Paragraph Four Explained
In 1984, Congress passed The Drug Price Competition and Patent Term Restoration Act that came to be known as the “Hatch-Waxman Act.” The Hatch-Waxman rules created processes and incentives for both branded and generic companies involving challenges to patents.
- Branded pharmaceutical companies are required to list patents involving composition of matter (substance), formulation, and method of use in the Food and Drug Administration “s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations , also known as the Orange Book.
- When applying to enter the market with a generic form of a reference product, the generic company files an Abbreviated New Drug Application (ANDA) and certifies against patents listed in the Orange Book. The certification states that either (a) FDA should approve of its generic version after the date the last patent expires (a “Paragraph 3” filing) or (b) that its generic product does not infringe on the listed patents or that those patents are not enforceable (a “Paragraph 4” filing actually called a Paragraph IV filing.1
- If the generic company files an ANDA with a Paragraph IV certification, then the branded company is notified. After the notice, the branded company has 45 days to file a patent infringement action against the generic company. After the suit has been filed, the FDA cannot approve of the application until the generic company successfully defends the suit or until 30 months, whichever comes first.
1 The Regulations also allow for two other types of certifications that are not relevant for The Paragraph Four Report. A Paragraph 1 certification states that there are no patents listed, and a Paragraph 2 certification states that the listed patents have expired.