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FDA Requires Reformulation and Recertification by Generic - Results in Dismissal of Declaratory Judgment Action

On January 18, 2011, the United States District Court for the District of New Jersey, in Paddock Laboratories, Inc. v. Ethypharm, S.A., an unpublished opinion, dismissed a declaratory judgment claim brought by an ANDA applicant because the FDA had required the ANDA applicant to reformulate its product and recertify to an Orange Book-listed patent.

Paddock submitted an ANDA seeking approval to market a generic version of Antara® (fenofibrate) capsules. Paddock Labs., Inc. v. Ethypharm, S.A., Civ. No. 09-3799, 2010 WL 149860 at *3. Paddocks ANDA had initially contained a Paragraph IV certification to Orange Book-listed Patent No. 7,101,574 (the 574 patent). Id. Paddock then provided notice of its Paragraph IV certification to Ethypharm, which did not sue for patent infringement within the statutory 45-day period and obtain a 30-month stay of FDA approval of Paddocks ANDA. Id. Following expiration of the 45-day period, Paddock filed a declaratory judgment action against Ethypharm seeking a ruling that Paddocks proposed generic product did not infringe the 574 patent. Id. Ethypharm moved to dismiss. Id. at 1.


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