Engagements

Economic analysis of generic test specification standards

This matter involved scientific tests for generic drug closeness to the brand, as required by the FDA. The plaintiff alleged deceptive conduct within the standards organization (the US Pharmacopeial Convention or USP) responsible for the generic test specifications. The specific antitrust allegation was that the conduct had led to market foreclosure of generic competition. A CRA expert provided economic analysis of the SDO’s IPR policy and analysis of the economic impact of the alleged breach of that policy.