`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
`
`
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`Inter Partes Review No. 2016-01103
`
`U.S. Patent 5,665,772
`
`
`PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER BRECKENRIDGE’S MOTION FOR JOINDER
`OF ITS PETITION ON CLAIM 7
`
`
`
`
`
`
`
`I.
`
`II.
`
`III.
`
`TABLE OF CONTENTS
`
`STATEMENT OF PRECISE RELIEF REQUESTED ................................... 1
`
`RESPONSE TO BRECKENRIDGE’S STATEMENT
`OF MATERIAL FACTS ................................................................................. 3
`
`STATEMENT OF REASONS FOR DENYING
`BRECKENRIDGE’S REQUESTED RELIEF AND FOR
`GRANTING NOVARTIS’S REQUESTED RELIEF .................................... 4
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Breckenridge’s -1103 Petition Is Time-Barred ..................................... 4
`
`Breckenridge’s Delay In Challenging Claim 7 Unfairly
`Provides Breckenridge With A Strategic Advantage............................ 7
`
`Breckenridge’s Contention That Institution On Claim 7
`Does Not Require Consideration Of The -1103 Record Is
`Wrong .................................................................................................... 9
`
`Petitioners’ Proposed Schedule For Joint Proceedings Is
`Unworkable And Prejudicial To Novartis And The Board ................ 11
`
`Breckenridge’s Role In Any Joint Proceedings Should Be
`Limited ................................................................................................ 12
`
`IV. CONCLUSION ............................................................................................. 13
`
`
`
`
`
`- i -
`
`
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Ariosa Diagnostics, Inc. v. Isis Innovation Ltd.,
`IPR2013-00250, Paper 24 (Sep. 3, 2013) ............................................. 6
`
`Ariosa Diagnostics, Inc. v. Isis Innovation Ltd.,
`IPR2013-00250, Paper 3 (Apr. 19, 2013) ............................................ 7
`
`Aventis Pharma Deutschland GmbH v. Lupin Ltd.,
`499 F.3d 1293 (Fed. Cir. 2007) .......................................................... 10
`
`Dell Inc. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00385, Paper 17 (Jul. 29, 2013) ............................................ 6
`
`Enzymotec Ltd. v. Neptune Tech. & Biores., Inc.,
`IPR2014-00556, Paper 19 (Jul. 9, 2014) .............................................. 6
`
`Geneva Pharm., Inc. v. Glaxosmithkline PLC,
`189 F. Supp. 2d 377 (E. D. Va. 2002) ............................................ 4, 10
`
`Geneva Pharm., Inc. v. Glaxosmithkline PLC,
`349 F.3d 1373 (Fed. Cir. 2003) ............................................................ 4
`
`In re Metoprolol Succinate Patent Litig.,
`494 F.3d 1011 (Fed. Cir. 2007) .......................................................... 11
`
`Lupin Ltd. v. Senju Pharm. Co., Ltd.,
`IPR2015-01871, Paper 13 (Jan. 25, 2016) ......................................... 12
`
`Samsung Elecs. Co. v. Va. Innovation Scis., Inc.,
`IPR2014-00557, Paper 10 (Jun. 13, 2014) ........................................... 6
`
`Samsung Elecs. Co. v. Va. Innovation Scis., Inc.,
`IPR2014-00557, Paper 3 (Mar. 28, 2014) ............................................ 7
`
`Target Corp. v. Destination Maternity Corp.,
`IPR2014-00508, Paper 28 (Feb. 12, 2015) ........................................... 6
`
`- ii -
`
`
`
`
`
`Target Corp. v. Destination Maternity Corp.,
`IPR2014-00508, Paper 31 (Feb. 12, 2015) ........................................... 7
`
`Teva Pharms. USA, Inc. v. Viiv Healthcare Co.,
`IPR2015-00550, Paper 11 (Jun. 25, 2015) ......................................... 13
`
`Statutes
`
`35 U.S.C. § 316(b) .......................................................................................... 9
`
`37 C.F.R. § 42.1(b) ......................................................................................... 9
`
`
`
`- iii -
`
`
`
`
`
`I.
`
`
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Patent Owner Novartis AG (“Novartis”) opposes the May 26, 2016 joinder
`
`motion of Petitioner Breckenridge Pharmaceutical, Inc. (“Breckenridge”). In that
`
`motion, Breckenridge seeks to join its petition for IPR2016-01103 (“-1103
`
`petition”) challenging claim 7 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
`
`
`
`
`
`Breckenridge’s joinder motion should be denied for four reasons.
`
`First, Breckenridge’s May 26, 2016 -1103 petition is time-barred.
`
`
`
` 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;
`
` Par moves to join with the -84 IPR its May 17, 2016 petition in IPR2016-
`
`01059 (“-1059 petition) challenging claim 7; and
`
` Roxane Laboratories, Inc. (“Roxane”) moves to join with the -84 IPR its
`
`May 26, 2016 petition in IPR2016-01102 (“-1102 petition”) challenging
`
`claims 1-3 and 7-10.
`
`Novartis opposes all such joinder motions.
`
`- 1 -
`
`
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`
`
`
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`Second, joinder of Breckenridge’s -1103 petition on claim 7 with Par’s -84
`
`IPR on claims 1-3 and 8-10 would allow Breckenridge to exploit the strategic
`
`advantage which Par gained by delaying its 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, Breckenridge wrongly assumes that the record at the institution stage
`
`in its -1103 IPR will be the same as that in Par’s -84 IPR. To the contrary: in
`
`opposing Breckenridge’s -1103 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 Breckenridge’s motion, joinder of
`
`the -1103 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 -1103 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, Breckenridge’s motion should be denied.
`
`- 2 -
`
`
`
`
`
`II. RESPONSE TO BRECKENRIDGE’S
`STATEMENT OF MATERIAL FACTS
`
`
`
`Novartis does not dispute Statements 1-5, 9 and 10 in Breckenridge’s
`
`Statement Of Material Facts. IPR2016-01103, Paper 4 at § II.
`
`
`
`Novartis disputes Statement 6, insofar as the exhibits and arguments of
`
`Breckenridge in the -1023 petition are not identical to those of Par in the -84 IPR.
`
`Breckenridge’s petition cites the expert declaration of a new expert, Dr. Steven W.
`
`Baldwin, who is not an expert in Par’s IPR2016-00084. See IPR2016-01023,
`
`Paper 1 at 4. Breckenridge also alleges that 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 IPR2016-01023, Paper 4 at 24 and IPR2016-00084, Paper
`
`2 at 26.
`
`
`
`Novartis disputes Statement 7, because Par’s -1059 petition 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
`
`- 3 -
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`
`
`
`
`(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 Statement 8, because Breckenridge’s -1103 petition does
`
`not present “the same grounds” as Par’s -84 IPR. Rather, Breckenridge’s -1103
`
`petition against claim 7 includes at least the differences enumerated above between
`
`the grounds in Par’s -84 IPR against claims 1-3 and 8-10 and the grounds in
`
`Par’s -1059 petition against claim 7.
`
`III. STATEMENT OF REASONS FOR DENYING
`BRECKENRIDGE’S REQUESTED RELIEF AND
`FOR GRANTING NOVARTIS’S REQUESTED RELIEF
`
`1.
`
`Breckenridge’s -1103 Petition Is Time-Barred
`
`
`
`In late 2014 Novartis sued Breckenridge and Par in the District of Delaware
`
`for infringement of the ’772 patent. D. Del. Civ. Nos. 14-1043, 14-1289.
`
`Breckenridge’s waiver of service of Novartis’s complaint was filed on August 27,
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`- 4 -
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`
`
`
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`2014. 14-1043, D.I. 7. Par accepted service of Novartis’s complaint on October
`
`27, 2014. 14-1289, D.I. 7. On February 19, 2015, Novartis in connection with the
`
`Delaware litigation served on Breckenridge and Par infringement contentions
`
`asserting that Breckenridge and Par specifically 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 of the ’772 patent—but omitting, to Novartis’s surprise, claim 7. The Board
`
`instituted the -84 IPR in a decision dated April 29, 2016. IPR2016-00084, Paper 8.
`
`
`
`On May 10, 2016, after the August 27, 2015 expiration of Breckenridge’s 35
`
`U.S.C. § 315(b) deadline, Breckenridge filed its -1023 petition challenging claims
`
`1-3 and 8-10 of the ’772 patent—also omitting claim 7.
`
`
`
`On May 17, 2016, after the October 27, 2015 expiration of Par’s 35 U.S.C.
`
`§ 315(b) deadline, Par filed its -1059 petition for the first time challenging claim 7
`
`of the ’772 patent, along with a motion seeking to join the -1059 petition with the -
`
`84 IPR. Par could have included claim 7 in its first petition. But Par did not do so,
`
`and Par in its joinder motion offered no explanation for not doing so.
`
`
`
`On May 26, 2016, nine months after the August 27, 2015 expiration of
`
`Breckenridge’s 35 U.S.C. § 315(b) deadline, Breckenridge filed its -1103 petition
`
`for the first time challenging claim 7 of the ’772 patent, along with a motion
`
`seeking to join the -1103 petition with Par’s -84 IPR. Breckenridge could have
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`- 5 -
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`
`
`
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`challenged claim 7 before expiry of the 35 U.S.C. § 315(b) deadline. But
`
`Breckenridge did not do so, and Breckenridge in its joinder motion offers no
`
`explanation for not doing so.
`
`
`
`Breckenridge’s -1103 petition against claim 7, like Par’s -1059 petition
`
`against claim 7, thus is time-barred under 35 U.S.C. § 315(b). And contrary to
`
`Breckenridge’s assertions, 35 U.S.C. § 315(c) does not permit Breckenridge under
`
`these circumstances to circumvent the 35 U.S.C. § 315(b) deadline through joinder.
`
`Breckenridge relies on Dell Inc. v. Network-1 Sec. Sols., Inc., IPR2013-
`
`00385, Paper 17 (Jul. 29, 2013), and Enzymotec Ltd. v. Neptune Tech. & Biores.,
`
`Inc., IPR2014-00556, Paper 19 (Jul. 9, 2014). Those authorities are irrelevant. In
`
`neither of those cases did the party requesting joinder seek to challenge a new
`
`claim, as Breckenridge does here.
`
`
`
`
`
`Breckenridge also relies on Ariosa Diagnostics, Inc. v. Isis Innovation Ltd.,
`
`IPR2013-00250, Paper 24 (Sep. 3, 2013); Target Corp. v. Destination Maternity
`
`Corp., IPR2014-00508, Paper 28 (Feb. 12, 2015); and Samsung Elecs. Co. v. Va.
`
`Innovation Scis., Inc., IPR2014-00557, Paper 10 (Jun. 13, 2014). Breckenridge’s
`
`reliance on those authorities is misplaced. In those proceedings, the petitioner—
`
`unlike Breckenridge and Par—offered a substantive explanation as to why the
`
`grounds in its new petition could not have been raised earlier. In Ariosa, the
`
`petitioner explained that it had launched a new product against which the patent
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`- 6 -
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`
`
`
`
`owner might assert the newly challenged claims. IPR2013-00250, Paper 3 (Apr.
`
`19, 2013) at 3. In Target, the petitioner explained that the patent owner had
`
`identified a new prior art reference in co-pending litigation after the first petition
`
`was filed. IPR2014-00508, Paper 31 (Feb. 12, 2015) at 1. In Samsung, the
`
`petitioner explained that the ground in the new petition was based in part on
`
`reasoning from the Board’s decision to institute the first petition. IPR2014-00557,
`
`Paper 3 (Mar. 28, 2014) at 2-3. None of the facts in these cases applies here.
`
`
`
`Put simply, Breckenridge’s -1103 petition is time-barred under 35 U.S.C.
`
`§ 315(b), and 35 U.S.C. § 315(c) does not permit Breckenridge, under these
`
`circumstances, to circumvent that bar through joinder.
`
`2.
`
`Breckenridge’s Delay In Challenging Claim 7 Unfairly
`Provides Breckenridge With A Strategic Advantage
`
`
`
`
`Breckenridge’s joinder motion is silent as to why it failed to file a petition
`
`challenging claim 7 of the ’772 patent before the end of the 35 U.S.C. § 315(b)
`
`period. Regardless of the reason, it nevertheless allowed Breckenridge, like 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.
`
`
`
`The conflict is as follows. As to claim 7, Breckenridge in its -1103 petition
`
`(like Roxane and Par in their -1102 and -1059 petitions) asserts that the purported
`
`- 7 -
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`
`
`
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`prior art “lead compound” rapamycin was formulated with various carriers and
`
`tested in animal studies for immunosuppressant properties. IPR2016-01103, Paper
`
`1 (May 26, 2016) at 29. Breckenridge also asserts that the administration of a
`
`compound for therapeutic effect implicitly includes the formulation of that
`
`compound. Id. at 51. 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.
`
`
`
`Breckenridge’s ground on claim 7 (like Roxane’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 Breckenridge (or Roxane or Par) challenged claim 7 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 institute the -84 IPR.
`
`The Board was deprived of that opportunity through Petitioners’ delay in
`
`challenging claim 7.
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`- 8 -
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`
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`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.
`
`
`
`Breckenridge’s professed concern for the “public interest” (IPR2016-01103,
`
`Paper 4 at 3) is belied by its own conduct. Novartis long ago—at least as early as
`
`its February 19, 2015 infringement contentions to Breckenridge in the co-pending
`
`Delaware litigation—put Breckenridge on notice that Novartis would assert claim
`
`7 of the ’772 patent against Breckenridge. Breckenridge nevertheless failed to
`
`challenge claim 7 of the ’772 patent until May 26, 2016. Insofar as there now
`
`exists a risk that claim 7 will remain in force while other challenged claims are
`
`canceled, Breckenridge has only itself to blame for creating that risk.
`
`3.
`
`Breckenridge’s Contention That Institution On Claim 7 Does
`Not Require Consideration Of The -1103 Record Is Wrong
`
`
`
`Breckenridge contends that “the only issue raised by the instant petition is
`
`the additional limitation included in claim 7.” IPR2016-01103, Paper 4 at 10. In
`
`that connection, Breckenridge assumes that in deciding whether to institute the
`
`-1059 case, the Board need only consider only the institution decision in the -84
`
`IPR and Breckenridge’s attorney argument regarding aspects of claim 7.
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`- 9 -
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`That assumption is wrong. Breckenridge forgets that Novartis is entitled to
`
`file a Preliminary Patent Owner Response in the -1103 case, in which Novartis can
`
`raise new arguments and rely on new evidence, including a new expert
`
`declaration.2 Breckenridge 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 -1103 case.
`
`Breckenridge 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. Two of the three
`
`cases cited by Breckenridge for that assertion, Aventis Pharma Deutschland GmbH
`
`v. Lupin Ltd., 499 F.3d 1293 (Fed. Cir. 2007) and Geneva Pharm. Inc. v.
`
`Glaxosmithkline PLC, 189 F. Supp. 2d 377 (E.D. Va. 2002), are distinguishable,
`
`and unlike here, neither involves a motivation to modify that was in any way
`
`
`
` Incredibly, while Breckenridge itself submitted an expert declaration in support
`
` 2
`
`of its -1103 petition, Breckenridge now seems to suggest that Novartis should not
`
`be permitted to cross-examine that expert declarant in the -1103 proceeding, and
`
`moreover that Novartis should cover any issues relevant to the -1103 petition when
`
`cross-examining the expert declarant in the -84 IPR.
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`- 10 -
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`
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`related to formulation or pharmaceutical compositions. The third case cited by
`
`Breckenridge, In re Metoprolol Succinate Patent Litig., 494 F.3d 1011 (Fed. Cir.
`
`2007) is irrelevant to Breckenridge’s assertion.
`
`4.
`
`Petitioners’ Proposed Schedule For Joint Proceedings Is
`Unworkable And Prejudicial To Novartis And The Board
`
`
`
`Breckenridge’s representations that joinder can occur without affecting the
`
`original one-year time frame for the -84 IPR are no longer accurate. IPR2016-
`
`01103, Paper 4 at 10.
`
`
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`Petitioners have proposed an alternate schedule for hypothetical joint
`
`proceedings in a June 15, 2016 email to the Board. According to that schedule,
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`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.
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`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.
`
`
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`The most straightforward solution to the scheduling quandaries presented by
`
`hypothetical joint proceedings is simply to deny joinder. And contrary to
`
`Breckenridge’s conclusory assertions of prejudice (IPR2016-01103, Paper 4 at 13),
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`Breckenridge has only itself to blame for the situation that it now finds itself in.
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`- 11 -
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`Breckenridge could have filed its -1103 petition before expiry of the one-year
`
`statutory bar.
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`5.
`
`Breckenridge’s Role In Any Joint Proceedings Should Be Limited
`
`
`
`Breckenridge acknowledges that the administrative convenience afforded by
`
`joinder is subordinate to the primary goal of all IPR proceedings: their “just,
`
`speedy, and inexpensive resolution.” Breckenridge further is willing to take an
`
`“understudy role” (id. at 11) in any joint proceedings. Accordingly,
`
`Breckenridge’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 of the -1103
`
`petition, and if the Board grants joinder of the -1059 petition, the Board should
`
`order Breckenridge (i) to rely solely on the petition and the evidence filed by Par in
`
`the -1059 petition; (ii) to share with Par the pages that will be allotted to Par in any
`
`-1059 IPR for written work product; and (iii) to share with Par the time that will be
`
`allotted to Par in any -1059 IPR for cross and redirect examination.
`
`
`
`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
`
`evidence provided by InnoPharma in IPR 903 . . . In other words, Lupin requests
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`- 12 -
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`
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`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
`
`Breckenridge’s joinder motion.
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`Dated: June 27, 2016
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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
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`CERTIFICATE OF SERVICE
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`I certify that a copy of the foregoing Patent Owner Novartis’s Opposition To
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`Petitioner Breckenridge’s Motion For Joinder Of Its Petition On Claim 7 was
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`served on June 27, 2016 by causing it to be sent by email to counsel for Petitioner
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`Breckenridge Pharmaceutical, Inc. in IPR2016-01103 and Petitioner Par
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`Pharmaceutical, Inc. in IPR2016-00084 at the following email addresses:
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`Breckenridge Pharmaceutical, Inc.
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`B. Jefferson Boggs, Esq. (jboggs@merchantgould.com)
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`Matthew L. Fedowitz, Esq. (mfedowitz@merchantgould.com)
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`Daniel R. Evans, Esq. (devans@merchantgould.com)
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`Mary Bram (mbram@merchantgould.com)
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`Par Pharmaceutical, Inc.
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`Daniel Brown (daniel.brown@lw.com)
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`Robert Steinberg (bob.steinberg@lw.com)
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`Jonathan M. Strang (jonathan.strang@lw.com)
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`/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
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`Dated: June 27, 2016
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`Tel. 212-218-2100
`Tel. 212-218-2100
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