Paper No. _______
`Date Filed: January 10, 2017
`
`Filed On Behalf Of: Novartis AG
`
`By: Nicholas N. Kallas
`
`NKallas@fchs.com
`
`ZortressAfinitorIPR@fchs.com
`
`(212) 218-2100
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`PAR PHARMACEUTICAL, INC.,
`BRECKENRIDGE PHARMACEUTICAL, INC. AND
`ROXANE LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`Case IPR2016-000841
`
`U.S. Patent 5,665,772
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT
`OF ITS MOTION TO EXCLUDE EVIDENCE
`
`
`
`1 The Board on October 27, 2016 joined Breckenridge’s IPR2016-01023 and
`Roxane’s IPR2016-01103 with Par’s IPR2016-00084 challenging claims 1-3 and
`8-10 of the ’772 patent.
`
`
`
`
`Date Filed: January 10, 2017
`
`Filed On Behalf Of: Novartis AG
`
`By: Nicholas N. Kallas
`
`NKallas@fchs.com
`
`ZortressAfinitorIPR@fchs.com
`
`(212) 218-2100
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`PAR PHARMACEUTICAL, INC.,
`BRECKENRIDGE PHARMACEUTICAL, INC. AND
`ROXANE LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`Case IPR2016-000841
`
`U.S. Patent 5,665,772
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT
`OF ITS MOTION TO EXCLUDE EVIDENCE
`
`
`
`1 The Board on October 27, 2016 joined Breckenridge’s IPR2016-01023 and
`Roxane’s IPR2016-01103 with Par’s IPR2016-00084 challenging claims 1-3 and
`8-10 of the ’772 patent.
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Belden, Inc. v. Berk-Tek, LLC
`805 F.3d 1064 (Fed. Cir. 2015) ...................................................................3, 5
`
`Facebook, Inc. v. Software Rights Archive, LLC,
`IPR2013-00479, Paper 54 (P.T.A.B. Feb. 2, 2015) ........................................ 3
`
`Genzyme Therapeutic Prods. Limited Partnership v. Biomarin
`Pharms. Inc.,
`825 F.3d 1360 (Fed. Cir. 2016) ...................................................................3, 5
`
`In re Nomiya,
`509 F.2d 566 (C.C.P.A. 1975) ......................................................................... 2
`
`In re NuVasive, Inc.,
`841 F.3d 966 (Fed. Cir. 2016) ......................................................................... 5
`
`InTouch Techs. Inc. v. VGO Comms., Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) ....................................................................... 2
`
`PharmaStem Therapeutics, Inc. v. ViaCell, Inc.,
`491 F.3d 1342 (Fed. Cir. 2007) ....................................................................... 2
`
`Statutes
`
`35 U.S.C. § 132 .......................................................................................................... 2
`
`Other Authorities
`
`77 Fed. Reg. 48,612 ................................................................................................... 4
`
`Regulations
`
`37 C.F.R. § 42.123(b) ................................................................................................ 4
`
`37 C.F.R. § 42.64(b) .................................................................................................. 4
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`37 C.F.R. § 42.64(c) ...............................................................................................1, 3
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`
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`
`i
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`Novartis submits this reply in support of its December 20, 2016 motion to
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`exclude evidence (Paper 54, “Motion”) and in response to Petitioners’ opposition
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`thereto (Paper 60, “Op.”). For the reasons set forth herein and in the Motion, the
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`Motion should be granted.
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`
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`Petitioners complain that the Motion does not identify with “required
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`specificity” where Novartis timely objected to certain evidence. Op. at 1, 7-8, 12,
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`14. Not true. Novartis fully complied with the requirement of § 42.64(c) that its
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`Motion “identify the objections in the record in order and . . . explain the
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`objections.” Motion at 1-2, pin-citing Novartis’s December 12, 2016 objections,
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`Paper 50 at, inter alia,16 (objecting to specific paragraphs of Jorgensen reply
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`declaration because they make new prima facie arguments), 20 (same for Ratain
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`reply declaration), 17-18 (objecting to specific paragraphs of Ratain reply
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`declaration because they are based on non-prior art documents), 2, 4-14, 18 and 21
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`(objecting to specific evidence in because it was not cited in the reply).2
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`Petitioners cite no authority to suggest that Novartis’s December 12 objections
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`must be more specific than they are. And regardless of the specificity of the
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`2 Ex. 1087 was not previously objected to on the ground that it was not cited in the
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`reply. Novartis thus withdraws § III.6 of the Motion as to Ex. 1087.
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`1
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`objections, Petitioners could not have been prejudiced by the eight days that
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`elapsed between the December 12 objections and the December 20 Motion.
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`
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`Petitioners rely on a statement from the ’772 patent to identify an alleged
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`motivation to modify rapamycin, and—in contrast to Petitioners’ cited authorities
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`PharmaStem and Nomiya—do not explain how that statement constitutes an
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`admission that the matter therein was also in the prior art. PharmaStem v.
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`ViaCell, 491 F.3d 1342, 1362 (Fed. Cir. 2007) (“the inventors cited several prior
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`art references”); In re Nomiya, 509 F.2d 566, 570-71 (C.C.P.A. 1975) (figures in
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`specification were “labeled prior art, ipsissimis verbis”). Indeed, Petitioners fail to
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`identify any prior art cited in their petition to support their alleged motivation. See
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`Op. at 2 (citing only their reply). Petitioners’ reliance on the statement in the ’772
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`patent to support their alleged motivation thus is improper. Motion, § III.1; see
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`also InTouch Techs. v. VGO Comms., 751 F.3d 1327, 1351-52 (Fed. Cir. 2014)
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`(rejecting obviousness analysis that relied on patent itself).3
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`3 Contrary to Petitioners’ misrepresentations (Op. at 1), Novartis has never argued
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`that the statement was 35 U.S.C. § 132 “new matter” or was added to “maintain a
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`priority date to which it was not entitled.” And Petitioners have never disputed the
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`October 9, 1992 priority date.
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`2
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`Petitioners try to salvage the new prima facie evidence they served on
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`December 5, 2016 by contending that a § 42.64(c) motion to exclude is not a
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`“proper vehicle” for excluding reply evidence and that Novartis did not seek the
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`Board’s permission to use the Motion for that purpose. Op. at 3-4. Though some
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`panels have asserted that a motion to exclude “normally is not the proper vehicle
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`for resolution of a dispute regarding reply arguments and evidence exceeding the
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`proper scope of a reply,” Facebook v. Software Rights Archive, IPR2013-00479,
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`Paper 54 at 37 (P.T.A.B. Feb. 2, 2015), no statute or regulation prohibits such use.
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`Indeed, the Federal Circuit suggests that patent owners can (and should) use
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`motions to exclude for that purpose. Belden v. Berk-Tek, 805 F.3d 1064, 1081
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`(Fed. Cir. 2015) (“[I]f the petitioner submits a new expert declaration with its
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`Reply, the patent owner . . . can move to exclude the declaration.”); Genzyme v.
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`Biomarin, 825 F.3d 1360, 1368 (Fed. Cir. 2016) (“If Genzyme had wanted the
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`Board to disregard those [reply] references, it could have filed a motion to exclude
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`them.”).4
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`4 Petitioners moreover admit that exclusion is warranted where a petitioner changes
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`its invalidity theory on reply. Op. at 4. That is what happened here. Novartis will
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`provide citations to Petitioners’ improper reply arguments, as authorized by the
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`Board on January 6, 2017.
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`3
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`Petitioners assert that the prima facie evidence identified in § III.3 and 4 of
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`the Motion constitutes proper reply, and that Novartis did not “even bother to
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`dispute” that point. Op. at 2-11. Not true. Petitioners bore the burden of proving
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`that the prior art would have motivated a POSA to modify rapamycin to arrive at
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`everolimus with a reasonable expectation that everolimus would have the
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`properties it actually has.5 Petitioners should have included all evidence on those
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`issues with their petition, or as § 42.64(b) or § 42.123(b) supplemental
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`information. They did not do so. Instead, they waited until reply to introduce such
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`evidence, thereby depriving Novartis of an opportunity to respond. That is not
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`allowed. Motion, § III.3 and 4; see also 77 Fed. Reg. 48,612, 48,620 (“Reply
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`evidence . . . must be responsive and not merely new evidence that could have
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`been presented earlier to support the movant’s motion.”). Petitioners now try to
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`excuse their gamesmanship under the pretext that they were not “obligated to
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`predict Novartis’s factual disputes,” or that their arguments “expressly respond” to
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`Novartis’s experts. Op. at 6, 8-9. These excuses miss the point. Petitioners were
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`5 Contrary to Petitioners’ misrepresentation (Op. at 10), Novartis has never
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`“realiz[ed]” that a POSA would have had a reasonable expectation that everolimus
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`would have improved water solubility and immunosuppressant activity, let alone
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`antitumor activity.
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`4
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`obligated to adduce, in the first instance, all evidence supporting their prima facie
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`case. A reply does not give them a second chance to satisfy that obligation.
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`Petitioners do not deny that the voluminous evidence identified in § III.6 of
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`the Motion was not cited in the reply. That evidence thus should be excluded or—
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`as Petitioners themselves recommend (Op. at 15)—should be given no weight.
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`Petitioners mischaracterize § III.7 of the Motion as “flagrantly deficient.”
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`Op. at 11. Petitioners misunderstand its purpose. As noted above, recent case law
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`(Berk-Tek, Genzyme and NuVasive) encourages patent owners to move to exclude
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`reply evidence at the earliest opportunity, lest they risk creating the impression that
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`they have waived their objections to such evidence. While Novartis cannot foresee
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`how the reply evidence will be used at oral argument or in the final decision (and
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`thus cannot now identify specific exhibits or grounds for objection), § III.7, out of
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`an abundance of caution in view of the recent case law, conditionally objects to the
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`misuse of such evidence in those contexts.
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`Last, while Petitioners accuse the Motion of “re-arguing the merits,”
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`Petitioners themselves indulge in pages of argument on reasonable expectation of
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`success and unexpected properties. Op. at 9-11, 12-14. Rather than perpetuate that
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`dispute here, Novartis states that it disagrees with Petitioners and reserves the right
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`to explain its disagreement at oral argument and/or as permitted by the Board.
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`5
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`Dated: January 10, 2017
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`Respectfully submitted,
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`
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`
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`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
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`6
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`CERTIFICATE OF SERVICE
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`I certify that a copy of the foregoing Patent Owner’s Reply In Support Of Its
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`Motion To Exclude Evidence was served on January 10, 2017 by causing it to be
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`sent by email to counsel for Petitioners at the following email addresses:
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`Daniel G. Brown (dan.brown@lw.com)
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`Robert Steinberg (bob.steinberg@lw.com)
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`Brenda L. Danek (Brenda.danek@lw.com)
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`
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`Jonathan M. Strang (jonathan.strang@lw.com)
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`Matthew L. Fedowitz (mfedowitz@merchantgould.com)
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`B. Jefferson Boggs (jboggs@merchantgould.com)
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`Daniel R. Evans (devans@merchantgould.com)
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`Keith A. Zullow (kzullow@goodwinlaw.com)
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`Marta Delsignore (mdelsignore@goodwinprocter.com)
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`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`Dated: January 10, 2017
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`7
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