Filed on behalf of: Par Pharmaceutical, Inc. et al.
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`Entered: January 3, 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., BRECKENRIDGE PHARMACEUTICAL,
`INC., AND ROXANE LABORATORIES, INC.
`Petitioners
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`v.
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`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-000841
`U.S. Patent No. 5,665,772
`_______________________
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`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`PETITIONERS’ OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
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`1 Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
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`Table of Contents
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`I.
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`II.
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`Topic 1 – The Board should deny Novartis’s motion to exclude
`evidence and argument pointing to relevant applicant-admitted prior
`art ..................................................................................................................... 1
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`Topic 2 – Novartis’s improper motion to consider its Lemke exhibits
`is moot because that evidence is already of record ......................................... 2
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`III. Topics 3, 4, 7 – The Board should deny Novartis’s motion to exclude
`evidence that allegedly exceeds the scope of a permissible reply ................... 2
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`A. Absent Board permission, a motion to exclude is not the proper
`vehicle for addressing Novartis’s contentions ...................................... 3
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`B.
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`C.
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`D.
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`E.
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`F.
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`G.
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`A petitioner may reply to the patent owner’s response ......................... 4
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`Topic 3(a) – It is undisputed that Fiebig (Ex. 1034) was timely
`submitted in reply to Novartis’s arguments .......................................... 5
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`Topic 3(b) – It is undisputed that Schwartz (Ex. 1117) was
`timely submitted in response to Novartis’s arguments ......................... 7
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`Topic 4(a) – It is undisputed that Dr. Jorgensen’s supplemental
`declaration (Ex. 1118) timely replied to Novartis’s arguments ............ 7
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`Topic 4(b) – It is undisputed that Dr. Ratain’s declaration (Ex.
`1119) timely replied to Novartis’s arguments ....................................... 9
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`Topic 7 –Novartis’s catch-all fails to identify any objections or
`evidence or otherwise demonstrate anything should be excluded ...... 11
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`IV. Topic 5 – The Board should deny Novartis’s motion to exclude
`relevant evidence rebutting its faulty unexpected results argument ............. 12
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`V.
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`Topic 6 – The Board should deny Novartis’s motion to exclude
`paragraphs and exhibits not cited in the Reply .............................................. 14
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`VI. Conclusion ..................................................................................................... 15
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`i
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`The Board should deny Novartis’s procedurally and substantively deficient
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`motion to exclude, which is largely a de facto sur-reply and motion to strike.
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`Novartis failed to point to where it timely objected with the required specificity,
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`and in many cases, it did not so object. Moreover, Novartis did not seriously
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`attempt to demonstrate that any evidence should be excluded because it is not
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`admissible under the Federal Rules of Evidence. Instead, it alleges procedural
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`defects or argues relevancy, contending that the Board should not give the cited
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`evidence and argument any weight. Given Novartis’s repeated procedural
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`violations and its frivolous motion, Petitioners reserve the right to seek sanctions
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`under 37 C.F.R. § 42.12.
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`I.
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`Topic 1 – The Board should deny Novartis’s motion to exclude evidence
`and argument pointing to relevant applicant-admitted prior art
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`In describing the known problems with rapamycin, the ’772 patent states
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`“rapamycin is highly insoluble, making it difficult to formulate stable galenic
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`compositions.” ’772 patent at 1:39-40. Novartis argues that it later added this
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`information to its original disclosure in violation of 35 U.S.C. § 132 (forbidding
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`addition of new matter) in an effort to maintain a priority date to which it was not
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`entitled, and therefore Petitioners cannot rely on it as evidence of the state of the
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`art as of that earlier, undeserved priority date. Mot. 3-4; see also POR 52 n.6.
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`However, it does not matter when Novartis added the admission. “Admissions in
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`the specification regarding the prior art are binding on the patentee for purposes of
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`1
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`

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`IPR2016-00084
`U.S. Patent No. 5,665,772
`a later inquiry into obviousness.” PharmaStem Therapeutics v. ViaCell, 491 F.3d
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`1342, 1362 (Fed. Cir. 2007); In re Nomiya, 509 F.2d 566, 571 & n.5 (CCPA 1975)
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`(the admission is binding whether made “in the application or in other papers
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`submitted during prosecution”). Moreover, this admission easily clears the “very
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`low bar for relevance” because it corroborates Petitioners’ own evidence showing
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`that rapamycin was known to be difficult to formulate because of its low solubility.
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`Reply 6; United States v. Rodríguez-Soler, 773 F.3d 289, 293 (1st Cir. 2014).
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`II. Topic 2 – Novartis’s improper motion to consider its Lemke exhibits is
`moot because that evidence is already of record
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`Novartis seeks to admit Lemke Chapters 6 and 10-12 into evidence on the
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`basis that Petitioners submitted Chapter 16, “Predicting Water Solubility.” Mot. 4-
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`5 (citing Fed. R. Evid. 106). Novartis’s request is moot because those Lemke
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`chapters are already of record and petitioners have not moved to exclude.
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`Petitioners do not acquiesce that anything else is required out of “fairness” or for
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`any other reason.
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`III. Topics 3, 4, 7 – The Board should deny Novartis’s motion to exclude
`evidence that allegedly exceeds the scope of a permissible reply
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`Novartis seeks to exclude as “untimely” two exhibits, multiple portions of
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`two expert declarations, and “any evidence that does not appear in instituted
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`Grounds 1 or 2” that Petitioners relied upon to establish obviousness. Mot. 5-12,
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`15. As explained in the following paragraphs, Novartis’s improperly raised
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`2
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`arguments fail because all of the complained-of evidence properly replies to
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`Novartis’s response—a point that Novartis does not even bother to dispute.
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`A. Absent Board permission, a motion to exclude is not the proper
`vehicle for addressing Novartis’s contentions
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`As an initial matter, the Board should deny Novartis’ motion rather than
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`reward Novartis’s repeated efforts to engage in self-help to garner additional
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`briefing on the merits, encouraging future parties to do the same. To be clear,
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`Novartis’s prima-facie arguments are addressing whether the evidence submitted
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`with the petition is sufficient by itself to demonstrate obviousness and Novartis is
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`impermissibly taking another shot at the merits of the petitions. Liberty Mutual Ins.
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`v. Progressive Cas. Ins., CBM2012-00002, Paper 66 at 62 (Jan. 23, 2014) (motion
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`to exclude “is not a mechanism to argue that a reply contains new arguments or
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`relies on evidence necessary to make out a prima facie case.”).
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`Thus, a motion to exclude is not the “proper vehicle” for addressing the
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`scope of a reply or reply evidence, absent Board permission—permission Novartis
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`lacks. Torrent Pharms. v. Novartis, IPR2014-00784, Paper 112 at 49 (Sept. 24,
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`2015); Facebook v. Software Rights Archive, IPR2013-00479, Paper 54 at 37 (Feb.
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`2, 2015) (citing cases); Corning v. DSM IP Assets, IPR2013-00052, Paper 88 at 22
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`n.13 (May 1, 2014) (motion to exclude “not an appropriate vehicle,” but granting
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`permission in that instance). Further, Novartis’s experienced counsel cannot claim
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`that it is unaware of the requirement to seek Board permission before making such
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`3
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`arguments in a filing. Ex. 1125 (email chain); see also 10X Genomics v. Univ. of
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`Chicago, IPR2015-01157, Paper 51 at 10-11 (Nov. 15, 2016) (ordering parties to
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`file lists of citations); Berk-Tek v. Belden, IPR2013-00057, Paper 46 at 43-44 (Mar.
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`18, 2014) (granting permission to address issue in motion to exclude), aff’d, 805
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`F.3d 1064, 1081 (Fed. Cir. 2015); Genzyme Therapeutic Prods. v. Biomarin
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`Pharm., 825 F.3d 1360, 1368 (Fed. Cir. 2016) (citing Belden).
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`B. A petitioner may reply to the patent owner’s response
`Novartis argues that Petitioners should have sought to supplement the record
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`after the POPR or presciently addressed all of Novartis’s arguments in the
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`petitions. Mot. 5-12, 15. Novartis misstates the procedure. A petitioner sets forth
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`its case in its petition, the patent owner responds, and then the petitioner replies to
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`the arguments the patent owner raised in its response. 37 C.F.R. § 42.23(b).
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`What a reply cannot do is change the theory of unpatentability or otherwise
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`re-do the petition. In re NuVasive, 841 F.3d 966, 969, 971 (Fed. Cir. 2016) (relying
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`on a new portion of the prior-art to teach a claim element); Corning at 11-13
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`(permissible to defend data from original experiment, but not to amend procedure
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`and re-perform); Toshiba v. Optical Devices, IPR2014-01447, Paper 34 at 40-41,
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`44-45 (Mar. 9, 2016) (new evidence and theory to prove a publication date ).
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`In contrast, a petitioner may respond to the patent owner’s criticisms even if
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`those criticisms address the prima facie case. For example, petitioner Berk-tek—
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`4
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`which did not file any expert declaration at all with its petition—properly
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`submitted a reply declaration from Mr. Baxter explaining the factual bases for
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`Berk-tek’s prima facie case of obviousness, including its motivation to combine
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`and modify the prior art. Belden, 805 F.3d at 1067-72, 1074. Although patent
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`owner Belden complained that “Mr. Baxter’s declaration contained arguments and
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`evidence necessary for the prima facie case of obviousness,” the Board properly
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`relied on Mr. Baxter’s testimony to reject Belden’s factual arguments, even using it
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`“in stating the affirmative reasons to find the motivation required for a prima facie
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`case.” Id. at 1071, 1079. The Federal Circuit affirmed. The prior art itself and the
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`petition “sufficed to supply a prima facie case of obviousness—as confirmed by
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`the Institution Decision.” Id. Mr. Baxter’s declaration properly responded Belden’s
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`reply evidence and “confirm[ed] the prima facie case.” Id. As explained in the
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`following sections, the same is true here.
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`C. Topic 3(a) – It is undisputed that Fiebig (Ex. 1034) was timely
`submitted in reply to Novartis’s arguments
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`The petitions established that a POSA, as a medicinal chemist, would be
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`motivated to address the source of rapamycin’s poor solubility which limited its
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`use in formulations: rapamycin itself. Pet. 4-9, 11, 16-18, 23-27, 32-34, 38-39, 41-
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`42 (citing evidence including Ex. 1003, Dr. Jorgensen’s declaration). In response,
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`Dr. Klibanov and Novartis attacked Petitioners’ prima facie case, arguing that
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`rapamycin’s solubility was not a known problem or that POSAs would have
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`5
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`instead limited themselves to a formulation approach. POR 51-55; Ex. 2092 ¶¶
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`150-160.
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`In reply to those arguments, Petitioners properly submitted additional
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`evidence confirming that a “POSA—a medicinal chemist—would have sought to
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`address the source of the problem—the compound itself—and chemically modified
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`rapamycin.” Reply 5-6. Formulation solutions, especially when working with
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`poorly soluble compounds, can be ineffective or introduce other problems. Id. at 6
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`(citing Ex. 1034 (prior-art rapamycin formulation abandoned due to toxicity) and
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`Ex. 1118); Ex. 1118 ¶¶ 9, 26, 33 (Dr. Jorgensen’s response to Dr. Klibanov’s
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`arguments)).
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`Novartis “cannot plausibly argue that it lacked notice” of this issue because
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`Novartis itself raised it in its response. Genzyme, 825 F.3d at 1367; POR 29 (“Par’s
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`case is premised on its assertion that rapamycin’s water solubility was sufficiently
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`problematic to limit pharmaceutical utility, create formulation difficulties….”),
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`POR 51-55. Petitioners are not obligated to predict Novartis’s factual disputes
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`regarding Petitioners’ prima facie case or to seek to supplement the record. Rather,
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`Petitioners properly submitted additional evidence in “rebuttal to contradict”
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`Novartis’s “allegation[s[ and…to confirm the veracity of [Petitioners’] original”
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`evidence that a medicinal chemist would be motivated to modify rapamycin itself.
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`6
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Corning at 11; Belden, 805 F.3d at 1079 (reply evidence “will commonly confirm
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`the prima facie case”).
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`D. Topic 3(b) – It is undisputed that Schwartz (Ex. 1117) was timely
`submitted in response to Novartis’s arguments
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`As with Fiebig, Novartis cannot plausibly argue that it lacked notice because
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`Petitioners permissibly relied on Schwartz when responding to Novartis’s
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`arguments. The petitions established that Yalkowsky and Lemke together teach
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`“improv[ing] the solubility of chemical compounds by adding flexible side chains
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`with solubilizing substituents.” Pet. 7, 23-24, 32-34, 44-48. In response, Dr.
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`Klibanov and Novartis argued that Yalkowsky’s teachings were limited to ideal
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`solutions and therefore not applicable to rapamycin in water. E.g., POR 17-18. In
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`reply to those arguments, Petitioners properly submitted additional evidence,
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`including Ex. 1117 (Schwartz), confirming that a POSA would have applied
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`Yalkowsky’s deviations from ideal solubility to a real system, as recognized in
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`Yalkowsky itself. Ex. 1118 ¶¶ 96-99; Reply 15-16; Ex. 1007 (Yalkowsky stating
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`“this type of approach could be used for the design of compounds having desired
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`solubility properties”).
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`E.
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`Topic 4(a) – It is undisputed that Dr. Jorgensen’s supplemental
`declaration (Ex. 1118) timely replied to Novartis’s arguments
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`Novartis similarly takes issue with several different portions of Dr.
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`Jorgensen’s supplemental declaration. Novartis’s motion fails to point to (because
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`7
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`it cannot) where it objected to these paragraphs on these specific grounds. Novartis
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`merely provided two blanket objections that must now be combined to arrive at
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`these paragraphs. Obj. 16. Moreover, Petitioners and Dr. Jorgensen were again
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`permissibly responding to statements made by Novartis and its experts, confirming
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`the prima facie case set forth with the petition. Novartis has no excuse for filing
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`this frivolous motion, as Dr. Jorgensen expressly explained why he was opining on
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`each topic.
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`Specifically, ¶¶ 17 and 20 of Dr. Jorgensen’s supplemental declaration
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`confirm his testimony submitted with the petition that a POSA would have selected
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`rapamycin as a lead compound and expressly respond to Dr. Roush’s arguments at
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`Ex. 2093 ¶¶ 161-164 and 171-175 on this issue. See also, e.g., Pet. 16-18, 26-27,
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`39, 41-42; Ex. 1003 ¶¶ 52-55, 132-137.
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`Likewise, ¶¶ 8-9, 25-26, and 32-33 confirm Dr. Jorgensen’s previous
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`testimony that an ordinarily skilled medicinal chemist would have been motivated
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`to improve rapamycin’s admittedly poor water solubility and expressly respond to
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`Dr. Klibanov’s arguments at Ex. 2092 ¶¶ 116, 150-151, 156-157. See also Fiebig
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`section above; Pet. 4-9, 11, 16-18, 23-27, 32-34, 38-39, 41-42; Ex. 1003 ¶¶ 52-57,
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`75-76, 89, 134, 138-140.
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`Similarly, ¶¶ 13-15, 82, 86-87, 89-99, and 101-102 confirm Dr. Jorgensen’s
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`previous testimony addressing what a POSA would have understood from reading
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`8
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`Yalkowsky and Lemke and expressly address Dr. Klibanov’s statements at Ex.
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`2092 ¶¶ 30, 70-71-108, 111, 124. See also Schwartz section above; Ex. 1118 ¶ 82
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`n.5 (explaining that opinion has not changed); Pet. 7, 23-24, 32-34, 44-48; Ex.
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`1003 ¶¶ 56, 77-79, 84-88, 146-149, 153.
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`Likewise, ¶¶ 10 and 53 confirm Dr. Jorgensen’s previous testimony that a
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`POSA would have selected the C40 hydroxyl groups as among the first positions
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`for modification and expressly address Dr. Roush’s testimony at Ex. 2093 ¶¶ 64-
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`83, 114-130, 206-216. See also Pet. 7, 18, 21-22, 29-32, 34-35, 42-44; Ex. 1003 at
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`¶¶ 52, 57, 62-66. 89-123, 141-145.
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`Finally, ¶¶ 11, 16, 23, 104-105, 107-108, and 110 confirm Dr. Jorgensen’s
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`previous testimony that a POSA would start by making small changes to have a
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`reasonable expectation of improving solubility while not interfering with activity
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`or introducing additional problems, and expressly addresses Dr. Roush’s testimony
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`to the contrary at Ex. 2093 ¶¶ 64-83, 114-130, 192-196. See also Pet. 6, 22-23, 43-
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`48; Ex. 1003 ¶¶ 52, 61, 65, 77-88, 101-104 122, 123, 135-136, 146-156, 168, 183.
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`F.
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`Topic 4(b) – It is undisputed that Dr. Ratain’s declaration (Ex.
`1119) timely replied to Novartis’s arguments
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`Having realized that it (and its expert) had confused reasonable expectation
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`of success with unexpected results, Novartis now seeks to re-argue both to further
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`confuse the issues. Novartis also brazenly misstates the Petition, claiming that it
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`“mentioned antitumor activity as part of an alleged motivation to select rapamycin
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`9
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`as a lead compound.” Mot. 10-11 (citing Pet. 11, 44). Not true. Although the
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`petition recognized that rapamycin has “antitumor and antifungal activity,” the
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`petition relied on rapamycin’s well-known reputation as “an extremely potent
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`immunosuppressant.” Pet. 11, 41 (A POSA “seeking to design an improved
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`immunosuppressant would select a lead compound with the desired biologic
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`activity.”), 44 (modifications “expected to result in a compound with
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`immunosuppressant activity”).
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`Apparently realizing that a POSA would indeed have had a reasonable
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`expectation of success in improving rapamycin’s solubility while retaining
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`immunosuppressant activity, Novartis now tries to set the bar higher by requiring a
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`reasonable expectation of maintaining rapamycin’s antitumor activity, among other
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`things. Mot. 10-11; POR 58-60. A patent owner’s response, however, is no more
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`able to change the petition’s theory of obviousness than a petitioner’s reply. And
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`here, Petitioners’ reply did not adopt or acquiesce to Novartis’s newly proposed
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`motivation, but permissibly addressed the substance of Novartis’s factual
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`assertions. Reply 17-18 n.6 (citing Ex. 1119 ¶¶ 32-36, 43, 101-106). Specifically,
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`Dr. Ratain expressly responded to Dr. Burris’s testimony at Ex. 2095 ¶¶ 82-88, 95-
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`97, explaining that Dr. Burris is wrong. A POSA would have expected everolimus
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`to retain at least some of rapamycin’s known antitumor activity based on its nearly
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`identical structure. Ex. 1119 ¶¶ 32-44, 56-61. Dr. Burris did not point to any
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`10
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`references ruling out FKBP binding as rapamycin’s antitumor mechanism, and, if
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`he had, those references would have been wrong. Everolimus, like rapamycin and
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`the other “rapamycins,” indeed achieve antitumor effects by binding to FKBP and
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`inhibiting the mTOR pathway. Ex. 1119 ¶¶ 101-106. Petitioners also used these
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`paragraphs to respond to Novartis’s unexpected-results arguments, which are
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`addressed in Topic 5.
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`G. Topic 7 –Novartis’s catch-all fails to identify any objections or
`evidence or otherwise demonstrate anything should be excluded
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`Without pointing to any specific exhibits, Novartis seeks to exclude “any
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`evidence” that does not appear in grounds 1 and 2. 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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`much less the required detailed explanation, of any particular evidence and
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`material facts at issue (37 C.F.R. §§ 42.20(c), 42.22(b)); and it failed to
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`demonstrate that any of the unidentified evidence was not properly submitted in
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`reply to Novartis’s own arguments.
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`11
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`IV. Topic 5 – The Board should deny Novartis’s motion to exclude relevant
`evidence rebutting its faulty unexpected results argument
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`Seeking to re-argue the merits under the guise of disputing the relevance of
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`various portions of Dr. Ratain’s testimony and supporting exhibits, Novartis
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`impermissibly argues for the first time in this proceeding that “after-acquired
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`evidence cannot be used ‘to undercut what appeared at the time of the patent
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`application to be unexpected results’” and that it would be unfair to use later
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`knowledge to show what would have been expected. Mot. 12-13 (citing Takeda
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`Chem. Indus v. Mylan Labs., 417 F. Supp. 2d 341, 386 (S.D.N.Y. 2006)). Again,
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`Novartis does not (and cannot) identify where it timely objected to this evidence
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`with the required specificity.
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`Moreover, well-settled Federal Circuit law cited earlier by Novartis
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`contradicts its own reading of Takeda district-court opinion. As Novartis
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`acknowledged in its response, “[f]or chemical compounds, the structure of the
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`compound and its properties are inseparable considerations in the obviousness
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`determination” because “[r]elevant secondary considerations often are not manifest
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`even until well after the issuance of a patent.” Genetics Inst. v. Novartis Vaccines,
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`655 F.3d 1291, 1307 (Fed. Cir. 2011) (citing In re Papesch, 315 F.2d 381, 391
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`(CCPA 1963)); POR 63; Reply 22. To be sure, the earlier Takeda case cannot and
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`did not overturn the long-settled law later enunciated in Genetics Institute. The
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`Takeda district court did not cite any Federal Circuit law, and further stated that
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`12
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`such after-acquired evidence could be used after a “careful analysis of relevance.”
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`417 F. Supp. 2d at 386. The Federal Circuit affirmed without reaching the issue,
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`instead pointing to substantial evidence supporting the district court’s findings. 492
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`F.3d 1350, 1361-62 (Fed. Cir. 2007) (“there was no reasonable expectation”
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`pioglitazone would possess compound b’s properties because “it was not a
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`homolog” (emphasis added)).
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`To show unexpected results, Novartis must compare the actual properties of
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`the compounds to show that there is a difference and then show that the difference
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`would have been unexpected. Reply 20-22. Contrary to Novartis’s new arguments,
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`later-acquired evidence is not a one-way street in the patentee’s direction. After
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`surveying the cases, the Papesch court concluded that, because “homologous”
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`compounds are presumed to have similar properties, the patentee must compare the
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`actual properties of the closest prior-art and claimed compounds to show an actual
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`difference is unexpected. 315 F.2d at 387-391. The Federal Circuit has not
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`deviated from Papesch. E.g., Aventis Pharma Deutschland v. Lupin, 499 F.3d
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`1293, 1301 (Fed. Cir. 2007) (“One who claims a compound, per se, which is
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`structurally similar to a prior art compound must rebut the presumed expectation
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`that the structurally similar compounds have similar properties.”); In re Dillon, 919
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`F.2d 688, 693-94 (Fed. Cir. 1990) (en banc) (“appellant has made no showing
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`overcoming the prima facie presumption of similar properties for those analogous
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`13
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`compositions”). In other words, a patentee must compare the compounds’ actual
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`properties because “[m]ere recognition of latent properties in the prior art does not
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`render nonobvious an otherwise known invention.” In re Baxter Travenol Labs,
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`952 F. 2d 388, 392 (Fed. Cir. 1991) (comparing later-discovered properties of the
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`prior art and claimed bags).
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`V. Topic 6 – The Board should deny Novartis’s motion to exclude
`paragraphs and exhibits not cited in the Reply
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`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’ Reply, contending that
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`“it is apparent” that Petitioners improperly incorporated arguments by reference or
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`failed to fully explain the cited evidence. Mot. 13-14. Novartis again did not
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`attempt to meet the basic requirements for a motion to exclude. It did not (and
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`cannot) point to where it timely objected to each of the cited exhibits and
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`paragraphs. For example, it seeks to exclude Exs. 1041-1063, 1065-1113, 1120-
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`1123, and Ex. 1118 ¶¶ 59-63, but it objected to only some of those. Obj. 2.
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`More importantly, Novartis did not even attempt to allege any specific
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`instance where the Reply improperly incorporated arguments, but merely states it
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`must be so because the Reply brief’s word count is close to the limit. Mot. 13.
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`Novartis cannot be allowed to abuse the process by filing a deficient motion in an
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`attempt to require Petitioners to spend pages and pages justifying every citation in
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`its Reply. Furthermore, there is no requirement to directly cite every exhibit used
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`14
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`IPR2016-00084
`U.S. Patent No. 5,665,772
`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. 1118 ¶¶ 5-16, 111), topic summaries and transitions (e.g.,
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`Ex. 1118 ¶¶ 24, 30-31, 36, 45-46), 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. 14 (citing, e.g., Hamilton Beach Brands v.
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`Courtesy Prods., IPR2014-01260, Paper 11 (Feb. 25, 2015) (refusing to give any
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`weight to bare citations without any explanation)).
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`VI. Conclusion
`For the above reasons, the Board should deny Novartis’s motion to exclude.
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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)
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`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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`/Matthew L. Fedowitz/
`By:
`Matthew L. Fedowitz
`(Reg. No. 61,386)
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`15
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`Dated: January 3, 2017
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`Merchant & Gould P.C.
`1900 Duke Street, Ste. 600
`Alexandria, VA 22314
`703-684-2500; 703-684-2501 (Fax)
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`Counsel for Petitioner
`Breckenridge Pharmaceutical, Inc.
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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
`212-813-8846; 646-558-4226 (Fax)
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`Counsel for Petitioner
`Roxane Laboratories, Inc.
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`IPR2016-00084
`U.S. Patent No. 5,665,772
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`16
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 3rd day of January,
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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)
`Raymond R. Mandra (Reg. No. 34,382)
`Peter J. Waibel (Reg. No. 43,228)
`Christina Schwarz (pro hac vice)
`Charlotte Jacobsen (pro hac vice)
`Susanne L. Flanders (pro hac vice)
`Jared L. Stringham (pro hac vice)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`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.