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PADMIN BUCH B.Pharm., MBA; CMC; PG Diploma in Patents Law OCTOBER 07, 2015 Ahmedabad

IPR Innovation & Global Market. ASSOCHAM & Dept of Pharmaceuticals, GoI Conference on IPR in Pharmaceuticals Balancing Innovation & Access. PADMIN BUCH B.Pharm., MBA; CMC; PG Diploma in Patents Law OCTOBER 07, 2015 Ahmedabad For preliminary discussions only.

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PADMIN BUCH B.Pharm., MBA; CMC; PG Diploma in Patents Law OCTOBER 07, 2015 Ahmedabad

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  1. IPR Innovation & Global Market ASSOCHAM& Dept of Pharmaceuticals, GoIConference onIPR in PharmaceuticalsBalancing Innovation & Access PADMIN BUCH B.Pharm., MBA; CMC; PG Diploma in Patents Law OCTOBER 07, 2015 Ahmedabad For preliminary discussions only. Details, data & assumptions are indicative

  2. Competitive Advantage Innovation is the key… 2

  3. Innovation….???Enterprising Gujarat & Gujarati …!! 3

  4. Patent applications filed with Indian Patent Office (Indicative) 4

  5. Global Patent filings( Indicative, for the Year 2013)

  6. 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 %

  7. 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

  8. 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.

  9. Innovations & IPR in PharmaceuticalsThe 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 9

  10. Pharma Innovations !!!

  11. World Economy : The Paradigm Shift Agri. Economy Industrial Economy Knowledge Economy • Innovation • Applied research • Science & Technology • IPR • Capital • Machinery • Management • Land • Labour 11

  12. The Indian Pharma Industry

  13. Zone/ Cluster Region Product Focus I Western India (Mumbai - Gujarat Axis) Bulk Drugs, Formulation & Merchant Exports II Northern India -do- III Southern India (Chennai-Hyderabad Axis) Primarily Bulk Drugs, Some Formulations Indian Pharma ZonesIndia has three distinct Pharma Clusters (Zones) of manufacturing bases. • Gujarat State is primarily a formulation zone

  14. Indian Pharmaceutical MarketGrowth projections by year 2020 14

  15. Indian Pharmaceutical MarketGrowth 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 15

  16. Indian 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 16

  17. 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.

  18. 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.

  19. 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

  20. Making Indian Pharma Industry Globally Competitive • IPR framework • Research & Development initiatives

  21. Indian IPR Laws framework • WTO compliant • Legally Sound • Fair & transparent • WTO plus provisions • Section 3(d) • Compulsory licensing

  22. Indian IPR FrameworkProposed National IPR Policy • May consider • Facilitating Utility patents • Encourage IPR / Patent base at the SMEs and Academic institutions • Fresh & global look at patenting of Herbal patents • Direct & indirect Financial incentives for filing Domestic & International patents (Gujarat model with modifications)

  23. Research & Development Initiatives . . .!!!

  24. R & D InitiativesGovernment & Industry • Special focus on Small and Medium scale Pharma sector • Financial & Technical assistance for Upgrading & Up scaling • Sound NDDS research work • Incentives for linking with Patent filing • Facilitating setting up common Research & Development Centers in Pharma zones / Clusters

  25. R & D PushGovernment & Industry • Increased & more result oriented incentives for basic research • FDI policy • Generic drugs • Herbal drugs –jointly with Drug control anfd IPR authorities

  26. To Conclude . . .

  27. 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

  28. Smart Life Style Disease Drugs

  29. THANK YOUPadmin Buch . . .phbuch3@gmail.com

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