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WCRX > SEC Filings for WCRX > Form 8-K on 13-Aug-2012All Recent SEC Filings

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Form 8-K for WARNER CHILCOTT PLC


13-Aug-2012

Other Events


Item 8.01 Other Events.

Warner Chilcott plc (the "Company") today announced the successful resolution of the Company's patent dispute with Par Pharmaceutical, Inc. ("Par") and EMET Pharmaceuticals LLC ("EMET") relating to the Company's ASACOL 400 mg product ("ASACOL 400"). The Company previously received a Paragraph IV certification notice letter from Par indicating that it had submitted to the U.S. Food and Drug Administration an Abbreviated New Drug Application ("ANDA") seeking approval to manufacture and sell a generic version of ASACOL 400. The Company and Medeva Pharma Suisse AG ("Medeva"), the licensor of U.S. Patent No. 5,541,170 (the "'170 Patent") covering ASACOL 400, subsequently filed a patent lawsuit against Par and EMET, the original filer and assignor of the ANDA, in the U.S. District Court for the District of New Jersey alleging infringement of the '170 Patent. On August 9, 2012, pursuant to a joint stipulation of dismissal, Par informed the court that it no longer intends to seek approval to market a generic version of ASACOL 400 prior to the expiration of the '170 Patent in July 2013 and has converted its original Paragraph IV certification for the '170 Patent to a Paragraph III certification. As a result, the Company and Medeva's action against Par and EMET was dismissed without prejudice.


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