ME1 11814121v.1

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

William J. O’Shaughnessy 

MCCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry St. 

Newark, NJ 07102 

Tel: (973) 622-4444 

Fax: (973) 624-7070 

OF COUNSEL: 

Dominick A. Conde 

Brian V. Slater 

Steven C. Kline 

John D. Carlin 

Joanna Garelick Goldstein 

FITZPATRICK, CELLA, HARPER 

& SCINTO 

1290 Avenue of the Americas 

New York, NY 10104 

Tel: (212) 218-2100 

Fax: (212) 218-2200 

Attorneys for Plaintiff 

Warner Chilcott Company, LLC 

WARNER CHILCOTT COMPANY, LLC, 

 Plaintiff, 

 v. 

MYLAN INC., MYLAN PHARMACEUTICALS 

INC. and FAMY CARE LTD., 

 Defendants. 

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C. A. No. 

COMPLAINT FOR PATENT INFRINGEMENT 

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Plaintiff Warner Chilcott Company, LLC, by its undersigned attorneys, brings this 

action against Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Famy Care Ltd. 

(collectively “Defendants”), and hereby alleges as follows: 

THE PARTIES 

1. Plaintiff Warner Chilcott Company, LLC (“Warner Chilcott”) is a limited 

liability company organized and existing under the laws of Puerto Rico, having offices at Union 

St., Road 195, Km 1.1, Fajardo, Puerto Rico. 

2. Upon information and belief, Defendant Mylan Inc. is a corporation 

organized and existing under the laws of Pennsylvania, having an office and place of business at 

1500 Corporate Drive, Canonsburg, Pennsylvania 15317. 

3. Upon information and belief, Defendant Mylan Pharmaceuticals Inc. 

(“Mylan Pharms”) is a corporation organized and existing under the laws of West Virginia, 

having an office and place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia 

26505. Upon information and belief, Mylan Pharms is a wholly-owned subsidiary of Mylan, Inc. 

4. Upon information and belief, Defendant Famy Care Ltd. (“Famy Care”) is 

organized and exists under the laws of the Republic of India and has a principal place of business 

at 3rd Floor, Brady House, 12/14, Veer Nariman Road, Fort, Mumbai – 400 001, India. 

5. Upon information and belief, Mylan Inc. is doing business in New Jersey. 

Upon information and belief Mylan Inc. is registered to do business in New Jersey. Mylan Inc., 

directly, or through its subsidiaries, including Mylan Pharms, has engaged in continuous and 

systematic contacts with New Jersey, and purposefully availed itself of this forum by, among 

other things, shipping, using, offering to sell, selling, or causing others to use, offer to sell, or sell 

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pharmaceutical products in New Jersey and deriving substantial revenue from such activities, 

and by filing counterclaims in New Jersey. 

6. Upon information and belief, Mylan Pharms is doing business in New 

Jersey. Upon information and belief Mylan Pharms is registered to do business in New Jersey. 

Mylan Pharms has engaged in continuous and systematic contacts with New Jersey, and 

purposefully availed itself of this forum by, among other things, shipping, using, offering to sell, 

selling, or causing others to use, offer to sell, or sell pharmaceutical products in New Jersey and 

deriving substantial revenue from such activities, and by filing counterclaims in New Jersey. 

7. Upon information and belief, Famy Care has engaged in continuous and 

systematic contacts with the United States by, among others things, on or about August 7, 2008, 

entering into an agreement with Mylan Inc. to file ANDAs for generic contraceptive products 

and to supply such products to customers in the United States. 

JURISDICTION AND VENUE 

8. This is an action for patent infringement arising under the patent laws of 

the United States, Title 35, United States Code. This Court has subject matter jurisdiction over 

this action based on 28 U.S.C. §§ 1331 and 1338(a).

9. This Court has personal jurisdiction over Mylan Inc. and Mylan Pharms, 

because, inter alia, Mylan Inc. and Mylan Pharms have purposefully availed themselves of the 

rights and benefits of New Jersey law. Upon information and belief, Defendants Mylan Inc. and 

Mylan Pharms. engage in the sale of a range of generic pharmaceutical products within the 

United States generally and New Jersey specifically. 

10. This Court has personal jurisdiction over Famy Care at least under Federal 

Rule of Civil Procedure 4(k)(2). 

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11. Venue is proper in this Court under 28 U.S.C. §§ 1391(b), (c) and (d) and 

1400(b). 

COUNT I 

CLAIM FOR INFRINGEMENT OF THE ‘394 PATENT

12. Warner Chilcott is the holder of New Drug Application (“NDA”) No. 21-

871, for Loestrin® 24 Fe, which contains the active ingredients norethindrone acetate and ethinyl 

estradiol. Loestrin® 24 Fe was approved by the United States Food and Drug Administration 

(“FDA”) on February 17, 2006, and is indicated for the prevention of pregnancy in women who 

elect to use it as a method of contraception. Loestrin® 24 Fe is sold as a 28-day oral 

contraceptive regimen that includes 24 active tablets comprising 1 mg norethindrone acetate and 

0.02 mg ethinyl estradiol, followed by 4 ferrous fumarate tablets (placebo). 

13. U.S. Patent No. 5,552,394 (“the ‘394 patent”) entitled “Low Dose Oral 

Contraceptives with Less Breakthrough Bleeding and Sustained Efficacy” lawfully issued from 

the United States Patent and Trademark Office on September 3, 1996. A copy of the ‘394 patent 

is attached as Exhibit A. 

14. Warner Chilcott is the sole owner of the ‘394 patent. 

15. The ‘394 patent relates to a method of female contraception, which 

comprises inter alia monophasicly administering a combination comprising 0.02 mg of ethinyl 

estradiol and 1 mg of norethindrone acetate for 24 days of a 28 day cycle. 

16. The ‘394 patent covers the use of Loestrin® 24 Fe in accordance with the 

labeling approved by the FDA and is listed in the FDA Approved Drug Products with 

Therapeutic Equivalence Evaluations (“the Orange Book”) for that product. 

17. Upon information and belief, Famy Care, together with its U.S. agent, 

Mylan Pharms, submitted to the FDA an Abbreviated New Drug Application (“ANDA”) filed 

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under 21 U.S.C. § 355(j), to obtain approval to engage in the commercial manufacture, use, or 

sale of a generic version of Loestrin® 24 Fe prior to the expiration of the ‘394 patent. 

18. Upon information and belief, Defendants’ ANDA directed to its proposed 

generic Loestrin® 24 Fe product has been assigned No. 20-2742. 

19. Upon information and belief, the composition that is the subject of 

Defendants’ ANDA is directed to 24 tablets containing 1 mg norethindrone acetate and 0.02 mg 

ethinyl estradiol, and 4 tablets containing 75 mg ferrous fumarate. 

20. Upon information and belief, Defendants’ ANDA was submitted with a 

certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) of the Federal Food, Drug and 

Cosmetic Act that the ‘394 patent is purportedly invalid, unenforceable, and/or will not be 

infringed by the manufacture, use or sale of Defendants’ ANDA product. 

21. Upon information and belief, Famy Care, Mylan Pharms and Mylan Inc. 

sent notice of that certification to Warner Chilcott on or about April 20, 2011. Warner Chilcott 

received that notice letter on or about April 21, 2011. 

22. By filing the Defendants’ ANDA under 21 U.S.C. § 355(j), for the 

purpose of obtaining approval to engage in the manufacture, use or sale of their ANDA product 

before the expiration of the ‘394 patent, Famy Care and its U.S. agent, Mylan Pharms, 

committed an act of infringement pursuant to 35 U.S.C. § 271(e)(2)(A). Further, the 

manufacture, use or sale of Defendants’ proposed ANDA product will also infringe one or more 

claims of the ‘394 patent. 

23. Upon approval of Defendants’ ANDA, Defendants will actively induce 

and/or contribute to infringement of the ‘394 patent. 

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24. Upon information and belief, the acts of Mylan Pharms and Famy Care 

complained of herein were done and are being done at the direction of, with the authorization of, 

and/or with the cooperation, participation and assistance of, and at least in part for the benefit of,

Mylan Inc. 

25. Warner Chilcott is entitled to relief provided by 35 U.S.C. § 271(e)(4), 

including an order from this Court that the effective date of the approval of Defendants’ ANDA 

be a date that is not earlier than the expiration date of the ‘394 patent, or any later expiration of 

exclusivity to which Warner Chilcott is or becomes entitled. 

26. This is an exceptional case, and Warner Chilcott is entitled to its costs and 

reasonable attorney fees. 

PRAYER FOR RELIEF

WHEREFORE, Plaintiff respectfully requests the following relief: 

(a) Judgment that Defendants have infringed one or more claims of the ‘394 

patent by submitting ANDA No. 20-2742; 

(b) A permanent injunction be issued restraining and enjoining Defendants 

Mylan Inc., Mylan Pharmaceuticals Inc. and Famy Care Ltd., their officers, agents, attorneys, 

and employees, and those acting in privity or concert with them, and their successors and 

assigns, from engaging in the commercial manufacture, use, offer to sell, or sale within the 

United States, or importation into the United States, of compositions that would infringe, induce 

infringement and/or contribute to infringement of the ‘394 patent; 

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(c) An order that the effective date of any approval of Defendants’ ANDA 20-

2742, be a date that is not earlier than the expiration of the ‘394 patent, or any later expiration of

exclusivity to which Warner Chilcott is or becomes entitled; and 

(d) Declaring this to be an exceptional case and awarding Plaintiff its attorney 

fees under 35 U.S.C. § 285; and 

(e) Such other and further relief as the Court may deem just and proper. 

June 2, 2011 Respectfully submitted, 

s/William J. O’Shaughnessy

William J. O’Shaughnessy 

MCCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry St. 

Newark, NJ 07102 

Tel: (973) 622-4444 

Fax: (973) 624-7070 

OF COUNSEL: 

Dominick A. Conde 

Brian V. Slater 

Steven C. Kline 

John D. Carlin 

Joanna Garelick Goldstein 

FITZPATRICK, CELLA, HARPER 

& SCINTO 

1290 Avenue of the Americas 

New York, NY 10104 

Tel: (212) 218-2100 

Fax: (212) 218-2200 

 

 Attorneys for Plaintiff Warner 

 Chilcott Company, LLC

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CERTIFICATION PURSUANT TO L. CIV. R. 11.2 

Plaintiffs, by their undersigned counsel, hereby certify pursuant to L. Civ. R. 11.2 

that the matters in controversy are not the subject of any other action pending in any other court 

or of any pending arbitration or administrative proceeding. 

June 2, 2011 Respectfully submitted, 

s/William J. O’Shaughnessy

William J. O’Shaughnessy 

MCCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry St. 

Newark, NJ 07102 

Tel: (973) 622-4444 

Fax: (973) 624-7070 

OF COUNSEL: 

Dominick A. Conde 

Brian V. Slater 

Steven C. Kline 

John D. Carlin 

Joanna Garelick Goldstein 

FITZPATRICK, CELLA, HARPER 

& SCINTO 

1290 Avenue of the Americas 

New York, NY 10104 

Tel: (212) 218-2100 

Fax: (212) 218-2200 

Attorneys for Plaintiff 

Warner Chilcott Company, LLC 

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