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`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC., and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.,
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`Plaintiffs,
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`Civil Action No.: 1:14-cv-03962-JBS-KMW
`
`
`Motion Date: October 3, 2014
`
`
`
`v.
`
`METRICS, INC., COASTAL
`PHARMACEUTICALS, INC., MAYNE
`PHARMA GROUP LIMITED, and MAYNE
`PHARMA (USA), INC.,
`
`
`Defendants.
`
`PLAINTIFFS’ REPLY BRIEF IN SUPPORT OF ITS MOTION FOR ORDER
`ENJOINING DEFENDANTS FROM PROSECUTING PARALLEL INTER PARTES
`REVIEW PROCEEDINGS (D.I. 32)
`
`
`
`Page 1 of 87
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`SENJU EXHIBIT 2020
`METRICS v. SENJU
`IPR2014-01043
`
`
`
`Case 1:14-cv-03962-JBS-KMW Document 49 Filed 09/02/14 Page 2 of 16 PageID: 1209
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`
`TABLE OF CONTENTS
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`Page
`
`I.
`
`II.
`
`INTRODUCTION ...............................................................................................................1
`
`ARGUMENT .......................................................................................................................2
`
`A.
`
`B.
`
`C.
`
`D.
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`E.
`
`F.
`
`Plaintiffs Do Not Seek a Preliminary Injunction .....................................................2
`
`Barring or Enjoining Metrics’ IPR Petitions Will Effectuate the Policy
`Underlying 35 U.S.C. § 315(a)(1) ...........................................................................3
`
`Barring or Enjoining Metrics’ IPR Petitions Will Avoid Conflict with
`the Hatch-Waxman Statutory Scheme .....................................................................4
`
`Barring or Enjoining Metrics’ IPRs Will Protect this Court’s Power to
`Resolve this Dispute ................................................................................................6
`
`Barring or Enjoining Metrics’ IPRs Will Avoid Potential
`Constitutional Problems ...........................................................................................7
`
`Prosecution of Metrics’ IPRs Should Be Enjoined Under the
`First-Filed Rule Even if Metrics Had a Right to File Them ....................................8
`
`G.
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`Plaintiffs Did Not “Ambush” Defendants ..............................................................10
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`III.
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`CONCLUSION ..................................................................................................................11
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`
`
`i
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`Page 2 of 87
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`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Bristol-Myers Squibb Co. v. Royce Labs., Inc.,
`69 F.3d 1130 (Fed. Cir. 1995)..................................................................................................10
`
`Consumer Watchdog v. Wisconsin Alumni Research Foundation,
`753 F.3d 1258 (Fed. Cir. 2014)..............................................................................................1, 7
`
`Crosley Corp. v. Hazeltine Corp.,
`122 F.2d 925 (3d Cir. 1941)...............................................................................................7, 8, 9
`
`Crosley Corp. v. Westinghouse Elec. & Mfg. Co.,
`130 F.2d 474 (3d Cir. 1942).......................................................................................................9
`
`Dickinson v. Zurko,
`527 U.S. 150 (1999) ...................................................................................................................7
`
`Eli Lilly & Co. v. Medtronic, Inc.,
`496 U.S. 661 (1990) .................................................................................................................10
`
`Fresenius USA, Inc. v. Baxter Int’l, Inc.,
`721 F.3d 1330, reh’g denied, 733 F.3d 1369 (Fed. Cir. 2013) ....................................2, 5, 6, 10
`
`Granfinanciera, S.A. v. Nordberg,
`492 U.S. 33 (1989) .....................................................................................................................8
`
`Katz v. Lear Siegler, Inc.,
`909 F.2d 1459 (Fed. Cir. 1990)..................................................................................................3
`
`Lab. Corp. of Am. Holdings v. Chiron Corp.,
`384 F.3d 1326 (Fed. Cir. 2004)..................................................................................................9
`
`Lindh v. Murphy,
`521 U.S. 320 (1997) ...................................................................................................................5
`
`Morton v. Mancari,
`417 U.S. 535 (1974) ...................................................................................................................6
`
`Patlex Corp. v. Mossinghoff,
`758 F.2d 594 (Fed. Cir. 1985)....................................................................................................8
`
`ScentAir Tech., Inc. v. Prolitec, Inc.,
`IPR2013-00179, Paper 9 (April 16, 2013) .......................................................................8, 9, 10
`
`ii
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`Page 3 of 87
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`Case 1:14-cv-03962-JBS-KMW Document 49 Filed 09/02/14 Page 4 of 16 PageID: 1211
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`
`Triangle Conduit & Cable Co. v. Nat’l Elec. Prods. Corp.,
`125 F.2d 1008 (3d Cir. 1942).....................................................................................................9
`
`U.S. v. Moy,
`241 U.S. 394 (1916) ...................................................................................................................7
`
`Watt v. Alaska,
`451 U.S. 259 (1981) ...................................................................................................................6
`
`Statutes
`
`35 U.S.C. § 271(e)(2)(A) ...............................................................................................................10
`
`35 U.S.C. § 271(e)(5) .......................................................................................................................3
`
`35 U.S.C. § 315(a)(1) ............................................................................................................. passim
`
`35 U.S.C. § 315(a)(2) ...................................................................................................................2, 4
`
`Other Authority
`
`Cooper v. Lee,
`Brief of Plaintiff, D.I. 4, No. 14-cv-672 (E.D.Va. June 5, 2014) ..............................................8
`
`H. Rep. No. 112-98 Part 1 ...............................................................................................................5
`
`
`
`
`
`
`
`iii
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`Page 4 of 87
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`
`I.
`
`INTRODUCTION
`
`The relief Plaintiffs request is justified either (a) by construing § 315(a)(1) of the IPR
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`provisions, in accordance with its manifest intent, as barring resort to IPR by a party that has
`
`provoked Hatch-Waxman Act litigation by challenging validity in an ANDA containing a
`
`Paragraph IV Certification or (b) by enjoining prosecution of the later-filed IPR raising the same
`
`issues under the All Writs Act. Both approaches effectuate the manifest intent behind the bar
`
`against resort to IPR where a patent challenger has already provoked district court litigation,
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`harmonize the IPR provisions of the AIA with the dispute-resolution procedures of the Hatch-
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`Waxman Act, protect the power of this Court to resolve this dispute, avoid duplication of effort,
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`avoid the risk of inconsistent judgments, avoid serious Constitutional questions regarding use of
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`IPR proceedings in cases like this, and redress a growing misuse of IPR proceedings by
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`threatening to file IPRs in order to extract economic concessions from patent owners.
`
`The thrust of Defendants’ opposition is that the AIA as a whole was enacted in full view
`
`of the Hatch-Waxman Act, whereby the statutory language should be literally construed to say
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`that what Defendants are trying to do must be legal. But the courts have already found that literal
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`application of some of the IPR provisions would be violative of equally visible legal precedent.
`
`See, e.g., Consumer Watchdog v. Wisconsin Alumni Research Foundation, 753 F.3d 1258 (Fed.
`
`Cir. 2014) (statutory provisions allowing appeal by inter partes reexamination petitioner
`
`inapplicable where petitioner lacks any real case or controversy). And just because something is
`
`technically legal does not make it right. All applications of the first-to-file rule involve second-
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`filed actions that the second-filer technically had a legal right to file, but the injunction
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`nonetheless lies to protect the jurisdiction of, and avoid interference with proceedings in, the
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`court where the first action was filed.
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`1
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`Page 5 of 87
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`That Congress may have considered in 2011 other provisions of the Hatch-Waxman Act
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`in other parts of an omnibus patent reform bill does not mean Congress did not overlook the
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`problem addressed by this motion. One thing Congress unquestionably did not have before it in
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`2011 was the Federal Circuit’s 2013 decision in Fresenius USA, Inc. v. Baxter Int’l, Inc., 721
`
`F.3d 1330, 1347, reh’g denied, 733 F.3d 1369 (Fed. Cir. 2013). Over substantial surprised
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`dissent on rehearing, that Court held that completion of a PTO Inter Partes Reexamination
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`proceeding voided a prior validity decision of a federal district court, and the years of effort
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`involved in trying that case, because all appellate proceedings arising from the district court
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`decision had not yet been completed. Congress could not rationally have intended the “race to
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`the Federal Circuit” scenario that will now result in Hatch-Waxman Act cases that cannot be
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`stayed pending conclusion of IPR proceedings (as the AIA contemplates in § 315(a)(2)) because
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`of the limited 30-month stay of ANDA regulatory approval under which such cases are litigated.
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`Nor does it appear that Congress contemplated the growing problem of using the threat of filing
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`IPR petitions in an effort to obtain commercial benefit or settlement opportunities from patent
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`owners, as Defendants have attempted to do in this case. See, e.g., Exs. 1 and 2. The abuse
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`potential of such threats is significant given the value of pharmaceutical patents and the fact that
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`the PTO has invalidated all claims in a remarkable percentage of completed IPR proceedings to
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`date. See Ex. 3. It falls to this Court, therefore, to solve these problems with the tools available to
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`it—statutory construction, the All Writs Act, and the Court’s very substantial discretion.
`
`II.
`
`ARGUMENT
`
`A.
`
`Plaintiffs Do Not Seek a Preliminary Injunction
`
`Plaintiffs do not seek a preliminary injunction, and the traditional four-factor test for a
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`preliminary injunction urged by Defendants does not apply to Plaintiffs’ motion. The standard
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`for granting a preliminary injunction “was developed to test the grant of the requested remedy
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`2
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`Page 6 of 87
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`Case 1:14-cv-03962-JBS-KMW Document 49 Filed 09/02/14 Page 7 of 16 PageID: 1214
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`before the case has been tried on the merits, [and] does not apply to the different question of
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`whether to enjoin the prosecution of concurrent litigation. In the latter case it is not controlling
`
`whether the plaintiff is likely to succeed on the merits.” Katz v. Lear Siegler, Inc., 909 F.2d
`
`1459, 1463 (Fed. Cir. 1990). As clearly stated in Plaintiffs’ opening brief, Plaintiffs seek a
`
`permanent injunction enjoining Defendants from pursuing parallel and later-filed actions in
`
`another forum. (See D.I. 10 at 5-6.) Defendants’ arguments regarding the application of the four
`
`factors considered when granting a preliminary injunction are, therefore, irrelevant. In any event,
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`that irreparable injury to, and balance of hardships in favor of, a successful district court litigant
`
`flows from potentially voiding a trial court validity decision based on a later-commenced
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`administrative proceeding cannot be seriously denied, nor can the public interest be served by
`
`such a waste of judicial resources.1
`
`B.
`
`Barring or Enjoining Metrics’ IPR Petitions Will Effectuate the
`Policy Underlying 35 U.S.C. § 315(a)(1)
`
`Barring or enjoining Metrics’ parallel IPR proceedings will effectuate the policy behind
`
`an important provision of the AIA statute barring institution of an IPR filed by a party who has
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`previously initiated an action challenging the validity of the same patent. See 35 U.S.C.
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`§ 315(a)(1). Such challenges are provoked in non-Hatch-Waxman cases by a potential infringer
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`filing a “declaratory judgment” action. Such declaratory judgment actions are forbidden by the
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`Hatch-Waxman Act, 35 U.S.C. § 271(e)(5), which instead provides that the patent challenge
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`must be initiated by filing an ANDA with a Paragraph IV Certification. Thus, in the
`
`
`1 Plaintiffs have separately addressed Defendants’ personal jurisdiction arguments in
`Plaintiffs’ Opposition to Defendants’ Motion to Dismiss. That motion is without merit at least
`because Metrics unconditionally accepted service of process in New Jersey through its registered
`New Jersey agent, thereby establishing consent to personal jurisdiction as a matter of law, and
`Defendants repeatedly have invoked this Court’s jurisdiction in other cases and have maintained
`continuous and systematic contacts with New Jersey.
`
`3
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`Page 7 of 87
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`Hatch-Waxman context, the filing of the Paragraph IV Certification is not only the full
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`equivalent of filing the declaratory judgment action barring IPR under § 315(a)(1), it is the only
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`way such a challenge can be initiated. It is entirely logical, therefore, to interpret the statute as
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`also barring IPR when a Paragraph IV Certification has been filed. The inartfulness of the
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`statutory wording reflects nothing more than Congressional failure to appreciate that in the
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`Hatch-Waxman context, a declaratory judgment action by a potential infringer is prohibited and
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`was replaced with the Paragraph IV procedure two decades earlier.
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`C.
`
`Barring or Enjoining Metrics’ IPR Petitions Will Avoid Conflict with
`the Hatch-Waxman Statutory Scheme
`
`Congress did not contemplate that the same patent challenger would in the usual case
`
`pursue an IPR and a civil action concurrently. The IPR statute expressly prohibits an IPR where
`
`the petitioner has previously initiated proceedings in district court. Even where the IPR is
`
`lawfully initiated, the statute expressly contemplates a stay of district court litigation awaiting the
`
`outcome of an IPR proceeding. See 35 U.S.C. § 315(a)(2). As noted in Plaintiffs’ opening brief,
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`this option is not realistically available in Hatch-Waxman Act litigation because of the objective
`
`of litigating the district court action during the pendency of the 30-month stay of ANDA
`
`regulatory approval provided by the statute. (D.I. 10 at 10-11.) Barring or enjoining Metrics’
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`IPRs avoids this conflict, apparently unforeseen by Congress, and preserves the statutory scheme
`
`contemplated by the Hatch-Waxman Act.
`
`Nothing in Defendants’ opposition brief requires a contrary result. Defendants cite
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`lobbying efforts of various pharmaceutical companies during the AIA legislative proceedings.
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`(See D.I. 32 at 19-21.) But the mere participation of pharmaceutical companies in the
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`Congressional debate on the AIA is irrelevant. Defendants do not point to any legislative history
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`that suggests that this particular conflict between the IPR statute and the Hatch-Waxman statute
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`4
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`Page 8 of 87
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`was known to Congress but ignored, nor do Defendants point to any legislative history where
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`Congress recognizes the unique mechanism initiating Hatch-Waxman litigation, its interaction
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`with the IPR statute, or the wasteful consequences of parallel proceedings now apparent from
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`Fresenius.
`
`Defendants point to other sections of the AIA where reference to aspects of the
`
`Hatch-Waxman Act is made, but no clear intent emerges from these sections foreclosing an
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`interpretation of § 315(a)(1) to include a Paragraph IV Certification. (See D.I. 32 at 17-19.) The
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`provisions of the AIA cited by Defendants relating to supplemental examination and joinder of
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`accused infringers are in completely unrelated parts of this expansive statute. Although some
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`provisions of the Hatch-Waxman Act are mentioned in these sections and not in the IPR section
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`of the statute, this different treatment does not suggest different intent when disparate parts of the
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`law evolved separately in the Congressional process. See Lindh v. Murphy, 521 U.S. 320, 329-30
`
`(1997).
`
`This is particularly true of the joinder provisions, which were intended to avoid the
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`favorite practice of some “Non-Practicing Entities” of joining entire industries in a single suit for
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`damages. See H. Rep. No. 112-98, Part 1, at 54. This problem is plainly distinguishable from
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`joining in a single action all parties who have provoked challenges to the validity of the same
`
`pharmaceutical patent and is wholly unrelated to the IPR provisions. As noted in Plaintiffs’
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`opening brief on this motion, the provisions relating to supplemental examination actually
`
`support barring or enjoining Metrics’ IPRs by equating allegations made in a Paragraph IV
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`Certification with those made in a civil action. (D.I. 10 at 10.)
`
`Barring or enjoining Metrics’ IPRs gives effect to the intent of both the IPR provisions of
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`the statute and the Hatch-Waxman Act, consistent with the long-settled canon of statutory
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`5
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`Page 9 of 87
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`construction that “when two statutes are capable of co-existence, it is the duty of the courts,
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`absent a clearly expressed congressional intention to the contrary to regard each as effective.”
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`Morton v. Mancari, 417 U.S. 535, 551 (1974). This requires reading “statutes to give effect to
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`each if [courts] can do so while preserving their sense and purpose.” Watt v. Alaska, 451 U.S.
`
`259, 267 (1981). Congress has expressed no clear intent to exempt Paragraph IV Certifications
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`from the meaning of “a civil action,” and thus this Court should not construe this statutory
`
`language to nullify the purpose and careful balance Congress struck in the Hatch-Waxman Act,
`
`particularly the importance of the 30-month stay. Interpreting § 315(a)(1) to include an ANDA
`
`filing with a Paragraph IV Certification or simply enjoining parallel prosecution of the later-filed
`
`IPR preserves both the purpose of the civil action bar and the framework underlying the
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`Hatch-Waxman Act.
`
`D.
`
`Barring or Enjoining Metrics’ IPRs Will Protect this Court’s Power
`to Resolve this Dispute
`
`If Metrics’ IPRs are allowed to proceed and a finding of unpatentability at the PTO is
`
`affirmed by the Federal Circuit before appellate affirmance of a potential judgment of validity by
`
`this Court, this Court’s effort and judgment in resolving this dispute will have been wasted. As
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`discussed previously, the Federal Circuit has held that PTO decisions in such circumstances
`
`trump the judgment of the district court, an outcome enjoining Metrics’ IPRs will avoid. See
`
`Fresenius, 721 F.3d at 1347. This race to the Federal Circuit in Hatch-Waxman cases, approved
`
`in Fresenius and now being undertaken by Metrics, cannot possibly have been intended by
`
`Congress, threatens this Court’s jurisdiction under the Hatch-Waxman Act to resolve this
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`dispute, and is a blatant attempt to moot any validity determination made by this Court.
`
`Enjoining Metrics’ second-filed IPRs disfavors Metrics’ forum shopping, discourages improper
`
`use of the IPR procedure to extract commercial concessions, and preserves this Court’s ability to
`
`6
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`Page 10 of 87
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`
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`Case 1:14-cv-03962-JBS-KMW Document 49 Filed 09/02/14 Page 11 of 16 PageID: 1218
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`hear a dispute plainly reserved to it by the Hatch-Waxman Act. Notwithstanding Defendants’
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`protestations to the contrary, what may or may not have happened in other cases with unknown
`
`facts in this emerging area of the law is utterly irrelevant. The issue here is committed to the
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`sound discretion of this Court on the unique facts of this case. Crosley Corp. v. Hazeltine Corp.,
`
`122 F.2d 925, 929 (3d Cir. 1941) (decision to enjoin parallel proceeding committed to district
`
`court’s discretion).
`
`E.
`
`Barring or Enjoining Metrics’ IPRs Will Avoid Potential
`Constitutional Problems
`
`Barring or enjoining Metrics’ IPRs will also avoid potential constitutional problems
`
`arising from conflicts between Article III and administrative proceedings. Just as statutes should
`
`be construed to avoid conflict with other statutes, it is well-settled that “a statute must be
`
`construed, if fairly possible, so as to avoid not only the conclusion that it is unconstitutional, but
`
`also grave doubts upon that score.” U.S. v. Moy, 241 U.S. 394, 401 (1916). As previously noted,
`
`constitutional flaws in the IPR provisions have already emerged. See Consumer Watchdog, 753
`
`F.3d at 1262. As discussed in Plaintiffs’ opening brief, allowing Metrics’ IPRs to go forward
`
`may raise a serious constitutional question whether valuable property was taken without due
`
`process of law in the context of a previously-issued, Orange Book-listed patent. (See D.I. 10 at
`
`11-12.)
`
`Moreover, broader separation of powers concerns arise when a defendant, subject to an
`
`infringement action in federal district court, is able to remove the issue of patent validity from
`
`determination by an Article III judge under a presumption of validity to instead be determined by
`
`an Article I tribunal with a lower standard of proof and no presumption of validity.2 The
`
`
`2 The Federal Circuit affirms PTO fact-finding if supported by “substantial evidence.”
`Dickinson v. Zurko, 527 U.S. 150 (1999).
`
`7
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`Page 11 of 87
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`
`Supreme Court has long held that Congress may not deny Article III adjudication of private
`
`property rights. See Granfinanciera, S.A. v. Nordberg, 492 U.S. 33, 51 (1989) (“[I]f a statutory
`
`right is not closely intertwined with a federal regulatory program, and if that right neither
`
`belongs to nor exists against the Federal Government, then it must be adjudicated by an Article
`
`III court.”). Although ex-parte reexamination withstood constitutional scrutiny in Patlex Corp. v.
`
`Mossinghoff, 758 F.2d 594, 604 (Fed. Cir. 1985), it did so upon classification of reexamination
`
`as “primarily a public concern” born out of a need to remedy defective governmental action. IPR
`
`proceedings, by contrast, cannot reasonably be characterized as “primarily a public concern”
`
`when IPRs so closely resemble private litigation involving private litigants disputing the
`
`privately-held property right of an issued patent. Tellingly, the PTAB itself has distinguished re-
`
`examination and IPRs, stating that “[a]n inter partes review is not original examination,
`
`continued examination or reexamination of the involved patent. Rather, it is a trial, adjudicatory
`
`in nature and constituting litigation.” ScentAir Tech., Inc. v. Prolitec, Inc., IPR2013-00179,
`
`Paper 9, at 4 (April 16, 2013). Thus, allowing adjudication of patent rights in IPRs raises grave
`
`constitutional concerns. See Brief of Plaintiff, D.I. 4, Cooper v. Lee, No. 14-cv-672 (E.D.Va.
`
`June 5, 2014). Barring or enjoining Metrics’ later-filed IPR proceedings avoids an interpretation
`
`of the AIA creating significant doubt about the constitutionality of the IPR provisions of the
`
`AIA.
`
`F.
`
`Prosecution of Metrics’ IPRs Should Be Enjoined Under the
`First-Filed Rule Even if Metrics Had a Right to File Them
`
`The first-filed rule is an equitable doctrine that allows courts to avoid duplication of
`
`judicial effort and the possibility of inconsistent judgments when parallel proceedings involve
`
`the same parties and the same issues, as in this case. Hazeltine, 122 F.2d at 929. Even if this
`
`Court finds that Metrics had a statutory right to file Metrics’ IPRs under the AIA, this does not
`
`8
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`Page 12 of 87
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`
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`preclude application of the first-filed rule. Indeed, in cases where courts have enjoined second-
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`filed actions in favor of first-filed actions involving the same parties and issues, it is generally
`
`the case that the party filing the second action had the right to file it. But courts, applying the
`
`equitable principles underlying the first-filed rule, still consistently exercise their power to enjoin
`
`second-filed actions to allow first-filed actions to proceed unencumbered. See, e.g., Hazeltine,
`
`122 F.2d at 930; Lab. Corp. of Am. Holdings v. Chiron Corp., 384 F.3d 1326, 1333 (Fed. Cir.
`
`2004); Crosley Corp. v. Westinghouse Elec. & Mfg. Co., 130 F.2d 474, 475 (3d Cir. 1942);
`
`Triangle Conduit & Cable Co. v. Nat’l Elec. Prods. Corp., 125 F.2d 1008, 1009-10 (3d Cir.
`
`1942).
`
`Here, Plaintiffs ask this Court to stop Metrics’ parallel IPR proceedings in favor of this
`
`first-filed, Hatch-Waxman litigation because, as discussed in Plaintiffs’ opening brief, the issues
`
`and parties are the same, parallel litigation in the district court and the PTAB will waste judicial
`
`resources and open up the possibility of inconsistent judgments, and Plaintiffs’ requested
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`injunction, far from aiding in an inequitable strategy for Plaintiffs, will stop Metrics’ attempts to
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`misuse the threat of IPR proceedings to secure commercial benefits in Hatch-Waxman Act
`
`litigation and will stop Metrics’ forum shopping after Metrics effectively initiated the present
`
`action. (See D.I. 10 at 13-15.)
`
`Moreover, although this case raises an issue of first impression regarding the application
`
`of the first-filed rule to enjoin an IPR, the plainly adjudicatory nature of IPR proceedings
`
`suggests that the factors supporting enjoining a second-filed district court action apply equally to
`
`an IPR. As discussed above, the PTAB itself has stated that “[a]n inter partes review is not
`
`original examination, continued examination or reexamination of the involved patent. Rather, it
`
`is a trial, adjudicatory in nature and constituting litigation.” ScentAir, IPR2013-00179, Paper 9,
`
`9
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`Page 13 of 87
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`
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`at 4. In addition, the Federal Circuit in Fresenius held that a finding of unpatentability at the
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`PTO affirmed by the Federal Circuit trumps an as-yet unaffirmed determination of validity at the
`
`district court, suggesting that IPRs should similarly be treated as equivalent to district court
`
`actions for purposes of application of the first-filed rule. Fresenius, 733 F.3d at 1347.
`
`G.
`
`Plaintiffs Did Not “Ambush” Defendants
`
`Contrary to Defendants’ protestations, Plaintiffs have not “ambushed” Defendants by
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`“prematurely” filing this suit. (D.I. 32 at 28-29.) Plaintiffs were entitled to initiate this action as
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`soon as Metrics voluntarily notified Plaintiffs on March 13, 2014 of its admittedly “infringing
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`ANDA submission.”3 35 U.S.C. § 271(e)(2)(A); see Bristol-Myers Squibb Co. v. Royce Labs.,
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`Inc., 69 F.3d 1130, 1135 (Fed. Cir. 1995) (citing Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661,
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`678 (1990)) (filing an ANDA with a Paragraph IV certification is the act that establishes
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`jurisdiction to resolve the dispute). Tellingly, Metrics does not—and indeed cannot—argue that
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`Plaintiffs’ filing of this action was improper or lacked a jurisdictional basis.4
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`That Plaintiffs initially desisted from filing suit in an attempt to negotiate with
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`Defendants to avoid unnecessary litigation is the antithesis of an “ambush.” Indeed, while
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`Defendants purport to relate the events they contend led to filing this action, conspicuously
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`3 In Defendants’ Answer to Plaintiffs’ unserved protective suit in Civil Action No. 14-cv-
`00141 in the Eastern District of North Carolina, Defendants describe Metrics’ ANDA
`submission in a heading as “METRICS’ INFRINGING ANDA SUBMISSION.” (Ex. 4 at ¶¶
`19-20 (emphasis in original).)
`4 Defendants’ refusal to concede either subject matter or personal jurisdiction in this
`Court provoked the filing of unserved protective suits here and in North Carolina to protect
`Plaintiffs in the event of a jurisdictional challenge. Defendants answered the unserved protective
`complaint in North Carolina in a shameless effort to advance that action ahead of this one and
`wrongly complain in their opposition of the self-inflicted injury in having done so.
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`10
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`Page 14 of 87
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`Case 1:14-cv-03962-JBS-KMW Document 49 Filed 09/02/14 Page 15 of 16 PageID: 1222
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`absent is any reference to any demand by Defendants on the eve of suit for concessions that
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`would have prejudiced this motion had filing been delayed.5
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`Defendants could have controlled the timing of this suit by retaining their activities in
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`confidence, which is customarily the case. Instead, Defendants took a calculated commercial risk
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`in providing Plaintiffs with notice of their infringing activity and Metrics’ improper threat to file
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`an IPR in an obvious attempt to wrest commercial and settlement concessions from Plaintiffs.
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`Having chosen to do so, Defendants cannot now claim to have been surprised by the proper
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`filing of suit seeking to remedy Defendants’ infringing actions.
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`III. CONCLUSION
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`For at least the reasons in Plaintiffs’ opening brief and discussed above, Plaintiffs
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`respectfully request that the Court grant its motion for an injunction enjoining Defendants from
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`continued prosecution of Metrics’ IPR Nos. 2014-01041 and 2014-01043 before the PTAB.
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`Dated: September 2, 2014
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`Respectfully submitted,
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`/s/ John F. Brenner
`John F. Brenner
`PEPPER HAMILTON, LLP
`Suite 400
`301 Carnegie Center
`Princeton, New Jersey, 08543-5276
`(609) 951-4193
`brennerj@pepperlaw.com
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`Attorneys for Plaintiffs
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH & LOMB
`PHARMA HOLDINGS CORP.
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`5 Defendants profess surprise that Metrics’ Paragraph IV Certification led inexorably to
`litigation. But Defendants told Plaintiffs that Metrics had filed an ANDA to copy this product,
`never once alleged non-infringement, and knew that Plaintiffs had already disputed allegations of
`invalidity of its presumptively valid patents by previously suing Lupin in this Court.
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`11
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`Page 15 of 87
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`Case 1:14-cv-03962-JBS-KMW Document 49 Filed 09/02/14 Page 16 of 16 PageID: 1223
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`Of Counsel:
`Bryan C. Diner
`Justin J. Hasford
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
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`12
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`Page 16 of 87
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`Case 1:14-cv-03962-JBS-KMW Document 49-1 Filed 09/02/14 Page 1 of 2 PageID: 1224
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`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.
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`Plaintiffs,
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`Civil Action No.: 1:14-cv-03962-JBS-KMW
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`v.
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`METRICS, INC., COASTAL
`PHARMACEUTICALS, INC., MAYNE
`PHARMA GROUP LIMITED, and MAYNE
`PHARMA (USA), INC.,
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`Defendants.
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`DECLARATION OF BRYAN C. DINER IN SUPPORT OF PLAINTIFFS’ REPLY
`BRIEF IN SUPPORT OF MOTION FOR ORDER ENJOINING DEFENDANTS FROM
`PROSECUTING PARALLEL INTER PARTES REVIEW PROCEEDINGS
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`I, Bryan C. Diner, hereby declare the following:
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`1.
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`I am an attorney at the Washington, DC office of Finnegan Henderson Farabow
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`Garrett & Dunner, LLP, and I represent Plaintiffs Senju Pharmaceutical Co., Ltd. (“Senju”),
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`Bausch & Lomb Incorporated (“B+L”) and Bausch & Lomb Pharma Holdings Corp. (“B+L
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`Pharma Holdings”) (collectively, “Plaintiffs”) in this action. I submit this Declaration in support
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`of Plaintiffs’ Reply Brief in Support of Motion for Order Enjoining Defendants from Prosecuting
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`Parallel Inter Partes Review Proceedings.
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`2.
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`Attached hereto as Exhibit 1 is a true and correct copy of Darlene Ghavimi,
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`“NPEs Can Potentially Use Inter Partes Review to Target the Life Sciences Industry,” (Ju