Paper No. ___
`Date Filed: October 16, 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.,
`ARGENTUM PHARMACEUTICAL LLC, AND
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`
`
`Case IPR2016-014791
`Patent No. 9,006,224
`
`
`
`NOVARTIS’S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE
`
`
`1 Argentum Pharmaceutical LLC was joined as a party to this proceeding via a
`Motion for Joinder in IPR2017-01063; West-Ward Pharmaceuticals International
`Limited was joined as a party via a Motion for Joinder in IPR2017-01078.
`
`
`
`
`Date Filed: October 16, 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.,
`ARGENTUM PHARMACEUTICAL LLC, AND
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`
`
`Case IPR2016-014791
`Patent No. 9,006,224
`
`
`
`NOVARTIS’S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE
`
`
`1 Argentum Pharmaceutical LLC was joined as a party to this proceeding via a
`Motion for Joinder in IPR2017-01063; West-Ward Pharmaceuticals International
`Limited was joined as a party via a Motion for Joinder in IPR2017-01078.
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`
`
`1. Dr. Ratain’s Incomplete Citations To Dr. Kulke’s Testimony ........................... 1
`
`2. Dr. Ratain’s Declarations .................................................................................... 2
`
`3. Material Not Cited In Petitioners’ Petition Or Reply ......................................... 4
`
`4. Evidence That Does Not Appear In Instituted Grounds ..................................... 5
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Flex-Rest, LLC v. Steelcase, Inc., 455 F.3d 1351 (Fed. Cir. 2006) ........................... 3
`
`Genzyme Therapeutic Prods. LP v. Biomarin Pharm. Inc., 825 F.3d
`1360 (Fed. Cir. 2016) ...................................................................................... 5
`
`In re NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016) ................................................. 5
`
`Rules
`
`F.R.E. 106 .................................................................................................................. 1
`
`F.R.E. 402 .................................................................................................................. 4
`
`F.R.E. 403 .................................................................................................................. 4
`
`F.R.E. 702 .................................................................................................................. 2
`
`Regulations
`
`37 C.F.R. § 42.24 ...................................................................................................... 4
`
`37 C.F.R. § 42.6(a)(3) ........................................................................................... 1, 4
`
`37 C.F.R. § 42.64(c) .................................................................................................. 1
`
`
`
`ii
`
`
`
`
`
`
`
`
`
`1.
`
`Dr. Ratain’s Incomplete Citations To Dr. Kulke’s Testimony
`
`Novartis moved under F.R.E. 106 to introduce portions of Dr. Kulke’s
`
`testimony that in fairness ought to be considered simultaneously with Dr. Ratain’s
`
`incomplete citations to such testimony. Paper 35 (“Mot.”) at 9-14. Petitioners
`
`argue that Novartis’s motion constitutes an improper “second sur-reply” without
`
`Board authorization. Paper 41 (“Op.”) at 2. Not so. F.R.E. 106 is an evidentiary
`
`rule. A motion to exclude is the appropriate vehicle for Novartis to preserve its
`
`F.R.E. 106 evidentiary objection to Dr. Ratain’s incomplete citations of Dr.
`
`Kulke’s testimony (Paper 24 at 7-8). 37 C.F.R. § 42.64(c). And Novartis’s
`
`substantive explanations supporting its F.R.E. 106 objection do not amount to a
`
`“de facto” unauthorized sur-reply. Contra Op. at 1. Such explanations are
`
`authorized and expressly required by 37 C.F.R. § 42.64(c) (“The motion must
`
`identify the objections in the record in order and must explain the objections. The
`
`motion may be filed without prior authorization from the Board.” (emphasis
`
`added)). Petitioners’ complaints are thus without merit.
`
`
`
`Petitioners’ observation that transcripts of Dr. Kulke’s testimony are exhibits
`
`in this proceeding (Op. at 3) is irrelevant to Novartis’s motion. The portions of the
`
`testimony that were omitted from Dr. Ratain’s supplemental declaration, and that
`
`Novartis seeks to introduce under F.R.E. 106, cannot be considered by the Board
`
`unless they are cited and discussed in a party’s paper. See 37 C.F.R. § 42.6(a)(3);
`
`
`
`1
`
`
`
`
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`Mot. at 6-8. Novartis thus had no alternative but to use its motion to bring to the
`
`Board’s attention those portions of Dr. Kulke’s testimony that in fairness ought to
`
`be considered simultaneously with Dr. Ratain’s incomplete citations.
`
`
`
`
`
`2.
`
`Dr. Ratain’s Declarations
`
`Novartis moved to exclude under F.R.E. 702 Dr. Ratain’s declarations, or
`
`alternatively, accord them little weight, because he lacks expertise with the claimed
`
`subject matter of the ’224 patent: PNET treatment. Mot. at 2-6. Petitioners’ three
`
`arguments opposing that part of Novartis’s motion do not rebut that fact.
`
`
`
`First, Petitioners argue that there is no support for the proposition that
`
`specialized expertise with PNET treatment is a necessary qualification for an
`
`expert in this IPR. Op. at 4. Petitioners are wrong. That proposition is supported
`
`by the claims of ’224 patent itself (directed specifically to PNET treatment); by
`
`Petitioners’ Ex. 1052 at 94-95 (NETs “represent a diagnostic and therapeutic
`
`challenge for non-specialized physicians”); and by Dr. Kulke’s deposition
`
`testimony, Ex. 1070 at 46:17-47:5 (specializing in PNET treatment “would mean
`
`having some experience in treating patients with these tumors and an interest in
`
`treating patients with these tumors”); 49:12-50:4 (PNET specialization requires a
`
`“[c]ombination of knowledge, experience, interest”). Petitioners ignore that
`
`evidence and instead selectively cite other parts of Dr. Kulke’s testimony to argue
`
`that PNETs are treated by non-NET-specializing doctors. Op. at 5. Petitioners’
`
`
`
`2
`
`
`
`
`
`argument misses the point. That PNETs may be treated by such doctors does not
`
`obviate the need for an expert in this IPR—which concerns a patent directed
`
`specifically to PNET treatment—to have some specialized expertise in PNETs.
`
`
`
`Second, Petitioners allege that Dr. Ratain possesses PNET treatment
`
`expertise. Op. at 5-6, citing Ex. 1119. But, outside of Dr. Ratain’s supplemental
`
`declaration, there is no documentary evidence to show that Dr. Ratain possesses
`
`such expertise. Mot. at 3-4. Petitioners do not address that lack of documentary
`
`evidence. Instead, Petitioners simply repeat Dr. Ratain’s assertions that he
`
`“enrolled NET patients on clinical trials” and “published on the treatment of
`
`NETs.” Op. at 6. As Novartis has explained, those vague and unsubstantiated
`
`assertions do not rebut Dr. Ratain’s clear admission that he lacks “special expertise
`
`in PNET.” Mot. at 3-4, citing Ex. 2040 at 304:8-9.
`
`
`
`Third, Petitioners argue that Dr. Ratain’s general experience with mTOR
`
`inhibitors qualifies him as an expert in the “field of invention,” because the
`
`specification of the ’224 patent discusses the use of mTOR inhibitors as anticancer
`
`agents. Op. at 7-9. That argument is baseless. The field of invention is defined by
`
`the claims, not the specification. Flex-Rest, LLC v. Steelcase, Inc., 455 F.3d 1351,
`
`1360-61 (Fed. Cir. 2006) (affirming exclusion of testimony of ergonomics expert
`
`on the validity of claims for computer keyboard design; although the patent
`
`specification discussed ergonomic issues, the claims did not). Dr. Ratain has no
`
`
`
`3
`
`
`
`
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`expertise in the field of invention of the ’224 patent claims: PNET treatment.
`
`
`
`
`
`3. Material Not Cited In Petitioners’ Petition Or Reply
`
`Novartis moved to exclude under F.R.E. 402 and 403 and 37 C.F.R. §§
`
`42.6(a)(3) and 42.24 the exhibits and paragraphs of Dr. Ratain’s declarations not
`
`cited in Petitioners’ petition or reply, because their relevance was not discussed
`
`therein and/or because Petitioners’ reliance on them constitutes improper
`
`incorporation by reference and violates the word limits for petitions and replies.
`
`Mot. at 6-8. Petitioners’ sole argument in opposition is that Novartis did not allege
`
`a specific instance of uncited material being incorporated by reference. That
`
`argument only makes Novartis’s point. Petitioners’ service of voluminous
`
`materials without any mention of them in their papers deprives Novartis and the
`
`Board of adequate notice of whether and/or how Petitioners intend to use them.
`
`And it allows Petitioners to circumvent the word limits for petitions and replies.
`
`For example, as the only alleged support for Petitioners’ assertion that CA20948 is
`
`a PNET model, Petitioners cite 2.5 pages of Dr. Ratain’s declarations to
`
`improperly incorporate by reference 5 exhibits, including De Jong (Ex. 1010),
`
`none of which Petitioners cite or discuss in their papers. Paper 1 at 32-33, citing
`
`Ex. 1003 ¶ 112; Paper 21 at 17-18, citing Ex. 1119 ¶¶ 44, 46-47. Petitioners also
`
`try to summarize in one incorrect statement regarding Novartis’s POSA definition
`
`5 pages of Dr. Ratain’s declaration citing 11 exhibits. Paper 21 at 3, citing Ex.
`
`
`
`4
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`
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`
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`1119 ¶¶ 7-16. But Petitioners cite none of those 11 exhibits or explain how they
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`allegedly support Petitioners’ statement. Petitioners further assert that “multiple
`
`clinical studies assessing new treatments for NETs … allowed patients to enroll
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`who had previously been treated with cytotoxic chemotherapy” but cite none of
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`those studies. Paper 21 at 11-12. Instead, Petitioners cite 2 pages of Dr. Ratain’s
`
`declaration improperly to incorporate by reference 7 references that allegedly
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`support 2 sentences in the reply. Paper 21 at 11-12, citing Ex. 1119 ¶¶ 37-38.
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`Petitioners’ uncited materials should be excluded.
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`
`
`
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`4.
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`Evidence That Does Not Appear In Instituted Grounds
`
`Novartis provisionally moved to exclude evidence not in the instituted
`
`Grounds, but that Petitioners seek to rely on to establish their prima facie case.
`
`Mot. at 8-9. Petitioners oppose Novartis’s motion because it does not specifically
`
`identify any objectionable evidence. Petitioners misunderstand its purpose.
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`Decisions such as Genzyme and NuVasive encourage patent owners to move to
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`exclude reliance on evidence outside of the instituted grounds, lest they risk
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`waiving objections to such misuse. Out of an abundance of caution, Novartis has
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`moved provisionally against any future misuse of evidence.
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`
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`Dated: October 16, 2017
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`Respectfully submitted,
`
`
`
`/ Nicholas N. Kallas /
`Nicholas N. Kallas
`Registration No. 31,530
`
`
`5
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`
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`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Novartis’s Reply In Support Of Its
`
`Motion To Exclude was served on October 16, 2017 by causing it to be sent by
`
`email to counsel for Petitioners at the following email addresses:
`
`Daniel G. Brown (daniel.brown@lw.com)
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`Brenda L. Danek (brenda.danek@lw.com)
`
`Kevin Laurence (klaurence@lpiplaw.com)
`
`Matthew Phillips (mphillips@lpiplaw.com)
`
`Tyler C. Liu (tliu@agpharm.com)
`
`Keith A. Zullow (kzullow@goodwinprocter.com)
`
`Marta E. Delsignore (mdelsignore@goodwinprocter.com)
`
`
`
`Dated: October 16, 2017
`
`
`
`
`
`
`
`/ 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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