Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 1 of 9 PageID #: 6452
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
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`
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`CA. No. 1:13-cv-01674-RGA
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`WATSON LABORATORIES, INC. and
`ACTAVIS LABORATORIES UT, INC.,
`
`
`Defendants.
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`SECOND AMENDED COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Reckitt Benckiser Pharmaceuticals Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Amended
`
`Complaint against Defendant Watson Laboratories, Inc. (“Watson”) and Actavis Laboratories
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`UT, Inc. (“Actavis”) (collectively “Defendants”) 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 Defendants’ submission of Abbreviated New Drug Applications (“ANDAs”) to the
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`Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic
`
`version of Plaintiff RBP’s Suboxone® sublingual film prior to the expiration of United States
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`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”).
`
`
`25865006
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`CA. No. 1:13-cv-01674-RGA
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`WATSON LABORATORIES, INC. and
`ACTAVIS LABORATORIES UT, INC.,
`
`
`Defendants.
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`SECOND AMENDED COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Amended
`
`Complaint against Defendant Watson Laboratories, Inc. (“Watson”) and Actavis Laboratories
`
`UT, Inc. (“Actavis”) (collectively “Defendants”) 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 Defendants’ submission of Abbreviated New Drug Applications (“ANDAs”) to the
`
`Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic
`
`version of Plaintiff RBP’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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`
`25865006
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`
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 2 of 9 PageID #: 6453
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`THE PARTIES
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`2.
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`Plaintiff RBP is a Delaware corporation having a principal place of business at
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`10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
`
`3.
`
`Plaintiff RBP UK is a United Kingdom corporation having a principal place of
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`business at 103-105 Bath Road, Slough, UK.
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`4.
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`Plaintiff MonoSol is a Delaware limited liability corporation having a principal
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`place of business at 30 Technology Drive, Warren, New Jersey.
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`5.
`
`On information and belief, Defendant Watson is a Delaware corporation having a
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`principal place of business at 311 Bonnie Circle, Corona, California, 92880.
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`6.
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`On information and belief, Defendant Actavis is a Delaware corporation having a
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`principal place of business at 577 East Chipeta Way, Salt Lake City, Utah, 84108.
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`JURISDICTION AND VENUE
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`7.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202.
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`8.
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`On information and belief, Defendants are in the business of, inter alia,
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`developing, manufacturing, obtaining regulatory approval, marketing, selling, and distributing
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`generic copies of branded pharmaceutical products in Delaware and throughout the United
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`States.
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`9.
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`This Court has personal jurisdiction over Defendants because of, inter alia,
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`Defendants’ incorporation in Delaware, their continuous and systematic contacts with corporate
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`entities within this judicial district, their previous submission to the jurisdiction of this judicial
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`district, and their marketing and sales activities in this judicial district, including, but not limited
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`to, the substantial, continuous, and systematic distribution, marketing, and/or sales of generic
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`pharmaceutical products to residents of this judicial district.
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 3 of 9 PageID #: 6454
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`10.
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`Venue is proper in this district under 28 U.S.C. §§ 1391 and 1400.
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`THE PATENTS-IN-SUIT
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`11.
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`Plaintiff RBP UK is the lawful owner of the ʼ832 patent, and Plaintiff RBP is an
`
`exclusive licensee of the ‘832 patent. The ʼ832 patent, entitled “Sublingual and Buccal Film
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`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
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`inventors. A true copy of the ’832 patent is attached hereto as Exhibit A.
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`12.
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`Plaintiff MonoSol is the lawful owner of the ʼ150 patent, and Plaintiff RBP is an
`
`exclusive licensee of the ʼ150 patent. The ʼ150 patent, entitled “Polyethylene Oxide-Based
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`Films and Drug Delivery Systems Made Therefrom,” duly and legally issued on September 13,
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`2011, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as
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`inventors. A true copy of the ʼ150 patent is attached hereto as Exhibit B.
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`13.
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`Plaintiff MonoSol is the lawful owner of the ʼ514 patent, and Plaintiff RBP is an
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`exclusive licensee of the ʼ514 patent. The ʼ514 patent, entitled “Uniform Films for Rapid
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`Dissolve Dosage Form Incorporating Taste-Masking Compositions,” duly and legally issued on
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`December 10, 2013, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M.
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`Fuisz as inventors. A true copy of the ʼ514 patent is attached hereto as Exhibit C.
`
`SUBOXONE® SUBLINGUAL FILM
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`14.
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`Plaintiff RBP is the holder of New Drug Application (“NDA”) No. 22-410 for
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`Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film.
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`15.
`
`On August 30, 2010, the FDA approved NDA No. 22-410 for the manufacture,
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`marketing, and sale of Suboxone® sublingual film for the maintenance treatment of opioid
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`dependence. Plaintiff RBP has sold Suboxone® sublingual film under NDA No. 22-410 since its
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`3
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`approval.
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 4 of 9 PageID #: 6455
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`16.
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`The patents-in-suit are listed in the FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations (the “Orange Book”) as covering Suboxone® sublingual
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`film.
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`DEFENDANTS’ ANDAS
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`17.
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`Plaintiffs received a letter from Defendant Watson dated August 27, 2013 (the
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`“Notification Letter”), stating that ANDA No. 204383 contains a certification pursuant to 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) alleging that the ʼ832 and ʼ150
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`patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale
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`of the generic product proposed in the ANDA.
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`18.
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`The Notification Letter further states that Defendant Watson submitted ANDA
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`No. 204383 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial
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`manufacture, use, and/or sale of buprenorphine hydrochloride and naloxone hydrochloride
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`sublingual film (“Defendants’ generic product”) before expiration of the patents-in-suit. On
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`information and belief, ANDA No. 204383 refers to and relies on Plaintiff RBP’s NDA for
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`Suboxone® sublingual film and purports to contain data showing bioequivalence of Defendants’
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`generic product with Suboxone® sublingual film.
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`19.
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`Plaintiffs commenced this action within 45 days of receiving the Notification
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`Letter.
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`20.
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`Plaintiffs received another letter from Defendant Watson dated February 4, 2014
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`(“the ‘514 Notification Letter”), stating that ANDA No. 204383 contains a Paragraph IV
`
`certification alleging that the ‘514 patent is invalid, unenforceable, and/or will not be infringed
`
`by the commercial manufacture, use, or sale of the generic product proposed in the ANDA.
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`4
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 5 of 9 PageID #: 6456
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`21.
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`The ‘514 Notification Letter further states that ANDA No. 204383 seeks approval
`
`for Defendant Watson to engage in commercial manufacture, use, or sale of Defendants’ generic
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`product before expiration of the ‘514 patent. On information and belief, ANDA No. 204383
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`refers to and relies on Plaintiff RBP’s NDA for Suboxone® sublingual film and purports to
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`contain data showing bioequivalence of Defendants’ generic product with Suboxone® sublingual
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`film.
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`22.
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`Plaintiffs filed an Amended Complaint within 45 days of receiving the ‘514
`
`Notification Letter.
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`23.
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`Plaintiffs received another letter from Defendant Actavis dated April 22, 2015
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`(the “April 2015 Notification Letter”), stating that ANDA No. 20-7087 contains a certification
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) alleging that the
`
`’514, ’150, and ’832 patents are invalid, unenforceable, and/or will not be infringed by the
`
`manufacture, use, or sale of the generic product proposed in the ANDA.
`
`24.
`
`The April 2015 Notification Letter further states that Defendant Actavis submitted
`
`ANDA No. 20-7087 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in
`
`commercial manufacture, use, and/or sale of a buprenorphine hydrochloride and naloxone
`
`hydrochloride sublingual film Defendants’ generic product before expiration of the patents-in-
`
`suit. On information and belief, ANDA No. 20-7087 refers to and relies on Plaintiff RBP’s NDA
`
`for Suboxone® sublingual film and purports to contain data showing bioequivalence of
`
`Defendants’ generic product with Suboxone® sublingual film.
`
`25.
`
`Plaintiffs filed this Second Amended Complaint within 45 days of receiving the
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`April 2015 Notification Letter.
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`5
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 6 of 9 PageID #: 6457
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`COUNT I
`(Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1-25 above as if fully set forth herein.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`26.
`
`27.
`
`claims of the ʼ832 patent.
`
`28.
`
`By filing and maintaining ANDA Nos. 204383 and 20-7087 under 21 U.S.C. §
`
`355(j) for the purposes of obtaining approval to engage in the commercial manufacture, use, sale
`
`and/or importation of Defendants’ generic product prior to the expiration of the ʼ832 patent,
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`Defendants have committed an act of infringement of the ʼ832 patent under 35 U.S.C. §
`
`271(e)(2).
`
`29.
`
`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 20-7087 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 1-29 above as if fully set forth herein.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`30.
`
`31.
`
`claims of the ʼ150 patent.
`
`32.
`
`By filing ANDA Nos. 204383 and 20-7087 under 21 U.S.C. § 355(j) for the
`
`purposes of obtaining approval to engage in the commercial manufacture, use, sale and/or
`
`importation of Defendants’ generic product prior to the expiration of the ʼ150 patent, Defendants
`
`have committed an act of infringement of the ʼ150 patent under 35 U.S.C. § 271(e)(2).
`
`6
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 7 of 9 PageID #: 6458
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`33.
`
`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 20-7087 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 1-33 above as if fully set forth herein.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`34.
`
`35.
`
`claims of the ʼ514 patent.
`
`36.
`
`By filing and maintaining ANDA Nos. 204383 and 20-7087 under 21 U.S.C. §
`
`355(j) seeks to obtain approval to engage in the commercial manufacture, use, sale and/or
`
`importation of Defendants’ generic product prior to the expiration of the ʼ514 patent, Defendants
`
`have committed an act of infringement of the ʼ514 patent under 35 U.S.C. § 271(e)(2).
`
`37.
`
`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 20-7087 to be a date which is not any earlier than the expiration date of the ʼ514
`
`patent, including any extensions of that date.
`
`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court enter:
`
`A.
`
`A judgment that Defendants have infringed each of the patents-in-suit under 35
`
`U.S.C. § 271(e)(2) by submitting and maintaining ANDA Nos. 204383 and 20-7087;
`
`B.
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`Preliminary and permanent injunctions, restraining and enjoining Defendants,
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`their 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
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`7
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 8 of 9 PageID #: 6459
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`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,
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`claimed in the patents-in-suit;
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`C.
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`An order that the effective date of any approval of ANDA Nos. 204383 and 20-
`
`7087 be a date that is not earlier than the expiration of the last to expire of the patents-in-suit,
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`including any extensions thereof and any later expiration of exclusivity associated with those
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`patents;
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`D.
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`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;
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`E.
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`A judgment granting Plaintiffs compensatory damages in an amount to be
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`determined at trial including both pre-judgment and post-judgment interest if Defendants
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`commercially manufacture, use, offer to sell, or sell in the United States, or import into the
`
`United States, Defendants’ generic product before the expiration of each patent-in-suit that
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`Defendants are found to infringe, including any extensions; and
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`F.
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`Any and all other relief as the Court deems just and proper.
`
`Dated: June 3, 2015
`
`Of Counsel:
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`J. Magnus Essunger
`TROUTMAN SANDERS LLP
`875 Third Avenue
`New York, NY 10022
`(212) 704-6000
`(212) 704-6288 (Fax)
`Daniel.ladow@troutmansanders.com
`James.bollinger@troutmansanders.com
`Timothy.heaton@troutmansanders.com
`
`Respectfully submitted,
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`
`/s/ Mary W. Bourke
`Mary W. Bourke (#2356)
`Dana K. Severance (#4869)
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`(302) 252-4330 (Fax)
`mbourke@wcsr.com
`dseverance@wcsr.com
`
`Attorneys for Plaintiffs
`
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`
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`8
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`Case 1:13-cv-01674-RGA Document 287 Filed 06/04/15 Page 9 of 9 PageID #: 6460
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`
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`Magnus.essunger@troutmansanders.com
`
`
`
`Puja P. Lea
`TROUTMAN SANDERS LLP
`600 Peachtree Street, NE
`Suite 5200
`Atlanta, GA 30308
`(404) 885-3000
`(404) 885-3900 (Fax)
`Puja.lea@troutmansanders.com
`
`Attorneys for Plaintiff Reckitt Benckiser
`Pharmaceuticals, Inc. & RB Pharmaceuticals
`Limited
`
`James F. Hibey
`Timothy C. Bickham
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington DC 20036
`(202) 429-3000
`(202) 429-3902 (Fax)
`jhibey@steptoe.com
`tbickham@steptoe.com
`
`Attorneys for Plaintiff MonoSol Rx, LLC
`
`
`
`9
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