Paper No. ____
`Date Filed: June 27, 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
`
`
`
`ROXANE LABORATORIES, INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`Inter Partes Review No. 2016-01102
`
`U.S. Patent 5,665,772
`
`
`PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER ROXANE’S MOTION FOR JOINDER
`
`
`
`
`Date Filed: June 27, 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
`
`
`
`ROXANE LABORATORIES, INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`Inter Partes Review No. 2016-01102
`
`U.S. Patent 5,665,772
`
`
`PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER ROXANE’S MOTION FOR JOINDER
`
`
`
`
`
`
`
`
`
`I.
`
`II.
`
`III.
`
`TABLE OF CONTENTS
`
`STATEMENT OF PRECISE RELIEF REQUESTED ................................... 1
`
`RESPONSE TO ROXANE’S STATEMENT OF
`MATERIAL FACTS ....................................................................................... 2
`
`STATEMENT OF REASONS FOR DENYING
`ROXANE’S REQUESTED RELIEF AND FOR
`GRANTING NOVARTIS’S REQUESTED RELIEF .................................... 4
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Roxane’s Petition Is Time-Barred ......................................................... 4
`
`Roxane’s Delay In Challenging Claim 7 Unfairly
`Provides Roxane With A Strategic Advantage ..................................... 6
`
`Roxane’s Contention That Institution On Claim 7 Does
`Not Require Consideration Of The -1102 Record Is
`Wrong .................................................................................................... 8
`
`Petitioners’ Proposed Schedule For Joint Proceedings Is
`Unworkable And Prejudicial To Novartis And The Board .................. 9
`
`Roxane’s Role In Any Joint Proceedings Should Be
`Limited ................................................................................................ 10
`
`IV. CONCLUSION ............................................................................................. 11
`
`
`
`
`
`- i -
`
`
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Aventis Pharma Deutschland GmbH v. Lupin Ltd.,
`499 F.3d 1293 (Fed. Cir. 2007) ............................................................ 9
`
`Dell Inc., Hewlett Packard Co. and NetApp, Inc. v. Elecs.
`and Telecomms. Research Inst.,
`IPR2015-00549, Paper 10 (Mar. 26, 2015) .......................................... 6
`
`Geneva Pharm., Inc. v. Glaxosmithkline PLC,
`189 F. Supp. 2d 377 (E. D. Va. 2002) .................................................. 3
`
`Geneva Pharm., Inc. v. Glaxosmithkline PLC,
`349 F.3d 1373 (Fed. Cir. 2003) ............................................................ 3
`
`Lupin Ltd. v. Senju Pharm. Co., Ltd.,
`IPR2015-01871, Paper 13 (Jan. 25, 2016) ......................................... 10
`
`Teva Pharms. USA, Inc. v. Viiv Healthcare Co.,
`IPR2015-00550, Paper 11 (Jun. 25, 2015) ......................................... 11
`
`Statutes
`
`35 U.S.C. § 316(b) .......................................................................................... 8
`
`37 C.F.R. § 42.1(b) ......................................................................................... 8
`
`- ii -
`
`
`
`
`
`I.
`
`
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Patent Owner Novartis AG (“Novartis”) opposes the May 26, 2016 joinder
`
`motion of Petitioner Roxane Laboratories, Inc. (“Roxane”). In that motion,
`
`Roxane seeks to join its petition for IPR2016-01102 (“-1102 petition”) challenging
`
`claims 1-3 and 7-10 of U.S. Patent No. 5,665,772 (“’772 patent”) with Par
`
`Pharmaceutical, Inc.’s (“Par”) instituted IPR2016-00084 (“-84 IPR”) challenging
`
`claims 1-3 and 8-10 of the ’772 patent.1
`
`
`
`
`
`
`
`Roxane’s joinder motion should be denied for four reasons.
`
`First, Roxane’s May 26, 2016 -1102 petition is time-barred.
`
`Second, joinder of Roxane’s -1102 petition with Par’s -84 IPR would allow
`
`Roxane to exploit the strategic advantage which Par gained by delaying its
`
`
`
` Also:
`
` 1
`
` Breckenridge moves to join with the -84 IPR its May 10, 2016 petition in
`
`IPR2016-01023 (“-1023 petition”) challenging claims 1-3 and 8-10 and its
`
`May 26, 2016 petition in IPR2016-01103 (“-1103 petition”) challenging
`
`claim 7; and
`
` Par moves to join with the -84 IPR its May 17, 2016 petition in IPR2016-
`
`01059 (“-1059 petition) challenging claim 7.
`
`Novartis opposes all such joinder motions.
`
`- 1 -
`
`
`
`
`
`challenge to claim 7 until after the Board instituted the -84 IPR, as explained
`
`below. The exploitation of such gamesmanship should not be encouraged.
`
`
`
`Third, Roxane wrongly assumes that the record at the institution stage in its
`
`-1102 IPR will be the same as that in Par’s -84 IPR. To the contrary: in opposing
`
`Roxane’s -1102 petition, Novartis is entitled in its Preliminary Response to make
`
`new arguments and to rely on new evidence not before the Board in Par’s -84 IPR.
`
`
`
`Fourth, contrary to the statements in Roxane’s motion, joinder of the -1102
`
`IPR will have a significant and prejudicial effect on the schedule. Indeed,
`
`Breckenridge, Par and Roxane (collectively, “Petitioners”) no longer appear to be
`
`pursuing the original -84 IPR schedule with respect to their follow-on claim 7
`
`petitions, including the -1102 petition. And the alternate schedule for hypothetical
`
`joint proceedings that Petitioners proposed in their June 15, 2016 email to the
`
`Board and discussed on a June 17, 2016 teleconference between the parties,
`
`effectively requires a separate trial on claim 7, thereby creating extra work for
`
`Novartis and the Board.
`
`
`
`For these reasons, Roxane’s motion should be denied.
`
`II. RESPONSE TO ROXANE’S STATEMENT OF MATERIAL FACTS
`
`
`
`Novartis does not dispute Statements 1-5 and 10 in Roxane’s Statement Of
`
`Material Facts. IPR2016-01102, Paper 3 at § II.
`
`- 2 -
`
`
`
`
`
`
`
`Novartis disputes Statement 6, because Par’s -1059 petition on claim 7 does
`
`not present “the same grounds” as Par’s -84 IPR. The -1059 petition addresses a
`
`new claim—claim 7—not mentioned in the -84 petition, and the ground it raises
`
`against claim 7, directed to a pharmaceutical composition, is not the same as the
`
`ground the Board instituted in the -84 IPR on claim 1, directed to a chemical
`
`compound. The Board instituted review on claim 1 based on the combination of
`
`five references: Morris, Van Duyne, Rossmann, Yalkowsky and Lemke. IPR2016-
`
`00084, Paper 8 at 18. However, Par acknowledges that those references are
`
`insufficient to render claim 7 obvious, because the -1059 petition adds a sixth
`
`reference, Hughes (discussed in -84 IPR Ground 2 addressing claims 8 and 9, but
`
`not claim 1) and attorney argument alleging that Hughes and Morris, in
`
`combination with other references, teach that rapamycin and rapamycin derivatives
`
`can be formulated with pharmaceutically acceptable carriers to arrive at a useful
`
`immunosuppressant, i.e., the pharmaceutical composition of claim 7 of the ’772
`
`patent. IPR2016-01059, Paper 1 (May 17, 2016) at, e.g., 11, 12, 29, 37, 42, 50, 52,
`
`53. Those arguments also are based upon a newly cited authority: Geneva Pharm.,
`
`Inc. v. Glaxosmithkline PLC, 189 F. Supp. 2d 377 (E. D. Va. 2002), aff’d 349 F.3d
`
`1373 (Fed. Cir. 2003). See IPR2016-01059, Paper 1 (May 17, 2016) at 3, 50.
`
`
`
`Novartis disputes Statements 7 and 8, because Roxane’s -1102 grounds are
`
`not “identical” to Par’s -84 and -1059 grounds. For example, Roxane alleges that
`
`- 3 -
`
`
`
`
`
`the Morris 1992 reference (Ex. 1005), which Par characterizes only as pre-AIA
`
`§ 102(a) art, also qualifies as pre-AIA § 102(b) art. Compare IPR2016-01102,
`
`Paper 2 at 26 and IPR2016-00084, Paper 2 at 26. Roxane alleges that the
`
`Rossmann 1980 reference (Ex. 1024) “discloses a method for deriving three-
`
`dimensional coordinates from stereo diagrams,” whereas Par does not. Compare
`
`IPR2016-01102, Paper 2 at 28 and IPR2016-00084, Paper 2 at 27. And Par alleges
`
`that Rossmann 1980 refers to software that would have allowed a person of
`
`ordinary skill to extract coordinates from two-dimensional figures, whereas
`
`Roxane does not. Compare IPR2016-00084, Paper 2 at 28 and IPR2016-01102,
`
`Paper 2 at 29.
`
`
`
`Novartis disputes Statement 9, and in particular the assertion that the validity
`
`of claim 7 “should rise and fall with the validity of the compound and method
`
`claims of the ’772 patent,” for the reasons set forth below in Section III.3.
`
`III. STATEMENT OF REASONS FOR DENYING
`ROXANE’S REQUESTED RELIEF AND
`FOR GRANTING NOVARTIS’S REQUESTED RELIEF
`
`1.
`
`Roxane’s Petition Is Time-Barred
`
`
`
`In late 2014 Novartis sued Petitioners in the District of Delaware for
`
`infringement of the ’772 patent. D. Del. Civ. Nos. 14-1043, 14-1196, 14-1289.
`
`Breckenridge’s waiver of service of Novartis’s complaint was filed on August 27,
`
`2014. 14-1043, D.I. 7. Roxane and Par accepted service of Novartis’s complaints,
`
`- 4 -
`
`
`
`
`
`respectively, on September 17, 2014 (14-1289, D.I. 8) and October 27, 2014 (14-
`
`1289, D.I. 7). On February 19, 2015, Novartis in the Delaware litigation served on
`
`all three Petitioners infringement contentions asserting each of them infringed
`
`claims 1-3 and 7-10 of the ’772 patent.
`
`
`
`On October 26, 2015, Par filed its -84 petition challenging claims 1-3 and 8-
`
`10—but omitting claim 7. The Board instituted the -84 IPR in a decision dated
`
`April 29, 2016. IPR2016-00084, Paper 8. On May 10, 2016, Breckenridge filed
`
`its -1023 petition challenging claims 1-3 and 8-10—also omitting claim 7. On
`
`May 17, 2016, Par filed its -1059 petition challenging claim 7 for the first time,
`
`and a motion seeking to join the -1059 petition with the -84 IPR. On May 26,
`
`2016, Breckenridge filed its -1103 petition challenging claim 7 for the first time,
`
`and a motion seeking to join the -1059 petition with the -84 IPR. On May 26,
`
`2016, Roxane filed its -1102 petition challenging claims 1-3 and 7-10 for the first
`
`time and a motion seeking to join the -1059 petition with the -84 IPR. None of the
`
`Petitioners has offered any excuse or explanation for their delays in filing their
`
`follow-on -1023, -1059, -1103 and -1102 petitions.
`
`
`
`Roxane’s deadline under 35 U.S.C. § 315(b) to file its -1102 petition against
`
`any claim of the ’772 patent expired long ago, on September 17, 2015. The -1102
`
`petition thus is time-barred. And contrary to Roxane’s assertions, 35 U.S.C.
`
`§ 315(c) does not permit Roxane here to circumvent the 35 U.S.C. § 315(b)
`
`- 5 -
`
`
`
`
`
`deadline through joinder, particularly where (i) Roxane has offered no explanation
`
`for its delay in challenging claims that it well knew Novartis was asserting against
`
`it; and (ii) as explained below in Sections III.3 and 4, joinder will result in
`
`additional time, effort and expense to Novartis and the Board. E.g., Harmonix
`
`Music Sys., Inc. v. Princeton Digital Image Corp., IPR2015-00271, Paper 15 (June
`
`2, 2015) at 10 (denying joinder where the petitioner “present[ed] no persuasive
`
`argument or evidence to explain why the grounds of unpatentability asserted in the
`
`Petition could not have been asserted in [a first] IPR”); Dell Inc., Hewlett Packard
`
`Co. and NetApp, Inc. v. Elecs. and Telecomms. Research Inst., IPR2015-00549,
`
`Paper 10 (Mar. 26, 2015) at 8 (“[W]hile Patent Owner does not oppose joinder . . .
`
`we cannot ignore the additional time, effort and expense that will fall to Patent
`
`Owner”).
`
`2.
`
`Roxane’s Delay In Challenging Claim 7 Unfairly
`Provides Roxane With A Strategic Advantage
`
`
`
`
`Roxane’s joinder motion is silent as to why it failed to file a petition
`
`challenging any claim of the ’772 patent, including claim 7 before the end of the
`
`35 U.S.C. § 315(b) period. Regardless of the reason, it nevertheless allowed
`
`Roxane, like Breckenridge and Par, to obtain a strategic advantage by relying on
`
`Par’s -84 petition which concealed a conflict between the obviousness grounds for
`
`claim 7 set forth in their delayed petitions, and the obviousness grounds for claims
`
`1-3 and 8-10 set forth in Par’s -84 petition.
`
`- 6 -
`
`
`
`
`
`
`
`The conflict is as follows. As to claim 7, Roxane in its -1102 petition (like
`
`Breckenridge and Par in their -1103 and -1059 petitions) asserts that the purported
`
`prior art “lead compound” rapamycin was formulated with various carriers and
`
`tested in animal studies for immunosuppressant properties. IPR2016-01102, Paper
`
`2 (May 26, 2016) at 27-28. Roxane also asserts that the administration of a
`
`compound for therapeutic effect implicitly includes the formulation of that
`
`compound. Id. at 56. By contrast, as to claims 1-3 and 8-10, Par in the -84 petition
`
`asserts that a POSA would have been motivated to undertake permanent chemical
`
`modification of rapamycin to arrive at a useful immunosuppressant, i.e., the
`
`rapamycin derivative everolimus, which is covered by claims 1-3 and 8-9 and
`
`specifically claimed in claim 10. IPR2016-00084, Paper 2 (Oct. 26, 2015) at, e.g.,
`
`40-44.
`
`
`
`Roxane’s ground on claim 7 (like Breckenridge’s and Par’s grounds on
`
`claim 7) conflicts with Par’s grounds on claims 1-3 and 8-10 in suggesting that a
`
`POSA did not have to modify rapamycin chemically to render it a useful
`
`immunosuppressant, but instead could have used formulation approaches to
`
`achieve that goal. Had Roxane (or Breckenridge or Par) challenged claims 1-3 and
`
`7-10 prior to the institution of Par’s -84 IPR, the Board would have had the
`
`opportunity to consider the above-mentioned conflict in deciding whether to
`
`- 7 -
`
`
`
`
`
`institute. The Board was deprived of that opportunity through Petitioners’ delay in
`
`challenging claim 7 along with claims 1-3 and 8-10.
`
`
`
`Granting the joinder of any of Petitioners’ petitions challenging claim 7
`
`under these circumstances would set a precedent that would allow petitioners to
`
`hide conflicts among their invalidity grounds by dividing those grounds across
`
`multiple, strategically delayed petitions. Clearly, that tactic is not one that would
`
`promote the “just, speedy, and inexpensive resolution of every proceeding.” 35
`
`U.S.C. § 316(b); 37 C.F.R. § 42.1(b). It should not be encouraged.
`
`3.
`
`Roxane’s Contention That Institution On Claim 7 Does
`Not Require Consideration Of The -1102 Record Is Wrong
`
`
`
`Roxane appears to assume that in deciding whether to institute the
`
`-1102 case, claim 7 presents only a minimal additional burden, and that the Board
`
`need only consider only the institution decision in the -84 IPR and Roxane’s
`
`additional attorney argument regarding aspects of claim 7.
`
`
`
`That assumption is wrong. Roxane forgets that Novartis is entitled to file a
`
`Preliminary Patent Owner Response in the -1102 case, in which Novartis can raise
`
`new arguments and rely on new evidence, including a new expert declaration.
`
`Roxane also has no support for its suggestion that the Board must only consider the
`
`differences between claim 7 and the claims at issue in the -84 IPR, and need not
`
`assess whether claim 7 is reasonably likely to be unpatentable in view of the prior
`
`art and evidence of record in the -1102 case.
`
`- 8 -
`
`
`
`
`
`Roxane further is wrong in asserting that the validity of a claim to a
`
`pharmaceutical composition comprising a compound necessarily rises and falls
`
`with a claim to a compound or method of using that compound. Aventis Pharma
`
`Deutschland GmbH v. Lupin Ltd., 499 F.3d 1293 (Fed. Cir. 2007) is
`
`distinguishable, at least because it does not involve—as here—a motivation to
`
`modify a compound that was in any way related to pharmaceutical formulations or
`
`pharmaceutical compositions.
`
`4.
`
`Petitioners’ Proposed Schedule For Joint Proceedings Is
`Unworkable And Prejudicial To Novartis And The Board
`
`
`
`Roxane represents that joinder “will not affect the Board’s ability to issue
`
`the decision within its required one-year time frame.” IPR2016-01102, Paper 3 at
`
`5. That representation is inaccurate.
`
`
`
`Petitioners have proposed an alternate schedule for hypothetical joint
`
`proceedings in a June 15, 2016 email to the Board. According to that schedule,
`
`only after nearly all of the papers have been filed in the -1102, -1103 and -1059
`
`proceedings on claim 7 would those proceedings come together with the -84 IPR.
`
`Joinder under that schedule would inconvenience Novartis and the Board at least
`
`by forcing them to conduct an independent trial for claim 7 with independent due
`
`dates. Such a schedule cannot be considered one that has “minimal impact” or one
`
`that promotes the “just, speedy, and inexpensive resolution” of the proceedings.
`
`
`
`The most straightforward solution to the scheduling quandaries presented by
`
`- 9 -
`
`
`
`
`
`hypothetical joint proceedings is simply to deny joinder. And contrary to Roxane’s
`
`conclusory assertions of prejudice (IPR2016-01102, Paper 3 at 9-10), Roxane has
`
`only itself to blame for the situation that it now finds itself in. Roxane could have
`
`filed its -1102 petition before expiry of the one-year statutory bar.
`
`5.
`
`Roxane’s Role In Any Joint Proceedings Should Be Limited
`
`
`
`Roxane acknowledges that the administrative convenience afforded by
`
`joinder is subordinate to the primary goal of all IPR proceedings: their “just,
`
`speedy, and inexpensive resolution.” Accordingly, Roxane’s role in any joint
`
`proceedings—should the Board decide to grant joinder for any follow-on
`
`petition—should be limited to minimize any prejudice to Novartis, the Board, and
`
`Par. Thus, if the Board grants joinder, Novartis asks that the Board order Roxane
`
`(i) to rely solely on the petition and the evidence filed by Par in the -84 IPR and
`
`any instituted IPR on claim 7; (ii) to share with Par the pages that are or will be
`
`allotted for written work product to Par in the -84 IPR and any instituted IPR on
`
`claim 7; and (iii) to share with Par the time that is or will be allotted for cross and
`
`redirect examination to Par in the -84 IPR and any instituted IPR on claim 7.
`
`
`
`Precedent exists for those limitations. See Lupin Ltd. v. Senju Pharm. Co.,
`
`Ltd., IPR2015-01871, Paper 13 (Jan. 25, 2016) at 4-5 (granting joinder upon
`
`Lupin’s agreement “to withdraw all additional arguments, as well as its supporting
`
`declaration of Dr. Lawrence, and proceed in IPR 903 based on the arguments and
`
`- 10 -
`
`
`
`
`
`evidence provided by InnoPharma in IPR 903 . . . In other words, Lupin requests
`
`permission to be added to the case caption as a petitioner in IPR 903, without any
`
`active participation or involvement that is separate from InnoPharma unless
`
`authorized by the Board upon a request pertaining to an issue unique to Lupin
`
`alone.”). Cf. Teva Pharms. USA, Inc. v. Viiv Healthcare Co., IPR2015-00550,
`
`Paper 11 (Jun. 25, 2015) at 6 (denying joinder where joinder raised the prospect
`
`that the parties and the Board would have to manage burdensome additional pages
`
`of briefing).
`
`IV. CONCLUSION
`
`
`
`For the foregoing reasons, Novartis respectfully requests that the Board deny
`
`Roxane’s joinder motion.
`
`
`
`
`
`
`
`
`
`Dated: June 27, 2016
`
`
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`
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`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
`
`- 11 -
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner Novartis’s Opposition To
`
`Petitioner Roxane’s Motion For Joinder Of Its Petition was served on June 27,
`
`2016 by causing it to be sent by email to counsel for Petitioner Roxane
`
`Laboratories, Inc. in IPR2016-01103 and Petitioner Par Pharmaceutical, Inc. in
`
`IPR2016-00084 at the following email addresses:
`
`Roxane Laboratories, Inc.
`
`Keith A. Zullow (kzullow@goodwinprocter.com)
`
`Marta Delsignore (mdelsignore@goodwinprocter.com)
`
`Par Pharmaceutical, Inc.
`
`Daniel Brown (daniel.brown@lw.com)
`
`Robert Steinberg (bob.steinberg@lw.com)
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`
`
`
`
`
`
`
`
`Dated: June 27, 2016
`
`
`
`
`
`
`
`
`
`
`
`/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
`
`
`
`- 12 -
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