Paper No. __
`Filed: July 15, 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 IPR2015-01103
`Patent 6,315,720
`________________
`
`PATENT OWNER REPLY IN SUPPORT OF
`ITS MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`Filed: July 15, 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 IPR2015-01103
`Patent 6,315,720
`________________
`
`PATENT OWNER REPLY IN SUPPORT OF
`ITS MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`Patent Owner Reply Motion to Exclude
`
`Case IPR2015-01103
`Patent 6,315,720
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`Patent Owner (“Celgene”) submits this reply in response to Petitioner’s
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`(“CFAD”) opposition to Celgene’s Motion to Exclude. See Paper 67 (“Opp.”).
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`I.
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`CFAD Relies on Exs. 1017 and 1012 for Hearsay Purposes
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`CFAD relied on Exs. 1017 and 1012 for hearsay purposes. See Paper 63
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`(“Mtn.”) 1-3. The arguments in CFAD’s opposition lack merit. First, CFAD’s use
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`of the exhibits is not admissible under Fed. R. Evid. 703, as CFAD alleges. Opp.
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`1, 3. “[Rule] 703 permits an expert” to rely on hearsay. Nestle Healthcare
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`Nutrition, Inc. v. Steuben Foods, Inc., IPR2015-00249, 2016 Pat. App. LEXIS
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`4337, *18–20 (June 2, 2016) (emphasis added). Here, there is no expert testimony
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`concerning the portions of these exhibits cited in CFAD’s reply because Dr. Fudin
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`did not address them initially, and CFAD did not submit an expert declaration with
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`its reply. See Mtn. 2.
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`Second, CFAD argues that it does not rely on Exs. 1017 and 1012 for
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`hearsay purposes because they are allegedly “demonstrative evidence” of CFAD’s
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`arguments, “regardless of whether the various statements [in them] are in fact
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`true.” Opp. 2; see also id. at 4. If the statements are not true, however, then they
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`are not “demonstrative evidence” for CFAD’s attorney argument. CFAD’s circular
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`logic does not change the fact that its use of the exhibits is not admissible under
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`Rule 801(c). Further, CFAD’s argument regarding how it allegedly uses Ex. 1012
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`at 7 and 137 (see Opp. 4) is irrelevant to Celgene’s objection regarding CFAD’s
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`Patent Owner Reply Motion to Exclude
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`Case IPR2015-01103
`Patent 6,315,720
`use of Ex. 1012 at 137 and 250 (Mtn. 2).1 Specifically, Celgene did not lodge a
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`
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`hearsay objection to CFAD’s use of the alleged “transcript as evidence of the
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`knowledge of a POSA relating to two programs in the prior art,” as CFAD alleges.
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`Compare Opp. 4 with Mtn. 2.
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`Third, CFAD argues that Celgene’s objections regarding Ex. 1017 are moot
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`because the Board made certain initial findings in the Institution Decision. Opp. 2-
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`3. CFAD ignores, however, that “the Board is not bound by any findings made in
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`its Institution Decision.” Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed.
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`Cir. 2016). Indeed, the Federal Circuit has noted the “significant difference
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`between a petitioner’s burden to establish a ‘reasonable likelihood of success’ at
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`institution, and actually proving invalidity by a preponderance of the evidence at
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`trial.” Id.
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`Fourth and finally, CFAD argues that its use of Ex. 1012 should be
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`permitted under the residual hearsay exception. Opp. 4-5. That exception is
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`“reserved for ‘exceptional cases,’ and is not ‘a broad license on trial judges to
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`admit hearsay statements that do not fall within one of the other exceptions.’”
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`Neste Oil OYJ v. Reg Synthetic Fuels, LLC, IPR2013-00578, Paper 53 at 10 (Mar.
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`12, 2015) (citation omitted). Further, for CFAD’s use of Ex. 1012 to be admissible
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`1 Despite CFAD’s claim (Opp. 4), Celgene’s motion clearly identifies the
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`statements CFAD relies upon at pages 137 & 250 of Ex. 1012 as hearsay. Mtn. 2.
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`Patent Owner Reply Motion to Exclude
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`Case IPR2015-01103
`Patent 6,315,720
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`under the residual exception, it must be more probative than other evidence CFAD
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`could have obtained through reasonable efforts. Fed. R. Evid. 807(3). CFAD
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`argues that Ex. 1012 is the “most probative evidence . . . as it is conclusive proof
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`that Patent Owner itself discussed [Clozaril and Accutane].” See Opp. 4-5. Of
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`course, this ignores the fact that Celgene’s objection is premised on something else
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`entirely, namely CFAD’s reliance on Ex. 1012 (at 137 and 250) “to allege that
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`statements were made in Ex. 1012 ‘in which the link between teratology and
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`genetic testing was made explicit.’” Mtn. 2. CFAD’s residual hearsay exception
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`argument is silent on this issue. It lacks merit for this additional reason.
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`II. CFAD Does Not Contest Celgene’s Objection to
`Ex. 1086 at 168:5-11, 166:3-7, 306:4-10
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`CFAD had no basis to rely on this testimony because it has nothing to do
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`with the challenged patent. See Mtn. 3. As such, CFAD correctly does not
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`challenge Celgene’s objection. See generally Opp.
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`III. CFAD Does Not Contest Celgene’s Objection to
`Ex. 1083 and Ex. 2061 at 515:1-516:16
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`Celgene objected to the above-referenced exhibits because Ex. 1083 was
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`published 11 years after the challenged patent’s filing date, and is therefore
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`irrelevant to whether a person of ordinary skill (“POSA”) would have had an
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`alleged motivation to arrive at the claimed inventions. See Mtn. 5-7. CFAD
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`ignores this argument entirely, and instead focuses on “unexpected results,” which
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`Patent Owner Reply Motion to Exclude
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`Case IPR2015-01103
`Patent 6,315,720
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`are not even at issue in this proceeding. See Opp. 6-7. Exhibit 1083 and the
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`corresponding testimony should be excluded.
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`IV. Celgene’s Relevancy Objections Go to Admissibility, not Weight
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`CFAD argues that Celgene’s relevancy objections “challenge the
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`sufficiency” of CFAD’s evidence. Opp. 5. Not so. Put simply, “[i]rrelevant
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`evidence is not admissible.” Fed. R. Evid. 402. Celgene’s objections challenge
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`the admissibility of irrelevant evidence that cannot make any fact of consequence
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`in determining the action more or less probable, as required by Fed. R. Evid. 401.
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`A. CFAD Does Not Contest Celgene’s Argument that
`Exs. 1084 and 1012 are Not Prior Art
`
`CFAD argues that Celgene’s objections regarding non-prior art go to weight,
`
`not admissibility. Opp. 6, 8. CFAD, however, does not provide any basis for its
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`argument. The obviousness inquiry requires determining what would have been
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`known by a POSA at the time of the invention. See Mtn. 3-4, 7-8. CFAD does
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`not dispute that a POSA could not have had access to Exs. 1084 and 1012 at the
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`time of the claimed inventions because they are not prior art. The exhibits are
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`irrelevant to obviousness and are therefore inadmissible. See Mtn. 3-4, 7-8.
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`B.
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`Exs. 1086 and 1087-91 Are Irrelevant Because They Do Not
`Cast Doubt On Dr. Frau’s Credibility, as CFAD Alleges
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`Celgene objected to certain portions of Ex. 1086, and Exs. 1087-91 in their
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`entirety, as irrelevant. See Mtn. 7. CFAD’s only argument for admissibility is that
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`they allegedly “cast doubt on the credibility of Dr. Frau’s testimony.” Opp. 7.
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`- 4 -
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`Patent Owner Reply Motion to Exclude
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`
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`Case IPR2015-01103
`Patent 6,315,720
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`Celgene respectfully submits that CFAD’s argument is nothing more than baseless
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`mudslinging meant to compensate for CFAD’s failure to provide testimony from
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`the vantage point of Dr. Frau’s proposed POSA. The testimony does not cast
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`doubt on Dr. Frau’s credibility, but instead reflects her careful consideration of
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`counsel’s often confusing questions, especially on legal issues. It is therefore
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`irrelevant and should be excluded.
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`V. CFAD Mischaracterized Dr. Frau’s Testimony and
`Mr. Williams’ Statement in Ex. 1012 at 119
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`CFAD does not dispute Celgene’s argument that it mischaracterized
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`Dr. Frau’s testimony and Mr. Williams’ statement. See Opp. 8-9. The objected-to
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`portions of Ex. 1086 (Mtn. 9-13) and Ex. 1012 (id. 14-15) should be excluded for
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`that reason alone. See Fed. R. Evid. 403. Further, CFAD states that it “does not
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`object to the Board’s consideration” of Dr. Frau’s entire deposition testimony
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`(Opp. 8), and appears to agree to the full consideration of Mr. Williams’ statement
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`in Ex. 1012 (at 118-19). See Opp. 9. Celgene agrees that its additional,
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`independent objections under Fed. R. Evid. 106 would be moot should the Board
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`also consider the portions of Exs. 1086 and 1012 cited in Celgene’s Motion. See
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`Mtn. 9-15.
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`Patent Owner Reply Motion to Exclude
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`Case IPR2015-01103
`Patent 6,315,720
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`Date: July 15, 2016
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` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
`F. Dominic Cerrito (Reg. No. 38,100)
`Andrew S. Chalson (pro hac vice)
`Eric C. Stops (Reg. No. 51,163)
`Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`andrewchalson@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`Anthony M. Insogna (Reg. No. 35,203)
`J. Patrick Elsevier (Reg. No. 44,668)
`JONES DAY
`12265 El Camino Real
`Suite 200
`San Diego, CA 92130
`Tel: (858) 314-1200
`Fax: (858) 314-1150
`aminsogna@jonesday.com
`jpelsevier@jonesday.com
`
`Gasper J. LaRosa
`JONES DAY
`222 E 41st Street
`New York, NY 10017
`Tel: (212) 326-3939
`Fax: (212) 755-7306
`gjlarosa@jonesday.com
`
`Attorneys for Celgene Corporation
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`- 6 -
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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 IPR2015-01103
`Patent 6,315,720
`________________
`
`CERTIFICATE OF SERVICE
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that PATENT
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`OWNER REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE
`
`EVIDENCE was served on July 15, 2016 by filing this document through the
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`Patent Review Processing System, as well as e-mailing a copy to
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`sabdullah@skiermontderby.com, sspires@skiermontderby.com,
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`pkota@skiermontderby.com, and pskiermont@skiermontderby.com.
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` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` QUINN EMANUEL URQUHART &
` SULLIVAN, LLP
` 51 Madison Avenue, 22nd Floor
` New York, NY 10010
` General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead Counsel for
`Celgene Corporation
`
`
`
`
`Date: July 15, 2016
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