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`Paul H. Kochanski
`
`LERNER, DAVID, LITTENBERG,
`
`KRUMHOLZ & MENTLIK, LLP
`600 South Avenue West
`
`Westfield, NJ 07090
`Tel: 908.654.5000
`
`Fax: 908.654.7866
`
`0fc0unsel.'
`H. Keeto Sabharwal (pro hac vice admission pending)
`Dennies Varughese
`Deborah Sterling (pro hac vice admission pending)
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`1100 New York Ave, N.W., Suite 800
`Washington, DC 20005-3934
`Tel: 202.772.8511
`
`Fax: 202.371.2540
`
`Attorneys for Defendant/Cozmrerclaim Plainrifl
`Amneal Pharmaceuticals, LLC
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Document Filed Electronically
`
`JAZZ PHARMACEUTICALS, INC.,
`
`Plaintiff/Counterclaim Defendant,
`
`V-
`
`AMNEAL PHARMACEUTICALS, LLC,
`
`Defendant/Counterclaim Plaintiff.
`
`Civil Action No. 13-391-ES-SCM
`
`District Judge Esther Salas
`Magistrate Judge Steven C. Mannion
`
`DEFENDANT AMNEAL PHARMACEUTICALS, LLC‘S
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`
`Defendant—Counterclaim Plaintiff Amneal Phannaceuticals, LLC ("Amneal") for its
`
`Answer, Defenses, and Counterclairns to the Complaint of Plaintiff-Counterclairn Defendant
`
`Jazz Pharmaceuticals, Inc. ("Jazz"), alleges as follows:
`
`

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`Nature of the Action
`
`1.
`
`Admitted in part and denied in part. Amneal admits only that the Complaint
`
`purports to be a civil action alleging infringement of United States Patent Nos. 6,472,431 ("the
`
`'43} patent"), 6,780,889 ("the ‘889 patent"), 7,262,219 ("the ’219 patent"), 7,851,506 ("the
`
`‘506 patent"), 7,895,059 ("the ‘O59 patent“), 8,263,650 ("the '650 patent"), and 8,324,275 ("the
`
`'275 patent") (collectively, "patents-in-suit") in response to Amneal's submission of Abbreviated
`
`New Drug Application ("ANDA") No. 203631 with the United States Food and Drug
`
`Administration ("FDA") for approval to market sodium oxybate oral solution 500 mg/mL.
`
`Amneal denies any remaining allegations or legal conclusions in Paragraph 1, and specifically
`
`denies that this action states a proper cause of action for patent infringement and denies that it
`
`has infringed, infringes, or will infringe any Valid claim of the patents—in—suit.
`
`The Parties
`
`2.
`
`3.
`
`On information and belief, admitted.
`
`Admitted.
`
`Jurisdiction and Venue
`
`4.
`
`Paragraph 4 contains conclusions of law to which no response is required.
`
`Amneal states that it will not contest subject—matter jurisdiction for purposes of this action only.
`
`To the extent any further response is required, Amneal denies any remaining allegations or legal
`
`conclusions in Paragraph 4.
`
`5.
`
`For purposes of this action, Amneal consents to this Court's personal jurisdiction.
`
`Amneal denies all other allegations contained in paragraph 5 of the Complaint.
`
`6.
`
`Paragraph 6 contains conclusions of law to which no response is required.
`
`Amneal will not contest venue for purposes of this action only. To the extent any further
`
`

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`response is
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`required, Amneal denies any remaining allegations or
`
`legal conclusions in
`
`Paragraph 6.
`
`The Patents-In-Suit
`
`7.
`
`Admitted in part and denied in part. Amneal admits that the '43} patent states on
`
`face
`
`that
`
`it
`
`is
`
`titled
`
`"Microbiologically
`
`Sound
`
`and
`
`Stable
`
`Solutions
`
`of
`
`Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy", that it issued on October 29,
`
`2002, and it lists Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad and
`
`Dayton Reardan as inventors. Amneal admits that a purported copy of the '43l patent is attached
`
`to the Complaint as Exhibit A. Amneal is Without knowledge or information sufficient to form a
`
`belief as to the remaining allegations of Paragraph 7, and on that basis denies those allegations.
`
`Amneal specifically denies that the '43} patent was duly and legally issued or that its claims are
`
`valid and enforceable.
`
`8.
`
`Admitted in part and denied in part. Amneal admits that the ‘889 patent states on
`
`face
`
`that
`
`it
`
`is
`
`titled
`
`"Microbiologically
`
`Sound
`
`and
`
`Stable
`
`Solutions
`
`of
`
`Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy", that it issued on August 24,
`
`2004, and it lists Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad and
`
`Dayton Reardan as inventors. Amneal admits that a purported copy of the '889 patent is attached
`
`to the Complaint as Exhibit B. Amneal is without knowledge or information sufficient to form a
`
`belief as to the remaining allegations of Paragraph 8, and on that basis denies those allegations.
`
`Amneal specifically denies that the ‘S89 patent was duly and legally issued or that its claims are
`
`Valid and enforceable.
`
`9.
`
`Admitted in part and denied in part. Amneal admits that the ‘219 patent states on
`
`face
`
`that
`
`it
`
`is
`
`titled
`
`"Microbiologically
`
`Sound
`
`and
`
`Stable
`
`Solutions
`
`of
`
`

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`Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy", that it issued on August 28,
`
`2007, and it lists Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad and
`
`Dayton Reardan as inventors. Amneal admits that a purported copy of the '2l9 patent is attached
`
`to the Complaint as Exhibit C. Amneal is without knowledge or information sufficient to form a
`
`belief as to the remaining allegations of Paragraph 9, and on that basis denies those allegations.
`
`Arnneal specifically denies that the '2l9 patent was duly and legally issued or that its claims are
`
`valid and enforceable.
`
`10.
`
`Admitted in part and denied in part. Arnneal admits that the “506 patent states on
`
`face
`
`that
`
`it
`
`is
`
`titled
`
`"Microbiologically
`
`Sound
`
`and
`
`Stable
`
`Solutions
`
`of
`
`Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy", that it issued on December 14,
`
`2010, it lists Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton
`
`Reardan as inventors, and it lists Jazz Pharmaceuticals, Inc. as the assignee. Amneal admits that
`
`a purported copy of the ‘S06 patent is attached to the Complaint as Exhibit D. Amneal is without
`
`‘knowledge or
`
`information sufficient
`
`to form a belief as to the remaining allegations of
`
`Paragraph 10, and on that basis denies those allegations. Amneal specifically denies that the
`
`‘S06 patent was duly and legally issued or that its claims are valid and enforceable.
`
`11.
`
`Admitted in part and denied in part. Amneal admits that the ‘O59 patent states on
`
`its face that it is titled "Sensitive Drug Distribution System and Method", that it issued on
`
`February 22, 2011, it lists Dayton T. Reardan, Patti A. Engle and Bob Gagne as inventors, and it
`
`lists Jazz Pharmaceuticals, Inc. as the assignee. Amneal admits that a purported copy of the
`
`‘O59 patent
`
`is attached to the Complaint as Exhibit E. Amneal
`
`is without knowledge or
`
`information sufficient to form a belief as to the remaining allegations of Paragraph 11, and on
`
`

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`that basis denies those allegations. Amneal specifically denies that the '059 patent was duly and
`
`legally issued or that its claims are valid and enforceable.
`
`12.
`
`Admitted in part and denied in part. Amneal admits that the '650 patent states on
`
`face
`
`that
`
`it
`
`is
`
`titled
`
`"Microbiologically
`
`Sound
`
`and
`
`Stable
`
`Solutions
`
`of
`
`Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy", that it issued on September 11,
`
`2012, it lists Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad and Dayton
`
`T. Reardan as inventors, and it lists Jazz Pharmaceuticals, Inc. as the assignee. Amneal admits
`
`that a purported copy of the ‘65O patent is attached to the Complaint as Exhibit F. Amneal is
`
`without knowledge or information sufficient to form a belief as to the remaining allegations of
`
`Paragraph 12, and on that basis denies those allegations. Amneal specifically denies that the
`
`'650 patent was duly and legally issued or that its claims are valid and enforceable.
`
`13.
`
`Admitted in part and denied in part. Amneal admits that the ‘Z75 patent states on
`
`face
`
`that
`
`it
`
`is
`
`titled
`
`“Microbiologically
`
`Sound
`
`and
`
`Stable
`
`Solutions
`
`of
`
`Gamma—HydroXybuty1'ate Salt for the Treatment of Narcolepsy", that it issued on December 4,
`
`2012,
`
`it
`
`lists Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad and
`
`Dayton T. Reardan as inventors, and it lists Jazz Pharmaceuticals, Inc. as the assignee. Arnneal
`
`admits that a purported copy of the '275 patent is attached to the Complaint as Exhibit G.
`
`Amneal is Without knowledge or information sufficient to form a belief as to the remaining
`
`allegations of Paragraph 13, and on that basis denies those allegations. Ainneal specifically
`
`denies that
`
`the '275 patent was duly and legally issued or that
`
`its claims are Valid and
`
`enforceable.
`
`

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`The XYREM® Drug Product
`
`14.
`
`Admitted in part and denied in part. Amneal admits that Jazz sells sodium oxybate
`
`oral solution under the registered trade name Xyrem®. Amneal
`
`is without knowledge or
`
`information sufficient to form a belief as to the remaining allegations of Paragraph 14, and on
`
`that basis denies those allegations.
`
`15.
`
`Admitted in part and denied in part. Amneal admits only that the '889, '2l9, ‘S06,
`
`‘O59,
`
`'650, and '275 patents are listed in the FDA's Orange Book. Amneal is without knowledge
`
`or information sufficient to form a belief as to the remaining allegations of Paragraph 15, and on
`
`that basis denies those allegations.
`
`Acts Giving Rise to This Suit
`
`16.
`
`Admitted in part and denied in part. Amneal admits that
`
`it filed ANDA
`
`No. 203631 ("Amneal's ANDA") with the FDA under § 505 of the Food, Drug, and Cosmetic
`
`Act ("FDCA") seeking approval to engage in the commercial use, manufacture, sale, offer for
`
`sale or importation of 500 mg/mL sodium oxybate oral solution ("Amneal's ANDA Product").
`
`Amneal denies the remaining allegations of Paragraph 16.
`
`17.
`
`Admitted in part and denied in part. Amneal admits that Amneal's ANDA
`
`contained a Written certification under 21 U.S.C. § 355(j)(2)(A)(Vii)(IV) ("Amneal's Paragraph
`
`IV Certification") that the claims of the '889,'2l9,'506,'059, ‘650, and '275 patents are invalid,
`
`unenforceable, and/or will not be infringed by Arnneal's ANDA Product. Amneal admits that
`
`Amneal's Paragraph IV Certification also stated that the claims of U.S. Patent Nos. 7,668,730
`
`(“the '730 patent"), 7,765,106 ("the '106 patent"), and 7,765,107 ("the ‘107 patent") are invalid,
`
`unenforceable, and/or will not be infringed by Amneal's ANDA Product. Amneal denies the
`
`remaining allegations of Paragraph 17.
`
`

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`18.
`
`Admitted in part and denied in part. Amneal admits that on December 7, 2012 it
`
`sent written notice to Jazz ("Amneal's Notice Letter") that the claims of the '889, the '2l9, the
`
`'506, the ‘O59, the '650, the '73 O, the 'lO6, and the '107 patents are invalid, unenforceable, and/or
`
`will not be infringed by Amneal's ANDA Product. Amneal admits that Amneal's Notice Letter
`
`states that Amneal seeks approval to engage in the commercial manufacture, use, and/or sale of
`
`500 mg/mL sodium oxybate oral solution before the expiration of the '889, the ‘219, the ‘S06, the
`
`‘O59, the '650, the '730, the '106, and the 'lO7 patents. Amneal denies the remaining allegations of
`
`Paragraph 18.
`
`Count I: Alleged Infringement of the ‘431 Patent
`
`19.
`
`Amneal repeats and realleges its responses to Paragraphs 1-18 of the Complaint.
`
`20.
`
`Admitted in part and denied in part. Amneal admits that it included a Paragraph
`
`IV Certification for the ‘889, ‘219, '506, ‘O59, '650, '730, '106, and'107 patents to obtain approval
`
`to engage in the commercial manufacture, use, and/or sale of SOO mg/mL sodium oxybate.
`
`Amneal also admits that based on Jazz's filing of the Complaint, and Amneal's denial thereof,
`
`there is an actual, substantial, and continuing justiciable controversy between Amneal and Jazz
`
`having adverse legal interests of sufficient immediacy and reality to warrant the issuance of a
`
`declaratory judgment regarding whether Amneal has infringed any valid enforceable claim of the
`
`‘431 patent. Amneal denies the remaining allegations of Paragraph 20.
`
`21 .
`
`Denied.
`
`22.
`
`Admitted.
`
`23.
`
`Denied.
`
`24.
`
`Denied.
`
`25.
`
`Denied.
`
`

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`26.
`
`Denied.
`
`27.
`
`Denied.
`
`28.
`
`Denied.
`
`Count II: Alleged Infringement of the ‘S89 Patent
`
`29.
`
`Amneal repeats and realleges its responses to Paragraphs 1~28 of the Complaint.
`
`30.
`
`Denied.
`
`3 1 .
`
`Admitted.
`
`32.
`
`Denied.
`
`3 3.
`
`Denied.
`
`34.
`
`Denied.
`
`35.
`
`Denied.
`
`3 6.
`
`Denied.
`
`37.
`
`Denied.
`
`Count III: Alleged Infringement of the '219 Patent
`
`38.
`
`Arnneal repeats and realleges its responses to Paragraphs 1-37 of the Complaint.
`
`39.
`
`Denied.
`
`40.
`
`Admitted.
`
`41 .
`
`Denied.
`
`42.
`
`Denied.
`
`43.
`
`Denied.
`
`44.
`
`Denied.
`
`45.
`
`Denied.
`
`46.
`
`Denied.
`
`

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`
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`Count IV: Alleged Infringement of the ‘S06 Patent
`
`47.
`
`Amneal repeats and realleges its responses to Paragraphs 1-46 of the Complaint.
`
`48.
`
`Denied.
`
`49.
`
`Admitted.
`
`50.
`
`Denied.
`
`5 1 .
`
`Denied.
`
`52.
`
`Denied.
`
`53.
`
`Denied.
`
`54.
`
`Denied.
`
`55.
`
`Denied.
`
`Count V: Alleged Infringement of the ‘O59 Patent
`
`56.
`
`Amneal repeats and realleges its responses to Paragraphs 1-55 of the Complaint.
`
`57.
`
`Denied.
`
`58.
`
`Admitted.
`
`59.
`
`Denied.
`
`60.
`
`Denied.
`
`61.
`
`Denied.
`
`62.
`
`Denied.
`
`63.
`
`Denied.
`
`64.
`
`Denied.
`
`Count VI: Alleged Infringement of the ‘650 Patent
`
`65.
`
`Arnneal repeats and realleges its responses to Paragraphs 1-64 of the Complaint.
`
`66.
`
`Denied.
`
`

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`67.
`
`Admitted.
`
`68.
`
`Denied.
`
`69.
`
`Denied.
`
`70.
`
`Denied.
`
`71.
`
`Denied.
`
`72.
`
`Denied.
`
`73.
`
`Denied.
`
`Count VII: Alleged Infringement of the ‘Z75 Patent
`
`74.
`
`Arnneal repeats and realleges its responses to Paragraphs 1-73 of the Complaint.
`
`75.
`
`Denied.
`
`76.
`
`Admitted.
`
`77.
`
`Denied.
`
`78.
`
`Denied.
`
`79.
`
`Denied.
`
`80.
`
`Denied.
`
`81 .
`
`Denied.
`
`82.
`
`Denied.
`
`PRAYER FOR RELIEF
`
`Amneal denies that Jazz is entitled to any judgment or relief against Amneal and,
`
`therefore, specifically denies paragraphs (A) through (K) of Jazz's Prayer for Relief.
`
`AMNEAL'S DEFENSES
`
`An allegation of any defense below is not an admission that Arnneal bears the burden of
`
`proof or persuasion on any claim or issue.
`
`

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`First Defense — Noninfringement of the '431 Patent
`
`83.
`
`Amneal‘s proposed product described in ANDA No. 203631 has not infringed,
`
`does not infringe, will not infringe, and will not contribute to or induce infringement of any
`
`valid and/or enforceable claim of the ’431 patent, literally or under the Doctrine of Equivalents.
`
`Second Defense — Invalidity of the '431 Patent
`
`84.
`
`Upon information and belief each claim of the '431 patent is invalid for failure to
`
`comply with the conditions and requirements of the patent laws of the United States, including
`
`without limitations, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Third Defense -~ Noninfringement of the '889 Patent
`
`85.
`
`A1nneal's proposed product described in ANDA No. 203631 has not infringed,
`
`does not infringe, will not infringe, and will not contribute to or induce infringement of any Valid
`
`and/or enforceable claim of the '889 patent, literally or under the Doctrine of Equivalents.
`
`Fourth Defense — Invalidity of the '889 Patent
`
`86.
`
`Upon information and belief, each claim of the '8 89 patent is invalid for failure to
`
`comply with the conditions and requirements of the patent laws of the United States, including
`
`without limitations, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Fifth Defense — Noninfringernent of the '219 Patent
`
`87.
`
`Amneal's proposed product described in ANDA No. 203631 has not infringed,
`
`does not infringe, will not infringe, and will not contribute to or induce infringement of any valid
`
`and/or enforceable claim of the '21 9 patent, literally or under the Doctrine of Equivalents.
`
`

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`Sixth Defense — Invalidity of the '219 Patent
`
`88.
`
`Upon information and belief, each claim of the '219 patent is invalid for failure to
`
`comply with the conditions and requirements of the patent laws of the United States, including
`
`without limitations, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Seventh Defense — Noninfringement of the ‘S06 Patent
`
`89.
`
`Amneal's proposed product described in ANDA No. 203631 has not infringed,
`
`does not infringe, will not infringe, and will not contribute to or induce infringement of any valid
`
`and/or enforceable claim of the ‘506 patent, literally or under the Doctrine of Equivalents.
`
`Eighth Defense — Invalidity of the ‘S06 Patent
`
`90.
`
`Upon information and belief, each claim of the '5 06 patent is invalid for failure to
`
`comply with the conditions and requirements of the patent laws of the United States, including
`
`Without limitations, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Ninth Defense —- Noninfringement of the ‘O59 Patent
`
`91.
`
`Amneal's proposed product described in ANDA No. 203631 has not infringed,
`
`does not infringe, will not infringe, and will not contribute to or induce infringement of any valid
`
`and/or enforceable claim of the ‘O59 patent, literally or under the Doctrine of Equivalents.
`
`Tenth Defense ~« Invalidity of the '059 Patent
`
`92.
`
`Upon information and belief, each claim of the ‘O59 patent is invalid for failure to
`
`comply with the conditions and requirements of the patent laws of the United States, including
`
`without limitations, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`

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`Eleventh Defense — Noninfringement of the '650 Patent
`
`93.
`
`A1nneal‘s proposed product described in ANDA No. 203631 has not infringed,
`
`does not infringe, will not infringe, and will not contribute to or induce infringement of any valid
`
`and/or enforceable claim of the '65 0 patent, literally or under the Doctrine of Equivalents.
`
`Twelfth Defense — Invalidig of the '650 Patent
`
`94.
`
`Upon information and belief, each claim of the ‘650 patent is invalid for failure to
`
`comply with the conditions and requirements of the patent laws of the United States, including
`
`without limitations, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Thirteenth Defense -_Noninfringement of the '275 Patent
`
`95.
`
`Amneal's proposed product described in ANDA No. 203631 has not infringed,
`
`does not infringe, will not infringe, and will not contribute to or induce infringement of any valid
`
`and/or enforceable claim of the ‘275 patent, literally or under the Doctrine of Equivalents.
`
`Fourteenth Defense — Invalidity of the '275 Patent
`
`96.
`
`Upon information and belief, each claim of the ‘275 patent is invalid for failure to
`
`comply with the conditions and requirements of the patent laws of the United States, including
`
`without limitations, 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Fifteenth Defense —- N0 Relief Available
`
`97.
`
`Jazz is barred from obtaining relief pursuant
`
`to one or more provisions of
`
`35 U.S.C. § 1, et seq., including but not limited to §§ 286 and 287.
`
`98.
`
`Jazz has not suffered any damages.
`
`99.
`
`Jazz is not suffering an irreparable injury.
`
`

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`
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`Sixteenth Defense — Failure to State a Claim
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`100.
`
`The Complaint, in whole or in part, fails to state a claim upon which relief can be
`
`granted.
`
`Reservation of Rights
`
`101. Amneal reserves the right to assert such other defenses, including but not limited
`
`to defenses of unenforceability as well as defense(s) raised by another defendant in this action or
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`any other action concerning the patents-in-suit, and damages that may appear as discovery
`
`proceeds in this case.
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`AMNEAL'S COUNTERCLAIMS
`
`Counterclairn Plaintiff Amneal Pharmaceuticals, LLC ("Amneal"), for its counterclaims
`
`against Counterclaim Defendant Jazz Pharmaceuticals, Inc., ("Jazz"), allege as follows:
`
`The Parties
`
`1.
`
`Amneal is a limited liability company organized under the laws of Delaware having
`
`its principal place of business at 440 U.S. Highway 22 West, Suite 104, Bridgewater, New Jersey,
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`08807.
`
`2.
`
`On information and belief, Counterclaim Defendant Jazz is a corporation organized
`
`and existing under the laws of the state of Delaware, having a principal place of business at 3180
`
`Porter Drive, Palo Alto, California 94304.
`
`Jurisdiction and Venue
`
`3.
`
`These counterclaims arise under the Declaratory Judgment Act, 28 U.S.C.
`
`§§ 2201 and 2202, under the United States Patent Laws, 35 U.S.C. § 1 er seq., and under
`
`21 U.S.C.
`
`§355(i)(5)(C)-
`
`

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`4.
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`This Court has subject~1natter jurisdiction based on 28 U.S.C. §§ 1331 and
`
`1338(a), 2201, and 2202, and 21 U.S.C. § 355(j)(5)(C).
`
`5.
`
`Jazz has submitted to personal jurisdiction in this Court by suing Amneal, and
`
`previously Roxane Laboratories inc. over the same patents, in this District. On information and
`
`belief, Jazz sells products here, including the Xyrem® product at issue in this case, and Jazz
`
`regularly conducts business in this District.
`
`6.
`
`This Court is the proper venue under 28 U.S.C. §§ 1391, l400(b), and 21 U.S.C.
`
`§ 355(i)(5)(C)(i)(H)-
`
`7.
`
`This is an action for declaratory relief seeking a declaration of noninfringement
`
`and invalidity of U.S. Patent Nos. 6,472,431 (“the '431 patent“), 6,780,889 (“the ‘889 patent"),
`
`7,262,219 ("the '219 patent”), 7,851,506 (“the '506 patent"), 7,895,059 ("the '059 patent“),
`
`8,263,650 ("the '650 patent"), 8,324,275 ("the ‘275 patent"), 7,668,730 ("the ‘730 patent"),
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`7,765,106 ("the 'l06 patent"), and 7,765,107 ("the ‘I07 patent") (collectively, "the counterclaim
`
`patents").
`
`Background
`
`8.
`
`The face of the '43l patent, titled "Microbiologically Sound and Stable Solutions
`
`of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," indicates that it issued on
`
`October 29, 2002.
`
`9.
`
`On information and belief, Jazz purports to be the owner of the '43l patent.
`
`10.
`
`The face of the ‘889 patent, titled "Microbiologically Sound and Stable Solutions
`
`of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," indicates that it issued on
`
`August 24, 2004.
`
`11.
`
`On information and belief, Jazz purports to be the owner of the ‘889 patent.
`
`

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`
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`12.
`
`The face of the ‘2l9 patent, titled “Microbiologically Sound and Stable Solutions
`
`of Garnrna-Hydroxybutyrate Salt for the Treatment of Narcolepsy," indicates that it issued on
`
`August 28, 2007.
`
`13.
`
`On information and belief, Jazz purports to be the owner of the '21 9 patent.
`
`14.
`
`The face of the ‘S06 patent, titled “Microbiologically Sound and Stable Solutions
`
`of Gamma—HydroXybutyrate Salt for the Treatment of Narcolepsy," indicates that it issued on
`
`December 14, 2010.
`
`15.
`
`On information and belief, Jazz purports to be the owner of the ‘506 patent.
`
`16.
`
`The face of the ‘059 patent,
`
`titled "Sensitive Drug Distribution System and
`
`Method," indicates that it issued on February 22, 2011.
`
`17.
`
`On information and belief, Jazz purports to be the owner of the ‘059 patent.
`
`18.
`
`The face of the ‘650 patent, titled “Microbiologically Sound and Stable Solutions
`
`of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," indicates that it issued on
`
`September 11, 2012.
`
`19.
`
`On information and belief, Jazz purports to be the owner of the '650 patent.
`
`20.
`
`The face of the ‘275 patent, titled "Microbiologically Sound and Stable Solutions
`
`of Gamma—Hydroxybutyrate Salt for the Treatment of Narcolepsy," indicates that it issued on
`
`December 4, 2012.
`
`21.
`
`On information and belief, Jazz purports to be the owner of the '275 patent.
`
`22.
`
`The face of the ‘730 patent,
`
`titled "Sensitive Drug Distribution System and
`
`Method," indicates that it issued on February 23, 2010. A true and correct copy of the ‘730 patent
`
`as it issued is attached to this Answer as Exhibit 1.
`
`23.
`
`On information and belief, Jazz purports to be the owner of the ‘730 patent.
`
`

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`24.
`
`The face of the ‘106 patent,
`
`titled "Sensitive Drug Distribution System and
`
`Method," indicates that it issued on July 27, 2010. A true and correct copy of the ‘106 patent as it
`
`issued is attached to this Answer as Exhibit 2.
`
`25.
`
`On information and belief, Jazz purports to be the owner of the ‘106 patent.
`
`26.
`
`The face of the 'l07 patent,
`
`titled "Sensitive Drug Distribution System and
`
`Method," indicates that it issued on July 27, 2010. A true and correct copy of the 'l07 patent as it
`
`issued is attached to this Answer as Exhibit 3.
`
`27.
`
`On information and belief, Jazz purports to be the owner of the '107 patent.
`
`28.
`
`Under 21 U.S.C. § 355(b)(1)(G) and 21 C.F.R. § 314.53, respectively, an NDA
`
`holder, here Jazz, must provide to the FDA the patent number and expiration date of any
`
`patent(s) that it believes "claims the drug for which the applicant submitted the application or
`
`which claims a method of using such drug" and "with respect to which a claim of patent
`
`infringement could reasonably be asserted if a person not licensed by the owner engaged in the
`
`manufacture, use, or sale of the drug."
`
`29.
`
`The FDA publishes patent(s) in an electronic, publicly available database called
`
`APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, also known as
`
`the "Orange Book." The FDA does not evaluate whether the claims of the disclosed patents
`
`actually cover the drug or method of using such drug, or whether the patent is valid; its actions
`
`are "purely ministerial." aaiPharma Inc. v. Thompson, 296 F.3d 227, 243 (4th Cir. 2002).
`
`30.
`
`Arnneal submitted ANDA No. 203631 ("Amneal’s ANDA") to the FDA seeking
`
`approval to engage in the commercial manufacture, use, and/or sale of 500 mg/mL sodium
`
`oxybate oral solution ("Amneal's ANDA Product").
`
`

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`31.
`
`Each of the counterclaim patents, except for the '431 patent, are listed in the
`
`FDA's Orange Book.
`
`32.
`
`Amneal submitted ANDA No. 203631 to the FDA seeking permission to market
`
`the proposed 500 mg/mL sodium oxybate oral solution.
`
`33.
`
`Amneal's ANDA contains a certification ("Amneal's Paragraph IV Certification")
`
`under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the claims of the '889,‘2l9,'506,'059,'650, ‘275, ‘730,
`
`‘l06, and ‘l07 patents are invalid, unenforceable, and/or will not be infringed by Amneal's
`
`ANDA Product.
`
`34.
`
`Jazz filed its Complaint in this Court alleging that Amneal's act of submitting
`
`ANDA No. 203631 infringes the patents—in-suit.
`
`35.
`
`Amneal denies that
`
`it
`
`infringes any valid and enforceable claim of the
`
`patents-in-suit, as well as the '730 patent, the '106 patent, and the ‘I07 patent.
`
`36.
`
`The present suit by Jazz impairs Amneal's ability to obtain approval of its ANDA
`
`No. 203 821 and market the proposed sodium oxybate product described therein.
`
`37.
`
`There remains a real and definite threat that Jazz may assert the '730, ‘l06, and
`
`'l07 patents against Amneal.
`
`38.
`
`To the extent that any of the counterclaim patents, including the '730, ‘l06, and/or
`
`’l07 patents, forms the basis for a prior ANDA applicant's eligibility for l80—exclusiVity under
`
`21 USC 355(j)(5)(B)(iv), they will preclude the approval of Amneal's ANDA No. 203631 unless
`
`Amneal secures a final court decision of noninfringernent, invalidity or unenforceability as to
`
`these patents.
`
`39.
`
`Based on Jazz's filing of the Complaint, and Amneal's denial thereof, there is an
`
`actual, substantial, and continuing justic-iable controversy between Amneal and Jazz having
`
`

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`
`
`adverse legal
`
`interests of sufficient
`
`immediacy and reality to warrant
`
`the issuance of a
`
`declaratory judgment regarding whether Arnneal has infringed any valid and enforceable claim
`
`of the counterclaim patents.
`
`40.
`
`Unless enjoined, Jazz will continue to assert that Amneal infringes the claims of
`
`the counterclaim patents, and Jazz is free to assert that Amneal infringes the claims of the
`
`'730,'lO6, and ‘I07 patents. Amneal believes that this will continue to interfere with Amneal's
`
`business with respect to 500 mg/mL sodium oxybate oral solution.
`
`41.
`
`Amneal will be irreparably harmed if Jazz is not enjoined from asserting the
`
`counterclaim patents against Amneal.
`
`Count I
`
`§Declarat0t_'y Judgment of Noninfringementl
`
`42.
`
`Amneal
`
`repeats and realleges
`
`its
`
`responses
`
`in Paragraphs
`
`1-41 of
`
`the
`
`Counterclaims as if fully set forth herein.
`
`43.
`
`Amneal's proposed sodium oxybate product described in ANDA No. 203631 has
`
`not infringed, does not infringe, will not infringe, and will not contribute to or induce the
`
`infringement of any Valid claim of the '431, '889, 219, ‘S06, ‘O59,
`
`'650, ‘275, '730, 'l06, and/or
`
`‘107 patents, either literally or under the doctrine of equivalents.
`
`44.
`
`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
`
`Amneal requests a declaration from the Court that Amneal does not infringe the claims of the
`
`‘43l, '889, ‘219, ‘S06, ‘O59, '650, '275, '730, '106, and/or '10? patents.
`
`

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`Count II
`
`gfleclaratogy Judgment of Patent Invalidity]
`
`45.
`
`Arnneal
`
`repeats and realleges
`
`its
`
`responses
`
`in Paragraphs
`
`1-45 of the
`
`Counterclaims as if fully set forth herein.
`
`46.
`
`Each claim of the '431, ‘889,
`
`'219, ‘S06,
`
`‘O59,
`
`'650,
`
`'275, "/'30,
`
`'106, and '10?’
`
`patents is invalid for failure to comply with one or more of the conditions and requirements for
`
`patentability under Title 35 of the United States Code, including but not limited to, 35 U.S.C.
`
`§§101, 102,103 and/or 112.
`
`47.
`
`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq., Amneal
`
`requests a declaration from the Court that the claims of the '431, '889, '2l9, ‘506, ‘O59,
`
`'650, '275,
`
`'73 0, ‘106, and/or'107 patents are invalid.
`
`DEMAND FOR JUDGMENT
`
`WHEREFORE, Amneal respectfully requests that this Court enter judgment in its favor
`
`and against Counterclaim Defendant Jazz and grant the following relief:
`
`A.
`
`Dismiss Jazz's Complaint with prejudice and deny each and every prayer for relief
`
`contained therein;
`
`B.
`
`Declare that by filing ANDA No. 203631, Amneal has not infringed,
`
`is not
`
`infringing, and will not infringe, not contribute to or induce infringement of, literally or under
`
`the Doctrine of Equivalents, any valid and enforceable claim of the '43l, ‘889, ‘219, ‘S06, ‘059,
`
`'650, '275, '730, 'l06, and'107 patents and that Amneal has a lawful right to obtain FDA approval
`
`of its ANDA