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`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
`
`
`
`
`
`
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`
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`PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION TO
`EXCLUDE EVIDENCE UNDER 37 C.F.R. § 42.64
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`
`
`
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`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
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`IPR2019-00207
`Patent Owner’s Reply Re Motion to Exclude Evidence
`
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`I.
`
`INTRODUCTION
`Amneal’s spoon-fed attorney argument served as the sole basis for certain
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`paragraphs in Dr. Michniak-Kohn’s and Dr. Gilmore’s expert reports. Therasense,
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`Inc. v. Becton, Dickinson & Co., 2008 WL 2323856, at *1 (N.D. Cal. May 22,
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`2008) (“One of the worst abuses in civil litigation is the attempted spoon-feeding
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`of client-prepared and lawyer-orchestrated ‘facts’ to a hired expert who then
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`“relies” on the information to express an opinion.”). Patent Owner seeks to
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`exclude paragraphs from Dr. Michniak-Kohn’s or Dr. Gilmore’s expert
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`declarations that explicitly rely on Dr. Osborne’s, Dr. Harper’s, or Dr. Kircik’s
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`deposition testimony.2 Both of Amneal’s experts, Dr. Michniak-Kohn and
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`Dr. Gilmore, admit that they did not review or possess Dr. Osborne’s,
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`Dr. Harper’s, or Dr. Kircik’s deposition testimony prior to submitting their
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`respective expert declarations. Instead, Dr. Michniak-Kohn and Dr. Gilmore admit
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`that the source of the paragraphs in question are Amneal’s counsel.
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`The paragraphs in question directly concern issues central to this proceeding.
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`But, Almirall was deprived of the opportunity to probe the bases of paragraphs in
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`2 Patent Owner’s motion seeks to exclude paragraphs 4, 15, 26, 35–37, 55, 59, 68,
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`70–73, 75, 78, 83, and 86 from Ex. 1043 and 8, 16, 17, 21, 26, 28, 37, 38, 40, and
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`46 from Ex. 1044 (“paragraphs in question”).
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`1
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`IPR2019-00207
`Patent Owner’s Reply Re Motion to Exclude Evidence
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`question. Instead, Amneal’s counsel instructed Dr. Michniak and Dr. Gilmore not
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`to answer, claiming that an expert’s declaration “speaks for itself.” Ex. 2069,
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`101:4-12 (“Well, the document says that she got that understanding from counsel
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`in Paragraph 15. So it speaks for itself.”). The right to explore and question the
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`bases of an expert’s opinion is fundamental to an inter partes review, as in any
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`exercise of due process. Amneal’s counsel blocked that fundamental right in the
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`most basic of ways – employing attorney work product as both a sword and a
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`shield. The Board should accordingly exclude Ex. 1043 at ¶¶ 4, 15, 26, 35-37, 55,
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`59, 68, 70-73, 75, 78, 83, and 86, as well as Ex. 1044 at ¶¶ 8, 16-17, 21, 26, 28,
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`37-38, 50 and 46.
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`II. ARGUMENT
`A. Almirall could not have raised an objection before Amneal’s
`expert testimony.
`Almirall raised a timely objection at the first possible instance. All but
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`conceding its counsel was the source of the “expert” testimony, Amneal resorts to
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`a fragile argument on procedural grounds, stating: “Almirall’s motion to exclude
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`should be denied because Almirall did not timely raise any objection to the
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`testimony of Dr. Michniak-Kohn and Dr. Gilmore.” Paper 46 at 2. Amneal’s
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`argument resolves to this: because the paragraphs in question began with “I
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`understand,” Almirall should have instantly understood they were sourced from
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`2
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`IPR2019-00207
`Patent Owner’s Reply Re Motion to Exclude Evidence
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`counsel and immediately objected to their admissibility. This shoot-before-you-
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`aim argument is unavailing on several scores.
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`First, Almirall could not assume what Amneal’s experts relied upon in
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`arriving at the paragraphs in question. That’s the very purpose of cross-
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`examination. Almirall required the expert’s testimony to understand the bases of
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`the paragraphs in question. It was only at the deposition that Almirall could
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`confirm that Amneal’s counsel was the sole basis for the paragraphs in question.
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`Second, Almirall quite reasonably expected it could probe the bases of the
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`paragraphs in question during the deposition, as a matter of proper course. It was
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`not until Amneal’s counsel instructed its experts to not answer that the paragraphs
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`in question were revealed as sword and shield attorney work product. Simply put,
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`Almirall could not have known that the paragraphs in question were inadmissible
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`prior to the depositions of Drs. Michniak-Kohn and Gilmore. Almirall’s objection
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`to the evidence was timely, as such.
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`B.
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`Evidence from Amneal’s counsel is not admissible under
`F.R.E. 702.
`The paragraphs in question amount to Amneal’s counsel proffering expert
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`opinions. Amneal mischaracterizes the paragraphs in question as “factual
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`statements,” but substantively the paragraphs in question are posited as expert
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`opinions and expert interpretations of evidence. See, e.g., Paper 41 at 5
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`3
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`IPR2019-00207
`Patent Owner’s Reply Re Motion to Exclude Evidence
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`(“I understand that Dr. Osborne conceded at his deposition that incompatibilities
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`are either visibly present or they do not exist.”); see generally id. at 2-5, 7-9. The
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`paragraphs in question are nothing more than Amneal’s attorneys argument
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`masked as an expert opinion.
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`Amneal justifies the use of attorney argument as expert opinion by
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`contending, “Almirall was also not deprived of the opportunity to cross-examine
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`Dr. Michniak-Kohn or Dr. Gilmore about the ‘veracity’ of the information supplied
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`by counsel.” Paper 46 at 7. Amneal argues that Almirall had the opportunity to
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`test the veracity of these statements by providing Dr. Osborne’s, Dr. Harper’s, or
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`Dr. Kircik’s testimony to Dr. Michniak-Kohn or Dr. Gilmore during their
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`respective deposition. But, Amneal misses the point: Amneal’s counsel is the sole
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`basis of the “expert” opinion, not Dr. Michniak-Kohn or Dr. Gilmore.
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`Amneal’s counsel interpreted the context of Dr. Osborne’s, Dr. Harper’s, or
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`Dr. Kircik’s testimony. Amneal’s counsel interpreted that testimony in the context
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`of the prior art as a whole, determined the weight of the evidence considered and
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`discounted, and, ultimately, Amneal’s counsel formed the expert opinion posited in
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`the paragraphs in question. Dr. Michniak-Kohn and Dr. Gilmore have no first-
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`hand knowledge of Amneal counsel’s process. To test the veracity of the
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`4
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`IPR2019-00207
`Patent Owner’s Reply Re Motion to Exclude Evidence
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`paragraphs in question, it is Amneal’s counsel that would need to be cross-
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`examined, as Almirall’s counsel stated. See Ex. 2069 at 176:5-10.3
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`III. CONCLUSION
`For the reasons above, Almirall requests that the identified paragraphs 4, 15,
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`26, 35-37, 55, 59, 68, 70-73, 75, 78, 83, and 86 of Exhibit 1043 and paragraphs 8,
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`16-17, 21, 26, 28, 37-38, 50 and 46 of Ex. 1044, and all argument related thereto,
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`be excluded from evidence.
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`3 Amneal’s counsel also improperly argues that if Dr. Michniak-Kohn’s and
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`Dr. Gilmore’s paragraphs are inadmissible, then so are certain paragraphs from
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`Dr. Osborne’s declaration. See Paper 46 at 6 n.2. First, Dr. Osborne has reviewed
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`and considered all the evidence that his declaration is based on unlike
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`Drs. Michniak-Kohn and Gilmore. Second, Dr. Osborne never stated Almirall’s
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`counsel was the sole basis for his testimony. Third, it is not clear from the
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`paragraphs Amneal cited if, and to what extent, Dr. Osborne relied on counsel.
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`Fourth, Almirall never instructed Dr. Osborne not to answer so Amneal could have
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`probed on cross-examination.
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`5
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`IPR2019-00207
`Patent Owner’s Reply Re Motion to Exclude Evidence
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`Dated: January 31, 2020
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`Respectfully submitted,
`
`
`
`
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`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
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`6
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`IPR2019-00207
`Patent Owner’s Reply Re Motion to Exclude Evidence
`
`
`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on January 31, 2020, the
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`foregoing PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO
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`EXCLUDE EVIDENCE UNDER 37 C.F.R. 42.64 was served by electronic mail
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`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 31, 2020
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`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`7
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