Paragraph IV Certification

Key facts

Legal basis

FD&C Act Sections 505(j)(2)(A)(vii)(IV) and 505(b)(2)(A)(iv)

Regulations

21 CFR 314.94(a)(12) and 314.50(i)

Patent owner suit window

45 days after receiving notice

Possible result

30-month stay of FDA approval

First-filer reward

180-day generic exclusivity for the first qualifying ANDA applicant

What is a Paragraph IV certification?

When a company files an Abbreviated New Drug Application (ANDA) or a 505(b)(2) application, it must address every patent listed in the Orange Book for the drug it relies on. The statute offers four certifications, named after its numbered paragraphs, and Paragraph IV is the one that challenges the patent.

Filing a Paragraph IV certification counts as an act of patent infringement under 35 U.S.C. 271(e)(2), even though no product has been sold. That legal device lets the brand company sue before launch, so patent disputes can be resolved while the FDA reviews the application.

The four patent certifications

For each listed patent, the applicant certifies one of the following:

• Paragraph I: no patent information has been submitted to the FDA.
• Paragraph II: the patent has expired.
• Paragraph III: the patent will expire on a stated date, and the applicant will wait for that date.
• Paragraph IV: the patent is invalid, unenforceable or will not be infringed.
• For a method-of-use patent, an applicant can instead file a section viii statement and carve the patented use out of its labeling.

How a Paragraph IV challenge unfolds

The applicant must send notice to the NDA holder and patent owner explaining why the patent is invalid or not infringed. If they sue within 45 days, FDA approval is generally stayed for 30 months unless a court resolves the case sooner.

The first applicant to submit a substantially complete ANDA with a Paragraph IV certification can earn 180 days of generic exclusivity, during which the FDA generally cannot approve later generic applications for the same drug. Forfeiture rules added in 2003 can strip that exclusivity, for example if the first filer fails to market in time.

Why Paragraph IV certifications matter

Paragraph IV activity is an early warning of loss of exclusivity. The FDA publishes a list of drugs for which it has received Paragraph IV applications, and the resulting litigation and settlements, including reverse payment deals scrutinized by the Federal Trade Commission, often set the real generic entry date rather than patent expiry.