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 MOTION TO EXCLUDE EVIDENCE1
`
`
`
`
`1 Authorization for Allergan to file a single motion to exclude, not to exceed
`
`18 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 MOTION TO EXCLUDE EVIDENCE1
`
`
`
`
`1 Authorization for Allergan to file a single motion to exclude, not to exceed
`
`18 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 CONTENTS
`
`
`Page
`
`
`INTRODUCTION .......................................................................................... 1
`I.
`BACKGROUND ............................................................................................ 2
`II.
`III. THE EXPERT TESTIMONY (EX1002, EX1105) IS UNRELIABLE ......... 3
`A. Dr. DeVore’s Unreliable Testimony Is Not Factually Grounded ........ 4
`B.
` Dr. Prestwich’s Testimony Is Likewise Not Reliable ......................... 5
`1.
`Dr. Prestwich’s New Claim Construction Lacks Support ......... 5
`2.
`Dr. Prestwich’s Scientific Theories Lack Support And
`Are Contracted By His Own Prior Testimony And
`Publications ................................................................................ 6
`IV. DR. PRESTWICH’S DECLARATION IS UNFAIRLY
`PREJUDICIAL ............................................................................................... 8
`A. New Claim Construction Argument ................................................... 10
`B. New Arguments And Evidence On Sadozai And Lebreton ............... 10
`C. New Arguments And Evidence On Kinney And Zhao ...................... 11
`D. Other New Arguments And Evidence ................................................ 12
`E.
`Petitioner Cannot Erase Dr. DeVore’s Unreliable Testimony
`With Dr. Prestwich’s New Testimony ............................................... 13
`Dr. Prestwich’s Declaration Evades Sections 314 And 325(d) ......... 15
`F.
`G. Dr. Prestwich’s Declaration Fails To Comply With Board Rules ..... 16
`V. MANY EXHIBITS DO NOT COMPORT WITH THE FEDERAL
`RULES OF EVIDENCE OR THE BOARD’S REGULATIONS ............... 16
`A.
`EX1077, EX1086, EX1102, EX1103, EX1116, EX1117, And
`EX1202 Should Be Excluded As Irrelevant ....................................... 17
`
`
`
`
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`-i-
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`
`
`
`
`TABLE OF CONTENTS
`(continued)
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`Page
`
`
`
`B.
`
`C.
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`EX1104 Should Be Excluded For Hearsay, Irrelevance, And
`For Petitioner’s Failure To Provide A Translation ............................ 17
`EX1083, EX1088, EX1107, EX1111, EX1114, EX1115,
`EX1116, and EX1117 Are Improperly Incorporated by
`Reference ............................................................................................ 17
`EX1076, EX1081, EX1085, EX1086, EX1087, EX1089,
`EX1090, and EX1202 Should Be Excluded as Irrelevant ................. 18
`VI. CONCLUSION ............................................................................................. 18
`
`D.
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`-ii-
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`I.
`
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c), Patent Owner Allergan Industrie, SAS
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`(“Allergan”) moves to exclude the declarations of Dr. Dale DeVore (EX1002) and
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`Dr. Glenn Prestwich (EX1105) and other exhibits as violating the Federal Rules of
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`Evidence and regulations governing inter partes review.2 Patent Owner timely
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`objected on August 19, 2020 (Paper 39) and November 12, 2020 (Paper 46).
`
`
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`Dr. DeVore offered conclusory, unreliable opinions untethered to the
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`science, contradicted by his own contemporaneous patents, and which he
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`abandoned on cross. His declaration should be excluded under Rule 702 and for
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`lack of candor. For its Replies, however, Petitioner turned to a new expert, Dr.
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`Prestwich, who submitted declarations in prior unsuccessful IPR challenges for
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`two patents at issue.3 Dr. Prestwich’s declaration here, and the new evidence he
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`cites, should be excluded as untimely, unfairly prejudicial, irrelevant, unreliable,
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`and violating the APA, AIA, and Board rules.
`
`
`2 All bases for exclusion of evidence pertain to all related IPRs unless
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`otherwise noted. Common citations are to documents filed in the -01617 IPR.
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`3 EX2200G and EX2200I (Teoxane v. Allergan, IPR2017-01906 and -02002
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`(institution denied on merits)); EX2200B and EX2200E (Galderma v. Allergan,
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`IPR2014-01417 and -01422). The ’519, ’013, and ’322 patents issued after the
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`examiner considered the Galderma declarations. EX2200L; EX2200M; EX2200N.
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`
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`1
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`
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`
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`II. BACKGROUND
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`
`
`From August to October 2019, Petitioner filed seven IPR petitions for the
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`six patents at issue, along with extensive declaration testimony from Dr. DeVore.
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`Paper 2; EX1002. Dr. DeVore’s then-unrebutted declaration was “at the core of
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`[the Board’s] decision whether to institute.” Paper 17 at 25 (PTAB, Mar. 20,
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`2020). Allergan cross-examined Dr. DeVore in August 2020, where he
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`acknowledged that his declaration does not reflect the complex state of the art and
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`uses hindsight. Paper 40 at 26-29. Dr. DeVore repeatedly reversed course from
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`his declaration, acknowledging he does not agree with the purported ease of the art.
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`Id. On September 1, 2020, Allergan filed its Responses, along with an expert
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`declaration from Dr. Berkland, well-supported by the contemporaneous literature,
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`and Dr. DeVore’s cross-examination.
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`
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`Shortly after Dr. DeVore’s deposition, Petitioner hired Dr. Prestwich.
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`EX2200, 17:11-16. In November 2020, Petitioner filed its Replies and a new 109-
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`page declaration by Dr. Prestwich. Allergan objected to Dr. Prestwich’s
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`declaration and sought approval to move to strike or, in the alternative, to submit
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`responsive evidence, which was denied. EX3003.4 Instead, the Board permitted a
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`short paper identifying improper arguments and evidence. Allergan then had a
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`4 Allergan understands that Paper 50 preserves its request to strike the
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`material identified there and does not duplicate that earlier request in this motion.
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`
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`2
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`
`
`
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`month to depose Dr. Prestwich and file its Sur-Replies.
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`III. THE EXPERT TESTIMONY (EX1002, EX1105) IS UNRELIABLE
`
`The Federal Rules of Evidence govern expert testimony in these IPRs. 3d-
`
`Matrix, Ltd. v. Menicon Co., IPR2014-00398, Paper 11 at 8 n.4 (PTAB, Aug. 1,
`
`2014). Expert testimony must be “based on sufficient facts or data” and “the
`
`product of reliable principles and methods” that are reliably applied to the facts of
`
`the case. Fed. R. Evid. 702, 703. The Board acts in “a gatekeeping role,” to
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`ensure the “scientific validity—and thus the evidentiary relevance and
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`reliability”—of any expert testimony. Daubert v. Merrell Dow Pharm., Inc., 509
`
`U.S. 579, 594–95, 597 (1993).
`
`
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`Here, both of Petitioner’s experts present unreliable testimony. They ask the
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`Board to believe that dermal fillers do not involve complex science and that
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`different components can be easily added, removed, and switched—all of which is
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`contradicted by the prior art, including their own writings. Allergan notes the
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`examples below, but both declarations are rife with similar infirmities, and should
`
`be excluded entirely under Rule 702. E.g., Intelligent Bio-Sys. v. Illumina
`
`Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Their opinions are not
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`“facts or data,” or “reliable principles and methods,” Fed. R. Evid. 702, and do not
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`“flow from existing research.” Daubert v. Merrell Dow Pharm., Inc., 43 F.3d
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`1311, 1317 (9th Cir. 1995).
`
`
`
`
`
`3
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`
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`
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`A. Dr. DeVore’s Unreliable Testimony Is Not Factually Grounded
`Dr. DeVore’s cross-examination revealed that his declaration (EX1002) is
`
`unreliable. Dr. DeVore conceded that he does not understand the relevant
`
`chemistry, and his declaration is litigation-driven and based on hindsight.
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`On cross-examination, Dr. Devore acknowledged unpredictability. EX2100,
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`103:20-104:4. All three experts agreed that a POSA must know the chemical
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`structures of the components (e.g., HA, lidocaine, crosslinkers) to understand any
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`interactions. EX2100, 45:17-47:8, 357:14-358:1; EX2200, 154:6-24; EX2013,
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`IV.E.2. But Dr. DeVore did not know the structures and was “not prepared to
`
`answer questions” about “how lidocaine interacts with HA.” EX2100, 359:6-
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`359:13. Dr. DeVore’s unreliable arguments (see Section IV.E., infra) warrant
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`exclusion under Fed. R. Evid. 702, and Petitioner’s unfairly prejudicial submission
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`of new Reply arguments and exhibits cannot cure.
`
`Dr. DeVore’s obviousness opinions are also rooted in hindsight, rendering
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`them unusable. Dr. DeVore conceded that he identified the claim limitations, and
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`then found “each of the pieces of that puzzle in individual prior art references.”
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`EX2100, 371:24-372:5. But obviousness “cannot be based on the hindsight
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`combination of components selectively culled from the prior art to fit the
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`parameters of the patented invention." ATD Corp. v. Lydall, Inc., 159 F.3d 534,
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`546 (Fed. Cir. 1998). Moreover, he did not put forward any reasonable expectation
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`
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`4
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`
`
`
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`of success on any specific ground across all the IPRs. EX2100, 470:21-474:11.
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`Dr. DeVore’s use of hindsight and failure to address essential obviousness
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`elements make his opinions inadmissible. See, e.g., Innogenetics, N.V. v. Abbott
`
`Labs., 512 F.3d 1363, 1374 n.2 (Fed. Cir. 2008).
`
`Dr. DeVore’s unreliability is further highlighted by his disregard for his duty
`
`of candor under 37 CFR § 42.1. He purposely misrepresented his credentials—that
`
`he had degrees in Biochemistry (not Food Science)—facts directly relevant to
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`issues here such as the POSA definition. EX2100, 311:11-314:10. And even if his
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`coursework included some biochemistry, it does not excuse his lack of candor and
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`taints all his testimony. BlackBerry Corp. v. Zipit Wireless, Inc., IPR2014-01506,
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`Paper 50 at 10 (PTAB, Mar. 29, 2016). EX1002 should be excluded under Rule
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`702.
`
`
`
`B.
`
` Dr. Prestwich’s Testimony Is Likewise Not Reliable
`Dr. Prestwich’s New Claim Construction Lacks Support
`1.
`Dr. Prestwich’s claim construction for “freely released” (improperly new,
`
`see Section IV.A) is unreliable. Dr. Prestwich offers a new claim construction that
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`“freely release” is the same as “controlled release.” EX1105, ¶¶ 36-37, 82
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`(“control of release allows for free release to occur by not restricting release”).
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`Neither Dr. DeVore nor Petitioner put forward that (or any) construction for
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`“freely released.” EX2200, 30:14-21. Dr. Prestwich’s construction is unsupported
`
`
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`5
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`
`
`
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`in the intrinsic record, and the extrinsic record contradicts him, too, including FDA
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`regulations, EX2200, 378:5-395:19; EX2200W (likening “controlled-release” to
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`“prolonged” release) and contemporaneous treatises, EX2200Z (describing
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`“controlled-release” and “sustained-release” as “slow”); EX2200ZZ (defining
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`“controlled-release” as “slower-than-normal”); EX2200AAA (describing
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`“controlled release” as “more consistent and stable [levels] compared to immediate
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`release”). Indeed, his own patent uses “sustained” and “controlled” release
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`interchangeably. EX2200CC, 1:65-2:5, 4:11-15 ( “non-covalent interactions”
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`between the drug and “modified HA functions as a vehicle which provides the
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`controlled release of a drug”).
`
`2.
`
`Dr. Prestwich’s Scientific Theories Lack Support And Are
`Contracted By His Own Prior Testimony And Publications
`Dr. Prestwich purports to calculate the osmolarity change from adding
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`
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`lidocaine HCl to a precursor HA gel and opines that the increase in ionic strength
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`caused by addition of 0.3% lidocaine HCl would not have discouraged a POSA
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`from combining lidocaine with a BDDE-crosslinked HA filler because a 10%
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`change in osmolarity would not impact the HA filler. EX1105, ¶¶ 52-56. This
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`unsupported assertion contradicts his prior testimony that the addition of the acidic
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`lidocaine HCl promotes HA degradation, and this degradation “may be more
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`pronounced” during autoclaving. EX2200G, ¶¶ 181, 183.
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`6
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`
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`Galderma/Teoxane Declarations, ¶ 83
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`Redline to EX1105, ¶ 176
`
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`To support his opinion on lidocaine precipitation due to pH increase, Dr.
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`Prestwich cites (but does not make an exhibit) a webpage for the aqueous solubility
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`of lidocaine free base. EX1105, ¶ 62. But Dr. Prestwich ignores that the PubChem
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`webpage reports three other values—each at least ten times lower than Dr.
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`Prestwich’s cherry-picked value. EX2200FFF. And Dr. Prestwich deleted his
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`prior testimony where he conceded that lidocaine freebase is nearly insoluble in
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`water. Compare EX1105, ¶ 173, with EX2200G, ¶ 82; Sur-Reply at 16.
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`
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`While Dr. Prestwich and Petitioner argue that BDDE and DEO are similar,
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`Dr. Prestwich’s published articles and patents contradict that. EX2200FF (article
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`stating “chemical nature of linker” affects filler properties); EX2200HH, col. 9, ll.
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`1-5 (Prestwich patent stating that HA gels “may be tailored” “[b]y appropriate
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`selection of a particular [BCDI crosslinker]”). And while Dr. Prestwich previously
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`recognized the differences in hydrophilicity and reactivity between BDDE and
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`DEO, he deleted that information here. EX2200, 279:1-280:7.
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`7
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`Galderma/Teoxane Declarations, ¶ 47
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`Redline to EX1105, ¶ 148
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`
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`Dr. Prestwich’s carefully edited opinions were “developed . . . expressly for
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`purposes of testifying.” Daubert, 43 F.3d at 1317. Indeed, Dr. Prestwich has
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`opined that an expert witness “cannot be reasonable and admit to the possibility
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`that more than one explanation is valid, that more than one rationale exists, or that
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`more than one method can be used.” EX2200V. His testimony has no indicia of
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`reliability, and EX1105 should be excluded under Fed. R. Evid. 702 and 703.
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`IV. DR. PRESTWICH’S DECLARATION IS UNFAIRLY PREJUDICIAL
`
`Even if Dr. Prestwich’s testimony meets the requirements of Rules 702 and
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`703 (it does not), the Board should exclude EX1105 as “its probative value is
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`substantially outweighed by a danger of . . . unfair prejudice.” Fed. R. Evid. 403.
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`Allowing EX1105, the new exhibits cited therein, and the citations to new portions
`
`of exhibits would unfairly prejudice Allergan as Petitioner’s submission of such
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`new evidence on Reply denies Allergan its rights under the AIA and APA. Board
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`proceedings are designed to focus on resolution of the issues raised in the Petition,
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`which must identify the grounds asserted and “identify ‘with particularity’ the
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`8
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`
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`‘evidence that supports the grounds for the challenge to each claim.’” Intelligent
`
`Bio-Sys., 821 F.3d at 1367–68 (citations omitted). Petitioner cannot wait until its
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`Reply to raise issues or present key evidence that cannot be met with Patent
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`Owner’s responsive evidence. See Intri-Plex Techs., Inc. v. Saint-Gobain
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`Performance Plastics Rencol Ltd., IPR2014-00309, Paper 83 at 13 (PTAB, Mar.
`
`23, 2015) (“[I]t is improper to sandbag one’s opponent by raising new matter in
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`reply.” (citation omitted)). Instead, to ensure compliance with the APA, the Board
`
`must “‘timely inform[]’ the patent owner of ‘the matters of fact and law asserted,’”
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`provide it an “opportunity for the submission and consideration of facts [and]
`
`arguments,’” and allow it “‘to submit rebuttal evidence . . . as may be required for
`
`a full and true disclosure of the facts.’” Dell Inc. v. Acceleron, LLC, 818 F.3d
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`1293, 1301 (Fed. Cir. 2016) (quoting Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064,
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`1080 (Fed. Cir. 2015)). A patent owner is deprived of that opportunity where a
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`petitioner changes the “thrust” of its challenge in reply. In re NuVasive, Inc., 841
`
`F.3d 966, 972 (Fed. Cir. 2016) (citation omitted). The opportunity to file a
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`responsive paper is an inadequate “substitute for the opportunity to present new
`
`arguments and evidence.” Id. at 972–73; see also Nestle-Purina Petcare Co. v.
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`Oil-Dri Corp. of Am., IPR2015-00737, Paper 37 at 24 (PTAB, Jun. 20, 2016)
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`(declining to consider new expert’s reply testimony where patent owner could no
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`longer respond).
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`
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`9
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`
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`Petitioner has deprived Allergan of adequate notice and opportunity to
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`respond to the new arguments and evidence raised in EX1105, and any probative
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`value is greatly outweighed by the unfair prejudice against Allergan. Petitioner’s
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`violation of the statutes and regulations governing IPRs is compounded by the fact
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`that Dr. Prestwich’s prior declarations were available when the Petitions were
`
`filed, yet omitted from the Petitions. EX2200, 23:10-18. It should be excluded
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`under Fed. R. Evid. 403.
`
`A. New Claim Construction Argument
`Dr. Prestwich’s new claim construction of “freely released” (see Section
`
`
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`II.B.1, supra) warrants exclusion of EX1105 because the “[patent owner] was
`
`denied the opportunity to file responsive evidence.” See The Scotts Co., LLC v.
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`Encap, LLC, IPR2013-00110, Paper 79 at 5-6 (PTAB, Jun. 24, 2014).
`
`B. New Arguments And Evidence On Sadozai And Lebreton
`EX1105 alters the instituted ground, Lebreton in view of Sadozai, to just
`
`
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`Lebreton and cites new EX2067 to support the claim that a POSA would have
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`added lidocaine to Lebreton’s BDDE-crosslinked HA filler. EX1105, ¶ 163; see
`
`also Reply at 27 (“Prollenium’s Ground is that a POSITA would simply add
`
`lidocaine to Lebreton’s gels.”). Dr. Prestwich also offers a new basis for
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`reasonable expectation of success by citing a new reference, EX1216, to allegedly
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`show that POSAs “knew that 0.3% (w/w) lidocaine had been used in [Elevess]”
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`
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`10
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`
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`and that Elevess included a pBCDI-crosslinked HA filler, and thus POSAs would
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`have expected it to work in a BDDE-crosslinked HA filler as well. EX1105, ¶¶ 39,
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`63, 159; EX2200, 264:4-8. In contrast, the references filed with the Petitions did
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`not show that Elevess used the pBCDI crosslinker; Dr. DeVore simply assumed it
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`based on his personal knowledge. EX2100, 111:21-24.
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`
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`Presenting a prima facie case of obviousness is something Petitioner was
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`required to do in its Petitions. Wasica Fin. GmbH v. Cont’l Auto. Sys., 853 F.3d
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`1272, 1286–87 (Fed. Cir. 2017) (citing new evidence in reply to meet claim
`
`limitations is not identifying grounds “with particularity”). Thus, Dr. Prestwich’s
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`new testimony and new exhibits EX2067 and EX1216 are improper, and Allergan
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`would be unfairly prejudiced should the Board consider them. See Nestle-Purina,
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`IPR2015-00737, Paper 37 at 24 (rejecting Petitioner’s “attempts to provide new
`
`arguments and evidence that were not set forth clearly in the Petition”).
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`C. New Arguments And Evidence On Kinney And Zhao
`Dr. Prestwich also makes new arguments in his discussion of the Kinney and
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`
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`Zhao grounds. EX1105, ¶¶ 96-119. First, Dr. Prestwich argues motivation to
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`combine by previously uncited Tables 1-3 in Zhao, along with new EX1112, to
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`allegedly show “structurally diverse crosslinkers” and that methods of making
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`them were well-known. EX1105, ¶ 118. But reply testimony cannot cite
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`“previously unidentified portions of a prior-art reference to make a meaningfully
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`
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`11
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`
`
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`distinct contention.” Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359,
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`1367 (Fed. Cir. 2015). Dr. Prestwich also newly alleges that a POSA would have
`
`been motivated to combine Kinney and Zhao because lidocaine allegedly could
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`stabilize HA formulations, citing new EX1114 and EX1115. EX1105, ¶¶ 75, 179.
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`
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`Second, Dr. Prestwich cites the challenged patents to supposedly illustrate
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`the POSA’s knowledge of various crosslinkers. EX1105, ¶ 107 (alleging Dr.
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`Berkland’s testimony “conflicts with the teachings of the Challenged Patents
`
`themselves”). But using the inventor’s work as a roadmap for obviousness is
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`forbidden. See, e.g., Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296
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`(Fed. Cir. 2012). None of these arguments or exhibits is proper the first time on
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`Reply, as motivation to combine must be shown in Petitioner’s prima facie case of
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`obviousness. In re Kahn, 441 F.3d 977, 989 (Fed. Cir. 2006) (citation omitted).
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`Allergan would be unfairly prejudiced unless EX1105 and the newly cited EX1114
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`and EX1115 are excluded under Rule 403.
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`D. Other New Arguments And Evidence
`Dr. Prestwich cites new evidence to try to meet various claim limitations.
`
`
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`For example, Dr. Prestwich cites Allergan’s 2013 communications with the FDA
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`(well after the priority date), EX1103, to try to allegedly demonstrate the 0.3%
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`lidocaine concentration requirement of the claim. EX1105, ¶ 160. For the claimed
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`sterility requirement, he cites another new exhibit, EX1107, to support his view
`
`
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`12
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`
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`that “[a]utoclaving was used to sterilize virtually all types of HA compositions
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`prior to 2008.” EX1105, ¶ 166. But neither the Petitions nor Dr. DeVore cited
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`EX1107. For the claimed “free HA” limitation, Dr. Prestwich cites new EX1210
`
`and claims it shows that a POSA would have been motivated to add free HA to a
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`BDDE-crosslinked HA filler. EX1105, ¶ 44. But EX1210 was never cited by Dr.
`
`DeVore or the Petitions—let alone included as part of any instituted grounds.
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`EX2200, 429:10-22. Allowing these new arguments and evidence, which were
`
`never in the Petitions or the instituted grounds, would be unfairly prejudicial to
`
`Allergan and should be excluded under Rule 403.
`
`E.
`
`Petitioner Cannot Erase Dr. DeVore’s Unreliable Testimony With
`Dr. Prestwich’s New Testimony
`Dr. DeVore’s contemporaneous patent stated that designing dermal fillers is
`
`
`
`“a formidable task,” involving “degrees of freedom” and “many complex factors,”
`
`undermining his entire declaration here. EX2128, 6:30-37. His own pre-litigation
`
`statements reveal his declaration has critical deficiencies and must be excluded
`
`under Rule 702. Allergan would be unfairly prejudiced under Rule 403 if Dr.
`
`Prestwich is permitted to provide new evidence and argument to try to support Dr.
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`DeVore’s declaration, which he abandoned on cross-examination.
`
`
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`For example, Dr. DeVore first asserted that 0.3% lidocaine could easily be
`
`added because it had been used in other products. EX1002, ¶¶139-40. When
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`crossed, he admitted it was not that easy: inclusion of lidocaine HCl in water
`
`
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`13
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`
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`
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`would result in a more acidic solution, elevated temperatures would increase
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`acidity and “[t]he higher the temperature, the less stable” HA is, and “[t]he more
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`acidic it is, the more degradation you’re going to get.” EX2100, 360:13-361:15;
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`73:16-18; 76:14-17. Now, Dr. Prestwich puts forward an extensive new
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`calculation to argue that 0.3% lidocaine would not affect HA stability. EX1105,
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`¶¶ 52-56; EX2200, 252:22-253:10 (“Dr. DeVore did not talk about this – the
`
`Henderson-Hasselbach equation – and the resulting sequelae.”).
`
`
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`As another example, Dr. DeVore claimed in his declarations that a POSA
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`could have been motivated by Monheit to add free HA. EX1002, ¶¶ 155-56. But
`
`he conceded at deposition that Monheit does not “suggest adding free HA as a
`
`lubricant to a monophasic gel.” EX2100, 454:3-15. Now, Dr. Prestwich cites
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`EX1210 instead. EX1105, ¶ 44. And while Dr. DeVore alleged that four
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`crosslinkers—BDDE, DEO, pBCDI, and DVS—were similar chemically, EX1002,
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`¶¶ 153, 189, on cross, he could not identify pBCDI and got “DEO and BDDE
`
`confused.” EX2100, 346:23-349:10; 354:6-11. Now, Dr. Prestwich cites new
`
`portions of Zhao and new EX1102, EX1103, EX1112, and EX1216 to contend
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`chemical similarity. EX1105, ¶¶ 107-10, 118. And Dr. DeVore opined without
`
`support that a POSA would not have expected interactions between lidocaine and
`
`HA, EX1002, ¶ 147, but during cross-examination he could not even identify the
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`structure of lidocaine or HA. EX2100, 58:9-59:3; 358:10-359:13. Now, Dr.
`
`
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`14
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`
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`Prestwich maintains that a POSA would not have expected interactions between
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`lidocaine and HA and points to an unfiled “Karp” reference. EX1105, ¶¶ 57-61.
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`
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`Even on the most basic issues in this case, Dr. Prestwich attempts to erase
`
`Dr. DeVore’s admissions. Compare EX2100, 367:13-368:11 (dermal fillers are
`
`not “something you take out of a recipe book and make”), with EX1105, ¶ 41 (“[I]t
`
`is a matter of simply making predictable substitutions in a well-established
`
`recipe.”). Rule 403 requires exclusion of EX1105 given the unfair prejudice of
`
`allowing Dr. Prestwich to seek to rehabilitate Dr. DeVore’s unreliable statements.
`
`F. Dr. Prestwich’s Declaration Evades Sections 314 And 325(d)
`Any consideration of EX1105 is even more prejudicial to Allergan because
`
`
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`Dr. Prestwich’s declaration selectively incorporates large swathes of his Galderma
`
`and Teoxane declarations. EX1105, ¶¶ 120-80; EX2200, 20:23-21:5 (Prestwich
`
`did a “re-edited” “copy and paste”). Both the Examiner and Board have already
`
`considered Dr. Prestwich’s prior opinions and rejected them. And, because
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`Petitioner initially submitted Dr. DeVore’s declarations, Dr. Prestwich’s frequent
`
`but futile challenges to the claims was not considered as a reason not to institute.
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`35 U.S.C. §§ 314, 325(d) (institution decision may consider whether “the same or
`
`substantially the same prior art or arguments previously were presented”). The
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`addition of Dr. Prestwich’s opinions now evades the Board’s precedent on
`
`institution. See Valve Corp. v. Elec. Scripting Prods., Inc., IPR2019-00062, Paper
`
`
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`15
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`
`
`
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`11 at 13-15 (PTAB, Apr. 2, 2019) (precedential) (denying institution to avoid
`
`“serial and repetitive attacks” where new petitioner submitted testimony from
`
`previous petitioner’s expert). EX1105 should be excluded under Rule 403.
`
`G. Dr. Prestwich’s Declaration Fails To Comply With Board Rules
`First, several paragraphs of EX1105 improperly cite evidence not submitted
`
`
`
`as an exhibit per 37 C.F.R. § 42.6(c), and likewise lack authentication per Fed. R.
`
`Evid. 901, as Petitioner has not established their identity. See EX1105, ¶¶ 59, 62
`
`n.1, 86, 161, 177. Those opinions, along with the underlying materials, should be
`
`excluded. Second, EX1105 should be excluded for improper incorporation by
`
`reference and evading the page limit for replies, violating 37 C.F.R. § 42.6(a)(3)
`
`and § 42.24(c). Petitioner’s Replies cite wide swathes of EX1105 to support
`
`conclusory assertions. E.g., Reply at 23 (citing ¶¶ 46-69 of EX1105). “[C]iting
`
`the Declaration to support conclusory statements that are not otherwise supported
`
`in the Petition also amounts to incorporation by reference.” Cisco Sys., Inc. v. C-
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`Cation Techs., LLC, IPR2014-00454, Paper 12 at 8–9 (PTAB Aug. 29, 2014).
`
`V. MANY EXHIBITS DO NOT COMPORT WITH THE FEDERAL
`RULES OF EVIDENCE OR THE BOARD’S REGULATIONS
`Petitioner’s Reply and Dr. Prestwich rely on new exhibits that violate the
`
`
`
`Federal Rules of Evidence and the Board’s regulations. The Board has broad
`
`discretion to exclude such improper evidence. CBS Interactive Inc. v. Helferich
`
`Patent Licensing, LLC, IPR2013-00033, Paper 79 at 3 (PTAB, Aug. 9, 2013).
`
`
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`16
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`
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`A. EX1077, EX1086, EX1102, EX1103, EX1116, EX1117, And
`EX1202 Should Be Excluded As Irrelevant
`Exhibits 10775, 1086 (“Maleki”), 1102, 1103, 1116, 1117, and 1202 purport
`
`to show a series of communications and publications that each postdate the priority
`
`date. These exhibits do not reflect a POSA’s knowledge or skill at or around the
`
`time of the invention and, thus, have no probative value for Prollenium’s prima
`
`facie obviousness case. See Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d
`
`1340, 1362 (Fed. Cir. 2009). They should be excluded under Rules 402 and 403 as
`
`irrelevant and confusing by mingling later developments with the prior art.
`
`B.
`
`EX1104 Should Be Excluded For Hearsay, Irrelevance, And For
`Petitioner’s Failure To Provide A Translation
`Exhibit 1104 is alleged to be a series of emails by the inventor Dr. Pierre
`
`
`
`Lebreton discussing competitor dermal filler press releases, which is inadmissible
`
`hearsay evidence. EX1104 should also be excluded under Rules 402 and 403
`
`because Petitioner cites EX1104 to show motivation to add lidocaine to a BDDE-
`
`crosslinked HA filler. Reply at 26 n.9. But “[t]he inventor’s own path itself never
`
`leads to a conclusion of obviousness.” Otsuka, 678 F.3d at 1296. Also, under 37
`
`C.F.R. § 42.63(b), Petitioner provides no foreign language translation.
`
`C. EX1083, EX1088, EX1107, EX1111, EX1114, EX1115, EX1116,
`and EX1117 Are Improperly Incorporated by Reference
`Exhibits 1083, 1088, 1107, 1111, 1114, 1115, 1116, and 1117 are cited by
`
`
`
`
`5 Allergan moves to exclude Exhibit 1077 in all but IPR2020-00084.
`
`
`
`17
`
`
`
`
`
`Dr. Prestwich, but are never cited in the Replies. Under 37 C.F.R. § 42.6(a)(3),
`
`these exhibits should be excluded, as they are “not incorporated in [the Replies]
`
`merely by [their] presence in the record.” See Kaz USA, Inc. v. Exergen Corp.,
`
`IPR2016-01437, Paper 43 at 35–36 (PTAB, Dec. 22, 2017).
`
`D. EX1076, EX1081, EX1085, EX1086, EX1087, EX1089, EX1090,
`and EX1202 Should Be Excluded as Irrelevant
`Exhibits 1076, 1081, 1085, 1086, 1087, 1089, 1090, and 1202, although
`
`
`
`identified in Petitioner’s Exhibit Lists on Reply, should be excluded under Rules
`
`402 and 403 as irrelevant. Exhibits 1076, 1081, 1087, and 1202 were not cited in
`
`any reply or declaration. Exhibits 1085, 1086, 1089, and 1090 were never filed.
`
`The exhibits have no probative value and should be excluded.
`
`VI. CONCLUSION
`
`Allergan requests that the Board grant this Motion to Exclude.
`
`
`
`
`
`Dated: December 9, 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
`
`
`
`
`18
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`
`
`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
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`19
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`UPDATED EXHIBIT LIST
`
`Exhibit No.
`
`Exhibit Description
`
`2001
`2002
`2003
`2004
`
`2005
`2006
`
`2007
`2008
`2009
`2010
`2011
`
`2012
`
`2013
`2014
`2015
`
`2016
`
`2017
`
`Juvéderm Ultra™ XC Label
`Juvéderm Ultra Plus™ XC Label
`Juvéderm Voluma® XC Label
`U.S. Patent Publication No. 2004/0101959 to Marko et al,
`published May 27, 2004
`Excerpts from U.S. 8,822,676 file history
`U.S. Patent Publication No. 2004/0127699 to Zhao et al,
`published July 1, 2004
`About Juvéderm Ultra Plus™ XC
`About Juvéderm Volbella® XC
`About Juvéderm Voluma® XC
`U.S. Patent 7,902,171 to Reinmüller et al.
`Declaration in support of unopposed motion for pro hac vice
`admission of Elizabeth Flanagan
`Updated Declaration in support of unopposed motion for pro hac
`vice admission of Elizabeth Flanagan
`Declaration of Cory J. Berkland, Ph.D
`Curriculum Vitae, Cory J. Berkland, Ph.D.
`Kuo, Practical Aspects of Hyaluronan Based Medical Products,
`Chs. 1-6, 2006. (“Kuo”)
`Hascall and Laurent, Hyaluronan: Structure and Physical
`Properties, Hyaluronan Today, Vol. 1, 1997,
`https://www.glycoforum.gr.jp/article/01A2.html. (“Hascall”)
`Cleland, et al., Polyelectrolyte Properties of Sodium Hyaluronate.
`2. Potentiometric Titration of Hyalyuronic Acid, Macromolecules
`Vol. 15, 1982; 386-395. (“Cleland”)
`
`20
`
`
`
`
`
`
`
`Exhibit No.
`
`Exhibit Description
`
`2018
`
`2019
`
`2020
`2021
`
`2022
`
`2023
`
`2024
`2025
`2026
`
`2027
`
`2028
`
`2029
`
`Knill, et al., Effect of Metal Ions on the Rheological Flow Profiles
`of Hyaluronate Solutions, Kennedy Ch. 21, Hyaluronan, 2002;
`175-180. (“Knill”)
`Kablik, et al., Comparative Physical Properties of Hyaluronic
`Acid Dermal Fillers, Dermatologi
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