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International Seminar on Evolvement of IPR and its Management

International Seminar on Evolvement of IPR and its Management Key IPR Issues / Provisions Affecting Business (Focus on Pharma Segment) By PADMIN BUCH B. Pharm, MBA, CMC Chief Consultant GITCO LTD, Ahmedabad February 10, 2008 Ahmedabad. GITCO PATENT ASSISTANCE CELL.

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International Seminar on Evolvement of IPR and its Management

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  1. International Seminar on Evolvement of IPR and its Management Key IPR Issues / Provisions Affecting Business (Focus on Pharma Segment) By PADMIN BUCHB. Pharm, MBA, CMCChief ConsultantGITCO LTD, Ahmedabad February 10, 2008 Ahmedabad

  2. 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

  3. GITCO PATENT ASSISTANCE CELL • Patent Awareness • Patent Counseling • Patent Drafting • Patent Filing • Thirty Patents filed so far • Initiated by Government of Gujarat

  4. 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

  5. Indian Drugs and Pharmaceutical Industry Quick Overview

  6. Indian Drugs and Pharmaceutical Industry - An Overview • Size of around US $ 6.5 Billion • Projected CAGR @ 13.6% • Exports estimated at @ 40% of turnover • Formulations @ 78%; Bulk Drugs @ 22% • Growth of Export : 22%, Domestic Market 8% to 10% • Also Highly fragmented Industry ◄◄◄ • Gujarat occupies a Prominent Position @ 42% plus share

  7. 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

  8. Patents in India: The Status • Two successive Governments in India have successfully navigated the path of TRIPS compliance • Resulted in The Patent (Amendment) Act 2005 • Amendments/Provisions to sustain interests of domestic (e.g. Pharma) industry. • Within the jurisdiction of WTO & TRIPS • Some issues not yet sorted out.

  9. INDIAN POSITION ON PATENT ISSUES

  10. INDIAN POSITION ON PATENT ISSUES

  11. Protecting Interests of Domestic Pharma Industry • Immunity for generic manufacturing • Exports of generic pharmaceutical products • Opposition to Grant of Patents • Terms of Patent • Compulsory Licensing

  12. The Patents (Amendment) Act 2005& TRIPS Key Provisions & Issues( More Relevant to Pharma): Status & Implications

  13. Key Provisions / Issues & implications : Patentability Criteria • Only New Entity can be patented • Has to be Substantially different • Substituted ” New Use “ for “Mere NewUse “ thereby denying patents on the new use of known substance • Difficult to seek Patent Extension on the basis of moderate improvements

  14. Patentability Criteria • Opportunity for early entry of Generics in India Market • Would benefit Generic Players • Also prevent Evergreening • Pressure from developed countries to at least allow Patenting of second uses of known products

  15. Key Provisions, Issues & its Impact Pre-Grant Opposition • Pre- grant opposition restored • Number of grounds restored to 11 • Provisions related to the mandatory provisions not restored. • To pay fees to access this information

  16. Key Provisions, Issues & 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

  17. Key Provisions Compulsory Licensing • Articles 27 & 31 of TRIPS lay down minimum conditions for Compulsory Licensing • Allows someone else to produce the Patented Product without consent of Patent holder • National emergencies, Urgencies, monopoly.. • Essentially for Domestic Market • Patent holder can continue to produce

  18. Compulsory Licensing • Para 6 of Doha Declaration( 2001) and WTO resolution of Aug 2003 • Waiver of the conditions under article 31(i) • Enabled to issue CL for Exports also • For countries with no or insufficient manufacturing capacity for pharmaceuticals • Waiver made permanent in December 2005 by WTO

  19. Compulsory Licensing : Export • License has to be awarded by that country(?) • With its low cost base and reverse engineering skill India can export to unregulated markets • Returns could be small • Plant set up to be of international norms : Higher Investment • Difficult for Small Units

  20. Key Provisions:Immunity For Generic Production • Drugs being produced & marketed by Indian Companies before 01-01-2005 • Can continue to be produced • After paying reasonable royalty • Such liability would accrue prospectively after granting Patent in India

  21. 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

  22. Some Other Current and Emerging Issues at International Level • The need (?) for World wide Patent System • Basis for awarding Patent rights, invention/filing • Patentability of new uses for known compounds (Article 27) • National Difference in Patentability (e.g. life sciences, IT) • Language consideration • Harmonization Patent Office Practices.

  23. 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

  24. Impact Analysis in Nutshell • Immediate Impact likely to be low/neutral • R & D Focus • Consolidation to attain critical size • Exports : Regulated Markets • In licensing of Patented Products • Outsourcing: Contract Manufacturing and Research • Litigations : Cost and damages • Patented Productsto Increase

  25. Consolidation : The Need • Weakness: Highly Fragmented Industry • Threat : Over dominance of MNCs/Large Companies • Opportunity : Consolidation • Attain Viable size of Operations to be competitive • Capital adequacy for sustained growth • Add to shrinking Products Portfolio

  26. 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 ?

  27. India and Gujarat have the potential to emerge as the Major R&D and Contract Manufacturing Hub…... It will surely happen

  28. THANK YOUPadmin Buch . . .GITCO LimitedGITCO HOUSEOpp: Sardar Patel StadiumNavrangpuraAhmedabad-380009Ph. No. (079) 26565333; 26569617; 26564618Fax : 079-26565279E-mail : gitcoltd@eth.net

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