INTERNATIONAL SYMPOSIUM ON

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• INTERNATIONAL SYMPOSIUM ON
• GLOBAL PERSPECTIVE ON PHARMA BIOTECH PATENTS
• AN OVERVIEW OF PHARMA AND BIOTECH INDUSTRY
• AND KEY IPR ISSUES
• ByPADMIN BUCHB. Pharm, MBA, CMCChief
  ConsultantGITCO LTD, Ahmedabad
• April 19, 2007
• Ahmedabad

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GITCO PATENT ASSISTANCE CELL

• GITCO is a multi-disciplinary consultancy
  organization
• Promoted by ICICI Bank, IDBI, State Govt.
  Corporations Nationalized Banks
• Offers Project, Management, Financial, Industrial
  Technical Consultancy Services
• Patent Assistance Cell is one of them

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GITCO PATENT ASSISTANCE CELL

• Patent Awareness
• Patent Counseling
• Patent Drafting
• Patent Filing
• Twenty Seven Patents filed so far
• Initiated by Government of Gujarat

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Cash Subsidy By State Government

• 50 (Maximum Rs. 5 Lakhs) against the expenses
  incurred by any organization, Institute,
  Individual or Industrial unit for obtaining
  patent registration.
• This assistance will be given only once per
  product/process per institution/individual.
• A pioneering initiative

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Pharma Industry The Churn Factors

• The Product Patent
• New MRP based Excise
• VAT
• Revised Schedule-M
• Unequal Taxation in states
• Price Control
• Dynamics of International Market

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Indian Drugs and Pharmaceutical Industry - An
Overview

• Size US 5.7billion(2005-06)(ASSOCHAM)
• Formulations _at_ 78 Bulk Drugs _at_ 22
• CAGR of 9.7 over last 5 years
• Growth of Export 22, Domestic Market 8 to
  10
• Exports estimated at US 3.5 Billions
• Also Highly fragmented Industry ???
• Gujarat occupies a Prominent Position _at_ 40 plus
  share

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Where Gujarat Pharma StandsIndia has three
distinct Pharma Clusters (Zones) of manufacturing
bases.
Gujarat is primarily a formulation zone
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INDIAN PHARMA OVERVIEW

• Strengths
• Highly developed industry
• High Intellectual Capital
• India a huge market
• 1.1 billion potential local patients
• Pro-active approach by several companies
• Low cost of drug development and clinical trials
  
• Strong Bio diversity
• Implementation of Product Patent act Modified
  Provisions

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Opportunities

• Outsourcing Contract Research and Manufacturing
• RD - Different strategies for SMEs
• Herbal Products
• Contract Manufacturing
• Bio-technology
• Generic Products
• Patent free segments of North American Europe
• Many others - for a proactive industry
• Low cost - high quality manufacturing hub

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BIOTECH SCENARIO(CourtesyBiotechnology in
GujaratStatus Paper by GSBTM
www.vibrantgujarat.com)
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BIOTECH SCENARIO

• Acknowledged as an economy leveler and a tool for
  socio-economic development
• New Diagnostic tools
• Prevention based healthcare
• Personalised medical treatment
• Genetic testing medicines
• Great contribution in Food Agri sector
• Also environment friendly, energy efficient
• Driven by Innovation,Research Enterprise

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GLOBAL SCENARIO

• The Global Biotechnology market 63 billion
  (2004-2005)
• Compound annual growth rate _at_ 18
• Market dominated by the United States
• The industry is rapidly maturing and is closer to
  profitability
• The agriculture and food segment also contributed
  significantly

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INDIAN SCENARIO

• Indian Biotechnology Industry growing _at_ 36.5
• Around 280 Companies and revenue of over USD 1.1
  billion (2004-05)
• Western region contributes 49.60
• Emerging vaccine hub Vaccines constitute the
  largest segment of the Indian Biopharma Industry
• India a competitive outsourcing destination for
  high-end laboratory and diagnostic testing
• 200 Biotech Companies employed 25,000 scientists
  in R D
• Total manpower in Biopharma segment is 11,800
• 40 National Research Institutes involving 15,000
  scientists

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GUJARAT SCENARIO

• Evolved from convergence of successful industries
• Spin off / dedicated units of large diversified
  companies(Intas,Zydus,Bayer,Cadila
  Pharma,Alembic,Maps,Span,Concorde,etc.)
• Dominated by health-care companies
• Product mix include
• Biopharmaceuticals
• Diagnostic kits/equipments
• Animal health-care products
• Preventive medicines
• Significant presence in agri-biotech Sector
• Has leading CROs Quintiles, Lambda, Synchron,

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GUJARAT SCENARIO

• 40 biotech companies 66 support organisations
• Average annual turnover of the industry to the
  tune of Rs. 500-600 Crores
• Investment worth Rs.200 crores between 2003-2007
• Proactive role of the State Government(Dept.of
  Science Technology and GSBTM)
• Interphase among Industry,Academia,Research
  Organisations Government

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Business Case Biotech in Gujarat
Source www.vibrantgujarat.com
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The Patents (Amendment) Act 2005(Indian Patent
Act)

• Key Provisions Relevant to Pharma
• Implications

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Patent Act Key Provisionsand implications
Patentability Criteria

• Only Really New entity can be patented
• Difficult to seek Patent Extension on the basis
  of moderate improvements
• Opportunity for early entry of Generics in India
  Market
• Would benefit Generic Players

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Patent Act Key Provisions its Impact

• Pre-Grant Opposition
• Most patent applications, especially with
  incremental modifications are likely to be keenly
  contested
• Benefit to Indian Generic Manufacturers and
  consumers
• On Flip side delay for even genuine applications

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Impact Analysis Immediate Impact

• Drugs based on Post-1995 molecules already being
  manufactured and sold in domestic market can
  continue .. On payment of a reasonable
  royalty to the patent holder.
• Such liability would accrue prospectively after
  granting Patent in India

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Immediate Impact

• Almost no existing products (launched before 2005
  in India) in the market would have to be
  withdrawn.
• Lack of clarity on Reasonable Royalty
• Estimates 2-4 of revenue from the product.

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Patent Litigations Threat

• Many Small Companies not aware of IP issues
• May face Litigations in future
• Patent Litigations are very costly
• Essential to perform Patent Analysis/ Mapping for
  newer drugs
• Also while acquiring a company IPR Valuation

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In-Licensing Opportunity

• Right given by Patent holder
• For marketing and distribution of Patented Drugs
• In return of Royalty or Profit sharing
• In-licensing to accelerate in next 3-4 years
• Opportunity for companies with strong domestic
  presence
• Also for niche players with strength in specific
  therapeutic segments

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Contract Manufacturing Opportunity

• Outsourcing (Formulations and Bulk Drugs) Market
  US 40 billions
• Estimated _at_ 900 millions in 2010
• Contract Manufacturing in Domestic Market
  Rs.10,000 crores
• Opportunity for Pro-active Small and Medium Units
• Plant set-up to be of standards required by
  Market / Regulatory Agencies
• Higher Investment and Professional Management
  Approach/Attitude

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• To adopt to the new Patent Regime, new business
  models would be in focus
• a) Contract Research
• b) Contract Manufacturing
• c) Co-marketing Alliances
• Herbal products ?

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India can Do It

• For India, possibilities are endless
• Large educational infrastructure
• Over 200 Universities
• Over 1500 Research Institutes
• Over 400 PhDs a year
• 8000 Pharma Graduates from 500 colleges
• IPR laws and mechanism being strengthened
• Curriculum of Institutions being revised
• Knowledge is Indias Intellectual Property
• Required business like approach from all
• Signs are Positive India will do it

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• India and Gujarat have the potential to emerge as
  the Major RD and Contract Manufacturing Hub...
• It surely will happen

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THANK YOU Padmin Buch . . .GITCO
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