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| SCMP > SEC Filings for SCMP > Form 8-K on 4-Jan-2013 | All Recent SEC Filings |
4-Jan-2013
Other Events
On January 2, 2013 (the "Notice Date"), Sucampo Pharmaceuticals, Inc. (the "Company") received a Paragraph IV certification notice letter (the "Notice Letter") regarding an ANDA submitted to the FDA by Anchen Pharmaceuticals, Inc. ("Anchen") requesting approval to market, sell and use a generic version of the Company's 8mcg and 24 mcg AMITIZAŽ (lubiprostone capsule) products.
In its Notice Letter, Anchen alleges that U.S. Patent Nos. 6,414,016, 6,583,174, 7,064,148, 7,417,067, 7,795,312, 8,026,393, 8,071,613, 8,088,934, 8,097,649, 8,097,653, and 8,114,890 (collectively, the "Patents"), which cover composition, formulations and methods of using AMITIZAŽ, are invalid, unenforceable and/or will not be infringed by Anchen's manufacture, use or sale of the products described in its ANDA. The latest of the Patents expire in 2027.
The Company is currently reviewing the Notice Letter. By statute, if the Company initiates a patent infringement lawsuit against Anchen within 45 days of the Notice Date, then the FDA would automatically stay approval of Anchen's ANDA until the earlier of 30 months from the Notice Date or entry of a district court decision finding the Patents invalid or not infringed. The Company intends to vigorously enforce its intellectual property.
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