PATENT AWARENESS …...

1. Emerging Scenario of Patent ProtectionIPR - NEED FOR COMPETITIVENESS FOR TEXTILES, PHARMA AND AGRO SECTORSByPADMIN BUCHChief ConsultantGITCO LTD, AhmedabadAugust 6, 2005.Vadodara

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

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. 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. 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. PATENTS - NEW & OLD Before 2005 : Now What can be patented A new process of making : New product (drug) discovered an existing drug after 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 and finally come under product agri-chemicals patent In case of Patent Violation Patent owner had to prove : Onus of providing non- that the patent had been violation of patent lies with violated the accused

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. 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. 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 • Anti-dumping duty • Counter Veiling Duty (CVD) • Social and Environment Clause • Safeguard Measures

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

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

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

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

18. Opportunities • 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

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 : • Creativity and • Innovation • Combined strategy and Action from Industry and Government

20. Thank You