Maximizing Pharmaceutical Patents Life Cycles

About

Is it fair? Is it foul?
Is it inequitable? Is it applicable?

Come to the only conference which provides real answers for both brand names and generics.

Current Hatch-Waxman litigation is replete with new controversies - all having substantial impact on the pharmaceutical patent endgame. The Federal Circuit has left many puzzled by its recent findings and reversals of inequitable conduct in certain Paragraph IV cases. In addition, the DC Circuit has now ruled that the FDA must make a decision regarding market entry of a follow-on biological product. Although this ruling leaves the FDA several options, it finally may force the agency to decide whether an abbreviated pathway for approval - similar to that for small molecules - now can be adopted safely for biologics. Last, but not least, the Supreme Court will be hearing the most pharmaceutical patent cases in recent memory. Meanwhile, on the legislative and regulatory front, the Generic Drug User Fee proposal, pediatric re-authorization under PDUFA, and patent reform and PTO rulemaking may also alter the endgame.

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. It's time to come to the one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies' current strategies and tactics against competitors in both camps. The publication from the seventh 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 event. An outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both the brand names and generics, as well as government representatives provide insights on:

• Applying the Orange Book Rules
• The critical link between patent life cycle management and patent portfolio management
• The Supreme Court and Patent Reform
  Top

  Contents & Contributors

  About

  Is it fair? Is it foul?
  Is it inequitable? Is it applicable?

  Come to the only conference which provides real answers for both brand names and generics.

  Current Hatch-Waxman litigation is replete with new controversies - all having substantial impact on the pharmaceutical patent endgame. The Federal Circuit has left many puzzled by its recent findings and reversals of inequitable conduct in certain Paragraph IV cases. In addition, the DC Circuit has now ruled that the FDA must make a decision regarding market entry of a follow-on biological product. Although this ruling leaves the FDA several options, it finally may force the agency to decide whether an abbreviated pathway for approval - similar to that for small molecules - now can be adopted safely for biologics. Last, but not least, the Supreme Court will be hearing the most pharmaceutical patent cases in recent memory. Meanwhile, on the legislative and regulatory front, the Generic Drug User Fee proposal, pediatric re-authorization under PDUFA, and patent reform and PTO rulemaking may also alter the endgame.

  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. It's time to come to the one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies' current strategies and tactics against competitors in both camps. The publication from the seventh 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 event. An outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both the brand names and generics, as well as government representatives provide insights on:

  • Applying the Orange Book Rules
  • The critical link between patent life cycle management and patent portfolio management
  • The Supreme Court and Patent Reform
    Top

    Contents & Contributors

    
    CHANGING LEGAL LANDSCAPE FOR THE LIFECYCLE GAME PLAN: WHAT ARE THE DRIVERS?, WHAT'S THE STRATEGY?
    George W. Johnston, LaRoche (Nutley, NJ)
    John C. Vassil, Morgan & Finnegan LLP (New York)
    
    FROM PRODUCT DEVELOPMENT TO PATENT PORTFOLIO MANAGEMENT TO PATENT LIFE CYCLES: STRATEGIES FOR A POST-MMA WORLD
    Michael A. Gollin, Venable LLP (Washington, DC)
    
    "COMPARABLE" BIOLOGICS BILL INTRODUCED
    Daniel A. Kracov, Arnold & Porter LLP (Washington, DC)
    
    APPLYING THE ORANGE BOOK RULES
    Bruce A. Pokras, Pfizer (New York)
    
    TO AND FDA REVIEW OF PHARMACEUTICAL TRADEMARKS, A TALE OF TWO AGENCIES
    Dickerson M. Downing, Morgan & Finnegan LLP (New York)
    
    NON-PATENT MARKET EXCLUSIVITIES
    Gregory J. Glover, MD, Pharmaceutical Law Group PC LLP (Washington, DC)
    
    505(B)(2) APPLICATIONS, FOLLOW-ON BIOLOGICS
    Donald A. Beers, Arnold & Porter LLP (Washington, DC)
    
    PATENT LITIGATION SETTLEMENTS: AVOIDING ANTITRUST PITFALLS
    M. Howard Morse, Drinker Biddle & Reath LLP (Washington, D.C.)
    
    SETTLING HATCH-WAXMAN LITIGATION: AN IN-HOUSE PERSPECTIVE
    Jerome A. Swindell, Johnson and Johnson (New Brunswick, NJ
    
    THE RIGHT BALANCE OF COMPETITION POLICY AND INTELLECTUAL PROPERTY LAW: A PERSPECTIVE ON SETTLEMENTS OF PHARMACEUTICAL PATENT LITIGATION
    Suzanne T. Michel, Federal Trade Commission (Washington, DC)
    Alden F. Abbott, Federal Trade Commission (Washington, DC)
    
    SCOPE OF THE SAFE HARBOR
    Brian D. Coggio, Greenberg Traurig LLP (New York)
    
    EYE ON THE SUPREME COURT
    Edward T. Lentz, Hoffman, Warnick & D'Alessandro LLC (Albany, NY)
    
    THE SUPREME COURT AND PATENT REFORM
    Janet B. Linn, Morgan Lewis & Bockius LLP (New York )
    
    EYE ON THE SUPREME COURT: KEY PATENT CASES
    Harold C. Wegner, Foley & Lardner LLP (Washington, DC)
    
    CHINA'S IP SYSTEM FOR THE PHARMACEUTICAL INDUSTRY
    Maria C. H. Lin, Morgan & Finnegan LLP (Shanghai Office)
    
    INDIAN PHARMACEUTICAL INDUSTRY – 2006
    Talat M. Ansari, India Practice Group, Kelley Drye & Warren LLP (New York)
    
    THE BASICS: STATUTORY AND REGULATORY ORANGE BOOKREQUIREMENTS
    Henry J. Renk, Partner, Fitzpatrick, Cella, Harper & Scinto (New York)
    
    EUROPEAN ROCHE BOLAR AND ITS IMPACT ON LIFE CYCLE STRATEGIES FOR U.S COMPANIES
    Dr. Andreas von Falck, Lovells (Düsseldorf, Germany)
    
    

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