Shores to Speak on Paragraph IV Litigation at ACI Master Symposium
DC-based Antitrust partner Laura Shores will participate as a panelist in “Revisiting Reverse-Payment Settlements and Antitrust Concerns Impacting Paragraph IV Litigation” on September 20, 2016. This panel is a part of American Conference Institute’s fourth annual Paragraph IV Disputes Master Symposium.
Paragraph IV of the Drug Price Competition and Patent Term Restoration Act, commonly referred to as Hatch-Waxman, enables a company to seek approval from the US Food and Drug Administration to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based.
Laura’s panel will address the following topics:
- Developing jurisprudence regarding patent settlements post-Actavis
- What constitutes a payment
- Differing judicial interpretations of the “Rule of Reason Test”
- Weighing anticompetitive harm and procompetitive benefits
- Authorized generics
- Structuring settlements in light of developing jurisprudence
- The resurgence of purchaser sham litigation claims
- The impact of cGMP’s and 483s on leverage and settlements
- Best strategies to communicate risks and rewards of settlement to clients
This ACI master symposium functions as a “meeting of the minds,” attracting preeminent patent litigators representing brand name and generic drug makers, leading in-house counsel, esteemed jurists and government representatives to discuss, analyze and interpret the latest controversies impacting Paragraph IV litigation.