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

Background

A number of generic drug companies sought FDA approval to market generic versions of a branded ADHD drug prior to the expiration of patents covering the branded drug. The generic drug companies filed Abbreviated New Drug Applications and Paragraph IV certifications asserting that patents covering the branded drug were invalid or not infringed. In response, the branded drug company filed claims of patent infringement against the generic drug companies.

Our Analysis

Intensity provided an expert report, deposition testimony, and trial testimony relating to an evaluation of the commercial success of patents covering the branded drug. As part of addressing patent validity, the court considered the testimony of a Intensity expert on whether the patented invention had been a commercial success.

Intensity analyzed economic issues involving market definition, commercial performance, and long-felt need in the marketplace. Intensity performed economic analysis to evaluate sales and market share of the branded drug among competing drugs in the marketplace. In addition, we organized and processed complex data and presented its findings from the data analysis at trial.

Intensity analyzed a number of economic issues to inform on whether commercial performance of the branded drug was driven by the patents-in-suit or other economic factors. These issues included pricing, discounting, profitability, marketing, and other potential drivers of sales. Intensity also evaluated the economic impact of marketing materials that FDA had found to be false and misleading to consumers.