Patent owner successfully challenges FDA regulatory review determination

Client(s) Patent owner

Jones Day successfully represented a patent owner in challenging the U.S. Food and Drug Administration's (FDA) regulatory review period determination for its drug. After the patent owner applied for a patent term extension under 35 U.S.C. § 156, the FDA determined the length of the drug's regulatory review period. Jones Day argued that the FDA acted contrary to law and arbitrarily and capriciously in deciding the regulatory review period for the drug. The U.S. District Court for the District of Columbia agreed, holding that the FDA's shifting approach to calculating regulatory review periods deprived the patent owner of fair notice and that the agency's failure to publicly acknowledge its change in position violated the Administrative Procedure Act.