Patents are of critical value for future commercial development of innovation. Knowledge of legal system dedicated for intellectual property rights is limited. Basic information concerning biotechnological invention and patenting are presented with focus on 'red' biotechnology.
Genetically modified organisms are the key step for innovative medicines. The innovative drugs in the 21st century will be in the majority of proteins, nucleic acids and their combinations. The critical issues in case of biopharmaceuticals are quality and reproducibility of production. These aspects are evident in biosimilars (generics) and protection of intellectual property rights.
Current status of innovative drug industry is briefly presented with emphasis on new biopharmaceuticals introduced in the years 1995-2007. Adverse effects and problems of safety and effectiveness of these pharmacotherapeutics are reviewed. A separate part of the manuscript is devoted to the newly introduced methods of molecular diagnostics based on pharmacogenomics and employed in personalized medicine. Theranostic approach consisting in a joint use of drugs and companion diagnostics are characterized.
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