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Indian Patent Law, Office Procedures
and Examination Practice for
Biotechnology Patent Applications
Dr. K.S. KARDAM
Deputy Controller of Patents & Designs
Indian Patent Office,
Boudhik Sampada Bhawan
Sector-14,Dwarka
New Delhi-110075
E-mail-kardam.ks@nic.in
Website: www.ipindia.nic.in
Dr.K.S.Kardam IPO New Delhi
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Provisions under the
Indian Patent Act 1970
for Biotechnological inventions
Dr.K.S.Kardam IPO New Delhi
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Patentable inventions
Sec.(2(1)(j)
Any product or process which is
Novel
Involving inventive step(non obvious)
Capable of industrial application
Sufficiently disclosed
Dr.K.S.Kardam IPO New Delhi
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Non-patentable inventions
Sec.(3)
Any invention –
use or commercial exploitation of which
would be contrary to public order or public
health
Causes serious prejudice to human,
animal or plant life or health or to the
environment
Discovery of any living thing or nonliving substance occurring in nature
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Non-patentable inventions
Sec.(3)
Mere Discovery of new form property of
known substance without any enhancement
in the efficacy or new property or new use of
known substance
Any process for the medicinal, surgical,
curative, prophylactic ,diagnostic or
therapeutic or other treatment of human
being and similar treatment of animals
Method of Agriculture or horticulture
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Non-patentable inventions
Sec.(3)
Plants and animals in whole or any parts
thereof other than micro-organisms
Seeds
Varieties and species
Essentially biological processes for the
production or propagation of plants and
animals
Traditional knowledge
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Deposition of biological material
to supplement description
Section 10(4)(d)(ii)-If the applicant mentions a
biological material in the specification and such
material is not available to publicThe applicant has to deposit said biological
material in the International Depository Authority
recognized under Budapest Treaty before filing of the
application
Also disclose the source and geographical origin of
said material
Non disclosure or wrong disclosure is a ground for
opposition and revocation
Dr.K.S.Kardam IPO New Delhi
PROCEDURE FOR GRANT OF PATENT
FILING OF APPLICATION
PUBLICATION OF APPLICATION
• IF P.S.IS FILED C.S. TO BE FILED WITHIN 12 MONTHS
• AFTER 18 MONTHS FROM P.D.
Pre-Grant Representation
REQUEST FOR EXAMINATION
• WITHIN 48 MONTHS FROM F.D.
• ALL OBJECTIONS TO BE COMPLIED
WITHIN 12 MONTHS
EXAMINATION u/s 12
GRANT OF PATENT
Refusal of Representation
Rejection of opposition
POST GRANT OPPOSITION
Decision of
Controller
High Court
REVOCATION OF PATENT
March 14, 2016
Appellate
Board
K.S.Kardam
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Judicial Precedence
Dr.K.S.Kardam IPO New Delhi
Kolkata High Court decision
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Dimminaco A.G v. Controller of Patents & Designs
Invention claimed related to process of producing vaccine
containing living organisms
Controller held the claims of invention relating to a process
for preparation of infectious bursitis vaccine, not patentable
as process claimed not a manner of manufacture under
section 2(1)(j) of the Act as it contained living organisms and
not resulting to substance
Controller decision was challenged in the high court
The grounds taken by the applicant –
Act does not bar such invention from patenting.
Patents already granted on such matters.
Process is a manner of manufacture
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Kolkata High Court decision
Court held that –
1.Word manufacture not define, dictionary meaning
attributed to in the particular trade or business can be
accepted.
2. The process for preparation of vaccine under specific
scientific conditions is a new process and the said vaccine is
useful for protecting poultry against contagious bursitis
infection
3. No statutory bar to accept a manner of manufacture as a
patentable even if the end product contains a living organism.
4.One of the common test is vendibility test.
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Kolkata High Court decision
Vendibility Test –
1. Test is satisfied if the invention results in the
production of some vendible items or it improves or
restores former conditions of a vendible item or its effect
is the preservation and prevention from deterioration of
some vendible product.
2. Vendible product means something which can be
passed on from one men to another upon transaction of
purchase and sale.
In other words the product should be a commercial entity
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Patent office Decisions
Dr.K.S.Kardam IPO New Delhi
Case decided by Patent Office
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(1377/Del/1999)
Invention related to a method for in vitro
production of isolated langerhans islets
endocrine cells free from fibroblasts so as to
be suitable for transplantation. The process
discloses the steps of culturing and
proliferating the cells and back and forth
aspiration to separate fibroblast from the cells,
which will be capable of differentiating into
insulin producing cells.
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Case decided by the Patent
office…………….(2)
The applicant argued the case on following
grounds:
1. That the process is novel and has utility as
fibroblast free langerhans islets are useful in the
enhanced production of insulin to control
diabetes.
2. Kolkata High Court has already allowed patenting
of a substance containing living organisms.
3. Indian Patent law does not bar the grant patent
for such invention.
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Case decided by the Patent
Office ……………(3)
The Controller refused the application under section 15
on the following grounds:
1. The end product of the process is nothing but a cluster of
cells or piece of tissues of human body.
2. The invention claimed is not patentable under section 3(I)
as a method of treatment of human being, since langerhans
islets are freshly taken from the body of patient in order to
treat them to remove fibroblast so as to increase secretion of
insulin.
3. The principles laid down in Kolkata High Court are not
applicable as the end product of the process of present
invention are not commercial entity and cannot be passed on
from one person to another upon the transaction of purchase
or sale.
Dr.K.S.Kardam IPO New Delhi
M/s. AGA Medical Corporation, USA
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[Patent Application No.1283/DEL/2004],
A method for determining the nominal or stretched
diameter of an internal opening or defect was held a
method of treatment as the said method was being
performed within body of a patient and particularly
determining the stretched diameter of a septal defect
within the heart of a patient is inseparably connected
with the method of treatment” and, therefore, was
not patentable under section 3(i) of the Patent Act
1970.
Dr.K.S.Kardam IPO New Delhi
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GENENTECH INC. 4064/DELNP/2004
Claims related to METHODS FOR IDENTIFYING TUMORS
THAT ARE RESPONSIVE TO TREATMENT WITH ANTI-ErbB2
ANTIBODIES
After determination that the patient suffers from cancer (such as,
Castration- Resistant Prostate Cancer-CRPC or ovarian cancer) that is
positive for HER2 phosphorylation, the patient will receive a loading dose
of 840 mg of rhuMAb 2C4 on day 1 of cycle 1 (first 21-day treatment
period), followed by 420 mg on day 1 of each subsequent 21-day cycle, as
continuous intravenous infusion .
The said MAb are already known as described in the description
Applicant submitted that improvement lies in new amounts of rhuMAb
(420 and 840 mg )
The controller refused the application under section 3(d) (new use of
known substance) as being dosage and 3(i) method of treatment
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Lonza Biologics PLC- 3871/DELNP/2005
Method of purifying an antibody, preferably an IgG antibody, comprising the steps in the
following sequence: (a)harvesting the antibody from a cell culture; (b) purifying the
antibody harvested in step (a) by means of protein A affinity chromatography; (c) obtaining
purified antibody and protein A-contaminant upon eluting bound antibody from said
protein A affinity chromatography column; (d) loading the purified antibody obtained in
step (c) in combination with contaminant protein A, onto an anion exchange material under
conditions of using a loading buffer having a displacer salt concentration of 1-150 mM and
pH of 6.5-9.0 and allowing binding of the protein A to the anion exchange material and
retaining the antibody in the flow-through; (e) collecting the antibody obtained in step (d)
in the flow-through of the anion exchange material whilst the contaminant protein A is
bound to the anion exchange material; and (f) further purifying the antibody by loading on,
binding to and eluting it from a second ion exchanger, which is a cation exchanger; wherein
a loading buffer having a pH of 4 to 7 and a salt gradient from 0.1 to 1.2 M salt are used and
the elution takes place at pH of 7 to 8 to achieve the level of contaminant protein A in the
pooled eluate to be <0.4 ng/mg antibody.
The application was opposed under section 25(1)on the ground of Not an invention within
the meaning of this Act or non Patentable under this Act
The controller rejected the opposition and proceeded to grant of patent
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Horticulture and agriculture
methods related cases
A method of producing mushroom plant
(64/Cal/79) and
a method for cultivation of an algae
(445/Del/93] were held not patentable under
section 3(h) and section 2(1)(j) of the Act.
Dr.K.S.Kardam IPO New Delhi
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Patent application not allowed
for (1)
A method of treating Neoplastic or cancerous growths comprising
administering to a patient in need thereof:
(a) an admixture comprising a cancer or tumor antigen expressed by said
cancer cells and a micro-fluidized antigen formulation, said antigen
formulation
comprising:
(i) a stabilizing detergent,
(ii) a micelle-forming agent, and
(iii) a biodegradable and biocompatible oil,
said antigen formulation being formulated as a stable oil-in-water
emulsion; wherein said admixture is administered to said patient
in an amount sufficient to induce a cytotoxic T.lymphocyte
response in said patient which is specific for the cancer or tumor
antigen contained in said admixture, and
(b) a therapeutically effective amount of at least one agent which is
capable of neutralizing or down regulating the activity of tumor and host
secreted immunosuppressive
Dr.K.S.Kardam IPO New Delhi
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Patent application not allowed
for (2)
A method for cloning an animal, particularly a mammal, with a
cloning efficiency of better than ten percent (10%), said method
comprising the steps of:
(a) inserting a somatic cell, or nucleus isolated from said somatic
cell, deriving from a somatic cell culture having undergone 5 or
more passages, into an enucleated oocyte to form a cybrid;
(b) activating the cybrid;
(c) culturing the activated cybrid;
(d) transferring the activated cybrid of step (c) into an appropriate
host such that the activated cybrid develops into a fetus;
(e) maintaining the fetus in the host until the fetus is capable of
surviving and maturating into a viable animal outside of said host
Dr.K.S.Kardam IPO New Delhi
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Patent application not allowed
for (3)
 Claim-1:
Seed of hybrid maize variety designated
33N56, representative seed of said variety
having been deposited under ATCC
Accession Number PTA-6417.
2. A maize plant, or a part thereof,
produced by growing the seed of claim 1.
 3. Pollen of the plant of claim 2.
 4. An ovule of the plant of claim 2
Dr.K.S.Kardam IPO New Delhi
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Patents granted
st
after 1 January 2005
Dr.K.S.Kardam IPO New Delhi
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Patents granted
PATENT
NUMBER
APPLICATION NUMBER TITLE OF INVENTION
236079
370/MUM/2004
METHOD FOR SYNTHESIS OF HUMAN RECOMBINANT INSULIN WITH
IMPROVED PROCESS EFFICIENCY
RELIANCE LIFE SCIENCES
PVT LTD.
231303
2898/CHENP/2005
VARIANT SUBTILISIN ENZYMES (SUBTILASES)
NOVOZYMES A/S
231288
168/MAS/1999
A METHOD OF TREATING SUNFLOWER PLANTS
INDIAN INSTITUTE OF
SCIENCE
228705
1087/DELNP/2005
"PLASMID-FREE CLONE OF E. COLI STRAIN DSM 6601"
PHARMA-ZENTRALE
GMBH
228492
1882/DELNP/2004
"POLYNUCLEOTIDE MOLECULE COMPRISING A NUCLEOTIDE SEQUENCE
PFIZER PRODUCTS INC.
THAT IS THE STREPTOMYCES AVERMETILIS AVEC ALLELE"
228220
668/MAS/1998
VACCINES AGAINST INFECTIONS CAUSED BY YF VIRUS; YF INFECTIOUS
cDNA, METHOD FOR PRODUCING A RECOMBINANT YF VIRUS FROM
THE YF INFECTIOUS cDNA AND PLASMIDS TO ASSEMBLE THE YF
INFECTIOUS cDNA
228182
2554/CHENP/2005
DNA CONSTRUCTS AND METHODS TO ENHANCE THE PRODUCTION OF MONSANTO
COMMERCIALLY VIABLE TRANSGENIC PLANTS
TECHNOLOGY, LLC
226291
709/DEL/2001
"A PROCESS FOR TRANSFERRING FOREIGN DNA INTO CALLUS CELLS OF DABUR RESEARCH
TAXUS SP."
FOUNDATION
225008
IN/PCT/2001/01208/K LIM MINERALIZATION PROTEIN SPLICE VARIANTS TO INDUCE BONE
OL
FORMATION
Dr.K.S.Kardam IPO New Delhi
APPLICANT NAME
FUNDACAO OSWALDO
CRUZ - FIOCRUZ
EMORY UNIVERSITY
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Patents granted
PATENT
NUMBER
APPLICATION NUMBER TITLE OF INVENTION
224298
490/MAS/1998
A METHOD OF IDENTIFYING A PHARMACOLOGICALLY ACTIVE
SUBSTANCE AND A DNA TEMPLATE FOR THE SAME
HOECHST
AKTIENGESELLSCHAFT
221076
629/MUMNP/2006
INTACT MINICELLS AS VECTORS FOR DNA TRANSFER AND GENE
THERAPY IN VITRO AND IN VIVO
ENGENEIC MOLECULAR
DELIVERY PTY LTD
218516
740/CHENP/2004
HEPATITIS C VIRUS VACCINE
ISTITUTO DI RICERCHI DI
BIOLOGIA MOLECOLARE
P. ANGELETTI SPA
218499
375/MAS/2003
PREPARATION OF OLIGOSACCHARIDE BIONANOPARTICLES FROM
MORINGA OLEIFERA LAM
DR. SAMBANDAM
SHANMUGASUNDARAM
217619
504/DEL/2004
A PLASMID CONSTRUCT FOR TESTING THE RESISTANCE OF HIV-1
SUBTYPE C VIRUS ISOLATES TO ANTIRETROVIRAL DRUGS IN VITRO.
SETH PRADEEP
217407
763/KOLNP/2004
A METHOD OF EXPRESSING A LIM MINERALIZATION PROTEIN IN A
NON-OSSEOUS MAMMALIAN CELL
WARSAW ORTHOPEDIC,
INC.
213334
423/MUMNP/2004
METHOD FOR PRODUCTION OF RECOMBINANT PROTEINS IN
MICROORGANISMS
N-ZYME BIOTEC GMBH
213289
826/MUM/2002
RECOMBINANT DNA MOLECULE ENCODING A NOVEL HUMAN
INTERFERON ALPHA 2B LIKE POLYPEPTIDE METHOD FOR PRODUCING
IT IN PICHIA AND ITS USE
CADILA HEALTHCARE
LIMITED
212080
1276/DEL/2002
"A PROCESS OF SYNTHESIZING HIGH QUANTITIES OF HUMAN
INTERFERON ALPHA 2a PROTEIN"
Dr.K.S.Kardam IPO New Delhi
APPLICANT NAME
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Patents granted
PATENT
NUMBER
APPLICATION NUMBER
TITLE OF INVENTION
208414
732/MUM/2000
STREPTOMYCES AVERMITILIS GENE DIRECTING THE RATIO OF B2:B1
PFIZER PRODUCTS INC.
AVERMECTINS
208063
IN/PCT/2001/58/CHE
A METHOD FOR PREPARING A YEAST STRAIN
199888
569/DEL/2001
"A PROCESS FOR PREPARING A PROTEINS, USED FOR DETECTION OF
UNIVERSITY OF DELHI
HIV ANTIBODIES"
199578
566/DEL/2002
"A PROCESS OF OBTAINING RECOMBINANT LAMBDOID
BACTERIOPHAGE AND THE RESULTANT NOVEL PHAGE DISPLAY
SYSTEM"
UNIVERSITY OF DELHI
189732
616/DEL/1998
"A PROCESS FOR PREPARATION OF AN IMPROVED PLASMID
FRAGMENTS"
IDEC PHARMACEUTICALS
CORPORATION
210988
IN/PCT/2001/01140/MU
M
CHIMERIC EXPRESSION PROMOTERS ORIGINATING FROM
COMMELINA YELLOW MOTTEL VIRUS AND CASSAVA VEIN MOSAIC
VIRUS
MERISTEM
THERAPEUTICS
210988
IN/PCT/2001/01140/MU
M
CHIMERIC EXPRESSION PROMOTERS ORIGINATING FROM
COMMELINA YELLOW MOTTEL VIRUS AND CASSAVA VEIN MOSAIC
VIRUS
MERISTEM
THERAPEUTICS
235741
1274/DEL/2002
"A PAIR OF OLIGONUCLEOTIDE PRIMERS FOR SPECIFIC
DEPARTMENT OF
AMPLIFICATION OF THE HUPB GENE OF MYCOBACTERIUM SPECIES" BIOTECHNOLOGY
232332
1149/DEL/2000
"HUMAN ORAL CANCER CELL LINE ESTABLISHED AND PROPAGATED THE DIRCTOR, ALL INDIA
IN VITRO FROM ORAL"
INSTITUTE OF MEDICAL
Dr.K.S.Kardam IPO New Delhi
APPLICANT NAME
NOVO NORDISK A/S
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Trend of Biotech Inventions
Filed In India
Isolated Nucleic acid encoding a gene
Novel polypeptides
Recombinant antibody
Recombinant oligonucleotides and primers, genes
Novel Peptide analogs
Waste water and sewage treatment using microorganism
Novel vaccines
DNA related inventions such as preparing plasmids, vectors etc
Primers
Method of preparation of recombinant hormones
Method of enzyme purification (recombinants)
Dr.K.S.Kardam IPO New Delhi
Application Filing trend of
Biotech inventions in India
Biotechnol
ogy
190
Electric Mechan Compu
al
ical
ter/
Electro
nics
1079
3304
2787
2211
101
1274
4734
5700
1525
2006-07 6354
3239
1223
2371
5536
5822
2774
2007-08 6375
4267
233
2210
6424
4842
1950
200809
3672
340
WIPO TRAINING OF TRAINERS PROGRAM ON
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Year
Chemical
Drug
Food
2004-05 3916
2316
2005-06 5810
5884
Dr.K.S.Kardam IPO New Delhi
1214
1844
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