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Five lawyers offer their experienced analysis of the Hatch-Waxman Act, a regulation intended to promote the marketing of generic drugs. The instructors begin with an explanation and a short history of the act before moving on to topics that include a discussion of industry incentives and limitations, antitrust legislation, Paragraph IV certification, ANDA exclusivity provisions, patent protection, creative patenting strategies and recent FTC investigations. They conclude with an explanation of numerous Orange Book strategies (sample topics are �Evergreening� and �Triggering the 30-Month Stay�) and a thorough examination of patent litigation settlements, using recent cases as models.

The Pharmaceutical Industry and the Hatch-Waxman Act
    I. Introduction
        A. Pharmaceutical Inventions
        B. Kenneth Dow, Chris Kelly, and Myra McCormack
        C. Terry Mahn and Ed Lentz
    II. Hatch-Waxman Act: An Overview (Ken Dow)
        A. Life Cycle of a Drug
        B. A Short History of Regulation
        C. Promoting Generic Drugs
        D. The ANDA
            1. Requirements
            2. Exclusivity Provisions
            3. Time Periods
        E. The Orange Book
        F. Paragraph IV Certification
        G. Changing Patent Statutes
            1. Limitations
            2. Patent Extensions
        H. Infringement Provisions
    III. Antitrust Issues in Hatch Waxman (Chris Kelly)
        A. The History
        B. Patent Protection
        C. Incentives
            1. Competition
            2. Invalid Patents
        D. FTC Investigations
            1. The 6(b) Investigation
            2. 180-Day Exclusivity
            3. Common Elements
            4. The Abbott Labs Case
                a. A Standstill
                b. Imbalance
                c. Prohibitions
            5. Antitrust Analysis
    IV. Claiming Strategies (Myra McCormack)
        A. Chemical
        B. Fingerprint
        C. Product-by-Process
        D. Prodrug
        E. Dosage Formulation
        F. Mechanism of Action
        G. Plasma Concentration
        H. Process of Administration
    V. Orange Book Strategies (Terry Mahn)
        A. An Overview of Orange Book Strategies
        B. NDA Tactics
            1. Getting Listed
            2. Case Law
            3. Evergreening the Orange Book
        C. ANDA Responses
        D. Litigation
            1. Delisting
            2. FTC Complaints
            3. Generic Exclusivity
            4. Triggering the 30-Month Stay
            5. Safe Harbor
    VI. Patent-Litigation Settlements (Edward Lentz)
        A. ANDA Exclusivity
        B. Risks
        C. Consent Decree
        D. Suits by Generic Competitors
        E. An Unhealthy Trend
        F. Red Flags
    AfterWords^SM