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6th International Seminar Intellectual Property Rights : Advantage business

6th International Seminar Intellectual Property Rights : Advantage business The Generic Advantage & Patent Drafting Strategies By PADMIN BUCH B. Pharm, MBA, CMC Chief Consultant GITCO , Ahmedabad February 14 , 2010 Ahmedabad. GITCO. GITCO is a multi-disciplinary consultancy organization

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6th International Seminar Intellectual Property Rights : Advantage business

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  1. 6th International Seminar Intellectual Property Rights : Advantage business The Generic Advantage & Patent Drafting Strategies ByPADMIN BUCHB. Pharm, MBA, CMCChief ConsultantGITCO , Ahmedabad February 14 , 2010 Ahmedabad

  2. GITCO • 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 • 42 Patents filed so far • Recognized by Government of Gujarat

  4. Cash Subsidy By State Government • Assistance @ 50% subject to maximum Rs.10 lacs for necessary expenditure for obtaining domestic patents by any industrial unit/institution. • Quantum of assistance can be enhanced to Rs.25 lacs for international patents by a company. • Maximum five patents per unit over a five years period will be eligible. • Source : Gujarat Industrial Policy 2009, GR. Dt. 27/02/2009

  5. The Global Pharmaceutical Market Size Reached $780-790 Billion in 2008 : ‘Pharmerging’markets have outperformed the global market growth

  6. There is Now a Fundamental Shift in Geographical Sources of Global Pharma Growth Global Pharmaceutical Geographic Breakdown to 2009 (US$) Pharmerging markets will contribute 34% towards global growth in 2009

  7. “Pharmerging”countries :Brazil, China, India, Indonesia, Mexico, Russia and Turkey

  8. India is Expected to be One of the Largest Emerging Pharma Market within the Next 5 Years Emerging Markets Growth Past, Present and Future (US$)

  9. 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 • Generic Drugs the key driver for growth of Indian Pharma Industry

  10. Generic Drugs • After expiry of Patents others can also manufacture that drug. • This is known a ‘Generic’ drug • Generic drugs are cheaper than patented counterpart • Are supposed to be just as effective.

  11. Key Factors For Growth Of Generics • Price sensitivity : Both in Developed and Developing country. • Developing countries (e.g. India) not favouring patent extension • R&D Production of “Big Pharma” is declining • Growth Rate: • Industry: 6-7%; • Generics Market : 11%

  12. Generic World: Patent Expiry of Major Drugs

  13. The Indian Advantage : Patent Act Provisions • India’s patent Act provides flexibility. • The generic (drugs) industry to be major beneficiary

  14. Key Provisions :Scope of Patentability & Pre-Grant Opposition • Defines what is Patentable • New Entity/ Substantially different can be patented • Difficult to seek Patent Extension on the basis of moderate improvements • Pre- grant opposition restored • Most patent applications, especially with incremental modifications are likely to be keenly contested • Benefit to Indian Generic Manufacturers and consumers

  15. Generics :The Indian Advantage… • The increased demand of Generics (cheaper and effective) is to shift the balance in World Pharma Market • “Pharmerging” countries expected to have 20% share by 2020 : a 60% increase • India: The main source of cheap and quality-medicines to the developing countries.

  16. To adopt to the new Patent Regime, new business models would be in focus • Generics • Contract Research & Manufacturing • Patent Drafting Strategies

  17. Importance of Patent Drafting “A claim demarcates in words the boundary of the invention which is analogous to a fence around a piece of land property” Dr. Milind Antani( Express Pharma)

  18. Patent Drafting Strategies : Advantages • Helps making Patent Water-tight • Avoid infringement on existing Patents • Prolong Life cycle of an invention • Sustain & increase market value of drug/medicine • Avoid/minimize hefty cost (patent rejection, infringement, litigation, etc.)

  19. Patent Drafting Strategies • Global Patent laws keep on changing • Awareness, training and skill imparting requirement to keep pace • Prior arts search very vital • Biggest challenge is to understand the invention itself, its complexity and putting it in the most correct form while drafting.

  20. Patent-drafting Strategies • Understand the relevant clauses of Patent Act clearly • Study all the relevant legal cases • Focus on socio-political under- currents of countries where Patent is being filed. • Look for common errors in Patent-Drafting (e.g. scope of Patent could be too narrow or too broad)

  21. Patent Drafting:Common Claim Errors by Non-US Applicants • Relying on one set of claims • Using reference numbers in claims • Not claiming methods of use • Claiming broader scope than supported by the description • Claiming subject matter that is not illustrated in a drawing • Improper use of multiple dependent claims Source: HSML,USA

  22. Patent Drafting:Types of Pharmaceutical Claims • Chemical Compounds • First medical use of novel (inventive) Compounds • Second Medical Use of Known Compounds • Swiss Style • Method

  23. Categories of Pharma/Medical Inventions(other than India) • Novel Chemical Compounds • “Pharmaceutical” agent comprising chemical Compounds • “Anti-cancer” agent comprising chemical compounds • Use of chemical compounds for manufacturing anti-cancer agent (Swiss-type) • Therapeutic or Diagnostic Method • Medical Devices

  24. Patentability of Pharma/Medical Inventions : Criterion • Novelty • Inventiveness • Industrial Applicability • Reproducibility/Enablement (EN)

  25. Patent Drafting: Different Countries • Countries try to strike a balance in Patent law : between private rights & public good. • Different countries have similar guidelines and regulations under different nomenclature • For example, Section 3(d) of Indian Patent Act (Standards & exclusions for Patentability) • European Patent Law has similar restrictions under clause “Inventive Step” • US Legal System : to prove “non-obviousness” • However interpretation may differ.

  26. Patentability: Country-specific Comparison

  27. Patent-Drafting Strategies :Avoiding Infringement of existing patents • Incase of a patented multi-component Formulations containing a combination of two or more ingredients, one may obtain a patent by changing the non-essential component not covered by the patent • May play around concentrations of different components • Process patents : change in steps • New drug delivery : improvement in efficacy

  28. To conclude….Patent Drafting Strategies • Build your Patent Claims like an Onion • Outer Shell : The independent (broadest) claim. • This may be rejected (due to prior art anticipation). • Peel off to reveal the next shell/claim • Keeping reserve layers of claims by anticipation

  29. Patent Drafting Strategies • Awareness at the scientist and academic level very essential. • Emerging Trend : Country specific Patent Drafting

  30. THANK YOU…Padmin Buch . . .GITCO LimitedGITCO HOUSEOpp: Sardar Patel StadiumNavrangpuraAhmedabad-380009,INDIAPh. No. 91-(079) 26565333; 26569617; 26564618Fax :91-079-26565279E-mail : gitcoltd@eth.net

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