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`Entered: October 10, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PAR PHARMACEUTICAL, INC., ARGENTUM PHARMACEUTICAL LLC,
`AND WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED,
`Petitioners
`v.
`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-014791
`U.S. Patent No. 9,006,224
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`
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`PETITIONERS’ OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
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`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.
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`
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`IPR2016-01479
`U.S. Patent No. 9,006,224
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`Table of Contents
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`I.
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`II.
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`The Board should deny Novartis’s motion to exclude as a thinly
`veiled second sur-reply .................................................................................... 2
`The Board should deny Novartis’s motion to exclude Dr. Ratain’s
`Declarations ..................................................................................................... 3
`III. The Board should deny Novartis’s motion to exclude paragraphs and
`exhibits not cited in the Reply ......................................................................... 9
`IV. Novartis’s catch-all fails to identify any objections or evidence or
`otherwise demonstrate anything should be excluded .................................... 10
`Conclusion ..................................................................................................... 11
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`V.
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`i
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`Novartis continually flouts the substantive and procedural rules established
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`by statute, the Code of Federal Regulations, and the Board’s Practice Guide. After
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`filing a six-page sur-reply to identify allegedly new arguments included in
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`Petitioners’ reply, Novartis spends an additional six pages in this motion making
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`new arguments on the merits. (Paper 35 (“Mot.”) 9-15.) The Board should deny
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`Novartis’s procedurally and substantively deficient motion to exclude, which is
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`largely a de facto second sur-reply.
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`Novartis moves to exclude three categories of evidence. First, Novartis
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`moves to exclude both of Dr. Ratain’s declarations under FRE 702. (Mot. 2-6.)
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`Novartis merely rehashes its previous arguments attacking Dr. Ratain’s testimony.
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`(POR 4-7.) Novartis again attempts to narrowly define the scope of relevant
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`testimony, but Dr. Ratain’s expertise and testimony is helpful to the factfinder in
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`analyzing the subject matter of the challenged claims. Second, Novartis seeks to
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`exclude paragraphs and exhibits not explicitly cited in a brief as incorporating
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`arguments by reference. Yet Novartis does not identify a single argument
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`impermissibly incorporated in Petitioners’ briefs because none were. Many of
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`these paragraphs are transitions or summaries in Dr. Ratain’s declarations. Finally,
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`Novartis includes a vague and generic request to exclude evidence that does not
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`appear in instituted grounds but is used to establish prima facie obviousness.
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`Novartis does not identify any such evidence in its motion, failing to meet the basic
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`1
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`requirements of 37 C.F.R. § 42.22. For all these reasons, Novartis fails to establish
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`that any evidence should be excluded.
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`I.
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`The Board should deny Novartis’s motion to exclude as a thinly veiled
`second sur-reply
`The Board should deny Novartis’ motion rather than reward Novartis’s
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`repeated efforts to engage in self-help to garner additional briefing on the merits,
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`encouraging future parties to do the same. To be clear, Novartis’s arguments
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`regarding its own expert’s testimony seek to bolster its as-filed Response,
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`impermissibly taking another shot at the merits of the petition. Liberty Mut. Ins. v.
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`Progressive Cas. Ins., No. CBM2012-00002, Paper No. 66 at 62 (P.T.A.B. Jan. 23,
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`2014). Novartis has essentially granted itself leave to file a motion for
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`observations for its own expert testimony to present arguments for a second sur-
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`reply.
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`A motion to exclude is not a motion for observations on the testimony of a
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`party’s own expert or an opportunity to present additional substantive arguments.
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`See 37 C.F.R. §§ 42.62(a), 42.64(c). To present such substantive argument,
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`Novartis required Board permission—permission Novartis lacks. See 77 Fed. Reg.
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`48,756, 48,767-68 (Aug. 14, 2012.) (opposing party must seek permission to file
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`motion for observations); see also, e.g., Torrent Pharm. Ltd. v. Novartis AG, No.
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`IPR2014-00784, Paper No. 112 at 49 (P.T.A.B. Sept. 24, 2015). Indeed,
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`Novartis’s counsel cannot claim that it is unaware of the requirement to seek Board
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`2
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`permission before making such substantive arguments, particularly here, where
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`Novartis already sought permission to file a limited sur-reply. Paper 26; Paper 28;
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`see also Berk-Tek v. Belden, No. IPR2013-00057, Paper No. 46 at 43-44 (P.T.A.B.
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`Mar. 18, 2014) (granting permission to address issue in motion to exclude), aff’d,
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`805 F.3d 1064, 1081 (Fed. Cir. 2015); Genzyme Therapeutic Prods. L.P. v.
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`Biomarin Pharm. Inc., 825 F.3d 1360, 1368 (Fed. Cir. 2016) (citing Belden).
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`Moreover, FRE 106, invoked by Novartis, does not authorize Novartis to
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`make such substantive arguments. FRE 106 provides that “[i]f a party introduces
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`all or part of a writing or recorded statement, an adverse party may require the
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`introduction, at that time, of any other part—or any other writing or recorded
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`statement—that in fairness ought to be considered at the same time.” (Emphasis
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`added.) The full transcripts of Dr. Kulke’s testimony are already in the record (Ex.
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`1070; Ex. 1095), and no “other part” of the transcripts needs to be “introduced.”
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`Further, FRE 106 “provides a basis for including, rather than excluding, evidence.”
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`Mobile Tech, Inc. v. Invue Sec. Prods. Inc., No. IPR2016-00892, Paper No. 35 at
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`68-69 (P.T.A.B. Sept. 28, 2017). As such, Novartis’s substantive arguments
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`presented under the guise of FRE 106 should be disregarded.
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`II. The Board should deny Novartis’s motion to exclude Dr. Ratain’s
`Declarations
`In its Response, Novartis sought to require that the relevant subject matter of
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`the ’224 patent be narrowly drawn specifically to exclude the strong testimony
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`3
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`from Petitioners’ expert, Dr. Ratain. (POR 4-7.) To that end, Novartis presented
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`testimony from its expert, Dr. Kulke, that a POSA would have “experience
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`conducting preclinical, clinical, and/or laboratory research relating to NETs,
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`including PNETs.” (Ex. 2041, ¶ 22.) Novartis now seeks to elevate the level of
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`skill even beyond what its expert opined because Dr. Ratain demonstrated that he
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`had “experience conducting preclinical, clinical, and/or laboratory research relating
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`to NETs, including PNETs.” (See Reply 2-4.) Novartis’s arguments should be
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`rejected for at least three reasons: (1) no evidence supports Novartis’s new
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`requirements for a POSA first articulated in its motion to exclude; (2) Dr. Ratain
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`has the experience Dr. Kulke testified qualifies as a “specialist” in NETs; and
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`(3) even if Dr. Ratain would not qualify as a POSA (although he does), Dr.
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`Ratain’s expertise provides useful insight into the perspective of a POSA that is
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`helpful to the factfinder.
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`Novartis argues that “[s]pecialized expertise with PNET treatment thus is a
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`necessary element of any expert’s qualifications in this proceeding.” (Mot. 3.)
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`Novartis fails to cite anything for such a proposition. (Id.) This is unsurprising as
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`Novartis’s expert only opined that a POSA would have “experience . . . relating to
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`4
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`NETs, including PNETs.” 2 (Ex. 2041, ¶ 22 (emphasis added).) Dr. Kulke never
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`offered the opinion that a POSA would have “specialized expertise with PNET
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`treatment.” In fact, Dr. Kulke testified that “PNETs are treated in North America
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`by medical oncologists” and admitted that even specialists outside of medical
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`oncology could possess the level of skill for a POSA. (Ex. 1070, 43:20-46:16.)
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`Dr. Kulke further acknowledged that not all doctors who treat NETs have research
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`experience in NETs nor are all NETs treated by doctors specializing in NETs. (Id.
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`47:6-25.) Dr. Kulke’s standard for the level of experience “relating to NETs,
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`including PNETS” is far broader than Novartis now seeks to impose. The record
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`does not support Novartis’s new standard for the qualifications of a POSA
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`articulated for the first time in its motion to exclude.
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`Even if Novartis’s new standard is applied, Dr. Ratain meets Dr. Kulke’s
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`standard for “specializing” in NETs. Dr. Kulke testified that doctors “specializing”
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`in NETs would have “some experience in treating patients with these tumors and
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`an interest in treating patients with these tumors.” (Ex. 1070, 46:17-47:5.) He
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`2 Dr. Kulke’s opinions regarding the level of ordinary skill in the art appear to be a
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`moving target. In the related district court litigation, Dr. Kulke opined that a
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`POSA did not necessarily have specific experience relating to NETs. (See Ex.
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`1119, ¶ 8.)
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`5
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`further acknowledged that “expertise could include many aspects of NET
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`knowledge and experience,” including analysis of clinical data on the treatment of
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`NETs. (Id. 51:8-18.) Dr. Kulke also acknowledged that experience related to
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`carcinoids could be relevant to PNETs. (Id. 52:13-16.) Dr. Ratain testified that he
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`has enrolled NET patients on clinical trials3 and has extensive experience in the
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`treatment of solid tumors, a category of tumors that includes NETs and PNETs,
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`and cell signaling pathways, such as mTOR, which are similarly related to treating
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`NETs and PNETs. (See Ex. 1119, ¶¶ 9-12.) Dr. Ratain has further published on
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`the treatment of NETs, analyzing clinical trial data to reflect on treatment efficacy
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`and clinical trial design. (Id. ¶ 12.) Such experiences certainly qualify as
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`possessing “some experience in treating patients with these tumors and an interest
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`in treating patients with these tumors.” (See Ex. 1070, 46:17-47:5 (emphasis
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`added).)
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`3 Novartis alleges that Dr. Ratain “has not cited any evidence” of his experience in
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`treating patients having NETs or PNETs. (Mot. 4 & n.1.) Dr. Ratain’s sworn
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`testimony regarding his professional experience is evidence. Black’s Law
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`Dictionary, available at thelawdictionary.org (stating definition of “legal evidence”
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`is “testimony that is allowed to be presented during a trial”).
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`6
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`Finally, Novartis’s argument should be rejected because Novartis applies the
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`wrong standard for excluding testimony under the considerations of Daubert or
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`FRE 702. Initially, “[t]he policy considerations for excluding expert testimony,
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`such as those . . . established by the Supreme Court in Daubert v. Merrell Dow
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`Pharm., Inc., 509 U.S. 579 (1993), are less compelling in bench proceedings such
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`as inter partes reviews than in jury trials.” Nestle Healthcare Nutrition, Inc. v.
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`Steuben Foods, Inc., No. IPR2015-00249, Paper No. 76 at 23 (P.T.A.B. June 2,
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`2016). The experienced Board does not require any gatekeeping to protect it from
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`being confused or misled by Dr. Ratain’s testimony. E.g., Seaboard Lumber Co. v.
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`United States, 308 F.3d 1283, 1301-02 (Fed. Cir. 2002). The Board is capable of
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`assessing Dr. Ratain’s (and Dr. Kulke’s) testimony and the relied upon art to
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`discern whether the proffered opinions are supported and reasonable. Novartis’s
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`reliance on Daubert does not support excluding Dr. Ratain’s declarations.
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`Novartis’s citation to FRE 702 also does not support excluding Dr. Ratain’s
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`declarations. Dr. Ratain has “sufficient technical expertise for the [] court to allow
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`him to testify.” S.E.B. S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1371
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`(Fed. Cir. 2010). “[T]he relevant inquiry regarding whether an expert should be
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`allowed to provide testimony . . . is not whether she is a POSA, but instead
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`whether the expert’s ‘knowledge, skill, experience, training, [and] education . . . is
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`likely to assist the trier of fact to understand the evidence.” Teva Neuroscience,
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`7
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`Inc. v. Watson Pharma, Inc., Nos. 10-5078, 11-3076, 2013 U.S. Dist. LEXIS
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`66862, at *12 (D.N.J. May 10, 2013), citing S.E.B., 594 F.3d at 1371; Mytee
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`Prods., Inc. v. Harris Research, Inc., 439 F. App’x 882, 887 (Fed. Cir. 2011)
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`(allowing testimony from expert who did not qualify as a POSA because he “had
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`experience relevant to the field of the invention”). “In determining who is
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`‘qualified in the pertinent art’ under FRE 702, [the court] need not find a complete
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`overlap between the witness’s technical qualifications and the problems
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`confronting the inventors or the field of endeavor for a witness to qualify as an
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`expert.” Captioncall, LLC v. Ultratec, Inc., No. IPR2015-00636, Paper No. 97 at 9
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`(P.T.A.B. Sept. 7, 2016). The “pertinent art,” as defined by the ’224 patent
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`specification, includes “the use of mTOR inhibitors in neuroendocrine tumor
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`treatment.” (Ex. 1001 at 1:4-5.) Indeed, the ’224 patent specification discusses
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`mTOR inhibitors and their use as anticancer agents, generally, in discussing the
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`background of the alleged invention. (Id. 1:6-2:40.) Further, Novartis initially
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`characterized the alleged invention as simply relating “specifically to a new use of
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`mTOR inhibitors,” in each of the seven provisional applications filed in the ’224
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`patent family. (E.g., Ex. 1002 at 382, 409, 432, 453, 480, 508, 535.) Thus, as the
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`’224 inventors acknowledged, the field of the invention relates to the use of mTOR
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`inhibitors as anticancer agents.
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`8
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`Here, Dr. Ratain has significant relevant expertise in the development of
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`drugs for the treatment of solid tumors and in the use of mTOR inhibitors as
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`anticancer agents. (E.g., Ex. 1003, ¶¶ 2-11; Ex. 1004; Ex. 1119, ¶¶ 7-12.) This
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`expertise is certainly “relevant to the field of the invention,” i.e., the use of mTOR
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`inhibitors as anticancer agents for the treatment of NETs, including PNETs, and
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`Dr. Ratain is thus qualified in the “pertinent art.” Husky Injection Molding Sys.
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`Ltd. v. Plastics Eng’g & Tech. Srvs., Inc., No. IPR2016-00431, Paper No. 11 at 23
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`(P.T.A.B. June 24, 2016), citing Mytee Prods., 439 F. App’x at 886-87 and
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`Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363-64 (Fed. Cir.
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`2008).
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`III. The Board should deny Novartis’s motion to exclude paragraphs and
`exhibits not cited in the Reply
`Novartis seeks to exclude portions of expert testimony and exhibits cited by
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`Petitioners’ experts that are not directly cited in Petitioners’ Petition or Reply,
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`contending that “[i]t is apparent” that Petitioners improperly incorporated
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`arguments by reference or failed to fully explain the cited evidence. (Mot. 6-8.)
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`Novartis does not even attempt to allege any specific instance where the
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`Petition or Reply improperly incorporated arguments, but merely states it must be
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`so because the Petition and Reply brief’s word counts are close to the limit. (Mot.
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`7.) Novartis cannot be allowed to abuse the process by filing a deficient motion in
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`an attempt to require Petitioners to spend pages and pages justifying every citation
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`9
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`in its briefs. Furthermore, there is no requirement to directly cite every exhibit used
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`by expert witnesses to form their considered opinions or to cite each paragraph of
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`an expert declaration, even those included for context such as the overall summary
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`and conclusion (e.g., Ex. 1003 ¶¶ 22-30, 93, 109, 124; Ex. 1119 ¶¶ 17-25), topic
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`summaries and transitions (e.g., Ex. 1003 ¶¶ 1-19, 50-52, 68; Ex. 1119 ¶¶ 26, 48,
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`53), and so forth.
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`In addition, Novartis does not contend that any of the complained-of
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`material is not admissible. Incorporation by reference is not grounds for excluding
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`the evidence, but as demonstrated by the two institution decisions Novartis cites, it
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`goes to the evidence’s weight. (Mot. 7-8 (citing, e.g., Hamilton Beach Brands v.
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`Courtesy Prods., No. IPR2014-01260, Paper No. 11 (P.T.A.B. Feb. 25, 2015)
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`(refusing to give any weight to bare citations without any explanation)).)
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`IV. Novartis’s catch-all fails to identify any objections or evidence or
`otherwise demonstrate anything should be excluded
`Without pointing to any specific exhibits, Novartis seeks to exclude “any
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`evidence” that does not appear in the instituted grounds. The Board should deny
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`Novartis’s flagrantly deficient motion because Novartis failed to meet any
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`requirements for a motion to exclude: it failed to point to and explain any timely
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`raised objections “identify[ing] the grounds for the objection with sufficient
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`particularity to allow correction in the form of supplemental evidence” because
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`there are none (37 C.F.R. § 42.64(b)(1), (c)); it failed to include any explanation,
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`10
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`IPR2016-01479
`U.S. Patent No. 9,006,224
`much less the required detailed explanation, of any particular evidence and
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`material facts at issue or the relief requested (37 C.F.R. §§ 42.20, 42.22); and it
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`failed to demonstrate that any of the unidentified evidence was not properly
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`submitted in reply to Novartis’s own arguments.
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`V. Conclusion
`For the above reasons, the Board should deny Novartis’s motion to exclude.
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`Dated: October 10, 2017
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`Respectfully submitted,
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`/Daniel G. Brown/
`By:
`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
`
`Counsel for Petitioner
`Par Pharmaceutical, Inc.
`
`/Kevin Laurence/
`By:
`Kevin Laurence (Reg. No. 38,219)
`Laurence & Phillips IP Law LLP
`1940 Duke Street, Suite 200
`Alexandria, VA 22314
`703-448-8787
`Counsel for Petitioner
`Argentum Pharmaceutical LLC
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`/Keith A. Zullow/
`By:
`Keith A. Zullow (Reg. No. 37,975)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
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`11
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`IPR2016-01479
`U.S. Patent No. 9,006,224
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`212-813-8846; 646-558-4226 (Fax)
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`Counsel for Petitioner
`West-Ward Pharmaceuticals
`International Limited
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`12
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 10th day of October,
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`2017, a true and correct copy of the foregoing PETITIONERS’ OPPOSITION
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`TO PATENT OWNER’S MOTION TO EXCLUDE was served by electronic
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`mail on Patent Owner’s lead and backup counsel at the following email address:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Charlotte Jacobsen (pro hac vice)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`Peter J. Waibel (Reg. No. 43,228)
`Gregory D. Ferraro (Reg. No. 36,134)
`NOVARTIS PHARMACEUTICALS CORPORATION
`One Health Plaza, Bldg. 430
`East Hanover, NJ 07936-1080
`Tel. 862-778-7838
`ZortressAfinitorIPR@fchs.com
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
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`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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