Paper No. ____
`Date Filed: June 10, 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. 2016-01023
`
`U.S. Patent 5,665,772
`
`PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER BRECKENRIDGE’S MOTION FOR JOINDER
`
`
`Date Filed: June 10, 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. 2016-01023
`
`U.S. Patent 5,665,772
`
`PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER BRECKENRIDGE’S MOTION FOR JOINDER
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`STATEMENT OF PRECISE RELIEF REQUESTED ...................................1
`
`RESPONSE TO BRECKENRIDGE’S STATEMENT
`OF MATERIAL FACTS.................................................................................2
`
`STATEMENT OF REASONS FOR DENYING
`BRECKENRIDGE’S REQUESTED RELIEF AND
`GRANTING NOVARTIS’S REQUESTED RELIEF ....................................3
`
`1.
`
`2.
`
`3.
`
`4.
`
`Joinder Prejudices Novartis, Par And The Board .................................3
`
`Denying Joinder Will Not Prejudice Breckenridge ..............................5
`
`The Board Should Deny Joinder In View Of The
`Prejudice To Novartis, Par And The Board..........................................6
`
`Breckenridge’s Participation In A Joint Proceeding
`Should Be Limited To Mitigate Any Prejudice To
`Novartis, Par And The Board................................................................8
`
`IV. CONCLUSION ...............................................................................................9
`
`- i -
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Dell Inc v. Elecs. and Telecomms. Research Inst.,
`IPR2015-00549, Paper 10 (Mar. 26, 2015).......................................... 7
`
`Dell Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385, Paper No. 17 (Jul. 29, 2013)..................................... 8
`
`Lupin Ltd. v. Senju Pharm. Co., Ltd.,
`IPR2015-01871, Paper 13 (Jan. 25, 2016) ........................................... 8
`
`Microsoft Corp. v. Proxyconn, Inc.,
`IPR2012-00026 and IPR2013-00109, Paper 80
`(Dec. 9, 2015)....................................................................................... 6
`
`Samsung Elecs. Co., Ltd. v. Arendi S.A.R.L.,
`IPR2014-01142, Paper 11 (Oct. 2, 2014)............................................. 7
`
`Teva Pharms. USA, Inc. v. Viiv Healthcare Co.,
`IPR2015-00550, Paper 11 (Jun. 25, 2015)........................................... 9
`
`ZTE Corp. v. Adaptix Inc.,
`IPR2015-01184, Paper 10 (Jul. 24, 2015)............................................ 7
`
`Statutes
`
`35 U.S.C. § 315(b).................................................................................. 1, 4, 6
`
`35 U.S.C. § 316(a)(11).................................................................................... 6
`
`- ii -
`
`
`
`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Patent Owner Novartis AG (“Novartis”) conditionally opposes the
`
`May 10, 2016 joinder motion by Petitioner Breckenridge Pharmaceutical,
`
`Inc. (“Breckenridge”). (IPR2016-01023, Paper 5.) In that motion,
`
`Breckenridge seeks to join its newly filed petition for IPR2016-01023 with
`
`Par Pharmaceutical, Inc.’s (“Par”) pending IPR proceeding IPR2016-00084.
`
`Breckenridge’s late-filed petition and joinder motion prejudices
`
`Novartis because the petition relies on a new expert declaration and a new
`
`argument, and risks prejudicing Novartis, Par and the Board by opening the
`
`door to the possibility that Breckenridge will raise further new exhibits or
`
`arguments in reply to Novartis’s patent owner response if Breckenridge’s
`
`petition is instituted and its joinder motion is granted. For these reasons,
`
`Breckenridge’s joinder motion should be denied.
`
`Novartis nevertheless will not oppose joinder, provided that the
`
`Breckenridge agrees, or the Board orders, that (i) the joint proceeding be
`
`based exclusively on the petition and evidence filed by Par in IPR2016-
`
`00084, (ii) Breckenridge share with Par the pages currently allotted to Par in
`
`IPR2016-00084 for any written work product; and (iii) Breckenridge share
`
`- 1 -
`
`
`
`with Par the time currently allotted to Par in IPR2016-00084 for the cross
`
`and re-direct examination of any witness.
`
`II.
`
`RESPONSE TO BRECKENRIDGE’S
`STATEMENT OF MATERIAL FACTS
`
`Novartis does not dispute Statements 1-5 and 7 set forth in
`
`Breckenridge’s Statement Of Material Facts. (IPR2016-01023, Paper 5 at
`
`§ II.)
`
`Novartis disputes Statement 6 insofar as the exhibits and arguments of
`
`Breckenridge are not identical to those of Par. First, whereas Par’s petition
`
`in IPR2016-00084 relies on the expert declaration of Dr. William L.
`
`Jorgensen, Breckenridge’s petition relies on the expert declaration of a new
`
`expert, Dr. Steven W. Baldwin, who is not an expert in Par’s IPR2016-
`
`00084. Even if Breckenridge withdraws Dr. Baldwin’s expert declaration—
`
`which Breckenridge said it would do, but to date has not done—Novartis
`
`still must respond to Breckenridge’s petition, which relies solely on Dr.
`
`Baldwin’s declaration, and does not cite any part of Dr. Jorgensen’s
`
`declaration. Second, Breckenridge 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.)
`
`- 2 -
`
`
`
`III.
`
`STATEMENT OF REASONS FOR DENYING
`BRECKENRIDGE’S REQUESTED RELIEF
`AND GRANTING NOVARTIS’S REQUESTED RELIEF
`
`1.
`
`Joinder Prejudices Novartis, Par And The Board
`
`In late 2014 Novartis sued Breckenridge, Roxane Laboratories, Inc.
`
`(“Roxane”) and Par in the District of Delaware for infringement of the
`
`patent at issue in this IPR: U.S. Patent No. 5,665,772 (“’772 patent”). (D.
`
`Del. Civ. No. 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) and Par accepted service of Novartis’s complaint on October 27, 2014.
`
`(14-1289, D.I. 7.) The Breckenridge, Roxane and Par suits have been
`
`consolidated. (14-1043, D.I. 18.) Trial in the consolidated Delaware
`
`litigation is scheduled to begin on August 29, 2016. (Id. at § 16.). The same
`
`counsels representing Novartis, Breckenridge and Par in the Delaware
`
`litigation are representing Novartis, Breckenridge and Par in these IPRs.
`
`Counsels for Breckenridge and Par collectively have relied upon the same
`
`briefing, experts and expert reports in the Delaware litigation—but, as noted
`
`above, have not done so here.
`
`On October 26, 2015, Par filed its petition for IPR2016-00084
`
`challenging claims 1-3 and 8-10 of the ’772 patent, including an expert
`
`- 3 -
`
`
`
`declaration by Dr. William L. Jorgensen. The Board instituted Par’s petition
`
`on April 29, 2016. (IPR2016-00084, Paper 8.) Novartis’s patent owner
`
`response in IPR2016-00084 currently is due on July 29, 2016, one month
`
`before the start of the Delaware trial (IPR2016-00084, Paper 9). Although
`
`Novartis and Par are attempting to negotiate an alternate due date for
`
`Novartis’s patent owner response that follows the Delaware trial, they have
`
`not yet reached an agreement on an alternate due date.
`
`On May 10, 2016—nine months after the expiration of Breckenridge’s
`
`August 27, 2015 deadline under 35 U.S.C. § 315(b) to file a petition against
`
`the ’772 patent —Breckenridge filed its petition challenging claims 1-3 and
`
`8-10 of the ’772 patent, relying on a declaration by a new expert, Dr. Steven
`
`W. Baldwin.1 Not only does the Breckenridge petition include a declaration
`
`1 During a June 1, 2016 conference call with the Board, Par agreed to allow
`
`Breckenridge to rely upon Dr. Jorgensen’s declaration, and Breckenridge
`
`said that it was willing to withdraw Dr. Baldwin’s declaration. However,
`
`Breckenridge has not yet withdrawn Dr. Baldwin’s declaration, and has not
`
`explained how it can proceed to rely upon Dr. Jorgensen’s declaration when
`
`its petition does not cite any part of Dr. Jorgensen’s declaration.
`
`- 4 -
`
`
`
`by an expert who is not an expert in Par’s IPR2016-00084, it also raises an
`
`argument not in Par’s IPR2016-00084. Specifically, Breckenridge 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.)
`
`Under these circumstances, joinder will prejudice Novartis by
`
`introducing a new expert declaration and a new argument to which Novartis
`
`will have to respond. Joinder also risks prejudicing Novartis, Par and the
`
`Board by opening the door to the possibility that Breckenridge will raise
`
`further new exhibits or arguments in reply to Novartis’s patent owner
`
`response.
`
`2.
`
`Denying Joinder Will Not Prejudice Breckenridge
`
`Denying joinder will not prejudice Breckenridge. Breckenridge offers
`
`speculation that it “may” be prejudiced if joinder is denied because “the
`
`decision in the Par IPR will likely impact the issues in the underlying
`
`[Delaware] litigation.” (IPR2016-01023, Paper 5 at 8.) But Breckenridge
`
`does not explain how such an outcome would prejudice Breckenridge.
`
`Indeed, if one accepts Breckenridge’s representation that its petition is
`
`“essentially identical” to Par’s (IPR2016-01023, Paper 5 at 6), the decision
`
`- 5 -
`
`
`
`in the Par IPR will be the same regardless of whether or not Breckenridge
`
`joins that proceeding.
`
`Moreover, to the extent Breckenridge argues that any joint
`
`proceedings must proceed according the current schedule in Par’s IPR2016-
`
`00084, Novartis disagrees. (IPR2016-01023, Paper 5 at 4-7 suggesting that
`
`a final decision must be rendered in a joint proceeding by one year after the
`
`date of institution of the Par IPR.) The statute and Board’s decisions are
`
`clear that the one-year deadline for a final decision does not apply to joint
`
`proceedings. 35 U.S.C. § 316(a)(11); Microsoft Corp. v. Proxyconn, Inc.,
`
`IPR2012-00026 and IPR2013-00109, Paper 80 (Dec. 9, 2015) at 6 (“[W]e
`
`are not persuaded that the Board is constrained by the 18-month deadline for
`
`issuing a final written decision under 35 U.S.C. § 316(a)(11). See supra.
`
`First, the 18-month deadline does not apply necessarily to joined cases, such
`
`as this one.”). The parties are currently working together to propose a
`
`schedule for the joint proceedings.
`
`3.
`
`The Board Should Deny Joinder In View Of
`The Prejudice To Novartis, Par And The Board
`
`Breckenridge delayed filing its petition and joinder motion until nine
`
`months after its 35 U.S.C. § 315(b) deadline. Breckenridge’s petition relies
`
`on a new expert declaration and a new argument. And the joinder of
`
`- 6 -
`
`
`
`Breckenridge’s petition, including that new argument, prejudices or risks
`
`prejudicing Novartis, Par and the Board, as discussed above in § III.1. By
`
`contrast, denying joinder will not prejudice Breckenridge, as discussed
`
`above in § III.2.
`
`Under these circumstances, the Board can and should exercise its
`
`discretion to deny joinder. See Samsung Elecs. Co., Ltd. v. Arendi S.A.R.L.,
`
`IPR2014-01142, Paper 11 (Oct. 2, 2014) at 4-8 (denying joinder where
`
`petitioner introduced new expert declaration and failed to substantiate its
`
`allegation that its arguments were “substantially identical” to those in the
`
`petition it sought to join); ZTE Corp. v. Adaptix Inc., IPR2015-01184, Paper
`
`10 (Jul. 24, 2015) at 4-5 (denying joinder where petitioner introduced new
`
`expert declaration, which “necessarily introduces a new expert declarant and
`
`potentially raises additional issues, and ‘the exact same evidence’ is not
`
`relied upon by Petitioners”); Dell 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.”).
`
`- 7 -
`
`
`
`4.
`
`Breckenridge’s Participation In A
`Joint Proceeding Should Be Limited To Mitigate
`Any Prejudice To Novartis, Par And The Board
`
`As Breckenridge acknowledges, the administrative convenience
`
`afforded by joinder is subordinate to the primary goal of all IPR
`
`proceedings: their “just, speedy, and inexpensive resolution.” Dell Inc. v.
`
`Network-1 Security Solutions, Inc., IPR2013-00385, Paper No. 17 (Jul. 29,
`
`2013) at 3.
`
`In view of that goal, Breckenridge’s participation in a joint proceeding
`
`should be limited to mitigate any delay or prejudice to Novartis, Par and the
`
`Board. Novartis thus will not oppose joinder if Breckenridge agrees or is
`
`ordered (i) to rely solely on the petition and evidence filed by Par in
`
`IPR2016-00084; (ii) to share with Par the pages currently allotted to Par in
`
`IPR2016-00084 for any written work product; and (iii) to share with Par the
`
`time currently allotted to Par in IPR2016-00084 for the cross and redirect
`
`examination of any witness.
`
`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
`
`- 8 -
`
`
`
`the arguments and 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).
`
`In sum, Novartis will not oppose joinder if Breckenridge’s
`
`participation in a joint proceeding is limited under the conditions (i)-(iii)
`
`described above. Novartis believes that those conditions are sufficient to
`
`mitigate any prejudice to Novartis, Par and the Board.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Novartis respectfully requests that the
`
`Board deny Breckenridge’s joinder motion.
`
`In the alternative, Novartis respectfully requests that the Board limit
`
`Breckenridge’s participation in a joint proceeding by ordering Breckenridge
`
`(i) to rely solely on the petition and evidence filed by Par in IPR2016-00084;
`
`(ii) to share with Par the pages currently allotted to Par in IPR2016-00084
`
`- 9 -
`
`
`
`for any written work product; and (iii) to share with Par the time currently
`
`allotted to Par in IPR2016-00084 for the direct and cross examination of any
`
`witness.
`
`Dated: June 10, 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
`
`- 10 -
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner Novartis’s
`
`Opposition To Petitioner Breckenridge’s Motion For Joinder was served by
`
`causing it to be sent by email to counsel for Petitioner Breckenridge
`
`Pharmaceutical, Inc. in IPR2016-01023 and Petitioner Par Pharmaceutical,
`
`Inc. in IPR2016-00084 at the following email addresses:
`
`Breckenridge Pharmaceutical, Inc.
`
`B. Jefferson Boggs, Esq. (jboggs@merchantgould.com)
`
`Matthew L. Fedowitz, Esq. (mfedowitz@merchantgould.com)
`
`Daniel R. Evans, Esq. (devans@merchantgould.com)
`
`Par Pharmaceutical, Inc.
`
`Daniel Brown (daniel.brown@lw.com)
`
`Robert Steinberg (bob.steinberg@lw.com)
`
`Dated: June 10, 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
`
`- 11 -
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