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Pharmaceutical Test Data Exclusivity
Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide. For each jurisdiction, in addition to explaining the available regulatory data protection – including both substantive and formal requirements for approvals and testing, protecti...
Antibody Patenting
Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have become firmly established in the ranks of blockbuster drugs, currently accounting for about half of the top 10 best-selling medicines. At the same time, a body of case law dealing specifically with the patentability of antibody-related inventions and the enforcement of antibody patents has emerged in major jurisdictions. The, at times, significant divergences between different jurisdictions have been compounded by recent decisions in the United States, which have severely curtailed the possibilities to obtai...
Patent Technology
The pace of US Technologies advancement is crucial to the US economy and its growth. Productivity and international competitiveness are important contributing factors. This book presents important analyses on patents, technology transfer and industrial competitiveness.
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