Drug Patent Settlements Between Rivals: A Survey

Abstract

This survey provides a detailed account of patent settlements reached between brand-name drug companies and their generic rivals over the past fourteen years, and the antitrust suits and investigations initiated in response. Thirty settlements of patent litigation involving twenty drugs fall within the scope of the study. Three patterns emerge from the data. First, antitrust activity in this area has continued to expand, including more than a dozen pending antitrust suits and agency investigations. Second, repeat players have emerged. Third, settlements have grown more sophisticated, particularly through the emergence of a second wave of settlements that avoids the mistakes of the first wave.

For an updated analysis based upon this survey, drawing upon a new dataset of 143 brand-generic settlements, see An Aggregate Approach to Antitrust: Using New Data and Rulemaking to Preserve Drug Competition, Columbia Law Review (2009), http://ssrn.com/abstract=1356530.

Keywords: agency, antitrust, Cipro, drug, exclusion payment, FTC, Federal Trade Commission, generic drugs, Hatch-Waxman, paragraph IV, patent, pay for delay, pharmaceutical, regulation, reverse payment, Schering, settlement, Sherman Act, tamoxifen