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IP Topics

By Steven J. Lee, Ph.D. and Joseph F. Nicholson - January 2005

International Pharmaceutical Law and Practice covers key pharmaceutical law topics in all of the major industrial countries and for each country discusses in detail:

  • Treaties and international law principles affecting patents, data exclusivity and other rights relating to pharmaceutical manufacture and sales
  • Patent procurement and the scope of patent protection afforded pharmaceutical subject matter
  • Substantive patentability requirements of novelty, utility and inventiveness
  • New drug approval process and supplementary approvals
  • Government price controls on pharmaceuticals and government drug payment plans
  • Obtaining an approval for a generic version of a drug
  • Compulsory Licensing

Chapter 19, The United States was contributed and co-authored by:

Dr. Steven J. Lee, Dr. Estelle J. Tsevdos, Donna M. Praiss, Joseph F. Nicholson, Azeen Roohi James, and Andrea H. Scheidt of Kenyon & Kenyon.