1. PH Buch 1 IPR - NEED FOR COMPETITIVENESS FOR TEXTILES, PHARMA AND AGRO SECTORS By PADMIN BUCH Chief Consultant GITCO LTD, Ahmedabad August 6, 2005. Vadodara Emerging Scenario of Patent Protection IPR - NEED FOR COMPETITIVENESS FOR TEXTILES, PHARMA AND AGRO SECTORS By PADMIN BUCH Chief Consultant GITCO LTD, Ahmedabad August 6, 2005. Vadodara

2. PH Buch 2 PATENT AWARENESS …... What is Patent/Patent Filing/Allied Aspects ------------------------------------------ Implications of TRIPS/New Patent Act   Taking up the Challenge   ------------------------------------------

3. PH Buch 3 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

4. PH Buch 4 GITCO PATENT ASSISTANCE CELL Patent Awareness Patent Counseling Library/Database Access Patent Drafting Patent Filing Fifteen Patents filed so far Initiated by Government of Gujarat

5. PH Buch 5 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

6. PH Buch 6 PATENTS - NEW & OLD Before 2005 :Now What can be patented A new process of making :New product (drug) discovered an existing drugafter January 1, 1995 For how long? Between 5 and 7 years :For 20 Years Applies to Process patents existed :Pharma and agri-chemicals exclusively for Pharma andfinally come under product agri-chemicalspatent In case of Patent Violation Patent owner had to prove :Onus of providing non- that the patent had beenviolation of patent lies with violatedthe accused

7. PH Buch 7 IPR’S EFFECT ON TEXTILES, PHARMA & AGRO Pharma is most and directly affected Mainly because of change from Process to Product Patent Next is Agro, Agro-chemicals and Food Processing Textiles is really not directly affected by IPR But Textiles is definitely affected by some WTO Provisions

8. PH Buch 8 IPR and COMPETITVENESS Era of protected market to be over IPR would eliminate “unfair advantage” Markets would open up Manufacturing may migrate to low cost but quality sources Survival of the “Fittest” (in production, marketing, technology) Indian SMEs are in a race & the race is on The necessity is to be competitive

9. PH Buch 9 TEXTILE AND CLOATHING - WTO/IPR IMPLICATIONS Quota system to go away w.e.f. 1-1-2005 An open world market Also imports from other countries to India Several non-Tariff/Non-Trade barriers applicable ã Anti-dumping duty ã Counter Veiling Duty (CVD) ã Social and Environment Clause ãSafeguard Measures

10. PH Buch 10 TEXTILES : THE CHALLENGES UNDER WTO/IPR Need to have competitive advantage More consolidation and vertical system Product innovation, high productivity, value addition Emphasis on MMF and clothing Opportunities : Apparels, made-ups, Technical Textiles, Knitwear Create Good storage capacity for fibers : Stable Raw Material prices Govt. Support : Infrastructure, Power Tariff Patents/Design registration for innovations : Nanotechnology, Blends, Machinery, Technical Textiles, etc.

11. PH Buch 11 IPR/WTO AND AGRO SECTOR Main Issues / Provisions Technical Barriers to Trade (TBT) Sanitary and Phyto - Sanitary (SPS) measures Trade Related Investment Measures (TRIMs) Intellectual Property Rights (IPR) Geographical Indication Bill (GIB)

12. PH Buch 12 IPR/WTO AND AGRO SECTOR : Affected Segments Agricultural Trade as a whole Agro Processing Seeds Food Processing Sector - most of the sub-sectors Herbal / Traditional Medicines Supporting segments like packaging, transportation, storage, etc.

13. PH Buch 13 Pharma Industry : The Churn Factors The Product Patent New MRP based Excise VAT Revised Schedule-M Dynamics of International Market Trouble for those who have not planned for Post-2005 ??

14. PH Buch 14 Product Patent and Related Provisions l Product Patent introduced -- but Process Patent Continue l But not for Products Patented …. After 1995 l A few relevant Provisions ….  Pre Grant and Post Grant Opposition  Patentability Criteria  Compulsory Licensing Conditions  Patenting of Software related inventions l Each needs to viewed in perspective

15. PH Buch 15 l According to an estimate based on current frequency of new drug discoveries in the world …... l 25% of the Indian Retail Market would be of Patented Drugs by 2015 l Prices of Patented Drugs would be higher l Some availability problems also in rural areas Drugs Prices and Availability

16. PH Buch 16 So ……….. l Product Patent has become a reality l The Mail Box and its interpretations would throw more realities l GoI’s stand on Provisions would also be crucial l A period of confusion, uncertainty, legal battles for some time l But all these are only side shows.

17. PH Buch 17 WTO – IPR - Threats & Opportunities Threats l Further squeeze on small units from large units in the off-patent products. l Post 2005, many formulations would not be available for manufacturing(Mail Box Applications) l Lack of WHO-GMP and Revised Sch-M. standards : Missing contract manufacturing opportunity. l Still prevailing ignorance/complacency l Lack of required funds. l Price rise ?

18. PH Buch 18 Outsourcing : Contract Research and Manufacturing R&D Herbal Products Contract Manufacturing Bio-technology Generic Products Patent free segments of North American & Europe Many others - for a proactive industry Opportunities

19. PH Buch 19 IPR : Textiles, Pharma, Agro : Competitive Advantage Cheap labour : Is this enough? Competitiveness is multi-dimensional  Cost  Quality  Time All three critical elements are inter-woven Also Research and Innovation protected by Patents under New set of Rules One has to be totally competitive - not almost To be competitive : ingredients of : ã Creativity and ã Innovation l Combined strategy and Action from Industry and Government

20. PH Buch 20 Thank You