Maximizing Pharmaceutical Patent Lifecycles

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.

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