Source: https://www.scribd.com/doc/149850876/Pfizer-Et-Al-v-Sandoz
Timestamp: 2017-04-25 00:01:30
Document Index: 380635160

Matched Legal Cases: ['§ 1331', '§ 1391', 'Application No. 022030', '§ 355', '§ 355', '§ 355', '§\n271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 285', '§ 271', '§ 505', '§ 355', '§ 285']

ScribdBrowseInterestsPolitics & Current AffairsCareer & MoneyPersonal GrowthFictionHealth & FitnessLifestyleEntertainmentBiographies & HistoryScience & TechBrowse byBooksAudiobooksNews & MagazinesSheet MusicBrowse allUploadSign inJoinPfizer Et. Al. v. SandozUploaded by PatentBlast0.0 (0)DownloadEmbedDescription: Pfizer et. al. v. SandozView MorePfizer et. al. v. SandozCopyright: Attribution Non-Commercial (BY-NC)Download as PDF, TXT or read online from ScribdFlag for inappropriate contentIN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC.and UCB PHARMA GMBH, Plaintiffs, v. SANDOZ INC., Defendant. ) ) ) ) ) C.A. No. ) ) ) )
COMPLAINT Plaintiffs Pfizer Inc. and UCB Pharma GmbH (collectively, “Plaintiffs”), by their undersigned attorneys, for their Complaint against Defendant Sandoz Inc. (“Sandoz”) allege: NATURE OF THE ACTION 1. This is an action for patent infringement under the patent laws of the
United States, Title 35 of the United States Code, arising from Sandoz’s filing of an Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug Administration (“FDA”), by which Sandoz seeks approval to market a generic version of Pfizer Inc.’s pharmaceutical product, Toviaz®, prior to the expiration of United States Patent Nos. 6,858,650 (“the ‘650 patent”), 7,384,980 (“the ‘980 patent”), 7,855,230 (“the ‘230 patent”), 7,985,772 (“the ‘772 patent”), and 8,338,478 (“the ‘478 patent”), which cover, inter alia, Toviaz® and/or its use. THE PARTIES 2. Plaintiff Pfizer Inc. (“Pfizer”) is a corporation organized and existing
under the laws of Germany, having a place of business at Alfred-Nobel-Strasse 10, Monheim, Germany 40789. 4. On information and belief, Sandoz is a company organized and existing
under the laws of the State of Colorado, having a principal place of business at 506 Carnegie Center, Suite 400, Princeton, New Jersey, 08540. On information and belief, Sandoz is in the business of making and selling generic pharmaceutical products, which it distributes in the State of Delaware and throughout the United States. On further information and belief, Sandoz has previously admitted that it is subject to this Court’s jurisdiction and has previously submitted to this Court’s jurisdiction. Sandoz has purposefully availed itself of the jurisdiction of this Court by, inter alia, asserting counterclaims in lawsuits filed against it in this District. JURISDICTION AND VENUE 5. This Court has subject matter jurisdiction over this action pursuant to 28
U.S.C. §§ 1331 and 1338(a). 6. This Court has personal jurisdiction over Sandoz by virtue of, inter alia, its
presence in Delaware, having conducted business in Delaware and having derived sybstantial revenue therefrom, having availed itself of the rights and benefits of Delaware law, previously consenting to personal jurisdiction in this Court, availing itself of the jurisdiction of this Court, and having engaged in systematic and continuous contacts with the State of Delaware. 7. 1400(b). THE PATENTS-IN-SUIT 8. issued the ‘650 On February 22, 2005, the United States Patent and Trademark Office patent, entitled “Stable 2 Salts of Novel Derivatives of 3,3Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and
Diphenylpropylamines.” At the time of its issue, the ‘650 patent was assigned to Schwarz Pharma AG. UCB, formerly known as Schwarz Pharma AG, currently holds title to the ‘650 patent, a copy of which is attached to this Complaint as Exhibit A. Pfizer is the exclusive licensee of the ‘650 patent. 9. On June 10, 2008, the United States Patent and Trademark Office issued
issued the ‘478 patent, entitled “Derivatives of 3,3-Diphenylpropylamines.” At the time of its issue, the ‘478 patent was assigned to UCB, which currently holds title to the ‘478 patent. A
copy of the ‘478 patent is attached to this Complaint as Exhibit E. Pfizer is the exclusive licensee of the ‘478 patent. TOVIAZ® 13. Pfizer holds approved New Drug Application No. 022030 (“the Toviaz®
NDA”) for fesoterodine fumarate extended-release tablets, in 4 and 8 mg dosage strengths, which Pfizer sells under the trade name, Toviaz®. 14. Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the
‘650, ‘980, ‘230, ‘772, and ‘478 patents are listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to Toviaz®. SANDOZ’S ANDA 15. On information and belief, Sandoz has submitted ANDA No. 204844
(“Sandoz’s ANDA”) to the FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market fesoterodine fumarate extended-release tablets in 4 and 8 mg dosage strengths (“Sandoz’s Product”). 16. On information and belief, Sandoz’s ANDA refers to and relies upon the
Toviaz® NDA and contains data that, according to Sandoz, demonstrate the bioequivalence of Sandoz’s Product and Toviaz®. 17. By letter to Pfizer and UCB, dated May 9, 2013, Sandoz stated that
Sandoz’s ANDA contained certifications, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that the ‘650, ‘980, ‘230, ‘772, and ‘478 patents are invalid, unenforceable, or will not be infringed by the commercial manufacture, use, or sale of Sandoz’s Product (the “Paragraph IV Certifications”). Sandoz attached a memorandum to its May 9, 2013 letter, in which it alleged factual and legal bases for its Paragraph IV Certifications. 4
paragraphs 1-17 of this Complaint. 19. Sandoz has infringed the ‘650 patent, pursuant to 35 U.S.C. §
271(e)(2)(A), by submitting Sandoz’s ANDA, by which Sandoz seeks approval from the FDA to sell, offer to sell, use, and/or engage in the commercial manufacture of Sandoz’s Product prior to the expiration of the ‘650 patent. 20. Sandoz’s sale, offer for sale, use, or commercial manufacture, of Sandoz’s
Product within the United States, or importation of Sandoz’s Product into the United States, during the term of the ‘650 patent would infringe the ‘650 patent under 35 U.S.C. §§ 271(a), (b), and/or (c). 21. Plaintiffs will be harmed substantially and irreparably if Sandoz is not
paragraphs 1-17 of this Complaint. 25. Sandoz has infringed the ‘980 patent, pursuant to 35 U.S.C.
§ 271(e)(2)(A), by submitting Sandoz’s ANDA, by which Sandoz seeks approval from the FDA to sell, offer to sell, use, and/or engage in the commercial manufacture of Sandoz’s Product prior to the expiration of the ‘980 patent.
Sandoz’s sale, offer for sale, use, or commercial manufacture, of Sandoz’s
Product within the United States, or importation of Sandoz’s Product into the United States, during the term of the ‘980 patent would infringe the ‘980 patent under 35 U.S.C. §§ 271(a), (b), and/or (c). 27. Plaintiffs will be harmed substantially and irreparably if Sandoz is not
paragraphs 1-17 of this Complaint. 31. Sandoz has infringed the ‘230 patent, pursuant to 35 U.S.C.
§ 271(e)(2)(A), by submitting Sandoz’s ANDA, by which Sandoz seeks approval from the FDA to sell, offer to sell, use, and/or engage in the commercial manufacture of Sandoz’s Product prior to the expiration of the ‘230 patent. 32. Sandoz’s sale, offer for sale, use, or commercial manufacture, of Sandoz’s
Product within the United States, or importation of Sandoz’s Product into the United States, during the term of the ‘230 patent would infringe the ‘230 patent under 35 U.S.C. §§ 271(a), (b), and/or (c). 33. Plaintiffs will be harmed substantially and irreparably if Sandoz is not
enjoined from infringing the ‘230 patent. 34. Plaintiffs have no adequate remedy at law.
paragraphs 1-17 of this Complaint. 37. Sandoz has infringed the ‘772 patent, pursuant to 35 U.S.C.
§ 271(e)(2)(A), by submitting Sandoz’s ANDA, by which Sandoz seeks approval from the FDA to sell, offer to sell, use, and/or engage in the commercial manufacture of Sandoz’s Product prior to the expiration of the ‘772 patent. 38. Sandoz’s sale, offer for sale, use, or commercial manufacture, of Sandoz’s
Product within the United States, or importation of Sandoz’s Product into the United States, during the term of the ‘772 patent would infringe the ‘772 patent under 35 U.S.C. §§ 271(a), (b), and/or (c). 39. Plaintiffs will be harmed substantially and irreparably if Sandoz is not
paragraphs 1-17 of this Complaint. 43. Sandoz has infringed the ‘478 patent, pursuant to 35 U.S.C.
§ 271(e)(2)(A), by submitting Sandoz’s ANDA, by which Sandoz seeks approval from the FDA
to sell, offer to sell, use, and/or engage in the commercial manufacture of Sandoz’s Product prior to the expiration of the ‘478 patent. 44. Sandoz’s sale, offer for sale, use, or commercial manufacture, of Sandoz’s
Product within the United States, or importation of Sandoz’s Product into the United States, during the term of the ‘478 patent would infringe the ‘478 patent under 35 U.S.C. §§ 271(a), (b), and/or (c). 45. Plaintiffs will be harmed substantially and irreparably if Sandoz is not
award of attorneys’ fees under 35 U.S.C. § 285. PRAYER FOR RELIEF WHEREFORE, Plaintiffs pray for a judgment in their favor and against Sandoz and respectfully request the following relief: A. B. C. D. E. F. A judgment that Sandoz has infringed the ‘650 patent; A judgment that Sandoz has infringed the ‘980 patent; A judgment that Sandoz has infringed the ‘230 patent; A judgment that Sandoz has infringed the ‘772 patent; A judgment that Sandoz has infringed the ‘478 patent; A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B) preliminarily and
permanently enjoining Sandoz, its officers, agents, servants, and employees, and those persons in active concert or participation with any of them, from manufacturing, using, offering to sell, or selling Sandoz’s Product within the United States, or importing Sandoz’s Product into the United
effective date of any approval of ANDA No. 204844, under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)), shall not be earlier than the expiration of the ‘650, ‘980, ‘230, ‘772, and ‘478 patents, including any extensions; H. If Sandoz commercially manufactures, uses, offers to sell, or sells
Sandoz’s Product within the United States, or imports Sandoz’s Product into the United States, prior to the expiration of any of the ‘650, ‘980, ‘230, ‘772, and ‘478 patents, including any extensions, a judgment awarding Pfizer monetary relief, together with interest; I. § 285; J. K. Costs and expenses in this action; and Such other relief as the Court deems just and proper. MORRIS, NICHOLS, ARSHT & TUNNELL LLP Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C.
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