©pganguli2002 presentations in the iim(amd) course july 3-4, 2003 prabuddha ganguli advisor...
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©pganguli2002
Presentations in the IIM(Amd) Course July 3-4, 2003
Prabuddha Ganguli
Advisor“VISION-IPR”
103 B SENATE, Lokhandwala Township,
Akurli Road, Kandivli East, Mumbai 400101
Tel: 91-22-28873766
e-mail: [email protected]
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Kn
ow
led
ge
acce
ss
gener
ate
application
tradeprotection
crea
te
IPR
The Knowledge Canopy
Info. security
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Rationale for IP Protection
• Organise in the best possible way human, economic and social relations thereby providing a framework for a fair distribution of the limited human resources available
• Stimulate creativity and inventiveness
• Protection for investments
• Recognition to inventors and enhance ethical standards in society
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Motivation for IP Protection and Management
• IPR Management helps to integrate the institution’s innovation process with a wide range of R&D partnerships
• Institutional IPR encourages partnership with other developers especially with SMEs in the innovation supply chain.
• Optimal use of extra-institutional knowledge. Avoid duplication and manage funs for R&D effectively
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Motivation for IP Protection and Management
• Create and retain R&D and Market Leadership.• Freedom to operate in a global environment• Enhance institutional image• Protection/Management of Institutional
Knowledge Assets• Competence and Knowledge Building• Earnings from innovations to pay for further
research and acquiring other technologies ( e.g. structuring contracts, licensing and cross-licensing)
• Contribute to long term growth
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A PATENT IS A GRANT BY
SOVEREIGN OR STATE TO A
PERSON GIVING EXCLUSIVE RIGHT
TO “MAKE., USE EXERCISE AND
VEND” AN INVENTION FOR A
LIMITED PERIOD, IN EXCHANGE FOR
DISCLOSING IT IN A PATNET SPECIFCATIONSuch that any one trained in the art can reproduce the invention.
RIGHT TO EXCLUDE OTHERS USING YOUR INVENTION
OWNER HAS A QUALIFIED RIGHT TO USE THE INVENTION
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TODAYYESTERYEARS
RESEARCH MODELS
TOMORROW…….
ISSUESRESEARCH PROCESS“APPROACHES”SOCIETAL IMPACTKNOWLEDGE OWNERSHIPBENEFITS SHARING
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YESTERYEARS
RESEARCH MODELS
Typically ConceptualState Funded Institutions“Open-Ended” Knowledge GenerationEnrichment of “Public Domain knowledgeCredits: Enhanced Peer Recognition
Typically ApplicationsPrivate Funded InstitutionsTargeted End PointsOptimised use of “Public Domain Knowledge”Value Addition as measure of competitive edgeProfits,Market dominanceProprietary Issues
UPSTREAM RESEARCHDOWNSTREAM RESEARCH
TODAYTOMORROW.
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TOMORROWYESTERYEARS
RESEARCH MODELS
TODAY
Partial Funding By Private Enterprises in Upstream ResearchIssues on knowledge FlowBenefits SharingPublications Research Schemes, Peer Group Recognition etc.Free use by Funding AgencyDiffused Ownership
MIDSTREAM
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TODAYYESTERYEARS
RESEARCH MODELS
TOMORROW…….
Blurring of boundaries between Upstream & Downstream ResearchOverlap between disciplinesQuantification of OwnershipFormalized benefit Sharing by PartnersOverlapping Claims by different ownersChallenges to Ownership CriteriaAnti competition or Monopolistic Issues
IRP Multi-tier innovation processOptimized use of global knowledge base
Intra-Enterprise resourcesExtra-Enterprise inputs
Global/National licensing issuesIntricate exclusive/non-exclusive benefits SharingOrganisational frameworks for rapid diffusion of innovation to business
TURBULENCE RAPIDS
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Demand for Patents Worldwide
9586045
7114126
5899089
4461369
3434628
23068401965487
1595950
1785760
2774582
593882
721657624495
640202
826572
751046702280
683874
685382
629611
0
1000000
2000000
3000000
4000000
5000000
6000000
7000000
8000000
9000000
10000000
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
First Filings
Total Filings
Ref: Intellectual Property Rigths.. Unleashing the Knowledge Economy P. Ganguli ( Tata McGraw Hill, New Delhi 2001)
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Annual Patent Globalization Index (PGI)
0
2
4
6
8
10
12G
lob
aliz
atio
n I
ndex
PGI 1.69 1.86 2.66 3.34 4.01 5.5 8.85 10.59
1991 1992 1994 1995 1996 1997 1999 2000
PGI = (Total Number of Patents Filed Worldwide) - (Number of First Filings Worldwide)(Number of First Filings Worldwide)
Ref: Intellectual Property Rigths.. Unleashing the Knowledge Economy P. Ganguli ( Tata McGraw Hill, New Delhi 2001)
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CK
1CONCEPTS PRODUCTS
CK
4CK
3
CK
2
CK
5
Route 1
Route 2
PROTECTED TOOLS, SOFTWARE, REAGENTS, GENE FRAGMENTS, SPECIALITY MATERIALS, LINKED TECHNOLOGIES , OF VARIOUS
KNOWLEDGE OWNERS
Check Posts on the Innovation Highway
Check Posts
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Case Studies• Honeywell in 1993 won $ 96 million from
Minolta for infringement of Honeywell’s auto-focus technology for cameras. Then got licensing deals worth $ 400 million from other manufacturers.
• Historic judgement of 1990 . Polaroid awarded $ 900 million from Kodak. Of this $455 was as lost interest on the damage of $ 454.
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Case Study
• Fonar vs. General Electric (small v big)Fonar filed several patents on Magnetic Resonance Imaging Techniques in 1970s.Subsequently GE and Hitachi entered the marketFonar filed infringement suits.Hitachi reached out of court settlements.GE in 1995 was ordered to pay $ 128.7 million. Interestingly Fonar’s annual revenue was only $17 million.
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Case Study
• Fonar vs. GEBasis of damages calculation :Fonar claimed lost profits for 600 MRI instruments.After argument from both sides the judge concluded the Fonar could sell only 75 instruments.
• Award therefore on lost profits for 75 instruments @ 371,000 per machine and royalty for 575 machines @ 65,000 per machine.
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Technology has g
enerally
prece
ded Law
Law has always been challenged by TechnologyLaw has been changed to accommodate technology change and societal needs
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Some Landmark JudgementsDiamond v. Chakravarti (in a matter dealing with biotechnology; 447 US 303 [1980])Diamond v. Diehr (concerning patenting of computer related inventions; 450 US 175, 209 USPQ97 (1981))State Street Bank & Trust Co v. Signature Financial Group (related to patenting of business methods; 47 USPQ 2d 1596 [Fed. Cir.1998], cert. Denied (US 1999 No. 98-657) Silhoutte International Schmredgesellschaft mbh & Co v. Hartlauer Handelsgesselschaft mbh ( related to parallel imports; 1998 in ECJ)
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CONCEPTS INNOVATION PROCESS
OUTPUT MARKET
B
usi
nes
s O
pp
ort
un
itie
sT
ech
no
log
y O
pti
on
s(
map
pin
g e
xerc
ise
)S
trat
egic
Op
tio
ns
W
ork
ing
th
rou
gh
th
e IP
gri
dP
aten
ts &
oth
er IP
R
Fili
ng
s/R
egis
trat
ion
sS
trat
egy
for
Fo
reig
n F
ilin
gs
L
icen
sin
g O
pti
on
sJo
int
Dev
elo
pm
ents
F
it in
IPR
Po
rtfo
lioM
arke
tin
g t
ieu
ps
P
rod
uct
Lif
ecyc
leM
anag
ing
IPR
Po
rtfo
lioM
on
ito
rin
g IP
RP
olic
ing
IPR
E
nfo
rcin
g IP
R
Record Maintenance & Updating IPR Information
Managing Intellectual Property
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Dissecting a PatentTEXT
OBJECT OF INVENTION
PRIOR ART DISCLOSE / DESCRIBE INVENTION EXAMPLES WITH SUPPORTING DATA
CLAIMS DEFINING THE MONPOLY CLAIMED THIS HELPS IN THE FINDING OF WHAT CONSTITUTES INFRINGMENT
ALSO SEPARATELY INCLUDE DIAGRAMS / FORMULAE IF NECESSARY IN THE SPECIFICATION. BUT NOT IN THE MAIN TEXT.
NOTE: What is disclosed and not claimed is effectively disclaimed
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PATENT DOCUMENT
BIBLOGRAPHIC INFORMATION
TEXT WITH DESCRIPTION & CLAIMS
DRAWINGS
ABSTRACT
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Patent Document
PRIOR ART
- PUBLIC (NOT PRIVATE) KNOWLEDGE
- LITERATURE - PATENT SPECIFICATION
- TEXT BOOKS
- BORCHURES
- JOURNALS
- LECTURES
- BROADCASTS
- PRODUCT SALES
- USE IN PUBLIC
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Patent Document
- Must be in a patent specification in such a way as to enable person trained in the art to practice the invention
- Beware:
- Disclosing too little is a ground for refusal of the patent, for opposition or for revocation.
Disclosure :
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BIBLOGRAPHIC INFORMATION
COUNTRY OF PUBLICATION NATIONAL PATENT CLASSIFICATION INT. PAT. CLASSIFICATION TITLE ABSTRACT INVENTOR APPLICANT APPLICATION NO. SERIAL NO. OF PATENT DATE OF APPLICATION PRIORITY DATE PRIORITY NO. PRIORITY COUNTRY REFERNCE CITED BY EXAMINER
Patent Document
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Patent DocumentWHY GOOD INFORMATION SOURCE
WELL STRUCTURED DOCUMENTS COVERS ALL FIELDS
CLASSIFIIED, INDEXED AND RETRIEVABLE DATABASES
FIRST APPEARANCE OF NEW TECHNOLOGIES
LARGEST SINGLE SOURCE
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Broad Format of a patent document ( an example )
OBJECT OF THE INVENTION
* THE INVENTION RELATES TO COSMETIC COMPOSITIONS FOR PROMOTING LIGHTENING OF THE SKIN
PRIOR ART
* J INVEST.DERMATOL AZELATIC ACID INHIBIT MELANIN BIOSYNTHESIS
JP 59157009 ASCORBIC ACID STERATE + HYDROQUINONE (UNSAFE)
DEFENITION OF THE INVENTION
* THE INVENTION PROVIDES SYNERGISTIC COMPOSITIONS SUITABLE FOR TOPICAL APPLICATION TO HUMAN SKIN, COMPRISING DICARBOXYLIC ACIDS/ESTERS/SALTS IN A COSMETICALLY ACCEPTABLE VEHICLE.
EXAMPLE
COMPOUND A gives lightning by 23%COMPOUND B gives 60% " do "
ADDITIVE A+B gives 83% if the compounds behaved independent of each other. SYNERGY gives 90% experiment result obtained by a formulation containing A & B in the ratio of 1:1
MAIN CLAIM:
A COSMETIC COMPOSITION FOR LIGHTENING SKIN COMPRISING 1 TO 25% DICARBOXYLIC ACID(S)/ ESTERS/SALTS, 1 TO 20% ASCORBIC ACID/ESTERS/SALTS, 0.1 TO 5% VITAMIN E OR ITS DERIVATIVES BY WEIGHT OF THE COMPOSITION
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Patenting life forms• It should not be forgotten that Louis Pasteur was
awarded U.S Patent Number 141,072 in 1873 for a yeast
• A man-made of microorganism was awarded in 1980. The US Supreme Court took a historic 5-4 decision in the case of Chakrabarty v. Diamond for the genetically engineered Pseudomonas aeruginosa bacterium that is capable of breaking down the four major components of crude oil.
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Patenting life forms
• The next major discontinuity in this direction was the award U.S Patent Number 4,736,866 for the “Harvard onco mouse” to Philip Leder and Tinothy A. Stweart of Harvard University on April 12, 1988. The claim in this patent was “ A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into the said mammal, or an ancestor of the said animal, at an embryonic stage.”
• In a recent decision in Canada onco mouse failed to get as patent in Canada
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Patenting of life forms
• The rat race continued and at least 16 patents have been awarded on inventions related to transgenic mice as models exhibiting specific pathologies such as ulcers, polio, Parkinson’s syndrome, inflamation, sickle cell anemia, Alzheimer’s Disease, Neuronal HIV infection, Cutaneous melanoma, Leukemia, Thrombocytopenia, etc.
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Patenting of life forms
• The patenting movement then took on to higher order animals with one of the first patents to be issued was U.S. Patent Number 5,476,995 for an invention that claimed a transgenic sheep that expressed the transgene in the mammary gland so as to produce the target protein in its milk. Since then there has been a spate of patents expressing diverse proteins in pig, sheep, goat, cattle (Fibrinogin, Protein C), Sheep (Blood coagulation), mouse (human antibodies), pig (human hemoglobin ) etc
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Hello Dolly !!!
• In January 2000 PPL Therapeutics, with Roslin Institute and Geron Corporation were granted two UK patents covering [March 2000 Volume 18 Number 3 pp 256 – 257]
the methodology of nuclear transfer using a quiescent donor cell to produce cloned nonhuman animals and animal (human or nonhuman) cells (GB2318578), as well as
the embryos, animals, and cell lines made using the technology (GB2331751). his technology resulted in the wold’s first cloned animal (the sheep Dolly).
• This technology does enable the cloning of a human embryo (and its growth to an early blastocyst stage), and the UK patent grants rights of ownership to those embryos.
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Share of Patents Claiming DNA Sequences in Plant Species
Others12%
Europe23%
Japan19%
USA45%
Data Source : Nature 399, 405 - 406 (1999)
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Patent Applications claiming DNA sequences
in Plant Species
0%
5%
10%
15%
20%
25%
30%
35%
40%Maize
Cereals and pulses
Fruits and Vegetables
Oilseeds and ModelPlantsFibres,beverages,herbsand spices
Data Source : Nature 399, 405 - 406 (1999)
% o
f A
pp
li ca t
i on
s fi
led
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Nutrition (20%) : Genes that determine the amount or type of sugar starch, oil or protein in
the plant, encode enriched proteins, and reduce the level of allogenic proteins in rice.
Pathogen resistance (20%) : Encode a wide variety of enzymes including
chitinases.
Regulatory DNA sequences (18%): Transcriptional promoters are
claimed that are in general tissue-specific. The gene sequences regulated by these promoters are also claimed in some cases.
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Plant development, :Several concern modification of Male sterility (18%) reproduction and ethylene
production and the extent and pattern of flowering
Herbicide tolerance( 7% ) : Genes encoding glutathione S-transferase IIIc, acetolactate
synthase, lycopene cyclase and a protein conferring glyphosate resistance. The complexity of gene function is well illustrated by the acetyl- CoA carboxylase gene, which confers herbicide tolerance in monocotyledon but is claimed primarily for regulating oil content.
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New Guidelines by USPTO for Patenting of Genes
• www.access.gpo.gov/su_docs/aces/fr-cont.html
• A gene can be patented but it must have a specific use. To show utility the applicant must show it had a credible and specific use(s)
• One of the features is that it must demonstrate a substantial use. This would hopefully restrict the patenting of frivolous attempts to patent genes.
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EUROPEAN BIOTECHNOLOGY DIRECTIVE
“DIRECTIVE ON THE LEGAL PORTECTION OF
BIOTECHNOLOGICAL IVENTIONS”
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DEFINITIONS
• BIOLOGICAL MATERIAL– Any material - containing genetic information and
capable of reproducing itself or being reproduced in a biological system. [Article 2.1a]
• A MICROBIOLOGICAL PROCESS– Any process involving, or performed upon or resulting in
a microbiological material [ Article 2.1 b]
N.B: - Microbiologically process are contrasted with
“Essentially Biological Process”.
- Essentially Biological processes for production of plants & animals are specifically excluded from patentability
[Article 4.3]
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PATENTABLE
PATENTABLE - NOVELTY, INVENTIVENES &
[ARTICLE 3.1] INDUSTRIAL APPLILCABILITY
even if they comprise of
BIOLOGICAL MATERIAL or
ARE PRODUCTED BY MEANS OF A
MICROBIOLOGICAL PROCESS
- where material is isolated from its natural environment or produced by means of a technical process, it may be the subject of an invention even if it previously occurred in nature [Article 3.2]
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PATENTABLE
PATENTABLE [Article 5.2]• Elements isolated from the human body [including gene
sequences & partial gene sequences] despite the fact that the isolated gene is identical to its naturally occuring counterpart.
WHY?• Because identification, purification & classification of a
gene & the reproduction of it outside the human body requires techniques & intellectual inputs.
HOWEVER
• Such inventions must disclose industrial applicability
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EXCLUDED FROM PATENTABILITY
• Plant & animal varieties and essentially biological process for production of plants & animals.– Essentially Biological Process. One which
consists entirely of natural phenomena such as crossing or selection
• Human Body at any stage of its formation or development including germ cells
• Simple discovery of a human gene without reference to specific function of gene or its protein
• Inventions on grounds of public morality.
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EXCLUSIONS
• Use of human embryos for commercial purposes. These exclusions do not affect inventions for diagnostic or therapeutic purposes which are applied to the human embryo for its benefit. Techniques for the coloring of non-human animals are excluded.
• Process for
– Cloning Human Beings
– Modifying germ line identity of Human Beings
– Modifying genetic identity of animals which are likely to cause them suffering without any substantial benefit to man or animal. Animals resulting from such modifications are excluded from patentability.
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SCOPE OF MONOPOLY OF BIOTECH PATENT
• Encompasses biological material obtained from propagation or multiplication of protected material.
• For patented Biotech process. Biological material produced will be protected, as will further material derived by propagation or multiplication from it.
• Protection conferred by a patent on product or process which contains or consists of genetic material extends to all material in which the product is incorporated.
eg : - A Patent for a specific animal gene will also protect the cell lines or tansgenic animals in which that gene is maintained and propagated. - A patent which claims a transferred plant cell will also cover the living plant of which it is part.
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MONOPOLY EXCEPTIONS
• PROVISIONS BENEFITING FARMERS– Farmer may propagate biological material obtained with
consent of the patentee only for his own farming activities. This does not apply when this is done for commercial purposes.
– Plant varieties are excluded from Patentability.
– If it is not possible to exploit a new plant variety without infringing prior existing patent, the Directive provides that a compulsory non exclusive licence should be granted.Similarly where a biotechnological invention cannot be exploited without a prior plant variety right the above provision should be invoked
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ETHICAL ISSUES
• These are addressed through recitals and are not in operable part of the directive.BIOPROSPECTING ISSSUES
• Patenting relating to biological natural derived from plant or animals should state the geographical place of origin of the material, if this information is known. However non reporting will not affect processing of patent application.
• When a patent covers biological material of human origin, or a use for that material, the person from whose body the material is taken must have had an opportunity of expressing free & informed consent that take up in accordance with national law. This is not expressed to be without prejudice to the validity of
rights arising from the granted patent.
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OBJECTIVES
• SCOPE OF LEGAL PROTECTION AVAILABLE TO BIOTECT PRODUCTS, PROCESS
• ENSURE LAW OF PATENTABILITY IN BIOTECH INVENTION HARMONISED ACROSS EUROPE IN PATENT OFFICES AND NATIONAL COURTS.
CONCERN - MORAL DIMENSIONS (?)• WILL THIS RESTRICT FREE FLOW OF INFORMATION BETWEEN
BIOTECH RESEARCHERS.
• WILL INDUSTRY MONOPOLISE BIOTECT PRODUCTS/ PROCESS THAT ARE CONTRARY TO HUMAN RIGHTS.
• WILL SUCH METHODS / TECHNIQUES INTERFERE WITH THE PROCESS OF HEALTH INSURANCE