Case 3:22-cv-01592-CCC Document 1 Filed 03/21/22 Page 1 of 79 PageID: 1
`
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Mallinckrodt Pharmaceuticals
`Ireland Limited
`
`
`
`Of Counsel:
`
`Preston K. Ratliff II
`Dana R. Weir
`Mi Zhou
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`MALLINCKRODT PHARMACEUTICALS
`IRELAND LIMITED,
`
`
`
`Plaintiff,
`
`
`
`
`
`
`
`Civil Action No. ___________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`
`
`v.
`
`ZYDUS PHARMACEUTICALS (USA) INC.
`and CADILA HEALTHCARE LIMITED,
`
`
`
`
`Defendants.
`
`
`
`
`
`
`
`Plaintiff Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt” or “Plaintiff”), for
`
`its Complaint against Defendants Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare
`
`Limited (collectively, “Zydus” or “Defendants”), hereby alleges as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Mallinckrodt Pharmaceuticals Ireland Limited is a company organized and
`
`existing under the laws of Ireland, having a registered address of College Business & Technology
`
`Park, Cruiserath Road, Blanchardstown, Dublin 15, D15 TX2V, Ireland. Mallinckrodt is a wholly-
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`owned subsidiary of Mallinckrodt plc. As set forth herein, Mallinckrodt is the assignee of U.S.
`
`Patent No. 9,399,012 (“the ’012 patent”), U.S. Patent No. 9,610,265 (“the ’265 patent”), U.S.
`
`Patent No. 9,987,238 (“the ’238 patent”), and U.S. Patent No. 10,383,834 (“the ’834 patent”)
`
`(collectively, the “Patents-in-Suit”).
`
`2.
`
`Upon information and belief, Defendant Zydus Pharmaceuticals (USA) Inc.
`
`(“Zydus USA”) is an entity organized and existing under the laws of the State of New Jersey,
`
`having a principal place of business at 73 Route 31 North, Pennington, New Jersey 08534.
`
`3.
`
`Upon information and belief, Defendant Cadila Healthcare Limited (“Cadila”) is
`
`an entity organized and existing under the laws of India, having a principal place of business at
`
`Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi
`
`Circle, S.G. Highway, Ahmedabad, Gujarat, 382481, India.
`
`4.
`
`Upon information and belief, Zydus USA is a wholly-owned subsidiary of Cadila.
`
`NATURE OF THE ACTION
`
`5.
`
`This is a civil action for infringement of the Patents-in-Suit pursuant to the Patent
`
`Laws of the United States, 35 U.S.C. §§ 100 et seq.; the Federal Food, Drug, and Cosmetic Act;
`
`21 U.S.C. §§ 301 et seq.; and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 et seq.
`
`JURISDICTION AND VENUE
`
`6.
`
`This Court has subject matter jurisdiction over this action under 28 U.S.C. §§ 1331,
`
`1338(a), and 2201(a).
`
`7.
`
`Upon information and belief, Cadila develops and manufactures generic versions
`
`of branded pharmaceutical products.
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`8.
`
`Upon information and belief, Cadila, either directly or through one or more of its
`
`agents, markets, distributes, sells, and/or imports generic versions of branded pharmaceutical
`
`products throughout the United States, including in this Judicial District.
`
`9.
`
`Upon information and belief, Zydus USA markets, distributes, sells, and/or imports
`
`generic versions of branded pharmaceutical products developed and/or manufactured by Cadila
`
`throughout the United States, including in this Judicial District.
`
`10.
`
`Zydus USA is registered with the State of New Jersey’s Division of Revenue and
`
`Enterprise Services as a business in the State of New Jersey under Entity Identification
`
`No. 0100915422.
`
`11.
`
`Zydus USA is registered with the State of New Jersey’s Department of Health as a
`
`drug wholesaler under Registration No. 5003171.
`
`12.
`
`Upon information and belief, Zydus USA, as an agent for Cadila, sent Mallinckrodt
`
`Hospital Products IP Limited (“Mallinckrodt Hospital Products IP,” currently registered under the
`
`name “Mallinckrodt Hospital Products IP Unlimited Company”) and Mallinckrodt Inc. a letter
`
`dated February 7, 2022 (“Zydus’s Notice Letter”), stating that Zydus USA has submitted
`
`Abbreviated New Drug Application (“ANDA”) No. 216467 (“Zydus’s ANDA”) seeking approval
`
`from the United States Food and Drug Administration (“FDA”) to engage in the commercial
`
`manufacture, use, or sale within the United States (including, upon information and belief, in the
`
`State of New Jersey) of a generic version of OFIRMEV® (acetaminophen injection,
`
`1,000 mg/100 mL (10 mg/mL) single-dose vials) (“Zydus’s ANDA Product”).
`
`13.
`
`Upon information and belief, Zydus USA and Cadila are agents of each other with
`
`respect to importing generic versions of branded pharmaceutical products into the United States
`
`and commercially manufacturing, marketing, distributing, and/or selling generic versions of
`
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`branded pharmaceutical products throughout the United States, and will do the same with respect
`
`to Zydus’s ANDA Product that is the subject of ANDA No. 216467, for which Zydus has sought
`
`approval from the FDA.
`
`14.
`
`Upon information and belief, Zydus USA and Cadila are acting in concert with each
`
`other with respect to importing generic versions of branded pharmaceutical products into the
`
`United States and commercially manufacturing, marketing, distributing, and/or selling generic
`
`versions of branded pharmaceutical products throughout the United States, and will do the same
`
`with respect to Zydus’s ANDA Product that is the subject of ANDA No. 216467, for which Zydus
`
`has sought approval from the FDA.
`
`15.
`
`Upon information and belief, Zydus USA, as an agent for Cadila, submitted
`
`Zydus’s ANDA with the FDA.
`
`16.
`
`Upon information and belief, the actions of Zydus, such as, causing Zydus’s ANDA
`
`to be submitted with the FDA and maintaining distribution channels throughout the United States,
`
`including in the State of New Jersey, establish that, if granted approval, Zydus will commercially
`
`manufacture, use, offer to sell, sell, and/or import Zydus’s ANDA Product throughout the United
`
`States, including in New Jersey.
`
`17.
`
`This Court has personal jurisdiction over Zydus USA, because, inter alia, Zydus
`
`USA: (1) is an entity organized and existing under the laws of the State of New Jersey; (2) has a
`
`principal place of business in New Jersey; (3) has purposely availed itself of the privilege of doing
`
`business in New Jersey, including, inter alia, by registering with the State of New Jersey’s
`
`Division of Revenue and Enterprise Services to do business in the State of New Jersey under
`
`Business Identification No. 0100915422 and securing a New Jersey wholesale drug distributor’s
`
`license under Registration No. 5003171; (4) markets, distributes, and sells generic versions of
`
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`branded pharmaceutical products throughout the United States, including in the State of New
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`Jersey; (5) upon information and belief, derives substantial revenue from the sale of its products
`
`in the State of New Jersey; and (6) upon information and belief, intends to, directly or indirectly
`
`through its affiliate, agent, and/or alter ego, market, sell, or distribute Zydus’s ANDA Product
`
`throughout the United States, including in the State of New Jersey.
`
`18.
`
`This Court also has personal jurisdiction over Zydus USA because, inter alia,
`
`Zydus USA has availed itself of the legal protections of the State of New Jersey by previously
`
`consenting to personal jurisdiction and asserting counterclaims in this Judicial District. See, e.g.,
`
`Valeant Pharm. North Am. LLC, et al. v. Zydus Pharm. (USA) Inc. and Cadila Healthcare Ltd.,
`
`et al., No. 2:18-13635 (BRM) (LDW) (D.I. 20, Defendants Zydus Pharmaceuticals (USA) Inc.,
`
`Zydus Worldwide DMCC, and Cadila Healthcare Limited’s Answer, Affirmative Defenses, and
`
`Counterclaims to Plaintiffs’ Complaint for Patent Infringement, Mar. 5, 2019); Takeda Pharm. Co.
`
`Ltd., et al. v. Zydus Pharm. (USA) Inc. and Cadila Healthcare Ltd., No. 3:18-11792 (FLW) (TJB)
`
`(D.I. 52, Answer, Affirmative Defenses, Counterclaims of Defendants, Apr. 29, 2019); Janssen
`
`Prod., L.P., et al. v. Zydus Pharm. (USA) Inc. and Cadila Healthcare Ltd., No. 3:20-00787 (FLW)
`
`(TJB) (D.I. 13, Consent Judgment and Order, June 19, 2020); Actelion Pharm. Ltd., et al. v. Zydus
`
`Pharm. (USA) Inc. and Cadila Healthcare Ltd., No. 3:19-22193 (BRM) (DEA) (D.I. 21, Consent
`
`Judgment and Order, July 10, 2020).
`
`19.
`
`This Court has personal jurisdiction over Cadila, because, inter alia, Cadila: (1) has
`
`purposely availed itself of the privilege of doing business in New Jersey directly or indirectly
`
`through its subsidiary, agent, and/or alter ego; (2) maintains pervasive, continuous, and systematic
`
`contacts with the State of New Jersey, including the marketing, distribution, and/or sale of generic
`
`versions of branded pharmaceutical products in the State of New Jersey; (3) upon information and
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`belief, derives substantial revenue from the sale of its products in the State of New Jersey; and
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`(4) upon information and belief, intends to, directly or indirectly through its subsidiary, agent,
`
`and/or alter ego, market, sell, or distribute Zydus’s ANDA Product throughout the United States,
`
`including in the State of New Jersey.
`
`20.
`
`This Court also has personal jurisdiction over Cadila because, inter alia, it has
`
`availed itself of the legal protections of the State of New Jersey by previously consenting to
`
`personal jurisdiction and asserting counterclaims in this Judicial District. See, e.g., Valeant Pharm.
`
`North Am. LLC, et al. v. Zydus Pharm. (USA) Inc. and Cadila Healthcare Ltd., et al., No. 2:18-
`
`13635 (BRM) (LDW) (D.I. 20, Defendants Zydus Pharmaceuticals (USA) Inc., Zydus Worldwide
`
`DMCC, and Cadila Healthcare Limited’s Answer, Affirmative Defenses, and Counterclaims to
`
`Plaintiffs’ Complaint for Patent Infringement, Mar. 5, 2019); Takeda Pharm. Co. Ltd., et al. v.
`
`Zydus Pharm. (USA) Inc. and Cadila Healthcare Ltd., No. 3:18-11792 (FLW) (TJB) (D.I. 52,
`
`Answer, Affirmative Defenses, Counterclaims of Defendants, Apr. 29, 2019); Janssen Prod., L.P.,
`
`et al. v. Zydus Pharm. (USA) Inc. and Cadila Healthcare Ltd., No. 3:20-00787 (FLW) (TJB)
`
`(D.I. 13, Consent Judgment and Order, June 19, 2020); Actelion Pharm. Ltd., et al. v. Zydus
`
`Pharm. (USA) Inc. and Cadila Healthcare Ltd., No. 3:19-22193 (BRM) (DEA) (D.I. 21, Consent
`
`Judgment and Order, July 10, 2020).
`
`21.
`
`Alternatively, this Court may exercise jurisdiction over Cadila pursuant to Fed. R.
`
`Civ. P. 4(k)(2) because, inter alia, (1) Mallinckrodt’s claims arise under federal law; (2) Cadila is
`
`a foreign defendant not subject to personal jurisdiction in any state’s court of general jurisdiction;
`
`and (3) Cadila has sufficient contacts with the United States as a whole, including, but not limited
`
`to, through its wholly-owned subsidiary, agent, and/or alter ego, submitting ANDAs to the FDA,
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`and importing, offering to sell, and/or selling pharmaceutical products throughout the United
`
`States, such that this Court’s exercise of jurisdiction over Cadila satisfies due process.
`
`22.
`
`This Court also has personal jurisdiction over Zydus because, inter alia, Zydus
`
`USA and Cadila have each committed, aided, abetted, contributed to, and/or participated in the
`
`commission of acts of patent infringement, including acts in the State of New Jersey, that have led
`
`to foreseeable harm and injury to Mallinckrodt in the State of New Jersey.
`
`23.
`
`Venue is proper in this Court as to Zydus USA under 28 U.S.C. §§ 1391(b), (c),
`
`and/or (d), and 1400(b) because Zydus USA is an entity organized and existing under the laws of
`
`the State of New Jersey, has a principal place of business in New Jersey, and has committed and
`
`will commit further acts of infringement in this Judicial District. Venue is proper for the additional
`
`reasons set forth above and for other reasons that will be presented to the Court if such venue is
`
`challenged.
`
`24.
`
`Venue is proper in this Court as to Cadila under 28 U.S.C. §§ 1391(c)(3) and
`
`1400(b) because Cadila is a foreign corporation and may be sued in any judicial district in the
`
`United States in which Cadila is subject to the court’s personal jurisdiction. Venue is proper for
`
`the additional reasons set forth above and for other reasons that will be presented to the Court if
`
`such venue is challenged.
`
`THE PATENTS-IN-SUIT
`
`25. Mallinckrodt owns the ’012 patent, which was duly and legally issued on July 26,
`
`2016 and is titled “Reduced Dose Intravenous Acetaminophen.” A copy of the ’012 patent is
`
`attached as Exhibit A.
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`26. Mallinckrodt owns the ’265 patent, which was duly and legally issued on April 4,
`
`2017 and is titled “Reduced Dose Intravenous Acetaminophen.” A copy of the ’265 patent is
`
`attached as Exhibit B.
`
`27. Mallinckrodt owns the ’238 patent, which was duly and legally issued on June 5,
`
`2018 and is titled “Reduced Dose Intravenous Acetaminophen.” A copy of the ’238 patent is
`
`attached as Exhibit C.
`
`28. Mallinckrodt owns the ’834 patent, which was duly and legally issued on
`
`August 20, 2019 and is titled “Reduced Dose Intravenous Acetaminophen.” A copy of the
`
`’834 patent is attached as Exhibit D.
`
`OFIRMEV®
`
`29. Mallinckrodt is the holder of New Drug Application (“NDA”) No. 022450, by
`
`which the FDA granted approval of the first intravenous formulation of acetaminophen available
`
`in the United States that is marketed under the trade name OFIRMEV®.
`
`30.
`
`OFIRMEV® (acetaminophen) injection is indicated for the management of mild to
`
`moderate pain in adult and pediatric patients 2 years and older, management of moderate to severe
`
`pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and
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`reduction of fever in adult and pediatric patients.
`
`31.
`
`Pursuant to 21 U.S.C. § 355(b)(l), the Patents-in-Suit are listed in the FDA
`
`publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (also known
`
`as the “Orange Book”) with respect to OFIRMEV®.
`
`ACTS GIVING RISE TO THIS ACTION
`
`32.
`
`Upon information and belief, Zydus USA submitted ANDA No. 216467 to the FDA
`
`under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(2)), seeking approval to
`
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`engage in the commercial manufacture, use, offer for sale, or sale within the United States, and/or
`
`importation into the United States, of Zydus’s ANDA Product before the expiration of the Patents-
`
`in-Suit.
`
`33.
`
`Zydus’s ANDA No. 216467 contains certifications under 21 U.S.C.
`
`§ 355(j)(2)(B)(iv)(II) (“Paragraph IV certification”) with respect to the Patents-in-Suit.
`
`34.
`
`On or about February 7, 2022, Zydus USA sent Mallinckrodt Hospital Products IP
`
`and Mallinckrodt Inc. Zydus’s Notice Letter, in which it represented that Zydus USA had
`
`submitted ANDA No. 216467 for Zydus’s ANDA Product and that Zydus’s ANDA identified
`
`OFIRMEV® (acetaminophen) injection, 1,000 mg/100 mL (10 mg/mL) single-dose vials as the
`
`Reference Listed Drug and included Paragraph IV certifications with respect to the Patents-in-
`
`Suit.
`
`35. Mallinckrodt Hospital Products IP first received Zydus’s Notice Letter on or about
`
`February 9, 2022.
`
`36. Mallinckrodt commenced this action within 45 days of the date of receipt of
`
`Zydus’s Notice Letter.
`
`COUNT I – INFRINGEMENT OF THE PATENTS-IN-SUIT
`
`37. Mallinckrodt re-alleges paragraphs 1-36 as if fully set forth herein.
`
`38.
`
`By seeking approval of ANDA No. 216467 to engage in the commercial
`
`manufacture, use, offer for sale, or sale within the United States, and/or importation into the United
`
`States, of Zydus’s ANDA Product before the expiration of the Patents-in-Suit, Zydus has infringed
`
`the Patents-in-Suit under 35 U.S.C. § 271(e)(2)(A).
`
`39. Mallinckrodt is entitled to relief provided by 35 U.S.C. § 271(e)(4), including an
`
`order of this Court that the effective date of the approval of ANDA No. 216467 be a date that is
`
`not earlier than the latest expiration date of each of the Patents-in-Suit, including any patent term
`
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`extensions and/or patent term adjustments, the period of any pediatric exclusivity associated with
`
`the Patents-in-Suit, and additional periods of exclusivity to which Mallinckrodt is or becomes
`
`entitled.
`
`40.
`
`The commercial manufacture, use, offer for sale, or sale within the United States,
`
`and/or importation into the United States, of Zydus’s ANDA Product, if approved by the FDA
`
`before the expiration of the Patents-in-Suit, for use in accordance with its proposed labeling, would
`
`infringe, induce, and/or contribute to the infringement of the Patents-in-Suit.
`
`41. Mallinckrodt is entitled to a declaration that, if Zydus commercially manufactures,
`
`uses, offers to sell, or sells within the United States, and/or imports into the United States, Zydus’s
`
`ANDA Product, or induces or contributes to any such conduct, it would further infringe the
`
`Patents-in-Suit pursuant to 35 U.S.C. §§ 271(a), (b), and/or (c).
`
`42.
`
`Upon information and belief, Zydus was aware of the existence of the Patents-in-
`
`Suit and was aware that the submission of ANDA No. 216467 to the FDA constituted an act of
`
`infringement of the Patents-in-Suit.
`
`43.
`
`Upon information and belief, Zydus was aware that the commercial manufacture,
`
`use, offer for sale, or sale within the United States, and/or importation into the United States, of
`
`Zydus’s ANDA Product before the expiration of the Patents-in-Suit would constitute an act of
`
`infringement of the Patents-in-Suit.
`
`44.
`
`Separate and apart from certain contentions regarding validity of the ’012 patent,
`
`Zydus’s Notice Letter does not identify any factual basis for, or any opinion of, noninfringement
`
`of Claims 1-15, 20, 22, 25-27, 29-31, 33, 34, 36-42, 45-50, 53, 54, 57, 58, 62-66, 69-71, 74-81,
`
`84, 85, 88, 89, 93-97, 100-102, and 105-109 of the ’012 patent.
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`45.
`
`Separate and apart from certain contentions regarding validity of the ’265 patent,
`
`Zydus’s Notice Letter does not identify any factual basis for, or any opinion of, noninfringement
`
`of Claims 1-4 and 6-10 of the ’265 patent.
`
`46.
`
`Separate and apart from certain contentions regarding validity of the ’238 patent,
`
`Zydus’s Notice Letter does not identify any factual basis for, or any opinion of, noninfringement
`
`of Claims 1-16 and 19-20 of the ’238 patent.
`
`47.
`
`Separate and apart from certain contentions regarding validity of the ’834 patent,
`
`Zydus’s Notice Letter does not identify any factual basis for, or any opinion of, noninfringement
`
`of Claims 1-6 and 8-11 of the ’834 patent.
`
`48. Mallinckrodt will be irreparably harmed by Zydus’s infringing activities unless
`
`those activities are enjoined by this Court. Mallinckrodt does not have an adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Mallinckrodt respectfully requests the following relief:
`
`A.
`
`A judgment that Zydus has infringed the Patents-in-Suit by submitting ANDA
`
`No. 216467 to the FDA;
`
`B.
`
`A declaration that the commercial manufacture, use, offer for sale, or sale within
`
`the United States, and/or importation into the United States, of Zydus’s ANDA Product will
`
`infringe or induce or contribute to the infringement of the Patents-in-Suit;
`
`C.
`
`An order issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective date of any
`
`approval of ANDA No. 216467 be a date that is not earlier than the latest expiration date of the
`
`Patents-in-Suit, including any patent term extensions and/or patent term adjustments, the period of
`
`any pediatric exclusivity associated with the Patents-in-Suit, and additional periods of exclusivity
`
`to which Mallinckrodt is or becomes entitled;
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`D.
`
`A preliminary and permanent injunction restraining and enjoining Zydus, its
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`directors, officers, agents, attorneys, affiliates, divisions, successors, and employees, and those
`
`acting in privity or concert with them, from engaging in the commercial manufacture, use, offer
`
`for sale, or sale within the United States, and/or importation into the United States, of any drug
`
`product, or use thereof, claimed in the Patents-in-Suit, before the latest expiration date of the
`
`Patents-in-Suit, including any patent term extensions and/or patent term adjustments, the period of
`
`any pediatric exclusivity associated with the Patents-in-Suit, and additional periods of exclusivity
`
`to which Mallinckrodt is or becomes entitled;
`
`E.
`
`An award to Mallinckrodt of monetary relief if Zydus commercially manufactures,
`
`uses, offers for sale, or sells within the United States, and/or imports into the United States, Zydus’s
`
`ANDA Product, or any other product that infringes or induces or contributes to the infringement
`
`of the Patents-in-Suit, before the latest expiration date of the Patents-in-Suit, including any patent
`
`term extensions and/or patent term adjustments, the period of any pediatric exclusivity associated
`
`with the Patents-in-Suit, and additional periods of exclusivity to which Mallinckrodt is or becomes
`
`entitled;
`
`F.
`
`A declaration that this is an exceptional case and an award to Mallinckrodt of its
`
`reasonable expenses including attorneys’ fees pursuant to 35 U.S.C. § 285;
`
`G.
`
`H.
`
`An award to Mallinckrodt of costs in this action; and
`
`Such other and further relief as the Court may deem just and proper.
`
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`Dated: March 21, 2022
`
`Of Counsel:
`
`Preston K. Ratliff II
`Dana R. Weir
`Mi Zhou
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
`
`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Mallinckrodt Pharmaceuticals
`Ireland Limited
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`Case 3:22-cv-01592-CCC Document 1 Filed 03/21/22 Page 14 of 79 PageID: 14
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`CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 & 40.1
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`I hereby certify that, to the best of my knowledge, the matter in controversy is not the
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`subject of any other action pending in any court or of any pending arbitration or administrative
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`proceeding.
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`Dated: March 21, 2022
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`Of Counsel:
`
`Preston K. Ratliff II
`Dana R. Weir
`Mi Zhou
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
`
`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Mallinckrodt Pharmaceuticals
`Ireland Limited
`
`
`- 14 -
`
`

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`Case 3:22-cv-01592-CCC Document 1 Filed 03/21/22 Page 15 of 79 PageID: 15
`Case 3:22-cv-01592-CCC Document1 Filed 03/21/22 Page 15 of 79 PagelD: 15
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`EXHIBIT A
`
`EXHIBIT A
`
`

`

`Case 3:22-cv-01592-CCC Document 1 Filed 03/21/22 Page 16 of 79 PageID: 16
`eISSNATTAATTTA
`
`US009399012B2
`
`a2) United States Patent
`US 9,399,012 B2
`(10) Patent No.:
`
`(45) Date of Patent: Jul. 26, 2016
`Royalet al.
`
`(54) REDUCED DOSE INTRAVENOUS
`ACETAMINOPHEN
`
`(75)
`
`Inventors: Mike Allan Royal, San Diego, CA (US);
`James Bradley Breitmeyer, Rancho
`Santa Fe, CA (US)
`
`(73) Assignee: MALLINCKRODTIP, Dublin (IE)
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1032 days.
`
`(21) Appl. No.: 12/270,796
`
`(22)
`
`Filed:
`
`Nov. 13, 2008
`
`(65)
`
`Prior Publication Data
`
`US 2009/0143474 Al
`
`Jun. 4, 2009
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/987,761, filed on Nov.
`13, 2007.
`
`(51)
`
`Int. Cl.
`AGIK 31/16
`A6IK 9/00
`AGIK 47/02
`AGIK 47/18
`(52) U.S.C
`CPC veeceeceeeeeen A6IK 9/0019 (2013.01); A61K 47/02
`(2013.01); A6IK 47/18 (2013.01); A6IK
`47/183 (2013.01)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(58) Field of Classification Search
`USPC viecesssescscesceeseecscnsscseecerseneeanecassentes 514/629
`
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`5,270,050 A
`5,384,124 A *
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`6,028,222 A *
`6,593,331 B2
`6,992,218 B2*
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`7,255,860 B2*
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`12/1993 Coquelet et al.
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`2/2000 Dietlinetal. oo. 564/4
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`1/2006 Dietlin ..... A61K 9/0019
`564/223
`...0.0... 424/145.1
`
`8/2007 Sheltonetal.
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`GP
`JP
`JP
`JP
`JP
`KR
`
`279405
`870101510
`1987-4229
`1999-5 14013
`2004-269363
`2006-5 17544
`1993-0011994
`
`6/1990
`12/1987
`1/1987
`11/1999
`9/2004
`7/2006
`3/1993
`
`OTHER PUBLICATIONS
`
`Pettersson et al., Journal of cardiothoracic and Vascular Anesthesia,
`2005;19(3):306-309.*
`McNeil Labs Pharmacologist Review of NDA 17-785, Apr. 5, 1976.
`PCT/US08/83458 Search Report dated Jan. 29, 2009.
`JP 2010-534188 Office Action dated May 14, 2013.
`
`Apotel Information Sheet, last revision Feb. 10, 1998, 2 pages.
`Budavari, et al.
`, “The Merck Index, 12th Edition; 1996, p.
`9—Acetaminophen.”
`Clements, et al.“Data point weighting in pharmacokinetic analysis:
`intravenous paracetamol in man.” J. Pharm. Pharmac., 1976, 28, p.
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`Depre, et al. “Tolerance and Pharmacokinetics of Propacetamol, a
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`Fairbrother, “Acetaminophen.” 1974, p. 1-109.
`JP 2010-534188 office action mailed Feb. 4, 2014.
`Rawlins,et al. “Pharmacokinetics of Paracetamol (Acetaminophen)
`after
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`Summary Basis of Approval (SBA) for Injectapap (NDA 17-785),
`May 27, 1986, p. 1-35.
`Yan,et al. “Study and Preparation of Paracetamol Solution for Injec-
`tion.” Pharmaceutical Bulletin 1986 21 (7), p. 387-389.
`Exhibit A to the Declaration of Dr. Mike A. Royal: “A True and.
`Correct Copy ofthe CrriculumVitae ofDr. Mike A. Royal;”15 pages.
`Exhibit B to the Declaration of Dr. Mike A. Royal: Andersonet al.;
`“Acetaminophen Analgesia in Children: Placebo Effect and Pain
`Resolution After Tonsillectomy;” Eur. J. Clin. Pharmacol; vol. 57; pp.
`559-569; 2001.
`Exhibit C to the Declaration ofDr. Mike A. Royal: Winingeret al.; “A
`Randomized, Double-Blind,
`Placebo-Controlled, Multicenter,
`Repeat-Dose Study of Two Intravenous Acetaminophen Dosing
`Regimensfor the Treatment of Pain After Abdominal Laparoscopic
`Surgery;” Clinical Therapeutics; vol. 32(14); pp. 2348-2369; 2010.
`Exhibit D to the Declaration of Dr. Mike A. Royal: Candiotti et al.;
`“Safety of Multiple-Dose Intravenous Acetaminophenin Adult Inpa-
`tients;” Pain Medicine; vol. 11; pp. 1841-1848; 2010.
`ExhibitE to the Declaration of Dr. Mike A. Royal: “McNeil’s Back-
`ground Package on Acetaminophen for the Nonprescription Drugs
`Advisory Committee;” Sep. 19, 2002; Downloaded Apr. 17, 2014; 75
`pages. http://www.fda.gov/ohrms/dockets/ac /02/briefing/3882b1__
`13__meneil-acetaminophen-htm.
`ExhibitF to the Declaration of Dr. Mike A. Royal: Juhlet al.; “Anal-
`gesic
`Efficacy
`and
`Safety
`of
`Intravenous
`Paracetamol
`(Acetaminophen) Administered as a 2 g Starting Dose Following
`Third Molar Surgery;” European Journal of Pain; vol. 10; pp. 371-
`377; 2006.
`Exhibit G to the Declaration of Dr. Mike A. Royal: Sinatra et al.;
`“Efficacy and Safety of Single and Repeated Administration of 1
`Gram Intravenous Acetaminophen Injection (Paracetamol) for Pain
`Managementafter Major Orthopedic Surgery;” Anesthesiology;vol.
`102(4); pp. 822-831; 2005.
`Exhibit H to the Declaration of Dr. Mike A. Royal: Moller et al.;
`“Onset of Acetaminophen Analgesia: Comparison of Oral and Intra-
`venous Routes After Third Molar Surgery;” British Journal of
`Anaesthesia; 94 (5); pp. 642-648; 2005.
`(Continued)
`
`Primary Examiner — San-Ming Hui
`(74) Attorney, Agent, or Firm — Mayer Brown LLP
`
`(57)
`
`ABSTRACT
`
`Described herein are compositions and methodsfor intrave-
`nous administration of acetaminophenat a single dose level
`of less than about 1000 mgfor the treatmentor prevention of
`pain (e.g., postoperative pain) and/or fever.
`
`109 Claims, No Drawings
`
`

`

`Case 3:22-cv-01592-CCC Document 1 Filed 03/21/22 Page 17 of 79 PageID: 17
`Case 3:22-cv-01592-CCC Document1 Filed 03/21/22 Page 17 of 79 PagelD: 17
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`US 9,399,012 B2
`
`Page 2
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`Exhibit I to the Declaration of Dr. Mike A. Royal: Singla et al.;
`“Plasmaand Cerebrospinal Fluid Pharmacokinetic Parameters After
`Single-Dose Administration of
`Intravenous, Oral, or Rectal
`Acetaminophen;”Pain Practice; vol. 12 (7); pp. 523-532; 2012.
`Exhibit J to the Declaration of Dr. Mike A. Royal: OFIRMEV®
`Prescribing Information; Patient Insert; 2013; 12 pages.
`Anandet al.; “Intravenous Acetaminophenvs. Ketorolac for Postop-
`erative Analgesia After Ambulatory Parathyroidectomy;” Scandina-
`vian Journal of Pain; vol. 4(4); pp. 249-253; 2013.
`Atef et al.; “Intravenous Paracetamol is Highly Effective in Pain
`Treatment After
`Tonsillectomy
`in
`Adults;’?
`Eur Arch
`Otorhinolaryngol; vol. 265(3); pp. 351-355; 2008.
`Cadence Pharmaceuticals Annual Report; 2012; 128 pages.
`Singla et al.; “A Phase III, Multi-Center, Open-Label, Prospective,
`Repeated Dose, Randomized, Controlled, Multi-Day Study of the
`Safety of Intravenous Acetaminophen in Adult Inpatients;” Poster
`Presentation; Presented at: 34th Annual Regional Anesthesia Meet-
`ing and Workshops; Apr. 30 to May 3, 2009; Phoenix, AZ.
`Candiotti et al.; “Opioid Adjuvants for Multimodal Pain Manage-
`ment;” Anesthesiology News; pp. 1-8; 2011.
`Marieret al.; “Application of Trial Simulations to Support Optimal
`DosingofIntravenous Acetaminophenin Pediatric Patients: Regula-
`tory Approval of the Product Based on a Minimum Number of
`Patients;” 1 page.
`“Cadence Pharmaceuticals Estimates Fourth Quarter and Full Year
`2013 Product Revenue and Provides Full Year 2014 Revenue Guid-
`ance;” The Wall Street Journal; Downloaded Jan. 18, 2104; 3 pages.
`http://online.wsj.com/article/PR-CO-20140113-905162.html.
`Pachecoetal.; “The Role of Multimodal Analgesia in the Periopera-
`tive Setting; A Special Feature on OFIRMEV® (Acetaminophen)
`Injection;” 2013; 10 pages.
`Schwartz et al.; “Intravenous Acetaminophen: An Alternative to
`Opioids for Pain Management?”; Hospital Pediatrics; vol. 3; pp.
`294-296; 2013.
`Susan Yudt; “Ofirmev® Use in Multi-Modal Pain Strategies;” Cali-
`fornia Association of Nurse Anesthetists, Spring Meeting; 2012; 22
`pages.
`Peacocket al.; “A Randomized Study of the Efficacy and Safety of
`Intravenous Acetaminophen Compared to Oral Acetaminophen for
`the Treatment of Fever;” Acad Emerg Med; vol. 18(4); 360-366;
`2011.
`Decision of Rejection for Japanese Patent Application No. 2010-
`534188; 3 pages.
`
`English Translation of the Decision of Rejection for Japanese Patent
`Application No. 2010-534188; 1 page.
`English Translation of Japanese Unexamined Patent Publication No.
`2004-269363; 6 pages.
`English Translation of Japanese Laid Open Patent Publication No.
`2006-517544; 7 pages.
`English Translation of Japanese Laid Open Patent Publication No.
`1999-514013 (11-514013); 22 pages.
`English Translation of EP Publication No. 0207193 corresponding to
`Japanese unexaminedPatent Publication No. 1987-4229(62/4229); 7
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`(Acetaminophen) Penetrates
`Kumpulainen et al.; “Paracetamol
`Readily Into the Cerebrospinal Fluid of Children After Intravenous
`Administration;” Pediatrics; vol. 119(4); pp. 766-771; 2007.
`Ameer et al.; “Absolute and Relative Bioavailability of Oral
`Acetaminophen Preparations;” Journal of Pharmaceutical Sciences;
`vol. 72(8); 955-958; 1983.
`Oscieret al.; “Paracetamol—A Review of Three Routes of Admin-
`ist