The 13th Annual

Maximizing Pharmaceutical Patent Lifecycles

The definitive Hatch-Waxman and BPCIA event for brand names and generics

Wednesday, October 10 to Thursday, October 11, 2012
New York Marriott Downtown, New York, NY

This conference is dedicated to the memory of:

John C. Vassil
Chairman Emeritus
(March 3, 1930 - March 6, 2012)


Unprecedented patent losses on small molecule pharmaceutical products having values in excess of $100 billion annually will occur in the next few years.

The pharmaceutical industry now stands on the edge of the patent cliff. By 2016, patents on myriad block buster pharmaceutical products for treating ailments and conditions ranging from asthma to high cholesterol to psychosis and beyond will go off patent. In addition, for the first time, US filers must engage in a race to the PTO under the America Invents Act’s first-to-file system, contend with global prior art, and prepare for battle in new PTO proceedings designed to challenge patents during and after the patent examination process. Moreover, as the industry digests recently issued FDA guidance on biosimilars, it remains anyone’s guess as to what effect, if any, these new medicinal entities and therapies will have on the patent end game. Now is the time that both brand name and generic companies must rethink the rules of the game and there is not a minute to lose.

New IP and industry dynamics coupled with evolving law and regulation have created new patent life cycle challenges for brand names and generics.

American Conference Institute’s (ACI’s) Maximizing Pharmaceutical Patent Life Cycles conference is the pharmaceutical industry’s leading and integral source for information and analysis on patent life cycle management for both small and now large molecule pharmaceutical products. It is the forum where lawyers, executives and policy makers for brand name and generic manufacturers gather each year to prepare for the life cycle challenges they currently face as well as those which they anticipate.

Prepare to meet these pharmaceutical life cycle challenges head-on.

The 13th ACI conference on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry –leading event. This year’ conference features:

  • Presentations from key representatives from the USPTO who will provide you with direct insights and the logic of this agency on some of most pressing life cycle management strategies that the industry is facing today

  • An update on biosimilars and how the further development of these second generation biological products will influence pharmaceutical patent life cycle and portfolio strategies in view of the further implementation of BPCIA and the inevitability of the patent cliff

  • Analyses of recent critical cases affecting patent life cycle planning including: Caraco (use codes); Prometheus (subject matter eligibility); Sun Pharma (double patenting); Ariad (patentability); and Therasense (inequitable conduct) - and strategies for using these cases to your advantage

Benefit from in-depth and practical training and strategy sessions that will address the essential and emerging focus of pharmaceutical patent life cycle management.

In response to your requests, we have added the following in-depth pre-conference training and strategy sessions:

Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Hatch-Waxman Strategies Relative to Patent Life Cycle Management will utilize the expertise of leading counsel for branded and generic manufacturers to discuss the specifics of the AIA’s reforms, including detailed discussions of
post-grant review, inter partes review, and supplemental proceedings, and;

PTA-PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry will offer critical instruction from leading practitioners and the PTO on the fundamentals and mechanics of PTA and PTE practice which help to ensure patent and profit longevity.

Nearly 3,000 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management for the last twelve years. This updated event will
bring you the latest legal strategies and tactics for successful maneuvering in the evolving patent endgame.

With all that’s at stake, you cannot afford to miss this conference.

Don’t delay – register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering on-line at www.americanconference/LifeCycles.