12th Annual Maximizing Pharmaceutical Patent Life Cycles/The American Conference Institute
04-Oct-2011
To
05-Oct-2011
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Source :
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Visits : 7921
Tuesday, October 04 to Wednesday, October 05, 2011
New York Marriott Downtown, New York, NY
The pharmaceutical industry stands at the edge of the patent cliff.
The era of biosimilars is in its infancy.
A new pharmaceutical patent paradigm has emerged which has radically altered the Rules of the Pharmaceutical Patent Endgame.
Get ready to play. Be part of the only event which for over a decade has prepared brand name and generic drug companies --- and biopharmaceutical companies for this moment.
Patents covering critical pharmaceutical products worth more than $133 billion annually ----ranging from cholesterol lowering drugs to anti-psychotics to asthma drugs and antibiotics --- are set to go off patent between now and 2016. In the midst of this small molecule patent onslaught, the pharmaceutical industry must assess how the application process for biosimilars as enacted by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) will interact with existing patent life cycles planning under Hatch-Waxman and other mechanisms.
Brand name manufacturers are struggling to fill a drying pipeline and extend patent life through statutory and regulatory conventions as well as strategic partnering. Meanwhile, generics eye the ultimate Hatch-Waxman prize of 180-day exclusivity— knowing that such opportunities in the future may be short-lived as there will be few patented drug products worth coveting. This scenario coupled with new decisions affecting forfeitures, Orange Book listings, methods claims and claims drafting are shaping the evolution of Hatch-Waxman. Industry observers warn that the balance of power designed by the Hatch-Waxman Act may completely unravel in the midst of this patent deluge.
There is also concern over how proposed patent reform will be yet another game changer. Moreover, the aggressive stance of various agencies including the PTO, FDA and FTC on various components of Hatch-Waxman adds to this metamorphosis.
Now is the time to come to the one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies’ current Hatch-Waxman strategies and tactics against competitors in both camps.
This 12th American Conference Institute event 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 conference.