Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 1 of 8
`
`Arthur B. Berger (6490)
`Samuel C. Straight (7638)
`RAY QUINNEY & NEBEKER P.C.
`36 South State Street, Suite 1400
`Salt Lake City, Utah 84111
`Telephone: (801) 532-1500
`aberger@rqn.com
`sstraight.@rqn.com
`
`Attorneys for Plaintiffs
`
`
`IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF UTAH
`CENTRAL DIVISION
`
`
`
`Plaintiffs Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.)
`
`(“Indivior”) and Indivior UK Limited (formerly known as RB Pharmaceuticals Limited)
`
`(“Indivior UK”) (collectively, “Plaintiffs”) file this Complaint against Defendant Actavis
`
`Laboratories UT, Inc. (“Actavis” or “Defendant”) and allege as follows:
`
`NATURE OF THE ACTION
`
`This is an action for patent infringement arising under the Food and Drug Laws
`
`1.
`
`and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively,
`
`arising from Actavis’s submission of an Abbreviated New Drug Application (“ANDA”) to the
`
`Food and Drug Administration (“FDA”) seeking approval to manufacture, use, and sell a generic
`
`
`
`
`INDIVIOR INC. and INDIVIOR UK
`LIMITED,
`
`
`Plaintiffs,
`
`v .
`
`ACTAVIS LABORATORIES UT, INC.,
`
`Defendant.
`
`
`
`
`COMPLAINT
`
`
`
`
`Civil Action No. 2:17-cv-01034-DBP
`
`
`
`
`Arthur B. Berger (6490)
`Samuel C. Straight (7638)
`RAY QUINNEY & NEBEKER P.C.
`36 South State Street, Suite 1400
`Salt Lake City, Utah 84111
`Telephone: (801) 532-1500
`aberger@rqn.com
`sstraight.@rqn.com
`
`Attorneys for Plaintiffs
`
`
`IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF UTAH
`CENTRAL DIVISION
`
`
`
`Plaintiffs Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.)
`
`(“Indivior”) and Indivior UK Limited (formerly known as RB Pharmaceuticals Limited)
`
`(“Indivior UK”) (collectively, “Plaintiffs”) file this Complaint against Defendant Actavis
`
`Laboratories UT, Inc. (“Actavis” or “Defendant”) and allege as follows:
`
`NATURE OF THE ACTION
`
`This is an action for patent infringement arising under the Food and Drug Laws
`
`1.
`
`and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively,
`
`arising from Actavis’s submission of an Abbreviated New Drug Application (“ANDA”) to the
`
`Food and Drug Administration (“FDA”) seeking approval to manufacture, use, and sell a generic
`
`
`
`
`INDIVIOR INC. and INDIVIOR UK
`LIMITED,
`
`
`Plaintiffs,
`
`v .
`
`ACTAVIS LABORATORIES UT, INC.,
`
`Defendant.
`
`
`
`
`COMPLAINT
`
`
`
`
`Civil Action No. 2:17-cv-01034-DBP
`
`
`
`
`Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 2 of 8
`
`version of Plaintiffs’ Suboxone® sublingual film prior to the expiration of United States Patent
`
`No. 9,687,454 (“the ’454 patent” or “the patent-in-suit”).
`
`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.
`
`On information and belief, Actavis is a corporation organized and existing under
`
`the laws of the State of Delaware and has a principal place of business at 577 Chipeta Way, Salt
`
`Lake City, UT 84108.
`
`JURISDICTION AND VENUE
`
`5.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`6.
`
`On information and belief, Actavis is in the business of, inter alia, developing,
`
`manufacturing, obtaining regulatory approval, marketing, selling, and distributing generic copies
`
`of branded pharmaceutical products in Utah and throughout the United States.
`
`7.
`
`This Court has personal jurisdiction over Actavis because of, inter alia, Actavis’s
`
`principal place of business in Utah; Actavis’s continuous and systematic contacts with the State
`
`of Utah; Actavis’s registration to do business in Utah; 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.
`
`
`
`2
`
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`Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 3 of 8
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`8.
`
`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400.
`
`THE PATENT-IN-SUIT
`
`9.
`
`Plaintiff Indivior UK is the lawful owner of the ’454 patent, and Plaintiff Indivior
`
`is an exclusive licensee of the ’454 patent. The ’454 patent, entitled “Sublingual and Buccal Film
`
`Compositions,” was duly and legally issued on June 27, 2017, naming Garry L. Myers, Samuel
`
`D. Hilbert, Bill J. Boone, Beuford Arlie Bogue, Pradeep Sanghvi, and Madhusudan Hariharan as
`
`inventors. A true copy of the ’454 patent is attached hereto as Exhibit A.
`
`SUBOXONE ® SUBLINGUAL FILM
`
`10.
`
`Plaintiff Indivior is the holder of New Drug Application (“NDA”) No. 22-410 for
`
`Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film.
`
`11.
`
`On August 30, 2010, the FDA approved NDA No. 22-410 for the manufacture,
`
`marketing, and sale of Suboxone® sublingual film for the treatment of opioid dependence.
`
`Plaintiff Indivior has sold Suboxone® sublingual film under NDA No. 22-410 since its approval.
`
`12.
`
`The ’454 patent is listed in the FDA’s Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”) as covering Suboxone® sublingual film.
`
`THE DRUG APPROVAL PROCESS
`
`13.
`
`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
`
`
`
`3
`
`
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`Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 4 of 8
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`protection and marketing exclusivity for these drugs expire, consumers would benefit from the
`
`availability of lower priced generic versions of approved drugs.
`
`14.
`
`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
`
`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.
`
`15.
`
`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.
`
`16. 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.
`
`17.
`
`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
`
`
`
`4
`
`
`
`Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 5 of 8
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`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).
`
`18.
`
`If the ANDA includes a Paragraph IV certification, the Hatch-Waxman Act
`
`requires the ANDA applicant to give notice 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
`
`(“Notification Letter”), “not later than 20 days after the date of the postmark on the notice with
`
`which the [FDA] informs the applicant that the application has been filed.” 21 U.S.C. §
`
`355(j)(2)(B).
`
`19.
`
`If the patent owner files an infringement action within 45 days of receiving the
`
`Notification Letter, a 30-month injunction or stay of the FDA approval is triggered, calculated
`
`from the date of receipt of the Notification Letter. See 21 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.
`
`ACTAVIS’S PARAGRAPH IV NOTICE
`
`20.
`
`Plaintiffs received Notification Letters from Actavis dated August 2, 2017 and
`
`August 24, 2017, stating that ANDA Nos. 204383 and 207087 contain Paragraph IV
`
`certifications alleging that the ’454 patent is invalid, unenforceable, and/or will not be infringed
`
`by the manufacture, use, or sale of the generic product proposed in the ANDA.
`
`
`
`5
`
`
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`Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 6 of 8
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`21.
`
`The Notification Letters further state that Actavis submitted ANDA Nos. 204383
`
`and 207087 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial
`
`manufacture, use, and/or sale of Actavis’s generic product before expiration of the patent-in-suit.
`
`On information and belief, ANDA Nos. 204383 and 207087 concern dosages of Defendant’s
`
`generic product and refer to and rely on Plaintiff Indivior’s NDA for Suboxone®
` sublingual film
`
`and purports to contain data showing bioequivalence of Actavis’s generic product with
`
`Suboxone® sublingual film.
`
`22.
`
`Plaintiffs commenced this action within 45 days of receiving the Notification
`
`Letters.
`
`COUNT 1
`Infringement of the ’454 Patent Under 35 U.S.C. § 271(e)(2)
`
`23.
`
`On information and belief, Actavis’s generic product is covered by one or more
`
`claims of the ’454 patent.
`
`24.
`
`By filing ANDA Nos. 204383 and 207087 under 21 U.S.C. § 355(j) for the
`
`purposes of obtaining approval to engage in the commercial manufacture, use, and/or sale of
`
`Actavis’s generic product prior to the expiration of the ’454 patent, Actavis has committed an act
`
`of infringement of the ’454 patent under 35 U.S.C. § 271(e)(2).
`
`25.
`
`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 Nos.
`
`204383 and 207087 to be a date which is not any earlier than the expiration date of the ’454
`
`patent, including any extensions of that date.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court enter:
`
`
`
`6
`
`
`
`Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 7 of 8
`
`A.
`
`A judgment that Actavis has infringed the ’454 patent under 35 U.S.C. §
`
`271(e)(2) by submitting and maintaining ANDA Nos. 204383 and 207087;
`
`B.
`
`A declaratory judgment that Defendant’s commercial manufacture within the
`
`United States of Actavis’s generic product would infringe the ’454 patent under 35 U.S.C. § 271;
`
`C.
`
`Preliminary and permanent injunctions, restraining and enjoining Actavis, 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 patent-in-suit;
`
`D.
`
`An order that the effective date of any approval of ANDA Nos. 204383 and
`
`207087 be a date that is not earlier than the expiration of the patent-in-suit, including any
`
`extensions thereof and any later expiration of exclusivity associated with the ’454 patent;
`
`E.
`
`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;
`
`F.
`
`A judgment granting Plaintiffs compensatory damages in an amount to be
`
`determined at trial including both pre-judgment and post-judgment interest if Actavis
`
`commercially manufactures, uses, offers to sell, or sells in the United States, or imports into the
`
`United States, Actavis’s generic product before the expiration of the patent-in-suit, including any
`
`extensions; and
`
`G.
`
`Any and all other relief as the Court deems just and proper.
`
`
`
`
`
`
`
`7
`
`
`
`Case 2:17-cv-01034-DBP Document 2 Filed 09/14/17 Page 8 of 8
`
`RAY QUINNEY & NEBEKER P.C.
`
`/s/ Arthur B. Berger
`Arthur B. Berger
`Samuel C. Straight
`
`Attorneys for Plaintiffs
`
`Dated: September 14, 2017
`
`Of Counsel:
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`J. Magnus Essunger
`TROUTMAN SANDERS LLP
`875 Third Avenue
`New York, New York 10022
`(212) 704-6000
`daniel.ladow@troutman.com
`james.bollinger@troutman.com
`timothy.heaton@troutman.com
`magnus.essunger@troutman.com
`
`Attorneys for Plaintiffs
`
`
`Jeffrey B. Elikan
`Jeffrey H. Lerner
`Erica N. Andersen
`COVINGTON & BURLING LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, D.C. 20001
`(202) 662-6000
`jelikan@cov.com
`jlerner@cov.com
`eandersen@cov.com
`
`Attorneys for Plaintiffs
`
`
`
`
`8
`
`
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