`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`INDIVIOR INC., INDIVIOR UK LIMITED,
`and MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`
`ACTAVIS LABORATORIES UT, INC.,
`
`Defendant.
`
`C.A. No. _______________
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Indivior Inc. (“Indivior”), Indivior UK Limited (“Indivior UK”), and MonoSol
`
`Rx, LLC (“MonoSol”)
`
`(collectively, “Plaintiffs”)
`
`file this Amended Complaint against
`
`Defendant Actavis Laboratories UT, Inc. (“Actavis” or “Defendant”) and allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the Food and Drug Laws
`
`and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively,
`
`arising from Defendant’s submission of Abbreviated New Drug Application (“ANDA”) No.
`
`204383 to the Food and Drug Administration (“FDA”) seeking approval to manufacture and sell
`
`a generic version of the 4 mg/1 mg (buprenorphine/naloxone) dosage strength of Plaintiff
`
`Indivior’s Suboxone® sublingual film prior to the expiration of United States Patent Nos.
`
`8,475,832 (“the ʼ832 Patent”); 8,017,150 (“the ʼ150 Patent”); and 8,603,514 (“the ’514 Patent”)
`
`(collectively, “the Patents-in-Suit”).
`
`
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`THE PARTIES
`
`2.
`
`Plaintiff Indivior is a Delaware corporation having a principal place of business at
`
`10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
`
`3.
`
`Plaintiff Indivior UK is a United Kingdom corporation having a principal place of
`
`business at 103-105 Bath Road, Slough, UK.
`
`4.
`
`Plaintiff MonoSol is a Delaware limited liability corporation having a principal
`
`place of business at 30 Technology Drive, Warren, New Jersey.
`
`5.
`
`On information and belief, Defendant Actavis is a Delaware corporation having a
`
`principal place of business at 577 Chipeta Way, Salt Lake City, Utah, 84108. Actavis previously
`
`operated under the name Watson Laboratories, Inc. (“Watson”).
`
`JURISDICTION AND VENUE
`
`6.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`7.
`
`On information and belief, Defendant is in the business of, interalia, developing,
`
`manufacturing, obtaining regulatory approval, marketing, selling, and distributing generic copies
`
`of branded pharmaceutical products in Delaware and throughout the United States.
`
`8.
`
`This Court has personal
`
`jurisdiction over Defendant because of, inter alia,
`
`Defendant’s incorporation in Delaware, its continuous and systematic contacts with corporate
`
`entities within this judicial district, its previous submission to the jurisdiction of this judicial
`
`district, and its marketing and sales activities in this judicial district, including, but not limited to,
`
`the substantial, continuous, and systematic distribution, marketing, and/or sales of generic
`
`pharmaceutical products to residents of this judicial district.
`
`9.
`
`Venue is proper in this district under 28 U.S.C. §§ 1391 and 1400.
`
`2
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`
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`Case 1:16-cv-01009-RGA Document 1 Filed 10/31/16 Page 3 of 15 PageID #: 3
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`THE PATENTS-IN-SUIT
`
`10.
`
`Plaintiff Indivior UK is the lawful owner of the ʼ832 Patent, and Plaintiff Indivior
`
`is an exclusive licensee of the ’832 Patent. The ʼ832 Patent, entitled “Sublingual and Buccal
`
`Film Compositions,” duly and legally issued on July 2, 2013, naming Garry L. Myers, Samuel D.
`
`Hillbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, and Madhusudan Hariharan as
`
`inventors. A true copy of the ’832 Patent is attached hereto as Exhibit A.
`
`11.
`
`Plaintiff MonoSol is the lawful owner of the ʼ150 Patent, and Plaintiff Indivior is
`
`an exclusive licensee of the ʼ150 Patent. The ʼ150 Patent, entitled “Polyethylene Oxide-Based
`
`Films and Drug Delivery Systems Made Therefrom,” duly and legally issued on September 13,
`
`2011, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as
`
`inventors. A true copy of the ʼ150 Patent is attached hereto as Exhibit B.
`
`12.
`
`Plaintiff MonoSol is the lawful owner of the ʼ514 Patent, and Plaintiff Indivior is
`
`an exclusive licensee of the ʼ514 Patent. The ʼ514 Patent, entitled “Uniform Films for Rapid
`
`Dissolve Dosage Form Incorporating Taste-Masking Compositions,” duly and legally issued on
`
`December 10, 2013, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M.
`
`Fuisz as inventors. A true copy of the ʼ514 Patent is attached hereto as Exhibit C.
`
`SUBOXONE SUBLINGUAL FILM
`
`13.
`
`Plaintiff Indivior is the holder of New Drug Application (“NDA”) No. 22-410 for
`
`Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film.
`
`14.
`
`On August 30, 2010, the FDA approved NDA No. 22-410 for the manufacture,
`
`marketing, and sale of Suboxone sublingual film for the maintenance treatment of opioid
`
`dependence. Plaintiff Indivior has sold Suboxone sublingual film under NDA No. 22-410 since
`
`its approval.
`
`3
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`15.
`
`On August 30, 2010, Suboxone sublingual film was approved in 2 mg/0.5 mg and
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`8 mg/2 mg dosage strengths (buprenorphine/naloxone base equivalents).
`
`16.
`
`On August 10, 2012, Suboxone sublingual film was approved in 4 mg/1 mg and
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`12 mg/3 mg dosage strengths (buprenorphine/naloxone base equivalents).
`
`17.
`
`The ’832 Patent, the ’150 Patent, and the ’514 Patent (collectively, the “Orange
`
`Book-Listed Patents”) are listed in the FDA’s Approved Drug Products with Therapeutic
`
`EquivalenceEvaluations(the “Orange Book”) as covering Suboxone sublingual film.
`
`THE DRUG APPROVAL PROCESS
`
`18.
`
`In 1984, Congress enacted the Drug Price Competition and Patent Term
`
`Restoration Act, commonly known as the “Hatch-Waxman Act” and codified at 21 U.S.C. § 355.
`
`The Hatch-Waxman Act was intended to balance two important public policy goals. First,
`
`Congress wanted to ensure that innovator drug manufacturers would have meaningful patent
`
`protection and a period of marketing exclusivity to enable them to recoup their investments in
`
`the development of valuable new drugs. Second, Congress sought to ensure that, once the patent
`
`protection and marketing exclusivity for these drugs expire, consumers would benefit from the
`
`availability of lower priced generic versions of approved drugs.
`
`19.
`
`Under 21 U.S.C. § 355(b)(1),
`
`the innovator drug manufacturer and NDA
`
`applicant is required to submit extensive testing and safety information concerning the drug. In
`
`addition, the NDA applicant must submit information on “any patent which claims the drug for
`
`which the applicant submitted the application or which claims a method of using such drug and
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`with respect to which a claim of patent infringement could reasonably be asserted.” Once the
`
`NDA is approved, the FDA lists this patent information in the Orange Book.
`
`4
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`20.
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`In contrast, the Hatch-Waxman Act allows ANDA applicants to obtain FDA
`
`approval for generic versions of previously-approved drugs without having to repeat
`
`the
`
`extensive testing required for a new drug application. Under 21 U.S.C. § 355(j), ANDAs can rely
`
`on FDA’s previous findings of safety and efficacy for an approved drug product, if they
`
`demonstrate, among other things, that the generic drug is bioequivalent to the previously-
`
`approved drug.
`
`21. When a generic manufacturer submits an ANDA, the FDA conducts a preliminary
`
`review of the application to ensure it is sufficiently complete to permit a substantive review. See
`
`21 C.F.R. § 314.101(b)(1). “Receipt of an [ANDA] means that FDA has made a threshold
`
`determination that the abbreviated application is sufficiently complete to permit a substantive
`
`review.” Id.
`
`22.
`
`Under 21 U.S.C. § 355(j)(2)(A)(vii), the ANDA must also include one of the
`
`following four certifications with respect to each of the patents listed in the Orange Book for the
`
`previously-approved drug product: (i) that the patent information has not been filed (“Paragraph
`
`I” certifications); (ii) that the patent has expired (“Paragraph II” certifications); (iii) that the
`
`patent will expire on a specific date, and the generic will stay off the market until that date
`
`(“Paragraph III” certifications); or (iv) that the “patent is invalid or will not be infringed by the
`
`manufacture, use, or sale of the new drug for which the application is submitted” (“Paragraph
`
`IV” certifications).
`
`23.
`
`If the ANDA includes a Paragraph IV certification, the Hatch-Waxman Act
`
`requires the ANDA applicant to give notice (“notice of Paragraph IV certification”) to the patent
`
`owner of the factual and legal basis for the applicant’s opinion that patents listed in the Orange
`
`Book are invalid or will not be infringed, “not later than 20 days after the date of the postmark on
`
`5
`
`
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`the notice with which the [FDA] informs the applicant that the application has been filed.” 21
`
`U.S.C. § 355(j)(2)(B).
`
`24.
`
`The patent owner can file an infringement action within 45 days of receiving the
`
`notice of Paragraph IV certification. Such a filing by the patent owner triggers a 30-month
`
`injunction or stay of the FDA approval, beginning on the date of receipt of the notice. See21
`
`U.S.C. § 355(j)(5)(B)(iii). This 30-month period is intended to allow time for judicial resolution
`
`on the merits of any patent infringement, validity, and/or enforceability claims, before the
`
`competitor is allowed entry into the market.
`
`25.
`
`Federal regulations also govern the timing of the notice of Paragraph IV
`
`certification by directing the generic manufacturer to send such notice “when it receives from
`
`FDA an acknowledgment letter stating that its [ANDA] is sufficiently complete to permit a
`
`substantive review.” 21 C.F.R. § 314.95(b).
`
`LITIGATION BACKGROUND
`
`26. Watson Laboratories, Inc. (“Watson”) filed Abbreviated New Drug Application
`
`(“ANDA”) No. 204383 with FDA seeking approval to market a generic version of the 2 mg/0.5
`
`mg; 4 mg/1 mg; and 8 mg/2 mg dosage strengths of Plaintiffs’ Suboxone sublingual film prior to
`
`the expiration of the ’150, ’832, and ’514 Patents.
`
`27. Watson Laboratories, Inc. is now known as Actavis Laboratories UT, Inc.
`
`28.
`
`Plaintiffs received a notice of Paragraph IV certification from Watson, dated
`
`August 27, 2013, stating that ANDA No. 204383 contains a Paragraph IV certification pursuant
`
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ʼ832 and ʼ150 Patents are invalid,
`
`unenforceable, and/or will not be infringed by the manufacture, use, or sale of the generic
`
`product proposed in the ANDA.
`
`6
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`29.
`
`On October 8, 2013, within 45 days of receiving the August 27, 2013 Notice
`
`Letter, Plaintiffs filed a Complaint against Watson Laboratories, Inc. and Actavis, Inc. for
`
`infringement of the ’832 and ’150 Patents, based on the filing of ANDA No. 204383. SeeC.A.
`
`1:13-cv-01674-RGA, D.I. 1 (D. Del.). The Complaint did not mention any specific strength of
`
`Watson’s proposed generic version of Suboxone sublingual film.
`
`30.
`
`Plaintiffs received a second notice of Paragraph IV certification from Watson,
`
`dated February 4, 2014, stating that ANDA No. 204383 contains a Paragraph IV certification
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ʼ514 Patent is invalid,
`
`unenforceable, and/or will not be infringed by the manufacture, use, or sale of the generic
`
`product proposed in the ANDA.
`
`31.
`
`Plaintiffs filed a First Amended Complaint against Watson on February 18, 2014
`
`for infringement of the ’832, ’150, and ’514 Patents, based on the filing of ANDA No. 204383
`
`and the August 27, 2013 and February 4, 3014 Notice Letters. SeeC.A. 1:13-cv-01674-RGA,
`
`D.I. 43 (D. Del.). The Complaint did not mention any specific strength of Watson’s proposed
`
`generic version of Suboxone sublingual film.
`
`32.
`
`Plaintiffs received a third notice of Paragraph IV certification from Actavis, dated
`
`April 22, 2015, stating that Actavis had filed a new ANDA, ANDA No. 207087, directed to a
`
`generic version of the 12 mg/3 mg strength of Suboxone sublingual film, and stating that Actavis
`
`had filed a new ANDA, ANDA No. 207087, and that ANDA No. 207087 contains a Paragraph
`
`IV certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ʼ832, ʼ150, and
`
`’514 Patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or
`
`sale of the generic product proposed in the ANDA.
`
`7
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`33.
`
`On June 4, 2015, Plaintiffs filed a Second Amended Complaint against Watson
`
`and Actavis for infringement of the ’832, ’150, and ’514 Patents, based on the filing of ANDA
`
`Nos. 204383 and 207087, and the August 27, 2013; February 4, 2014; and April 22, 2015 Notice
`
`Letters. SeeC.A. 1:13-cv-01674-RGA, D.I. 287 (D. Del.). The Complaint did not mention any
`
`specific strength of Watson’s proposed generic version of Suboxone sublingual film.
`
`34.
`
`During fact and expert discovery in C.A. 1:13-cv-01674-RGA (D. Del.), the
`
`parties addressed all strengths of Watson’s proposed generic version of Suboxone sublingual
`
`film, including the 4 mg/1 mg dosage strength.
`
`35. Watson, Actavis, and Plaintiffs went
`
`to trial
`
`in C.A. 1:13-cv-01674-RGA
`
`regarding ANDA Nos. 204383 and 207087 in November and December of 2015. At trial, all
`
`parties addressed all strengths of Watson’s proposed generic version of Suboxone sublingual
`
`film, including the 4 mg /1 mg dosage strength.
`
`36.
`
`At no time did Watson take the position that the 4 mg/1 mg dosage strength was
`
`not properly part of the trial of C.A. 1:13-cv-01674-RGA.
`
`37.
`
`On June 3, 2016, the U.S. District Court for the District of Delaware issued a
`
`Trial Opinion in which it found, among other things, that the asserted claims of the ’514 Patent
`
`are valid and infringed by all strengths of Watson’s proposed generic version of Suboxone
`
`sublingual film. SeeC.A. 1:13-cv-01674-RGA (D. Del.), D.I. 446.
`
`38.
`
`On June 28, 2016, the U.S. District Court for the District of Delaware issued a
`
`judgment providing, interalia:
`
`ORDERED AND ADJUDGED, for the reasons set forth in the Court’s Trial
`Opinion dated June 3, 2016 (D.I. 446 in C.A. No. 13-1674), that Final Judgment
`is hereby entered in favor of Plaintiffs and against Watson, that asserted claims
`62, 64, 65, 69, and 73 of the ’514 patent were not shown to be invalid;
`
`8
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`Case 1:16-cv-01009-RGA Document 1 Filed 10/31/16 Page 9 of 15 PageID #: 9
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`ORDERED AND ADJUDGED, for the reasons set forth in the Court's Trial
`Opinion dated June 3, 2016 (D.I. 446 in C.A. No. 13-1674), that Final Judgment
`is hereby entered in favor of Plaintiffs and against Watson, that Watson’s ANDA
`products that are the subject of ANDA Nos. 204383 and 207087, in 2 mg/0.5 mg,
`4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg dosage strengths, infringe asserted
`claims 62, 64, 65, 69, and 73 of the ’514 patent;
`
`. . . .
`
`ORDERED that, pursuant to 35 U.S.C. § 27I(e)(4)(A), the Food and Drug
`Administration (“FDA”) shall not make the effective date of any final approval of
`Watson’s ANDA Nos. 204383 and 207087 earlier than the date of expiration of
`the ’514 patent[.]
`
`See C.A. 1:13-cv-01674-RGA (D. Del.), D.I. 453. These judgments are not yet final and non-
`
`appealable.
`
`39.
`
`On December 31, 2014, Plaintiffs also filed a declaratory judgment action against
`
`Watson, alleging infringement of U.S. Patent No. 8,900,497 (the “’497 Patent”) based on ANDA
`
`No. 204383. The ’497 Patent relates to processes of making film compositions, and is not listed
`
`in the Orange Book. SeeC.A. No. 1:14-cv-1574-RGA (D. Del.), D.I. 1.
`
`40.
`
`On July 4, 2015, Plaintiffs amended their declaratory judgment complaint to also
`
`reference ANDA No. 207807. SeeC.A. No. 1:14-cv-1574-RGA (D. Del.), D.I. 34.
`
`41.
`
`42.
`
`Trial on the ’497 Patent is set for November 2016.
`
`On September 16, 2016, Plaintiffs received a Notice Letter from Actavis
`
`regarding ANDA No. 204383, and specifically addressing the 4 mg/1 mg dosage strength of
`
`Actavis’ proposed generic version of Suboxone sublingual film. The September 16, 2016 Notice
`
`Letter contains a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV
`
`certification”) alleging that the ’150, ’832, and ’514 Patents are invalid, unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale of the 4 mg/1 mg dosage strength of
`
`Actavis’ proposed version of Suboxone sublingual film.
`
`9
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`43.
`
`The Notification Letter further states that Actavis submitted ANDA No. 204383
`
`to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial manufacture,
`
`use, and/or sale of the 4 mg/1 mg dosage strength of a buprenorphine hydrochloride and
`
`naloxone hydrochloride sublingual film before expiration of the Patents-in-Suit. On information
`
`and belief, ANDA No. 204383 refers to and relies on Plaintiff Indivior’s NDA for Suboxone
`
`sublingual film and purports to contain data showing bioequivalence of Defendant’s generic
`
`product with Suboxone sublingual film.
`
`44.
`
`On October 12, 2016, Plaintiffs received yet another Notice Letter from Actavis
`
`regarding ANDA No. 204383, and specifically addressing the 4 mg/1 mg dosage strength of
`
`Actavis’ proposed generic version of Suboxone sublingual film. This letter was substantially
`
`identical to the September 16, 2016, except it added Indivior UK (the owner of the ’832 Patent),
`
`and corrected some typographical errors.
`
`45.
`
`Plaintiffs commenced this action within 45 days of receiving the September 16,
`
`2016 Notification Letter.
`
`COUNT I
`
`(Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1–46 above as if fully set forth herein.
`
`On information and belief, the 4 mg/1 mg dosage strength of Defendant’s generic
`
`46.
`
`47.
`
`product is covered by one or more claims of the ʼ832 Patent.
`
`48.
`
`By filing and maintaining ANDA No. 204383 under 21 U.S.C. § 355(j), and
`
`attempting to obtain approval
`
`to engage in the commercial manufacture, use, sale and/or
`
`importation of the 4 mg/ 1 mg dosage strength of Defendant’s generic product prior to the
`
`10
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`Case 1:16-cv-01009-RGA Document 1 Filed 10/31/16 Page 11 of 15 PageID #: 11
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`expiration of the ʼ832 Patent, Defendant has committed an act of infringement of the ʼ832 Patent
`
`under 35 U.S.C. § 271(e)(2).
`
`49.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`interalia, an order of this Court that the FDA set the effective date of approval for ANDA No.
`
`204383 to be a date which is not any earlier than the expiration date of the ʼ832 Patent, including
`
`any extensions of that date.
`
`COUNT II
`
`(Infringement of the ʼ150 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1–46 above as if fully set forth herein.
`
`On information and belief, the 4 mg/1 mg of Defendant’s generic product is
`
`50.
`
`51.
`
`covered by one or more claims of the ʼ150 Patent.
`
`52.
`
`By filing ANDA No. 204383 under 21 U.S.C. § 355(j), and attempting to obtain
`
`approval to engage in the commercial manufacture, use, sale and/or importation of the 4 mg/1
`
`mg dosage strength of Defendant’s generic product prior to the expiration of the ʼ150 Patent,
`
`Defendant has committed an act of infringement of the ʼ150 Patent under 35 U.S.C. § 271(e)(2).
`
`53.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
`
`204383 to be a date which is not any earlier than the expiration date of the ʼ150 Patent, including
`
`any extensions of that date.
`
`COUNT III
`
`(Infringement of the ʼ514 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1–46 above as if fully set forth herein.
`
`Defendant’s generic product is covered by one or more claims of the ʼ514 Patent.
`
`54.
`
`55.
`
`11
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`56.
`
`The 4 mg/1 mg dosage strength has already been found to infringe Claims 62, 64,
`
`65, 69, and 73 of the ’514 Patent. SeeC.A. 1:13-cv-01674-RGA (D. Del.), D.I. 453.
`
`57.
`
`By filing ANDA No. 204383 under 21 U.S.C. § 355(j), and attempting to obtain
`
`approval to engage in the commercial manufacture, use, sale and/or importation of the 4 mg/1
`
`mg dosage strength Defendant’s generic product prior to the expiration of the ʼ514 Patent,
`
`Defendant has committed an act of infringement of the ʼ514 Patent under 35 U.S.C. § 271(e)(2).
`
`58.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`interalia, an order of this Court that the FDA set the effective date of approval for ANDA No.
`
`204383 to be a date which is not any earlier than the expiration date of the ʼ514 Patent, including
`
`any extensions of that date. Indeed, the Court has already granted Plaintiffs this relief. SeeC.A.
`
`1:13-cv-01674-RGA (D. Del.), D.I. 453.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court enter:
`
`A.
`
`A judgment that Defendant has infringed each of the Orange Book-Listed Patents
`
`under 35 U.S.C. § 271(e)(2) by submitting and maintaining ANDA No. 204383;
`
`B.
`
`Preliminary and permanent injunctions, restraining and enjoining Defendant, its
`
`officers, agents, attorneys, affiliates, divisions, successors and employees, and those acting in
`
`privity or concert with them,
`
`from engaging in, causing, or
`
`inducing the commercial
`
`manufacture, use, offer to sell, or sale within the United States, or importation into the United
`
`States, of drugs and formulations, or from inducing and/or encouraging the use of methods,
`
`claimed in the Patents-in-Suit;
`
`C.
`
`An order that the effective date of any approval of ANDA No. 204383 be a date
`
`that is not earlier than the expiration of the last to expire of the Patents-in-Suit, including any
`
`extensions thereof and any later expiration of exclusivity associated with those Patents;
`
`12
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`Case 1:16-cv-01009-RGA Document 1 Filed 10/31/16 Page 13 of 15 PageID #: 13
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`D.
`
`A judgment and order finding that this is an exceptional case within the meaning
`
`of 35 U.S.C. § 285 and awarding to Plaintiffs their reasonable attorneys’ fees;
`
`E.
`
`A judgment granting Plaintiffs compensatory damages in an amount
`
`to be
`
`determined at
`
`trial
`
`including both pre-judgment and post-judgment
`
`interest
`
`if Defendant
`
`commercially manufactures, uses, offers to sell, or sells in the United States, or imports into the
`
`United States, Defendant’s generic product before the expiration of each Patent-in-Suit that
`
`Defendant is found to infringe, including any extensions; and
`
`F.
`
`Any and all other relief as the Court deems just and proper.
`
`Dated: October 31, 2016
`
`Respectfully submitted,
`
`_/s/MaryW.Bourke_____________
`Mary W. Bourke (#2356)
`Dana K. Severance (#4869)
`Daniel M. Attaway (#5130)
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`mbourke@wcsr.com
`dseverance@wcsr.com
`dattaway@wcsr.com
`
`AttorneysforPlaintiffs
`
`OF COUNSEL:
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`J. Magnus Essunger
`Sujatha Vathyam
`TROUTMAN SANDERS LLP
`875 Third Avenue
`New York, NY 10022
`(212) 704-6000
`Daniel.ladow@troutmansanders.com
`James.bollinger@troutmansanders.com
`Timothy.heaton@troutmansanders.com
`Magnus.Essunger@troutmansanders.com
`Sujatha.Vathyam@troutmansanders.com
`
`Puja Patel Lea
`TROUTMAN SANDERS LLP
`600 Peachtree Street, NE, Suite 5200
`Atlanta, GA 30308
`
`13
`
`
`
`Case 1:16-cv-01009-RGA Document 1 Filed 10/31/16 Page 14 of 15 PageID #: 14
`
`(404) 885-3000
`Troy.kleckley@troutmansanders.com
`Puja.lea@troutmansanders.com
`
`Charanjit Brahma
`TROUTMAN SANDERS LLP
`580 California Street, Suite 1100
`San Francisco, CA 94101-1032
`(415) 477-5700
`Charanjit.brahma@troutmansanders.com
`
`Jeffrey B. Elikan
`Jeffrey H. Lerner
`Erica N. Andersen
`R. Jason Fowler
`Ashley Kwon
`COVINGTON & BURLING LLP
`One CityCenter
`850 10th St. NW
`Washington, DC 20001
`(202) 662-6000
`jelikan@cov.com
`jlerner@cov.com
`eandersen@cov.com
`jfowler@cov.com
`akwon@cov.com
`
`Kurt G. Calia
`COVINGTON & BURLING LLP
`333 Twin Dolphin Drive, Suite 700
`Redwood Shores, CA 94065
`(650) 632-4700
`kcalia@cov.com
`
`AttorneysforPlaintiffsIndiviorInc.and
`IndiviorUK Limited
`
`James F. Hibey
`Rachel M. Hofstatter
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington DC 20036
`(202) 429-3000
`jhibey@steptoe.com
`rhofstatter@steptoe.com
`
`14
`
`
`
`Case 1:16-cv-01009-RGA Document 1 Filed 10/31/16 Page 15 of 15 PageID #: 15
`
`Cassandra A. Adams
`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas
`New York, NY 10036
`(212) 506-3905
`cadams@steptoe.com
`
`AttorneysforPlaintiffMonoSolRx,LLC
`
`37532285
`
`15
`
`