Paper No. 66
`Filed: June 30, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC,
`
`PETITIONER,
`
`V.
`
`CELGENE CORPORATION,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2015-01102
`Patent 6,315,720
`___________________
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S
`MOTION TO EXCLUDE EVIDENCE
`
`
`Filed: June 30, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC,
`
`PETITIONER,
`
`V.
`
`CELGENE CORPORATION,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2015-01102
`Patent 6,315,720
`___________________
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S
`MOTION TO EXCLUDE EVIDENCE
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`
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`
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`Patent Owner has submitted a sprawling motion to exclude that
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`encompasses, inter alia, Patent Owner’s own exhibits and certain evidence that
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`Patent Owner merely argues is unpersuasive (rather than objectionable on
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`evidentiary grounds). Petitioner respectfully submits that Patent Owner’s motion is
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`meritless in its entirety and may be summarily dismissed. Petitioner nevertheless
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`hereby responds to each of Patent Owner’s arguments in turn.
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`I.
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`THE BOARD SHOULD DENY PATENT OWNER’S MOTION TO
`EXCLUDE EXHIBIT 1017 (“MUNDT”) BECAUSE IT IS
`ADMISSIBLE UNDER FED. R. EVID. 703, BECAUSE IT IS NOT
`HEARSAY, AND BECAUSE PATENT OWNER’S OBJECTIONS
`ARE MOOT
`
`Exhibit 1017 (“Mundt”) is a publication cited in the Petition in part to
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`corroborate its expert’s testimony and was credited by the Board in its Decision
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`instituting IPR. (See Paper 21 at 13, 22.) It was also cited in the declarations of
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`both of Celgene’s experts. (See Frau Decl. (Ex. 2059) at 45 (“Mundt discloses the
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`use of IVR in telephone surveys for research and treatment of compulsive
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`disorders”); DiPiro Decl. (Ex. 2060) at 23-24, 39.).)
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`Exhibit 1017 is admissible under Federal Rule of Evidence 703 as material
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`relied upon by Patent Owner’s expert witnesses in forming their opinions. Fed. R.
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`Evid. 703; see, e.g., Nestle, IPR2015-00249, Paper 76, 2016 Pat. App. LEXIS
`
`4337, at *18–20 (finding material relied upon by expert “admissible under Fed. R.
`
`Evid. 703” “even if [it] is hearsay”).
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`
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`1
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`
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`The foregoing is dispositive of Patent Owner’s objections. Petitioner further
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`notes, however, that the Board may also reject Patent Owner’s objections on the
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`basis that the statements are not hearsay because they are not offered for the truth
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`of the matter asserted. Fed. R. Evid. 801(c). Patent Owner’s motion confusingly
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`treats Petitioner’s “argu[ment]” and statements from Exhibit 1017 together as one
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`and the same (see Paper 62 at 2), but this is not so. Petitioner cites Exhibit 1017 as
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`demonstrative evidence that a POSA would have known to use IVR in a variety of
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`settings. (See Paper 54 at 24.) The fact that Mundt expressly contemplates the use
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`of IVR for different applications corroborates Petitioner’s expert’s testimony.
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`Exhibit 1017 contradicts Patent Owner’s argument to the contrary, even regardless
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`of whether the various statements in Exhibit 1017 are in fact true Petitioner thus
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`offers Patent Owner’s Exhibit 2064 for a non-hearsay purpose. See Fed. R. Evid.
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`801(c).
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`Finally, Petitioner further notes that the Board may dismiss Patent Owner’s
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`objections as moot. The Board has already correctly held “the evidence of record
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`demonstrates that one skilled in the art had reason to use interactive voice response
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`systems to conduct patient surveys.” (Paper 21 at 22.) The Board thus need not
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`reach Patent Owner’s objections concerning Exhibit 1017 in order to confirm the
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`determination already made by the Board in its institution decision. See, e.g.,
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`Samsung, IPR2014-00408, Paper No. 48, 2015 Pat. App. LEXIS 12520, at *34
`
`
`
`2
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`
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`(same; further stating “We agree that the Board, sitting as a non-jury tribunal, is
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`well-positioned to assign appropriate weight to the evidence without the need for
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`formal exclusion.”). The Board may accordingly dismiss Patent Owner’s
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`objections as moot.
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`II. THE BOARD SHOULD DENY PATENT OWNER’S MOTION TO
`EXCLUDE EXHIBIT 1012 (“FDA MEETING PART 1”) BECAUSE IS
`ADMISSIBLE UNDER FED. R. EVID. 703, BECAUSE IT IS A
`PUBLIC RECORD, BECAUSE IT IS NOT HEARSAY, AND
`BECAUSE IT IS ADMISSIBLE UNDER THE RESIDUAL HEARSAY
`EXCEPTION,
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`Exhibit 1012 (“FDA Meeting Part 1”) is an official FDA meeting transcript
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`cited, relied upon, and considered a credible source by Petitioner’s expert Dr.
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`Jeffrey Fudin. (See Fudin Decl. (Ex. 1027) at 18-20, 23, and 32 (discussing a
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`POSA’s knowledge of the Clozaril® and Accutane® programs.)
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`Exhibit 1012 is admissible under Federal Rule of Evidence 703 as material
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`relied upon by Petitioner’s expert witness. Fed. R. Evid. 703; see, e.g., Nestle,
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`IPR2015-00249, Paper 76, 2016 Pat. App. LEXIS 4337, at *18–20 (finding
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`material relied upon by expert “admissible under Fed. R. Evid. 703” “even if [it] is
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`hearsay”).
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`Exhibit 1012 is also admissible under the public records hearsay exception.
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`Fed. R. Evid. 803(8). The document is a record of activities at the FDA, and Patent
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`Owner has not shown that the document lacks trustworthiness (indeed Patent
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`3
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`
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`Owner itself introduced the document in a related proceeding, IPR2015-01092).
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`See id.
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`The foregoing is dispositive of Patent Owner’s objections. Petitioner further
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`notes, however, that the Board may also reject Patent Owner’s motion on the basis
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`that it identifies no hearsay statements that are offered for the truth of the matter
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`asserted. Fed. R. Evid. 801(c). First, Patent Owner’s motion does not identify with
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`specificity any statement in Exhibit 1012 that it is challenging as hearsay. (See
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`Paper 62 at 2.). But see PTO Patent Trial Practice Guide, 77 Fed. Reg. 48756,
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`48767 (Aug. 14, 2012) (“A motion to exclude must explain why the evidence is
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`not admissible….”). Further, Petitioner does not quote or cite any statement in
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`Exhibit 1012 at 7 and 137 for its truth; rather, Petitioner cites the transcript as
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`evidence of the knowledge of a POSA relating to two programs in the prior art.
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`Petitioner thus offers Patent Owner’s Exhibit 1012 for a non-hearsay purpose. See
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`Fed. R. Evid. 801(c).
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`Petitioner further submits that even if its citation to Exhibit 1012 somehow
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`constituted hearsay—which it does not—the evidence would still be admissible
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`under the residual hearsay exception. Fed. R. Evid. 807. The FDA meeting
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`transcript (1) is a public record with circumstantial guarantees of trustworthiness;
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`(2) is offered as evidence of a material fact, i.e. that a POSA knew about Clozaril®
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`and Accutane®; (3) is the most probative evidence on this point, as it is conclusive
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`4
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`proof that Patent Owner itself discussed those two programs as a matter of public
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`record; and (4) is in the interests of justice to admit, particularly considering that
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`Patent Owner itself introduced this evidence in a related proceeding. See IBM
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`Corp. v. Intellectual Ventures II LLC, IPR2015-00092, Paper 44, 2016 Pat. App.
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`LEXIS 2069, *86–87 (PTAB Apr. 25, 2016) (applying Fed. R. Evid. 807);
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`Samsung, IPR2014-00408, Paper No. 48, 2015 Pat. App. LEXIS 12520, at *34
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`(“We agree that the Board, sitting as a non-jury tribunal, is well-positioned to
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`assign appropriate weight to the evidence without the need for formal exclusion.”).
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`III. PATENT OWNER’S RELEVANCE OBJECTIONS TO EXHIBITS
`1086, 1084, 2061, 1083, AND 1012 GO TO THE WEIGHT AND
`SUFFICIENCY OF EVIDENCE, NOT ADMISSIBILITY
`
`Evidence is relevant if it has any tendency to make a fact of consequence in
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`determining the action more or less probable than it would be without the
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`evidence. Fed. R. Evid. 401. A motion to exclude evidence “may not be used to
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`challenge the sufficiency of the evidence to prove a particular fact.” PTO Patent
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`Trial Practice Guide, 77 Fed. Reg. 48756, 48767 (Aug. 14, 2012).
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`Patent Owner moves to exclude, in whole or in part, Exhibits 1086, 1084,
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`2061, 1083, and 1012 on the basis that the evidence is irrelevant. (Paper 62 at 3–8.)
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`None of Patent Owner’s objections are plausible on their face. All of Patent
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`Owner’s objections improperly go to the weight, not admissibility, of the evidence.
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`
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`5
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`
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` Exhibit 1084 contains statements by Patent Owner’s expert, Dr. Joseph
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`T. DiPiro, that are relevant because they are inconsistent with and
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`contradict Dr. DiPiro’s testimony in this proceeding regarding whether a
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`POSA would have experience with restricted distribution systems. (See
`
`Paper 54 at 5.) Patent Owner’s objection that Dr. DiPiro’s statements
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`post-date the claimed invention—like Dr. DiPiro’s testimony in this
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`case—goes to the weight of the evidence, not its admissibility.
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` Exhibit 2061 contains statements by Petitioner’s expert, Dr. Jeffrey
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`Fudin, that are relevant because they show that Dr. Fudin’s “proposed
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`POSA would be a clinician who ‘could’ design successful methods for
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`risk management in delivering medication by drawing upon the support
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`of a ‘multi-disciplinary team.’” (See Paper 54 at 4.) At deposition, Dr.
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`Fudin was directly responding to questions from Patent Owner’s counsel
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`regarding the field of the claimed invention. (See Ex. 2061 at 190:15–18.)
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`Patent Owner’s contention that this testimony does not relate to the
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`claimed invention (Paper 62 at 4-5) is meritless.
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` Exhibits 1083 and 2061 contain relevant admissions by Patent Owner’s
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`fact declarant, John Freeman, that the S.T.E.P.S. program was not 100%
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`successful in achieving the claimed invention’s express goal to “prevent
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`fetal exposure,” contradicting Patent Owner’s suggestions to the contrary
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`
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`6
`
`
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`regarding the “unexpected results” of the claimed invention. (See Paper
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`54 at 10 n.4.) Patent Owner’s objection that its own argument was not
`
`directed to the express goal of the claimed invention (Paper 62 at 6)
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`would seem to render Patent Owner’s argument irrelevant, not
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`Petitioner’s. And Patent Owner’s objection that this evidence concerns
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`worldwide results goes to the weight of the evidence, not its
`
`admissibility.
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` Exhibits 1086 and 1087-1091 contain transcripts and video of the
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`testimony of Patent Owner’s expert, Dr. Frau, that are relevant because
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`they cast doubt on the credibility of Dr. Frau’s testimony. (Paper 54 at 6
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`n.2.) Patent Owner’s attempt to characterize the evidence in its favor
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`goes to the evidence’s weight, not its admissibility. The Board has
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`already authorized Petitioner to submit “in each proceeding, 30 minutes
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`of video excerpts from the deposition of Dr. Frau.” (Ex. 1092 (Email
`
`from Andrew Kellog, USPTO, to Frank Calvosa and Sadaf Abdullah,
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`dated May 25, 2016).) The Board, sitting as a non-jury tribunal, is
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`perfectly capable of considering and “assign[ing] appropriate weight to
`
`the evidence[.]” Samsung, IPR2014-00408, Paper No. 48, 2015 Pat. App.
`
`LEXIS 12520, at *34.
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`
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`7
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`
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` Exhibit 1012 is a 1997 FDA meeting transcript submitted by Petitioner
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`that contains relevant admissions by Celgene employees concerning the
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`the awareness in the field of the Clozaril® and Accutane® programs.
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`Patent Owner’s objection that Exhibit 1012 may-or-may-not qualify as
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`“prior art” again goes to the evidence’s weight, not its admissibility.
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`IV. PATENT OWNER’S OBJECTIONS THAT PETITIONER
`“MISCHARACTERIZES” DR. FRAU’S TESTIMONY IN EXHIBIT
`1086 GO TO THE WEIGHT AND SUFFICIENCY OF EVIDENCE,
`NOT ADMISSIBILITY, AND ARE MOOT
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`Patent Owner challenges Petitioner’s characterizations of the testimony of
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`Patent Owner’s expert, Dr. Frau, while conceding that its motion is moot if “the
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`Board considers the testimony with its surrounding context[.]” (Paper 62 at 9-13.)
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`Petitioner respectfully submits that Patent Owner’s objections once again go
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`to the weight of the evidence, not its admissibility. See Trial Practice Guide, 77
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`Fed. Reg. 48756, 48767 (Aug. 14, 2012); Samsung, IPR2014-00408, Paper No. 48,
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`2015 Pat. App. LEXIS 12520, at *34 (“[T]he Board, sitting as a non-jury tribunal,
`
`is well-positioned to assign appropriate weight to the evidence without the need for
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`formal exclusion.”). In any event, however, Petitioner has already submitted the
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`entirety of Dr. Frau’s deposition testimony. (See Ex. 1086.) Petitioner does not
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`object to the Board’s consideration thereof, which Petitioner submits supports its
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`own arguments. Patent Owner’s objections are therefore all moot.
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`
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`8
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`V.
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`PATENT OWNER’S OBJECTIONS THAT PETITIONER
`“MISCHARACTERIZES” MR. WILLIAMS’ STATEMENT IN
`EXHIBIT 1012 GO TO THE WEIGHT AND SUFFICIENCY OF
`EVIDENCE, NOT ADMISSIBILITY
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`Patent Owner’s motion submits arguments in response to Petitioner’s Reply
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`that appear to be, in effect, a surreply regarding the what Patent Owner refers to as
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`the “testimony” of Mr. Williams. (See Paper 62 at 14 (citing Paper 54 at 10-12).)
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`Patent Owner seeks to exclude one page of Exhibit of 1012 because it is “devoid of
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`the context” of the two pages right before that page. (See Paper 62 at 15.) This
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`argument is defies logic. Petitioner introduced the entirety of Exhibit 1012 –
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`including Mr. Williams’s “full testimony” and the two pages in question. Patent
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`Owner’s objections are mere arguments of persuasion that go to the weight of the
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`evidence, not its admissibility. See Trial Practice Guide, 77 Fed. Reg. 48756,
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`48767 (Aug. 14, 2012); Samsung, IPR2014-00408, Paper No. 48, 2015 Pat. App.
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`LEXIS 12520, at *34.
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`For all the foregoing reasons, the Board should deny Patent Owner’s Motion
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`to Exclude Evidence in its entirety.
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`9
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`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`Lead Counsel for Petitioner
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice)
`Sadaf R. Abdullah (pro hac vice)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6621
`Back-Up Counsel for Petitioner
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`
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`10
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`June 30, 2016
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
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`counsel for Patent Owner a true and correct copy of the foregoing Petitioner’s
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`Response to Patent Owner’s Motion to Exclude Evidence by electronic means on
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`June 30, 2016, at the following addresses of record:
`
`Francis Cerrito
`nickcerrito@quinnemanuel.com
`
`Eric C. Stops
`ericstops@quinnemanuel.com
`
`Frank C. Calvosa
`frankcalvosa@quinnemanuel.com
`
`Anthony Insogna
`aminsogna@jonesday.com
`
`J. Patrick Elsevier
`jpelsevier@jonesday.com
`
`Gasper J. LaRosa
`gjlarosa@jonesday.com
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`Dated: June 30, 2016
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`Respectfully submitted,
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`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`Counsel for Petitioner
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