Indian association of lady vets presentation
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this presentation was made in the all india seminar of lady vets association in bangalore
Transcript of 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
