This project was completed by Intensity. Intensity joined Secretariat on February 1, 2023.

Background

A generic drug company filed an Abbreviated New Drug Application (ANDA) seeking approval to sell a generic version of a branded sedative drug prior to the expiration of patents covering the branded drug. The generic drug company also filed paragraph IV certification, asserting that the patents covering the branded drug were invalid as obvious. In response, the branded drug company filed claims of patent infringement against the generic drug company.

Our Analysis

Intensity performed an evaluation of the commercial success of the branded sedative drug and the patents-in-suit. Intensity determined whether the commercial performance of branded drug was attributable to the patents-in-suit or other economic factors, and whether such performance was commercially successful.

Intensity analyzed sales and economic profits of the branded drug. We evaluated those sales and profits in an appropriate economic context by defining a relevant market and comparing sales of the branded drug to relevant benchmarks.