Free COMPLAINT - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SEPRACOR INC., UCB S.A., and UCB, INC., Plaintiffs, v. SYNTHON PHARMACEUTICALS, INC., SYNTHON HOLDING B.V., SYNTHON B.V., and SYNTHON LABORATORIES, INC. Defendants. ) ) ) ) ) ) ) ) ) ) )

C. A. No. __________

COMPLAINT FOR PATENT INFRINGEMENT Plaintiffs Sepracor Inc., UCB S.A. and UCB, Inc. (hereinafter "Plaintiffs") for their Complaint against Defendants Synthon Pharmaceuticals, Inc. ("Synthon Pharma"), Synthon Holding B.V. ("Synthon Holding"), Synthon B.V., ("Synthon")and Synthon Laboratories, Inc. ("Synthon Labs") (collectively, "Defendants") hereby allege as follows: PARTIES 1. Plaintiff Sepracor Inc. ("Sepracor") is a corporation organized and existing

under the laws of the State of Delaware having a principal place of business at 84 Waterford Drive, Marlborough, Massachusetts 01752. 2. Plaintiff UCB S.A. is a Belgium corporation having a principal place of

business at Allee de la Recherche 60, B-1070 Brussells, Belgium. 3. Plaintiff UCB, Inc. is a corporation organized and existing under the laws

of the State of Delaware having a principal place of business at 1950 Lake Park Drive, Smyrna, GA 30080.

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4.

Upon information and belief, Defendant Synthon Pharma is a North

Carolina corporation having a principal place of business at 9000 Development Drive, P.O. Box 110487, Research Triangle Park, North Carolina 27709. 5. Upon information and belief, Defendant Synthon Pharma, submitted

Abbreviated New Drug Application ("ANDA") No. 90-229 to the United States Food and Drug Administration ("FDA") under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)). 6. Upon information and belief, Defendant Synthon Pharma, itself and on behalf

of its parent Defendant Synthon Holding and its sister companies Defendants Synthon and Synthon Labs, manufactures and/or distributes numerous generic drugs for sale and use throughout the United States, including this judicial district. 7. Upon information and belief, Defendant Synthon Holding is a Dutch

entity having a principal place of business at Microweg 22, 6545 CM Nijmegen, Netherlands. 8. Upon information and belief, Defendant Synthon Holding is the ultimate

parent of Defendants Synthon Pharma, Synthon B.V., and Synthon Laboratories, Inc. 9. Upon information and belief, Defendant Synthon Holding, itself and through

its subsidiaries and agents Defendants Synthon, Synthon Labs, and Synthon Pharma, manufactures and/or distributes numerous generic drugs for sale and use throughout the United States, including this judicial district. 10. Upon information and belief, Defendant Synthon is a Dutch entity having a

principal place of business at Microweg 22, P.O. Box 7071, 6503 GN Nijmegen, Netherlands. 11. Upon information and belief, Defendant Synthon, itself and on behalf of its

parent Defendant Synthon Holding and its sister companies Defendants Synthon Pharma and

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Synthon Labs, manufactures and/or distributes numerous generic drugs for sale and use throughout the United States, including this judicial district. 12. Upon information and belief, Defendant Synthon Labs is a Virginia

corporation having a principal place of business at 7130 Heritage Village Plaza, Suite 201, Gainesville, Virginia 20155. 13. Upon information and belief, Defendant Synthon Labs, itself and on behalf of

its parent Defendant Synthon Holding and its sister companies Defendants Synthon and Synthon Pharma, manufactures and/or distributes numerous generic drugs for sale and use throughout the United States, including this judicial district. NATURE OF THE ACTION 14. This is a civil action for infringement of United States Patent No.

5,698,558 ("the `558 patent") (Exhibit A). This action is based upon the Patent laws of the United States, 35 U.S.C. § 100 et seq. JURISDICTION AND VENUE 15. This action arises under the patent laws of the United States of America,

Title 35, United States Code. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a). 16. This Court has personal jurisdiction over each of the Defendants by virtue of

the fact that, inter alia, each Defendant has committed, or aided, abetted, contributed to and/or participated in the commission of, the tortious act of patent infringement that has led to foreseeable harm and injury to Plaintiffs.
17.

Upon information and belief, this Court has personal jurisdiction over

Defendant Synthon Pharma by virtue of, inter alia, its systematic and continuous contacts with

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Delaware, including through its parent Synthon Holdings and its sister companies Synthon and Synthon Labs. 18. Upon information and belief, this Court has personal jurisdiction over

Defendant Synthon Holding by virtue of, inter alia, its systematic and continuous contacts with Delaware, including through its subsidiaries and agents Synthon, Synthon Pharma and Synthon Labs. 19. Upon information and belief, this Court has personal jurisdiction over

Defendant Synthon by virtue of, inter alia, its systematic and continuous contacts with Delaware, including through its parent Synthon Holdings and its sister companies Synthon Pharma and Synthon Labs. 20. Upon information and belief, this Court has personal jurisdiction over

Defendant Synthon Labs by virtue of, inter alia, its systematic and continuous contacts with Delaware, including through its parent Synthon Holdings and its sister companies Synthon Pharma and Synthon. 21. 1400(b). THE PATENT-IN-SUIT 22. On December 16, 1997, the United States Patent and Trademark Office Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and

("the PTO") issued the `558 patent, titled "Methods for Treating Allergic Disorders Using Optically Pure (-) Cetirizine," to Sepracor Inc., the assignee of the named inventor Nancy M. Gray. 23. Plaintiff Sepracor is the record owner of the `558 patent.

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24. of the `558 patent. 25.

Plaintiff UCB S.A. (and its subsidiary UCB Inc.) is the exclusive licensee

On May 25, 2007, the FDA approved New Drug Application ("NDA")

No. 022064 for levocetirizine dihydrochloride 5 mg tablets. 26. UCB Inc. is the holder of NDA No. 022064 for levocetirizine

dihydrochloride 5 mg tablets, which it sells under the registered name XYZAL®. 27. The `558 patent is listed in the Approved Drug Products with Therapeutic

Equivalence Evaluations ("Orange Book") as covering XYZAL®.

ACTS GIVING RISE TO THIS ACTION COUNT I ­ INFRINGEMENT OF THE `558 PATENT BY DEFENDANTS SYNTHON PHARMA, SYNTHON LABS, SYNTHON HOLDING, AND SYNTHON 28. Upon information and belief, Defendant Synthon Pharma, submitted ANDA

No. 90-229 to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)). ANDA No. 90-229 seeks FDA approval for the commercial manufacture, use and sale of a generic tablet product containing 5 mg of levocetirizine dihydrochloride ("the Synthon Generic Product") ANDA No. 90-229 specifically seeks FDA approval to market the Synthon Generic Product prior to the expiration of the `558 patent. 29. Upon information and belief, Defendant Synthon Pharma submitted ANDA

No. 90-229 on behalf of its parent Synthon Holding and its sister companies Synthon Labs and Synthon. 30. Plaintiffs have received a letter dated February 28, 2008 from Synthon

Pharmaceuticals notifying them that Synthon's ANDA No. 90-229 included a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a "Paragraph IV Certification") that, in Synthon's opinion, the

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`558 patent is invalid, unenforceable or will not be infringed by the commercial manufacture, use or sale of the levocetirizine products described in ANDA No. 90-229. 31. Plaintiffs commenced this action within 45 days of the date they received

Synthon's notice of ANDA No. 90-229 containing the Paragraph IV certification. 32. Synthon Pharma's submission of ANDA No. 90-229 to the FDA with a

Paragraph IV Certification constitutes infringement of the `558 patent under 35 U. S.C. § 271 (e)(2). Moreover, if Synthon Pharma commercially manufactures, uses, offers to sell, sells, or imports any of the Synthon Generic Products, or induces or contributes to any such conduct, it would further infringe the `558 patent under 35 U.S.C. § 27 1(a), (b) and/or (c). 33. Synthon Labs is jointly and severally liable for any infringement of the `558

patent. Upon information and belief, Synthon Labs participated in, contributed to, aided, abetted and/or induced Synthon Pharma's submission of ANDA No. 90-229 and its Paragraph IV Certification allegations to the FDA. 34. Synthon Labs' participation in, contribution to, aiding, abetting and/or

inducement of the submission of ANDA No. 90-229 and its Paragraph IV Certification allegations to the FDA constitutes infringement of the `558 patent under 35 U.S.C. § 271(e)(2). Moreover, if Synthon Labs commercially manufactures, uses, offers to sell, sells, or imports any of the Synthon Generic Products, or induces or contributes to any such conduct, it would further infringe the `558 patent under 35 U.S.C. § 27 1(a), (b) and/or (c). 35. Synthon Holding is jointly and severally liable for any infringement of the

`558 patent. Upon information and belief, Synthon Holding participated in, contributed to, aided, abetted and/or induced Synthon Labs' submission of ANDA No. 90-229 and its Paragraph IV Certification allegations to the FDA.

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36.

Synthon Holding's participation in, contribution to, aiding, abetting and/or

inducement of the submission of ANDA No. 90-229 and its Paragraph IV Certification allegations to the FDA constitutes infringement of the `558 patent under 35 U.S.C. § 271(e)(2)(A). Moreover, if Synthon Holding commercially manufactures, uses, offers to sell, sells, or imports any of the Synthon Generic Products, or induces or contributes to any such conduct, it would further infringe the `558 patent under 35 U.S.C. § 27 1(a), (b), (c) and/or (f). 37. Synthon is jointly and severally liable for any infringement of the `558

patent. Upon information and belief, Synthon participated in, contributed to, aided, abetted and/or induced Synthon Labs' submission of ANDA No. 90-229 and its Paragraph IV Certification allegations to the FDA. 38. Synthon's participation in, contribution to, aiding, abetting and/or

inducement of the submission of ANDA No. 90-229 and its Paragraph IV Certification allegations to the FDA constitutes infringement of the `558 patent under 35 U.S.C. § 271(e)(2)(A). Moreover, if Synthon commercially manufactures, uses, offers to sell, sells, or imports any of the Synthon Generic Products, or induces or contributes to any such conduct, it would further infringe the `558 patent under 35 U.S.C. § 271(a), (b), (c) and/or (f). 39. No. 90-229. 40. 41. Defendants' actions render this an exceptional case under 35 U.S.C. § 285. Plaintiffs will be irreparably harmed by Defendants' infringing activities Defendants were aware of the `558 patent prior to filing ANDA

unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law. PRAYER FOR RELIEF WHEREFORE, Plaintiffs pray for judgment as follows: A. That all Defendants have infringed the `558 patent;

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B.

That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval

of Defendants' ANDA identified in this Complaint shall not be earlier than the expiration date of the `558 patent, including any extensions; C. That Defendants, their officers, agents, servants and employees, and those

persons in active concert or participation with any of them, be preliminarily and permanently enjoined from commercially manufacturing, using, offering for sale, selling, or importing any of the proposed generic versions of Plaintiffs' XYZAL® product identified in this Complaint and any other product that infringes or induces or contributes to the infringement of the `558 patent, prior to the expiration of the `558 patent, including any extensions; D. E. That this case is exceptional under 35 U.S.C. § 285; That Plaintiffs be awarded the attorney fees, costs and expenses that they

incur prosecuting this action; and F. just and proper. MORRIS, NICHOLS, ARSHT & TUNNELL LLP That Plaintiffs be awarded such other and further relief as this Court deems

/s/ Mary B. Graham
___________________________________ Mary B. Graham (#2256) James W. Parrett, Jr. (#4292) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] Attorneys for Sepracor Inc., UCB S.A. and UCB, Inc.

OF COUNSEL: Gregory L. Diskant Jeffrey I.D. Lewis Melissa Mandrgoc PATTERSON BELKNAP WEBB & TYLER LLP 1133 Avenue of the Americas New York, NY 10036 (212) 336-2000 Dated: April 10, 2008
2289450

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EXHIBIT A

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