What is a Paragraph IV patent certification?
A branded pharmaceutical company must identify patents that claim their drug or a method of using their drug. These patents are listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly called the Orange Book). An ANDA applicant must include with its application one of the following certifications with respect to each of the patents listed in the Orange Book: • Patent information has not been submitted (Paragraph I) • The patent has expired (Paragraph II) • The ANDA applicant will not seek final approval before the date the patent expires (Paragraph III) • The patent is invalid, unenforceable, or will not be infringed by the ANDA applicant’s product (Paragraph IV). An ANDA applicant does not need to certify to patents claiming uses for which the applicant is not seeking approval. If a Paragraph IV certification is filed, the brand company is notified and then has 45 days to file a patent infringement action against the generic company. If a
