7th Annual

Maximizing Pharmaceutical Patents Life Cycles

The definitive Hatch-Waxman event for brand names and generics

Monday, October 23, 2006

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

    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

      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)



    DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0