UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 8-K

 

 

Current Report

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report: September 1, 2011

Date of earliest event reported: September 1, 2011

 

 

Warner Chilcott Public Limited Company

(Exact name of registrant as specified in its charter)

 

 

 

Ireland   0-53772   98-0626948

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

1 Grand Canal Square

Docklands

Dublin 2, Ireland

(Address of principal executive offices, including zip code)

+353 1 897 2000

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01 Other Events.

Warner Chilcott plc (the “Company”) today announced that it received a Paragraph IV certification notice letter from Watson Laboratories, Inc. – Florida (“Watson”) indicating that Watson had submitted to the U.S. Food and Drug Administration (“FDA”) an Abbreviated New Drug Application seeking approval to manufacture and sell a generic version of ATELVIA (risedronate sodium) 35 mg delayed-release tablets, one of the Company’s products for the treatment of postmenopausal osteoporosis. The notice letter contends that the Company’s U.S. Patent Nos. 7,645,459 and 7,645,460, two formulation and method patents expiring in January 2028 (together, the “ATELVIA Patents”), are invalid, unenforceable and/or not infringed.

The Company is currently reviewing the details of the Paragraph IV certification notice letter from Watson and expects to file an infringement lawsuit against Watson within 45 days of its receipt of the Paragraph IV certification notice letter. Additionally, ATELVIA has FDA exclusivity through October 2013, and Watson did not certify against the Company’s U.S. Patent No. 5,583,122, a new chemical entity patent which covers all of the Company’s ACTONEL and ATELVIA products and expires in June 2014 (including a 6-month pediatric extension of regulatory exclusivity). The Company intends to vigorously defend the ATELVIA Patents and protect its legal rights and continues to have full confidence in the intellectual property protecting ATELVIA.

Caution Concerning Forward-Looking Statements

This Current Report on Form 8-K includes certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the current expectations and beliefs of the management of the Company and are subject to uncertainty and changes in circumstances. Actual results may vary materially from those expressed or implied by the statements herein due to changes in economic, business, competitive, technological and/or regulatory factors, as well as other factors affecting the operation of the business of the Company. More detailed information about these factors may be found in the filings by the Company with the Securities and Exchange Commission, including its most recent annual report on Form 10-K for the year ended December 31, 2010. The Company is under no obligation, and expressly disclaims any obligation, to update or alter the forward-looking statements, whether as a result of new information, future events or otherwise.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

WARNER CHILCOTT PUBLIC LIMITED COMPANY
By:  

/s/ Paul Herendeen

Name:   Paul Herendeen
Title:   Executive Vice President and Chief Financial Officer

Date: September 1, 2011

 

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