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

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

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

2003 1975 1987 $138 $318 $802 $115 $318 $802

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 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:

New drug
introduction

Organizations are confidently investing in
hard core research for NCEs

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

Till 1995 1995-2005 2005 onwards
Generic version of branded products already off patent before 95
Generic version developed for branded products patented before 95
Generic versions of the branded drugs patented between 1995 and 2005
Generic versions of the branded drugs patented after 2005

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

Indian Vet Pharma – Post patent Era Indian Vet Pharma Post patent Era
DOMESTIC FORMULATIONS
IPR Regime
Likely to witness higher growth
In Licensing
GENERICS BUSINESS
Increasing competitive landscape
Pricing pressure
Aggressive build up of products
Acquisitions
Export potentiality
CONTRACT MANUFACTURING
JV/ Alliances
INDIGENOUS R&D
NDDS/NCE/ANDA
Out Licensing
High Investment

% % % 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

[email_address] 09341263965

Indian association of lady vets presentation

by Tanweer Alam Natural Remedies

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