RAVI DHAR REVIEWS: “UNDERSTANDING INTELLECTUAL PROPERTY & TECHNOLOGY MANAGEMENT FOR PRODUCT DEVELOPMENT IN CURRENT GLOBAL SCENARIO” Ravi Dhar, Ph.D., f-STEM in.linkedin.com/pub/ravi-dhar/18/71b/895 (Email: [email protected]) University of Kashmir, Srinagar 16/4/2014 1 RD_UOK_April-2014 INTERNATIONAL CONFERENCE ON CELLULAR AND MOLECULAR MECHANISMS OF DISEASE PROCESSES (April 13-16, 2014) 16.4.2014
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Dr. Ravi Dhar on Intellectual Property & Technology Management_ University of Kashmir_2014_f
For scholars and srudents who want to understand the basics of Intellectual property & Technology Management
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Nescafe; GloFish***/ARTSK_NII/ Prozac/ Tylenol : Trade Mark
Maruti, Honda Model XX : Design Registration
Internet Explorer, Gene Sequences & Music : Copyright
Coke, Techniques to generate enzymes : Trade Secrets Traditional Knowledge & New Plant Varieties
South Indian Silk sarees/ Bengal cotton cloth/Bikaji Bhujia : Geographical Indicators
(***The GloFish is a trademarked transgenic zebrafish (Danio rerio) expressing a red fluorescent protein from a sea anemone under the transcriptional control of
the promoter from the myosin light peptide-2 gene of zebrafish1. Produced and patented by a group at the National University of Singapore)
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Technology Management Process
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Invention
Disclose Invention to Patent Office
Review & Approval
Protect Intellectual Property (Patent)/Grant
Find Potential Licensee/Industrial Partner
NDA/CDA/ License
Upscale/Prototype/Clincal or Field Trials
Production/ Marketing & Commercialization
Royalties Tech
nolo
gy M
ana
gem
ent Pro
cess
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Technology/Innovation Management Process 1. Idea/Proof of Concept : Technical Assessment
2. File a Patent (Prior Art Search: Novelty/non-Obviousness/Utility) / (Publish Manuscript)
3. Grant Process at Patent Office : Be patient
4. Find an Industrial Partner : Be Patient or float your Start-up Company
5. MoUs_NDA : TTO or Attorney or Agencies
6. Licence , DA : TTO or Attorney
7. Exchange Know-how_MoUs : You and Industry
8. Demand Signing Amount : You + University
9. Furnish Data (Importance of Record Book): You + Industry
10. Freedom to Operate Analysis : TTO/ Patent Attorney
11. Industrial Partner will Validate Data>Upscale>Pilot run
12. Milestone Payments : You + University
13. Industry will Manufacture, Commercialize, Market Product
14. Distribution of Royalty on Sales : You + University + Industry
Nescafe; GloFish***/ARTSK_NII/ Prozac/ Tylenol : Trade Mark
Maruti, Honda Model XX : Design Registration
Internet Explorer, Gene Sequences & Music : Copyright
Coke, Techniques to generate enzymes : Trade Secrets Traditional Knowledge & New Plant Varieties
South Indian Silk sarees/ Bengal cotton cloth/Bikaji Bhujia : Geographical Indicators
(***The GloFish is a trademarked transgenic zebrafish (Danio rerio) expressing a red fluorescent protein from a sea anemone under the transcriptional control of
the promoter from the myosin light peptide-2 gene of zebrafish1. Produced and patented by a group at the National University of Singapore)
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Human Creativity in Front Line Areas
Rigorous Experimentation
Laboratories, under Controlled Conditions
Clinical or Field Trials
Credit assigned to: (a) Organization, University or Laboratory
(b) Inventor or Innovator
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Relationship
between
Innovation, Basic Science, Economy & IPR
Basic Sciences Research
Fundamental Discoveries & Inventions
Solutions=Commercially
Relevant
Applications or Products
Ro
le o
f Vario
us P
layers
(F
un
din
g A
ge
nc
ies
/Co
llab
ora
tors
/
Co
ns
ortia
)
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Cycl
e o
f Eco
nom
y
Basic Sciences Research
Fundamental Discoveries/
Inventions
Solutions=Commercially
Relevant
Applications or Products
Ro
le o
f Vario
us P
layers
) (F
un
din
g A
ge
nc
y/C
olla
bo
rato
rs/
Co
ns
ortia
)
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Cycl
e o
f Eco
nom
y
Pro
tect
ion o
f In
tellect
ual Pro
pert
y
(Pa
tents
/TM
/Copyri
ghts
etc
)
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IPR & Entrepreneurship- Essentials
• Highly competitive Subject
• Be open minded & helpful
• Learn to act in a team
• Be pleasant
• Participate in discussions
• Learn to face stresses
• Learn to respond to a change
• Never be biased
• Analyze facts (Trust-but-Verify)
• Accept failures or mistakes
• All of the above is linked to Entrepreneurship
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Innovation Ecosystem & Patent Laws
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IP Protection
1
2
3
4 6
7
5
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IP Protection
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(
Indian Patent Act, 1970, 1972, 2005, 2006…..) 2[(ii]
viii) in relation to any other State, the High Court for that State;
1."invention" means any new and useful-
2. art, process, method or manner of manufacture; and includes any new and
useful improvement of any of them, and an alleged invention;\
1."legal representative" means a person who in law represents the estate of a
deceased person;
1. "medicine or drug" includes-
2. all medicines for internal or external use of human beings or animals, 3. all substances intended to be used for or in the diagnosis, treatment, mitigation
or prevention of diseases in human beings or animals, 1. all substances intended to be used or in the maintenance of public health, or the
prevention or control of any epidemic disease among human beings or animals, 1. insecticides, germicides, fungicides, weedicides and all other substances
intended to be used for the protection or preservation of plants, 1. all chemical substances which are ordinarily used as intermediates in the
preparation or manufacture of any of the medicines or substances above
It is the birthplace of the World Wide Web. The main site at Meyrin also has a large computer centre containing very powerful data-processing facilities primarily for experimental data analysis and, to make them available to researchers elsewhere; has historically been a major wide area networking hub.
CERN's main function is to provide the particle accelerators and other infrastructure
needed for high-energy physics research. Numerous experiments have been constructed at CERN by international collaborations to make use of them.
Tumor-Fighting Immune Cells to Attack Cancer (Researchers at UCLA’s Jonsson Comprehensive Cancer Center have created a large, well-armed troop of tumor-seeking immune
system cells to locate and attack dangerous melanomas)
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Incremental Innovations
Oil-Eating Bacteria to Clean up Oil Spills That certain bacteria have the ability to metabolize oil isn’t a new discovery of course. Back in 1989, bacteria were used
experimentally in attempts to clean up the 11 million gallons of crude oil spilled by the Exxon Valdez after it ran aground off the
coast of Alaska. Though it made little to no difference back then, now that researchers have a complete blueprint for the oil-
hungry bacteria: Alcanivorax borkumensis, they’ll have the ability to optimize the conditions for these bugs, enabling them to soak
up the hundreds of millions of liters of oil that enter our waters each year
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Engineered Tobacco Plants as Biofuel The challenge researchers faced was that this precious oil is mostly found in tobacco seeds, and tobacco plants only produce about 600 kg of seeds
per acre. However, they have now found ways to genetically engineer the plants so that their leaves express more oil. According to one of the
project’s researchers, Dr. Andrianov, they have been able to modify plants to produce 20-fold more oil in the leaves. Andrianov says “”Based on these
data, tobacco represents an attractive and promising ‘energy plant’ platform, and could also serve as a model for the utilization of other high-
biomass plants for biofuel production.”
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Stem cell culturing without the use of animal substances (in
a completely chemically-defined environment)
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Innovations Having Immediate Social
Impact Improved/ Affordable versions of B.P machine
Cycle rickshaw with a small engine
Bag containing Tea leaves with a thin (painful) or thick
Classical Definition: “A mental or intellectual activity” which results in a useful Technology related to an industrial design or a machine comprises Industrial Property (=IP).
IP is generated by Inventors or Innovators****
Over years this term evolved into Intellectual Property which includes Patents, Copyright, Trade Mark, Trade Secrets, Geographical Indicators, Protection of Plant Varieties etc.
Forms of Intellectual Property
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Property:
Tangible (which can be seen)
House, Expressway Road a commercial activity
Non-tangible (which can not be described as such)
Vaccine
Computer chip a commercial activity
Innovators desire:
Legal protection of innovations;
Compensation + Awards to keep their
innovative spirit going
Governments of various countries agreed to do the
needful
Net Result:
These regulations keep the “fire in the genius going”
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Innovation Index Issues?
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Innovation Index for us?
Our Issues
Can we innovate alone?
Do we need to innovate alone?
Current Economic Scenario in the world necessitates us to
join hands ; & draw more out of less
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Top 10 in the Global Innovation Efficiency
Index •China
•India
•Republic of Moldova
•Malta
•Switzerland
•Paraguay
•Serbia
•Estonia
•Netherlands
•Sri Lanka (source: WIPO)
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Group-1
Group-2
Group-3
Why IP Rights are Necessary!
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Creation of IP needs financial support
IP Rights boost innovation
by protecting the :interest of inventor
IP generates :revenue
IP results in :commerce
Commerce is :trans-continental
Commerce is :regulated
Commercial :practices should be uniform for
healthy business ethics
(WTO + WIPO)
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Incentives from Property Ownership are
Deeply
Rooted in Law (John Locke (1632-1704)– Father of Liberalism)
John Locke uses the word property in both broad and narrow
senses. In a broad sense, it covers a wide range of human interests
and aspirations; more narrowly, it refers to material goods. He
argues that property is a natural right and it is derived from labour.
Locke believed that ownership of property is created by the
application of labour. In addition, property precedes government and
government cannot "dispose of the estates of the subjects arbitrarily."
Karl Marx later critiqued Locke's theory of property in his social
theory.
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Evolution & Historical Perspective
Technology development in India & elsewhere: Historical perspective
Protection of Creative Glass Blower’s Art in Italy, 1449
USA: Patent protection initiated by President Jefferson (1793)
Intellectual Property Rights (WIPO Classification)
(A) Copyright and rights related to copyright
(B) Industrial property: (1) trademarks and geographical indications
(2) industrial designs (protected by patents), and
(3) trade secrets.
What are “intellectual property rights”? Intellectual property rights can be defined as the rights given to people over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creations for a certain period of time.
Salient Features of IP
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IP shares many characteristics associated with real
and personal property
IP is an asset – it can be bought, sold, licensed,
exchanged or given away like any other form of
property; but Indian Banks do not give loans?
IP owner has the right to prevent unauthorized use
or sale of property
However, IP is intangible (it can’t be defined)
Intellectual Property : A Complex & Serious Subject
Science & Technology
IPR, Patent Laws
Commerce
International Trade Relations
Business Development & Networking
Negotiation Skills
Economics
Accounting
Public Opinion
Ethics
(Anybody who works in this area needs a flexible attitude)
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Creativity i.e., Innovation results in IP
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Innovation generates Intellectual Property
Intellectual Property in Biotech Sector is generated
through rigorous experimentation but is more complex
Innovation changes life styles e.g., tele-medicine by use of mobile phones/ pacemaker/ vaccine/ recombinant crop
Relevance of Technologies in Current Global
Scenario in Biotech sector
Requirement of people friendly technologies for health
care/ Agriculture/Environment/Fuels etc
Growth of biotech institutes
Increase in number of skilled & semi-skilled people
Increase in international & national collaborations
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Current Advantages • Robust economical scenario******
• Promising potential to be a global player in the arena of
biotechnology
• Large pool of skilled and cost competitive manpower
• Well developed and integrated scientific infrastructure
• Advanced chemical synthesis technologies
• Manufacturing practices conforming to US and EU norms
• Diverse biological resources
• Globally recognized as a producer of low cost, high quality
bulk drugs and formulations.
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Funding
for
Innovative Research in Biotech Sector
---GoI Effort & Evolution of BIRAC---
Funding Support (loans or grants) in INR
BIG SIBRI BIPP CRS BISS & UIC
50 Lacs 2 Cr 50 Cr > Case to case Case to case
National Biotechnology Policy
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Source: BIRAC website (modified)
Why Technologies?
Is Change Useful!
S.
No.
Old Technology New Technology
1. Test Tube Eppendorf Tube
2. Petri Dish Tissue Culture Flask
3. External Pace maker Implantable Pace Maker
4. Mercury Column B.P.
measuring machine
Digital B.P. machine
5. Drugs Target Specific Drugs
6. ELIZA tests PCR amplified Tests
High level of Technology : Higher Royalty or Prices
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This makes life more comfortable!!!
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Technology Sectors & Investment
Opportunities
•Agriculture and Plant Biotechnology
•Medicinal and Aromatic plants
•Animal Biotechnology
•Aquaculture and Marine Biotechnology
•Seri biotechnology
•Stem Cell Biology
•Human Genetics and Genome Analysis
•Environmental Biotechnology
•Microbial and Industrial Biotechnology
•Healthcare
•Bio-Fuels
•Bio Pesticides
•Bio-Informatics
•Software Support
•Mechatronics
Legal Protection to Human Creativity !
Patents : Glivec, Immuvac, Humira mAb, Pandylfu
Trade Mark : Nescafe;
GloFish***/
ARTSK_NII/Prozac/Tylenol
Design Registration : Honda Model XX
Copyright : Internet Explorer, Gene Sequences & Music
Trade Secrets : Coke, Techniques to generate enzymes
Traditional Knowledge & Protection of New Plant Varieties
Geographical Indicators : South Indian Silk sarees/ Bengal cotton cloth
(***The GloFish is a trademarked transgenic zebrafish (Danio rerio) expressing a red fluorescent protein from a sea anemone under the transcriptional
control of the promoter from the myosin light peptide-2 gene of zebrafish1. Produced and patented by a group at the National University of Singapore)
Obviousness, means that “a person having ordinary skill in
the art” would not know how to solve the problem at
which the invention is directed by using exactly the
same mechanism.
The obviousness standard prevents the patenting of
relatively insignificant differences between the
invention and the prior art
The invention must provide one or more new and
unexpected results
Test tube vs Eppendorf tubes
Round bottom is Novelty
(1840-50)
Non-obvious
Round pointed bottom is Novelty?
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Tissue Culture Flasks
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Vaccine :
Antibody (a protein or peptide)
+ Adjuvant (binds Ab to target)
+ Antifungal (Thimerosal)
+ Envelope-hypothetical (that can not be
digested by enzymes)
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Obviousness (contd)
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Prior art can be combined in an obviousness determination, that is, more than one reference can be cited by the examiner as showing different features of the invention which, taken together, render the invention obvious
Obviousness is inherently a subjective determination, as the examiner cannot be, or know the mind of, the hypothetical “one skilled in the art.”
Non-obvious to Whom?
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A patent will NOT be issued if a person having ordinary skill in the field of the invention would consider the invention obvious at the time of creation
The law considers a person having ordinary skill in the art to be a worker in the field of the invention who:
Has ordinary skill
Is totally knowledgeable about all the prior art in his or her field
Pure Fantasy, but no other realistic way to determine non-obviousness
The PTO creates a hypothetical person and tries to weigh the obviousness of the invention against the knowledge this hypothetical person would possess
Examples of Obviousness
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Non-obvious: Slight Physical Changes – Dramatic Result
Sometimes, a very slight change in shape, slope, size, or material can produce a patentable invention that operates entirely differently and produces totally unexpected results
Non-obvious: New Use Inventions
Do not involve any physical change to old invention
Must be different use of known product or process and produce new, unexpected results
Obvious: Different Element, Similar Function
Courts have held that substituting a different, but similarly functioning, element for one of the elements in a known combination creates a novel invention but an obvious one.
Examples of Obviousness (contd)
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Obvious: Old Concept, New Form
The PTO will consider as obvious the mere carrying forward of an old
concept, or a change in form and degree, without a new result (notches on
inner rim of steering wheel for better grip, obvious because of medieval
sword handles)
Obvious: Duplication of Parts
Usually consider the duplication of a part as obvious unless new results can
be observed
Obvious: Portability, Size, Speed, and Integration
Making devices portable, making parts smaller or larger, faster or slower,
making elements adjustable, parts integral, separable, etc. will be considered
obvious unless new, unexpected results can be shown
Rationale Examples
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The following examples will demonstrate the appropriate fact findings to support rationales suggested for Company “A” and provide an explanation of how the rationales lead to a conclusion of obviousness under 35 USC 103.
USE OF KNOWN TECHNIQUES TO IMPROVE
SIMILAR DEVICES IN THE SAME WAY
We claim:
A cholesteric color filter comprising:
A barrier coating formed on a cholesteric filter layer, said barrier layer preventing oxidation of the filter.
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Substrate
Substrate
Liquid Crystal Layer
Barrier Coating
Cholesteric Filter
Layer
Cholesteric Color Filter
Adapted from Application No. 10/191,445
USE OF KNOWN TECHNIQUES TO IMPROVE
SIMILAR DEVICES IN THE SAME WAY
Reference B teaches applying a
barrier coating 78 to a color filter
86 to prevent oxidation of the
color filter.
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Reference A teaches a cholesteric
color filter having a layer 200 of
material having a cholesteric order
and known to have a problem with
oxidization.
USE OF KNOWN TECHNIQUES TO IMPROVE
SIMILAR DEVICES IN THE SAME WAY
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• The prior art references teach all of the claimed elements. • The difference between the prior art and the claimed invention is the use of a barrier coating to prevent oxidation in a cholesteric color filter. • The prior art shows adding a barrier coating to a color filter to prevent oxidation.
Applying This Rationale:
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Disruptive Technologies
are an outcome of
Convergence of Technologies
Convergence of Technologies
Systems at
Molecular Level
Self Replicating
Biological Processes
Self Assembly
Intelligent, Evolvable, Adaptive System
Biotechnology Nanotechnology
Information Technology (Source: National Science Foundation, USA, 2006; modified)
Future unknown
Technologies
?
For H
um
an U
se
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Green technology
Technology Management
&Transfer
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Proof of Concept Legal Protection
Validation In house Experimental Production
MARKET SALES
Components of Technology Management
Clinical Trials/Field Trials
Technology Transfer Process Technology
(A Vaccine/Therapeutic Agent/GM Crop etc)
(Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical Evaluation (Toxicity + Animal & Human Studies)>
The organization of the product development process is a key
success factor within the organization of large manufacturers. Key
issues are:-
•the process of product development
•the underlying philosophy, especially platform strategies
•the relation and integration of product and process/manufacturing
engineering
•the involvement of suppliers into the product development process
•the responsibility of product development departments within
the launch process
As a consequence of the increasing demand for higher product
development process performance, many - not to say all - OEMs have
built their one-site-development centers. The purpose is clear and
means co-locating of all involved faculties in one site.
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Contract Research Services
• Physical and chemical characterization
• Formulation development for small and macromolecules
• Reverse Engineering
• Release and Stability testing
• Container/closure selection
• Process development
• Scale-up and technical transfer to manufacturing
• Manufacture for GLP Toxicology support
• Extractables and Leachables evaluation
• Product life-cycle management
• IND, NDA and aNDA support.
Disposal of Technology
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Disposal of Technologies
We may get a Patent for a Technology or License it to an
Industry after :-
Evaluation : Apply “Go- No Go –Kill” concept (on the
basis of maturity/market requirement etc)
Upscale
License after Valuation
Production
Monitor
Sales & Royalty
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Technology Valuation
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Acthar Gel for infantile spasms ?
Value Grid mapping of Technology /
Product Portfolios
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Great Expectations:
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Biotechnology & Allied Areas
(National & International collaborations
will play
a great role in these areas)
Quality of Science is essential for
Technology Development….
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Canada
Korea
Italy
Netherlands
Switzerland
India
BelgiumSweden
Russian Federation
Poland
Australia
Brazil
Spain
United States
Germany
France
China
Japan
United Kingdom
1998 2008
Canada
Korea
Italy
Netherlands
Switzerland
India
BelgiumSweden
Russian Federation.
Poland
China
Japan
Australia
Brazil
Spain
United States
Germany
France
United Kingdom
Source: OECD (2010) Measuring Innovation: A New Perspective
?
?
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Improved Quality of Science needs: 1) Big Budgets & Political will 2) Pool of Skilled Manpower 3) Technology Platforms 4) Intense & meaningful Collaborations
Technology Transfer A complex process involving series of well thought of steps:
1. Research
2. Pre-Disclosure
3. Invention Disclosure
4. Assessment
5. Protection
6. Upscale
7. Make a Start-up Company or Use Existing Company
8. Licensing
9. Marketing & Commercialization
10. Revenue Generation
11. Royalty Sharing or Charity?
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Technology Transfer Process
Drugs/Vaccines/GM crops/Bio-processes etc
(Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical Evaluation (Toxicity + Animal & Human
countries to balance international obligations w.r.t
domestic/national interests
World was more divided before TRIPS
This impeded the international trade & knowledge
diffusion
Conflicts around TRIPs
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TRIPs (Relevant Titles & Parts & Sections) Parts Sec. Articles Content I - 1-8 General Provisions & Basics II - Scope on use of IPR 1 9-14 Copyrights 2 15-21 Trademarks 3 22-24 Protection of Geog. Indicators 4 25-26 Industrial Designs
5 27-34 Patents 6 35-38 Layout designs 7 39 Protection of undisclosed information 8 40 Control Anti-competitive practices III Enforcement of IPR 1-5 41-61 General/ Admn. Procedures/ Criminal Procedures/ IV 62 Acquisition & Maintenance of IPRs & Related Inter-parties procedures V 63-64 Dispute Prevention & Settlement VI 65-67 Transitional Agreements VII 68-73 Institutional Agreements; Final Provisions (Reference example : Part II, Sec. 5, Article 27-34, Patents)
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Place of the TRIPS Agreement in the Multilateral
Trading System?
• One of the fundamental characteristics of the TRIPS Agreement is that
it makes protection of intellectual property rights an integral part of the
multilateral trading system, as embodied in the WTO.
• The TRIPS Agreement is often described as one of the three “pillars” of
the WTO, the other two being trade in goods (the traditional domain of the
GATT) and trade in services.
•That implies that the TRIPS Agreement applies to all WTO members. It
also means that the provisions of the agreement are subject to the
integrated WTO dispute settlement mechanism which is contained in the
Dispute Settlement Understanding (the “Understanding on Rules and
Procedures Governing the Settlement of Disputes”).
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TRIPS
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The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.
TRIPS contains requirements that nations' laws must meet for: copyright rights, including the rights of performers, producers of sound recordings and broadcasting organizations; geographical indications, including appellations of origin; industrial designs; integrated circuit layout-designs; patents; monopolies for the developers of new plant varieties; trademarks; trade dress; and undisclosed or confidential information. TRIPS also specifies enforcement procedures, remedies, and dispute resolution procedures.
“India BT Industry to reach Rs. 36,107 by 2010”-BioSpectrum, October, 2010
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The articles below were the top 10 for 2012. Some surprised me as to how fast they rose in the rank. I hope you read them all ready, but if you have not, here they are: •3 Main startup traits attract money and talent •Working hard is not enough •The One Word Entrepreneurs Do Not Say
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