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WCRX > SEC Filings for WCRX > Form 8-K on 29-Jul-2013All Recent SEC Filings

Show all filings for WARNER CHILCOTT PLC



Other Events

Item 8.01. Other Events.

Warner Chilcott plc (together with its subsidiaries, the "Company") has entered into a settlement and license agreement (the "Agreement") with Mylan Inc. and Mylan Pharmaceuticals Inc. (together, "Mylan") and Famy Care Ltd. ("Famy Care") to resolve patent litigation related to the Company's U.S. Patent No. 5,552,394 (the "'394 Patent"), which covers LOESTRIN 24 FE and expires July 22, 2014. Pursuant to the Agreement, Mylan and Famy Care have agreed, among other things, not to commence marketing their generic equivalent LOESTRIN 24 FE product until the earlier of (i) July 1, 2014 or (ii) the date on which a third party (other than pursuant to the Company's January 2009 settlement and license agreement) enters the market with a generic version of LOESTRIN 24 FE in the United States with or without authorization from the Company. Pursuant to the Agreement, the Company's pending '394 Patent litigation with Mylan and Famy Care will be dismissed. The Agreement is required to be submitted to, and is subject to the review of, the U.S. Department of Justice and the Federal Trade Commission.

The Company had previously received a Paragraph IV certification notice letter from Mylan, as U.S. agent for Famy Care, indicating that Famy Care had submitted to the U.S. Food and Drug Administration an Abbreviated New Drug Application seeking approval to manufacture and sell a generic version of LOESTRIN 24 FE. The Company subsequently filed a lawsuit against Famy Care and Mylan in the U.S. District Court for the District of New Jersey charging each with infringement of the '394 Patent. For further information with respect to the Company's '394 Patent litigation, including prior settlement and license agreements relating thereto, see the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2013, which is available on the Company's website.

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