dr. ravi dhar on intellectual property & technology management_ university of kashmir_2014_f
DESCRIPTION
For scholars and srudents who want to understand the basics of Intellectual property & Technology ManagementTRANSCRIPT
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
16/4/2014 RD_UOK_April-2014
2
Happy 2014
to
Colleagues & Scholars
Acknowledgements
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3
DBT, GoI
NII
NIH
USDA, JHU, NYU
BU {Drs. Gerald Keusch, Ashley Stevens & Altaf Lal}
Kellogg’s Business School, Center for Biotechnology, North Western University
Nature Biotechnology, International Journal of Technology, Bio-Materials, Nature Nano-technology , MIT Technology Review, MedGadget
Various Websites (USPTO, IPO) , Books, NYT
Several Colleagues (Vinita & Sibi @ BIRAC)
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Special Thanks:
University of Kashmir
Department of Biotechnology, KU
Dr. Raies Qadri
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A bio-
engineered
heart-valve,
a small
example of
the top-down
approach. Courtesy of
Wikimedia Commons
16/4/2014 RD_UOK_April-2014 6
Fast New Test could find Leprosy before
Damage is Lasting
American researchers developed the test, and Brazil’s drug-
regulatory agency registered it last month. A Brazilian diagnostics
company, OrangeLife, will manufacture it on the understanding that
the price will be $1 or less.
“This will bring leprosy management out of the Dark Ages,” said
Dr. William Levis, who has treated leprosy patients at a Bellevue
Hospital outpatient clinic for 30 years.
A new diagnostic test has been created to
diagnose leprosy out of a smart-phone and
a simple test strip reader
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Problems Big or Small
Need Solutions
Finding Solutions would also lead to
Entrepreneurship & Jobs
Related Education
Tech
no
logie
s/Solu
tions C
om
merce
16/4/2014 RD_UOK_April-2014 8
Technologies are Generated by
Act of Mind.
The commodity Developed or produced
is thus called as Intellectual Property
WISH LIST Want an ideal Device for Detection of Cancer from Human
Saliva
Want a tea + saffron mix which has higher levels of anti-oxidants
& can cure flu
Want quick Detection of Drug Resistant Cerebral Malaria by
a simple Staining method
Want a blood thinner drug from a local plant “A”
A folding but flying car which can occupy a small space
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How to full-fill the Wish List?
Problems are Solved by Innovative thinking; so -
Innovate!
Innovate!
Innovate!
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Academic or Industry Led R&D
Basic & Applied Research
Funding (Public or Private)
Both Applied or Basic Research result
In Product Development for
Public Consumption
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IP Protection
1
2
3
4 6
7
5
Definition of Intellectual Property?
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13
“A mental or intellectual activity” which result in useful Technologies or products like vaccines, drugs, medical
devices, expression vectors, plant varieties, better varieties of Saffron, energy solutions etc.
The technologies or products may be given legal protection
IP is generated by Inventors or Innovators
Intellectual Property includes Patents, Copyright, Trade Mark, Trade Secrets, Geographical Indicators, Protection of Plant Varieties etc.
Products (=inventions) & Type of Legal
Protection:
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14
Invention/Product Legal Protection
Humira mAb, Gene Sequencers, PCR machine,
Pandyflu, Immuvac
Patent/ Trade Secret
Nescafe, FloFish/ARTSK_NII/ Gillette Soap Trade Mark
Maruti, Honda Model XXX Design Registration
Internet Explorer, Gene Sequences & Music Copyright
Coke, Techniques to generate enzymes Trade Secrets
Traditional Knowledge & New Plant Varieties Protection of Plant
Varieties Act
South Indian Saress, Bengal Cloth, Bikaneri Bhujia Geographical Indicators
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Research to Identify problems & Opportunities
Communicate & Advance
Test & Select Concepts
Develop Concepts
Ideation: Generate Ideas
Analysis & Synthesize Idea
Formulate Questions Innova
tion S
yst
em
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What is innovation?
“The process of translating an idea or
invention into a product or service that
creates value due to its’ utility or usefulness
for which customers will pay To be called an innovation, an idea must be
replicable at an economic cost and must satisfy a
specific need.
Innovation involves deliberate application of
information, imagination and initiative in deriving
greater or different values from resources, and
includes all processes by which new ideas are
generated and converted into useful products”.
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How do we innovate?
We use our Intellect to do so!
Those who innovate may become entrepreneurs.
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18
Proof of Concept Legal Protection
Validation In house Experimental Production
MARKET SALES
Components of Technology Management
Clinical Trials/Field Trials
Innovation & Enterprise Individuals/
Universities/ Key Players
Institutes/
Industries
Invention/ Technology
Investment
Enterprise/Start up Company
Royalty Reap the Fruits of Innovation if
the product is commercialized
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Contribution to Economy
IP
Protection/
Patents
How do we generate
Intellectual Property?
Research
Legal Protection/Patent
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Practical leads/
PoC/
Invention/Product
File a Patent/
License the
Technology; or
Sell Technology
Develop & Manufacture
Product (commercial activity)
Company/
Enterprise
20
En
trep
ren
eu
rship
Innovators desire or demand:
Legal protection for 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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Idea/Technology (Business preposition)
Start-up Company & Execute (Players, Team, Fund-raising, IP; know your roles & profit sharing)
Create Products (Players, Team, Fund-raising, IP; know your roles & profit sharing)
Grow as an Entrepreneur
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Innovations should be:
Purposeful
Affordable
Useful for an individual or society
Easy to use
Safe to use
Easy to manufacture
Approved by Society
Should have component of Corporate Social
responsibility
Unaffordable Price: At $28,000 a Vial,
Questcor Finds Profits??
An anti-inflammatory drug called H.P. Acthar Gel, used for
treatment of gout back in the early 1990s, and developed
in the 1950s by a division of Armour & Company, the
meatpacking company that once ruled the Union Stock
Yards of Chicago.
As in the 1950s, Acthar is still extracted from the pituitary glands of
slaughtered pigs — essentially a by-product of the meatpacking industry.
Acthar is used to treat infantile spasms, also known as West syndrome, a rare, sometimes fatal epileptic disorder that generally strikes
before the age of 1.
In 2007, it raised the price overnight, to more than $23,000 a vial, from $1,650, bringing the cost of a typical course of treatment for infantile
spasms to above $100,000. It said it needed the high price to keep the drug on the market.
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Inventions or Products; & Type of Legal
Protection: Products Legal Protection Glivec, Immuvac, Humira mAb, Samsung Galaxy
Gene Sequencers, PCR machine, Pandylfu : Patents
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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25
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Technology Management Process
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27
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
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Inventions or Products & Type of Legal
Protection:
Products Legal Protection Glivec, Immuvac, Humira mAb, Samsung Galaxy
Gene Sequencers, PCR machine,Pandylfu : Patents
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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34
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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35
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
16/4/2014 RD_UOK_April-2014 38
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
referred to;
(Source: http://ipindia.nic.in/ipr/patent/patact1970-3-99.html)
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Indian Patent Laws (Biotech)
Sec 2 (1) (j): Inventions (novelty, inventive steps & industrial
applications)
Sec 10(4)(d): Mandatory deposition of biological (A) to (D)
Materials in IDA & disclosing date & number of deposit at
Institution with proper characterization
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Exclusions of Patenting Biotechnological
inventions in India
Sec 3(b) : Morality/ethical issues
Sec 3(c) : Scientific principles, natural living/ non-living
Sec 3(d) : Mere discovery of known substance
Sec 3(e) : Mere admixture
Sec 3(h) : Agricultural/horticultural methods
Sec 3(i) : Method of human/animal treatment
Sec 3(j) : Human/animal in whole or parts
Sec 3(k) : Computer program
Sec 3(p) : Traditional knowledge
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IP Protection
1
2
3
4 6
7
5
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44
Caution: Applicable if the “Product is Great, Easy to Use & Affordable”
Dreams
Intellectual Efforts Generate Technologies
(i.e. generate IP)
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45
Technologies have been generated under two
types of Revolutions:
(A) Industrial Revolution
(B) Knowledge Revolution
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Scientific Eras & Technology
Generation
Industrial Growth Knowledge Driven Revolution
Biotech will
touch zenith
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Global Biotechnology Scenario
Europe : Knowledge based bio-economy
North America : Synthetic Biology
Asia/Pacific rim
/Latin America : Coming up as powerful players
India : Attempting to do all of above
Africa : Lags behind [Source: Current Opinions in Biotechnology, 23:827-829 (2012)]
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What We Need?
Innovations need platforms as they are emerging in the
world’s most advanced countries, and India has the
potential to capitalize on this platform as well.
In fact, our performance to date has been low. Nonetheless,
we observe a gradual change.
Our innovative_commercialization record has been weak; we have a limited
ability to harness risk capital; we have a shortage of critical, highly skilled talent;
and our slow regulatory approvals process could limit the pace of development.
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What we essentially need? (J&K)
Simple/ Affordable/ Mass utilization/ Incremental
Technologies related to silk-worm/ trout farming
Technologies to Improve Pashmina Goat breeding
Plant propagation/ Highly improved Varieties of Saffron
Micro-prospecting
Solutions for T.B./Infectious diseases/ Cancer Biomarkers
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Technologies/ Solutions
Societal Relevance/Simple solutions or
technologies
Incremental
Disruptive
Futuristic
Business Impact
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Inventions/Technologies
From Social angle (Social Impact)
Social : (=cheap, easy to use; “Jugaad”?)
From Scientific angle (Technical Impact)
Incremental: (=small but useful innovations)
Disruptive : (=great path-breaking inventions)
Futuristic : (=as used by space agencies)
From Business Angle (Business Impact)
Sustenance of economy
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Sta
ges
of
Tech
nolo
gy L
ife C
ycl
e
RPV=Remotely Piloted Vehicle
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53
[www.]
Disruptive Technologies
www: Our Constant Companion
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54
Imagine World without www at CERN
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.
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Oxford Nanopore Technologies Ltd.
is entering the gene-sequencing race
with a new portable device to
analyze DNA on the go.
The product, called MinION, is about
the size of a USB memory stick, the
closely held Oxford, England-based
company said today. MinION will be
ready for sale in the second half of
the year at a cost of less than $900.
It’s a smaller version of the GridION
device that Oxford Nanopore is
developing.
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Chemical Shield on Clothes and Fatigues
Clothes impervious to Coffee Stains and Biological agents
By a process called as Electro-spinning
U.S. Airforce + University of Michigan
(Source: J. American Chemical Society 13.2.2013)
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ASIA
Threatened Medicinal Plant Species in Asia
Mishimi teeta (Coptis teeta) (anti-inflammatory &
anti-bacterial).
Chirata (Swertia chirayita: anti-Hepatitis-B activity) have
highly localized ecological jurisdiction in the high altitude
regions of Eastern Himalaya.
Sarpangadha (Rauvolfia serpentina:anti-hypertensive &
anti-Schizopherinia) is another promising species of NE
India, but over-exploitation of the species from wild
habitat has obstructed the popularization of the species as
commercially cultivable crop
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"Shockwave technology could be applied to the tea
processing unit to help kill major pests, prepare land
for cultivation, minimise overall time of withering
and other costs in the tea factories“
A similar mechanism could be developed to treat
pests in orchards in Kashmir
Source: IISc Bangalore
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The invention of monel valves and their use in
the industry
The use of monel valves has increased over the past decade
as a measure to combat corrosive and unfriedly industrial
environments. Monel K500, Monel 400, A494 MR-35-1 are
often used in HF Acid applications.
The alloy used in Monel valves was
developed in the 1920s, the alloy is still
known as Monel alloy K-500 (http://www.super-duplex-valves.com).
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Use of Engineering Plastics for
Diagnostic X-ray equipment
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U_Mass, Amherst Chemical Engineers Boost
Petrochemical Output From Biomass By 40%
Chemical engineers at the University of Massachusetts
Amherst, using a catalytic fast pyrolysis process that
transforms renewable non-food biomass into
petrochemicals, have developed a new catalyst that boosts
the yield for five key "building blocks of the chemical
industry" by 40 percent compared to previous methods. This
sustainable production process, which holds the promise of
being competitive and compatible with the current petroleum
refinery infrastructure, has been tested and proven in a
laboratory reactor, using wood as the feedstock, the research
team says 16/4/2014 RD_UOK_April-2014 62
Arctic Groundbreaking technologies
The two recipients of the 2012 Spotlight on Arctic Technology Award, as it is
called, were Texas-based seismic solutions company ION Geophysical's under-ice
towed marine streamer and Transkor Group Inc.'s Aqua magnetic tomography
method (MTM).
ION’s towed marine streamer technology is designed for high latitude operations
and is used in a dual-vessel and icebreaker system. The polarclass icebreaker
clears a path for the seismic vessel, while the towing system prevents the
remaining ice from damaging the cables in tow, keeping them in the water even
under wind gusts of over 100 knots.
The technology is able to withstand extreme temperatures and pole magnetics, which not
only reduces damage to the equipment and to the quality of the data acquired but also
extends the traditional season for data acquisition in the Arctic and allows for such
acquisition to take place further north.
Transkor’s Aqua MTM technology is designed to assess offshore ferromagnetic pipelines
and determine the probability of stress-deformed state anomalies. It can inspect the entire
length of pipelines and detect pipe sags, strains and twists, boasting a rate of anomaly
detection of over 80 per cent. The inspection determines and reports the deviation of
a pipe material stress-deformed state and estimates the period of accident free operation
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Health & Medicine
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65
World's First Bionic Eye Approved for Use in
Europe [Video] | Fast ...
7 Mar 2011 ... bionic eye Could blindness soon be a thing of the
past? A California company called Second Sight recently
received approval in Europe to sell ...
www.scientificamerican.com/article.cfm?id=steps-owards...bionic...
Retina
16/4/2014 RD_UOK_April-2014 66
13.2.2013 (New York Times)
Latest Invention for the Blind from U.S.A :
The technique Allows blind to visualize
shapes
A Conversation With Nick Goldman Double
Helix Serves Double Duty http://www.nytimes.com/2013/01/29/science/using-dna-to-store-digital-information.html?ref=science&_r=0
A group of researchers at the European Bioinformatics Institute reported in the
journal Nature that they had managed to store digital information in synthetic
DNA molecules, then recreated the original digital files without error.
The amount of data, 739 kilobytes all told, is hardly prodigious by today’s
microelectronic storage standards: all 154 of Shakespeare’s sonnets, a scientific
paper, a color digital photo of the researchers’ laboratory, a 26-second excerpt
from the Rev. Dr. Martin Luther King Jr.’s “I have a dream” speech and a
software algorithm. Nor is this the first time digital information has been stored
in DNA.
But the researchers said their new technique, which includes error-correction
software, was a step toward a digital archival storage medium of immense
scale. Their goal is a system that will safely store the equivalent of one million CDs in
a gram of DNA for 10,000 years.
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Metal Hip Implants
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Metal Hip Implants
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70
Microsoft and the University of Washington are developing an electronic
contact lens that can non-invasively monitor and wirelessly report blood
sugar levels (Jan 5, 2012)
New Drug for Treatment of Tuberculosis 31.12.2012 (N.Y. Times)
A new drug, to be called Sirturo, was discovered by scientists at Janssen, the
pharmaceuticals unit of Johnson & Johnson, and is the first in a new class of
drugs that aims to treat the drug-resistant strain of the disease, has been
approved by FDA. (Dr. Anil Kaul of J&J)
“This is quite a milestone in the story of therapy for TB,” Dr. Paul Stoffels, the chief
scientific officer at Johnson & Johnson, said in an interview. He said the approval was
the first time in 40 years that the agency had approved a drug that attacked
tuberculosis in a different way from the current treatments on the market. Sirturo works
by inhibiting an enzyme needed by the tuberculosis bacteria to replicate and spread
throughout the body.
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FDA approves test that detects 11 causes of
infectious gastroenteritis from single sample January 16, 2013
The xTAG Gastrointestinal Pathogen Panel (GPP), manufactured by
Luminex, detects 11 viral, bacterial and parasitic causes of gastroenteritis,
including Clostridium difficile toxin A/B, Escherichia coli O157, Salmonella,
Shigella, norovirus, rotavirus A, Cryptosporidium and giardia. It is the
first test capable of simultaneously detecting each factor from a single
sample.
Approval for xTAG GPP followed results of a study comparing its
efficacy with that of individual tests that detected each cause of
gastroenteritis, incorporating data from 1,407 adult patients and 313
pediatric patients with suspected infectious gastroenteritis, as well as
203 patients with confirmed gastroenteritis. The xTAG GPP performed
comparably to individual tests. “The test could also allow clinicians
and public health professionals to more quickly identify and
investigate the source of potential gastroenteritis outbreaks.”
Merck tests needle-free vaccines •Suzanne Elvidge
Journal name: Nature Biotechnology; Volume: 30,, Page: 1155, Year published: (2012); DOI: doi:10.1038/nbt1212-1155a, Published
online , 07 December 2012
In October, 2012, the Whitehouse Station, New Jersey–based
Merck agreed to license a novel vaccine delivery system from
Sydney, Australia–based biotech Vaxxas, for testing with an
undisclosed Merck vaccine candidate. The biotech's Nanopatch,
needle-free delivery platform is a densely packed array
(>20,000/cm2) of 110-μm-long needles dry-coated with vaccine.
The antigens are…
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Bacterial shield for seeds Emily Waltz
Journal name:Nature BiotechnologyVolume: 30,Page:1158Year published:(2012)DOI:doi:10.1038/nbt1212-
1158aPublished online 07 December 2012
Agribusiness giant Syngenta will pay up to $113 million to acquire
Pasteuria Bioscience, a small biotech with a novel natural process to
control nematode pests in plants. Under the terms of the agreement, the
Basel-based Syngenta giant will acquire Pasteuria for $86 million, with
additional deferred payments of up to…
16/4/2014 RD_UOK_April-2014 74
Hand held Ultrasonic machine
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Diagnosing Malaria with one drop of body
fluid
Researchers from the Aarhus University in Denmark have developed a
new test to diagnose malaria infections very quickly and with a high
sensitivity. The test measures the activity of the enzyme topo-isomerase-I
from the Plasmodium parasite, which causes malaria.
The new method is based on a technology which the researchers call Rolling Circle Enhanced
Enzyme Activity Detection (REEAD). This method is able to diagnose malaria infection with
just a single drop of blood or saliva, and on top of that it has high sensitivity and no special training
is required to perform the test. Other features of the REEAD method are the
ability to detect the infection of less common malaria parasites and
measure whether the Plasmodium infection is resistant to drugs.
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Singapore based Veredus Laboratories announced the launch of its
VereMTB multiplexed lab-on-a-chip for the detection of various mutations of
Mycobacterium responsible for causing tuberculosis as well as nine other similar clinically
interesting mycobacterium. The chip identifies the specific mycobacterium within three (3) hours
after being presented with a sample of coughed up direct sputum.
The technology doesn’t require culturing the bacteria, a slow process that can
extend into days when rapid detection is key.
Veredus VereMTB Chip for Fast Diagnosis of
TB by Gene Ostrovsky on Nov 9, 2012
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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
handle (comfortable)
Dhara oil pack with an easy to remove seal
Table fork with a knife on edge
Drug eluting stent
Airport Baggage Handling on Ground
Honey manufacturing from Apiaries
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Innovations Having Social Impact Evolution of Camera
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Conclusion
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S.
N
o.
Status of
Technology
Method of Disposal Outcome
1. Societal/
Jugaad
Short tem life, but useful in daily life – should be used
due to cheap price, but safety precautions be
considered. Maternal & child health, Rickshaws, pens etc.
Useful
2. Disruptive Great use, great products, long life, really change the
world e.g., Cell phone, PCR, Vaccine, Pen drive sized Gene
Sequencers, Microwave for cancer cure, Space-crafts
V.V. Useful
3. Incremental Sustains Disruptive or incremental innovation, very
useful: new models of Phone or pressure cookers,
microwaves
Fairly useful/
maintenance)
4. Futuristic Concept of Cell phone was futuristic in 1960-70s; Cloud
computing for war or navigation is useful today; keep under
wraps for future use
Very thoughtful
5. Great
Business
Model for
any of the
above
Shampoo sachet, small packs of tooth paste.
Tata Nano had a bad business model/ Colgate tooth paste
had great business model
(Necessary for
money generation;
No one works for
charity)
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Take a Break, Relax & Look at
this!
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Technology Addiction
“I fear the day when technology
overlaps with our humanity. The world
will only have a generation of idiots." –
Albert Einstein
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“Everything should be made as simple as possible, but no
simpler.” Only a handful, however, have had the opportunity to discuss the concept with the physicist over breakfast. As an applied-
mathematics student at Harvard, Dr. Neumann had a two-hour breakfast with Einstein on Nov. 8, 1952. What the young math
student took away was a deeply held philosophy of design that has remained with him for six decades and has been his governing
principle of computing and computer security. “His biggest contribution is to stress the ‘systems’ nature of the security and
reliability problems,” said Steven M. Bellovin, chief technology officer of the Federal Trade Commission. “That is, trouble occurs
not because of one failure, but because of the way many different pieces interact.”
What is Intellectual Property? Def.
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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)
(http://www.earlyamerica.com/review/winter2000/jefferson.html)
India : Extension of British Patent Laws- Act VI of 1856
In India, during British era : modifications in British Labor Laws to protect
dissemination of technology related information to others (1942)
Patent Laws of India – Post Independence (1970, 2005)
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Industrial Property Rights Systems
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IPRS encourages the talented inventors
(=creators/innovators) to further industrial
development
Research & Investment
Essential Requirements/ Life Comforts
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Technology Generation
Industrial Revolution
Knowledge Driven Revolution
Ramifications of
Biotechnology
Will
Touch
Zenith in future
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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)
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Examples of IP Protection:
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PATENTS
Patents?
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PATENT: may be granted for a new (novel), non-
obvious (having inventive step), and useful (having
utility) invention
It gives the patent holder a right to prevent others from practicing the invention
(unless licensed by the inventor), for a certain period of time (typically 20 years from
the filing date of a patent application).
What are the Parts of a Patent?
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Abstract
Background of the Invention
Summary of the Invention
Figures with brief descriptions
Detailed description or “specification”
Fully discloses what the invention is
How it is made?
How it can be used?
Claim(s): sets the legal boundaries of protection
Independent
Dependent
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Step 1: Prior Art as home work?
Pace Maker Drug Eluting Stent
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Medication
Pore to release drug into blood vessel
Blood Vessel
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A Vaccine
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PANDYFLU vaccine
DBT-BIRAC Supported
Product - 2011
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GloFish®™
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Patents & IP Protection of our Works
“Patent protection does not result in owning the invention by the inventor but
protects, others from repeating the effort which has already been made”
Characteristics of a Patent :
Novelty : (=something new & different)
Inventive Step : (=non-obviousness)
Industrial Application : (=utility)
A patent has a life : 20 years
It has to be renewed periodically by payment of money
“ Patent System Adds fuel to interest to the fire of the genius”
Ref. to Indian Patent Laws !!
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Examples: Patents
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Pandyflu vaccine : (anti-flu vaccine: Panacea + BIRAC)
Immuvac : (anti-leprosy vaccine/immunomodulator: Cadila)
ARTSK_NII : (artificial wound healing membrane: NII)
Paracetamol : (pain killer)
Therapeutic Antibodies : (Humira)(auto-immune disorders)
Recombinant Banana?? (QUT + BIRAC)
Recombinant Cotton : (Textiles: Monsanto)
Straw Water Purifiers : (US Army)
K-Series Engine : (Motor Car)
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Novelty
1
2 3 4
Protein Adjuvant Vaccine
Cough
Syrup Excepients Cough Syrup
Perishable
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A
B
C
1
2 3 4
Protein
Adjuvant
+ Thimerosal
Vaccine
Cough
Syrup Excepients
Cough Syrup
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A
B
C
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Obviousness
Obviousness
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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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145
Green technology
Technology Management
&Transfer
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146
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147
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)>
Invention Disclosure
Assessment/ Screening
Patent Protection
Licensing & Monitoring
Technology Transfer
(Active Pharmaceutical ingredient> Drug Product(Dosage & Delivery Systems)> Analytic Methods> Stability)
Product Development & Commercialization
Revenue & Monitoring
(http://www.nii.res.in/faculty-06/RaviDhar.htm)
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University/
Institute/
Organization
Start-up Company
/Entrepreneur or a
Big Company
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150
Main Stages of Product Development
Activity:
1) Idea Generation
2) Idea Screening
3) Concept Development and Testing
4) Business Analysis
5) Beta Testing or Market Testing
6) Technical Implementation
7) Commercialization
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Management : Product Development
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
Studies)>
Invention Disclosure
Assessment/ Screening
Patent Protection
Licensing & Monitoring
Technology Transfer
(Active Pharmaceutical ingredient> Drug Product(Dosage & Delivery Systems)> Analytic Methods> Stability)
Commercialization
Revenue & Monitoring
(http://www.nii.res.in/faculty-06/RaviDhar.htm)
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Startup Company
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Organizations with Integrated Innovation & IP Management have High Quality (economically
valuable) Patent Portfolios
Patent Quality Impact on Performance
(+)
High Potential
(++)
Innovation
Leaders
Losers
(-)
Activists
(--)
(low) (high)
Patents/R&D Expenditure Ernst, 2008; Chicago
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Strike a Balance
!!!Word of Caution !!!
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GMCs
Raises Ethical/ Social or
Religious Issues !
International Trade
&
Trade Practices
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IP & International Agreements
Various treaties for different components of IPR
Paris Convention for Protection of Industrial Property (1883) Mother of all IPR harmonization Process. Revised several times; last
revision in 1967 followed by an amendment in 1979. Article 30 covers IPR
related to Patents etc.; 170 countries
Lisbon Agreement on Geographical indicators (1958)
Patent Cooperation Treaty (PCT), 144 countries (1970, 1984, 1989)
Budapest Treaty for Deposition of Microorganisms (1977)
(List in the Gazette of India; Part II; No. 456, New Delhi, May 30, 2003); 50 countries
Community Trademarks (1996)
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WTO & WIPO
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Uniform trade practices across nations regulated
by WTO. Organization which develops ground-rules for
international Commerce & mediates trade disputes.(153
members)
(Web Site : www. wto.org)
Uniform IP practices are regulated by WIPO. WIPO
is responsible for the promotion of the protection of
intellectual property throughout the world through
cooperation among States, .... (179 members)
(Web Site :www.wipo.int)
TRIPs
TRIPS agreement gives enough room for member
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
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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.
TRIPS
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Protection and enforcement of all intellectual
property rights shall meet the objectives to
contribute to the promotion of technological
innovation and to the transfer and dissemination
of technology, to the mutual advantage of
producers and users of technological knowledge
and in a manner conducive to social and
economic welfare, and to a balance of rights and
obligations.
Facts about Innovation Process
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Innovation should be of societal relevance
Innovation Process is uncertain
Many times it is unpredictable, more-so when related to Biological systems
Innovation process creates new competencies
Knowledge generation depends on a cumulative process that links prior knowledge in the economy
Various factors influence speed of innovation
Scientific discovery & Innovation is deeply linked
Innovation output has weak relationship with market demand
Biotech in India: Parameters
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Contributors to Indian Biotech-IP
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Funding Organizations (DBT/ICMR/ICAR/CSIR/Charitable)
Academic Partners (Public/Private/Industry/Academia/NGOs)
Industry
Private Sector
Technology Acquisition
Within a nation
Between nations
Strengths for Developing Technologies Strengths Quality of Basic Research
R& D Personnel Infrastructure
Quality of Business Facilitation
India
Low High
Needs Improvement
Low
U.S.A. V. High
V.High
Great
Great
Germany V. Good
V. High
Great
Good
Weaknesses Pharma & Chemical Industry
Exposure to Entrepreneurs
Personnel Mobility
Venture Capital Angel Investors
Permits/Licenses & Approvals No. of Pilot Plants
High/Ranbaxy Problem?
Lack experience
Very Low
V.Few
None
Slow Process
Lack of Proof +-
Low
V. High
High
Many
Many
Quick
Proof +++
High
Low
Low
Few
None
Slow
Lack of Proof+
Opportunities White Biotechnology/Industrial Biot. Maturing Biotechnology Firms
Low
Very Few
Accepted
Large numbers
Accepted
Yes
Threats Green Genetic Technology
Competition over High Potentials
Danger of Exodus of Key Industries
Commercialization Abroad
Competition to West
Clear Consumer Benefits Growth of Aged Population
Controversial Little
Debatable
Low
Yes: Drugs/ Fermentation
Products needs to be increased No : 60% youth
Applicable
V. High
Biotech Flourishing
Low
Yes/No (East)
High
Yes
Low Acceptance
Very High
High Danger
Yes; including Patents
Yes from East
Low
Yes
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SWOT (strengths, Weakness, Opportunities, Threats) analysis in Life Sciences
Western India : Revenues Rs. 12,137 Crores (=43% share) Aurangabad : Agri-/bio-manufacturing;
Mumbai : Bio-pharmaceuticals & Stem Cell Research;
Ahmedabad/ Baroda : Agri-biotech, Bio-pharmaceuticals, Enzymes,
Bio-information & Contract Research
Pune : Agri-biotech, Bioinformatics, Bio-processing,
Stem Cell Research & Vaccines
Southern India : Revenues Rs. 5084 Crores (=16% share)
Chennai : Bio-information, Bio-pharmaceuticals,
Genomics, Marine Biotech. 48 Firms Hyderabad : Vaccines
Mysore : Bio-diesel
Bangalore : Industrial Biotech
Northern India : Revenues Rs. 1453 Crores (=15% share)
Delhi/ Gurgaon/ Noida : Agri-biotech, Bio-fuels, Genomics
Lucknow : Bio-information & Bio-pharmaceutics 48 Firms
115 Firms
120 Firms
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Challenging Areas in Tech Management
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IP Mining
FTOs
Technology Mapping (BIRAC initiated this-2012)
Infringements
Licensing
Institutional IP policies
How to gel Public and Private effort ??
IP rights are being felt as a burden to innovation?
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Role of Public Private Partnerships
Government
BIPP/SBIRI
•Funding Agency Private
CRS/BIG
Charitable
•Academic Institution
•Industry
•CRO
•Marketing Agency
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Innovation/ Proof of Concept/ Product
Validation/Product Development/Sale
Deliberate on Royalty issues
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“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
•Indecision can kill your business •Freaking Out is Not a Management Style
•Need Money? A Few Links to Possible Investors •Are You Involved or Committed in a Startup?
•The best guru for entrepreneurship and startup for your company
•Networking is not a one sided activity
•Mergers and acquisitions take thought and planning
Taffy Williams is on Twitter by @twilli2861
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