Published on February 4, 2014
IP protected invention in the Field of Biotechnology Karan veer singh
Micro organisms Following forms of Micro organisms can be patented under Indian system of patenting – – – – Isolated Mutated Adapted Recombinant • Mandatory deposition of the micro organism in an IDA • Source and geographical origin to be disclosed
Recombinant Micro-Organism Genomic DNA Vector DNA Process and Product Patentable Ligate Recombinant clone in plasmid vector Protein product Patentable Micro-organism, variants Patentable Products -Human insulin -Immunoglobulin -vaccine -Blood clotting factor -Bt-toxin
Plant Processes Patentable Inventions • Processes involving plants to increase the yield • Genetic transformation • Tissue culture methods • Micro-propagation • Somatic embryogenesis
Gene Patents Useful Product • Claims • DNA of specific function/nucleotide sequence • Protein/Polypeptide from DNA sequence (if novel) • Recombinant plasmid (vector) • GM Organism containing the plasmid • A process for the production of the product
Application of DNA sequences in relation to patent claims • Diagnostic testing • Research tools -BRCA1 -CCR5 Receptor -MSP 1 Antigen • Gene Therapy -Cystic fibrosis -Various cancers • Production of proteins -Human Insulin -Epo
Gene Patent • Human/Animal genes can be patentable if they can be distinguished from genes as they naturally occur in human / animal bodiesnaturally occurring genes cannot be patented • First gene patent was for cystic fibrosis gene (US 5,776,677) • Not patentable in India at present.
Application of Patents to DNA Sequences • As long as form in which DNA sequence is claimed would not exist in nature without human intervention, sequence may be subject of a patent claim Examples • DNA sequence in isolated form • DNA sequence together with another sequence • DNA sequence that does not exist in nature even if close to it
Process vs. Product • Patents may be issued over DNA sequences, on ways of making DNA sequences, or on ways of using DNA sequences • A patent on the DNA sequence itself prevents all others from making, using, selling or importing that DNA sequence for any industrial purpose
Research Exemptions • Exception to Infringement- Sec. 47 (3) • Inventions may be used without fear of infringement for – Research – Experiments – Education and training
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