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

January 31, 2011

By David M. Conca & Anthony Michael

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the United States District Court for the District of New Jersey, in Paddock Laboratories, Inc. v. Ethypharm, S.A., an unpublished opinion, dismissed a declaratory judgment claim brought by an ANDA applicant because the FDA had required the ANDA applicant to reformulate its product and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