IP issues in AGRI-

BIOTECHNOLOGY
Malathi Lakshmikumaran
Lakshmi Kumaran & Sridharan
malathi@lakshmisri.com
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 above
and 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 Processes
UK 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 Processes
Patentable Inventions
Processes involving plants to
increase the yield
Genetic transformation
Tissue culture methods
Micro-propagation
Somatic embryogenesis

Gene Patents
Useful 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
Issues
Plant regeneration
Plant transformation
Gene sequences
Promoters
Vectors
Screening techniques
Plant 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 data
narrow host range
safe to mammals
safe to non-target
organisms
Mode-of-action
receptor-mediated
NPTII
Selectable 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)