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.
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
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.