Cases & Deals

Patent owner challenges FDA regulatory review determination

Clients Patent owner

Jones Day represents 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. The complaint argues that the FDA acted contrary to law and arbitrarily and capriciously in deciding the regulatory review period for the drug.