Case 1:16-cv-01009-RGA Document 8 Filed 11/04/16 Page 1 of 15 PageID #: 190
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`INDIVIOR INC., INDIVIOR UK
`LTD., and MONOSOL RX, LLC,
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`
`Plaintiffs,
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`DEFENDANT’S ANSWER AND AFFIRMATIVE DEFENSES TO
`PLAINTIFFS’ COMPLAINT FOR PATENT INFRINGEMENT
`
`Defendant Actavis Laboratories UT, Inc., by and through its undersigned attorneys,
`
`v.
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`
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`
`
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`ACTAVIS LABORATORIES UT, INC.,
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`
`C.A. No. 16-1009-RGA
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`Defendant.
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`answers the complaint of plaintiffs Indivior Inc., Indivior UK Ltd., and MonoSol Rx, LLC as
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`follows:
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`AS TO THE NATURE OF THE ACTION
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`1.
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`Defendant admits that plaintiffs purport to bring this action under the patent laws
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`of the United States. Defendant further admits that it submitted ANDA No. 204383 to the FDA
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`seeking approval
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`to manufacture and sell a generic version of
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`the 4 mg/1 mg
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`(buprenorphine/naloxone) dosage strength of Suboxone® sublingual film prior to expiration of
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`U.S. Patent No. 8,475,832, U.S. Patent No. 8,017,150, and U.S. Patent No. 8,603,514. Except as
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`expressly admitted, defendant denies the remaining allegations of paragraph 1.
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`AS TO THE PARTIES
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`2.
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`Defendant lacks knowledge or information sufficient to form a belief about the truth
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`of the allegations contained in paragraph 2 and therefore denies them.
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`1
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`3.
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`Defendant lacks knowledge or information sufficient to form a belief about the truth
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`of the allegations contained in paragraph 3 and therefore denies them.
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`4.
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`Defendant lacks knowledge or information sufficient to form a belief about the truth
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`of the allegations contained in paragraph 4 and therefore denies them.
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`5.
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`Defendant admits that Actavis Laboratories UT, Inc., formerly known as Watson
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`Laboratories, Inc. (Delaware), is a Delaware corporation having a place of business at 577 Chipeta
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`Way, Salt Lake City, Utah 84108.
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`AS TO JURISDICTION AND VENUE
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`6.
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`Defendant does not contest that the Court has subject matter jurisdiction over this
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`action.
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`7.
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`Defendant admits that Actavis Laboratories UT, Inc. is a pharmaceutical company
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`engaged in the business of developing and manufacturing generic pharmaceutical products, some
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`of which are ultimately distributed, marketed, and/or sold in Delaware and throughout the United
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`States. Except as expressly admitted, defendant denies any remaining allegations contained in
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`paragraph 7.
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`8.
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`Defendant does not contest personal jurisdiction for purposes of this action only.
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`Except as expressly admitted, defendant denies any remaining allegations contained in paragraph
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`8.
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`9.
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`Defendant does not contest that venue is proper in this District for purposes of this
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`action only.
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`AS TO THE PATENTS-IN-SUIT
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`10.
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`Defendant admits that the face of the ’832 patent states that it issued on July 2,
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`2013, and that it is entitled “Sublingual and Buccal Film Compositions.” Defendant further admits
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`2
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`that the face of the ’832 patent identifies Garry L. Myers, Samuel D. Hilbert, Bill J. Boone, B.
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`Arlie Bogue, Pradeep Sanghvi, and Madhusudan Hariharan as inventors, and also identifies RB
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`Pharmaceuticals Limited as the assignee. Defendant also admits that Exhibit A to the complaint
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`appears to be a copy of the ’832 patent. Defendant lacks knowledge or information sufficient to
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`form a belief as to the truth of the remaining allegations in paragraph 10 and therefore denies them.
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`11.
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`Defendant admits that the face of the ’150 patent states that it issued on September
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`13, 2011, and that it is entitled “Polyethylene Oxide-Based Films and Drug Delivery Systems
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`Made Therefrom.” Defendant further admits that the face of the ’150 patent identifies Robert K.
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`Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as inventors, and also identifies
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`MonoSol Rx, LLC as the assignee. Defendant also admits that Exhibit B to the complaint appears
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`to be a copy of the ’150 patent. Defendant lacks knowledge or information sufficient to form a
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`belief as to the truth of the remaining allegations in paragraph 11 and therefore denies them.
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`12.
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`Defendant admits that the face of the ’514 patent states that it issued on December
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`10, 2013, and that it is entitled “Uniform Films For Rapid Dissolve Dosage Form Incorporating
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`Taste-Masking Compositions.” Defendant further admits that the face of the ’514 patent identifies
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`Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as inventors, and also
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`identifies MonoSol Rx, LLC as the assignee. Defendant also admits that Exhibit C to the complaint
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`appears to be a copy of the ’514 patent. Defendant lacks knowledge or information sufficient to
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`form a belief as to the truth of the remaining allegations in paragraph 12 and therefore denies them.
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`AS TO SUBOXONE® SUBLINGUAL FILM
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`13.
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`Defendant admits that the Approved Drug Products with Therapeutic Equivalence
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`Evaluations (the “Orange Book”) entry for NDA No. 22410 for Suboxone® sublingual film
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`identifies Indivior Inc. as the applicant holder. Except as expressly admitted, defendant lacks
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`3
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`knowledge or information sufficient to form a belief about the truth of any remaining allegations
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`in paragraph 13 and therefore denies them.
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`14.
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`Defendant admits that the Orange Book entry for NDA No. 22410 identifies the
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`FDA approval date as August 30, 2010 for
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`the 2 mg/0.5 mg and 8 mg/2 mg
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`(buprenorphine/naloxone) dosage strengths of the Suboxone® sublingual film. Defendant further
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`admits that Suboxone® sublingual film is indicated for treatment of opioid dependence and should
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`be used as part of a complete treatment plan to include counseling and psychosocial support.
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`Defendant lacks knowledge or information sufficient to form a belief about the truth of any
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`remaining allegations in paragraph 14 and therefore denies them.
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`15.
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`Defendant admits that the Orange Book entry for NDA No. 22410 identifies the
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`FDA approval date as August 30, 2010 for
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`the 2 mg/0.5 mg and 8 mg/2 mg
`
`(buprenorphine/naloxone) dosage strengths of the Suboxone® sublingual film. Except as
`
`expressly admitted, defendant denies any remaining allegations contained in paragraph 15.
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`16.
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`Defendant admits that the Orange Book entry for NDA No. 22410 identifies the
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`FDA approval date as August 10, 2012 for
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`the 4 mg/1 mg and 12 mg/3 mg
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`(buprenorphine/naloxone) dosage strengths of the Suboxone® sublingual film. Except as
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`expressly admitted, defendant denies any remaining allegations contained in paragraph 16.
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`17.
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`Defendant admits that the ’832 patent, the ’150 patent, and the ’514 patent are listed
`
`in the Orange Book entry for NDA No. 22410. Except as otherwise expressly admitted, defendant
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`denies any remaining allegations contained in paragraph 17.
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`AS TO THE DRUG APPROVAL PROCESS
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`18.
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`Defendant answers that paragraph 18 states a legal conclusion to which no response
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`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
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`4
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`the federal statutory framework commonly known as the Hatch-Waxman Act. Except as expressly
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`admitted, defendant denies any remaining allegations contained in paragraph 18.
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`19.
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`Defendant answers that paragraph 19 states a legal conclusion to which no response
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`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
`
`the federal statutory framework commonly known as the Hatch-Waxman Act. Except as expressly
`
`admitted, defendant denies any remaining allegations contained in paragraph 19.
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`20.
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`Defendant answers that paragraph 20 states a legal conclusion to which no response
`
`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
`
`the federal statutory framework commonly known as the Hatch-Waxman Act. Except as expressly
`
`admitted, defendant denies any remaining allegations contained in paragraph 20.
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`21.
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`Defendant answers that paragraph 21 states a legal conclusion to which no response
`
`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
`
`the federal statutory framework commonly known as the Hatch-Waxman Act. Defendant further
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`answers that 21 C.F.R. § 314.101 sets forth certain regulations implementing the Hatch-Waxman
`
`Act. Except as expressly admitted, defendant denies any remaining allegations contained in
`
`paragraph 21.
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`22.
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`Defendant answers that paragraph 22 states a legal conclusion to which no response
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`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
`
`the federal statutory framework commonly known as the Hatch-Waxman Act. Except as expressly
`
`admitted, defendant denies any remaining allegations contained in paragraph 22.
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`23.
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`Defendant answers that paragraph 23 states a legal conclusion to which no response
`
`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
`
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`5
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`the federal statutory framework commonly known as the Hatch-Waxman Act. Except as expressly
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`admitted, defendant denies any remaining allegations contained in paragraph 23.
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`24.
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`Defendant answers that paragraph 24 states a legal conclusion to which no response
`
`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
`
`the federal statutory framework commonly known as the Hatch-Waxman Act. Except as expressly
`
`admitted, defendant denies any remaining allegations contained in paragraph 24.
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`25.
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`Defendant answers that paragraph 25 states a legal conclusion to which no response
`
`is required, but if a response is required defendant admits that 21 U.S.C. § 355 et seq. sets forth
`
`the federal statutory framework commonly known as the Hatch-Waxman Act. Defendant further
`
`answers that 21 C.F.R. § 314.95 sets forth certain regulations implementing the Hatch-Waxman
`
`Act. Except as expressly admitted, defendant denies any remaining allegations contained in
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`paragraph 25.
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`26.
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`27.
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`28.
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`AS TO THE LITIGATION BACKGROUND
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`Admitted.
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`Admitted.
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`Defendant admits that it sent a notice letter to Reckitt Benckiser Pharmaceutical,
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`Inc., RB Pharmaceuticals, Ltd., and MonoSol RX, LLC dated August 27, 2013, stating that it had
`
`submitted ANDA No. 204383 to the FDA to obtain approval to engage in the commercial
`
`manufacture, use or sale of its 2 mg/0.5 mg and 8 mg/2 mg (buprenorphine/naloxone) sublingual
`
`film identifying NDA No. 22410 for Suboxone® sublingual film as the Reference Listed Drug,
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`and that ANDA No. 204383 contains a Paragraph IV certification that the ’832 patent and the ’150
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`patent are invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of
`
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`6
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`the 2 mg/0.5 mg and 8 mg/2 mg dosage strengths of defendant’s proposed generic product. Except
`
`as expressly admitted, defendant denies any remaining allegations contained in paragraph 28.
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`29.
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`Defendant admits
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`that Reckitt Benckiser Pharmaceuticals,
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`Inc., RB
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`Pharmaceuticals Ltd., and MonoSol RX, LLC filed the complaint in C.A. No. 13-cv-01674-RGA
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`(D. Del.) on October 8, 2013, and that the complaint alleges that ANDA No. 204383 infringes the
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`’832 and ’150 patents. Defendant further admits that the complaint does not expressly identify
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`any specific dosage strengths. Except as expressly admitted, defendant denies any remaining
`
`allegations contained in paragraph 29.
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`30.
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`Defendant admits that it sent a notice letter to Reckitt Benckiser Pharmaceutical,
`
`Inc., Reckitt Benckiser (North America) Inc., and MonoSol RX, LLC dated February 4, 2014,
`
`stating that ANDA No. 204383 contains a Paragraph IV certification that the ’514 patent is invalid,
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`unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic products
`
`proposed in the ANDA. Except as expressly admitted, defendant denies any remaining allegations
`
`contained in paragraph 30.
`
`31.
`
`Defendant admits
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`that Reckitt Benckiser Pharmaceuticals,
`
`Inc., RB
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`Pharmaceuticals Ltd., and MonoSol RX, LLC filed the first amended complaint in C.A. No. 13-
`
`cv-01674-RGA (D. Del.) on February 18, 2014, and that the first amended complaint alleges that
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`ANDA No. 204383 infringes the ’832, ’150, and ’514 patents. Defendant further admits that the
`
`first amended complaint does not expressly identify any specific dosage strengths. Except as
`
`expressly admitted, defendant denies any remaining allegations contained in paragraph 31.
`
`32.
`
`Defendant admits that it sent a notice letter to Reckitt Benckiser Pharmaceutical,
`
`Inc., Reckitt Benckiser (North America) Inc., and MonoSol RX, LLC dated April 22, 2015, stating
`
`that it had submitted ANDA No. 207087 to the FDA to obtain approval to engage in the
`
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`7
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`commercial manufacture, use or sale of its 12 mg/3 mg (buprenorphine/naloxone) sublingual film
`
`identifying NDA No. 22410 for Suboxone® sublingual film as the Reference Listed Drug, and
`
`that ANDA No. 207087 contains a Paragraph IV certification that the ’832 patent, the ’150 patent,
`
`and the ’514 patent are invalid, unenforceable, and/or will not be infringed by the manufacture,
`
`use or sale of the 12 mg/3 mg dosage strength of defendant’s proposed generic product. Except
`
`as expressly admitted, defendant denies any remaining allegations contained in paragraph 32.
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`33.
`
`Defendant admits that Reckitt Benckiser Pharmaceuticals Inc., RB Pharmaceuticals
`
`Ltd., and MonoSol RX, LLC filed a second amended complaint for patent infringement in C.A.
`
`No. 13-cv-01674-RGA (D. Del.) on June 4, 2015. Defendant further admits that the second
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`amended complaint purports to relate to defendant’s ANDA Nos. 204383 and 207087, and
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`defendant’s August 27, 2013, February 4, 2014, and April 22, 2015 notice letters. Defendant also
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`admits that the second amended complaint did not expressly identify any specific dosage strengths.
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`Except as expressly admitted, defendant denies any remaining allegations contained in paragraph
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`33.
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`34.
`
`Defendant admits that fact and expert discovery in CA. No. 13-cv-01674-RGA (D.
`
`Del.) included discovery relevant to all dosage strengths of ANDA Nos. 204383 and 207087.
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`Except as expressly admitted, defendant denies any remaining allegations contained in paragraph
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`34.
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`35.
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`Defendant admits that the U.S. District Court for the District of Delaware
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`conducted a bench trial in November and December of 2015 in CA No. 13-cv-1674-RGA, and that
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`testimony at trial addressed all dosage strengths of ANDA Nos. 204838 and 207087. Except as
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`expressly admitted, defendant denies any remaining allegations contained in paragraph 35.
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`36.
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`Admitted.
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`8
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`37.
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`Defendant admits that the U.S. District Court for the District of Delaware issued a
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`trial opinion on June 3, 2016 in C.A. No. 13-cv-1674-RGA. Defendant further answers that the
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`trial opinion speaks for itself and is the best evidence of its contents. Except as expressly admitted,
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`defendant denies any remaining allegations contained in paragraph 37.
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`38.
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`Defendant admits that the U.S. District Court for the District of Delaware issued
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`judgment on June 28, 2016 in C.A. No. 13-cv-1674-RGA. Defendant further admits that the
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`judgment is not final and is the subject of a pending motion pursuant to Rule 59 of the Federal
`
`Rules of Civil Procedure. Defendant further answers that the judgment speaks for itself and is the
`
`best evidence of its contents. Except as expressly admitted, defendant denies any remaining
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`allegations contained in paragraph 38.
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`39.
`
`Defendant admits that Reckitt Benckiser Pharmaceuticals Inc. and MonoSol RX,
`
`LLC filed a complaint for patent infringement against defendant on December 31, 2014 seeking
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`declaratory judgment that manufacture of generic products pursuant to ANDA No. 204383 would
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`infringe U.S. Patent No. 8,900,497, C.A. No. 1:14-cv-1574-RGA (D. Del.). Defendant further
`
`admits that the ’497 patent is not listed in the Orange Book for Suboxone® sublingual film. Except
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`as expressly admitted, defendant denies any allegations contained in paragraph 39.
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`40.
`
`Defendant admits that on June 4, 2015, Reckitt Benckiser Pharmaceuticals Inc. and
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`MonoSol RX, LLC filed an amended complaint for patent infringement in C.A. No. 1:14-cv-1574-
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`RGA (D. Del.) adding reference to defendant’s ANDA No. 207087. Except as expressly admitted,
`
`defendant denies the allegations contained in paragraph 40.
`
`41.
`
`42.
`
`Admitted.
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`Defendant admits that it sent a notice letter to Indivior Inc. and MonoSol RX, LLC
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`dated September 16, 2016, stating that it had submitted ANDA No. 204383 to the FDA to obtain
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`9
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`approval to engage in the commercial manufacture, use or sale of its 4 mg/1 mg
`
`(buprenorphine/naloxone) sublingual film identifying NDA No. 22410 for Suboxone® sublingual
`
`film as the Reference Listed Drug, and that ANDA No. 204383 contains a Paragraph IV
`
`certification that the ’832 patent, the ’150 patent, and the ’514 patent are invalid, unenforceable,
`
`and/or will not be infringed by the manufacture, use or sale of the 4 mg/1 mg dosage strength of
`
`defendant’s proposed generic product. Except as expressly admitted, defendant denies any
`
`remaining allegations contained in paragraph 42.
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`43.
`
`Defendant admits that ANDA No. 204383 identifies NDA No. 22410 for
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`Suboxone® sublingual film as the Reference Listed Drug, and that ANDA No. 204383 contains
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`data demonstrating that the proposed 4 mg/1 mg (buprenorphine/naloxone) dosage strength ANDA
`
`product meets FDA requirements for bioequivalence with respect to Suboxone® sublingual film.
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`Defendant further admits that ANDA No. 204383 seeks FDA approval to engage in the
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`commercial manufacture, use or sale of its generic 4 mg/1 mg (buprenorphine/naloxone)
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`sublingual film prior to expiration of the ’832 patent, the ’150 patent, and the ’514 patent. Except
`
`as expressly admitted, defendant denies any remaining allegations contained in paragraph 43.
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`44.
`
`Defendant admits that it sent a notice letter to Indivior Inc., Indivior UK Ltd., and
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`MonoSol RX, LLC dated October 12, 2016, stating that it had submitted ANDA No. 204383 to
`
`the FDA to obtain approval to engage in the commercial manufacture, use or sale of its 4 mg/1 mg
`
`(buprenorphine/naloxone) sublingual film identifying NDA No. 22410 for Suboxone® sublingual
`
`film as the Reference Listed Drug, and that ANDA No. 204383 contains a Paragraph IV
`
`certification that the ’832 patent, the ’150 patent, and the ’514 patent are invalid, unenforceable,
`
`and/or will not be infringed by the manufacture, use or sale of the 4 mg/1 mg dosage strength of
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`defendant’s proposed generic product. Defendant further admits that the October 12, 2016 letter
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`10
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`corrects certain typographical errors in the September 16, 2016 notice letter. Except as expressly
`
`admitted, defendant denies any remaining allegations contained in paragraph 44.
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`45.
`
`Admitted.
`
`AS TO COUNT I
`(Infringement of the ’832 Patent Under 35 U.S.C. § 271(e)(2))
`
`46.
`
`Defendant repeats and incorporates by reference their answers to paragraphs 1-45
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`as if fully set forth here.
`
`47.
`
`48.
`
`49.
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`Denied.
`
`Denied.
`
`Denied.
`
`COUNT II
`(Infringement of the ’150 Patent Under 35 U.S.C. § 271(e)(2))
`
`50.
`
`Defendant repeats and incorporates by reference its answers to paragraphs 1-49 as
`
`if fully set forth here.
`
`51.
`
`52.
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`53.
`
`Denied.
`
`Denied.
`
`Denied.
`
`COUNT III
`(Infringement of the ’514 Patent Under 35 U.S.C. § 271(e)(2))
`
`54.
`
`Defendant repeats and incorporates by reference its answers to paragraphs 1-53 as
`
`if fully set forth here.
`
`55.
`
`56.
`
`Denied.
`
`Defendant answers that paragraph 56 states a legal conclusion to which no response
`
`is required, but if a response is required defendant responds that there is a pending motion pursuant
`
`to Rule 59 of the Federal Rules of Civil Procedure in C.A. No. 1:13-cv-1674-RGA (D. Del.)
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`11
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`regarding alleged infringement of the ’514 patent and on that basis denies the allegations contained
`
`in paragraph 56.
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`57.
`
`58.
`
`Denied.
`
`Denied.
`
`AS TO THE PRAYER FOR RELIEF
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`The remainder of plaintiffs’ complaint recites a prayer for relief to which no response is
`
`required. To the extent that a response is required, defendant denies that plaintiffs are entitled to
`
`any remedy or relief, including those requested.
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`AFFIRMATIVE DEFENSES
`
`Without any admission as to the burden of proof, burden of persuasion, or the truth of any
`
`allegation in plaintiffs’ complaint, defendant states the following affirmative defenses:
`
`First Affirmative Defense
`
`The claims of the ’832 patent, the ’150 patent, and the ’514 patent are invalid for failure to
`
`comply with the statutory provisions of Title 35 of the United States Code, including without
`
`limitation, one or more of sections 101, 102, 103, 111, 112, 116, 135, 256, and 287, and/or the
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`doctrine of obviousness-type double patenting.
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`12
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`Second Affirmative Defense
`
`The manufacture, use, sale, offer for sale, or importation of the buprenorphine
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`hydrochloride and naloxone hydrochloride sublingual films that are the subject of ANDA
`
`No. 204383 will not infringe, directly or indirectly, any valid and/or enforceable claim of the ’832
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`patent, the ’150 patent, or the ’514 patent.
`
`Third Affirmative Defense
`
`The filing of ANDA No. 204383 has not infringed, and will not infringe, directly or
`
`indirectly, any valid and/or enforceable claim of the ’832 patent, the ’150 patent, or the ’514 patent.
`
`Fourth Affirmative Defense
`
`The manufacture, use, sale, offer for sale, or importation of the buprenorphine
`
`hydrochloride and naloxone hydrochloride sublingual films that are the subject of ANDA No.
`
`207087 will not infringe, directly or indirectly, any valid and/or enforceable claim of the ’832
`
`patent, the ’150 patent, or the ’514 patent.
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`Fifth Affirmative Defense
`
`The filing of ANDA No. 207087 has not infringed, and will not infringe, directly or
`
`indirectly, any valid and/or enforceable claim of the ’832 patent, the ’150 patent, or the ’514 patent.
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`Sixth Affirmative Defense
`
`Plaintiffs’ complaint fails to state a claim upon which relief may be granted.
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`Seventh Affirmative Defense
`
`Defendant’s actions in defending this case do not give rise to an exceptional case under 35
`
`U.S.C. § 285.
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`13
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`Eighth Affirmative Defense
`
`Defendant has not willfully infringed any valid claims of the ’832 patent, the ’150 patent,
`
`or the ’514 patent.
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`Ninth Affirmative Defense
`
`The relief requested in the complaint is barred by the doctrines of estoppel and/or waiver.
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`Tenth Affirmative Defense
`
`Any additional defenses or counterclaims that discovery may reveal.
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`WHEREFORE, Defendant requests that plaintiffs’ complaint be dismissed with prejudice
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`and that defendant be awarded the costs of this action, their attorneys’ fees, and all other relief this
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`Court deems just and proper.
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`Dated: November 4, 2016
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`Respectfully Submitted,
`
` __/s/ John C. Phillips, Jr.___________
`John C. Phillips, Jr. (#110)
`Megan C. Haney (#5016)
`PHILLIPS, GOLDMAN, MCLAUGHLIN &
`HALL, P.A.
`1200 North Broom Street
`Wilmington, DE 19806
`(302) 655-4200 (telephone)
`(302) 655-4210 (facsimile)
`jcp@pgmhlaw.com
`mch@pgmhlaw.com
`
`Attorneys for Defendant
`
`
`
`14
`
`

`

`Case 1:16-cv-01009-RGA Document 8 Filed 11/04/16 Page 15 of 15 PageID #: 204
`
`Of Counsel:
`
`George C. Lombardi
`Michael K. Nutter
`Tyler G. Johannes
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601
`(312) 558-5600 (telephone)
`(312) 558-5700 (facsimile)
`mnutter@winston.com
`
`-and-
`
`Stephen Smerek
`David P. Dalke
`WINSTON & STRAWN LLP
`333 S Grand Ave, Suite 3800
`Los Angeles, CA 90071
`Phone: (213) 615-1700
`pperkowski@winston.com
`ddalke@winston.com
`
`Attorneys for Defendant
`
`
`
`
`
`
`
`
`
`
`15
`
`