Paper No. ____
`Date Filed: June 17, 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.,
`Petitioner
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`Inter Partes Review No. 2016-01059
`
`U.S. Patent 5,665,772
`
`
`PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER PAR’S MOTION FOR JOINDER
`
`
`
`
`Date Filed: June 17, 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.,
`Petitioner
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`
`
`Inter Partes Review No. 2016-01059
`
`U.S. Patent 5,665,772
`
`
`PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER PAR’S MOTION FOR JOINDER
`
`
`
`
`
`
`
`I.
`
`II.
`
`III.
`
`TABLE OF CONTENTS
`
`STATEMENT OF PRECISE RELIEF REQUESTED ................................... 1
`
`RESPONSE TO PAR’S STATEMENT OF MATERIAL
`FACTS ............................................................................................................. 3
`
`STATEMENT OF REASONS FOR DENYING PAR’S
`REQUESTED RELIEF AND FOR GRANTING
`NOVARTIS’S REQUESTED RELIEF .......................................................... 4
`
`1.
`
`2.
`
`3.
`
`4.
`
`Par’s -1059 Petition Is Time-Barred ..................................................... 4
`
`Par’s Conduct In Delaying Filing Its -1059 Petition
`Provided A Strategic Advantage And Such Conduct
`Should Not Be Encouraged ................................................................... 9
`
`Par’s Contention That Institution On Claim 7 Does Not
`Require Consideration Of The -1059 Record Lacks
`Support ................................................................................................ 11
`
`Par’s Initial Proposed Schedule Is Highly Prejudicial To
`Novartis And Its Alternate Schedule Effectively Allows
`For A Separate Trial On Claim 7 In Violation Of The
`One Year Statutory Bar ....................................................................... 13
`
`IV. CONCLUSION ............................................................................................. 14
`
`
`
`
`
`- i -
`
`
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Ariosa Diagnostics v. Isis Innovation Ltd.,
`IPR2013-00250, Paper 24 (Sep. 3, 2013) ............................................. 6
`
`Ariosa Diagnostics 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) .......................................................... 12
`
`Dell Inc. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00385, Paper 17 (Jul. 29, 2013) ............................................ 8
`
`Enzymotec Ltd. v. Neptune Techs. & Biores., Inc.,
`IPR2014-00556, Paper 19 (Jul. 9, 2014) .............................................. 8
`
`Geneva Pharm., Inc. v. Glaxosmithkline PLC,
`189 F. Supp. 2d 377 (E. D. Va. 2002) ............................................ 4, 12
`
`Geneva Pharm., Inc. v. Glaxosmithkline PLC,
`349 F.3d 1373 (Fed. Cir. 2003) ............................................................ 4
`
`Kyocera Corp. v. Softview LLC,
`IPR2013-00004, Paper 15 (Apr. 24, 2013) .......................................... 8
`
`Medtronic, Inc. v. Norred,
`IPR2014-823, Paper 12 (Dec. 8, 2014) ................................................ 6
`
`Micro Motion, Inc. v. Invensys Sys., Inc.,
`IPR2014-1409, Paper 14 (Feb. 18, 2015) ............................................. 5
`
`Reloaded Games, Inc. v. Parallel Networks LLC,
`IPR2014-950, Paper 12 (Oct. 22, 2014) ............................................... 5
`
`Samsung Elecs. Co. v. Va. Innovation Scis., Inc.,
`IPR2014-00557, Paper 10 (Jun. 13, 2014) ........................................... 7
`
`- ii -
`
`
`
`
`
`Samsung Elecs. Co. v. Va. Innovation Scis., Inc.,
`IPR2014-00557, Paper 3 (Mar. 28, 2014) ............................................ 7
`
`Samsung Elecs. Co., Ltd. v. Affinity Labs. of Tex., LLC,
`IPR2015-820, Paper 12 (May 15, 2015) .......................................... 6, 7
`
`Skyhawke Techs., LLC v. L&H Concepts, LLC,
`IPR2014-1485, Paper 13 (Mar. 20, 2015) ............................................ 6
`
`Target Corp. v. Destination Maternity Corp.,
`IPR2014-00508, Paper 28 (Feb. 12, 2015) ........................................... 6
`
`Target Corp. v. Destination Maternity Corp.,
`IPR2014-00508, Paper 31 (Feb. 12, 2015) ........................................... 7
`
`Zhongshan Broad Ocean Motor Co. v. Nidec Motor
`Corp.,
`IPR2015-00762, Paper 16 (Oct. 5, 2015) ............................................. 8
`
`Statutes
`
`35 U.S.C. § 315(b) .................................................................................. 1, 5, 9
`
`35 U.S.C. § 315(c) .................................................................................. 1, 5, 9
`
`35 U.S.C. § 316(b) ........................................................................................ 11
`
`37 C.F.R. § 42.1(b) ....................................................................................... 11
`
`
`
`- iii -
`
`
`
`
`
`I.
`
`
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Patent Owner Novartis AG (“Novartis”) opposes the May 17, 2016 joinder
`
`motion by Petitioner Par Pharmaceutical, Inc. (“Par”). In that motion, Par seeks to
`
`join its newly filed petition for IPR2016-01059, which challenges claim 7 of U.S.
`
`patent No. 5,665,772 (“’772 patent”), with its recently instituted proceeding
`
`IPR2016-00084 (“-84 IPR”), which challenges claims 1-3 and 8-10 of the ’772
`
`patent.
`
`
`
`
`
`Par’s joinder motion should be denied for four reasons.
`
`First, Par’s May 17, 2016 petition for IPR2016-01059 (“-1059 petition”) is
`
`time-barred. On October 27, 2014, Novartis served on Par a complaint alleging
`
`that Par infringed the ’772 patent. The one-year period under 35 U.S.C. § 315(b)
`
`for Par to file a petition challenging any claim of the ’772 patent thus expired on
`
`October 27, 2015. And 35 U.S.C. § 315(c) does not permit Par, under these
`
`circumstances, to circumvent that one-year § 315(b) deadline through joinder.
`
`
`
`Second, Par’s joinder motion provides no explanation for its delay in filing
`
`the -1059 petition. Even accepting as true Par’s counsel’s representation that “I
`
`wasn’t on the team at the time, but it was an inadvertent omission” (Ex. 1031 at
`
`19), that delay permitted Par to conceal the fact that its obviousness ground for
`
`claim 7 conflicts with its obviousness grounds for claims 1-3 and 8-10. By
`
`delaying the -1059 petition, Par unfairly denied Novartis and the Board an
`
`- 1 -
`
`
`
`
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`opportunity to consider that conflict and maximized its chances that the -84 IPR
`
`would be instituted.
`
`
`
`Third, Par wrongly assumes that the record at the institution decision stage
`
`in the -1059 case will be the same as that in the -84 IPR. To the contrary: in
`
`opposing the -1059 petition, Novartis is entitled in its Preliminary Response to
`
`make new arguments and to rely on new evidence (including testimonial evidence,
`
`which was not previously permitted), that was not before the Board in the -84 IPR
`
`when it issued its institution decision. .
`
`
`
`Fourth, Par has failed to establish that granting its motion for joinder will
`
`have no more than a minimal impact on the schedule. Par no longer appears to be
`
`pursuing the schedule proposed in its joinder motion, which was not workable.
`
`And, the alternate schedule Par proposed to the Board by email on June 15, 2016
`
`requires the Board to conduct a separate trial on its -1059 claim 7 petition that is
`
`not synchronized with the instituted -84 IPR until Due Date 5. While Novartis
`
`understands that the Board will issue shortly a schedule setting forth certain due
`
`dates for the -84 and -1059 IPRs (among others), Novartis presently does not have
`
`the benefit of that schedule. Granting Par’s joinder request and schedule would
`
`create substantial additional work for Novartis and the Board .
`
`
`
`Par’s joinder motion and its time-barred -1059 petition should be denied.
`
`- 2 -
`
`
`
`
`
`II. RESPONSE TO PAR’S
`STATEMENT OF MATERIAL FACTS
`
`
`
`Novartis does not dispute Statements 1, 2, 5 and 6 in Par’s Statement Of
`
`Material Facts. (IPR2016-01059, Paper 3 at § III.)
`
`
`
`Novartis disputes Statement 3, because the -1059 petition does not present
`
`“the same grounds” as the instituted -84 IPR. The -1059 petition addresses a new
`
`claim—claim 7 of the ’772 patent—that was not mentioned in the initial petition.
`
`And, contrary to Par’s statement, the ground raised against claim 7, directed to a
`
`pharmaceutical composition, is not based on “the exact same prior art” that the
`
`Board relied on in instituting review in the -84 proceeding on claim 1, which is
`
`directed to a chemical compound, from which claim 7 depends. Specifically, the
`
`Board instituted review on compound 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 as the -1059 petition adds a sixth reference,
`
`Hughes (which only was discussed in its -84 IPR in Ground 2, which concerns
`
`claims 8 and 9, 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,
`
`- 3 -
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`
`
`
`
`50, 52, 53.) Moreover, those new arguments 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) . (IPR2016-01059, Paper 1
`
`(May 17, 2016) at 3, 50.)
`
`
`
`Novartis also disputes statement 4 to the extent Par suggests that the -1059
`
`petition relies on the same portions of the references, or the same arguments
`
`regarding those references as it relied on in the -84 IPR.
`
`III. STATEMENT OF REASONS FOR
`DENYING PAR’S REQUESTED RELIEF AND FOR
`GRANTING NOVARTIS’S REQUESTED RELIEF
`
`1.
`
`Par’s -1059 Petition Is Time-Barred
`
`
`
`In late 2014 Novartis sued Par in the District of Delaware for infringement
`
`of the ’772 patent. (D. Del. Civ. No. 14-1289, D.I. 1.) 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 Par
`
`infringement contentions asserting that Par specifically infringed claims 1-3 and 7-
`
`10 of the ’772 patent.
`
`
`
`On October 26, 2015, one day before the October 27, 2015 expiration of
`
`Par’s 35 U.S.C. § 315(b) deadline, Par filed its -84 petition challenging claims 1-3
`
`and 8-10 of the ’772 patent, but—to Novartis’s surprise—not claim 7. The Board
`
`instituted IPR2016-00084 in a decision dated April 29, 2016. (IPR2016-00084,
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`- 4 -
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`
`
`
`
`Paper 8.) On May 13, 2016, Novartis timely filed a request for a rehearing of the
`
`Board’s institution decision. (IPR2016-00084, Paper 10.) The Board’s decision on
`
`Novartis’s request is still pending.
`
`
`
`On May 17, 2016, seven months after the October 27, 2015 expiration of
`
`Par’s 35 U.S.C. § 315(b) deadline, Par filed its -1059 petition challenging claim 7
`
`of the ’772 patent, along with a motion seeking to join the -1059 and -84 petitions.
`
`Par well could have included claim 7 in its first petition. But Par did not do so, and
`
`Par in its joinder motion offers no explanation for not doing so.
`
`
`
`Par’s -1059 petition thus is time-barred under 35 U.S.C. § 315(b). And
`
`contrary to Par’s assertions, 35 U.S.C. § 315(c) does not permit Par under these
`
`circumstances to circumvent the 35 U.S.C. § 315(b) deadline through joinder.
`
`Indeed, the Board routinely has denied joinder where a petitioner—like Par—did
`
`not raise any ground in its new petition that could not have been raised in its first
`
`petition, and instead simply sought joinder of the new petition as a means to
`
`circumvent a 35 U.S.C. § 315(b) deadline and to steal a “second bite at the apple.”
`
`See Micro Motion, Inc. v. Invensys Sys., Inc., IPR2014-1409, Paper 14 (Feb. 18,
`
`2015) at 14 (“The proposed ground directed to claim 43 is a second bite at the
`
`apple for Petitioner. In IPR2014-00393, Petitioner neglected to include an analysis
`
`of claim 43 and offers now the analysis it could have offered then.”); Reloaded
`
`Games, Inc. v. Parallel Networks LLC, IPR2014-950, Paper 12 (Oct. 22, 2014) at
`
`- 5 -
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`
`
`
`
`4-5 (denying joinder where petitioner sought a “second bite of the apple” and did
`
`not raise any ground that could not have been raised when filing the earlier
`
`petition); Samsung Elecs. Co., Ltd. v. Affinity Labs. of Tex., LLC, IPR2015-820,
`
`Paper 12 (May 15, 2015) at 4-5 (“[W]e agree with Patent Owner that Petitioner
`
`provides no reasoned justification for the delay in asserting the grounds based on
`
`Hu.”); Medtronic, Inc. v. Norred, IPR2014-823, Paper 12 (Dec. 8, 2014) at 5-7
`
`(denying joinder “to add additional challenges based on prior art references we
`
`already have considered”).1
`
`
`
`Par relies on Ariosa Diagnostics 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.,
`
`
`
` At least one panel has held that 35 U.S.C. § 315(c) applies only to the joinder of
`
` 1
`
`new parties, and does not permit the joinder of two petitions by the same party, as
`
`Par here requests. See Skyhawke Techs., LLC v. L&H Concepts, LLC, IPR2014-
`
`1485, Paper 13 (Mar. 20, 2015) at 3-4 (“A person cannot be joined as a party to a
`
`proceeding in which it is already a party. The statute does not refer to the joining
`
`of a petition or new patentability challenges presented therein, nor does the statute
`
`refer to the joining of a new issue (as opposed to a person).”) (emphasis in
`
`original).
`
`- 6 -
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`
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`
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`Inc., IPR2014-00557, Paper 10 (Jun. 13, 2014), to support its joinder motion.
`
`Par’s reliance on those authorities is misplaced. In those proceedings, the
`
`petitioner—unlike Par—offered in its joinder motion a substantive explanation as
`
`to why the grounds in its new petition could not have been raised in its first
`
`petition. In Ariosa, the petitioner explained that it had launched a new product
`
`against which the patent 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. And in Samsung, the petitioner explained that the challenged claims in
`
`the new petition were a subset of those in the first petition, and 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.
`
`
`
`By contrast, Par in its joinder motion offers no explanation as to why the
`
`ground in its new petition—which Par itself asserts is based on the “same prior art,
`
`expert declaration, and other submitted evidence” (IPR2015-01059, Paper 3 at 7)
`
`as its first petition—was not raised in its first petition. Nothing about Par’s
`
`circumstances changed in the seven months between October 26, 2015 and May
`
`17, 2016 to justify Par’s delay in raising that ground.
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`- 7 -
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`
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`Par also relies on Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp.,
`
`IPR2015-00762, Paper 16 (Oct. 5, 2015), to support its joinder motion. Par’s
`
`reliance on that authority is equally misplaced. In Zhongshan, the petitioner
`
`sought to correct a procedural deficiency in its first petition—a failure to file a 37
`
`C.F.R. § 42.63(b) affidavit attesting to the accuracy of an English-language
`
`translation of a Japanese reference—by filing a second petition including that
`
`affidavit. Id. at 7. The Board granted joinder, noting that “Petitioner is not
`
`attempting to cure a deficiency of the merits of a ground asserted in the prior
`
`Petition by filing a second Petition. Thus . . . this case is not similar to a case in
`
`which a petitioner seeks to introduce additional grounds based on additional prior
`
`art through a second petition.” Id. at 8 (emphasis added). By contrast, Par is
`
`attempting through its second petition to cure a deficiency of the merits by
`
`introducing an additional ground with additional arguments against an additional
`
`claim—precisely the situation distinguished by Zhongshan.
`
`
`
`Par further relies on Dell Inc. v. Network-1 Sec. Sols., Inc., IPR2013-00385,
`
`Paper 17 (Jul. 29, 2013), Enzymotec Ltd. v. Neptune Techs. & Biores., Inc.,
`
`IPR2014-00556, Paper 19 (Jul. 9, 2014), and Kyocera Corp. v. Softview LLC,
`
`IPR2013-00004, Paper 15 (Apr. 24, 2013). Those authorities are irrelevant
`
`because they concern motions to join a new party, not a motion to join two
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`- 8 -
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`
`
`
`
`petitions by the same party, as Par requests. Moreover, in none of those cases did
`
`the party requesting joinder seek to challenge a new claim, as Par does here.
`
`
`
`Put simply, Par’s -1059 petition is time-barred under 35 U.S.C. § 315(b),
`
`and 35 U.S.C. § 315(c) does not permit Par, under these circumstances, to
`
`circumvent that bar through joinder.
`
`2.
`
`Par’s Conduct In Delaying Filing Its -1059
`Petition Provided A Strategic Advantage
`And Such Conduct Should Not Be Encouraged
`
`
`
`Par’s joinder motion is completely silent as to why Par delayed challenging
`
`claim 7 and filing its -1059 petition. Whether that delay was the result of an
`
`“inadvertent mistake” or an express strategic decision to conceal a conflict between
`
`its obviousness ground for claim 7, as set forth in the -1059 petition, and its
`
`obviousness grounds for claims 1-3 and 8-10, as set forth in the -84 petition, Par
`
`should not be permitted to gain a strategic advantage as a result of that delay.
`
`
`
`The conflict between the obviousness grounds of the -1059 petition and the
`
`–84 petition is as follows. As to claim 7, Par in the -1059 petition asserts that the
`
`purported prior art “lead compound” rapamycin was formulated with various
`
`pharmaceutically acceptable carriers and tested in animal studies for
`
`immunosuppressant properties, i.e., the pharmaceutical composition of claim 7.
`
`(IPR2016-01059, Paper 1 (May 17, 2016) at 28-29.) Par also asserts that the
`
`administration of a compound for therapeutic effect implicitly includes the
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`- 9 -
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`
`
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`formulation of that compound. (Id. at 50.) 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.) Par’s obviousness ground against claim 7 thus
`
`conflicts with Par’s obviousness grounds against 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. By delaying the -1059 petition, Par maximized its chances that
`
`the -84 petition would be instituted.
`
`
`
`Had Par included claim 7 in its -84 petition, Novartis would have had an
`
`opportunity to expose the conflict in Par’s grounds, and the Board would have had
`
`the opportunity to consider that conflict in deciding whether to institute
`
`proceedings on the -84 petition. Novartis and the Board were deprived of those
`
`opportunities through Par’s delay in challenging claim 7.
`
`
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`Such delay—resulting (intentionally or not) in a strategic advantage for one
`
`party to the detriment of the other party and the Board—should not be
`
`countenanced or encouraged. Granting Par’s joinder motion under these
`
`circumstances would set a precedent that would allow a petitioner to hide any
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`- 10 -
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`
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`conflict or contradiction among its 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).
`
`
`
`Last, it bears noting that Par’s professed concern for the “public interest”
`
`(IPR2016-01059, Paper 3 at 10) is belied by its behavior here. Novartis long
`
`ago—at least as early as its February 19, 2015 infringement contentions to Par in
`
`the co-pending Delaware litigation—put Par on notice that Novartis would assert
`
`claim 7 of the ’772 patent against Par in that litigation. Par nevertheless failed to
`
`challenge to claim 7 of the ’772 patent until May 17, 2016. Insofar as there now
`
`exists a risk that claim 7 will remain in force while other challenged claims are
`
`canceled, Par has only itself to blame for creating that risk.
`
`3.
`
`Par’s Contention That Institution On Claim 7 Does Not
`Require Consideration Of The -1059 Record Lacks Support
`
`
`
`Par contends that “the only issue raised by the instant petition is the
`
`additional limitation included in claim 7.” (IPR2016-01059, Paper 3 at 13.) In that
`
`contention, Par assumes that in deciding whether to institute the -1059 case, the
`
`Board need only consider the institution decision in the -84 IPR and Par’s
`
`additional attorney argument regarding certain aspects of claim 7. That
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`assumption is wrong. Par forgets that Novartis is entitled to file a Preliminary
`
`Patent Owner Response in the -1059 case, in which Novartis can raise new
`
`- 11 -
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`
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`arguments and rely on new evidence, including new testimonial evidence.2 And,
`
`Par 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 -1059 case.
`
`Moreover, Par is incorrect in suggesting that 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. The two cases cited by Par, 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 from this case, and unlike the instant case, neither involves a
`
`
`
` Incredibly, while Par itself submitted an expert declaration in support of its -1059
`
` 2
`
`petition, Par now seems to suggest that Novartis should not be permitted to cross-
`
`examine that expert declarant in the -1059 proceeding, and moreover that Novartis
`
`should cover any issues relevant to the -1059 petition when cross-examining the
`
`expert declarant in the -84 IPR, even if the -1059 IPR is not instituted at the time of
`
`the cross-examination. This is yet another example of Par’s attempt to gain a
`
`strategic advantage while depriving Novartis of a fair opportunity to defend the
`
`validity of its patent.
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`- 12 -
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`motivation to modify that was in any way related to formulation or pharmaceutical
`
`compositions.
`
`4.
`
`Par’s Initial Proposed Schedule Is Highly Prejudicial To Novartis
`And Its Alternate Schedule Effectively Allows For A Separate
`Trial On Claim 7 In Violation Of The One Year Statutory Bar
`
`
`
`The schedule proposed in Par’s motion is highly prejudicial to Novartis and
`
`not practicable. Based on the discussion during the June 17, 2016 scheduling call
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`with the Board, Novartis understands that Par is no longer pursuing that schedule.
`
`Thus, the statements in Par’s motion that joinder can occur without impacting the -
`
`84 IPR schedule are no longer applicable.
`
`
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`Par has proposed an alternate schedule as set forth in the parties’ June 15,
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`2016 joint email to the Board. That schedule requires that the -1059 IPR, if
`
`instituted and joined, proceed on a completely different timeline from the -84 IPR
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`for each of the substantive Due Dates 1 through 4. That is, Par proposes a separate
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`trial for claim 7, if instituted and joined, that will be consolidated with the -84 IPR
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`only at the very end of the trial phase. While Novartis understands that the Board
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`intends to issue a schedule shortly setting forth certain due dates for the -84 and -
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`1059 IPRs (among others)—assuming that the Board were to grant Par’s joinder
`
`motion and scheduling proposal—the Board effectively would allow Par to
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`inconvenience Novartis and the Board with an independent trial for claim 7 with
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`independent due dates. Only after nearly all of the papers have been filed in the -
`
`- 13 -
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`
`
`
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`1059 proceeding would the -1059 proceeding come together with the -84
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`proceeding. Such a schedule cannot be considered one that has only “minimal
`
`impact” or one that promotes the “just, speedy, and inexpensive resolution” of the
`
`proceedings.
`
`IV. CONCLUSION
`
`
`
`For the foregoing reasons, Novartis respectfully requests that the Board deny
`
`Par’s joinder motion.
`
`
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`
`
`
`
`
`
`Dated: June 17, 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
`
`- 14 -
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner Novartis’s Opposition To
`
`Petitioner Par’s Motion For Joinder was served by causing it to be sent by email to
`
`counsel for Petitioner Par Pharmaceutical, Inc. in IPR2016-01059 at the following
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`email addresses:
`
`Par Pharmaceutical, Inc.
`
`Daniel Brown (daniel.brown@lw.com)
`
`Robert Steinberg (bob.steinberg@lw.com)
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`
`
`
`
`/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
`
`
`
`Dated: June 17, 2016
`
`
`
`
`
`
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`
`
`- 15 -
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