
Contents
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What is Biotechnology? What is Biotechnology?
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Patents and Biotechnology Patents and Biotechnology
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Microbiological Inventions Microbiological Inventions
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Patentability of Microorganisms Patentability of Microorganisms
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Description and Deposition Requirements Description and Deposition Requirements
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The Budapest Treaty The Budapest Treaty
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Recombinant DNA Technology Recombinant DNA Technology
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Scientific Background Scientific Background
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Gene-splicing techniques Gene-splicing techniques
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Transformation and expression Transformation and expression
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Isolation of the gene product Isolation of the gene product
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Patentable Inventions in Recombinant DNA Technology Patentable Inventions in Recombinant DNA Technology
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General techniques General techniques
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Specific gene products and DNA sequences Specific gene products and DNA sequences
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Patentable Subject Matter Patentable Subject Matter
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Inventive Step Inventive Step
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Breadth of Claims Breadth of Claims
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Sufficiency, Enablement, and the Written Disclosure Requirement Sufficiency, Enablement, and the Written Disclosure Requirement
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Monoclonal Antibody Technology Monoclonal Antibody Technology
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Scientific Background Scientific Background
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Patentability Patentability
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More Recent Technologies More Recent Technologies
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Genomics Genomics
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Proteomics Proteomics
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Antisense Technology Antisense Technology
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RNA Interference RNA Interference
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Stem and Progenitor Cells Stem and Progenitor Cells
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Cell and Gene Therapy Cell and Gene Therapy
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Pharmacogenomics Pharmacogenomics
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Biosimilars and Follow-on Biologics Biosimilars and Follow-on Biologics
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14 Biotechnological Inventions
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Published:December 2016
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Abstract
This chapter considers the law governing the patentability of biological inventions, including microbiological inventions, recombinant DNA technology, and monoclonal antibody technology. Patent protection for biotechnological inventions is of immense commercial importance. But patent law and practice have been unable to keep up with the rapid scientific progress in this field; issues such as inventive step, sufficiency of disclosure, and permissible breadth of claims have proved troublesome. There has been much litigation of biotech patents and courts have found it difficult in such a rapidly moving field to determine what was the general knowledge of the skilled person at the time that the invention was made. Another problem is the opposition of special interest groups to anything related to genetic engineering, particularly the existence of patents in this area.
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