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    Impact of new patent regulation in

    Indianherbal veterinary industry and thegrowingopportunity aheadDr (Capt) Tanweer AlamNatural Remedies, India

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    ANIMAL HEALTH MARKET INDIA

    0

    50

    100

    150

    200

    250

    CATTLE POULTRY PET OTHERS

    $ 445 Million

    Source: CLFMA,India

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    Indian AHP Market

    8.6%9%

    5

    6

    7

    8

    9

    10

    11

    12

    in value in volume

    Growth

    Source: CLFMA,India

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    Indian AHP Market

    Top 20 companies

    contribute55 % of market value

    More than300 companies

    0%

    20%

    40%

    60%

    80%

    100%

    Source: CLFMA,India

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    Indian Herbal Veterinary Market

    SyntheticMarketHerbal Market

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    Patent

    Product Patent

    Process Patent

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    Evolution of patent laws inIndia..

    Western style patent regulation and recognizemajorlyproduct patent

    (Upto 1970)

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

    Heavy dependency on import of bulk drugsand formulations

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    New Patent Era : A paradigm shift !

    Reverseengineering

    business model

    research basedbusiness model

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    Reason behind focus on Herbal

    Research in India?

    http://images.google.co.in/imgres?imgurl=http://uuhsc.utah.edu/transplant/images/spotImages/kidneyResearch.jpg&imgrefurl=http://uuhsc.utah.edu/transplant/kidney/kidneyResearch.html&h=220&w=220&sz=14&hl=en&start=6&tbnid=-9ZJTPdIN1pziM:&tbnh=107&tbnw=107&prev=/images%3Fq%3Ddrug%2Bresearch%26imgsz%3Dsmall%257Cmedium%257Clarge%257Cxlarge%26gbv%3D2%26hl%3Den%26sa%3DG
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    Classical

    Patent &

    Proprietory

    52%48%

    Pie of Indian Herbal product segment ( Before 200

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    Classical

    Patent &

    Proprietory

    45%55%

    Pie of Indian Herbal product segment ( After 2005

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    Herbal product development

    Chemical Constituents

    Of Herbs

    Primary Metabolites Secondary MetabolitesOthers

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    Conventional Approach

    in-vivo

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    New Approach

    in vitro

    in vivo

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    Huge Medicinal PlantBio-diversity

    Huge Market Demandacross the world

    Reason behind focus on Herbal

    Research in India?

    Global Herbal Market- $ 62 BillionIndias present share- 1%Global Vet Herbal Market- $ 3 Billion

    Indias present share- 2.5%

    India 8th largest country in natural resources47,000 plant species7,500 species cited as medicinal plants

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    Reason behind focus on Herbal

    Research in India?

    Cost Effective

    NCE research

    http://images.google.co.in/imgres?imgurl=http://syntares-unipharm.de/_images/photos/BXP42110_vials-of-medicine.jpg&imgrefurl=http://syntares-unipharm.de/en/company/index.html&h=400&w=328&sz=30&hl=en&start=20&tbnid=5JqAY5Ex5y8T5M:&tbnh=124&tbnw=102&prev=/images%3Fq%3Ddrug%2Bresearch%26gbv%3D2%26hl%3Den%26sa%3DG
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    $138

    $318

    $802

    $115

    $318

    $802

    20031975 1987

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    Pharmaceutical Research and Development (R & D)Process

    DefinitionsIND = Investigational New Drug ApplicationFDA = U.S. Food and Drug AdministrationNDA = New Drug ApplicationSource: www.Innovation.org

    http://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_D
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    Economics of Pharmaceutical Intellectual Property (IP) BestCase

    Patent Filing Marketing AuthorisationGranted

    ExclusivityPeriod(~11.5

    Years)

    Elapsed Time (8.5+ Years)

    ?

    http://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_Dhttp://www.innovation.org/index.cfm/nonav/Inside_R_&_D
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    Opportunities Ahead

    Identification ofnew constituents of herb

    Tribulus terrestris

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    Opportunities Ahead

    Identification ofnew medicinal property of actives

    Andrographoloids

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    Opportunities Ahead

    Mutiple drug developmentfrom one herb

    Boerhavia diffusa

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    Opportunities Ahead

    Identification of PRSfor qualitative standardization

    Phyllanthus amarus

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    Opportunities Ahead

    Contract research inPhytochemical drug discovery

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    [email protected]

    3H22

    mailto:[email protected]:[email protected]