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6th International Seminar

Intellectual Property Rights : Advantage business

The Generic Advantage & Patent Drafting Strategies

By

PADMIN BUCHB. Pharm, MBA, CMC

Chief ConsultantGITCO , Ahmedabad

February 14 , 2010Ahmedabad

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GITCOGITCO

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

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GITCO Patent Assistance CellGITCO Patent Assistance Cell

Patent AwarenessPatent CounselingPatent DraftingPatent Filing 42 Patents filed so farRecognized by

Government of Gujarat

Patent AwarenessPatent CounselingPatent DraftingPatent Filing 42 Patents filed so farRecognized by

Government of Gujarat

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Cash Subsidy By State GovernmentCash 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

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

growth

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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

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

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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$)

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Indian Drugs and Pharmaceutical Indian Drugs and Pharmaceutical Industry - An OverviewIndustry - 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

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Generic DrugsGeneric 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.

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Key Factors For Growth Of GenericsKey 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%

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Generic World: Generic World:

Patent Expiry of Major DrugsPatent Expiry of Major Drugs

YearNo. 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 22Source: Chemical Weekly (May 2008) & ToI July 2008

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The Indian Advantage : Patent Act The Indian Advantage : Patent Act ProvisionsProvisions

India’s patent Act provides flexibility.

The generic (drugs) industry to be major beneficiary

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Key Provisions :Key Provisions :Scope of Patentability & Pre-Grant Scope of Patentability & Pre-Grant

OppositionOpposition

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

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Generics :Generics :

The Indian Advantage…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.

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To adopt to the new Patent Regime, new business models would be in focus

a) Genericsb) Contract Research &

Manufacturing

c) Patent Drafting Strategies

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Importance of Patent DraftingImportance 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)

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Patent Drafting Strategies : Patent Drafting Strategies : AdvantagesAdvantages

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.)

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Patent Drafting Strategies

Global Patent laws keep on changingAwareness, training and skill imparting requirement to keep pacePrior arts search very vitalBiggest challenge is to understand the invention itself, its complexity and putting it in the most correct form while drafting.

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Patent-drafting StrategiesPatent-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)

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Patent Drafting:Patent Drafting:Common Claim Errors by Non-US ApplicantsCommon 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

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Patent Drafting:Patent Drafting:Types of Pharmaceutical ClaimsTypes of Pharmaceutical Claims

Chemical Compounds First medical use of novel

(inventive) Compounds Second Medical Use of Known

Compounds Swiss Style Method

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Categories of Pharma/Medical Categories of Pharma/Medical InventionsInventions

(other than India)(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

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Patentability of Pharma/Medical Inventions : CriterionPatentability of Pharma/Medical Inventions : Criterion

Novelty Inventiveness Industrial Applicability Reproducibility/Enablement

(EN)

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Patent Drafting: Different CountriesPatent 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.

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Patentability: Country-specific ComparisonPatentability: Country-specific Comparison

Category of Invention

JPO EPO USPTO IPA

Chemical Entity

1st Use X

2nd Use X X X

Swiss type No Need No Need X

New Method Source: HK Acharya & Co.

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Patent-Drafting Strategies :Patent-Drafting Strategies :Avoiding Infringement of existing patentsAvoiding 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

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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

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Patent Drafting StrategiesPatent Drafting Strategies

Awareness at the scientist and academic level very essential.

Emerging Trend : Country specific Patent Drafting

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THANK YOU…THANK YOU…

Padmin Buch . . .Padmin Buch . . .

GITCO LimitedGITCO LimitedGITCO HOUSEGITCO HOUSEOpp: Sardar Patel StadiumOpp: Sardar Patel StadiumNavrangpuraNavrangpuraAhmedabad-380009,INDIAAhmedabad-380009,INDIAPh. No. 91-(079) 26565333; 26569617; 26564618Ph. No. 91-(079) 26565333; 26569617; 26564618Fax :91-079-26565279Fax :91-079-26565279E-mail : gitcoltd@eth.netE-mail : gitcoltd@eth.net