ACI's 7th Annual Paragraph IV Disputes
In the nine years since its inception, American Conference Institute’s (ACI’s) Paragraph IV Disputes conference has become the pharmaceutical industry’s leading forum on Hatch-Waxman litigation. Each spring, the “who’s who” of Hatch-Waxman litigators and industry decision makers, as well as members of the judiciary and key government representatives gather in New York City at this conference to assess the implications and imprimaturs of court cases, legislation, and industry behaviors which affect the patent endgame and the pursuit of related profits. This “must-attend” event serves the legal and business needs of both branded and generic drug makers by providing invaluable “take aways” for legal strategies and cost-analysis for every facet of this complex litigation from pre-suit considerations to case fi lings through final adjudication.
In the course of the next eighteen months, the industry will scale the next escarpments of the proverbial patent cliff which will bring an additional 90 billion dollars in patent losses when block buster drugs such as Nexium, Lunesta, Abilify, Crestor and Restasis all go off patent. This will result in increased ANDA litigation between brands and generics, as well as increased challenges among generics vying to be the first to obtain the highly coveted prize of 180-day exclusivity. However, there will also be new challenges to face. Brands and generics must assess of the impact and utilization of PTO proceedings which have provided alternative and parallel forums to the Federal Courts. Then, there is the uncertainty of the fall out from the Supreme Court’s decision in Actavis, which may add to the already astronomicalcost of these litigations as settlements may be both legally and economically infeasible.
In response to these challenges, ACI is pleased to present this year’s Paragraph IV Disputes conference. We welcome you to join our exceptional faculty and your peers as we explore not only the latest legal nuances affecting the essentials of Hatch-Waxman litigation, but also new dilemmas affecting patent sustainability and vulnerability, the impact of IPR and PGR, the new standard of review in claim contruction under Teva v. Sandoz, new controversies in personal and general jurisdiction as well as implications for Paragraph IV cases under 101 subject matter patentability and 112 indefiniteness.
Greg Morris and Bruce Wexler of the Paul Hastings Intellectual Property practice are featured panelists for this conference.
For additional information and to register, visit