Indian Patent Law, Office Procedures and Examination Practice for Biotechnology Patent Applications

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6 Δεκ 2012 (πριν από 4 χρόνια και 6 μήνες)

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Dr.K.S.Kardam IPO New Delhi

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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

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Provisions under the


Indian Patent Act 1970

for Biotechnological inventions

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Any product or process which is


Novel


Involving inventive step(non
-

obvious)


Capable of industrial application


Sufficiently disclosed


Patentable inventions
Sec.(2(1)(j)

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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 non
-
living substance occurring in nature

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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

Non
-
patentable inventions
Sec.(3)

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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

Non
-
patentable inventions
Sec.(3)

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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

Deposition of biological material
to supplement description

March 16, 2013

K.S.Kardam

PROCEDURE FOR GRANT OF PATENT

PUBLICATION OF APPLICATION

REQUEST FOR EXAMINATION

EXAMINATION u/s 12

GRANT OF PATENT


REVOCATION OF PATENT

POST GRANT OPPOSITION



AFTER 18 MONTHS FROM P.D.



WITHIN 48 MONTHS FROM F.D
.



ALL OBJECTIONS TO BE COMPLIED


WITHIN 12 MONTHS



IF P.S.IS FILED C.S. TO BE FILED WITHIN 12 MONTHS


FILING OF APPLICATION


Decision of

Controller

Appellate

Board

High Court

Pre
-
Grant Representation

Refusal of Representation

Rejection of opposition

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Judicial Precedence

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Kolkata High Court decision

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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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.

Kolkata High Court decision


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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


Kolkata High Court decision


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Patent office Decisions

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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.


Case decided by Patent Office


(1377/Del/1999)

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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.


Case decided by the Patent
office…………….(2)

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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.

Case decided by the Patent
Office ……………(3)

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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.

M/s. AGA Medical Corporation, USA
[Patent Application
No.1283/DEL/2004],

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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 treatme
nt





GENENTECH INC. 4064/DELNP/2004

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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


Lonza Biologics PLC
-

3871/DELNP/2005

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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
.

Horticulture and agriculture
methods related cases

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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

Patent application not allowed
for (1)

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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


Patent application not allowed
for (2)

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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

Patent application not allowed
for (3)

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Patents granted


after 1
st

January 2005

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Patents granted

PATENT
NUMBER

APPLICATION NUMBER

TITLE OF INVENTION

APPLICANT NAME

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
THAT IS THE STREPTOMYCES AVERMETILIS AVEC ALLELE"

PFIZER PRODUCTS INC.

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

FUNDACAO OSWALDO
CRUZ
-

FIOCRUZ

228182


2554/CHENP/2005

DNA CONSTRUCTS
AND METHODS TO ENHANCE THE PRODUCTION OF
COMMERCIALLY VIABLE TRANSGENIC PLANTS

MONSANTO
TECHNOLOGY, LLC

226291


709/DEL/2001

"A PROCESS FOR TRANSFERRING FOREIGN DNA INTO CALLUS CELLS OF
TAXUS SP
."

DABUR RESEARCH
FOUNDATION

225008


IN/PCT/2001/01208/K
OL

LIM MINERALIZATION PROTEIN SPLICE VARIANTS TO INDUCE BONE
FORMATION

EMORY UNIVERSITY

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Patents granted

PATENT
NUMBER

APPLICATION NUMBER

TITLE OF INVENTION

APPLICANT NAME

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"

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Patents granted

PATENT
NUMBER

APPLICATION NUMBER

TITLE OF INVENTION

APPLICANT NAME

208414


732/MUM/2000

STREPTOMYCES AVERMITILIS GENE

DIRECTING THE RATIO OF B2:B1
AVERMECTINS

PFIZER PRODUCTS INC.

208063


IN/PCT/2001/58/CHE

A METHOD FOR PREPARING A YEAST STRAIN

NOVO NORDISK A/S

199888


569/DEL/2001

"A PROCESS FOR PREPARING A PROTEINS, USED FOR DETECTION OF
HIV ANTIBODIES"

UNIVERSITY OF DELHI

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
AMPLIFICATION OF THE HUPB GENE OF MYCOBACTERIUM SPECIES"

DEPARTMENT OF
BIOTECHNOLOGY

232332


1149/DEL/2000

"HUMAN ORAL CANCER CELL LINE ESTABLISHED AND PROPAGATED
IN VITRO FROM ORAL"

THE DIRCTOR, ALL INDIA
INSTITUTE OF MEDICAL

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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)


Trend of Biotech Inventions
Filed In India

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Application Filing trend of
Biotech inventions in India

Year

Chemical

Drug

Food

Electric
al

Mechan
ical

Compu
ter/

Electro
nics

Bio
-
technol
ogy

2004
-
05

3916

2316

190

1079

3304

2787

1214

2005
-
06

5810

2211

101

1274

4734

5700

1525

2006
-
07

6354

3239

1223

2371

5536

5822

2774

2007
-
08

6375

4267

233

2210

6424

4842

1950

2008
-
09

5884

3672

340

1844

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THE FEE SCHEDULE

On what payable


Prov./Comp spec.


PAGES EXCEEDING 30


CLAIMS EXCEEDING 10

*Request for extension of
time

REQUEST FOR EARLY
PUBLICATION


Request for Examination


EXPRESS REQUEST FOR
EXAMN.

*Change of Applicant

*Notice of Opposition
*Certified Copy
\
Certificate

*On a petition

*Restoration of lapsed
patent

Form

2

-

-

4

9

18

18


6

7


--

15

Individual

1000

100

200

1000/2000/3000

2500

2500

3500


1500

1000

1000

1500

1500

Legal Entity

4000

400

800

4000/8000/1200

10000

10000

14000


2000

6000

4000

4000

6000

RENEWAL FEES

3
rd

to 6
th

Year(per
year)

6
th

to 10
th

Year

do
--

11
th

to 15
th

Year
---
do
-
--

16
th

to 20
th

year
----
do
---


500


1500

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20000

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-
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