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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