Case 1:14-cv-03962-JBS-KMW Document 10-1 Filed 07/10/14 Page 1 of 16 PageID: 59
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`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`METRICS, INC., COASTAL
`PHARMACEUTICALS, INC., MAYNE
`PHARMA GROUP LIMITED, and MAYNE
`PHARMA (USA), INC.,
`
`
`Defendants.
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`
`
`
`I.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.
`
`
`Plaintiffs,
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`
`
`Civil Action No.: 1:14-cv-03962-JBS-KMW
`
`PLAINTIFFS’ BRIEF IN SUPPORT OF
`MOTION FOR ORDER ENJOINING
`DEFENDANTS FROM PROSECUTING
`PARALLEL INTER PARTES REVIEW
`PROCEEDINGS
`
`Return Date: August 4, 2014
`
`INTRODUCTION
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`Plaintiffs in the above-captioned patent infringement suit, which arises under the
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`Hatch-Waxman Act, hereby move under the All Writs Act to enjoin pursuit of a
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`subsequently-filed, parallel federal proceeding initiated by Defendants that (1) threatens to
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`disrupt this proceeding, (2) threatens to disrupt the careful balance of competing interests
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`embodied in the Hatch-Waxman statutory scheme, and (3) threatens the jurisdiction of this
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`Court. Specifically, Defendants initially selected the federal district court as the forum to resolve
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`this patent dispute by filing an Abbreviated New Drug Application (“ANDA”) containing
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`so-called “Paragraph IV” Certifications that the patents here in suit are invalid. Now Defendants
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`are attempting an end run around the power of this Court to resolve the dispute they provoked by
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`subsequently filing in the U.S. Patent and Trademark Office (“PTO”) a request for Inter Partes
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`Review (“IPR”) under the recently enacted America Invents Act (“AIA”) seeking to invalidate
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`these patents on essentially the same grounds. Because the Hatch-Waxman Act provides a
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`period of only 30 months to litigate this dispute before FDA approval may be granted, this action
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`cannot be stayed to await the outcome of the IPR, which was a mechanism envisioned in the AIA
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`Page 1 of 16
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`SENJU EXHIBIT 2016
`METRICS v. SENJU
`IPR2014-01043
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`in non-Hatch-Waxman cases to avoid conflict with proceedings in federal district courts. For at
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`least the reasons set forth below, an order from this Court enjoining Defendants from pursuing
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`this subsequent proceeding is needed to avoid unintended and unforeseen conflict between these
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`two statutory schemes and to protect the power of this Court to resolve this dispute.
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`II.
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`BACKGROUND
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`Plaintiffs Senju Pharmaceutical Co., Ltd. (“Senju”), Bausch & Lomb Incorporated
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`(“B+L”) and Bausch & Lomb Pharma Holdings Corp. (“B+L Pharma Holdings”) (collectively,
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`“Plaintiffs”) respectfully move this Court for an order enjoining Defendants Metrics, Inc.
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`(“Metrics”), Coastal Pharmaceuticals, Inc. (“Coastal”), Mayne Pharma Group Limited (“Mayne
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`Pharma”), and Mayne Pharma (USA), Inc. (“Mayne Pharma USA”) (collectively, “Defendants”)
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`from prosecuting IPR Nos. 2014-01041 and 2014-01043 before the PTO Patent Trial and Appeal
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`Board (“PTAB”). These IPR petitions challenge on alleged obviousness grounds all claims of
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`U.S. Patent No. 8,129,431 (“the ’431 patent”) and U.S. Patent No. 8,669,290 (“the ’290 patent”),
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`which, along with U.S. Patent No. 8,754,131 (“the ’131 patent”), are the patents-in-suit in this
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`Hatch-Waxman case. Prior to Metrics’ filing of these IPR petitions, Metrics filed an ANDA
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`with Paragraph IV Certifications challenging the ’431 and ’290 patents on identical obviousness
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`grounds, thereby provoking the present action.1
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`
`1 While Metrics has filed IPR petitions challenging the ’431 and ’290 patents, which are
`both listed in the U.S. Food and Drug Administration’s (“FDA’s”) Approved Drug Products with
`Therapeutic Equivalence Evaluations (“the Orange Book”), Plaintiffs’ Complaint in this case
`also asserts infringement of the ’131 patent. Plaintiffs have submitted the ’131 patent for listing
`in the Orange Book and expect the FDA will soon do so. Plaintiffs expect that Metrics will then
`similarly submit a Paragraph IV Certification with the FDA challenging the validity of the ’131
`patent on obviousness grounds. To Plaintiffs’ knowledge, Metrics has not yet filed an IPR
`petition challenging the ’131 patent before the PTAB. To the extent Metrics submits an IPR
`petition challenging the ’131 patent, Plaintiffs’ instant request for injunctive relief would
`likewise be applicable to such a petition.
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`2
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`The ’431, ’290 and ’131 patents disclose and claim novel formulations of bromfenac, the
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`active pharmaceutical ingredient in the successful ophthalmic drug Prolensa®. (Ex. 1; Ex. 2; Ex.
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`3.) Prolensa® is approved by the FDA for treatment of post-operative inflammation and
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`reduction of ocular pain in patients who have undergone cataract surgery. (Ex. 4.) Prolensa®
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`received FDA approval in April 2013 and immediately garnered acclaim in the medical
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`community based on highly favorable clinical study data demonstrating “the benefits of the new
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`formulation.” (Ex. 5.)
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`Seeking to capitalize on Prolensa®’s success, at least two different generic drug
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`companies have submitted ANDAs requesting FDA approval for the commercial marketing of
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`generic copies of Prolensa® before the patents-in-suit expire. By letters dated December 19,
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`2013, and May 13, 2014, Lupin Limited (“Lupin”) stated that it had filed an ANDA for a generic
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`version of Prolensa® with Paragraph IV Certifications challenging the ’431 and ’290 patents,
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`respectively, primarily on validity grounds. (Ex. 6 at ¶ 16; Ex. 7 at ¶ 16.) By filing these
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`Paragraph IV Certifications challenging the ’431 and ’290 patents, Lupin provoked Hatch-
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`Waxman lawsuits before this Court for infringement of these patents.2 (Ex. 6; Ex. 7.) These
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`suits remain pending, with fact discovery having begun and contentions and claim construction
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`proceedings pursuant to the New Jersey Local Patent Rules scheduled to proceed shortly. (Ex.
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`8.)
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`Nearly four months after the date of Lupin’s first Paragraph IV Notice Letter, Metrics
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`sent a letter to Plaintiffs dated March 13, 2014, in which Metrics stated that it also had submitted
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`an ANDA for a generic version of Prolensa® with a Paragraph IV Certification challenging the
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`’431 patent. (Ex. 9.) That letter was an unambiguous admission that Metrics had infringed
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`2 Plaintiffs expect that Lupin will also challenge the ’131 patent once it is listed in the
`FDA’s Orange Book.
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`3
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`Plaintiffs’ patent under 35 U.S.C. § 271(e)(2). Metrics subsequently filed an additional
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`Paragraph IV Certification challenging the ’290 patent, with the main thrust of the challenge to
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`both patents centering on validity. (Ex. 10.) By filing these Paragraph IV Certifications
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`challenging the ’431 and ’290 patents, Metrics, as Lupin had before it, provoked the present
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`Hatch-Waxman lawsuit before this Court for infringement of these patents. (D.I. 1.)
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`Given that Lupin was the first filer of an ANDA for a generic version of Prolensa® with a
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`Paragraph IV Certification challenging the ’431 patent, Metrics—as a later filer—is statutorily
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`blocked by the Hatch-Waxman Act from receiving FDA approval of its ANDA for at least 180
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`days after Lupin obtains FDA approval, unless Lupin forfeits its 180-day exclusivity period. 21
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`U.S.C. § 355(j)(5)(B)(iv). Accordingly, Metrics, knowing that its delay in filing its ANDA
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`would subordinate it to Lupin’s 180-day exclusivity period, attempted to circumvent the very
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`provisions of the Hatch-Waxman Act that it had invoked through its Paragraph IV Certification.
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`In its March 13 letter, Metrics stated that it had prepared but not yet filed an IPR petition seeking
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`cancellation of all the claims in the ’431 patent. (Ex. 9.) Metrics’ letter made clear Metrics’
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`intent to circumvent the judicial framework of the Hatch-Waxman Act and threatened the
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`disruptive filing of the draft IPR petition to extract a commercially favorable agreement from
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`Plaintiffs. (Id.) In subsequent non-confidential discussions, Metrics confirmed its intention to
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`procure from Plaintiffs early market entry, either with its ANDA product or with an authorized
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`generic, in derogation of Lupin’s 180-day exclusivity period.
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`Metrics ultimately filed IPR petitions on June 26, 2014—after the present case was
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`filed—challenging all claims of the ’431 and ’290 patents on alleged obviousness grounds. (Ex.
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`11; Ex. 12.) By letter dated the same day as Metrics’ IPR petitions, Metrics purported to notify
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`Plaintiffs of its Paragraph IV Certifications against the ’431 and ’290 patents and purported to
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`4
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`provide statements of the factual and legal bases for its obviousness allegations in the present
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`district court litigation. (Ex. 10.) Notably, Metrics’ Paragraph IV Notice Letter and its IPR
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`petitions raise identical obviousness allegations. (Compare Ex. 10 with Ex. 11 and Ex. 12.)
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`III. LEGAL STANDARDS
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`While this motion raises a question of first impression relating to the interplay between
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`Hatch-Waxman Act litigation in federal court and IPR proceedings in the PTO, the existing law
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`relating to pursuit of parallel legal proceedings provides useful guidance. In this regard, the All
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`Writs Act gives this Court the power to issue all orders necessary in aid of its jurisdiction,
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`including the power to enjoin a party from pursuing parallel litigation in another forum. 28
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`U.S.C. § 1651 (1980); see, e.g., Phillips Beverage Co. v. Belvedere, S.A., 204 F.3d 805, 806 (8th
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`Cir. 2000) (affirming district court’s authority under the All Writs Act to order defendant to
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`withdraw from a later-filed action before the United States Customs Service); Carlough v.
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`Amchem Products, Inc., 10 F.3d 189, 204 (3d Cir. 1993) (affirming district court’s authority
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`under the All Writs Act to order class action plaintiffs to refrain from further prosecution of state
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`court action). A decision to enjoin concurrent proceedings in another forum is predicated on “the
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`proceedings involv[ing] the same parties and issues.” Katz v. Lear Siegler, Inc., 909 F.2d 1459,
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`1463 (Fed. Cir. 1990).
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`The “first-to-file” rule is also relevant. That rule, which was originally articulated by the
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`Supreme Court in 1824, states that “in all cases of concurrent jurisdiction, the Court which first
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`has possession of the subject must decide it.” Smith v. M'Iver, 22 U.S. 532, 535 (1824). The
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`Third Circuit formally adopted this rule in Crosley Corp. v. Hazeltine Corp., 122 F.2d 925, 929
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`(3d Cir. 1941), adding that “the party who first brings a controversy into a court of competent
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`jurisdiction for adjudication should, so far as our dual system permits, be free from the vexation
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`of subsequent litigation over the same subject matter.” Id. at 930. It is well settled that courts
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`may apply this rule to enjoin pursuit of a later-filed proceeding in favor of the first-filed action.
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`See, e.g., Lab. Corp. of Am. Holdings v. Chiron Corp., 384 F.3d 1326, 1333 (Fed. Cir. 2004)
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`(affirming that the District of Delaware did not abuse its discretion in enjoining a patent
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`infringement action in the Northern District of California where the Delaware declaratory
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`judgment action was first-filed and involved the same patents and parties); Crosley Corp. v.
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`Westinghouse Elec. & Mfg. Co., 130 F.2d 474, 475 (3d Cir. 1942) (reversing district court
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`decision not to enjoin second-filed suit); Hazeltine, 122 F.2d at 930 (ordering district court to
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`enjoin second-filed patent infringement action in favor of first-filed declaratory judgment
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`action); Triangle Conduit & Cable Co. v. Nat'l Elec. Prods. Corp., 125 F.2d 1008, 1009-10 (3d
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`Cir. 1942) (reversing district court decision not to enjoin second-filed suit).
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`In a similar vein, Courts have enjoined parallel proceedings where there has been an
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`earlier selection of an alternate forum for resolution of the dispute. See Texas Instruments Inc. v.
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`Tessera, Inc., 231 F.3d 1325, 1332 (Fed. Cir. 2000) (vacating district court’s denial of
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`preliminary injunction motion to enjoin defendant from continued participation in an
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`International Trade Commission infringement action on a finding that plaintiff would likely
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`succeed in proving the ITC action is covered by a forum selection clause for the District of
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`California); General Protecht Group, Inc. v. Leviton Mfg. Co., Inc., 651 F.3d 1355, 1365 (Fed.
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`Cir. 2011) (affirming district court grant of preliminary injunction enforcing a forum selection
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`clause and enjoining participation in a later-filed ITC action). As discussed further below,
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`application of these and other factors strongly justifies enjoining Defendants from parallel
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`pursuit of Metrics’ IPR petitions.
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`IV. ARGUMENT
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`A.
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`An Injunction Is Appropriate Because Metrics Selected the Federal
`District Court Forum and Initiated This District Court Action By
`Filing Its Paragraph IV Certification
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`The procedures mandated by the Hatch-Waxman Act demonstrate that Metrics selected
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`the district court forum and initiated the current district court infringement action just as surely
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`as if it had filed an action for declaratory judgment of patent invalidity in district court. Indeed,
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`the statute provides that in lieu of such a declaratory judgment action, an ANDA filer who
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`alleges patent invalidity starts the proceeding by filing a Paragraph IV Certification challenging
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`the patent. 21 U.S.C. § 355(j)(2)(A)(vii)(IV). The patent owner must then file the suit thus
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`provoked in the forum mandated by the Hatch-Waxman Act—a federal district court—on pain of
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`losing the 30-month stay of FDA approval of the generic copy provided by statute to allow
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`resolution of the dispute before disruptive market entry. 21 U.S.C. § 355(j)(5)(B)(iii).
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`Defendants knew that Plaintiffs were already asserting their patents against another generic
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`challenger at the time Metrics informed Plaintiffs that they had infringed Plaintiffs’ patent by
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`filing an ANDA with a Paragraph IV Certification. There could be no doubt that Metrics’
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`actions would, and were intended to, provoke the same response. Just as Courts have enjoined
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`parties from initiating actions in derogation of prior selections of the appropriate forum, so too
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`should Defendants be enjoined from repudiating Metrics’ prior selection of federal district court
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`as the forum to resolve this dispute. See, e.g., Texas Instruments, 231 F.3d at 1332; General
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`Protecht, 651 F.3d at 1365.
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`1.
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`The Requested Injunction Is Supported By the Objectives of
`the Hatch-Waxman Act
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`Pursuit by Metrics of its IPR petitions is contrary to the Hatch-Waxman statutory
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`framework. In enacting the Hatch-Waxman Act, Congress sought to attain a balance between
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`the interests of brand name pharmaceutical companies and generic drug manufacturers. See, e.g.,
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`Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1360 (Fed. Cir. 2010).
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`Congress allowed generic manufacturers to use a drug claimed in a patent to prepare an ANDA
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`for a generic copy of the patented drug without liability for infringement. 35 U.S.C. § 271(e)(1).
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`When a generic manufacturer seeks FDA approval to market its generic copy before expiration
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`of any Orange Book-listed patents covering the drug, the Hatch-Waxman Act permits the generic
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`to file a Paragraph IV Certification asserting that the patent “is invalid or will not be infringed by
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`the manufacture, use, or sale” of the generic drug for which the ANDA is being submitted. 21
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`U.S.C. § 355(j)(2)(A)(vii). A Paragraph IV Certification is a statutory act of patent infringement
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`that initiates Hatch-Waxman litigation in federal district court and also typically results in a
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`statutory stay of FDA approval of the ANDA for 30 months so that the district court may
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`adjudicate issues of infringement and validity. See Bristol-Myers Squibb Co. v. Royce Labs.,
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`Inc., 69 F.3d 1130, 1135 (Fed. Cir. 1995); 35 U.S.C. § 271(e)(2); 21 U.S.C. § 355(j)(5)(B)(iii).
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`In this manner, the Hatch-Waxman statutory framework “strikes a balance between two
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`potentially competing policy interests--inducing pioneering development of pharmaceutical
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`formulations and methods and facilitating efficient transition to a market with low-cost, generic
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`copies of those pioneering inventions at the close of a patent term.” Novo Nordisk, 601 F.3d at
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`1360. The essence of that balance is the generic’s right to prepare and file its ANDA without
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`liability for infringement given in exchange for the patent owner’s right to resolve the dispute in
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`federal court under the protection of the 30-month stay of FDA approval of the generic product.
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`Through Metrics’ filing of its ANDA with its Paragraph IV Certifications challenging the
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`’431 and ’290 patents, Defendants availed themselves of the benefits of the Hatch-Waxman
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`statutory scheme. Just as a party who accepts a benefit from another may be obligated to pay for
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`it under the law of unjust enrichment, Cohen v. Home Ins. Co., 230 N.J.Super. 72, 82 (App. Div.
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`1989) (quoting Callano v. Oakwood Park Homes Corp., 91 N.J.Super. 105, 108-109
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`(App.Div.1966)) (“Where a case shows that it is the duty of the defendant to pay, the law imparts
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`to him a promise to fulfill that obligation.”), and just as one who has fully performed his
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`obligations is entitled under the law of contracts to expect full performance from the other side,
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`Borough of W. Caldwell v. Borough of Caldwell, 26 N.J. 9, 26 (1958) (“Acceptance by
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`performance rather than an executory promise to perform may give rise to a unilateral
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`contract.”), so too should Metrics be required to honor the generic side of the Hatch-Waxman
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`bargain by allowing the dispute to be resolved in federal court. Defendants should not be
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`permitted to undermine the Hatch-Waxman statutory scheme by later challenging the same
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`patents on the same grounds in IPR proceedings.
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`2.
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`The Requested Injunction Is Supported By the Objectives of
`the AIA
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`Permitting Defendants to pursue parallel IPR proceedings under the circumstances of this
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`case is also contrary to the objectives of the America Invents Act. The relevant statutory
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`provision, 35 U.S.C. § 315(a)(1), entitled “Inter partes review barred by civil action,” states that
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`“[a]n inter partes review may not be instituted if, before the date on which the petition for such a
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`review is filed, the petitioner or real party in interest filed a civil action challenging the validity
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`of a claim of the patent.” The reason for the rule is self-evident—a party should not be permitted
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`to provoke two separate proceedings in two separate forums seeking essentially the same relief.
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`Under the Hatch-Waxman Act, a generic challenger initiates district court litigation by
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`challenging the Orange Book-listed patent at issue through a Paragraph IV Certification filed
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`with its ANDA. The Courts have made clear that the filing of a Paragraph IV Certification is the
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`jurisdictional action that provokes a Hatch-Waxman lawsuit. See, e.g., Bristol-Myers Squibb, 69
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`F.3d at 1135 (Fed. Cir. 1995) (citing Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678
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`(1990)).
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`Defendants thus initiated the present case in this Court, prior to Metrics’ submission of its
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`IPR petitions to the PTAB, through Metrics’ Paragraph IV Certifications challenging the same
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`’431 and ’290 patents that Metrics now seeks to challenge on the same grounds in its IPR
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`petitions. (Ex. 10; Ex. 11; Ex. 12.) Metrics’ filing of its ANDA with a Paragraph IV
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`Certification was thus the full, functional equivalent of filing a civil action in district court.
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`Indeed, other portions of the AIA addressing “supplemental examination” treat the filing of a
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`Paragraph IV Certification as the functional equivalent of a civil action. See 35 U.S.C.
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`§ 257(c)(2)(A) (requiring supplemental examination to be filed prior to inequitable conduct
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`being alleged “with particularity in a civil action, or set forth with particularity in a notice . . .
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`under section 505(j)(2)(B)(iv) . . . .”). There is no reason apparent from the AIA or its legislative
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`history, other than mere oversight regarding who actually provokes Hatch-Waxman litigation,
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`not to recognize a Paragraph IV Certification as the equivalent of initiating a civil action for
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`purposes of the IPR prohibition as well. Accordingly, pursuit by Metrics of its later-filed IPR
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`petitions challenging the ’431 and ’290 patents is contrary to the objectives of 35 U.S.C. §
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`315(a). For at least this additional reason, the Court should enjoin Defendants from prosecuting
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`Metrics’ IPR petitions before the PTAB.
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`3.
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`The Requested Injunction Avoids Conflict Between the
`Hatch-Waxman Act and the AIA
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`In addition, and importantly, parallel prosecution of the Metrics IPRs will create
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`apparently unforeseen and unintended conflict between the Hatch-Waxman Act and the AIA.
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`The AIA sought to avoid conflict between IPR proceedings and district court litigation by (1)
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`prohibiting patent challengers that had provoked district court litigation from seeking IPRs, (2)
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`providing in 35 U.S.C. § 315 that the IPR requestor would be estopped from asserting the same
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`defenses in court, and (3) by providing in 35 U.S.C. § 315 that district court litigation could be
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`stayed to await the outcome of the PTO proceeding. Such a stay is not feasible in this case
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`because the Hatch-Waxman Act provides only a 30-month stay of FDA approval to sell the
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`generic copy. Plaintiffs would be severely prejudiced if they were required to sit idly by as two
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`years or more of that stay period were squandered on an unsuccessful bid by Metrics to defeat
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`the patents in the PTO and at the Federal Circuit. Nor does the estoppel solve the problem here,
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`because Plaintiffs must pursue the same issues in this same Court in the pending action against
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`Lupin. All of these problems are solved by the exercise by this Court of its sound discretion to
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`enjoin Metrics from repudiating its initial decision to select the federal district court as the forum
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`to resolve this dispute through its original Paragraph IV Certification.
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`4.
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`An Injunction Is Required to Avoid a Constitutionally
`Questionable Statutory Construction
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`Enjoining Defendants from pursuing Metrics’ IPRs in this case will also avoid a
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`construction of the IPR provisions of the AIA that would raise serious constitutional questions as
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`applied to previously-issued, Orange Book-listed patents. As noted above, the Hatch-Waxman
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`Act was a balanced legislative compromise in which the right to prevent some research uses of
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`patented drugs was taken from pharmaceutical patent owners in exchange for the right to seek
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`injunctive relief in any resultant patent disputes before an Article III judge, in a federal district
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`court, under a statutory presumption of validity, where adverse trial court fact-findings would be
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`reversed if “clearly erroneous,” under the protection of a 30-month stay of generic FDA
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`approval. Orange Book-listed patents issued before the date IPRs under the AIA became
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`effective carried with them that exclusionary property right. Were the government now found to
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`have mandated that this property right can be taken by a non-Article III administrative official,
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`applying no presumption of patent validity, under circumstances where adverse agency fact-
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`finding will be sustained on the basis of a mere “substantial evidence” standard,3 a very
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`substantial question of whether valuable property has been taken without due process of law
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`would arise. See, e.g., Logan v. Zimmerman, 455 U.S. 422 (1982) (holding that an established
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`state procedure which deprives a party from using an adjudicatory procedure without proper
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`procedural safeguards destroys the party’s property right protected by the due process clause).
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`Enjoining the later-filed IPR proceeding in this peculiar circumstance avoids such a
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`constitutionally questionable construction of the statute.
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`B.
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`An Injunction Is Required to Protect This Court’s Power to Resolve
`This Dispute
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`The Metrics IPRs, if allowed to proceed, carry with them a very real threat of destroying
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`the power of this Court to resolve this dispute and should be enjoined for that additional reason.
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`Here, appeals from both the judgment of this Court and the judgment of the PTAB would lie in
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`the Federal Circuit. In Fresenius USA, Inc. v. Baxter International, Inc., 721 F.3d 1330, reh’g
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`denied, 733 F.3d 1369 (Fed. Cir. 2013), a patent infringement action had been tried to judgment
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`in favor of the patentee, had been appealed, and had been affirmed on the merits but for a minor
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`issue requiring resolution on remand. In the interim, a conflicting PTO decision that the same
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`patent claims were not patentable had reached the Federal Circuit and, apparently due in part to
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`the restricted scope of review of PTO fact findings in that Court, had been affirmed.4 The
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`Federal Circuit held that the PTO decision trumped the district court judgment, wiping out the
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`years of effort that the court and the parties had spent trying the case.
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`3 The Federal Circuit affirms PTO fact-finding if supported by “substantial evidence.”
`Dickinson v. Zurko, 527 U.S. 150 (1999)
`4 See supra note 3.
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`Case 1:14-cv-03962-JBS-KMW Document 10-1 Filed 07/10/14 Page 13 of 16 PageID: 71
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`In the instant case, Defendants plainly are attempting to obtain a PTO decision and a final
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`affirmance at the Federal Circuit before a final decision on appeal in this action that Defendants
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`themselves initiated, in an effort to moot any validity determination made by this Court and
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`evade the statutory framework of the Hatch-Waxman Act. Enjoining Defendants from pursuing
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`this improper strategy will protect this Court’s jurisdiction to resolve this dispute, conserve
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`judicial resources, and prevent the possibility of conflicting judgments and competing Federal
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`Circuit appeals.
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`B. Metrics’ IPRs Should Be Enjoined Under the First-Filed Rule
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`Because the first-filed rule is grounded on equitable principles to avoid “vexation of
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`subsequent litigation over the same subject matter” and the “waste of judicial time and energy …
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`in cases involving the same issues and the same parties,” including the possibility of conflicting
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`judgments, its application is particularly appropriate in the instant action. Hazeltine, 122 F.2d at
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`930.
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`The District of New Jersey has utilized a six-factor test to guide the court in deciding
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`whether to apply the first-filed rule and enjoin a party from pursuing a subsequently-filed action
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`that evaluates whether:
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`1.
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`5.
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`6.
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`the court has jurisdiction;
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`the suit in whose favor the injunction is sought was filed first;
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`the issues are the same;
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`the parties are the same;
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`parallel litigation will mean duplicate expenditures of judicial effort and the
`possibility of inconsistent judgments; and
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`the injunction will not aid the movant in an inequitable strategy or work an
`impermissible hardship on one or more of the parties.
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`Case 1:14-cv-03962-JBS-KMW Document 10-1 Filed 07/10/14 Page 14 of 16 PageID: 72
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`See Specialty Ins. Agency, Inc. v. Walter Kaye Associates, Inc., No. 89-1708, 1989 WL 65618, at
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`*5 (D.N.J. June 7, 1989).
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`Defendants cannot dispute that this Court has jurisdiction or that this action was filed
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`before Metrics submitted its IPR petitions. Defendants also cannot dispute that Metrics’ IPR
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`petitions challenge all claims of the ’431 and ’290 patents on the same obviousness grounds as
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`Metrics’ Paragraph IV Certifications and thus involve the same parties and issues as in the
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`instant, first-filed suit. See, e.g., Hazeltine, 122 F.2d at 930. Moreover, allowing both actions to
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`proceed would duplicate judicial effort and create the possibility of inconsistent judgments. For
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`the reasons noted above, the risk of inconsistent judgments here is particularly problematic.
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`While the first-filed rule is not appropriate when the movant seeks an injunction “in order
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`to protect his own forum-shopping, interfere with a more developed proceeding; maintain an
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`inconveniently-located, anticipatory suit; or evade the regular application of prevailing law,”
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`Specialty Ins. Agency, Inc., 1989 WL 65618, at *4, none of these situations is present here. By
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`filing an ANDA with a Paragraph IV Certification, Defendants effectively selected the district
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`court forum for resolution of this dispute and equally effectively initiated district court litigation.
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`Now, Defendants, not Plaintiffs, seek to engage in forum-shopping through Metrics’ IPR
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`submissions before the PTAB. Defendants, not Plaintiffs, seek to interfere with more developed
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`proceedings, as Defendants initiated the instant action long before Metrics submitted its IPR
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`petitions, and the instant action is related to the Lupin litigation which already has proceeded to
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`fact discovery and is approaching contentions and claim construction proceedings. (Ex. 8.)
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`Because the Lupin litigation and the instant litigation involve substantially similar factual and
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`legal issues and are pending before the same Court, these cases likely will be consolidated and
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`Case 1:14-cv-03962-JBS-KMW Document 10-1 Filed 07/10/14 Page 15 of 16 PageID: 73
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`proceed to trial on the same schedule. Application of the first-filed rule would prevent this
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`schedule from being disrupted.
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`In addition, Defendants, not Plaintiffs, seek to evade the regular application of prevailing
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`law. As discussed above, Metrics’ demands for commercial concessions as the price for
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`avoiding disruptive IPR proceedings appear to be calculated to evade the consequences of
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`Metrics’ non-first filer status; i.e., Lupin’s 180 days of exclusivity.
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`Finally, enjoining Defendants from further prosecution of Metrics’ IPRs will not work an
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`impermissible hardship. To the contrary, permitting Defendants to proceed with Metrics’ IPRs
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`after initiating the present action would be significantly inequitable to Plaintiffs and would
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`impose hardship on the parties and the Court, for at least the reasons discussed above, thus
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`favoring application of the first-filed rule.
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`V.
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`CONCLUSION
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`For at least the reasons discussed above, Plaintiffs respectfully request that the Court
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`grant its motion for an injunction enjoining Defendants from continued prosecution of Metrics’
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`IPR Nos. 2014-01041 and 2014-01043 before the PTAB.
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`Dated: July 10, 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.
`15
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`Of Counsel:
`Bryan C. Diner
`Jus