FDA Stance At Conflict With Court Ruling On Generic Exclusivity

In a Federal Register policy statement, the US Food and DrugAdministration has taken a stance conflicting with a court ruling and said that the 180-day generic marketing exclusivity will go to the first company successfully defending a Paragraph IV certification. A DC federal court had ruled, in Mova vs Kessler, that a company should receive the exclusivity based on its first-to-file status, without taking into account whether the applicant is later sued for patent infringement.

The FDA based its subsequent decision to grant Genpharm exclusivity for generic ranitidine based on its status as first-to-file, according to Health News Daily, which said the agency will again rely on its previous interpretation of the generic exclusivity regulation which requires that for a generic to qualify for the exclusivity, the first Abbreviated New Drug Approval applicant submitting a Para IV certification to the listed patent must be sued for patent infringement and successfully defend that suit.

The original FDA interpretation of the regulation was upheld in federal court, when Novopharm successfully challenged the FDA's ruling in favor of Genpharm. The decision was later stayed in appellate court, Health News Daily noted. The Novopharm case is now on expedited appeal, while the Mova case has been appealed to the DC court of Appeals.