Regulatory Q&A: US patent law and The Orange Book

This week Kelly Del Dotto, principal at USA-based patent firm Fish & Richardson P.C., provides context on the all-important Orange Book.

A key part of the patent landscape, the Orange Book provides a reference list of therapeutics that the US Food and Drug Administration (FDA) has approved, making it convenient for physicians to find generic equivalents.

The Pharma Letter asked Ms Del Dotto, an intellectual property and life sciences litigation attorney, for an overview of changes made under the recent Orange Book Transparency Act, as well as an insight into potential exclusivity changes under consideration by the US Congress.