throbber
Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 1 of 16 PageID #: 339
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`
`
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`RECKITT BENCKISER
`PHARMACEUTICALS, INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
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`
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`
`
`C.A. No. 13-2003-RGA
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`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
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`Plaintiffs,
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`Defendant.
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`ANSWER AND COUNTERCLAIMS FOR
`DEFENDANT ALVOGEN PINE BROOK, INC.
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`Defendant Alvogen Pine Brook, Inc. (“Alvogen”), by and through its undersigned
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`attorneys, hereby answers each of the numbered paragraphs of the First Amended Complaint,
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`filed January 24, 2014 by Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc. (“RBP”), RB
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`Pharmaceuticals Limited (“RBP UK”) and MonoSol Rx, LLC (individually “MonoSol”)
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`(collectively “Plaintiffs”). Except as expressly admitted below, Alvogen denies each allegation
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`of Plaintiffs’ First Amended Complaint.
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`NATURE OF THE ACTION
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`1.
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`Alvogen admits that Plaintiffs purport to bring this action under the Food and
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`Drug Laws and the Patent Laws of the United States. Alvogen further admits that Alvogen Pine
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`Brook Inc. submitted ANDA No. 205954 to the Food and Drug Administration (“FDA”)
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`pursuant to 21 U.S.C. § 355(j) to obtain approval to market buprenorphine hydrochloride and
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`naloxone hydrochloride sublingual film (“the Alvogen product”) prior to the expiration of United
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`ALVOGEN PINE BROOK, INC.,
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`

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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 2 of 16 PageID #: 340
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`States Patent Nos. 8,475,832 (“the ʼ832 patent”), 8,017,150 (“the ʼ150 patent”), and 8,603,514
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`(“the ʼ514 patent”) (collectively, “the patents-in-suit”). Alvogen denies the remaining
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`allegations in paragraph 1.
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`THE PARTIES
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`2.
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`Alvogen lacks knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 2 and therefore Alvogen denies same.
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`3.
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`Alvogen lacks knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 3 and therefore Alvogen denies same.
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`4.
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`Alvogen lacks knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 4 and therefore Alvogen denies same.
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`5.
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`6.
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`Alvogen admits the allegations in paragraph 5.
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`Alvogen admits the allegations in paragraph 6.
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`JURISDICTION AND VENUE
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`7.
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`Alvogen does not contest that this Court has subject matter jurisdiction over this
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`action.
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`8.
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`Alvogen does not contest that this Court has personal jurisdiction over Alvogen
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`Pine Brook Inc. for the purposes of this action. Alvogen denies the remaining allegations in
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`paragraph 8.
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`9.
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`Alvogen does not contest venue in this district for purposes of this action.
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`THE PATENTS-IN-SUIT
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`10.
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`Alvogen admits that the ’832 patent states that it issued on July 2, 2013. Alvogen
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`admits that the ’832 patent is entitled “Sublingual and Buccal Film Compositions.” Alvogen
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`admits that Garry L. Myers, Samuel D. Hillbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi,
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`2
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`

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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 3 of 16 PageID #: 341
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`and Madhusudan Hariharan are listed as inventors on the face of the ’832 patent. Alvogen
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`admits that Plaintiff RBP is listed as the assignee on the face of the ’832 patent. Alvogen admits
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`that a purported copy of the ’832 patent is attached to the First Amended Complaint as Exhibit
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`A. Alvogen denies that the ’832 patent was duly and legally issued. Alvogen lacks knowledge
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`or information sufficient to form a belief as to the truth of the remaining allegations of paragraph
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`10 of the First Amended Complaint and therefore denies them.
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`11.
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`Alvogen admits that the ’150 patent states that it issued on September 13, 2011.
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`Alvogen admits that the ’150 patent is entitled “Polyethylene Oxide-Based Films and Drug
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`Delivery Systems Made Therefrom.” Alvogen admits that Robert K. Yang, Richard C. Fuisz,
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`Garry L. Myers, and Joseph M. Fuisz are listed as inventors on the face of the ’150 patent.
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`Alvogen admits that Plaintiff MonoSol is listed as the assignee on the face of the ’150 patent.
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`Alvogen admits that a purported copy of the ’150 patent is attached to the First Amended
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`Complaint as Exhibit B. Alvogen denies that the ’150 patent was duly and legally issued.
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`Alvogen lacks knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations of paragraph 11 of the First Amended Complaint and therefore denies
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`them.
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`12.
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`Alvogen admits that the ’514 patent states that it issued on December 10, 2013.
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`Alvogen admits that the ’514 patent is entitled “Uniform Films for Rapid Dissolve Dosage
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`Forms Incorporating Taste-Masking Compositions.” Alvogen admits that Robert K. Yang,
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`Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz are listed as inventors on the face of the
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`’514 patent. Alvogen admits that Plaintiff MonoSol is listed as the assignee on the face of the
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`’514 patent. Alvogen admits that a purported copy of the ’514 patent is attached to the First
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`Amended Complaint as Exhibit C. Alvogen denies that the ’514 patent was duly and legally
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`3
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 4 of 16 PageID #: 342
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`issued. Alvogen lacks knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations of paragraph 12 of the First Amended Complaint and therefore denies
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`them.
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`SUBOXONE® SUBLINGUAL FILM
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`13.
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`Alvogen admits that the Approved Drug Products with Therapeutic Equivalence
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`Evaluations (the “Orange Book”) entry identifies “Reckitt Benckiser” as the applicant for New
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`Drug Application (“NDA”) No. 22-410 for Suboxone® (buprenorphine hydrochloride and
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`naloxone hydrochloride) sublingual film. Alvogen lacks knowledge or information sufficient
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`to form a belief about the truth of the remaining allegations in paragraph 13 of the First
`
`Amended Complaint and therefore denies them.
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`14.
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`Alvogen admits that the Orange Book identifies August 30, 2010 as the
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`approval date for NDA No. 22-410 directed to the 2 mg/0.5 mg and 8 mg/2 mg dosages of
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`Suboxone sublingual film. Alvogen admits that the labeling for Suboxone® sublingual film
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`currently states that Suboxone® sublingual film is “indicated for maintenance treatment of
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`opioid dependence.” Alvogen lacks knowledge or information sufficient to form a belief as to
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`the truth of the remaining allegations in paragraph 14 of the First Amended Complaint and
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`therefore denies them.
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`15.
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`Alvogen admits that the ’832, ’150, and ʼ514 patents are identified in the Orange
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`Book for Suboxone® sublingual film. Alvogen lacks knowledge or information sufficient to
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`form a belief as to the truth of the remaining allegations in paragraph 15 of the First Amended
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`Complaint and therefore denies them.
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`4
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 5 of 16 PageID #: 343
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`DEFENDANT’S ANDA
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`16.
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`Alvogen admits that Alvogen Pine Brook, Inc. sent letters, dated October 25,
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`2013, and November 21, 2013, to Plaintiffs, and that such letters stated that ANDA No. 205954
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`contains a Paragraph IV certification stating that the ’832 and ’150 patents are invalid,
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`unenforceable, and/or will not be infringed by the manufacture, use, or sale of the generic
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`product proposed in the ANDA. Alvogen lacks knowledge or information sufficient to form a
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`belief as to the truth of the remaining allegations in paragraph 16 of the First Amended
`
`Complaint and therefore denies them.
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`17.
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`Alvogen admits that it submitted ANDA No. 205954 to the FDA under 21
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`U.S.C. § 355(j), seeking approval to engage in commercial manufacture, use, and/or sale of
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`the Alvogen product before expiration of the patents-in-suit. Alvogen admits that ANDA
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`No. 205954 identifies the NDA for Suboxone® sublingual film as the Reference Listed Drug.
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`To the extent that paragraph 17 of the First Amended Complaint contains additional
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`allegations, Alvogen denies them.
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`18. Alvogen lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations in paragraph 18 of the First Amended Complaint and therefore denies
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`them.
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`19. Alvogen admits that Alvogen Pine Brook, Inc. sent a letter, dated December 10,
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`2013, to Plaintiffs, and that such letter stated that ANDA No. 205954 contains a Paragraph IV
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`certification stating that the ʼ514 patent is invalid, unenforceable, and/or will not be infringed
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`by the manufacture, use, or sale of the generic product proposed in the ANDA. Alvogen lacks
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`knowledge or information sufficient to form a belief as to the truth of the remaining allegations
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`in paragraph 19 of the First Amended Complaint and therefore denies them.
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`5
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 6 of 16 PageID #: 344
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`20. Alvogen admits that it submitted ANDA No. 205954 to the FDA under 21
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`U.S.C. § 355(j), seeking approval to engage in commercial manufacture, use, and/or sale of
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`the Alvogen product before expiration of the patents-in-suit. Alvogen admits that ANDA
`
`No. 205954 identifies the NDA for Suboxone® sublingual film as the Reference Listed Drug.
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`To the extent that paragraph 20 of the First Amended Complaint contains additional
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`allegations, Alvogen denies them.
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`21. Alvogen lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations in paragraph 21 of the First Amended Complaint and therefore denies
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`them.
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`22.
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`Alvogen lacks knowledge or information sufficient to form a belief as to the
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`truth of the allegations in paragraph 22 of the First Amended Complaint and therefore denies
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`them.
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`COUNT I
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`(Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(e)(2))
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`23.
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`Alvogen repeats and realleges its answers to paragraphs 1-22 as if fully set forth
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`herein.
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`24.
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`25.
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`Denied.
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`Alvogen admits that it submitted ANDA No. 205954 with a Paragraph IV
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`certification pursuant to 21 U.S.C. § 355(j). Alvogen denies the remaining allegations in
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`paragraph 25 of the First Amended Complaint.
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`26.
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`Denied.
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`6
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 7 of 16 PageID #: 345
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`COUNT II
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`(Infringement of the ʼ150 Patent Under 35 U.S.C. § 271(e)(2))
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`27.
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`Alvogen repeats and realleges its answers to paragraphs 1-26 as if fully set forth
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`herein.
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`28.
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`29.
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`Denied.
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`Alvogen admits that it submitted ANDA No. 205954 with a Paragraph IV
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`certification pursuant to 21 U.S.C. § 355(j). Alvogen denies the remaining allegations in
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`paragraph 29 of the First Amended Complaint.
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`30.
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`Denied.
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`COUNT III
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`(Infringement of the ʼ514 Patent Under 35 U.S.C. § 271(e)(2))
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`31.
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`Alvogen repeats and realleges its answers to paragraphs 1-30 as if fully set forth
`
`herein.
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`32.
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`33.
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`Denied.
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`Alvogen admits that it submitted ANDA No. 205954 with a Paragraph IV
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`certification pursuant to 21 U.S.C. § 355(j). Alvogen denies the remaining allegations in
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`paragraph 33 of the First Amended Complaint.
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`34.
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`Denied.
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`PRAYER FOR RELIEF
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`Defendant denies that Plaintiffs are entitled to any remedy or relief, including those
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`requested in the First Amended Complaint.
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`7
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 8 of 16 PageID #: 346
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`AFFIRMATIVE DEFENSES
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`Without any admission as to the burden of proof, burden of persuasion, or the truth of any
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`allegation in Plaintiffs’ First Amended Complaint, Defendant states the following affirmative
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`defenses:
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`First Affirmative Defense
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`The claims of the ’832, ’150, and ’514 patents are invalid for failure to comply
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`with the statutory provisions of Title 35 of the United States Code, including without limitation,
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`one or more of Sections 101, 102, 103, 111, 112, 116, 135, 256, and 287, and/or the doctrine of
`
`obviousness-type double patenting.
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`Second Affirmative Defense
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`The manufacture, use, sale, offer for sale, or importation of the Alvogen Product that is
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`the subject of ANDA No. 205954 will not infringe, directly or indirectly, any valid and/or
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`enforceable claim of the ’832 ’150, and/or ’514 patents.
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`Third Affirmative Defense
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`The filing of ANDA No. 205954 has not infringed, and will not infringe, directly or
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`indirectly, any valid and/or enforceable claim of the ’832, ’150, and/or ’514 patents.
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`Fourth Affirmative Defense
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`Plaintiffs’ First Amended Complaint fails to state a claim upon which relief may be
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`granted.
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`Fifth Affirmative Defense
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`Defendant’s actions in defending this case do not give rise to an exceptional case under
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`35 U.S.C. § 285.
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`8
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`

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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 9 of 16 PageID #: 347
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`COUNTERCLAIMS
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`For its counterclaims against Plaintiffs/Counterclaim-Defendants Reckitt Benckiser
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`Pharmaceuticals, Inc. (“RBP”), RB Pharmaceuticals Limited (“RBP UK”), and MonoSol Rx,
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`LLC (“MonoSol”) (collectively “Counterclaim-Defendants”), Defendant/Counterclaim-Plaintiff
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`Alvogen Pine Brook, Inc. (“Alvogen”) alleges as follows:
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`THE PARTIES
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`1.
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`Alvogen is a Delaware corporation having a principal place of business at 10
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`Bloomfield Avenue, Building B, Pine Brook, New Jersey.
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`2.
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`On information and belief, as stated in its First Amended Complaint against
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`Alvogen, RBP is a corporation organized and existing under the laws of the State of Delaware,
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`having a principal place of business at 10710 Midlothian Turnpike, Suite 430, Richmond,
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`Virginia.
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`3.
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`On information and belief, as stated in its First Amended Complaint against
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`Alvogen, RBP UK is a corporation organized and existing under the laws of the United
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`Kingdom, having a principal place of business at 103-105 Bath Road, Slough, UK.
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`4.
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`On information and belief, as stated in its First Amended Complaint against
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`Alvogen, MonoSol is a limited liability corporation organized and existing under the laws of the
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`State of Delaware, having a principal place of business at 30 Technology Drive, Warren, New
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`Jersey.
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`JURISDICTION AND VENUE
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`5.
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`These counterclaims arise under the Patent Act, 35 U.S.C. §§ 1 et seq., and the
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`Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202. To the extent that the Court has subject
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`matter jurisdiction over Counterclaim-Defendants’ claims against Alvogen, this Court has
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`9
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 10 of 16 PageID #: 348
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`subject matter jurisdiction over these counterclaims under 28 U.S.C. §§ 2201 and 2202 and 35
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`U.S.C. §§ 1331 and 1338(a).
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`6.
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`This Court has personal jurisdiction over RBP because, among other reasons, it
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`subjected itself to the jurisdiction of this Court by filing its First Amended Complaint against
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`Alvogen.
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`7.
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`This Court has personal jurisdiction over RBP UK because, among other reasons,
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`it subjected itself to the jurisdiction of this Court by filing its First Amended Complaint against
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`Alvogen.
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`8.
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`This Court has personal jurisdiction over MonoSol because, among other
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`reasons, it subjected itself to the jurisdiction of this Court by filing its First Amended Complaint
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`against Alvogen.
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`9.
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`To the extent that venue is appropriate for Counterclaim-Defendants’ claims
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`against Alvogen, venue is also appropriate in this Court for Alvogen’s counterclaims. Venue is
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`also proper in this judicial district under 28 U.S.C. § 1391(b) and (c).
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`10.
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`There is an actual and justiciable controversy between the parties as to the
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`infringement, validity, and enforceability of United States Patent Nos. 8,475,832 (“the ’832
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`patent”), 8,017,150 (“the ’150 patent”), and 8,603,514 (“the ʼ514 patent”).
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`BACKGROUND
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`11.
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`Upon information and belief, as stated in its First Amended Complaint, RBP
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`holds approved New Drug Application (“NDA”) No. 22-410 for Suboxone® (buprenorphine
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`hydrochloride and naloxone hydrochloride) sublingual film.
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`12.
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`NDA holders are required to disclose to the FDA the patent numbers of patents
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`claiming the drug or the method of using such drug for which the NDA is submitted. The FDA
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`10
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 11 of 16 PageID #: 349
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`identifies these patents in the FDA publication entitled Approved Drug Products with
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`Therapeutic Equivalence Evaluations (the “Orange Book”).
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`13.
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`The ’832 patent, entitled “Sublingual and Buccal Film Compositions,” states that
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`it issued on July 2, 2013.
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`14.
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`Upon information and belief, as stated in its First Amended Complaint, RBP
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`UK claims to be the assignee of the ’832 patent.
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`15.
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`The ’150 patent, entitled “Polyethylene Oxide-Based Films and Drug
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`Delivery Systems Made Therefrom,” states that it issued on September 13, 2011.
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`16.
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`Upon information and belief, as stated in its First Amended Complaint,
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`MonoSol claims to be the assignee of the ’150 patent.
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`17.
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`Upon information and belief, as stated in its First Amended Complaint, RBP
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`claims to hold an exclusive license to the ’150 patent.
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`18.
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`The ’514 patent, entitled “Uniform Films for Rapid Dissolve Dosage Forms
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`Incorporating Taste-Masking Compositions,” states that it issued on December 10, 2013.
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`19.
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`Upon information and belief, as stated in its First Amended Complaint,
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`MonoSol claims to be the assignee of the ’514 patent.
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`20.
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`Upon information and belief, as stated in its First Amended Complaint, RBP
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`claims to hold an exclusive license to the ’514 patent.
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`21.
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`Upon information and belief, Counterclaim-Defendants, including MonoSol and
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`RBP, caused the ’832, ’150, and ’514 patents to be listed in the Orange Book as patents that
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`claim the drug and/or claim a method of using such a drug for which RBP submitted NDA No.
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`22-410.
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`11
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 12 of 16 PageID #: 350
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`22.
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`Alvogen submitted its ANDA No. 205954 to obtain FDA approval to engage in
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`the commercial manufacture, use, and sale of the Alvogen Product before the expiration of the
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`’832, ’150, and ’514 patents.
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`23.
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`Alvogen’s ANDA No. 205954 contains a “Paragraph IV” certification under
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`U.S.C. § 505(j)(2)(A)(vii)(IV) that the claims of the ’832, ’150, and ’514 patents are invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of the
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`Alvogen Product.
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`24.
`
`On January 24, 2014, Counterclaim-Defendants filed their First Amended
`
`Complaint against Alvogen alleging infringement of the ’832, ’150, and ’514 patents.
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`COUNT I
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`(Non-Infringement of the ’832 Patent)
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`25.
`
`Alvogen repeats and realleges the allegations in paragraphs 1-24 above as if
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`fully set forth herein.
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`26. The manufacture, use, sale, offer for sale and/or importation of the Alvogen
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`Product will not infringe, directly or indirectly, any valid or enforceable claim of the ’832
`
`patent.
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`27.
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`There is an actual and justiciable controversy between the parties concerning
`
`whether the manufacture, use, offering for sale, or importation of the Alvogen Product will
`
`infringe the ’832 patent.
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`28.
`
`Alvogen is entitled to a judicial declaration that it has not infringed and does
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`not infringe—literally or under the doctrine of equivalents, directly or indirectly, by inducement
`
`or contribution—any valid claim of the ’832 patent.
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`12
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 13 of 16 PageID #: 351
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`COUNT II
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`(Non-Infringement of the ’150 Patent)
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`29.
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`Alvogen repeats and realleges the allegations in paragraphs 1-28 above as if
`
`fully set forth herein.
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`30.
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`The manufacture, use, sale, offer for sale, and/or importation of the Alvogen
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`Product will not infringe, directly or indirectly, any valid or enforceable claim of the ’150
`
`patent.
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`31.
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`There is an actual and justiciable controversy between the parties concerning
`
`whether the manufacture, use, offering for sale, or importation of the Alvogen Product will
`
`infringe the ’150 patent.
`
`32.
`
`Alvogen is entitled to a judicial declaration that it has not infringed and does
`
`not infringe—literally or under the doctrine of equivalents, directly or indirectly, by inducement
`
`or contribution—any valid claim of the ’150 patent.
`
`COUNT III
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`(Non-Infringement of the ’514 Patent)
`
`33.
`
`Alvogen repeats and realleges the allegations in paragraphs 1-32 above as if
`
`fully set forth herein.
`
`34.
`
`The manufacture, use, sale, offer for sale, and/or importation of the Alvogen
`
`Product will not infringe, directly or indirectly, any valid or enforceable claim of the ’514
`
`patent.
`
`35.
`
`There is an actual and justiciable controversy between the parties concerning
`
`whether the manufacture, use, offering for sale, or importation of the Alvogen Product will
`
`infringe the ’514 patent.
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`
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`13
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`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 14 of 16 PageID #: 352
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`36.
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`Alvogen is entitled to a judicial declaration that it has not infringed and does
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`not infringe—literally or under the doctrine of equivalents, directly or indirectly, by inducement
`
`or contribution—any valid claim of the ’514 patent.
`
`COUNT IV
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`(Invalidity of the ’832 Patent)
`
`37.
`
`Alvogen repeats and realleges the allegations in paragraphs 1-36 above as if
`
`fully set forth herein.
`
`38.
`
`On information and belief, the claims of the ’832 patent are invalid for failure to
`
`comply with the statutory prerequisites of Title 35 of the United States Code, including without
`
`limitation, one or more of Sections 101, 102, 103, 111, 112, 116, 132, 135, 256, and 287, and/or
`
`the doctrine of obviousness-type double patenting.
`
`39.
`
`There is an actual and justiciable controversy between the parties concerning
`
`whether the ’832 patent claims are invalid.
`
`40.
`
`Alvogen is entitled to a judicial declaration that the claims of the ’832 patent
`
`are invalid.
`
`COUNT V
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`(Invalidity of the ’150 Patent)
`
`41.
`
`Alvogen repeats and realleges the allegations in paragraphs 1-40 above as if
`
`fully set forth herein.
`
`42.
`
`On information and belief, the claims of the ’150 patent are invalid for failure to
`
`comply with the statutory prerequisites of Title 35 of the United States Code, including without
`
`limitation, one or more of Sections 101, 102, 103, 111, 112, 116, 132, 135, 256, and 287,
`
`and/or the doctrine of obviousness-type double patenting.
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`14
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`

`
`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 15 of 16 PageID #: 353
`
`
`43.
`
`There is an actual and justiciable controversy between the parties concerning
`
`whether the ’150 patent claims are invalid.
`
`44.
`
`Alvogen is entitled to a judicial declaration that the asserted claims of the
`
`’150 patent are invalid.
`
`COUNT VI
`
`(Invalidity of the ’514 Patent)
`
`45.
`
`Alvogen repeats and realleges the allegations in paragraphs 1-44 above as if
`
`fully set forth herein.
`
`46.
`
`On information and belief, the claims of the ’514 patent are invalid for failure to
`
`comply with the statutory prerequisites of Title 35 of the United States Code, including without
`
`limitation, one or more of Sections 101, 102, 103, 111, 112, 116, 132, 135, 256, and 287,
`
`and/or the doctrine of obviousness-type double patenting.
`
`47.
`
`There is an actual and justiciable controversy between the parties concerning
`
`whether the ’514 patent claims are invalid.
`
`48.
`
`Alvogen is entitled to a judicial declaration that the asserted claims of the
`
`’514 patent are invalid.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Alvogen prays that the Court enter judgment in its favor and against
`
`Counterclaim-Defendants as follows:
`
`a.
`
`Dismissing the First Amended Complaint with prejudice and denying each
`
`request for relief made by Plaintiffs;
`
`b.
`
`Declaring that the filing of ANDA No. 205954 has not infringed, does not
`
`infringe, and would not infringe any valid and enforceable claims of the ’832, ’150,
`
`and/or ’514 patents;
`
`
`
`15
`
`
`

`
`Case 1:13-cv-02003-RGA Document 30 Filed 02/04/14 Page 16 of 16 PageID #: 354
`
`
`c.
`
`Declaring that the manufacture, use, sale, offer for sale, and/or importation into
`
`the United States of the Alvogen Product that is the subject of ANDA No. 205954 does not, and
`
`will not, infringe any valid and enforceable claim of the ’832, ’150, and/or ’514 patents;
`
`d.
`
`e.
`
`f.
`
`g.
`
`Declaring that the claims of the ’832, ’150, and ’514 patents are invalid;
`
`Awarding Alvogen its costs and expenses in this action;
`
`Awarding Alvogen its attorneys’ fees pursuant to 35 U.S.C. § 285; and
`
`Awarding other and further relief as this Court deems just and proper.
`
`
`
`
`
`/s/ Jeffrey T. Castellano
`Karen E. Keller (No. 4489)
`Jeffrey T. Castellano (No. 4837)
`SHAW KELLER LLP
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`kkeller@shawkeller.com
`jcastellano@shawkeller.com
`Attorneys for Defendant
`Alvogen Pine Brook, Inc.
`
`
`
`
`
`OF COUNSEL:
`Steven H. Sklar
`Gregory C. Bays
`LEYDIG, VOIT & MAYER, LTD.
`Two Prudential Plaza
`180 N. Stetson Ave., Suite 4900
`Chicago, IL 60601
`(312) 616-5600
`
`Dated: February 4, 2014
`
`
`
`
`16

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