ph buch 1 padmin buch b.pharm., mba; cmc; pg diploma in patents law october 07, 2015 ahmedabad for...
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PADMIN BUCH B.Pharm., MBA; CMC; PG Diploma in Patents Law
OCTOBER 07, 2015Ahmedabad
For preliminary discussions only. Details, data & assumptions are indicative
ASSOCHAMASSOCHAM& Dept of Pharmaceuticals, GoI& Dept of Pharmaceuticals, GoI
Conference onConference onIPR in PharmaceuticalsIPR in Pharmaceuticals
Balancing Innovation & AccessBalancing Innovation & Access
IPR Innovation & Global Market
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CompetitivCompetitive e
AdvantageAdvantage
Innovation is the key…
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Innovation….???Innovation….???Enterprising Gujarat & Gujarati …!!Enterprising Gujarat & Gujarati …!!
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Patent applications filed with Indian Patent Office (Indicative)
Year Total Patent applications
filed
Patent applications
from India(Indicative)
Patent applications from Gujarat
(Indicative)
2013-14 43000 9800
(22.00%)590
(6.00%)
2012-13 42500 9500
(20.00%)570
(6.00%)
2011-12 39400 8670(22.00%)
435
(5.00%)
Source : Indian patent office
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Global Patent filings( Indicative, for the Year 2013)
Country Patents filed % Share(indicative)
Total patents filed : 26,00,000
China 825,136 33%
USA 571,612 22%Japan 328,436 12%India 43,031 1.6%
Source : WIPO ( Dec 2014)
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Pharma Patents in India
In Indian pharmaceutical sector, the number of patents filed have increased from little over 3500 in 2004-05 to over 5500 in 2013-14,
CAGR @ 5.00 %
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Patent Cooperation Treaty (PCT) filings
Though it is not a patent filing system, it is, however, indicative of patent-filing trends around the world.
Together, China and US accounted for 87% of the total growth in filings under WIPO's PCT, which saw some 2,15,000 applications in 2014
After China, India (1,394) is the largest user of the PCT system among BRICS countries
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PCT filing by Indian Pharma sector
With about 290 PCT applications, Pharma sector is second in the list of top Indian filers under the Patent Cooperation Treaty (PCT) in 2014, seeking protection internationally for their inventions.
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Innovations & IPR in PharmaceuticalsInnovations & IPR in PharmaceuticalsThe Game ChangerThe Game Changer
We have moved in to the era of Ideas, Creativity, Inventions and Intellectual Properties- intensively and aggressively
Intellectual property (IP) has emerged as a key tool in Value Creation and Growth
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Pharma Innovations !!!Pharma Innovations !!!
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World Economy : The Paradigm ShiftWorld Economy : The Paradigm Shift
Agri. Economy
Industrial Economy
Knowledge Economy
Land
Labour
CapitalMachineryManagement
InnovationApplied researchScience & TechnologyIPR
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The Indian Pharma Industry
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Indian Pharma ZonesIndian Pharma ZonesIndia has three distinct Pharma Clusters (Zones) of India has three distinct Pharma Clusters (Zones) of
manufacturing bases.manufacturing bases.
Primarily Bulk Drugs, Some Formulations
Southern India (Chennai-Hyderabad Axis)
III
-do-Northern IndiaII
Bulk Drugs, Formulation & Merchant Exports
Western India (Mumbai - Gujarat Axis)
I
Product FocusRegionZone/ Cluster
Gujarat State is primarily a formulation Gujarat State is primarily a formulation zonezone
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Indian Pharmaceutical MarketIndian Pharmaceutical Market
Growth projections by year 2020Growth projections by year 2020
Assumed CAGR(%)
Status Projected Size (Billion US $)
Most Likely
10 Pessimistic case
35.00
14.50 Base case 55.00
17 Aggressive case
70.00
Source :India Pharma 2020 Report, McKinsey & Co.
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Indian Pharmaceutical MarketIndian Pharmaceutical Market
Growth projectionsGrowth projections
By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size
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Indian Pharmaceutical IndustryIndian Pharmaceutical Industry
Indian pharmaceutical manufacturing facilities registered with US Food and Drug Administration (USFDA) as on March 2014-15 was the highest at 550 plus for any country outside the US.
Every 3rd DMF filed in US is from India
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Generic Opportunity
US $ 40 billion worth of drugs in the USA and US $ 25 billion worth of drugs in Europe are going off patent .
This translates to an opportunity of additional export of US $19.5bn
A rise in geriatric population making the nations to move to cheaper APIs and formulations which
are India’s forte.
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Generics
In order to overcome low margins, some generic drug manufacturers are venturing into the super generics opportunity.
Sold for a significantly higher price than their pure generic counterparts, super generics account for 18% of all spending on drugs.
Bio-similar drugs will account for more than $20 Billion in revenue by the end of 2020.
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Generics- India
Supplier of High Quality, Low Cost generic drugs
Recognized by UNICEF as global leader in supply of generics
Accounts for 40% of Generic drugs in USA India is the manufacturing hub for most of
the countries
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Making Indian Pharma Industry Making Indian Pharma Industry Globally Competitive Globally Competitive
IPR frameworkResearch & Development
initiatives
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Indian IPR Laws framework
WTO compliantLegally SoundFair & transparentWTO plus provisions
– Section 3(d)– Compulsory licensing
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Indian IPR FrameworkProposed National IPR Policy
May considerFacilitating Utility patentsEncourage IPR / Patent base at the
SMEs and Academic institutionsFresh & global look at patenting of
Herbal patentsDirect & indirect Financial incentives for
filing Domestic & International patents (Gujarat model with modifications)
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Research & Development Initiatives . . .!!!
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R & D InitiativesGovernment & Industry
Special focus on Small and Medium scale Pharma sectorFinancial & Technical assistance for
Upgrading & Up scalingSound NDDS research workIncentives for linking with Patent filingFacilitating setting up common Research
& Development Centers in Pharma zones / Clusters
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R & D PushGovernment & Industry
Increased & more result oriented incentives for basic research
FDI policyGeneric drugsHerbal drugs –jointly with Drug
control anfd IPR authorities
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To Conclude . . .To Conclude . . .
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Pharma : Innovation & IPR
Industry,IPR authorities, DoP and Drug Control Administration to collaborate
Formulating a road map Identify, cultivate and create 1000
Smart Pharma units from the Small & Medium Sector
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Smart
Life Style Disease Drugs
