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    Course Information

7340  The Pharmaceutical Industry and the Hatch-Waxman Act

Course Length    136 minutes
Course Price    $ 119.00

Volume discounts and subscriptions are available; for more information, contact Cognistar Sales.

    Accreditation Information


Click on jurisdiction below for more details.
>>  2.25  credits    CA
>>  2.75  credits    CO  WV

    About the Instructor(s)


  Robert Armitage
Eli Lilly & Co.

Robert A. Armitage, Vice-President and General Patent Counsel, Lilly Research Laboratories, Eli Lilly & Co.

  Kenneth Dow
Centocor, Inc.

Kenneth Dow, vice president, patent law, at Centocor, Inc. (a wholly owned subsidiary of Johnson & Johnson)

  Chris Kelly
Kaye Scholer

Chris Kelly, special counsel in the antitrust, intellectual property, E-commerce technology and competition group at Kaye Scholer

  Ed Lentz
Morgan, Lewis & Bockius

Ed Lentz, partner at Morgan, Lewis & Bockius, focusing on Intellectual Property issues

  Terry Mahn
Fish & Richardson

Terry Mahn, managing principal in the Washington, D.C. office of Fish & Richardson

  Myra McCormack
Johnson & Johnson

Myra McCormack is a patent attorney with Johnson & Johnson in New Brunswick, N.J., and former chair of the AIPLA Professional Programs Committee. She holds a B.A. from St. Olaf College, a Ph.D. from the University of Minnesota, and a J.D. from the University of San Diego School of Law.



    Outline + Synopsis

Outline Synopsis
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
    AfterWordsSM


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.


    Content Provided By

 

The American Intellectual Property Law Association (AIPLA) is a 16,000-member, national bar association constituted primarily of lawyers in private and corporate practice, in government service, and in the academic community. The AIPLA represents a wide and diverse spectrum of individuals, companies and institutions involved directly or indirectly in the practice of patent, trademark, copyright and unfair competition law, as well as other fields of law affecting intellectual property. Members represent both owners and users of intellectual property.

AIPLA was formed in 1897 in order to maintain a high standard of professional ethics, to aid in the improvements in laws relating to intellectual property and in their proper interpretation by the courts, and to provide legal education to the public and to its members on intellectual property issues.

To qualify for membership, applicants must be members in good standing of the bar of a court of record of the United States or any state. Foreign affiliate members must be able to practice in a court of general jurisdiction in their countries to be considered for membership, or be registered to practice with the Patent and/or Trademark Office of their country of citizenship. AIPLA also has student memberships available for those regularly enrolled in a law school approved by the Association of American Law Schools. Approximately 70% of the active members are in private practice, 30% in corporate practice, with the remainder in the government or academia.

AIPLA holds three regularly scheduled conferences a year, Mid-Winter, Spring and Fall, at which the association offers educational seminars on the latest developments in intellectual property law. In addition, AIPLA holds many stand-alone seminars on specialized areas of intellectual property law at varying times of the year in locations around the United States. The association also produces a number of informative publications including the AIPLA Quarterly Journal (a scholarly law journal published four times a year), the AIPLA Bulletin (an overview of AIPLA meetings published online three times a year), and CD-ROMs and tapes which include papers or speeches presented by speakers at the meetings. The AIPLA also publishes the Report of the Economic Survey biennially.

Furthermore, the AIPLA is actively involved in shaping U.S. intellectual property policy through its work on legislation and federal regulations affecting intellectual property cases in the U.S. courts. Internationally, the AIPLA has spearheaded a worldwide campaign to reduce the costs of procurement and enforcement of patents, regularly participates in meetings of the World Intellectual Property Organization, and maintains close relations with foreign IP officials and practitioners.




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7340  The Pharmaceutical Industry and the Hatch-Waxman Act

Course Price     $ 119.00

course is not for sale

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Volume discounts and subscriptions are available; for more information, contact Cognistar Sales.

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