1 PH Buch 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
1PH Buch
PH Buch
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
2PH Buch
PH Buch
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
3PH Buch
PH Buch
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
4PH Buch
PH Buch
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
5PH Buch
PH Buch
The Global Pharmaceutical Market Size Reached $780-790 Billion in 2008 : ‘Pharmerging’ markets have outperformed the global market
growth
6PH Buch
PH Buch
There is Now a Fundamental Shift in Geographical Sources of Global Pharma Growth
Global Pharmaceutical Geographic Breakdown to 2009 (US$)
Pharmerging markets will contribute 34% towards global growth in 2009
7PH Buch
PH Buch
““Pharmerging”Pharmerging” countries :countries : Brazil, China, India, Indonesia, Brazil, China, India, Indonesia, Mexico, Russia and TurkeyMexico, Russia and Turkey
8PH Buch
PH Buch
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$)
9PH Buch
PH Buch
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
10PH Buch
PH Buch
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.
11PH Buch
PH Buch
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%
12PH Buch
PH Buch
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
13PH Buch
PH Buch
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
14PH Buch
PH Buch
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
15PH Buch
PH Buch
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.
16PH Buch
PH Buch
To adopt to the new Patent Regime, new business models would be in focus
a) Genericsb) Contract Research &
Manufacturing
c) Patent Drafting Strategies
17PH Buch
PH Buch
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)
18PH Buch
PH Buch
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.)
19PH Buch
PH Buch
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.
20PH Buch
PH Buch
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)
21PH Buch
PH Buch
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
22PH Buch
PH Buch
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
23PH Buch
PH Buch
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
24PH Buch
PH Buch
Patentability of Pharma/Medical Inventions : CriterionPatentability of Pharma/Medical Inventions : Criterion
Novelty Inventiveness Industrial Applicability Reproducibility/Enablement
(EN)
25PH Buch
PH Buch
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.
26PH Buch
PH Buch
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.
27PH Buch
PH Buch
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
28PH Buch
PH Buch
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
29PH Buch
PH Buch
Patent Drafting StrategiesPatent Drafting Strategies
Awareness at the scientist and academic level very essential.
Emerging Trend : Country specific Patent Drafting
30PH Buch
PH Buch
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 : [email protected] : [email protected]