Dear Colleague:This year marks the 10th anniversary of ACI’s industry-leading Paragraph IV Disputes conference. From the time of our first Paragraph IV Disputes conference through to its present iteration, we have witnessed the ongoing evolution of the Hatch-Waxman pharmaceutical patent endgame. The rules of this endgame which once seemed straight forward have been reframed by the Medicare Modernization Act, America Invents Act, and to some extent the Affordable Care Act. There are now questions about where you can file suit and which forum to file in. There is still little if no clarity on how to settle one of these cases and not run the risk of government scrutiny despite a Supreme Court decision.
However, through this metamorphosis and continuing evolution, one thing has remained certain: each spring, the who’s who of Hatch-Waxman litigators, industry decision makers and stakeholders, as well as Judges — now from two different forums — and government representatives will gather in New York City to attend ACI’s Paragraph IV Disputes event. They will come to confer with one another, discuss, evaluate and assess new and evolving jurisprudence, the latest crags of the patent cliff, and related legal and economic consequences. This conference remains the constant. It is the only event which shapes the law, policy and proceedings of Paragraph IV litigation.
In this 10th anniversary year, we will continue to bring you up-to-the minute information on the latest developments impacting Paragraph IV disputes and how it will impact every facet of this complex type of litigation from pre-suit considerations, case filings, final adjudication and every step in between. We will examine victories and vanquishments before the District Court and PTAB, the ongoing jurisdictional debate, new Momenta controversies which reach beyond the safe harbor to the to the “making” provisions of 271 (g)(1), the on sale bar controversy of Angiomax, further opinions on divided and induced infringement, new twists on obviousness, claim construction and damages. Against this backdrop, we will explore how the economic losses of nearly $130 billion will affect the balance of power between brand name and generic companies when drugs such as Humira, Crestor, Benicar, Cubicin and Kaletra go off patent this year.
Also, by popular demand this year’s event will feature mock parallel proceedings before the District Court and PTAB, in addition to a keynote by the FTC and two Judicial Roundtables — one with District Court Judges and the other with PTAB Judges. There will also be an IPR Master Class and a Biosimilars Boot Camp.
In short, this year’s conference will help you rewrite your Hatch-Waxman patent playbook for the next decade by helping you develop strategies for the defensive moves and offensive plays of this very complicated and high stakes endgame
Clearly, there is not a moment to lose in this ruthless endgame of no-holds bar litigation. Do not be left behind. Register today by calling 1-888-224-2480, faxing your registration form to
1-877-927-1563 or online.
We look forward to seeing you this spring in New York City.
Very truly yours,
Lisa J. Piccolo, Esq.
Senior Industry Manager, Life Sciences and Health Care
American Conference Institute
For Information on Sponsorship Opportunities please contact Esther Fleischhacker