CRA addressed issues relating to commercial success in patent litigation on behalf of an innovator company commercializing a drug for a rare disease. CRA addressed sales growth, profitability, and performance relative to other treatments for the same rare condition. In addition, CRA considered the characteristics of the product enabled by the patent in suit, taking into account clinical trial findings, product advantages reflected in company and public materials, and the company’s marketing activities.
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...