Free Complaint - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE : : : : : : : Civil Action No.: ___________ : : : : :

CIMA LABS, INC., AZUR PHARMA LIMITED, and AZUR PHARMA INTERNATIONAL III LIMITED, Plaintiffs, vs. BARR LABORATORIES, INC and BARR PHARMACEUTICALS, INC., Defendants.

COMPLAINT FOR PATENT INFRINGEMNT Plaintiffs CIMA LABS, INC. ("CIMA"), Azur Pharma Limited and Azur Pharma International III Limited (jointly with Azur Pharma Limited, "Azur") (collectively with CIMA, "Plaintiffs"), by and through their undersigned attorneys, for their Complaint against Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc. (jointly "Barr" or "Defendants"), allege as follows: THE PARTIES 1. Plaintiff CIMA is a corporation organized and existing under the laws of

Delaware, having its principal place of business at 10000 Valley View Road, Eden Prairie, Minnesota 55344. 2. Plaintiff Azur Pharma Limited is a limited company organized and existing under

the laws of Ireland, having a principal place of business at 45 Fitzwilliam Square, Dublin 2, Ireland. 3. Azur Pharma International III Limited is a limited liability company organized

and existing under the laws of Bermuda, having a principal place of business at Clarendon

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House, 2 Church Street, Hamilton, Bermuda HM11. 4. Upon information and belief, defendant Barr Laboratories, Inc. is a corporation

organized and existing under the laws of Delaware, having its principal place of business at 225 Summit Avenue, Montvale, NJ 07645. 5. Upon information and belief, defendant Barr Pharmaceuticals, Inc. is a

corporation organized and existing under the laws of Delaware, having its principal place of business at 225 Summit Avenue, Montvale, NJ 07645. Upon information and belief, Barr Pharmaceuticals, Inc. controls, directs, and/or dominates the actions of Barr Laboratories, Inc. 6. Upon information and belief, Barr manufactures numerous generic drugs for sale

and use throughout the United States, including in this judicial district, itself and through its affiliates. NATURE OF THE ACTION 7. This is a civil action for patent infringement arising under the Patent Laws of the

United States, 35 U.S.C. § 1 et seq. JURISDICTION AND VENUE 8. This Court has jurisdiction over the subject matter of this action pursuant to 28

U.S.C. §§ 1331, 1338(a), 2201 and 2202. 9. Barr is subject to personal jurisdiction in this judicial district by virtue of, inter

alia, its incorporation under the laws of Delaware, its conduct of business in this State, its purposeful availment of the rights and benefits of Delaware law and its systematic and continuous contacts with the State. 10. Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391(b) and/or

(c) and/or 1400(b). 2
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ACTS GIVING RISE TO CLAIMS FOR PATENT INFRINGEMENT 11. On February 15, 2000, the United States Patent and Trademark Office issued U.S.

Patent No. 6,024,981, entitled "Rapidly Dissolving Robust Damage Form" (the "'981 patent"). A copy of the '981 patent is attached as Exhibit A. 12. An ex parte reexamination of the '981 patent was requested on or

about August 22, 2005 (Control No. 90/007,684), and reexamination was ordered on or about October 7, 2005. A second ex parte reexamination of the '981 patent was filed on or about September 7, 2006 (Control No. 90/008,133), and reexamination was ordered on or about September 28, 2006. The two ex parte reexaminations of the '981 patent were consolidated on or about January 8, 2007. 13. With respect to the `981 reexamination, a final Office Action was issued by the

patent examiner on July 6, 2007. CIMA filed a response to that Office Action on September 6, 2007. On December 5, 2007, CIMA filed a Notice of Appeal and supporting brief traversing the patent examiner's final office action. The patent examiner filed an Answer to CIMA's brief on March 20, 2008, and CIMA filed its Reply brief on May 20, 2008. CIMA has also requested oral argument before the Board of Patent Appeals and Interferences ("BPAI"). 14. By way of assignment from the original inventors, CIMA owns all rights, title and

interest in and to the '981 patent, including the right to sue and recover for patent infringement. 15. On April 24, 2001, the United States Patent and Trademark Office issued U.S.

Patent No. 6,221,392, entitled "Rapidly Dissolving Robust Damage Form" (the "'392 patent"). A copy of the '392 patent is attached as Exhibit B. 16. An inter partes reexamination of the '392 patent was filed on July 28, 2006

(Control No. 95/000,160) by KV Pharmaceutical, and reexamination was ordered on or about 3
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September 13, 2006. 17. With regard to the inter partes reexamination of the '392 patent, the patent On October 18, 2007, CIMA

examiner issued an office action on September 18, 2007.

responded to the examiner's office action and subsequently, on November 23, 2007, KV Pharmaceutical filed an additional response. On April 10, 2008 the patent examiner issued a Right of Appeal Notice. On May 29, 2008, CIMA filed a Notice of Appeal, and on July 29, 2008, CIMA filed its Appeal Brief. 18. By way of assignment from the original inventors, CIMA owns all rights, title and

interest in and to the '392 patent, including the right to sue and recover for patent infringement. 19. Azur Pharma Limited is the exclusive licensee to the '981 and '392 patents for

clozapine orally disintegrating tablets in the United States. Under the exclusive license, CIMA manufactures FAZACLOTM, a clozapine product, for Azur. As the licensee of the `981 and `392 patents with regard to products containing various amounts of clozapine, Azur Pharma Limited has standing to sue Barr for patent infringement. 20. The '981 patent and '392 patent (sometimes collectively referred to as the

"patents in suit") are listed, by Azur International III Limited, holder of NDA No. 21-590, in a publication known as the Orange Book (formally entitled Approved Drug Products with Therapeutic Equivalence Evaluations) as covering FAZACLOTM, clozapine orally disintegrating tablets in 12.5 mg, 25 mg and 100 mg dosages. As holder of NDA No. 21-590 covering FAZACLOTM, clozapine orally disintegrating tablets in 12.5 mg, 25 mg and 100 mg dosages, Azur International III Limited has standing to sue Barr for patent infringement. 21. Upon information and belief, Barr submitted to the United States Food and Drug

Administration ("FDA") Abbreviated New Drug Application ("ANDA") No. 90-308 under the 4
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Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j). Through this ANDA, Barr seeks the approval of the FDA necessary to engage in the commercial manufacture, use, offer for sale and sale of generic versions of clozapine orally disintegrating tablets in 25 mg and 100 mg dosages. ANDA No. 90-308 specifically seeks FDA approval of the proposed generic versions prior to the expiration of the patents in suit. 22. No earlier than July 14, 2008, Plaintiffs received a letter from Barr notifying them

that ANDA No. 90-308 containing a Paragraph IV Certification had been submitted to the FDA ("Paragraph IV Notice Letter"). The Paragraph IV Notice Letter and, upon information and belief, ANDA No. 90-308, allege that the '981 patent and the '392 patent are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the generic versions of clozapine orally disintegrating products for which Barr seeks FDA approval. 23. Plaintiffs have commenced this action within forty-five (45) days of receipt of the

Paragraph IV Notice Letter. COUNT ONE INFRINGEMENT OF THE '981 PATENT 24. Plaintiffs repeat and reallege each and every allegation contained in the foregoing

paragraphs as though fully set forth herein. 25. Upon information and belief and subject to F.R.C.P. 11(b)(3), Defendants'

submission of ANDA No. 90-308 to the FDA constitutes infringement of the '981 patent under 35 U.S.C. § 271(e)(2)(A). 26. Upon information and belief and subject to F.R.C.P. 11(b)(3), Defendants'

manufacture, use, offer for sale and/or sale (including in Delaware) of their proposed generic versions for which Defendants seek approval from the FDA under ANDA No. 90-308 will 5
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infringe, contribute to the infringement of and induce the infringement of one or more of the claims of the '981 patent. 27. Upon information and belief and subject to F.R.C.P. 11(b)(3), Defendants were

aware at the time of submission of ANDA No. 90-308 and continue to be aware that the proposed generic versions for which Defendants seek approval from the FDA under ANDA No. 90-308, if approved, will be made, used and/or sold (including in Delaware) in contravention of Plaintiffs' rights in and to the '981 patent. 28. Upon information and belief and subject to F.R.C.P. 11(b)(3), the conduct by Barr

renders this case "exceptional" as described in 35 U.S.C. § 285. 29. Plaintiffs will be irreparably harmed if the infringing activities of Barr in relation

to the '981 patent are not enjoined by this Court. Plaintiffs do not have an adequate remedy at law. COUNT TWO INFRINGEMENT OF THE '392 PATENT 30. Plaintiffs repeat and reallege each and every allegation contained in the foregoing

paragraphs as though fully set forth herein. 31. Upon information and belief and subject to F.R.C.P. 11(b)(3), Defendants'

submission of ANDA No. 90-308 to the FDA constitutes infringement of the '392 patent under 35 U.S.C. § 271(e)(2)(A). 32. Upon information and belief and subject to F.R.C.P. 11(b)(3), Defendants'

manufacture, use, offer for sale and/or sale (including in Delaware) of their proposed generic versions for which Defendants seek approval from the FDA under ANDA No. 90-308 will infringe, contribute to the infringement of and induce the infringement of one or more of the 6
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claims of the '392 patent. 33. Upon information and belief and subject to F.R.C.P. 11(b)(3), Defendants were

aware at the time of submission of ANDA No. 90-308 and continue to be aware that the proposed generic versions for which Defendants seek approval from the FDA under ANDA No. 90-308, if approved, will be made, used and/or sold (including in Delaware) in contravention of Plaintiffs' rights in and to the '392 patent. 34. Upon information and belief and subject to F.R.C.P. 11(b)(3), the conduct by Barr

renders this case "exceptional" as described in 35 U.S.C. § 285. 35. Plaintiffs will be irreparably harmed if the infringing activities of Barr in relation

to the '392 patent are not enjoined by this Court. Plaintiffs do not have an adequate remedy at law. PRAYER FOR RELIEF WHEREFORE, Plaintiffs respectfully request the following relief: A. A judgment that Defendants have infringed the patents in suit by submission of

ANDA No. 90-308 and that the manufacture, use, offer for sale or sale of the generic versions proposed by Defendants to the FDA in ANDA No. 90-308, if marketed, would infringe, induce or contribute to the infringement of the patents in suit; B. An order pursuant to 35 U.S.C. § 271(e)(4)(A) decreeing the effective date of any

approval of ANDA No. 90-308 be subsequent to the date of the last to expire of the patents in suit; C. A preliminary and permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B)

prohibiting Barr, its officers, agents, attorneys, and employees and those acting in active concert or participation with any of them, from engaging in the commercial manufacture, use, offer for 7
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sale, sale or importation of the generic versions proposed by Defendants to the FDA in ANDA No. 90-308 or any other product that infringes, induces or contributes to the infringement of one or more of any of the claims in the patents in suit prior to expiration, including any extensions; D. Monetary relief and damages, including damages for willful infringement,

pursuant to 35 U.S.C. § 284, if the Defendants commercially manufacture, use, offer for sale or sell the generic versions proposed by Defendants to the FDA in ANDA No. 90-308 or any other product that infringes, induces or contributes to the infringement of one or more of any of the claims in the patents in suit prior to expiration, including any extensions; E. A declaration that this case is exceptional under 35 U.S.C. § 271(e)(4)(C) and 35

U.S.C. § 285 and an award of attorneys' fees, costs and expenses to Plaintiffs; F. Such other and further relief as this Court may deem just and proper.

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MCCARTER & ENGLISH, LLP /s/ Daniel M. Silver Michael P. Kelly (DE ID # 2295) Andrew S. Dupre (DE ID # 4621) Daniel M. Silver (DE ID # 4758) Renaissance Centre 405 N. King Street, 8th Floor Wilmington, DE 19801 (302) 984-6300 (302) 984-6399 (fax) [email protected] [email protected] [email protected] Attorneys for CIMA LABS, INC.

ASHBY & GEDDES /s/ Steven J. Balick Steven J. Balick (DE ID # 2114) John G. Day (DE ID # 2403) Lauren E. Maguire (DE ID # 4261) 500 Delaware Avenue, 8th Floor PO. Box 1150 Wilmington, DE 19899 (302) 654-1888 (302) 654-2067 (fax) [email protected] jday@ ashby-geddes.com lmaguire@ ashby-geddes.com Neil F. Greenblum Michael J. Fink Stephen M. Roylance P. Branko Pejic GREENBLUM & BERNSTEIN, P.L.C. 1950 Roland Clarke Place Reston, VA 20191 Telephone: (703) 716-1191 Facsimile: (703) 716-1180 [email protected] [email protected] [email protected] [email protected] Attorneys for Azur Pharma Limited and Azur International III Limited

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SECTION I. - PLAINTIFFS' ATTORNEY'S INFORMATION Attorneys for CIMA LABS, INC. MCCARTER & ENGLISH LLP Michael P. Kelly (DE ID# 2295) Andrew S. Dupre (DE ID# 4621) Daniel M. Silver (DE ID# 4758) Renaissance Centre 405 N. King Street, 8th Floor Wilmington, DE 19801 (302) 984-6300 (302) 984-6399 (fax) [email protected] [email protected] [email protected] Attorneys for Azur Pharma Limited and Azur International III Limited ASHBY & GEDDES, P.A. Steven J. Balick (DE ID # 2114) 500 Delaware Avenue, 8th Floor PO. Box 1150 Wilmington, DE 19899 (302) 654-1888 (302) 654-2067 (fax) [email protected]

SECTION VIII. - RELATED CASES
CIMA Labs Inc., et. al. v. KV Pharmaceutical Co., et. al., No. 03-cv-02477-JNE-JSM (D. Minn. filed Mar. 17, 2003) CIMA Labs Inc. v. KALI Laboratories, Inc., No. 06-cv-01970-DRD-MAS (D. N.J. filed Apr. 28, 2006) CIMA Labs Inc. et. al. v. Actavis Group, HF., et. al., No. 07-cv-00893-DRD-ES (D. N.J. filed Feb. 23, 2007)

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