This document discusses patenting of microorganisms, recombinant DNA, plant processes, gene patents, and applications of DNA sequences in India. Key points: 1) Isolated, mutated, adapted, and recombinant microorganisms can be patented under Indian law, and must be deposited in an IDA with disclosed source and geography. 2) Recombinant DNA techniques allow for patenting of processes, products, microorganisms and their variants, and proteins. 3) Plant processes involving increasing yield, genetic transformation, tissue culture, micropropagation, and somatic embryogenesis are patentable. 4) Gene patents can claim DNA sequences, proteins, recombinant plasmids, GM organisms, and production processes

1. IP protected invention in the
Field of Biotechnology
Karan veer singh

2. 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

3. 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

4. Plant Processes
Patentable Inventions
• Processes involving plants to
increase the yield
• Genetic transformation
• Tissue culture methods
• Micro-propagation
• Somatic embryogenesis

5. 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

6. 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

7. 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.

8. 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

9. 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

10. Research Exemptions
• Exception to Infringement- Sec. 47 (3)
• Inventions may be used without fear of
infringement for
– Research
– Experiments
– Education and training