Case 1:19-cv-00552-UNA Document 1 Filed 03/22/19 Page 1 of 35 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MALLINCKRODT HOSPITAL PRODUCTS ) IP LIMITED, MALLINCKRODT HOSPITAL ) PRODUCTS INC., and NEW PHARMATOP ) L.P., ) ) C.A. No. ____________ Plaintiffs, ) ) v. ) ) ALTAN PHARMA LTD., ) ) Defendant. COMPLAINT FOR PATENT INFRINGEMENT Plaintiffs Mallinckrodt Hospital Products IP Limited, Mallinckrodt Hospital Products Inc., and New Pharmatop L.P. (“Plaintiffs”), by their attorneys, file this Complaint for patent infringement against Defendant Altan Pharma Ltd. (“Defendant” or “Altan”) and allege as follows: PARTIES 1. Plaintiff Mallinckrodt Hospital Products IP Limited (“Mallinckrodt Hospital Products IP”) 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 Hospital Products IP is a wholly-owned subsidiary of Mallinckrodt plc. As set forth herein, Mallinckrodt Hospital Products IP is the assignee of U.S. Patent No. 9,399,012 (the “’012 patent”), U.S. Patent No. 9,610,265 (the “’265 patent”), and U.S. Patent No. 9,987,238 (the “’238 patent”), and is the exclusive sub-licensee of U.S. Patent No. 6,992,218 (the “’218 patent”) (collectively, the “Patents-in-Suit”). Case 1:19-cv-00552-UNA Document 1 Filed 03/22/19 Page 2 of 35 PageID #: 2 2. Plaintiff Mallinckrodt Hospital Products Inc. (“Mallinckrodt Hospital Products”), formerly Cadence Pharmaceuticals, Inc. (“Cadence”), is a company organized and existing under the laws of Delaware, having a principal place of business at 675 McDonnell Blvd., Hazelwood, Missouri 63042. Mallinckrodt Hospital Products is a wholly-owned subsidiary of Mallinckrodt plc. 3. Plaintiff New Pharmatop L.P. (“New Pharmatop”) is a Delaware limited partnership having its registered office c/o Corporation Services Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware. As set forth herein, New Pharmatop is the current assignee of the ’218 patent. 4. Upon information and belief, Defendant Altan Pharma Ltd. is a company organized under the laws of Ireland, having a principal place of business at 2 Harbour Square, Crofton Road, Dun Laoghaire, Co. Dublin, Ireland. Upon information and belief, Altan is in the business of manufacturing, distributing, and selling pharmaceutical products throughout Europe, Latin America, and Asia, and intends to expand sales to the United States, including in this judicial district. 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. This Court has personal jurisdiction over Altan by virtue of actions Altan has taken for purposes of engaging in injury-causing and wrongful market conduct in this District. - 2 - Case 1:19-cv-00552-UNA Document 1 Filed 03/22/19 Page 3 of 35 PageID #: 3 See Acorda Therapeutics, Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 759-60 (Fed. Cir. 2016), cert. denied, 137 S. Ct. 625, 196 L. Ed. 2d 580 (2017). 8. This Court has personal jurisdiction over Altan because, inter alia, upon information and belief, Altan has submitted New Drug Application (“NDA”) No. 209841 (the “Altan NDA”), claiming bioequivalence to Plaintiffs’ OFIRMEV® injectable acetaminophen product, and Altan is currently seeking nationwide approval of its proposed product. By a letter dated February 8, 2019 and received after that date (the “Altan Letter”), Altan stated that it had submitted NDA No. 209841 seeking approval to engage in the commercial manufacture, use, sale or offer for sale, and/or importation of Acetaminophen Solution for Infusion 10 mg/mL (the “Altan NDA Product”) prior to the expiration of the ’218 Patent. Altan’s submission of the Altan NDA constitutes infringement of the Patents-in-Suit pursuant to 35 U.S.C. § 271(e). Altan’s tortious act of infringing the Patents-in-Suit causes concrete harm to Plaintiffs. 9. This Court has personal jurisdiction over Altan because, inter alia, upon information and belief, Altan, through the submission of the Altan NDA, intends to commercially manufacture, use, import, market, offer for sale, and sell the Altan NDA Product throughout the United States, including in this District, in the event the United States Food and Drug Administration (“FDA”) approves the Altan NDA. 10. This Court has personal jurisdiction over Altan because, inter alia, upon information and belief, Altan is in the business of developing pharmaceutical drug products that it distributes in Europe, Latin America, and Asia, and intends to distribute in the United States, including in this District. 11. This Court has personal jurisdiction over Altan because, inter alia, upon information and belief, Altan, itself or through one of its business partners and/or affiliates, - 3 - Case 1:19-cv-00552-UNA Document 1 Filed 03/22/19 Page 4 of 35 PageID #: 4 intends to enter into agreements with pharmaceutical retailers, wholesalers, or distributors, providing for the distribution of its products throughout the United States, including in this District. 12. This Court has personal jurisdiction over Altan because, inter alia, upon information and belief, Altan, itself or through one of its business partners or affiliates, intends to distribute pharmaceutical drug products throughout the United States, including in this District. 13. This Court has personal jurisdiction over Altan because, inter alia, upon information and belief, Altan intends to sell pharmaceutical drug products in pharmacies throughout the United States, including in this District. 14. This Court has personal jurisdiction over Altan because, inter alia, upon information and belief, Altan intends to derive substantial revenue from selling various pharmaceutical drug products and doing business throughout the United States, including in this District. 15. Alternatively, this Court has jurisdiction over Altan under Federal Rule of Civil Procedure 4(k)(2)(A) because: (a) Plaintiffs’ claims arise under federal law; (b) Altan is a foreign defendant not subject to general personal jurisdiction in the Courts of any state; and (c) Altan has sufficient contacts with the United States as a whole, not least through its commercialization of a drug in the United States, such that this Court’s exercise of jurisdiction over Altan satisfies due process. 16. Venue is proper in this judicial district under 28 U.S.C. §§ 1391(c)(3) and/or 1400(b). Upon information and belief, Altan is a foreign entity that may be sued in any judicial district in the United States in which it is subject to the Court’s personal jurisdiction. As set forth supra, Altan is subject to the Court’s personal jurisdiction in this District. - 4 - Case 1:19-cv-00552-UNA Document 1 Filed 03/22/19 Page 5 of 35 PageID #: 5 17. This action involves patents that have already been at issue in prior actions before this Court. The ’218 Patent was at issue in the following exemplary actions: Cadence Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, No. 11-733; Cadence Pharmaceuticals, Inc. v. InnoPharma Licensing LLC, No. 14-1225; Mallinckrodt IP v. Mylan Laboratories Ltd., No. 14-1499; and Mallinckrodt IP v. B. Braun Medical Inc., No. 17-365. The ’012 Patent was previously at issue before this Court in the actions captioned Mallinckrodt IP v. InnoPharma Licensing LLC, No. 16-1116; Mallinckrodt IP v. Mylan Laboratories Ltd., No. 16-1115; and Mallinckrodt IP v. B. Braun Medical Inc., No. 17-365. The ’265 patent was previously at issue in the action captioned Mallinckrodt IP v. B. Braun Medical Inc., No. 17-660. The ’238 patent was previously at issue in the action captioned Mallinckrodt IP v. B. Braun Medical Inc., No. 18- 1090. THE PATENTS-IN-SUIT 18. The ’218 patent, titled “Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles,” was duly and legally issued by the United States Patent and Trademark Office (“PTO”) on January 31, 2006. Named inventors Francois Dietlin and Daniele Fredj assigned the application which issued as the ’218 patent to SCR Pharmatop (“Pharmatop”). 19. Pharmatop, which subsequently assigned the ’218 patent to New Pharmatop, granted an exclusive license to the ’218 patent to Bristol-Myers Squibb Company (“BMS”) with a right to sublicense. BMS granted Cadence (now Mallinckrodt Hospital Products) a sublicense, which was exclusive even to BMS, to the ’218 patent with regard to all rights pertinent hereto. As a result of the corporate restructuring following the purchase of Cadence by Mallinckrodt plc, Mallinckrodt Hospital Products IP is the exclusive sub-licensee of the ’218 patent. A true and correct copy of the ’218 patent is attached as Exhibit A. - 5 - Case 1:19-cv-00552-UNA Document 1 Filed 03/22/19 Page 6 of 35 PageID #: 6 20. Claim 1 of the ’218 patent recites: “[a] method for preparing an aqueous solution with an active nature susceptible to oxidation, which is paracetamol, while preserving for a prolonged period, comprising deoxygenation of the solution by bubbling with at least one inert gas and/or placing under vacuum, until the oxygen content is below 2 ppm, and optionally the aforementioned aqueous solution with an active principle is topped with an inert gas atmosphere heavier than air and placed in a closed container in which the prevailing pressure is 65,000 Pa maximum, and the oxygen content of the aqueous solution is below 2 ppm, and optionally the deoxygenation of the solution is completed by addition of an antioxidant.” 21.