Maximizing Pharmaceutical Patent Life Cycles (877L06.ADV)

Venue: Grand Hyatt San Francisco

Location: San Francisco, California, United States

Event Date/Time: Jun 13, 2006 End Date/Time: Jun 14, 2006
Early Registration Date: Apr 01, 2006
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Pharmaceutical patents --- and the life cycles of such patents --- are governed by the provisions of the Hatch-Waxman Act. This law established a “balance of power” between brand name and generic pharmaceutical products by setting time tables for patent expirations and the introduction of generic products into the market place. The passage of the Medicare Modernization Act (“MMA”) in November 2003 and the FDA’s Final Rule on Generic entry amended the Hatch Waxman time tables. Title XI of the MMA, like the provisions of the Final FDA Rule (“Final Rule (as amended)”) that it ultimately superseded, substantially curtailed the ability of the brand name pharmaceutical companies to extend patent expirations and quickened the pace of the entry of generic pharmaceuticals into the marketplace.

However, the MMA and the Final Rule are not the only factors affecting pharmaceutical patents. The heightening political controversy over generic/follow-on biologics ( a huge issue on the West Coast), patent reform, importation, re-importation and counterfeiting may force additional Hatch Waxman amendments.

Other issues include:

-How the interplay of MMA and the Final Rule (as amended) will affect:
-Orange Book listings and challenges
-Paragraph IV Certifications
-Exclusivity: 180 day exclusivity, orphan drug, pediatric and beyond
-The effects of the Integra and Housey decisions on the Hatch Waxman Safe Harbor
-The threat of compulsory licensing to US patents

Counsel to brand name and generic pharmaceutical companies need to constantly stay abreast of these issues. We have held this event on 6 previous occasions in light of this need. This will be our seventh program on this topic and our first West Coast installment.


Additional Information

Please visit the ACI website for more information and to register.