NOVARTIS PHARMACEUTICALS CORPORATION, NOVARTIS PHARMA AG, and NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant.

05-CV-1887

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

2005 U.S. Dist. Ct. Pleadings 870112; 2008 U.S. Dist. Ct. Pleadings LEXIS 724

June 24, 2008

Complaint

COUNSEL:  [*1]  Andrew T. Berry, Jonathan M. H. Short, Mark H. Anania, MCCARTER & ENGLISH, LLP, 100 Mulberry Street, Newark, NJ 07102, Telephone: (973) 622-4444, Facsimile: (973) 624-7070, Attorneys for Plaintiffs, Novartis Pharmaceuticals Corporation, Novartis AG, Novartis Pharma AG and Novartis International Pharmaceutical Ltd.
 
Of Counsel: Robert L. Baechtold, Nicholas N. Kallas, Hugh C. Barrett, Simon D. Roberts, FITZPATRICK, CELLA, HARPER & SCINTO, 30 Rockefeller Plaza, New York, NY 10112-3801, Phone: (212) 218-2100, Facsimile: (212) 218-2200.

TITLE: FIRST AMENDED COMPLAINT AND DEMAND FOR JURY TRIAL

TEXT: Plaintiffs Novartis Pharmaceuticals Corporation, Novartis Pharma AG and Novartis International Pharmaceutical Ltd. (hereinafter collectively "Novartis"), for their First Amended Complaint for patent infringement herein against defendant Teva Pharmaceuticals USA, Inc. allege as follows:
PARTIES
1. Plaintiff Novartis Pharmaceuticals Corporation ("NPC") is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 59 Route 10, East Hanover, New Jersey 07936.
2. Plaintiff Novartis Pharma AG ("Novartis AG") is a corporation [*2]  organized and existing under the laws of Switzerland, having an office and place of business at Lichtstrasse 35, CH-4056 Basel, Switzerland.
3. Plaintiff Novartis International Pharmaceuticals Ltd. ("NIP") is a corporation organized and existing under the laws of Bermuda, having an office and place of business at Hurst Holme, 12 Trott Road, Hamilton HM LX, Bermuda.
4. On information and belief, Teva Pharmaceuticals USA, Inc. ("Teva USA") is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 1090 Horsham Road, P.O. Box 1090, North Wales, Pennsylvania 19454-1090. On information and belief, Teva USA is registered to do business in New Jersey, having appointed a registered agent in New Jersey, and having regular and established places of business at 92 Route 46 East, Elmwood Park, New Jersey 07407, and at 8/10 Gloria Lane, Fairfield, New Jersey 07004.
JURISDICTION AND VENUE
5. This action arises under the patent laws of the United States of America. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a).
6. Venue [*3]  is proper in this judicial district pursuant to 28 U.S.C. §§ 1391(b) and (c), and 28 U.S.C. § 1400(b).
CLAIM FOR PATENT INFRINGEMENT
7. Plaintiff NPC holds an approved new drug application ("NDA") No. 20-363 for Famvir(R) tablets (125 mg, 250 mg and 500 mg), which tablets contain the active ingredient famciclovir. Famvir(R) tablets are approved by the United States Food and Drug Administration ("FDA") for the treatment of acute herpes zoster (shingles), the treatment or suppression of recurrent genital herpes in immunocompetent patients and the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients. Famvir(R) tablets are sold in the United States by Plaintiff NPC.
8. The active ingredient in the Famvir(R) tablets, famciclovir, is known chemically as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate or 2-amino-9-(4-acetoxy-3-acetoxymethylbut-1-yl)purine.
9. Plaintiff NIP is the owner of United States Patent No. 5,246,937 ("the '937 patent"). The '937 patent was duly and legally issued on September 21, 1993.
10. The '937 patent claims 2-amino-9-(4-acetoxy-3-acetoxymethylbut-1-yl)purine,  [*4]  pharmaceutically acceptable salts thereof, and pharmaceutical compositions containing them, as well as methods of treating herpes virus infections. A true copy of the '937 patent is attached hereto as Exhibit A.
11. On information and belief, Teva USA submitted to the FDA an abbreviated new drug application ("ANDA") under the provisions of 21 U.S.C. § 355(j), seeking approval to engage in the commercial manufacture, use, and sale of famciclovir 125 mg, 250 mg and 500 mg tablets.
12. On information and belief, Teva USA submitted its ANDA to the FDA for the purpose of obtaining approval to engage in the commercial manufacture, use, or sale of its famciclovir 125 mg, 250 mg and 500 mg tablets before the expiration of the '937 patent.
13. On information and belief, Teva USA made, and included in its ANDA, a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) ("Paragraph IV") that, in its opinion and to the best of its knowledge, the '937 patent is invalid or will not be infringed.
14. The relevant statute (21 U.S.C. § 355(j)(2)(B)(iv)(II)) requires that a notice of the Paragraph IV certification ("Notice Letter")  [*5]  "include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed." The FDA Rules and Regulations (21 C.F.R. § 314.95(c)(6)) further require that the detailed statement include "[f]or each claim of a patent alleged to be invalid or unenforceable, a full and detailed explanation of the grounds supporting the allegation."
15. On information and belief, on or about February 22, 2005, Teva USA sent a Notice Letter, purporting to comply with the provisions of 21 U.S.C. § 355(j)(2)(B) and the FDA regulations relating thereto, to Novartis Corporation, Novartis International AG, and Plaintiffs NPC and NIP.
16. In the Notice Letter, Teva USA did not provide the detailed statement required by, and therefore failed to comply with, the statutory provisions set forth in paragraph 14, above, as to the '937 patent.
17. On information and belief, when Teva USA filed its ANDA, it was aware of the '937 patent and was aware that the filing of its ANDA with the request for its approval prior to the expiration of the '937 patent was an act of infringement of this patent.  [*6]  On information and belief, Teva was aware that it had the obligations to make a good faith evaluation and have a reasonable belief that the patent for which it is seeking approval is invalid, before submitting its Paragraph IV certification to the FDA representing that the '937 patent was invalid, and to provide detailed reasons supporting that assertion in its Notice Letter, but Teva USA failed to make that evaluation or provide the required detailed factual and legal bases in its Notice Letter.
18. By filing the ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, or sale of its proposed famciclovir 125 mg, 250 mg and 500 mg tablets before the expiration of the '937 patent, Teva USA has committed an act of infringement under 35 U.S.C. § 271(e)(2).
19. On information and belief, Teva USA's famciclovir 125 mg, 250 mg and 500 mg tablets were approved by the FDA on August 24, 2007 - the same day the 30-month FDA stay of approval expired. Teva's generic famciclovir products are approved for the same indications as Novartis' Famvir(R) products.
20. Teva USA proceeded at it own [*7]  risk to directly use, sell and offer to sell its famciclovir 125 mg, 250 mg and 500 mg tablets embodying the claimed inventions of the '937 patent within the United States after it gained FDA approval. On information and belief, on or before August 24, 2007 Teva USA began to import and/or commercially manufacture famciclovir 125 mg, 250 mg and 500 mg tablets. Since that date, Teva USA has marketed and sold its generic famciclovir tablets in the United States. These acts by Teva USA constitute direct infringement of compound and composition Claims 9 and 19 of the '937 patent.
21. Further, upon information and belief, Teva USA has induced and is actively inducing others to directly infringe method Claims 14-18 of the '937 patent. Specifically, Teva USA encourages others to sell, offer to sell, and/or use famciclovir 125 mg, 250 mg and 500 mg tablets within the United States through its distributors to nationwide retailers and various online distributors. Such uses occur at the active behest of Teva USA, and with Teva USA's intent, knowledge and encouragement. Specifically, Teva induces physicians to prescribe Teva's famciclovir tablets for the same indications as Novartis' Famvir(R)  [*8]  products, therefore inducing infringement of those method claims of the '937 patent under 35 U.S.C. § 271(b).
22. Novartis is entitled to an award of damages for the importation, manufacture, commercial sale and use in the United States of Teva USA's famciclovir 125 mg, 250 mg and 500 mg tablets.
23. Because Teva USA's infringement is willful, Novartis is entitled to an enhancement of the award of damages from Teva USA.
24. Moreover, this is an exceptional case and Novartis is entitled to an award of its reasonable attorney fees under 35 U.S.C. § 285.
PRAYER FOR RELIEF
WHEREFORE, Novartis respectfully requests the following relief:
A. Judgment that Teva USA has infringed Claims 9 and 14-19 of the '937 patent by filing the aforesaid ANDA relating to Teva USA's famciclovir 125 mg, 250 mg and 500 mg tablets;
B. Judgment that Teva USA has infringed and induced infringement of Claims 9 and 14-19 of the '937 patent by importing or commercially manufacturing, and by marketing and selling, Teva USA's famciclovir 125 mg, 250 mg and 500 mg tablets.
C. A permanent injunction restraining and enjoining Teva USA and its officers, agents,  [*9]  attorneys and employees, and those acting in privity or concert with it, from engaging in the commercial manufacture, use, offer to sell, or sale within the United States, or importation into the United States, of famciclovir 125 mg, 250 mg and 500 mg tablets as claimed in the '937 patent;
D. An order that Teva USA pay to Novartis damages in an amount adequate to compensate Novartis for those infringements;
E. Judgment that Teva's infringements have been willful, that this is an exceptional case under 35 U.S.C. § 285 and that Novartis is entitled to its costs and reasonable attorney fees;
F. An order that Teva USA pay to Novartis enhanced damages up to treble the amount as provided by 35 U.S.C. § 284;
G. An order that Teva USA must recall all of its unsold generic famciclovir product; and
H. Such other and further relief as the Court may deem just and proper.
JURY DEMAND
Pursuant to Fed. R. Civ. P. 38, Novartis hereby demands a trial by jury of all issues in this case that are so triable by right.
 
Dated: June 18, 2008
 
Of Counsel:
Robert L. Baechtold
Nicholas N. Kallas
Hugh [*10]  C. Barrett
Simon D. Roberts
FITZPATRICK, CELLA, HARPER
& SCINTO
30 Rockefeller Plaza
New York, NY 10112-3801
Phone: (212) 218-2100
Facsimile: (212) 218-2200
 
By: /s/ Andrew T. Berry
Andrew T. Berry
Jonathan M. H. Short
Mark H. Anania
MCCARTER & ENGLISH, LLP
100 Mulberry Street
Newark, NJ 07102
Telephone: (973) 622-4444
Facsimile: (973) 624-7070
Attorneys for Plaintiffs
Novartis Pharmaceuticals Corporation,
Novartis AG, Novartis Pharma AG and
Novartis International Pharmaceutical Ltd.

[SEE EXHIBIT A IN ORIGINAL]
CERTIFICATE OF SERVICE
The undersigned hereby certifies that true copies of Plaintiffs' First Amended Complaint and Demand for Jury Trial, were caused to be served on June 24, 2008, upon the following:
 
Counsel for Plaintiff TEVA PHARMACEUTICALS USA, INC.
 
By Overnight Mail and Email:
ROLAND H. SCHWILLINSKI
GOODWIN PROCTER LLP
EXCHANGE PLACE
53 STATE STREET
BOSTON, MA 02109
rschwillinski@goodwinprocter.com
 
By Electronic Filing, Overnight Mail, and Email:
MICHAEL E. PATUNAS
LITE, DEPALMA, GREENBERG & RIVAS, LLC
TWO GATEWAY CENTER
12TH FLOOR
NEWARK, NJ 07102
mpatunas@ldgrlaw.com [*11] 
 
Dated: June 24, 2008
 
Of Counsel:
Robert L. Baechtold
Nicholas N. Kallas
Hugh C. Barrett
Simon D. Roberts
FITZPATRICK, CELLA, HARPER
& SCINTO
30 Rockefeller Plaza
New York, NY 10112-3801
Phone: (212) 218-2100
Facsimile: (212) 218-2200
 
By: /s/ Andrew T. Berry
Andrew T. Berry
Jonathan M. H. Short
Mark H. Anania
MCCARTER & ENGLISH, LLP
100 Mulberry Street
Newark, NJ 07102
Telephone: (973) 622-4444
Facsimile: (973) 624-7070
Attorneys for Plaintiffs
Novartis Pharmaceuticals Corporation,
Novartis AG, Novartis Pharma AG and
Novartis International Pharmaceutical Ltd.