authors “compiled” the results.
`
`Moreover, the asserted “skepticism,” “concern,” or “disbelief” that Allergan infers
`
`from the authors’ conclusions about the data originated from the speaker—not any
`
`testing instrument. Thus, without knowing when these statements were made,
`
`relative to the observed event, FRE 803(1) is no basis for admission.5
`
`The state of mind exception also does not apply. Allergan again speculates
`
`about “doubt” the authors may have had and the purpose of the test. PO Opp. MTE
`
`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
`
`
`offered for the results and conclusions described in them. And they would
`
`contradict the earlier evidence expressing no concerns about lidocaine degradation,
`
`and thus cannot be used as evidence of skill in the art. The reports should also be
`
`excluded under FRE 402. See Section I, above; Pet. MTE 3 n.4.
`
`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
`
`unidentified authors to show that none are declarants in these IPRs. Pet. MTE 2.
`
`4
`
`
`
`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.
`
`To the extent the reports could be considered statements of belief, the exception
`
`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
`
`(motive, intent, or plan) as required by FRE 803(3).
`
`Last, without citing any hearsay exception, Allergan asserts the Vivacy
`
`Reports are admissible “because both parties have cited filings” from the
`
`Oppositions, so there is “no prejudice” to Prollenium to admit them. PO Opp. MTE
`
`8. But Prollenium’s use of Allergan statements characterizing the state of the art,6
`
`which did not refer or relate to Vivacy’s supposed testing, is irrelevant to whether
`
`the non-party Vivacy reports are admitted. And the hearsay exceptions concern
`
`guarantees of trustworthiness, not “prejudice.”
`
`As for Allergan’s argument that paragraph 182 of Berkland’s declaration is
`
`admissible even if the Vivacy Reports are not, as noted in Section I above, the later
`
`(e.g., 2014) statements purporting to contradict the earlier evidence and
`
`assumptions in Molliard are not relevant of the level of skill around 2008. Thus the
`
`Vivacy Reports’ probative value cannot “substantially outweigh” anything. And
`
`
`6 Allergan doesn’t not dispute these non-hearsay party admissions. FRE 801(d)(2).
`
`5
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`Berkland’s “opinion” simply recites the hearsay evidence about the testing.
`
`EX2013 ¶ 182. Allergan cannot simply have Berkland restate another’s
`
`conclusions and call it an expert opinion to get around the rule against hearsay.
`
`III. THE CITED PORTIONS OF PRESTWICH DEPOSITION
`
`Prollenium moves to exclude three portions of Prestwich’s deposition
`
`because Allergan’s questions probed topics on which Prestwich did not offer
`
`opinions. Allergan contends these exchanges are admissible because Prestwich
`
`“offered opinions in all of these areas.” PO Opp. MTE 11. But Allergan fails to cite
`
`anything within Prestwich’s declaration where these “offered opinions” might be
`
`found. Instead, Allergan (again) retreads its arguments that Prestwich’s Declaration
`
`should be struck or excluded entirely. Id. at 11-12. As to Allergan’s questions about
`
`the Grounds in general, Allergan argues these “call[] into question his reliability.”
`
`PO Opp. MTE 12. But the cited testimony reflects that Prestwich focused on the
`
`necessary technical information to respond to technical issues raised by
`
`Berkland/Allergan, not his “reliability.” Likewise, as to the line of questions about
`
`the ’519 patent Petition, they were not “germane” to his declaration because it is
`
`undisputed (and plain without Allergan “confirm[ing],” PO Opp. MTE 13)
`
`Prestwich offered no testimony on those documents or priority dates. The question
`
`is not whether the cross-examination was related to the “Grounds” but whether it
`
`related to Prestwich’s direct testimony. It was not, so it should not be considered.
`
`6
`
`
`
`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
`
`
`
`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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