`
`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 Motion to Exclude
`Under 37 C.F.R. § 42.64(c)1
`
`
`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 paper has been
`filed in each case recited in the consolidated caption.
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`TABLE OF CONTENTS
`
`
`I.
`II.
`
`INTRODUCTION ........................................................................................... 1
`ARGUMENT ................................................................................................... 1
`A. Exhibits 2083 and 2084 are inadmissible hearsay .......................................... 1
`B. Multiple exhibits are irrelevant as non-prior art used to argue no expectation
`of success at the time of the priority date ....................................................... 4
`C. Portions of Dr. Prestwich’s deposition testimony are inadmissible because
`Allergan’s questions strayed far beyond the scope of the direct testimony for
`which Prollenium presented him .................................................................... 6
`1. Dr. Prestwich did not offer opinions related to specific grounds in his
`direct testimony .......................................................................................... 8
`2. Dr. Prestwich did not offer opinions regarding the priority date of claims
`in the challenged patents ............................................................................ 9
`3. Dr. Prestwich did not offer testimony regarding the public availability of
`documents submitted to FDA ................................................................... 11
`III. CONCLUSION ............................................................................................. 12
`
`
`
`
`
`
`
`i
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`TABLE OF ABBREVIATIONS
`
`Abbreviation
`BDDE
`Challenged
`Patents
`HA
`POSITA
`1505 Sur-Reply
`0084 Sur-Reply
`Sur-Replies
`
`1505 Response
`
`
`
`
`
`Term
`butanediol diglycidyl ether
`U.S. Patent Nos. 8,450,475; 8,357,795; 9,238,013;
`9,358,322; 8,822,676; and 9,089,519, collectively
`hyaluronic acid
`Person of Ordinary Skill in the Art
`IPR2019-01505, Patent Owner’s Sur-Reply, Paper 52
`IPR2020-00084, Patent Owner’s Sur-Reply, Paper 48
`IPR2019-01505, Patent Owner’s Sur-Reply, Paper 52;
`IPR2019-01506, Patent Owner’s Sur-Reply, Paper 54;
`IPR2019-01508, Patent Owner’s Sur-Reply, Paper 55;
`IPR2019-01509, Patent Owner’s Sur-Reply, Paper 53;
`IPR2019-01617, Patent Owner’s Sur-Reply, Paper 53;
`IPR2019-01632, Patent Owner’s Sur-Reply, Paper 54; and
`IPR2020-00084, Patent Owner’s Sur-Reply, Paper 48,
`collectively
`IPR2019-01505, Patent Owner Response, Paper 41 (cited as
`exemplary of citations for the remaining proceedings)
`
`ii
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`I.
`
`INTRODUCTION
`
`Under 37 C.F.R. § 42.64(c), Petitioner Prollenium US Inc. (“Prollenium”)
`
`moves to exclude certain evidence, submissions, and information presented by
`
`Patent Owner Allergan Industrie, SAS (“Allergan”) in the IPRs of the Challenged
`
`Patents. A single, combined motion to exclude is filed in each proceeding in the
`
`joint caption above, given the overlap in evidence and issues.2
`
`II. ARGUMENT
`
`As described below, certain of Petitioner’s evidence should be excluded and
`
`not considered by the Board under applicable rules of the Federal Rules of
`
`Evidence (“FRE”) or rules of the Board. Petitioner timely objected to this evidence
`
`in accordance with 37 C.F.R. § 42.64 (whether by filing or on the record during a
`
`deposition). See, e.g., Petitioner’s Objections, IPR2019-01505, Paper 42 (filed in
`
`each proceeding).
`
`A. Exhibits 2083 and 2084 are inadmissible hearsay
`
`Statements by a declarant not made in this proceeding offered to prove the
`
`truth of the matter asserted in the statement are inadmissible as hearsay. FRE
`
`801(c). Allergan’s Exhibits 2083 and 2084 are inadmissible as hearsay without an
`
`exception.
`
`
`2 The Board authorized this combined motion by email on December 8, 2020.
`
`1
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`These two exhibits contain lab reports submitted by a third-party, Vivacy
`
`Laboratories, during its opposition proceedings of European Patent EP2349203
`
`(the “Vivacy Reports”). EX2083, 1; EX2084, 1; see also EX2050 ¶¶ 7-8.3 The
`
`Vivacy Reports purportedly provide the results of two sets of testing on rheological
`
`properties of the HA gels with lidocaine and polyols claimed in those patents,
`
`before and after sterilization. Id. The documents are signed by three individuals
`
`collectively (some of whose identities cannot even be determined), in 2010 and
`
`2014. EX2083, 3; EX2084, 6 (noting “illegible” signatures on original French
`
`document at page 12). None of those declarants, whoever they are, have offered
`
`testimony in these IPRs.
`
`Both Allergan and its declarant Dr. Berkland rely on these declarants’
`
`statements—testing supposedly performed by the individuals identified within the
`
`documents, as well as those individuals’ conclusions about the testing, contained
`
`within the documents—for their truth. Allergan offers the Vivacy Reports to allege
`
`“surprise” or “disbelief” at the ability to sterilize an HA filler with lidocaine due to
`
`supposed concerns with lidocaine degradation. E.g., 1505 Response 34-35. Dr.
`
`Berkland similarly cites the Vivacy Reports because they “showed” that lidocaine
`
`
`3 The opposed patent is the European counterpart of Allergan’s Molliard exhibit.
`
`See EX2067, 1(30); see also 1505 Sur-Reply 11.
`
`2
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`had “deleterious effects” and “degraded” the tested gels. EX2013 ¶ 182.
`
`Specifically, the truth they point to is that lidocaine compositions degrade with
`
`heat sterilization; indeed, the testing and results described in the documents can
`
`only corroborate Allergan’s arguments if they are true. E.g., 1505 Response 35.
`
`This is the epitome of hearsay. See, e.g., US Endodontics, LLC v. Gold Std.
`
`Instruments, LLC, No. PGR2015-00019, 2016 WL 7985423, at *16 (P.T.A.B. Dec.
`
`28, 2016) (excluding test reports relied upon for the truth of their results as
`
`hearsay). Nor can Dr. Berkland rely on these hearsay statements made in service of
`
`an adversarial proceeding by another party challenging an unrelated patent; the
`
`statements were made long after the priority date for expectation of success (in
`
`2010 and 2014, respectively) and offered to show “influence of lidocaine in the
`
`presence of mannitol.” EX2084, 2 (emphasis added).4
`
`Thus, Exhibits 2083-2084 and Dr. Berkland’s testimony relying on them
`
`(EX2013 ¶ 182) should be excluded.
`
`
`4 Prollenium also objected and now moves to exclude under FRE 402 on this basis
`
`and for the same reasons as the inadmissible exhibits discussed in Section II.B.
`
`3
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`B. Multiple exhibits are irrelevant as non-prior art used to argue no
`expectation of success at the time of the priority date
`
`Exhibits 2059-2060 are not admissible as irrelevant because they are non-
`
`prior art improperly relied upon by Allergan to allege a lack of a reasonable
`
`expectation of success. Irrelevant evidence is not admissible. FRE 402. Evidence is
`
`relevant if “it has any tendency to make a fact more or less probable than it would
`
`be without the evidence” and “the fact is of consequence in determining the
`
`action.” FRE 401. Reasonable expectation of success is evaluated at or around the
`
`priority date, not based on privately conducted, litigation-driven testing years later.
`
`See Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 976 (Fed.
`
`Cir. 2014); cf. NantKwest, Inc. v. Lee, 686 Fed. App’x 864, 868 n.2 (Fed. Cir. 2017)
`
`(finding that the post-filing failure of clinical trials was irrelevant to the question of
`
`whether there was an expectation of success at the time of the priority date).5
`
`Here, Allergan cites Exhibits 2059-2060 as evidence of an alleged lack of
`
`expectation of success—however, all these exhibits long post-date the August 2008
`
`priority date of the Challenged Patents.
`
`
`5 While non-prior art may be used for some purposes, showing a reasonable
`
`expectation of success is not among them. See Yeda Research v. Mylan Pharms.
`
`Inc., 906 F.3d 1031, 1041-42 (Fed. Cir. 2018).
`
`4
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`Exhibit 2059 is an article published in 2016 that analyzes the properties of
`
`seven different HA gels with lidocaine that used various crosslinking technologies
`
`(NASHA, CPM, 3D Matrix, IPN-Like, RHA, Vycross, and OBT). EX2059, 600.
`
`Allergan cites Exhibit 2059 to argue that, among products that use BDDE as the
`
`crosslinker, different crosslinking processes result in “vastly different final
`
`products.” E.g., 1505 Response 10. However, the analysis detailed in Exhibit 2059
`
`was not completed before the priority date—in fact, at least three of the HA gels
`
`were not even tested until 2014. EX2059, 602.
`
`Exhibit 2060 is an article published in 2018 that examines the rheological
`
`properties of several gels with and without lidocaine and concludes that adding
`
`lidocaine appeared to “modify their rheological properties … to a variable extent.”
`
`EX2060, Abstract, 954. Allergan relies on both Exhibits 2059 and 2060 to argue
`
`that the addition of lidocaine to the HA gels tested in Exhibits 2059-2060 modifies
`
`the rheological properties of the HA gel. E.g., 1505 Response 15. Again, the 2018
`
`information was not available to a POSITA anywhere near the priority date. In fact,
`
`the author suggests it was new in that he notes Allergan had “presented” its then-
`
`new lidocaine product as “similar to its predecessor … with lidocaine ‘simply’
`
`added to the product, associated with strictly the same injectability for both
`
`products,” but that he had a “different impression” based on his own clinical
`
`experience with the product. EX2060, 952-54; see also id. at 954 (noting his
`
`5
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`rheological testing showed Juvéderm Ultra 3 product values were “fairly close” to
`
`those of the non-lidocaine predecessor). Thus, the reference itself indicates
`
`whatever teachings it imparts was not necessarily known closer to the time of the
`
`invention.
`
`While non-prior art may be relevant to expectation of success if the non-
`
`prior art indicates what was expected by a POSITA at the time of the priority date,
`
`Allergan has not utilized the evidence in this way. In fact, Allergan explicitly relies
`
`on Exhibits 2059 and 2060 to allege expectation of success “several years after the
`
`priority date.” E.g., 1505 Response 15. Thus, Allergan cites these exhibits to show
`
`a POSITA’s expectation of success at an immaterial point in time. Because non-
`
`prior art is irrelevant to the issue of expectation of success, Exhibits 2059-2060
`
`should be excluded under FRE 401/402.
`
`C.
`
`Portions of Dr. Prestwich’s deposition testimony are inadmissible
`because Allergan’s questions strayed far beyond the scope of the
`direct testimony for which Prollenium presented him
`
`Dr. Prestwich’s direct testimony (EX1105) was narrowly focused on
`
`responding to certain factual issues—primarily related to motivation to combine
`
`and the reasonable expectation of success—subsidiary to the ultimate conclusion
`
`of obviousness for two groups of Grounds in Prollenium’s IPRs. Prollenium did
`
`not present direct testimony or opinions from Dr. Prestwich with respect to all
`
`instituted Grounds (or even opinions related to all of the references cited in the
`
`6
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`petitions). Rather, as Dr. Prestwich noted during cross-examination, his direct
`
`testimony was provided in “response to the declaration of Dr. Berkland” and thus
`
`was limited to “necessary information” relevant to evaluating Dr. Berkland’s
`
`opinions. EX2200, 81:23-24; 466:17-21. That “necessary information” included
`
`the bases for his opinions, including “the technology and concepts relating to
`
`properties of [HA] dermal fillers” and “clarifications” or “corrections of matters
`
`represented incompletely or inaccurately by Dr. Berkland.” EX1105 ¶¶ 2-4. A
`
`cursory review of even the Table of Contents for his declaration shows the vast
`
`majority of his testimony focuses on these technical issues, and even more
`
`specifically on the factual question of expectation of success, in response to the
`
`similar focus by Allergan and Dr. Berkland on those issues. See, e.g., EX1105, 2-3
`
`(Sections VII, IX.A.1, and IX.B.1 addressing motivations comprising 3 pages,
`
`while Sections VIII, IX.A.2, and IX.B.2 addressing issues about expectation of
`
`success comprising at least 40 pages).
`
`During Prestwich’s cross-examination, however, Allergan posed several
`
`lines of questions that were outside the scope of his narrow, direct testimony.
`
`Prollenium objected on the record, pursuant to 37 C.F.R § 42.64(a), and Prollenium
`
`now moves to exclude the improper cross-examination testimony cited in the Sur-
`
`7
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`Replies that is unrelated to the issues for which Dr. Prestwich was offered. See
`
`FRE 611(b) and 37 CFR § 42.53(d)(5)(ii).6
`
`In particular, the following cross-examination testimony (EX2200) upon
`
`which Allergan relies in its Sur-Replies should be excluded: 429:10 to 432:13,
`
`432:15 to 433:25, 434:2-20, 434:22 to 436:15, 437:4-16, and 445:13 to 450:2.
`
`1.
`
`Dr. Prestwich did not offer opinions related to specific
`grounds in his direct testimony
`Allergan’s Sur-Replies criticize Dr. Prestwich’s testimony as “incomplete”
`
`because he “did not opine on all references in the grounds,” 1505 Sur-Reply 6-7,
`
`citing to Dr. Prestwich’s cross-examination testimony at EX2200, 429:10 to
`
`432:13.
`
`In the cited passage, Allergan asked numerous questions regarding the
`
`composition of the Grounds, including whether Piron 2008 (EX1210), Monheit
`
`
`6 Prollenium similarly objected to several other portions of the deposition
`
`testimony that Allergan has not cited it in its merits briefing, so there is no cause to
`
`move to exclude it at this time. To the extent that Allergan cites any new,
`
`previously uncited testimony of Dr. Prestwich (or Dr. DeVore, for that matter) in
`
`further papers, Prollenium will address its inadmissibility, if needed, at that time.
`
`8
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`(EX1022), and Smith (EX1009) were included in any of the instituted Grounds.7
`
`These questions were outside the scope of his direct testimony and pertain to legal
`
`conclusions about the structure and selection of Prollenium’s Grounds in the
`
`Petition. Cf. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018) (“[T]he
`
`petitioner is master of its complaint ….”). Prollenium objected to the line of
`
`questions based on scope and form of the question on that basis. In fact, Dr.
`
`Prestwich noted that the particular Grounds were a “legal point” that he was “not
`
`clear on” at the time of his testimony. EX2200, 431:9-10. The Board should
`
`exclude the cross-examination testimony at 429:10 to 432:13 (cited at, e.g., 1505
`
`Sur-Reply 7).
`
`2.
`
`Dr. Prestwich did not offer opinions regarding the priority
`date of claims in the challenged patents
`Allergan’s Sur-Reply cites Prestwich’s cross-examination testimony at
`
`EX2200, 432:15-433:25, 434:2-20, 434:22-436:15, and 437:4-16 to support the
`
`contention that Dr. Prestwich “never opined that any of the claims lack priority.”
`
`
`7 E.g., “Are you aware of Smith being a ground of the petition?” and “Do you
`
`understand that there is a distinction between what is in the grounds and what other
`
`exhibits are being offered?”
`
`9
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`0084 Sur-Reply 24.8 Allergan is free argue in its brief—correctly—that Dr.
`
`Prestwich offered no testimony related to the lack-of-priority arguments raised in
`
`the IPR challenging the ’519 patent. Prollenium’s Reply does not rely on any reply
`
`declarant for that issue. See IPR00084, Reply 39-41.
`
`So it is improper to question and cite Dr. Prestwich’s testimony on an issue
`
`Allergan concedes was not part of his direct testimony. In these passages,
`
`Allergan’s counsel asked questions about the priority applications to which the
`
`Challenged Patents claim priority as well as about the Weinkle, Juvéderm Ultra
`
`Plus XC PMA Memo, and the 2010 Lebreton ’438 publications (EX1070, EX1060,
`
`and EX1072) that are only used in the anticipation Grounds 1-3 of the petition
`
`challenging the ’519 patent. Allergan then cites five pages of deposition testimony
`
`for the simple, indisputable proposition that Prestwich never opined on priority.
`
`Thus, this testimony is outside of the scope of Dr. Prestwich’s direct testimony and
`
`relates to legal conclusions, as Prollenium objected on the record. The testimony at
`
`EX2200, 432:15-433:25, 434:2-20, 434:22-436:15, and 437:4-16 (cited at 0084
`
`Sur-Reply 24) should be excluded.
`
`
`8 While denominated as four separate citations, in reality, these citations encompass
`
`all but about 11 lines of the testimony between 432:15 to 437:16—five pages
`
`worth of testimony.
`
`10
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`
`3.
`
`Dr. Prestwich did not offer testimony regarding the public
`availability of documents submitted to FDA
`In its Sur-Replies, Allergan contends that Elevess required modifications
`
`(the details of which were not publicly available) to address shelf-life issues. E.g.,
`
`1505 Sur-Reply 18. Allergan seeks to support this allegation by citing Dr.
`
`Prestwich’s Cross-Examination Testimony at EX2200, 445:13-450:2. Id.
`
`In this portion of testimony, Allergan asked numerous questions regarding a
`
`PMA supplement (EX2123). Allergan then cites five pages of deposition testimony
`
`to support the contention that the manufacturing modifications underlying a PMA
`
`supplement were not publicly available. Allergan’s citation is a transparent attempt
`
`to bolster its positions using improper cross-examination outside the scope of Dr.
`
`Prestwich’s direct. But both Allergan’s own witness and DeVore had previously
`
`testified a POSITA would not have had access to the underlying details associated
`
`with such a submission. See, e.g., EX1200, 333:25-334:23; EX2100, 248:10-19.
`
`Whatever modifications Anika may have chosen to make after Elevess was
`
`approved by FDA in 2006 are separate from Dr. Prestwich’s limited testimony
`
`regarding Elevess—that a POSITA would have known that Elevess was approved
`
`by FDA for use as a dermal filler and stable. EX1105 ¶ 162. Thus, the cited cross-
`
`examination testimony is outside of the scope of Dr. Prestwich’s direct testimony.
`
`11
`
`
`
`IPR2019-01505, IPR2019-01506, IPR2019-01508, IPR2019-01509,
`IPR2019-01617, IPR2019-01632, IPR2020-00084
`
`Therefore, the Board should exclude the cross-examination testimony at EX2200,
`
`445:13-450:2 (cited at, e.g., 1505 Sur-Reply 18).
`
`III. CONCLUSION
`
`For the foregoing reasons, the challenged evidence does not meet the
`
`threshold for admissibility and should be excluded from the record.
`
`Respectfully submitted,
`
`
`
`/Warren Thomas/
`Warren J. Thomas
`Reg. No. 70,581
`Meunier Carlin & Curfman, LLC
`999 Peachtree St. NE
`Suite 1300
`Atlanta, GA 30309
`
`12
`
`
`
`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 9, 2020, a copy of Petitioner’s Motion to Exclude under 37
`C.F.R. § 42.64(c) 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
`
`
`13
`
`