indian association of lady vets presentation

Rudolf Virchow

“Between animal and human medicine there is no dividing line, nor should there be”

Post patent era : An update& role of lady vets in it

Dr (Capt) Tanweer Alam

Indian Pharma Market

Evolution of patent laws in India..

Western style patent regulation and recognized majorly product patent

.

(Upto 1970)

Foreign companies prospered well with over 90% of IPI market share and 80% of ownership

Heavy dependency on import of bulk drugs and formulations

Evolution of patent laws in India..

New drugs were available cheaply and import got substituted with reverse engineered drugs by local companies

Introduction of DPCO

Indian Patent Act 1970, which recognized process patent

(1970-2005)

Two major steps

of Indian Govt

Foreign ownership decreased to just 36% in 1995 as compared to 80% in pre 70’ period

Evolution of patent laws in India..

Patent mandated to the inventor for 20 years

Amendment in 1970 Patent Act to introduce product patenting in three sectors

(Jan 2005)

Pharma Agro-chemicals and Food

Present Impact of New Patent Era

Impetus on NCE research

$138

$318

$802

$115

$318

$802

20031975 1987

Pharmaceutical Research and Development (R & D) Process

DefinitionsIND = 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 Period (~11.5 Years)

Elapsed Time (8.5+ Years)

?

1. Indian pharmaceutical industry is now poised to take full advantage of the size they have achieved with the help of process patents

2. India is a huge market with (I) a high intellectual capital and capable

work-force (II) low cost of drug development and clinical

trials

Opportunities include:

Present Impact of New Patent Era

New drug introduction

Present Impact of New Patent Era

Consolidation effort in R&D activities

In 2003, licensing deals contributed to 20% of total sales and set to increase to 40% by 2009.

For many, it is a biz model as well

Contract Research in drug discovery and clinical trials

Present Impact of New Patent Era

Still, the focus is on generics …

Two prong Global Market Domestic Market

Present Impact of New Patent Era

No major impact on pricing

Still a vast Global market Vs Indian market gap

Phyto-chemical based research works in full throttle

Present Impact of New Patent Era

On herbal segment…

New Approach of Herbal Drug

Development

Ethno-medical information

Selection and standardization of

in vitro assays

Validation of safety and efficacy using in

vivo models

Marketing

Screening program-Select plants-Select plant parts-Select solvent

Bioactivity guided

fractionation

Development of prototype

formulation (Based on compatibility

studies)

Standardization and Chemical fingerprinting

0 1 2 3

2006

1990

1970

1950

1900

% % %

Gender gap in patenting…

1

1.4

1.5

1.7

2.8

*HARVARD GAZETTE ARCHIVES

Patenting Procedure…

Patent search Confirming the patentability of the claim (i) Novelty (ii) Inventiveness (Non-obviousness) (iii) Usefulness

Patent filing with requisite fee followed by request for examining the patent

Opposition,sealing & granting of patent Patent protection International patenting

Opportunities for Lady Scientists

CRO Bioinformatics, Regulatory Affairs , IPR field R&D – key driving area for all organisations Patent Attorney consultants

tanweer@naturalremedy.com09341263965