ph buch 1 international seminar on evolvement of ipr and its management key ipr issues / provisions...
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International Seminar on Evolvement of IPR and its Management
Key IPR Issues / Provisions Affecting Business(Focus on Pharma Segment)
By
PADMIN BUCHB. Pharm, MBA, CMC
Chief ConsultantGITCO LTD, Ahmedabad
February 10, 2008Ahmedabad
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GITCO PATENT ASSISTANCE CELLGITCO PATENT ASSISTANCE CELL
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 Thirty Patents filed so farInitiated by Government of
Gujarat
Patent AwarenessPatent CounselingPatent DraftingPatent Filing Thirty Patents filed so farInitiated by Government of
Gujarat
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Cash Subsidy By State GovernmentCash Subsidy By State Government
50% (Maximum Rs. 5 Lakhs) against the expenses incurred by any organization, Institute, Individual or Industrial unit for obtaining patent registration.
This assistance will be given only once per product/process per institution/individual.
A pioneering initiative
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Indian Drugs and
Pharmaceutical Industry
Quick Overview
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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 ◄◄◄ Gujarat occupies a Prominent Position @ 42%
plus share
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INDIAN PHARMA : OVERVIEWINDIAN PHARMA : OVERVIEWStrengths:
Highly developed industry High Intellectual Capital India a huge market: 1.1 billion potential local
patients Pro-active approach by several
companies Low cost of drug development
and clinical trials Strong Bio diversity Implementation of Product
Patent act : Modified Provisions
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Patents in India: The StatusPatents in India: The Status
Two successive Governments in India have
successfully navigated the path of TRIPS
compliance
Resulted in The Patent (Amendment) Act 2005
Amendments/Provisions to sustain interests of
domestic (e.g. Pharma) industry.
Within the jurisdiction of WTO & TRIPS
Some issues not yet sorted out.
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INDIAN POSITION ON PATENT ISSUESINDIAN POSITION ON PATENT ISSUES
Sr. WTO Requirement Patent Law Status
1 Both process and product Patents must be available in all fields of Technology
The Indian Patents (Amendment) Act, 2005
Complied
2 Duration of Patent : 20 years
-do- Complied
3 No discrimination between domestic and imported products
-do- Complied
4 Micro organisms, non-biological and microbiological processes must be patented
-do- Referred to expert committee
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INDIAN POSITION ON PATENT ISSUESINDIAN POSITION ON PATENT ISSUES
Sr. WTO Requirement Patent Law Status
5 Plant varieties must be protected through either patents or sui generis system
Not protected. Some protection under Plant Varieties and Farmers Right (PPVFR) Act 2001
The plants varieties and Breeders Rights Bill at Draft stage.
6 Defination and Patentability of New Chemical Entity (NCE)
The Indian Patent (Amendment) Act. 2005
Referred to experts committee
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Protecting Interests of Domestic Pharma Protecting Interests of Domestic Pharma IndustryIndustry
Immunity for generic manufacturing
Exports of generic pharmaceutical products
Opposition to Grant of Patents Terms of Patent Compulsory Licensing
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The Patents (Amendment) Act 2005The Patents (Amendment) Act 2005& TRIPS& TRIPS
Key Provisions & Issues( More Relevant to Pharma):
Status & Implications
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Key Provisions / Issues & Key Provisions / Issues & implications : implications :
Patentability CriteriaPatentability Criteria
Only New Entity can be patented Has to be Substantially different Substituted ” New Use “ for “Mere New
Use “ thereby denying patents on the new use of known substance
Difficult to seek Patent Extension on the basis of moderate improvements
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Patentability CriteriaPatentability Criteria
Opportunity for early entry of Generics in India Market
Would benefit Generic Players Also prevent Evergreening Pressure from developed countries to at
least allow Patenting of second uses of known products
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Key Provisions, Issues & its ImpactKey Provisions, Issues & its Impact
Pre-Grant Opposition
Pre- grant opposition restored
Number of grounds restored to 11
Provisions related to the mandatory
provisions not restored.
To pay fees to access this information
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Key Provisions, Issues & its ImpactKey Provisions, Issues & its Impact
Pre-Grant Opposition
Most patent applications, especially with incremental modifications are likely to be keenly contested
Benefit to Indian Generic Manufacturers and consumers
On Flip side : delay for even genuine applications
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Key ProvisionsKey Provisions
Compulsory Licensing
Articles 27 & 31 of TRIPS lay down minimum conditions for Compulsory Licensing
Allows someone else to produce the Patented Product without consent of Patent holder
National emergencies, Urgencies, monopoly..
Essentially for Domestic Market Patent holder can continue to produce
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Compulsory LicensingCompulsory Licensing
Para 6 of Doha Declaration( 2001) and WTO
resolution of Aug 2003
Waiver of the conditions under article 31(i)
Enabled to issue CL for Exports also
For countries with no or insufficient
manufacturing capacity for pharmaceuticals
Waiver made permanent in December 2005 by
WTO
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Compulsory Licensing : ExportCompulsory Licensing : Export
License has to be awarded by that country(?)
With its low cost base and reverse
engineering skill India can export to
unregulated markets
Returns could be small Plant set up to be of international norms :
Higher Investment
Difficult for Small Units
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Key Provisions:Key Provisions:Immunity For Generic ProductionImmunity For Generic Production
Drugs being produced & marketed by
Indian Companies before 01-01-2005
Can continue to be produced
After paying reasonable royalty
Such liability would accrue prospectively
after granting Patent in India
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Patent Litigations ThreatPatent Litigations ThreatMany Small Companies not aware of IP
issues
May face Litigations in future
Patent Litigations are very costly
Essential to perform Patent Analysis/
Mapping for newer drugs
Also while acquiring a company : IPR
Valuation
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Some Other Current and Emerging Some Other Current and Emerging Issues at International LevelIssues at International Level
The need (?) for World wide Patent System
Basis for awarding Patent rights, invention/filing
Patentability of new uses for known compounds (Article 27)
National Difference in Patentability (e.g. life sciences, IT)
Language considerationHarmonization Patent Office Practices.
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In-Licensing OpportunityIn-Licensing Opportunity
Right given by Patent holderFor marketing and distribution of
Patented Drugs In return of Royalty or Profit sharing In-licensing to accelerate in next 3-4
yearsOpportunity for companies with strong
domestic presenceAlso for niche players with strength in
specific therapeutic segments
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Impact Analysis in NutshellImpact Analysis in Nutshell
Immediate Impact likely to be low/neutral
R & D Focus Consolidation to attain critical
size Exports : Regulated Markets In licensing of Patented
ProductsOutsourcing : Contract
Manufacturing and ResearchLitigations : Cost and damagesPatented Products to Increase
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Consolidation : The NeedConsolidation : The Need
Weakness: Highly Fragmented Industry
Threat : Over dominance of MNCs/Large
Companies
Opportunity : Consolidation Attain Viable size of Operations to be competitive
Capital adequacy for sustained growth
Add to shrinking Products Portfolio
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To adopt to the new Patent Regime, new business models would be in focus
a) Contract Research b) Contract Manufacturingc) Co-marketing Alliances
Herbal products ?
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India and Gujarat have the potential to emerge as the Major R&D and Contract Manufacturing Hub…...
It will surely happen
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THANK YOUTHANK YOU Padmin Buch . . .Padmin Buch . . .
GITCO LimitedGITCO LimitedGITCO HOUSEGITCO HOUSEOpp: Sardar Patel StadiumOpp: Sardar Patel StadiumNavrangpuraNavrangpuraAhmedabad-380009Ahmedabad-380009Ph. No. (079) 26565333; 26569617; 26564618Ph. No. (079) 26565333; 26569617; 26564618Fax : 079-26565279Fax : 079-26565279E-mail : [email protected] : [email protected]