Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 1 of 10 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No. ________________
`
`))))))))))))
`
`RECKITT BENCKISER
`PHARMACEUTICALS, INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`v.
`
`Plaintiffs,
`
`ALVOGEN PINE BROOK, INC. and
`ALVOGEN GROUP, INC.
`
`Defendants.
`
`COMPLAINT
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Complaint
`
`against Defendants Alvogen Pine Brook, Inc. (“Alvogen PB”) and Alvogen Group, Inc.
`
`(“Alvogen Group”) (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 Defendant Alvogen PB’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 version of Plaintiff RBP’s Suboxone® sublingual film prior to the expiration
`
`of United States Patent Nos. 8,475,832 (“the ʼ832 patent”) and 8,017,150 (“the ʼ150 patent”)
`
`(collectively, “the patents-in-suit”).
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No. ________________
`
`))))))))))))
`
`RECKITT BENCKISER
`PHARMACEUTICALS, INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`v.
`
`Plaintiffs,
`
`ALVOGEN PINE BROOK, INC. and
`ALVOGEN GROUP, INC.
`
`Defendants.
`
`COMPLAINT
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Complaint
`
`against Defendants Alvogen Pine Brook, Inc. (“Alvogen PB”) and Alvogen Group, Inc.
`
`(“Alvogen Group”) (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 Defendant Alvogen PB’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 version of Plaintiff RBP’s Suboxone® sublingual film prior to the expiration
`
`of United States Patent Nos. 8,475,832 (“the ʼ832 patent”) and 8,017,150 (“the ʼ150 patent”)
`
`(collectively, “the patents-in-suit”).
`
`
`
`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 2 of 10 PageID #: 2
`
`THE PARTIES
`
`2.
`
`Plaintiff RBP is a Delaware corporation having a principal place of business at
`
`10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
`
`3.
`
`Plaintiff RBP 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 Alvogen Group is a Delaware corporation
`
`having a principal place of business at 10 Bloomfield Avenue, Building B, Pine Brook, New
`
`Jersey.
`
`6.
`
`On information and belief, Defendant Alvogen PB is a Delaware corporation
`
`having a principal place of business at 10 Bloomfield Avenue, Building B, Pine Brook, New
`
`Jersey.
`
`7.
`
`8.
`
`On information and belief, Alvogen PB is a subsidiary of Alvogen Group.
`
`JURISDICTION AND VENUE
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`9.
`
`This Court has personal jurisdiction over Alvogen Group because Alvogen Group
`
`is incorporated in Delaware, has previously submitted to the jurisdiction of this judicial district,
`
`and directly and/or indirectly engages in marketing and sales activities in this judicial district,
`
`including, but not limited to, the substantial, continuous, and systematic marketing and/or selling
`
`of generic pharmaceutical products to residents of this judicial district.
`
`10.
`
`This Court has personal jurisdiction over Alvogen PB because Alvogen PB is
`
`incorporated in Delaware, has previously submitted to the jurisdiction of this judicial district, and
`
`2
`
`
`
`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 3 of 10 PageID #: 3
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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
`
`products to residents of this judicial district.
`
`11.
`
`Venue is proper in this district under 28 U.S.C. §§ 1391 and 1400.
`
`THE PATENTS-IN-SUIT
`
`12.
`
`Plaintiff RBP UK is the lawful owner of the ʼ832 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.
`
`13.
`
`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
`
`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.
`
`SUBOXONE® SUBLINGUAL FILM
`
`14.
`
`Plaintiff RBP is the holder of New Drug Application (“NDA”) No. 22-410 for
`
`Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film.
`
`15.
`
`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 RBP has sold Suboxone® sublingual film under NDA No. 22-410 since its
`
`approval.
`
`3
`
`
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`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 4 of 10 PageID #: 4
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`16.
`
`The patents-in-suit are listed in the FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (the “Orange Book”) as covering Suboxone® sublingual
`
`film.
`
`DEFENDANTS’ ANDA
`
`17.
`
`Plaintiffs received letters from “Alvogen” dated October 25, 2013 and November
`
`21, 2013 (the “Notification Letters”), stating that ANDA No. 205954 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 patents are invalid, unenforceable, and/or will not be infringed by the commercial
`
`manufacture, use, or sale of the generic product proposed in the ANDA.
`
`18.
`
`The Notification Letters further state that Alvogen PB submitted ANDA No.
`
`205954 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial
`
`manufacture, use, or sale of buprenorphine and naloxone sublingual film (“Defendants’ generic
`
`product”) before expiration of the patents-in-suit. On information and belief, ANDA No. 205954
`
`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.
`
`19.
`
`Plaintiffs commenced this action within 45 days of receiving the Notification
`
`Letter dated October 25, 2013.
`
`COUNT I
`(Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1-19 above as if fully set forth herein.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`20.
`
`21.
`
`claims of the ʼ832 patent.
`
`4
`
`
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`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 5 of 10 PageID #: 5
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`22.
`
`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, or sale of Defendants’ generic
`
`product prior to the expiration of the ʼ832 patent, Defendants have committed an act of
`
`infringement of the ʼ832 patent under 35 U.S.C. § 271(e)(2).
`
`23.
`
`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 ʼ832 patent, including
`
`any extensions of that date.
`
`COUNT II
`(Declaratory Judgment of Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(a-c))
`
`24.
`
`25.
`
`Plaintiffs reallege paragraphs 1-23 above as if fully set forth herein.
`
`On information and belief, unless enjoined by this Court, Defendants plan and
`
`intend to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or
`
`importation of Defendants’ generic product with its proposed labeling immediately following
`
`approval of ANDA No. 205954.
`
`26.
`
`On information and belief, Defendants’ commercial importation, manufacture,
`
`use, sale, and/or offer for sale of Defendants’ generic product before the expiration of the ʼ832
`
`patent would infringe one or more claims of the ʼ832 patent under 35 U.S.C. § 271(a)-(c).
`
`27.
`
`On information and belief, by seeking approval to distribute Defendants’ generic
`
`product with its proposed labeling, Defendants intend to cause others, specifically, for example,
`
`medical professionals and patients, to perform acts that Defendants know will infringe one or
`
`more claims of the ʼ832 patent.
`
`5
`
`
`
`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 6 of 10 PageID #: 6
`
`28.
`
`On information and belief, unless enjoined by this Court, Defendants plan and
`
`intend to, and will, actively induce infringement of one or more claims of the ʼ832 patent
`
`immediately following approval of ANDA No. 205954.
`
`29.
`
`On information and belief, unless enjoined by this Court, Defendants plan and
`
`intend to, and will, contribute to the infringement of one or more claims of the ʼ832 patent
`
`immediately following approval of ANDA No. 205954.
`
`30.
`
`On information and belief, Defendants know that Defendants’ generic product
`
`and its proposed labeling are especially made or adapted for use in infringing one or more claims
`
`of the ʼ832 patent, and that Defendants’ generic product and its proposed labeling are not
`
`suitable for any substantial noninfringing use.
`
`31.
`
`The acts of infringement by Defendants set forth above will cause Plaintiffs
`
`irreparable harm for which they have no adequate remedy at law, and those acts will continue
`
`unless enjoined by this Court.
`
`COUNT III
`(Infringement of the ʼ150 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1-31 above as if fully set forth herein.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`32.
`
`33.
`
`claims of the ʼ150 patent.
`
`34.
`
`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
`
`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).
`
`35.
`
`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.
`
`6
`
`
`
`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 7 of 10 PageID #: 7
`
`205954 to be a date which is not any earlier than the expiration date of the ʼ150 patent, including
`
`any extensions of that date.
`
`COUNT IV
`(Declaratory Judgment of Infringement of the ʼ150 Patent Under 35 U.S.C. § 271(a))
`
`36.
`
`37.
`
`Plaintiffs reallege paragraphs 1-35 above as if fully set forth herein.
`
`On information and belief, unless enjoined by this Court, Defendants plan and
`
`intend to engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or
`
`importation of Defendants’ generic product with its proposed labeling immediately following
`
`approval of ANDA No. 205954.
`
`38.
`
`On information and belief, Defendants’ commercial importation, manufacture,
`
`use, sale, and/or offer for sale of Defendants’ generic product before the expiration of the ʼ150
`
`patent would infringe one or more claims of the ʼ150 patent under 35 U.S.C. § 271(a).
`
`39.
`
`The acts of infringement by Defendants set forth above will cause Plaintiffs
`
`irreparable harm for which they have no adequate remedy at law, and those acts will continue
`
`unless enjoined by this Court.
`
`PRAYER FOR RELIEF
`
`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 No. 205954;
`
`B.
`
`A declaratory judgment that Defendants’ commercial manufacture, use, offer to
`
`sell, or sale within the United States, or importation into the United States, of Defendants’
`
`generic product would infringe each of the patents-in-suit under 35 U.S.C. § 271(a);
`
`7
`
`
`
`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 8 of 10 PageID #: 8
`
`C.
`
`A declaratory judgment that Defendants’ commercial offer to sell or sale within
`
`the United States of Defendants’ generic product would infringe the ʼ832 patent under 35 U.S.C.
`
`§ 271(b-c);
`
`D.
`
`Preliminary and permanent injunctions, restraining and enjoining Defendants,
`
`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
`
`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;
`
`E.
`
`An order that the effective date of any approval of ANDA No. 205954 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;
`
`F.
`
`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;
`
`G.
`
`A judgment granting Plaintiffs compensatory damages in an amount to be
`
`determined at trial including both pre-judgment and post-judgment interest if Defendants
`
`commercially manufacture, use, offer to sell, or sell in the United States, or imports into the
`
`United States, Defendants’ generic product before the expiration of each patent-in-suit that
`
`Defendants are found to infringe, including any extensions; and
`
`H.
`
`Any and all other relief as the Court deems just and proper.
`
`8
`
`
`
`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 9 of 10 PageID #: 9
`
`Dated: December 6, 2013
`
`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
`
`Of Counsel:
`
`Daniel A. Ladow
`James M. Bollinger
`TROUTMAN SANDERS LLP
`405 Lexington Avenue
`New York, NY 10174
`(212) 704-6000
`(212) 704-5929 (Fax)
`daniel.ladow@troutmansanders.com
`james.bollinger@troutmansanders.com
`
`Troy S. Kleckley
`Puja R. Patel
`TROUTMAN SANDERS LLP
`600 Peachtree Street, NE
`Suite 5200
`Atlanta, GA 30308
`(404) 885-3000
`(404) 885-3900
`troy.kleckley@troutmansanders.com
`puja.patel@troutmansanders.com
`
`9
`
`
`
`Case 1:13-cv-02003-RGA Document 1 Filed 12/06/13 Page 10 of 10 PageID #: 10
`
`Attorneys for Plaintiffs
`Reckitt Benckiser Pharmaceuticals, Inc.
`and RB Pharmaceuticals Limited
`
`Of Counsel:
`
`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
`
`WCSR 31531080v1
`
`10
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