`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No. 13-CV-2003 RGA
`
`))))))))))))
`
`RECKITT BENCKISER
`PHARMACEUTICALS, INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`v.
`
`Plaintiffs,
`
`ALVOGEN PINE BROOK, INC.
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`Defendants.
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`FIRST AMENDED COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc. (“RBP”), RB Pharmaceuticals Limited
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`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Amended
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`Complaint against Defendant Alvogen Pine Brook, Inc. (“Alvogen PB” or “Defendant”)
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`pursuant to Fed. R. Civ. P 15(a)(2) and Defendant’s written consent (see D.I. 18, D.I. 19), and
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`allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the Food and Drug Laws
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`and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively,
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`arising from Defendant Alvogen PB’s submission of an Abbreviated New Drug Application
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`(“ANDA”) to the Food and Drug Administration (“FDA”) seeking approval to manufacture, use,
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`and sell a generic version of Plaintiff RBP’s Suboxone® sublingual film prior to the expiration
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`of United States Patent Nos. 8,475,832 (“the ʼ832 patent”) and 8,017,150 (“the ʼ150 patent”),
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`and 8,603,514 (“the ’514 patent”) (collectively, “the patents-in-suit”).
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`
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 2 of 9 PageID #: 156
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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.
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`3.
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`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.
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`On information and belief, Defendant Alvogen PB is a Delaware corporation
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`having a principal place of business at 10 Bloomfield Avenue, Building B, Pine Brook, New
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`Jersey.
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`6.
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`7.
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`On information and belief, Alvogen PB is a subsidiary of Alvogen Group, Inc.
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`JURISDICTION AND VENUE
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`8.
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`This Court has personal jurisdiction over Alvogen PB because Alvogen PB is
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`incorporated in Delaware, has previously submitted to the jurisdiction of this judicial district, and
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`engages in marketing and sales activities in this judicial district, including, but not limited to, the
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`substantial, continuous, and systematic marketing and/or selling of generic pharmaceutical
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`products to residents of this judicial district.
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`9.
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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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`10.
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`Plaintiff RBP UK is the lawful owner of the ʼ832 patent. The ʼ832 patent, entitled
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`“Sublingual and Buccal Film Compositions,” duly and legally issued on July 2, 2013, naming
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`Garry L. Myers, Samuel D. Hillbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, and
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`2
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`
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 3 of 9 PageID #: 157
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`Madhusudan Hariharan as inventors. A true copy of the ’832 patent is attached hereto as Exhibit
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`A.
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`11.
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`Plaintiff MonoSol is the lawful owner of the ʼ150 patent, and Plaintiff RBP is an
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`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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`12.
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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 Forms 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.
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`SUBOXONE® SUBLINGUAL FILM
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`13.
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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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`14.
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`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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`approval.
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`15.
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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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`3
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 4 of 9 PageID #: 158
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`DEFENDANT’S ANDA
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`16.
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`Plaintiffs received letters from “Alvogen” dated October 25, 2013 and November
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`21, 2013 (the “Notification Letters”), stating that ANDA No. 205954 contains a certification
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`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) alleging that the
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`ʼ832 and ʼ150 patents are invalid, unenforceable, and/or will not be infringed by the commercial
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`manufacture, use, or sale of the generic product proposed in the ANDA.
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`17.
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`The Notification Letters further state that Alvogen PB submitted ANDA No.
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`205954 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial
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`manufacture, use, or sale of buprenorphine and naloxone sublingual film (“Defendant’s generic
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`product”) before expiration of the patents-in-suit. On information and belief, ANDA No. 205954
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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 Defendant’s generic product with Suboxone® sublingual
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`film.
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`18.
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`Plaintiffs commenced this action within 45 days of receiving the Notification
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`Letter dated October 25, 2013.
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`19.
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`Plaintiffs received another letter from “Alvogen” dated December 10, 2013 (the
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`“’514 Notification Letter”), stating that ANDA No. 205954 contains a Paragraph IV certification
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`alleging that the ʼ514 patent is invalid, unenforceable, and/or will not be infringed by the
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`commercial manufacture, use, or sale of the generic product proposed in the ANDA.
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`20.
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`The ʼ514 Notification Letter further states that ANDA No. 205954 seeks approval
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`for Alvogen to engage in commercial manufacture, use, or sale Defendant’s generic product
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`before expiration of the ʼ514 patent. On information and belief, ANDA No. 205954 refers to and
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`4
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 5 of 9 PageID #: 159
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`relies on Plaintiff RBP’s NDA for Suboxone® sublingual film and purports to contain data
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`showing bioequivalence of Defendant’s generic product with Suboxone® sublingual film.
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`21.
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`Plaintiffs have subsequently received additional letters identical to the ‘514
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`Notification Letter.
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`22.
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`Plaintiffs filed this Amended Complaint within 45 days of receiving the ʼ514
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`Notification Letter.
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`COUNT I
`(Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(e)(2))
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`Plaintiffs reallege paragraphs 1-22 above as if fully set forth herein.
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`On information and belief, Defendant’s generic product is covered by one or more
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`23.
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`24.
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`claims of the ʼ832 patent.
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`25.
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`By filing ANDA No. 205954 under 21 U.S.C. § 355(j) for the purposes of
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`obtaining approval to engage in the commercial manufacture, use, or sale of Defendant’s generic
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`product prior to the expiration of the ʼ832 patent, Defendant has committed an act of
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`infringement of the ʼ832 patent under 35 U.S.C. § 271(e)(2).
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`26.
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`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
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`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
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`205954 to be a date which is not any earlier than the expiration date of the ʼ832 patent, including
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`any extensions of that date.
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`COUNT II
`(Infringement of the ʼ150 Patent Under 35 U.S.C. § 271(e)(2))
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`Plaintiffs reallege paragraphs 1-26 above as if fully set forth herein.
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`On information and belief, Defendant’s generic product is covered by one or more
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`27.
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`28.
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`claims of the ʼ150 patent.
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`5
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 6 of 9 PageID #: 160
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`29.
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`By filing ANDA No. 205954 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
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`Defendant’s generic product prior to the expiration of the ʼ150 patent, Defendant has committed
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`an act of infringement of the ʼ150 patent under 35 U.S.C. § 271(e)(2).
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`30.
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`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.
`
`205954 to be a date which is not any earlier than the expiration date of the ʼ150 patent, including
`
`any extensions of that date.
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`COUNT III
`(Infringement of the ʼ514 Patent Under 35 U.S.C. § 271(e)(2))
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`Plaintiffs reallege paragraphs 1-30 above as if fully set forth herein.
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`On information and belief, Defendant’s generic product is covered by one or more
`
`31.
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`32.
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`claims of the ʼ514 patent.
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`33.
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`By filing ANDA No. 205954 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
`
`Defendant’s generic product prior to the expiration of the ʼ514 patent, Defendant has committed
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`an act of infringement of the ʼ514 patent under 35 U.S.C. § 271(e)(2).
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`34.
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`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
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`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
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`20-5954 to be a date which is not any earlier than the expiration date of the ʼ514 patent,
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`including any extensions of that date.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court enter:
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`6
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`
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 7 of 9 PageID #: 161
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`A.
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`A judgment that Defendant has infringed each of the patents-in-suit under 35
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`U.S.C. § 271(e)(2) by submitting and maintaining ANDA No. 205954;
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`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
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`in privity or concert with them, from engaging in, causing, or inducing the commercial
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`manufacture, use, offer to sell, or sale within the United States, or importation into the United
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`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 No. 205954 be a date
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`that is not earlier than the expiration of the last to expire of the patents-in-suit, including any
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`extensions thereof and any later expiration of exclusivity associated with those patents;
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`D.
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`A judgment and order finding that this is an exceptional case within the meaning
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`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 imports into the
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`United States, Defendant’s 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.
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`7
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`
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 8 of 9 PageID #: 162
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`Dated: January 24, 2014
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`Of Counsel:
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`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
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`Respectfully submitted,
`
`/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
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`TROUTMAN SANDERS LLP
`405 Lexington Avenue
`New York, NY 10174
`(212) 704-6000
`(212) 704-6288 (Fax)
`Daniel.ladow@troutmansanders.com
`James.bollinger@troutmansanders.com
`Timothy.heaton@troutmansanders.com
`
`Troy S. Kleckley
`TROUTMAN SANDERS LLP
`600 Peachtree Street, NE
`Suite 5200
`Atlanta, GA 30308
`(404) 885-3000
`(404) 885-3900 (Fax)
`Troy.kleckley@troutmansanders.com
`
`Attorneys for Plaintiff Reckitt Benckiser
`Pharmaceuticals, Inc. & RB Pharmaceuticals
`Limited
`
`James F. Hibey
`Timothy C. Bickham
`Houda Morad
`Stephanie L. Sconewald
`STEP TOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington DC 20036
`(202) 429-3000
`(202) 429-3902 (Fax)
`jhibey@steptoe.com
`tbickham@steptoe.com
`hmorad@steptoe.com
`sschonew@steptoe.com
`
`Attorneys for Plaintiff MonoSol Rx, LLC
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`8
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`Case 1:13-cv-02003-RGA Document 23 Filed 01/24/14 Page 9 of 9 PageID #: 163
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`CERTIFICATE OF SERVICE
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`I hereby certify that on January 24, 2014, I caused the foregoing to be electronically filed
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`with the Clerk of the Court using CM/ECF which will send electronic notification of such filing
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`to all registered participants.
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`Additionally, I hereby certify that true and correct copies of the foregoing were caused to
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`be served on January 24, 2014, upon the following individuals via electronic mail:
`
`Steven H. Sklar
`Gregory C. Bays
`LEYDIG, VOIT & MAYER, LTD.
`Two Prudential Plaza
`180 N. Stetson Avenue, Suite 4900
`Chicago, IL 60601
`(312) 616-5600
`(312) 616-5700 (Fax)
`ssklar@leydig.com
`gbays@leydig.com
`
`Karen E. Keller
`Jeffrey T. Castellano
`David M. Fry
`SHAW KELLER LLP
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`kkeller@shawkeller.com
`jcastellano@shawkeller.com
`dfry@shawkeller.com
`
`Attorneys for Defendants Alvogen Pine Brook,
`Inc.
`
`Attorneys for Defendants Alvogen Pine Brook,
`Inc.
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`
`/s/ Mary W. Bourke
`Mary W. Bourke (#2356)
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`Telephone (302) 252-4320
`mbourke@wcsr.com
`
`31875671
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`9