Under the Hatch–Waxman act, patentees must list patents related to their approved drug in the FDA's Approved Drug Products publication (the 'Orange book'). When a manufacturer files an ANDA for a generic drug, it must consult the Orange book and certify that there is no listed patent information for the proposed drug, that the listed patents have expired or will do so before any generic product is marketed, or that the patents listed are invalid or will not be infringed by the generic drug (also known as 'paragraph IV certification'). Because GSK's cephalosporin antibiotic cefuroxime (Ceftin) was approved before the Hatch–Waxman Act came into effect in 1984, GSK was exempt from listing the Ceftin-related patents in the Orange Book, and therefore ANDA applicants attempting to market generics of such drugs are not required to file a certification.
The Federal Circuit agreed with Apotex's argument that the mere filing of an ANDA — and in particular one without a paragraph IV certification of invalidity and/or non-infringement — cannot constitute grounds for a wilful infringement finding. They noted that, in any case, filing an ANDA is a highly artificial act of infringement and gives rise only to a limited set of legal consequences. Judge Dyk agreed that Apotex's ANDA had infringed the '181 and '883 patents, but dissented on jurisdictional grounds to the infringement ruling because no damages were being sought and the patents have expired, making the whole issue moot.
