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
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