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PH Buch

1


INTERNATIONAL SYMPOSIUM ON

GLOBAL PERSPECTIVE ON PHARMA & BIOTECH PATENTS



AN OVERVIEW OF PHARMA AND BIOTECH INDUSTRY

AND KEY IPR ISSUES



By


PADMIN BUCH

B. Pharm, MBA, CMC


Chief Consultant

GITCO LTD, Ahmedabad



April 19, 2007


Ahmedabad

PH Buch

2

GITCO PATENT ASSISTANCE CELL


GITCO

is a multi
-
disciplinary
consultancy organization


Promoted by ICICI Bank, IDBI, State
Govt. Corporations & Nationalized
Banks


Offers Project, Management, Financial,
Industrial & Technical Consultancy
Services


Patent Assistance Cell

is one of them

PH Buch

3

GITCO PATENT ASSISTANCE CELL


Patent Awareness


Patent Counseling


Patent Drafting


Patent Filing



Twenty Seven Patents
filed so far


Initiated by Government of
Gujarat

PH Buch

4

Cash Subsidy By State Government


50% (Maximum Rs. 5 Lakhs) against
the
expenses incurred

by any
organization, Institute, Individual or
Industrial unit
for obtaining patent
registration.


This assistance will be given only
once per product/process per
institution/individual.


A pioneering initiative

PH Buch

5

Pharma Industry : The Churn Factors


The Product Patent


New MRP based Excise


VAT


Revised Schedule
-
M


Unequal Taxation in
states



Price Control


Dynamics of
International Market

PH Buch

6

Indian Drugs and Pharmaceutical
Industry
-

An Overview


Size

:
US
$

5
.
7
billion(
2005
-
06
)(
ASSOCHAM
)


Formulations

@

78
%
;

Bulk

Drugs

@

22
%


CAGR

of

9
.
7

over

last

5

years


Growth

of

Export

:

22
%
,

Domestic

Market

8
%

to

10
%


Exports

estimated

at

US

$

3
.
5

Billions


Also

Highly

fragmented

Industry

◄◄◄


Gujarat

occupies

a

Prominent

Position

@

40
%

plus

share

PH Buch

7

Where Gujarat Pharma Stands

India has three distinct Pharma Clusters
(Zones) of manufacturing bases.

Primarily Bulk
Drugs, Some
Formulations

Southern India
(Chennai
-
Hyderabad Axis)

III

-
do
-

Northern India

II

Bulk Drugs,
Formulation &
Merchant Exports

Western India
(Mumbai
-

Gujarat
Axis)

I

Product Focus

Region

Zone/
Cluster

Gujarat is primarily a formulation zone

PH Buch

8

INDIAN PHARMA : OVERVIEW

Strengths:


Highly developed industry


High Intellectual Capital



India a huge market:



1.1 billion potential local
patients


Pro
-
active approach by several
companies


Low cost of drug development
and clinical trials


Strong Bio diversity


Implementation of Product
Patent act : Modified Provisions

PH Buch

9


Outsourcing : Contract Research and
Manufacturing


R&D
-

Different strategies for SMEs


Herbal Products


Contract Manufacturing


Bio
-
technology


Generic Products


Patent free segments of North American &
Europe


Many others
-

for a proactive industry


Low cost
-

high quality manufacturing hub


Opportunities

PH Buch

10

BIOTECH SCENARIO

(Courtesy:Biotechnology in Gujarat;Status Paper by GSBTM &
www.vibrantgujarat.com)

PH Buch

11

BIOTECH SCENARIO


Acknowledged as an
economy leveler

and a
tool for
socio
-
economic development


New Diagnostic tools


Prevention based healthcare


Personalised medical treatment


Genetic testing & medicines


Great contribution in Food & Agri sector


Also environment friendly, energy efficient


Driven by Innovation,Research & Enterprise



PH Buch

12

GLOBAL SCENARIO


The

Global

Biotechnology

market

:

$
63

billion

(
2004
-
2005
)


Compound

annual

growth

rate

@

18
%


Market

dominated

by

the

United

States


The

industry

is

rapidly

maturing

and

is

closer

to

profitability



The

agriculture

and

food

segment

also

contributed

significantly


PH Buch

13

INDIAN SCENARIO


Indian

Biotechnology

Industry

growing

@

36
.
5

%


Around

280

Companies

and

revenue

of

over

USD

1
.
1

billion

(
2004
-
05
)


Western

region

contributes

49
.
60
%


Emerging

vaccine

hub
:

Vaccines

constitute

the

largest

segment

of

the

Indian

Biopharma

Industry


India

a

competitive

outsourcing

destination

for

high
-
end

laboratory

and

diagnostic

testing



200

Biotech

Companies

employed

25
,
000

scientists

in

R

&D


Total

manpower

in

Biopharma

segment

is

11
,
800


40

National

Research

Institutes

involving

15
,
000

scientists

PH Buch

14

GUJARAT SCENARIO


Evolved

from

convergence

of

successful

industries


Spin

off

/

dedicated

units

of

large

diversified

companies(Intas,Zydus,Bayer,Cadila

Pharma,Alembic,Maps,Span,Concorde,etc
.
)


Dominated

by

health
-
care

companies


Product

mix

include
:


Biopharmaceuticals


Diagnostic

kits/equipments


Animal

health
-
care

products


Preventive

medicines


Significant

presence

in

agri
-
biotech

Sector


Has

leading

CROs

:

Quintiles,

Lambda,

Synchron,


PH Buch

15

GUJARAT SCENARIO


40 biotech companies & 66 support
organisations


Average annual turnover of the industry to
the tune of Rs. 500
-
600 Crores


Investment worth Rs.200 crores between
2003
-
2007


Proactive role of the State
Government(Dept.of Science & Technology
and GSBTM)


Interphase among
Industry,Academia,Research Organisations
& Government

PH Buch

16

Business Case: Biotech in Gujarat

Source: www.vibrantgujarat.com

PH Buch

17


The Patents (Amendment) Act 2005

(Indian Patent Act)

Key Provisions
Relevant to
Pharma


&

Implications

PH Buch

18

Patent Act : Key Provisions

and implications :


Patentability Criteria


Only Really New entity can be patented


Difficult to seek Patent Extension on
the basis of moderate improvements


Opportunity for early entry of Generics
in India Market


Would benefit Generic Players

PH Buch

19

Patent Act : Key Provisions & its Impact

Pre
-
Grant Opposition


Most patent applications, especially with
incremental modifications are likely to be
keenly contested


Benefit to Indian Generic Manufacturers
and consumers


On Flip side

: delay for even genuine
applications

PH Buch

20

Impact Analysis : Immediate
Impact

“Drugs

based

on

Post
-
1995

molecules

already

being

manufactured

and

sold

in

domestic

market

can

continue



………
..

On

payment

of

a

reasonable

royalty

to

the

patent

holder
.



Such

liability

would

accrue

prospectively

after

granting

Patent

in

India”

PH Buch

21

Immediate Impact


Almost

no

existing

products

(launched

before

2005

in

India)

in

the

market

would

have

to

be

withdrawn
.




Lack

of

clarity

on

“Reasonable

Royalty”


Estimates

:

2
-
4
%

of

revenue

from

the

product
.

PH Buch

22

Patent Litigations Threat


Many Small Companies not aware of IP
issues


May face Litigations in future


Patent Litigations are very costly


Essential to perform
Patent Analysis/
Mapping
for newer drugs


Also while acquiring a company :

IPR
Valuation

PH Buch

23

In
-
Licensing Opportunity


Right given by Patent holder


For marketing and distribution of
Patented Drugs


In return of Royalty or Profit sharing


In
-
licensing to accelerate in next 3
-
4
years


Opportunity for companies with strong
domestic presence


Also for niche players with strength in
specific therapeutic segments

PH Buch

24

Contract Manufacturing Opportunity


Outsourcing

(Formulations

and

Bulk

Drugs)

Market

:

US

$

40

billions


Estimated

@

$

900

millions

in

2010



Contract

Manufacturing

in

Domestic

Market

:

Rs
.
10
,
000

crores


Opportunity

for

Pro
-
active

Small

and

Medium

Units


Plant

set
-
up

to

be

of

standards

required

by

Market

/

Regulatory

Agencies


Higher

Investment

and

Professional

Management

Approach/Attitude

PH Buch

25


To adopt to the new
Patent Regime,
new
business models

would
be in focus


a) Contract Research

b) Contract Manufacturing

c) Co
-
marketing Alliances



Herbal products ?

PH Buch

26

India can Do It


For India, possibilities are endless


Large educational infrastructure


Over 200 Universities


Over 1500 Research Institutes


Over 400 PhDs a year


8000 Pharma Graduates from 500 colleges


IPR laws and mechanism being strengthened


Curriculum of Institutions being revised


Knowledge is India’s Intellectual Property


Required : business like approach from all


Signs are Positive : India will do it

PH Buch

27

India

and

Gujarat

have

the

potential

to

emerge

as

the

Major

R&D

and

Contract

Manufacturing

Hub

...







It

surely

will

happen

PH Buch

28


THANK YOU







Padmin Buch . . .


GITCO Limited

GITCO HOUSE

Opp: Sardar Patel Stadium

Navrangpura

Ahmedabad
-
380009

Ph. No. (079) 26565333; 26569617; 26564618

Fax : 079
-
26565279

E
-
mail : gitcoltd@eth.net