1. PH Buch 1 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

2. PH Buch 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. PH Buch 3 GITCO Patent Assistance Cell Patent Awareness Patent Counseling Patent Drafting Patent Filing 42 Patents filed so far Recognized by Government of Gujarat Patent Awareness Patent Counseling Patent Drafting Patent Filing 42 Patents filed so far Recognized by Government of Gujarat

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

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

8. PH Buch 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. PH Buch 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. PH Buch 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. PH Buch 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. PH Buch 12 Generic World: Patent Expiry of Major Drugs Year No. of Drugs going out of Patent Estimated Sales (US $ Billion) 20071420 to 25 20081018 to 22 20090620 to 25 20100910 to 15 20111025 to 30 20121020 to 22 Source: Chemical Weekly (May 2008) & ToI July 2008

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

14. PH Buch 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. PH Buch 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. PH Buch 16 To adopt to the new Patent Regime, new business models would be in focus a) Generics b) Contract Research & Manufacturing c) Patent Drafting Strategies

17. PH Buch 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. PH Buch 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. PH Buch 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. PH Buch 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. PH Buch 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. PH Buch 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. PH Buch 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. PH Buch 24 Patentability of Pharma/Medical Inventions : Criterion Novelty Inventiveness Industrial Applicability  Reproducibility/Enablement (EN)

25. PH Buch 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. PH Buch 26 Patentability: Country-specific Comparison Category of Invention JPOEPOUSPTOIPA Chemical Entity 1 st Use X 2 nd Use XXX Swiss type No Need No NeedX New Method Source: HK Acharya & Co.

27. PH Buch 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. PH Buch 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. PH Buch 29 Patent Drafting Strategies  Awareness at the scientist and academic level very essential.  Emerging Trend : Country specific Patent Drafting

30. PH Buch 30 THANK YOU… Padmin Buch... GITCO Limited GITCO HOUSE Opp: Sardar Patel Stadium Navrangpura Ahmedabad-380009,INDIA Ph. No. 91-(079) 26565333; 26569617; 26564618 Fax :91-079-26565279 E-mail : gitcoltd@eth.net THANK YOU… Padmin Buch... GITCO Limited GITCO HOUSE Opp: Sardar Patel Stadium Navrangpura Ahmedabad-380009,INDIA Ph. No. 91-(079) 26565333; 26569617; 26564618 Fax :91-079-26565279 E-mail : gitcoltd@eth.net