As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange BOOK” for the INNOVATOR drug. This certification must state one of the following:

• that the REQUIRED patent information relating to such patent has not been filed (Para I certification);
• that such patent has expired (Para II certification);
• that the patent will expire on a particular date (Para III certification); or
• that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).

A certification under PARAGRAPH I or II permits the ANDA to be APPROVED immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.

As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following:

A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.