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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: ramugang@vsnl.com

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Session 1

Analytical Framework

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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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Key issue : Ownership of Knowledge

versus

IPR plays a decisive role

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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

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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

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anag

ing

IPR

Po

rtfo

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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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Beware !!!!Beware !!!!

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Session 2

Patent Drafting

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Invention to satisfy

• Novelty

Non-Obviousness

Utility

to qualify for a patent

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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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Session 3

Biotechnology Directive

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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