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6 th International Seminar Intellectual Property Rights : Advantage business The Generic Advantage & 6 th 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 PH Buch 1

GITCO l GITCO is a multi-disciplinary consultancy organization l Promoted by ICICI Bank, IDBI, GITCO l GITCO is a multi-disciplinary consultancy organization l Promoted by ICICI Bank, IDBI, State Govt. Corporations & Nationalized Banks l Offers Project, Management, Financial, Industrial & Technical Consultancy Services l Patent PH Buch Assistance Cell is one of them 2

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

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

The Global Pharmaceutical Market Size Reached $780790 Billion in 2008 : ‘Pharmerging’ markets have The Global Pharmaceutical Market Size Reached $780790 Billion in 2008 : ‘Pharmerging’ markets have outperformed the global market growth PH Buch 5

There is Now a Fundamental Shift in Geographical Sources of Global Pharma Growth Global 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 PH Buch 6

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

India is Expected to be One of the Largest Emerging Pharma Market within the 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$) PH Buch 8

Indian Drugs and Pharmaceutical Industry - An Overview l Size of around US $ Indian Drugs and Pharmaceutical Industry - An Overview l Size of around US $ 6. 5 Billion l Projected CAGR @ 13. 6% l Exports estimated at @ 40% of turnover l Formulations @ 78%; Bulk Drugs @ 22% l Growth of Export : 22%, Domestic Market 8% to 10% l Also Highly fragmented Industry ü Generic Drugs the key driver for growth of Indian Pharma Industry PH Buch 9

Generic Drugs l After expiry of Patents others can also manufac l This is Generic Drugs l After expiry of Patents others can also manufac l This is known a ‘Generic’ drug l Generic drugs are cheaper than patented cou l Are supposed to be just as effective. PH Buch 10

Key Factors For Growth Of Generics Price sensitivity : Both in Developed and Developing Key Factors For Growth Of Generics Price sensitivity : Both in Developed and Developing l Developing countries (e. g. India) not favouring paten l R&D Production of “Big Pharma” is declining l ● Growth Rate: ØIndustry: 6 -7%; ØGenerics Market : 11% PH Buch 11

Generic World: Patent Expiry of Major Drugs Year No. of Drugs going out of Generic World: Patent Expiry of Major Drugs Year No. of Drugs going out of Patent Estimated Sales (US $ Billion) 2007 14 20 to 25 2008 10 18 to 22 2009 06 20 to 25 2010 09 10 to 15 2011 10 25 to 30 2012 10 20 to 22 Source: Chemical Weekly (May 2008) & To. I July 2008 PH Buch 12

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

Key Provisions : Scope of Patentability & Pre-Grant Opposition l Defines what is Patentable Key Provisions : Scope of Patentability & Pre-Grant Opposition l Defines what is Patentable l New Entity/ Substantially different can be patented Difficult to seek Patent Extension on the basis of modera l Pre- grant opposition restored l Most patent applications, especially with incremental mo l Benefit to Indian Generic Manufacturers and consumer l PH Buch 14

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

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

Importance of Patent Drafting “A claim demarcates in words the boundary of the invention 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) PH Buch 17

Patent Drafting Strategies : Advantages l l l Helps making Patent Water-tight Avoid infringement Patent Drafting Strategies : Advantages l l l 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. ) PH Buch 18

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

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

Patent Drafting: Common Claim Errors by Non-US Applicants l l l Relying on one Patent Drafting: Common Claim Errors by Non-US Applicants l l l 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 PH Buch 21

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

Categories of Pharma/Medical Inventions (other than India) l l l Novel Chemical Compounds “Pharmaceutical” Categories of Pharma/Medical Inventions (other than India) l l l 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 PH Buch 23

Patentability of Pharma/Medical Inventions : Criterion Novelty l Inventiveness l Industrial Applicability ÜReproducibility/Enablement (EN) Patentability of Pharma/Medical Inventions : Criterion Novelty l Inventiveness l Industrial Applicability ÜReproducibility/Enablement (EN) l PH Buch 24

Patent Drafting: Different Countries l l l Countries try to strike a balance in Patent Drafting: Different Countries l l l Countries try to strike a balance in Patent law : be Different countries have similar guidelines and reg For example, Section 3(d) of Indian Patent Act (Stand European Patent Law has similar restrictions unde US Legal System : to prove “non-obviousness” However interpretation may differ. PH Buch 25

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

Patent-Drafting Strategies : Avoiding Infringement of existing patents l Incase of a patented multi-component Patent-Drafting Strategies : Avoiding Infringement of existing patents l 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 l May play around concentrations of different components l Process patents : change in steps l New drug delivery : improvement in efficacy PH Buch 27

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

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

THANK YOU… Padmin Buch. . . GITCO Limited GITCO HOUSE Opp: Sardar Patel Stadium 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 : [email protected] net PH Buch 30