throbber
Paper No. _______
`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
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket