Reverse payment settlements, also referred to as pay-for-delay agreements, describe a settlement of patent infringement litigation between a branded pharmaceutical company and generic in which payment is received by the generic from the branded pharmaceutical company. In typical patent infringement litigation settlement, the alleged infringer pays the patent holder. In a reverse settlement, the reverse occurs.
In recent years, these agreements have caused considerable argument within the pharma industry of both the United States and the European Union. Antitrust agencies and courts have come to conflicting conclusions regarding the agreements' conformity with competition rules.
The question agencies and courts seek to answer is whether a reverse payment settlement includes payment by the incumbent firm to keep a competitor out of the market (pay for delay) or compensation that is competitively benign. Since the Supreme Court's decision in Actabis, district courts have been attempting to follow a rule-of-reason approach described by the decision. However, considerable disagreement persists about what aspects of these settlements may demonstrate that a deal is anticompetitive or not.
In this LIVE Webcast, a notable panel of thought leaders and professionals assembled by The Knowledge Group will provide the audience with an in-depth analysis of the fundamentals as well as recent developments in the dynamic area of antitrust enforcement.
Key topics include:
- Pay-For-Delay Settlements—A Legal Primer
- "By Object" Vs. "By Effect" Infringements
- Recent Claims on Patent Settlements
- Identifying and Mitigating Risks
- Antitrust Enforcement Priorities
- Reverse Payment Agreements: Costs and Damages
- Role of No Authorized Generic Clauses and Ancillary Agreements
- Recent Legal Issues and Insights
David Blackburn - Vice President, NERA Economic Consulting
Megan Browdie - Associate, Cooley
Ted Davis - Vice President, Analysis Group
Stephanie Demperio, Ph.D. - Senior Consultant, NERA Economic Consulting
David Hull - Partner, Van Bael & Bellis
Cleve B. Tyler, Ph.D - Director, Berkeley Research Group
Event details and registration