`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`
`AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`
`Case IPR2019-002071
`Patent 9,517,219
`
`
`
`
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE UNDER
`37 C.F.R. § 42.64
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
`
`
`
`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c), Patent Owner Almirall, LLC (“Almirall”)
`
`moves to exclude from evidence portions of Exhibits 1043 and 1044, the second
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`declarations of Petitioners’ experts Drs. Michniak-Kohn and Gilmore, which were
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`submitted by Petitioners Amneal Pharmaceuticals LLC and Amneal
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`Pharmaceuticals of New York, LLC (together, “Petitioners”) with its Reply (Paper
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`28). Specifically, Almirall seeks to exclude as unreliable opinion the paragraphs
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`of those Exhibits in which Drs. Michniak-Kohn and Gilmore purport to present
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`opinions as to the import of deposition testimony of any of Almirall’s experts,
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`without having attended those depositions or read those deposition transcripts.
`
`This motion is timely pursuant to the Scheduling Order dated May 10, 2019 (Paper
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`14).
`
`II. LEGAL STANDARDS
`The Federal Rules of Evidence govern the admissibility of evidence and
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`expert testimony in an inter partes review. 37 C.F.R. § 42.62(a). Expert testimony
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`that is not “based on sufficient facts or data” or is not “the product of reliable
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`principles and methods” is not admissible. Fed. R. Evid. 702. Federal Rule of
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`Evidence 702 serves “a ‘gatekeeping role,’ the objective of which is to ensure that
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`expert testimony admitted into evidence is both reliable and relevant.” Sundance,
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`Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1360 (Fed. Cir. 2008).
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`1
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`
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`III. ARGUMENT
`A.
`Paragraphs 4, 15, 26, 35–37, 55, 59, 68, 70–73, 75, 78, 83, and 86 of
`Exhibit 1043 Should Be Excluded as Unreliable
`Exhibit 1043 is the second declaration of Dr. Bozena Michniak-Kohn,
`
`submitted by Petitioners in support of their Reply. In Paragraph 3, Dr. Michniak-
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`Kohn states that the basis for her opinion expressed therein is “Dr. Osborne’s
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`Declaration (EX2057) as well as certain documents cited in Dr. Osborne’s
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`declaration, and the documents cited herein.” Ex. 1043 ¶ 3. However, despite
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`opining in seventeen separate paragraphs as to the import of statements made by
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`Almirall’s experts during deposition, Dr. Michniak-Kohn did not once cite to any
`
`deposition transcripts:
`
` “I understand that Dr. Osborne has also admitted that John Steven
`Garrett, the inventor of the Garrett reference, was heavily involved
`in the development of the 5% ACZONE formulation.” Ex. 1043
`¶ 4.
`
` “I understand Dr. Osborne admitted at his deposition that 7.5%
`dapsone is within the range of 5-10% dapsone disclosed in
`Garrett.” Id. ¶ 15.
`
` “Notably, I understand Dr. Osborne admitted during his deposition
`that a POSA reading Lathrop would have understood 7.5%
`dapsone to be a preferred embodiment.” Id. ¶ 26.
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`2
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`
` “I understand Dr. Osborne agreed at his deposition that a POSA
`would have understood that quantum satis or Q.S. means an
`‘amount which is enough.’ I also understand that Dr. Osborne
`agreed at his deposition that water is the formulator’s ‘currency’
`when it comes to modifying amounts of the compositions in a
`formulation.” Id. ¶ 35.
`
` “In any event, the challenged claims do not require an FDA-
`approved (or approvable) product. I understand Dr. Osborne also
`agreed at his deposition.” Id. ¶ 36.
`
` “I understand Dr. Osborne admitted at his deposition that this
`Opinion dealt with cosmetic products, which were very different
`from topical pharmaceutical products and could not be used to
`assess the safety of acne products.” Id. ¶ 37.
`
` “I understand Dr. Osborne agreed at his deposition that the yield
`value of gelling agents are not publicly available.” Id. ¶ 55.
`
` “Bonacucina also discloses that Sepineo can be easily rubbed into
`the skin, which I understand Dr. Osborne also agreed at his
`deposition is needed for acne treatments that are applied topically
`to the face, like dapsone.” Id. ¶ 59.
`
` “I also understand that Dr. Osborne conceded that using pre-
`neutralized thickeners like Sepineo would be a time-saver for
`researchers.” Id. ¶ 68.
`
` “I understand Dr. Osborne admitted at his deposition that he has no
`direct knowledge of any of the experiments Dr. Warner performed
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`3
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
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`and does not have any other support for his unexpected results
`arguments.” Id. ¶ 70.
`
` “I understand Dr. Osborne testified during his deposition that he
`was not aware how Dr. Warner performed any of the experiments
`that were disclosed in Dr. Warner’s declaration. I understand Dr.
`Osborne did not know how Dr. Warner performed his preliminary
`evaluation, nor did he know how Dr. Warner came up with the five
`candidate thickening agents he ended up screening: Carbopol 980,
`Sepineo P 600, PPG-12/SMDI Copolymer, Povidone Eicosene
`(30:70), and Polyvinyl alcohol. AMN1017, 290. It is also my
`understanding that Dr. Osborne also did not know how the dapsone
`formulations with PPG-12/SMDI, Povidone Eicosene, and
`Polyvinyl alcohol fared in Dr. Warner’s preliminary screening
`experiments. I also understand that Dr. Osborne testified that he
`could not confirm that the preparation processes for the
`formulations with either Carbopol or Sepineo were even the same.
`Notably, I understand Dr. Osborne agreed that he would have
`found it beneficial to have more detail in the Warner declaration.”
`Id. ¶ 71.
`
` “I understand that Dr. Osborne conceded at his deposition that a
`POSA would expect to succeed when modifying topical
`compositions.” Id. ¶ 72.
`
` “I understand that Dr. Osborne at his deposition described
`Carbopol as having peculiarities.” Id. ¶73.
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`4
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`
` “Indeed, I understand that at his deposition Dr. Osborne admitted
`that Dr. Boyd Poulsen’s statements—which Dr. Osborne relies
`upon— are not representative of the positions of FDA or AAPS.”
`Id. ¶ 75.
`
` “I understand Dr. Osborne admitted during his deposition that
`Ostwald ripening cannot occur if the drug is dissolved in the
`composition. Thus, even if a POSA was discouraged from utilizing
`a suspension formulation, she could completely dissolve the
`dapsone, as taught by Garrett, to avoid Ostwald ripening issues.”
`Id. ¶ 78.
`
` “I understand that Dr. Osborne conceded at his deposition that
`incompatibilities are either visibly present or they do not exist.”
`Id. ¶ 83.
`
` “I understand that Almirall, Dr. Kircik, and Almirall’s prior expert
`dermatologist, Dr. Harper, do not dispute that dapsone is not
`effective against rosacea.” Id. ¶ 86.
`
`When asked about these statements during cross-examination, Dr. Michniak-Kohn
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`admitted that she did not read, and was not provided, the deposition transcripts of
`
`any of Almirall’s experts. Ex. 2068 at 8:4–20:19.2 Instead, she testified that each
`
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`2 During cross-examination, it became clear that Dr. Michniak-Kohn had come to
`
`her understanding of Almirall’s experts’ deposition testimony via counsel rather by
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`5
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
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`of these statements were provided to her by counsel. See, e.g., Ex. 2068 at 8:19–
`
`9:4 (“I did not read -- I was not provided [Dr. Osborne’s] deposition, and the
`
`information here is as provided by counsel.”); id. at 20:10–14.
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`These statements, and the opinions in the paragraphs that rely on these
`
`statements, should be excluded as unreliable. Dr. Michniak-Kohn took counsel’s
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`representations of other expert testimony at face value, without reviewing context
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`or coming to her own conclusion regarding the veracity of those statements.
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`Indeed, she refused (pursuant to counsel’s instruction) to disclose the
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`circumstances of how she came to the understandings reflected in the above
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`paragraphs. See, e.g., Ex. 2068 at 9:7–10, 14:21–15:1, 18:8–11, 18:20–21, 19:15–
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`16. Petitioner’s decision to hide behind privilege deprives Almirall of the
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`opportunity to examine those portions of its own experts’ deposition testimony on
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`which Dr. Michniak-Kohn relies without citation. Accordingly, the opinions in
`
`these paragraphs relying on the truth of these representations should be excluded as
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`unreliable under Federal Rule of Evidence 702.
`
`
`
`
`relying on the deposition transcripts themselves. At that point, Almirall objected
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`on the record. Ex. 2068 at 8:4–20:19.
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`6
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`
`B.
`
`Paragraphs 8, 16, 17, 21, 26, 28, 37, 38, 40, and 46 of Exhibit 1044
`Should Be Excluded as Unreliable
`Exhibit 1043 is the second declaration of Dr. Elaine Gilmore submitted by
`
`Petitioners in support of their Reply. In Paragraph 5, Dr. Gilmore lists the
`
`documents she considered “[i]n formulating [her] opinions.” Ex. 1043 ¶ 5. No
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`deposition transcript was included in that list. Despite this, Dr. Gilmore opined in
`
`in ten separate paragraphs as to the import of statements made by Almirall’s
`
`experts during deposition:
`
` “I understand from Amneal’s counsel that Dr. Kircik testified
`during deposition that before 2012 he often used dapsone along
`with other drugs, and that is precisely the point: dapsone was an
`obvious drug to use for the treatment of acne.” Ex. 1044 ¶ 8.
`
` “I understand from counsel that Dr. Kircik testified at his
`deposition that his approach to the treatment of acne is similar.” Id.
`¶ 16.
`
` “I understand that Almirall’s prior dermatologist expert, Dr. Julie
`Harper, testified at her deposition that she frequently used dapsone
`to treat acne.” Id. ¶ 17.
`
` “I understand that Dr. Kircik testified that he used this regimen
`prior to November 2012.” Id. ¶ 21.
`
` “I understand that Dr. Kircik testified that he frequently used
`dapsone to treat rosacea if other FDA-approved treatments, such as
`metronidazole or azelaic acid, failed for a particular patient or
`
`7
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`
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`
`otherwise, Dr. Kircik used dapsone in combination with those
`other approved treatments to treat rosacea.” Id. ¶ 26.
`
` “I understand that Dr. Kircik testified that dapsone was one of the
`products he used to treat both rosacea and acne. I further
`understand that he testified, and I agree, that the only other product
`known to be useful for treating both conditions was azelaic acid.”
`Id. ¶ 28.
`
` “I understand that Dr. Kircik testified that adapalene was
`occasionally used to treat rosacea. But I understand that he testified
`that such use was “very, very” rare—retinoids like adapalene are
`known to be irritating to the skin, and patients with rosacea are
`extremely susceptible to irritability.” Id. ¶ 28 n.2.
`
` “I understand that Dr. Kircik testified at deposition that he used
`Aczone 5% as a monotherapy maintenance treatment before
`2012….” Id. ¶ 37.
`
` “I understand from counsel that Dr. Kircik testified that he
`administered dapsone with tretinoin and benzoyl peroxide. I
`further understand from counsel that Dr. Harper testified that she
`would add dapsone to each of benzoyl peroxide, tretinoin,
`tazarotene, adapalene, and azelaic acid and that she might use
`dapsone on its own as a maintenance therapy.” Id. ¶ 38.
`
` “I am not aware of any studies that compared the three [topical
`retinoids], but there was a general view in the field that tazarotene
`was the most effective but least well-tolerated, while adapalene
`was the least effective but best-tolerated of the three. I understand
`
`8
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
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`from counsel that Drs. Harper and Kircik agreed with this
`hierarchy.” Id. ¶ 40.
`
` “[R]etinoids like adapalene are only very, very rarely used to treat
`rosacea. I understand that Dr. Kircik agreed during his deposition.”
`Id. ¶ 46.
`
`When asked about these statements during cross-examination, Dr. Gilmore
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`admitted that she did not read, and was not provided, the deposition transcripts of
`
`any of Almirall’s experts. Ex. 2069 at 167:4–184:9.3 Instead, she testified that
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`these statements were provided to her by counsel, and was instructed not to testify
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`further regarding the context of her understanding. See, e.g., id. at 177:18–178:3,
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`182:20–184:2.
`
`For the same reasons as discussed in Section III.A supra regarding similar
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`statements in the second declaration of Dr. Michniak-Kohn, the above statements
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`of Dr. Gilmore and the opinions in the paragraphs that rely on these statements,
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`should be excluded as unreliable under Federal Rule of Evidence 702.
`
`
`3 As with similar objectionable testimony by Dr. Michniak-Kohn, Almirall
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`objected on the record at Dr. Gilmore’s deposition. Ex. 2069 at 167:4–184:9.
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`9
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`
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`IV. CONCLUSION
`For the reasons above, Almirall requests that the identified paragraphs of
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`Exhibits 1043 and 1044, and all argument related thereto, be excluded from
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`evidence.
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`
`
`Dated: January 17, 2020
`
`
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`
`
`
`
`10
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`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on January 17, 2020, the
`
`foregoing PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`UNDER 37 C.F.R. 42.64 was served by electronic mail on the following counsel
`
`of record for Petitioners:
`
`Dennies Varughese
`Adam C. LaRock
`Tyler C. Liu
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW, Suite 600
`Washington, DC 20005
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`tliu-PTAB@skgf.com
`
`
`Jitendra Malik
`Alissa M. Pacchioli
`Heike S. Radeke
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`heike.radeke@kattenlaw.com
`Lance Soderstrom
`Katten Muchin Rosenman LLP
`575 Madison Avenue
`New York, NY 10022-2585
`lance.soderstrom@kattenlaw.com
`
`Dated: January 17, 2020
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`
`
`
`
`
`
`
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