Impact of new patent regulation in

Indian
herbal veterinary industry and the
growing
Dr (Capt) Tanweer Alam
opportunity
Natural Remedies, India ahead
ANIMAL HEALTH MARKET – INDIA

$ 445 Million
250

200

150

100

50

0
CATTLE POULTRY PET OTHERS
Source: CLFMA,India
Indian AHP Market

12
11
10
9
9% Growth
8 8.6%
7
6
5
in value in volume

Source: CLFMA,India
 Indian AHP Market

More than
300 companies
100%

80%

Top 20 companies 60%

contribute 40%
55 % of market value
20%

0%

Source: CLFMA,India
Indian Herbal Veterinary Market

Synthetic
Market
Herbal Market
Patent

 Product Patent

 Process Patent
 Evolution of patent laws in
India..
(Upto 1970)

Western style patent regulation and recognized

majorly product patent

Foreign companies prospered well with over 90%

of IPI market share and 80% of ownership

Heavy dependency on import of bulk drugs

and formulations
New Patent Era : A paradigm shift !

Reverse
research based
engineering
business model
business model
Reason behind focus on Herbal
Research in India?




Reason behind focus on Herbal
Research in India?


Pie of Indian Herbal product segment ( Before 2005

48% 52%

Classical

Patent &
Proprietory
Pie of Indian Herbal product segment ( After 2005 )

55%
45%

Classical

Patent &
Proprietory
Herbal product development

Chemical Constituents
Of Herbs

Primary Metabolites Secondary Metabolites

Others



 Isobologram
INCREASING CONCENTRATION
OF HERBAL EXTRACT - Y

C
B
A

A - SYNERGISM
INCREASING CONCENTRATION i.e., 2+ 2 >
OF HERBAL EXTRACT - X B - ADDITIVITY i.e., 2 + 2 =4
C - ANTAGONISM i.e., 2 + 2 < 4
Conventional Approach

in-vivo
 New Approach

in vitro

in vivo
Reason behind focus on Herbal
Research in India?

Huge Medicinal Plant Huge Market Demand

Bio-diversity across the world

India – 8th largest country in natural resources Global Herbal Market- $ 62 Billion
47,000 plant species India’s present share- 1%
7,500 species cited as medicinal plants Global Vet Herbal Market- $ 3 Billion
India’s present share- 2.5%
Reason behind focus on Herbal
Research in India?

 CostEffective
NCE research
 $802
$802

$318
$318
$138
$115

1975 1987 2003

 Pharmaceutical Research and Development (R & D)
Process

Definitions
IND = Investigational New Drug Application
FDA = U.S. Food and Drug Administration
NDA = New Drug Application
Source: www.Innovation.org
Economics of Pharmaceutical Intellectual Property (IP) Best
Case

Patent Filing Marketing Authorisation

Granted
?

Exclusivity
Elapsed Time (8.5+ Years) Period
(~11.5
Years)
Opportunities Ahead…

Identification of
new constituents of herb
Tribulus terrestris
Opportunities Ahead…

Identification of
new medicinal property of actives
Andrographoloids
Opportunities Ahead…

Mutiple drug development

from one herb
Boerhavia diffusa
Opportunities Ahead…

Identification of PRS
for qualitative standardization
Phyllanthus amarus
Opportunities Ahead…

Contract research in
Phytochemical drug discovery
tanweer@naturalremedy.com

3H22