malathi ip agri feb 12 2008
TRANSCRIPT
Scope
Different Forms of IP Indian Patent Act Genetically modified plants
Patent - Protection of plant related inventions
US grants Plant Patents Utility Patents Plant Variety Protection
THE IPR CYCLE
Creation
Protection Exploitation
The Patents Act - Post 2005 Definitions
•Sec. 2(j) Invention • Any new product or process• Involves an Inventive Step• Capable Of Industrial Application
Sec. 2(ja) Inventive Step – Feature involving• Technical advancement; or• Economic significance; or • Combination of aboveand makes it non obvious to a person skilled in the art
WHAT IS NOT PATENTABLE?
•Methods of Agriculture and horticulture•Method of treatment of human being or animals•Plants and animals •Essentially biological process for production of plants •The mere discovery of any new property or mere new use for a known substance or the mere use of a known process.
Indian Patents Act
Section 3(j) Plants and animals in whole or any
part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.
Inventions not patentable…
Significant Amendments.. Not excluded from patentability:
•New section 3 (i) does not mention “or plants”
•Thus, patent possible for processes for treatment of plants•to render them free of disease or •to increase their economic value or that of their products.
•No bar on process of production of GMO.
Section 3(c) Inventions not patentable…Mere discovery of a scientific
principle or the formulation of an abstract theory or discovery of any living thing or non living substances occurring in nature.
INDIAN PATENT ACT
Sec 3(j): Essentially Biological Processes
Grey Area - between Essentially Biological Processes and non-biological processes
Processes exist where biological reproduction is employed
Steps consisting of direct human intervention could warrant patentability
Essentially Biological ProcessesUK Examination Guidelines suggest the following:• To be judged on the basis of the invention• Extent of human intervention to be considered• But human contribution should not be trivial
Lubrizol / Hybrid plants [1990] OJEPO 71
Plant ProcessesPatentable Inventions Processes involving plants to
increase the yield Genetic transformation Tissue culture methods Micro-propagation Somatic embryogenesis
Gene PatentsUseful Products 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 GM
plant
•Sec 47 : Any machine, apparatus or other articles of which patent is granted ……….may be used, by any person, for the purpose merely of experiment or research including the imparting of instructions to pupils:
•Madey v. Duke University (U.S. Fed. Cir.) – Experimental Use Defence.
Research Exemption
Genetically Modified Plants
Patents related to tissue culture
technology
IssuesPlant regenerationPlant transformationGene sequencesPromotersVectorsScreening techniquesPlant variety protection
Shoots regeneration from hypocotyl of B. juncea
Regeneration Protocols
Leaves Roots Hypocotyls Cotyledons Callus Rhizogenic calli Somatic embryogenesis
Ti Plasmid of Agrobacterium
Vectors for Transformation
Binary vectors including methods for their assembling and their use
Modified binary vectors & methods Cointegrated vectors
Transformation of Plants by Agrobacterium
Select for with antibiotic or herbicide resistance
“cloning”
Cotton Transformation Hypocotyl Cotton explants Meristematic cells of cotton shoot tips
Cotton Petiole Embryogenic callus Root callus
Case Study Bt Plants
Bacillus thuringiensis strains
Lepidopterous – butterflies cryI, cryII Dipterous – flies and mosquitoes, cryII, cryIV Coleopterous – beetles, cryIII Nematodes Ants
Most potent strain, B. t. var. kurstaki HDI• Isolated in the sixties
Endotoxins of Bt Most Bt preparation contain
spores that have inclusion bodies composed of d-endotoxins
At least 50 d-endotoxin genes have been isolated, these fall into 16 groups
Endotoxin genes are usually born on large plasmids
CryIA(c)Insecticidal activity> 99% nature identical
Commercial microbial products (30 years)
Extensive safety / environmental datanarrow host rangesafe to mammalssafe to non-target organisms
Mode-of-actionreceptor-mediated
NPTIISelectable marker
FDA approved processing aid / food additive
Ubiquitous in nature
enteric and soil microorganisms
Defined activity
requires ATP
Genes inserted and proteins produced in Bt Cotton
RB Pro cryIA(c) Term Pro nptII Term aad
AAD
Bacterial selection prior to plant production
Gene driven by bacterial promoter
Protein is not expressed in plant
Common in nature
LB
Bt transformed cotton untransformed cotton
Transgenic Cotton
Bacillus thuringiensis
Methods & compositions for detection of bacterial endotoxins
kits for detection of endotoxins strains -higher yields of endotoxins mutations at different(a.a.) positions hybrid Bt-novel broad spectrum various strains of Bt(mutants)
