Situation: A leading international life sciences company had to explain in court why its settlement of patent litigation with a potential generic entrant was driven by legitimate business considerations.
CRA contribution: CRA assembled a team with expertise in the pharmaceuticals industry, antitrust analysis, and game theory. Our economic analysis of the settlement accounted for the business risks facing the parties as well as the potential for a delay in generic entry.
Result: CRA’s expert analysis supported the defendant’s pre-trial motions, which were successful in having the case dismissed.
Biosimilars: Economic Issues for IP Litigation
In July 2021, the U.S. Food and Drug Administration granted a determination of interchangeability to a biosimilar drug for the first time. This approval has...