Maximizing Pharmaceutical Patent Life Cycles
Venue: New York City
|Event Date/Time: Jul 09, 2004|
The rules of the patent endgame have dramatically changed in the last year. The introduction of the Final FDA Rule in June 2003 set the tone for change through its provisions on patent listings and stays. Yet, it was not until the passage of the Medicare Modernization Act (“MMA”) this past November that the game was officially re-invented. Title XI of the MMA, like the provisions of the Final FDA Rule “The Final Rule”* that it superseded, substantially curtails the ability of the brand names to extend patent life and quickens the pace of the entry of generic pharmaceuticals into the marketplace.
However, the heightening political controversy over generic biologics, importation, re-importation and counterfeiting may force the re-invention of the game yet again. What course of action should your company take in the midst of these dynamic legal, regulatory, and political changes? Does your company, whether brand name or generic, have the offensive moves and defensive plays it now needs to maximize its most lucrative or potentially lucrative products?
As counsel to either a brand name or generic pharmaceutical company, you need a complete understanding of the latest legal developments and their implications for your company’s life cycle strategies. This fifth and updated American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you thoughtful, targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both brand names and generics, as well as government representatives. They will provide insights on:
How the interplay of MMA and the Final Rule 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 Safe Harbor
The threat of compulsory licensing to US patents
The potential effects of re-importation on the patent endgame