India's IPR Policy on Biotechnology - Aidic

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India’s IPR Policy on
Biotechnology

Intellectual Property of Biotech
Processes : Main Regulatory and
Legal Aspects

Dua Associates, India

Presented by

Vidya B. Mehrish

Dua Associates, India

(
vidyamehrish@duaassociates.com
)

on February 16, 2006

Forum: AIDIC, BIOTECH GROUP

BIOTECH PROCESSES OVERVIEW WORKSHOP,

MILANO, ITALY


February 16, 2006

2

Overview of Presentation


What is Biotechnology?



Why is Biotechnology Important for India?



Indian Government Initiatives



Potential Areas for Investment in the Indian Biotechnology Sector



Intellectual Property Rights of Biotechnology (Legal Frame Work)

Dua Associates, India

February 16, 2006

3

What is Biotechnology
?

Biotechnology includes:



Recombinant DNA and Genetic Engineering


Cell Cultures


Waste Treatment and Utilization


Enzymes and Biocatalysts


Fuels


Nitrogen Fixation


Fermentation and Pharmaceuticals

Dua Associates, India

February 16, 2006

4

Why is Biotechnology

Important for India?


For

a

country

like

India,

biotechnology

is

a

powerful

enabling

technology

that

can

revolutionize

agriculture,

healthcare,

industrial

processing

and

environmental

sustainability

.



Biotechnology

as

a

business

segment

for

India

has

the

potential

of

generating

revenues

to

the

tune

of

US
$

5

million

and

creating

one

million

jobs

by

2010

through

products

and

services
.



Clinical

development

services

can

generate

in

excess

of

US
$

1
.
5

billion

while

bio
-
services

or

outsourced

research

services

can

garner

a

market

of

US
$

1

billion

over

this

time

scale
.

Dua Associates, India

February 16, 2006

5

Why is Biotechnology

Important for India?


With

approximately

200

industries,

the

growth

of

the

biotech

sector

in

India

has

been

rapid
.

Current

estimates

indicate

that

the

industry

grew

by

39
%

annually

to

reach

a

value

of

US
$

705

million

in

2003
-
2004
.




Currently,

the

bio
-
pharma

sector

occupies

the

largest

market

share

of

76
%

followed

by

bio
-
agri

8
.
42
%
,

bio
-
services

7
.
70
%
,

industrial

products

5
.
50
%

and

bio
-
informatics

2
.
45
%
.




The

current

policy

review

envisages

an

annual

turnover

of

US
$

5

billion

by

2010
.




Dua Associates, India

February 16, 2006

6

Indian Government Initiatives


Import

Duty

Exemption

(Promotion

of

Import

Duties

on

key

R&D,

contract

manufacturing

/

clinical

trial

equipment

and

duty

credit)


Tax

Deduction

on

R&D

Expenditure

(Extending

the

150
%

weighted

average

tax

deduction

on

R&D

expenditure

under

section

35

(
2
AB)

of

the

Indian

Income

Tax

Act

until

2010
)
.



Priority

Sector

Lending

(Enable

lending

by

Indian

banks

to

biotech

companies

as

priority

sector

lending)
.



Customs

Duty

Removal

(Remove

customs

duty

on

raw

materials

imported

into

India,

that

go

into

making

the

finished

product

is

imported

duty

free)
.



Simplification

of

Procedures

(Simplification

and

streamlining

of

procedures

for

import,

clearance

and

storage

of

biological,

land

acquisition,

obtaining

environmental

and

pollution

control

approvals

would

be

simplified

and

streamlined

within

shorter

time

frame

lines

through

consultations

with

various

central

and

state

government

departments)
.



Fostering

Inter
-
Company

Relationships

(
The

Indian

Government

further

intends

to

make

efforts

to

remove

hurdles

for

contract

research

especially

for

input

output

norms

and

tax

on

revenue

generated

through

contract

research

/

R&D)
.




Developing

Communication

Systems

(One

significant

feature

of

the

biotech

industry

is

the

fluidity

and

variety

of

its

inter
-
company

relationships,

traditionally

much

greater

than

in

other

industries)
.


Dua Associates, India

February 16, 2006

7

Potential Areas for Investment in
the Indian Biotechnology Sector


Agriculture and Food Biotechnology



Industrial Biotechnology



Preventive and Therapeutic Medical Biotechnology



Regenerative and Genomic Medicine



Pharmaco
-
genomics



Bio
-
engineering and Nano
-
biotechnology



Bio
-
informatics and IT Enabled Biotechnology



Clinical Biotechnology and Research Services



Dua Associates, India

February 16, 2006

8

Intellectual Property Rights of
Biotechnology : Legal Aspects


In

India,

a

patent

can

be

obtained

only

for

an

invention

which

means

a

new

product

or

process

involving

an

inventive

step

and

capable

of

industrial

application
.



In

order

to

be

patentable,

an

invention

must

concern

a

new

and

useful

manner

of

manufacture
.

The

word

“manufacture”

applies

not

o
nly

to

things

made

but

to

the

practice

of

making,

to

principles

carried

into

practice
.

Essentially,

if

the

starting

material

remains

unaltered

by

the

process,

and

the

end

product

also

remains

the

same

as

the

starting

material,

the

process

is

understood

as

“no

manufacture”

from

the

patentability

perspective
.




To

be

patentable

an

invention

must

have

(i)

technical

advancement

over

existing

knowledge,

(ii)

economic

significance,

(iii)

or

both

which

makes

the

invention

not

obvious

to

a

person

skilled

in

the

art
.

If

the

subject

matter

of

the

invention

is

novel,

non
-
obvious

and

the

invention

has

industrial

applicability,

it

can

be

patented

in

India
.

Indian

Patents

Act,

1970

§

2
(j)
.


Dua Associates, India

February 16, 2006

9

Intellectual Property Rights of
Biotechnology : Legal Aspects

Changes

to

Indian

legislation

in

keeping

with

international

legislative

framework



Subsequent

to

the

enactment

of

TRIPS,

Indian

Patent

law

has

changed

in

the

following

ways

:



A

uniform

twenty

(
20
)

years

for

all

patents

granted

after

May

20
,

2003
;



A

reciprocal

arrangement

with

all

convention

countries,

union

of

countries

and

inter
-
governmental

organizations
;



Products

made

patentable

in

all

fields

of

technology

from

January

1
,

2005
;




The

extension

of

the

rights

of

the

patentee
;



For

product

patent

applications

on

pharmaceuticals

and

agro
-
chemicals

filed

before

January

1
,

2005
,

under

the

mail

box

system,

request

for

examination

is

to

be

filed

within

thirty

six

months

from

the

date

of

priority
.

Dua Associates, India

February 16, 2006

10

Intellectual Property Rights of
Biotechnology: Legal Aspects


Rights

of

patentee

for

mail

box

applications

extend

from

the

date

of

grant

of

patent
.



For

patents

granted

on

mail

box

applications

which

include

Biotechnology

inventions,

patent

holder

is

entitled

to

receive

reasonable

royalty

from

such

enterprise

which

has

made

significant

investment

and

has

been

producing

and

marketing

the

concerned

product

prior

to

January

1
,

2005

and

which

continues

to

manufacture

the

product

covered

by

the

patent

on

the

date

of

grant

of

patent

and

no

infringement

proceedings

can

be

instituted

against

such

enterprise
.

Dua Associates, India

February 16, 2006

11

Intellectual Property Rights of
Biotechnology: Legal Aspects


Compulsory

licenses

are

available

for

manufacture

and

export

of

patented

pharmaceutical

products

to

any

country

which

has

insufficient

or

no

manufacturing

capacity

in

the

pharmaceutical

sector

for

the

concerned

product

to

address

public

health

problems

subject

to

the

condition

that

compulsory

license

has

been

granted

by

such

country

or

such

country

by

notification

allows

importation

of

patented

pharmaceutical

product

from

India
.



A

major

concern

of

pharmaceutical

industries

concerning

amendments

in

the

compulsory

license

procedure

is

that

it

can

be

granted

to

any

interested

person

if

the

patented

invention

is

not

available

to

the

public

at

a

reasonable

affordable

price
.

The

term

‘Affordable’

is

a

relative

term

which

however,

has

not

been

defined
.



Dua Associates, India

February 16, 2006

12

Intellectual Property Rights of
Biotechnology: Legal Aspects


Yet

another

concern

is

that

amended

act

allows

generic

manufacturers

who

were

producing

and

marketing

products

of

a

mail

box

patentee

before

January

1
,

2005

to

continue

doing

so

on

payment

of

a

reasonable

royalty
.



Bolar

provision

included

making,

using

or

selling

patented

product

before

expiry

of

the

term

of

patent

for

obtaining

regulatory

approvals
.

Bolar

provision

now

includes

“Importing”
.

Thus,

while

considerable

period

of

the

patent

holder

is

wasted

in

obtaining

regulatory

approvals,

the

generic

producer

has

advantage

that

immediately

on

expiry

of

the

term

of

patent,

he

can

commence

production
.


Dua Associates, India

February 16, 2006

13

Intellectual Property Rights of
Biotechnology : Its Regulatory Framework


Legislative

framework

:

The

Drugs

and

Cosmetics

Act,

1940

and

the

Drugs

and

Cosmetics

Rules,

1945

as

amended

from

time

to

time,

regulate

recombinant

pharma

products
.




Authorities

:

The

Drugs

Controller

General

of

India

(DCGI),

the

State

Drugs

Controller

and

the

Recombinant

Drugs

Advisory

Committee

(RDAC)

constituted

by

the

Ministry

of

Health

and

Family

Welfare

regulate

the

recombinant

pharma

products
.




Steps

involved

in

the

approval

process

of

a

biotechnology

product

-




Proposal

(examination

of

proposal

in

light

of

the

bio
-
safety

regulation

and

guidelines)



Approval

of

Review

Committee

on

Genetic

Manipulation

(RCGM)

(Examination

of

information

for

R&D

work,

approval

of

pre
-
clinical

trial

based

on

evaluation

of

data

physico
-
chemical

and

biochemicals

characterization

of

the

process

and

the

final

product




Genetic

Engineering

Approval

Committee

Drugs

Controller

of

India

(Approves

Clinical

Trials

and

Containment

Facilities

and

Evaluates

Clinical

Trials)



Dua Associates, India

February 16, 2006

14

Intellectual Property Rights of
Biotechnology : Its Regulatory Framework


Approval

for

Manufacture

and

Marketing

(Currently,

there

are

multiple

regulators,

multiple

ministries,

lack

of

coordination,

lack

of

a

linear

progression

in

the

responsibilities

of

a

regulator

and

lack

of

a

linear

progression

in

the

approval

process

and

committees

working

outside

their

areas

of

expertise)
.



Proposals

to

streamline

the

process

:



The

Institutional

Bio
-
Safety

Committee

will

monitor

all

development

work

(up

to

20

litres)

and

recommend

to

RCGM

for

Animal

Toxicity

Tests

(ATT)

&

Scale

Up
.



RCGM

will

evaluate

the

recombinant

technology

and

grant

permission

for

scale

up



R&D,

review

and

approve

for

pre
-
clinical

animal

toxicity

tests

and

evaluate

ATT

data

and

recommend

to

DCGI

for

Human

Clinical

Trial

(HCT)
.



DCGI

will

permit

Human

Clinical

Trials,

review

Human

Clinical

Trial

Data,

grant

permission

for

Manufacture

and

Marketing

of

the

product

and

inspect

the

facility

where

the

product

is

manufactured
.



GEAC

will

review

the

manufacturing

process

to

ensure

that

the

LMO

(Living

Modified

Organism)

is

“inactivated”

during

the

process

and

send

its

recommendations

to

the

Drugs

Controller

General

of

India

within

the

specified

time
.


Dua Associates, India

February 16, 2006

15

Future Proposals by the Indian Government to
further steam
-
line the Regulatory Aspect of the
Indian Biotechnology sector



National

Biotechnology

Regulatory

Authority




In
-
service

Center

for

Training

of

Professionals



Guidelines

for

Transgenic

Research



Special

Regulatory

Cell



Review

Committee

on

Genetic

Manipulation

(RCGM)

Evaluation

of

Recombinant

Technology


Dua Associates, India