12th Annual Maximizing Pharmaceutical Patent Life Cycles

American conference Institute’s (ACI’s) Maximizing Pharmaceutical Patent Life Cycles conference is the pharmaceutical industry’s leading 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.

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

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. This patent decline does not only pose problems for brand name drug manufacturers, but also proves troubling for generics; the ultimate Hatch-Waxman prize of 180-day exclusivity may be short-lived in the future as there will be few patented drug products worth coveting. Moreover, as the industry awaits 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 endgame.

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

This 12th 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’s conference features:

• Presentations from key representatives from the USPTO (invited), FTC, and FDA (invited). They will provide you with direct insights and the logic of these agencies on some of most pressing life cycle management challenges that the industry is facing today, including the latest on:
  • Patent reform; PTE and PTA determinations; and reissue and reexam proceedings
  • Pay-for-delay and the findings of the FTC Report on the IP Market Place
  • Forfeiture determinations
• An update on biosimilars and 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
• In-depth discussions on key regulatory developments impacting life cycle management including
  • REMS studies
  • Use codes, skinny labeling, and carve outs, and their relationship to divided infringement and inducement theories
  • Regulatory bars to exclusivity
• Analyses of recent critical cases affecting patent life cycle planning including: Sun Pharma (double patenting); Microsoft (standard of invalidity); Ariad (patentability); 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 essentials and emerging focus of pharmaceutical patent life cycle management.

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

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 on the fundamentals and mechanics of PTA and PTE practice which help to ensure patent and profit longevity; and

Working group on global pharmaceutical patent life cycle management strategies for established and emerging markets: A practical, hands-on guide to patent extensions and exclusivities Available to pharmaceutical products Around the World will offer in-depth and pragmatic advice for navigating patent systems in Europe and emerging BRIC markets

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 nearly 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.

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