`Date Filed: December 20, 2016
`
`Filed On Behalf Of: Novartis AG
`
`By: Nicholas N. Kallas
`
`NKallas@fchs.com
`
`ZortressAfinitorIPR@fchs.com
`
`(212) 218-2100
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`PAR PHARMACEUTICAL, INC.,
`BRECKENRIDGE PHARMACEUTICAL, INC. AND
`ROXANE LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`
`Case IPR2016-000841
`U.S. Patent 5,665,772
`
`
`
`
`PATENT OWNER’S
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`1 The Board on October 27, 2016 joined Breckenridge’s IPR2016-01023 and
`Roxane’s IPR2016-01103 with Par’s IPR2016-00084 challenging claims 1-3 and
`8-10 of the ’772 patent. Because the three Petitioners’ arguments and evidence are
`substantively identical, this motion cites only papers from IPR2016-00084.
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ............................................................................................... 1
`
`II. ARGUMENT ....................................................................................................... 3
`
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Petitioners’ Argument And Expert Opinions That Rely
`On The ’772 Patent Specification Should Be Excluded
`As Irrelevant .......................................................................................... 3
`
`Exhibit 1008 Is Incomplete And In Fairness Should Be
`Considered Alongside Other Evidence Under F.R.E.106 ..................... 4
`
`Exhibits 1034 And 1117 Should Be Excluded As
`Untimely ................................................................................................ 5
`
`The Paragraphs Of Petitioners’ December 5, 2016 Reply
`Expert Declarations That Raise New Prima Facie
`Arguments Should Be Excluded As Untimely ..................................... 8
`
`a.
`
`b.
`
`Jorgensen December 5, 2016 Reply Declaration ........................ 8
`
`Ratain December 5, 2016 Reply Declaration ...........................10
`
`Dr. Ratain’s Opinions On Unexpected Results Based On
`Information Dated After October 9, 1992 Are Irrelevant
`And Should Be Given No Weight .......................................................12
`
`The Evidence Not Cited In Petitioners’ Reply Should Be
`Excluded ..............................................................................................13
`
`Any Other Evidence Not Included In Grounds 1 And 2
`Should Be Excluded ............................................................................15
`
`III. CONCLUSION .................................................................................................15
`
`
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Corning Inc. v. DSM IP Assets B.V., IPR2013-00052, Paper 88
`(P.T.A.B. May 1, 2014) ...............................................................................7, 9
`
`Fidelity Nat. Information Servs., Inc. v. Datatreasury Corp.,
`IPR2014-00490, Paper 9 (P.T.A.B. Aug. 13, 2014) ......................................14
`
`Genzyme Therapeutic Prods. Limited Partnership v. Biomarin
`Pharms. Inc.,
`825 F.3d 1360 (Fed. Cir. 2016) .....................................................................15
`
`Hamilton Beach Brands, Inc. v. Courtesy Prods. LLC,
`IPR2014-01260, Paper 11 (P.T.A.B. Feb. 25, 2015) ....................................14
`
`In re NuVasive, Inc.,
`841 F.3d 966 (Fed. Cir. 2016) ...................................................................9, 15
`
`In re Rosuvastatin Calcium Patent Litig.,
`703 F.3d 511 (Fed. Cir. 2012) .......................................................................11
`
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ......................................................................... 4
`
`O2 Micro Int’l Ltd. v. Monolithic Power Sys., Inc.,
`467 F.3d 1355 (Fed. Cir. 2006) .....................................................................10
`
`Otsuka Pharm. Co. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) ....................................................................... 3
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`492 F. Supp. 2d 353 (S.D.N.Y. 2007) ...........................................................11
`
`Takeda Chem. Indus., Ltd. v Mylan Labs., Inc.,
`417 F. Supp. 2d 341 (S.D.N.Y. 2006) ...........................................................12
`
`Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) .............................................................. 12, 13
`
`Toshiba Corp. v. Optical Devices, LLC,
`IPR2014-01447, Paper 34 (P.T.A.B. Mar. 9, 2016) ........................................ 7
`
`
`
`ii
`
`
`
`
`
`Yamanouchi Pharm. Co., Ltd. v. Danbury Pharmacal, Inc.,
`231 F.3d 1339 (Fed. Cir. 2000) .....................................................................11
`
`Statutes
`
`35 U.S.C. § 312(a)(3) ................................................................................ 6, 8, 10, 15
`
`Other Authorities
`
`77 Fed. Reg. at 48,767 ...........................................................................................7, 8
`
`Rules
`
`F.R.E. 106 ..............................................................................................................1, 4
`
`F.R.E. 402 ........................................................................................................ passim
`
`Regulations
`
`37 § C.F.R. 42.22(a)(2) ............................................................................................13
`
`37 C.F.R § 42.123(b) ................................................................................................. 7
`
`37 C.F.R. § 42.104(b) ...................................................................................... passim
`
`37 C.F.R. § 42.23 .................................................................................................7, 13
`
`37 C.F.R. § 42.24(c)(1) ........................................................................................2, 13
`
`37 C.F.R. § 42.6(a)(3) ..........................................................................................2, 14
`
`37 C.F.R. § 42.64(b) .................................................................................................. 7
`
`
`
`
`
`
`
`iii
`
`
`
`
`
`I.
`
`
`
`INTRODUCTION
`
`Patent Owner Novartis moves to exclude the following evidence:
`
`1. Petitioners’ arguments and the opinions of Petitioners’ expert Dr.
`
`William Jorgensen that rely upon the specification of ’772 patent itself as evidence
`
`of the prior art, i.e., Exhibit 1003 (the October 26, 2015 Jorgensen declaration), ¶¶
`
`21, 54 and 75; and Exhibit 1118 (the December 5, 2016 Jorgensen reply
`
`declaration), ¶¶ 8, 9, 25 and 26. Any argument or expert opinion in that regard
`
`should be excluded as irrelevant under F.R.E. 402. IPR2016-00084, Paper 11 at 2;
`
`Paper 50 at 16.
`
`2. Exhibit 1008 (Lemke Chapter 16). That exhibit is one chapter of a 142-
`
`page book and thus is incomplete. IPR2016-00084, Paper 11 at 6. If the Board
`
`considers Exhibit 1008, F.R.E. 106 requires that the Board in fairness also consider
`
`other relevant chapters from that book, i.e., Exhibit 2045 and Exhibit 2104.
`
`3. Exhibits 1034 (Fiebig) and 1117 (Schwartz). Those exhibits address
`
`elements of Petitioners’ prima facie case and should have been served with the
`
`October 25, 2015 petition. Because they were not served until December 5, 2016
`
`with Petitioners’ reply, they are untimely. IPR2016-00084, Paper 50 at 3.
`
`4. Exhibit 1118, ¶¶ 8-11, 13-17, 20, 23, 25-26, 32-33, 53, 82, 86-87, 89-99,
`
`101-102, 104-105, 107-108 and 110, and Exhibit 1119 (the December 5, 2016
`
`reply declaration of Petitioners’ expert Dr. Mark J. Ratain), ¶¶ 32-36, 43, 57 and
`
`
`
`
`
`
`
`101-106. Those paragraphs in Petitioners’ reply expert declarations address
`
`elements of Petitioners’ prima facie case and should have been served with the
`
`October 25, 2015 petition. Because they were not served until December 5, 2016
`
`with Petitioners’ reply, they are untimely. IPR2016-00084, Paper 50 at 16, 20.
`
`5. Exhibit 1119, ¶¶ 41, 46, 49-50, 52, 54, 58, 60, 76, 88, 97 and 100-107,
`
`and the post-October 9, 1992 evidence cited therein (i.e., Exhibits 1044-1050,
`
`1055-1061, 1065-1069, 1088, 1093, 1098, 1100-1107, 1120 and 1122), insofar as
`
`Petitioners rely on those materials to rebut the unexpectedness of any of
`
`everolimus’s properties. Those paragraphs and exhibits are irrelevant to the
`
`unexpected nature of everolimus’s properties, and should be given no weight.
`
`IPR2016-00085, Paper 50 at 17-18.
`
`6. Petitioners’ “reply” evidence not cited in the reply, i.e., Exhibits 1036-
`
`1038, 1041-1063, 1065-1113, 1117 and 1120-1123; Exhibit 1118, ¶¶ 5-12, 14, 16,
`
`24, 30-31, 36, 45-46, 59-63, 79-81 and 111; and Exhibit 1119, ¶¶ 14-31, 37-42 and
`
`44. Petitioners’ service of those materials on December 5, 2016 without any
`
`citation to them in the reply constitutes an improper incorporation by reference
`
`under 37 C.F.R. § 42.6(a)(3) and a violation of the word limit for replies set forth
`
`in 37 C.F.R. § 42.24(c)(1). IPR2016-00084, Paper 50 at 2, 4-14, 18 and 21.
`
`
`
`2
`
`
`
`
`
`7. Any evidence that does not appear in instituted Grounds 1 or 2, and that
`
`Petitioners seek to rely upon to establish any element of their prima facie case
`
`against claims 1-3 and 8-10 of the ’772 patent. IPR2016-00084, Paper 50 at 22.
`
`II. ARGUMENT
`
`
`1.
`
`Petitioners’ Argument And Expert Opinions That Rely On
`The ’772 Patent Specification Should Be Excluded As Irrelevant
`
`
`
`
`In this IPR, Petitioners challenge claims 1-3 and 8-10 of the ’772 patent
`
`covering Novartis’s immunosuppressant and antitumor compound everolimus.
`
`Petitioners bear the burden of proving prima facie obviousness by showing that a
`
`person of ordinary skill in the art (“POSA”) would have been motivated by the
`
`prior art as of October 9, 1992 to select rapamycin as a lead compound, and would
`
`have been motivated by the prior art to modify rapamycin to arrive at everolimus
`
`with a reasonable expectation of success in obtaining everolimus’s properties.
`
`Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1291 (Fed. Cir. 2012).
`
`
`
`Petitioners, in attempting to identify a prior art motivation to modify
`
`rapamycin, rely on a statement in the specification of the ’772 patent that
`
`“rapamycin is highly insoluble, making it difficult to formulate.” Exhibit 1001,
`
`col. 1, ll. 39-40. Petitioners and their expert Dr. Jorgensen contend that statement
`
`is evidence of the state of the art as of October 9, 1992. Exhibit 1003, ¶¶ 21, 54
`
`and 75; Exhibit 1118, ¶¶ 8-9 and 25-26. They are wrong. A specification may not
`
`
`
`3
`
`
`
`
`
`be used as prior art “absent some admission that matter disclosed in the
`
`specification is in the prior art.” In re Wertheim, 541 F.2d 257, 269 (C.C.P.A.
`
`1976). Here, it was Petitioners’ burden to show that the statement on which they
`
`rely in the ’772 patent specification constituted an admission that the matter therein
`
`was in the prior art. Petitioners did not and cannot do so. Indeed, the statement on
`
`which Petitioners rely did not even appear in the October 9, 1992 priority
`
`application for the ’772 patent—and thus could not have constituted an admission
`
`about the state of the art as of that date. See Exhibit 2057 (GB ’220 priority
`
`application) at 2.
`
`
`
`Petitioners’ arguments and expert opinions that rely on the above-mentioned
`
`statement in the ’772 patent specification as evidence of the prior art should be
`
`excluded as irrelevant under F.R.E. 402.
`
`2.
`
`Exhibit 1008 Is Incomplete And In Fairness Should Be
`Considered Alongside Other Evidence Under F.R.E. 106
`
`
`
`
`Petitioners rely on Exhibit 1008 (Lemke Chapter 16) in connection with
`
`their allegation that a POSA would have been motivated to modify rapamycin by
`
`adding hydroxyl groups, carboxylic acids or amines. Exhibit 1008, however, is
`
`just one chapter of a 142-page book by Thomas L. Lemke titled “Review of
`
`Organic Functional Groups.” Under F.R.E. 106, fairness demands that Exhibit
`
`1008, concerning water solubility, be considered with other relevant chapters from
`
`that book, including Exhibit 2045 (Lemke Chapters 10-12) and Exhibit 2104
`4
`
`
`
`
`
`
`
`(Lemke Chapter 6), which, inter alia, teach that carboxylic acids and amines would
`
`have been of particular interest for the purpose of increasing water solubility
`
`because they are ionizable, and can form salts that significantly increase water
`
`solubility. IPR2016-00084, Paper 27 at 13.
`
`
`
`
`
`3.
`
`Exhibits 1034 And 1117 Should Be Excluded As Untimely
`
`Petitioners, as part of their prima facie case, allege that a POSA would have
`
`been motivated to modify rapamycin to improve its water solubility for
`
`immunosuppressive use by making specific chemical modifications, and
`
`Petitioners rely in part on Exhibit 1007 (Yalkowsky) for the allegation that a POSA
`
`would make specific types of chemical modifications. IPR2016-00084, Paper 2 at
`
`23. But—as Novartis told Petitioners in its February 2, 2016 preliminary
`
`response—Petitioners’ alleged motivation ignores that, even assuming a POSA
`
`was motivated to increase rapamycin’s water solubility, the POSA first would have
`
`considered other approaches, including formulation approaches. IPR2016-00084
`
`Paper 7 at 20. Moreover, the petition fails to explain how Yalkowsky, which
`
`addresses ideal solubility, is applicable to rapamycin’s solubility in water. In fact,
`
`Yalkowsky is not applicable to rapamycin’s solubility in water. Id. at 24-26.
`
`
`
`Petitioners belatedly try to salvage their alleged motivation-to-modify by
`
`citing, for the first time in reply, two decades-old references: Exhibit 1034
`
`(Fiebig), which Petitioners assert shows that formulation approaches “could be
`
`
`
`5
`
`
`
`
`
`ineffective or introduce other problems” (IPR2016-00084, Paper 46 at 6), and
`
`Exhibit 1117 (Schwartz), which Petitioners’ expert asserts shows that the same
`
`“trends” can be seen in ideal and non-ideal solutions (Exhibit 1118, ¶¶ 97-99, cited
`
`in IPR2016-00084, Paper 46 at 16).
`
`
`
`Petitioners’ belated reliance on those exhibits for their prima facie case
`
`violates 35 U.S.C. § 312(a)(3) (requiring that a petition identify “with
`
`particularity” the evidence that supports a petitioner’s challenges) and 37 C.F.R. §
`
`42.104(b) (requiring that a petition identify the specific portions of the evidence
`
`that support a petitioner’s challenges, and establishing that “[t]he Board may
`
`exclude or give no weight to the evidence where a party has failed to state its
`
`relevance or to identify specific portions of the evidence that support the
`
`challenge.”). There is no reason why Petitioners could not have found and served
`
`the decades-old Fiebig and Schwartz references with the petition. Indeed, Par, in a
`
`related proceeding, concedes that it is “not an excuse” for a petitioner to have
`
`failed to conduct a reasonably diligent search of the relevant art before filing its
`
`petition. IPR2016-01059, Paper 20 at 6. Nor should Petitioners be excused for
`
`failing to explain in their petition how one of their primary references, Yalkowsky,
`
`applies to the motivation alleged by Petitioners in this proceeding.
`
`
`
`Further, Petitioners—at least as early as Novartis’s February 2, 2016
`
`preliminary response—were on notice of Novartis’s arguments that POSAs would
`
`
`
`6
`
`
`
`
`
`have considered using formulation approaches to increase rapamycin’s water
`
`solubility for immunosuppressive use prior to making chemical modifications, and
`
`that Yalkowsky’s ideal solubility teachings are inapplicable to the non-ideal
`
`solution of rapamycin in water. Petitioners thus also could have served Fiebig and
`
`Schwartz as supplemental evidence or information under 37 C.F.R. §§ 42.64(b) or
`
`42.123(b) shortly after the April 29, 2016 institution of IPR2016-00084. See
`
`Toshiba Corp. v. Optical Devices, LLC, IPR2014-01447, Paper 34 at 44-45
`
`(P.T.A.B. Mar. 9, 2016) (noting petitioners’ missed opportunities to serve evidence
`
`earlier as supplemental evidence under 37 C.F.R. §§ 42.64(b) and 42.123(b)).
`
`Petitioners did not do so. Instead, Petitioners waited over half a year to serve
`
`Fiebig and Schwartz with their December 5, 2016 reply.
`
`
`
`That is not allowed. See Toshiba Corp., IPR2014-01447, Paper 34 at 45-46
`
`(37 C.F.R. § 42.23, governing replies, “does not authorize or otherwise provide a
`
`means for supplementing the evidence of record. As explained in the Office Patent
`
`Trial Practice Guide, ‘a reply that . . . belatedly presents evidence will not be
`
`considered and may be returned.’ 77 Fed. Reg. at 48,767 . . . Although Petitioner
`
`was aware early on of the possible need for such supplemental evidence or
`
`information in this proceeding, Petitioner made no apparent effort to take
`
`advantage of the available procedures.”); Corning Inc. v. DSM IP Assets B.V.,
`
`IPR2013-00052, Paper 88 at 11-16 (P.T.A.B. May 1, 2014) (declining to consider
`
`
`
`7
`
`
`
`
`
`reply that introduced new anticipation evidence: “[s]uch evidence, and Corning’s
`
`argument relying on such evidence, exceeded the proper scope of a reply.”); Trial
`
`Practice Guide, 77 Fed. Reg. at 48,767 (“Examples of indications that a new issue
`
`has been raised in a reply include new evidence necessary to make out a prima
`
`facie case for the patentability or unpatentability of an original or proposed
`
`substitute claim, and new evidence that could have been presented in a prior
`
`filing.”).
`
`
`
`
`
`
`
`Fiebig and Schwartz should be excluded.
`
`4.
`
`
`
`
`The Paragraphs Of Petitioners’ December 5, 2016
`Reply Expert Declarations That Raise New
`Prima Facie Arguments Should Be Excluded As Untimely
`
`a.
`
`Jorgensen December 5, 2016 Reply Declaration
`
`Exhibit 1118 (December 5, 2016 Jorgensen reply declaration) raises new
`
`arguments that address elements of Petitioners’ prima facie case, and thus should
`
`have been included with the petition pursuant to 35 U.S.C. § 312(a)(3) and 37
`
`C.F.R. § 42.104(b). Specifically:
`
` ¶¶ 17 and 20 address the alleged motivation to select rapamycin as
`
`a lead compound;
`
` ¶¶ 8-9, 25-26 and 32-33 address the alleged motivation to improve
`
`rapamycin’s water solubility;
`
`
`
`8
`
`
`
`
`
` ¶¶ 13-15, 82, 86-87, 89-99 and 101-102 address the alleged
`
`relevance of Yalkowsky and Lemke to that motivation;
`
` ¶¶ 10 and 53 address the alleged motivation to modify the C40
`
`position of rapamycin;
`
` ¶ 11 addresses the alleged motivation to modify that position with
`
`certain substituents; and
`
` ¶¶ 16, 23, 104-105, 107-108 and 110 address the alleged
`
`reasonable expectation of successfully obtaining an
`
`immunosuppressant compound with improved water solubility.
`
`
`
`There is no reason why Dr. Jorgensen could not have included those prima
`
`facie arguments in his first declaration served with the petition. It would be
`
`manifestly unfair to allow Petitioners to introduce those arguments now, thereby
`
`depriving Novartis and its experts a substantive opportunity to respond to them.
`
`Corning, IPR2013-00052, Paper 88 at 11-16 (“It would be manifestly unfair to
`
`allow Corning to substitute new %RAU data in the Reply when DSM had no
`
`briefing opportunity to address any issues with the new evidence.”); In re
`
`NuVasive, Inc., 841 F.3d 966, 972-973 (Fed. Cir. 2016) (Board abused its
`
`discretion by allowing petitioner to introduce new prima facie argument on reply,
`
`without providing patent owner an opportunity to respond; observations on cross-
`
`examinations did not suffice to remedy prejudice to patent owner). Cf. O2 Micro
`
`
`
`9
`
`
`
`
`
`Int’l Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355, 1367-68 (Fed. Cir. 2006)
`
`(district court did not abuse its discretion in excluding untimely supplemental
`
`expert declarations).
`
`
`
`For these reasons and the reasons set forth supra at II.3., the above-
`
`mentioned paragraphs of Exhibit 1118 should be excluded.
`
`
`
`
`
`b.
`
`Ratain December 5, 2016 Reply Declaration
`
`
`
`Exhibit 1119 (December 5, 2016 Ratain reply declaration) likewise raises
`
`arguments that address elements of Petitioners’ prima facie case, and thus should
`
`have been included with the petition pursuant to 35 U.S.C. § 312(a)(3) and 37
`
`C.F.R. § 42.104(b). Specifically, ¶¶ 32-36, 43, 57 and 101-106 belatedly allege
`
`that a POSA in 1992 would have been motivated to modify rapamycin to improve
`
`its solubility, and that a POSA in 1992 would have had a reasonable expectation
`
`that everolimus and rapamycin would have similar antitumor properties. IPR2016-
`
`00084, Paper 46 at 17-18, n.6.
`
`
`
`There is no reason why Dr. Ratain’s prima facie arguments regarding the
`
`motivation to modify rapamycin could not have been included with the petition,
`
`and it would be manifestly unfair to allow Petitioners to introduce those arguments
`
`now. See supra, II.4.a. And while the petition mentioned antitumor activity as
`
`part of an alleged motivation to select rapamycin as a lead compound (IPR2016-
`
`00084, Paper 2 at 11), and also alleged that a POSA would have been motivated to
`
`
`
`10
`
`
`
`
`
`modify rapamycin “without losing rapamycin’s biological activity” (id. at 44), the
`
`petition neglected to include any evidence to show that a POSA would have had a
`
`reasonable expectation that everolimus would have any antitumor properties—let
`
`alone antitumor properties similar to those of rapamycin. Such evidence should
`
`have been included with the petition as part of Petitioners’ prima facie case. See
`
`Sanofi-Synthelabo v. Apotex, Inc., 492 F. Supp. 2d 353, 390 (S.D.N.Y. 2007) (“To
`
`determine whether a given compound is obvious compared to a prior art
`
`compound, any and all properties of those compounds must be considered, even
`
`where the prior art has not disclosed the relevant properties of the prior art.”), aff’d,
`
`550 F.3d 1075 (Fed. Cir. 2008); In re Rosuvastatin Calcium Patent Litig., 703 F.3d
`
`511, 517-18 (Fed. Cir. 2012); Yamanouchi Pharm. Co., Ltd. v. Danbury
`
`Pharmacal, Inc., 231 F.3d 1339, 1345 (Fed. Cir. 2000) (“[T]he ordinary medicinal
`
`chemist would not have expected [the claimed compound] to have the ‘most
`
`desirable combination of pharmacological properties’ that it possesses.”).
`
`
`
`Moreover, insofar as Petitioners’ rely upon Exhibit 1119, ¶¶ 101-106 and the
`
`post-October 9, 1992 information therein to support their prima facie case, those
`
`paragraphs are irrelevant under F.R.E. 402 and should be given no weight, as
`
`provided under 37 C.F.R. § 42.104(b). That is because it is legally improper to
`
`rely on post-priority date information to determine whether a POSA in October
`
`1992 would have had a reasonable expectation that everolimus would have
`
`
`
`11
`
`
`
`
`
`antitumor properties. See Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492
`
`F.3d 1350, 1356 (Fed. Cir. 2007) (holding that a reasonable expectation of success
`
`must be based on an analysis of the prior art).
`
`
`
`For these reasons and the reasons set forth supra at II.3. and II.4.a.,
`
`Petitioners cannot now rectify these deficiencies for the first time upon reply.
`
`Exhibit 1119, ¶¶ 32-36, 43, 57 and 101-106 should be excluded, or alternatively
`
`given no weight in support of Petitioners’ prima facie case, as provided by 37
`
`C.F.R. § 42.104(b).
`
`5.
`
`Dr. Ratain’s Opinions On Unexpected Results
`Based On Information Dated After October 9, 1992
`Are Irrelevant And Should Be Given No Weight
`
`
`
`
`Additionally, insofar as Petitioners rely upon Exhibit 1119, ¶¶ 41, 46, 49-50,
`
`52, 54, 58, 60, 76, 88, 97 and 100-107, and the post-October 9, 1992 evidence cited
`
`therein (i.e., Exhibits 1044-1050, 1055-1061, 1065-1069, 1088, 1093, 1098, 1100-
`
`1107, 1120 and 1122) to challenge the unexpectedness of any of everolimus’s
`
`properties, those paragraphs and exhibits are irrelevant under F.R.E. 402 and
`
`should be given no weight, as provided under 37 C.F.R. § 42.104(b). That is
`
`because it is legally improper to rely on such post-priority date information to
`
`determine whether everolimus’s properties would have been unexpected as of
`
`October 9, 1992. Takeda Chem. Indus., Ltd. v Mylan Labs., Inc., 417 F. Supp. 2d
`
`341, 385-86 (S.D.N.Y. 2006) (after-acquired evidence cannot be used “to undercut
`
`
`
`12
`
`
`
`
`
`what appeared at the time of the patent application to be unexpected results . . . [I]t
`
`would be entirely unfair to the patent applicant to discount what appeared at the
`
`time of an application to be unexpected results because our advancing and
`
`improved scientific knowledge allows us to understand why such results are to be
`
`expected”), aff’d sub nom., Takeda, 492 F.3d at 1364.
`
`6.
`
`The Evidence Not Cited In
`Petitioners’ Reply Should Be Excluded
`
`
`
`
`The majority of Petitioners’ evidence served on December 5, 2016 is not
`
`even cited—let alone discussed—in the reply. That uncited evidence includes no
`
`fewer than 83 of Petitioners’ reply exhibits (totaling about 1,500 pages), and
`
`significant portions of the December 5, 2016 reply expert declarations of Drs.
`
`Jorgensen and Ratain (totaling 56 pages), i.e., Exhibits 1036-1038, 1041-1063,
`
`1065-1113, 1117 and 1120-1123; Exhibit 1118, ¶¶ 5-12, 14, 16, 24, 30-31, 36, 45-
`
`46, 59-63, 79-81 and 111; and Exhibit 1119, ¶¶ 14-31, 37-42 and 44.
`
`
`
`Petitioners’ reply is 5,573 words, close to the 5,600-word limit set forth in
`
`37 C.F.R. § 42.24(c)(1). It is apparent that Petitioners ran out of space in the reply
`
`to explain the significance of their “reply” evidence—which explanations are
`
`required by 37 C.F.R. §§ 42.23 and 42.22(a)(2)—and instead shoehorned those
`
`explanations into their reply expert declarations.
`
`
`
`13
`
`
`
`
`
`
`
`Such tactics are not allowed. See 37 C.F.R. § 42.6(a)(3) (“Arguments must
`
`not be incorporated by reference from one document into another document.”);
`
`Hamilton Beach Brands, Inc. v. Courtesy Prods. LLC, IPR2014-01260, Paper 11 at
`
`7 (P.T.A.B. Feb. 25, 2015) (“Without a sufficient explanation why Liu and
`
`relevant hospitality industry regulations would render obvious the preamble of
`
`claim 1, the citations to the Krause and Slocum Declarations amount to
`
`incorporation by reference of arguments made in those declarations that
`
`circumvent the page limits that apply to petitions.”); Fidelity Nat. Information
`
`Servs., Inc. v. Datatreasury Corp., IPR2014-00490, Paper 9 at 11 (P.T.A.B. Aug.
`
`13, 2014) (“[T]he Petition’s extensive reliance on citations to the Gray Declaration
`
`in lieu of citations to the references themselves amounts to an incorporation by
`
`reference of arguments made in the Gray Declaration into the Petition, thereby
`
`circumventing the page limits that apply to petitions. We, therefore, decline to
`
`consider the information found only in the Gray Declaration.”). Note too that, in
`
`Hamilton and Fidelity, the Board declined to consider portions of expert
`
`declarations that had been cited—albeit not explained—by a petitioner. Here, by
`
`contrast, Petitioners did not even bother to cite in their reply the paragraphs of the
`
`reply expert declarations identified herein.
`
`
`
`For these reasons, the above-mentioned uncited evidence should be
`
`excluded.
`
`
`
`14
`
`
`
`
`
`7.
`
`Any Other Evidence Not Included In
`Grounds 1 And 2 Should Be Excluded
`
`
`
`Last, Novartis moves to exclude under F.R.E. 402, 35 U.S.C. § 312(a)(3)
`
`and 37 C.F.R. § 42.104(b) any evidence that does not appear in instituted Grounds
`
`1 or 2 and that Petitioners rely upon to establish any element of their prima facie
`
`case against claims 1-3 and 8-10 of the ’772 patent (other than evidence used for
`
`the limited purposes of describing the state of the art or reinforcing the meaning of
`
`a prior art reference that appears in Grounds 1 or 2). See NuVasive, 841 F.3d at
`
`972-973 (Board abused its discretion by relying on portion of prior art reference
`
`that was first identified by petitioner in its reply; that portion of the reference did
`
`not merely describe the state of the art, but instead was the sole prior art disclosure
`
`of disputed claim elements relied upon by the Board); Genzyme Therapeutic
`
`Prods. Limited Partnership v. Biomarin Pharms. Inc., 825 F.3d 1360, 1368 (Fed.
`
`Cir. 2016) (parties should move to exclude a reference not cited in instituted
`
`grounds).
`
`III. CONCLUSION
`
`
`
`For the foregoing reasons, the evidence identified herein should be excluded.
`
`
`
`15
`
`
`
`
`
`
`
`
`
`
`
`Dated: December 20, 2016
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`/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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`16
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Motion to Exclude
`
`Evidence was served on December 20, 2016 by causing it to be sent by email to
`
`counsel for Petitioners at the following email addresses:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Daniel G. Brown (dan.brown@lw.com)
`
`Robert Steinberg (bob.steinberg@lw.com)
`
`Brenda L. Danek (Brenda.danek@lw.com)
`
`
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`Matthew L. Fedowitz (mfedowitz@merchantgould.com)
`
`B. Jefferson Boggs (jboggs@merchantgould.com)
`
`Daniel R. Evans (devans@merchantgould.com)
`
`Keith A. Zullow (kzullow@goodwinlaw.com)
`
`Marta Delsignore (mdelsignore@goodwinprocter.com)
`
`
`
`Dated: December 20, 2016
`
`
`
`
`
`
`
`
`
`17
`
`
`
`
`
`/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
`
`