Document Type
Article
Publication Date
2022
Abstract
Pay-for-delay settlements arise when the brand drug company compensates the generic in some form to delay entry to market, thereby effectively eliminating the 180-day exclusivity on the market the generic is entitled to under law. At the federal level, the Supreme Court has established factors to determine whether such agreements violate antitrust law, policymakers have introduced legislation to curb the practice, and the Federal Trade Commission continues to actively police such deals. At the state level, California Attorney General Xavier Becerra made headlines for securing legal settlements in July 2019 with several pharmaceutical companies accused of participating in pay-for-delay agreements. Highlights of the legal settlements included injunctions and $70 million in monetary payments. California has also taken the lead at enacting legislation. Assembly Bill 824, Preserving Access to Affordable Drugs, increases antitrust scrutiny of settlement agreements between branded and generic pharmaceutical manufacturers, as well as innovator biologic and biosimilar manufacturers. he law imposes a presumption of illegality, shifting the burden of proof from enforcers and plaintiffs to drug companies accused of anticompetitive behavior to show that the arrangement is not anticompetitive. his article explores the recent legislation and ensuing litigation challenging the bounds of this legislation in California.
Recommended Citation
Jordan Paradise, The Status of California's Pay-for-Delay Legislation and Litigation, 2022 FDLI Update 42 (2022).
Included in
Antitrust and Trade Regulation Commons, Food and Drug Law Commons, State and Local Government Law Commons