K.SAI SANTHOSH

RAM/13-50

SEED SCIENCE & TECHNOLOGY

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property

Land and building

Gold and cash

Intellectual

Trade

It is property that you can’t see.

It is not real property (land) or personal property (things).

It is property that can only be perceived by the intellect.

Like Real Property:

It can be bought, sold, licensed, exchanged, given away.

The owner can prevent unauthorized use.

Not simply knowledge or discovery.

A range of property rights accorded to “creations of the

mind”.

Intellectual activity resulting from the industrial, scientific,

literary or artistic fields.

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Intellectual Property Rights

IPRs refers to “the legal ownership of by a person or

business of an invention/ discovery attached to a

particular product/ process which protects the

owner against unauthorized copying or

limitation.”

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Basic objectives of balanced IP Protection- To

Acknowledge & appreciate the creativeexpression.

Empower creative persons.

Promote innovation through exclusive rights.

Public disclosure to expand knowledge stock.

Support for markets in technology.

Support diffusion and incremental innovation.

Technology specialists can induce the larger firmsto license as well.

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The Role of IPRs

Copyright

Patents

Plant breeder’s rights(PBR)

Trade secrets

Other IPs Geographical Indications

Trade marks

Industrial Designs

Integrated Circuits

Plant Varieties protection

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Nature of IP.

Pace of Technology Development.

Associated Costs.

Security Considerations.

Need to show Inventions

Duration of Protection.

The Type of Protection Sought.

Definition:

The bundle of exclusive rights granted to the authors/creators of original works of expression that are fixed into a tangible medium

Exclusive Rights:

Right to reproduce

Right to make derivative works

Right to distribute

Right to publicly display and perform

Right to perform sound recordings publicly by means of digital audio transmissions

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EXAMPLES: 1.Authored and edited books.

2.Audio and Video Cassettes.

3.In Biotechnology the Copyright may cover DNA sequence data that may be published

Computer software has been included under the (Information Technology Act 2000)

The copy right is limited both in time and extent.

Does not prevent another person from using either idea

or the information contained in a copyright material.

Any word, symbol or device (or combination) that

differentiates a company or individual’s products and

services from competitors.

Symbol helps the consumer to identify products of a

particular company.

Mark must be used in connection with public distribution of

goods or services to secure legal rights.

Marks is the symbol is directly related to the company.

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The possibilities are almost limitless.

Trademarks may be one or a combination of

words, letters, and numbers.

They may consist of drawings, symbols, three-

dimensional signs such as the shape and

packaging of goods, audible signs or colors used

as distinguishing features.

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An exclusive right given to an inventor by the government toexclude others from imitating, manufacturing, using or sellingthe invention in question for commercial use for specified time.

There are three kinds of patents:

A utility patent on the functional aspects of products andprocesses;

A design patent on the ornamental design of useful objects;

A plant patent on a new variety of a living plant.

Patents do not protect idea, structures and methods

that apply technological concepts.

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1856 Act for protection of inventions on the basis of British law of 1852

1859 Patent monopolies called exclusive privileges (14 year)

1872 Patents and Designs Act

1883 Protection of Inventions Act

1888 Inventions and Designs Act

1911-1947 Modern patent era by Patents and Designs Act. First time an

authority call Controller General of Patents appointed

1959 Justice Ayyangar’s report

1967 Patent Act bill introduced in the Parliament

1970 The Patents Act passed by the parliament

1972 The Patents Act-1970 came into force on April 20, 1972

1994 Amendment by ordinance to include Exclusive Marketing Rights (EMR’s)

1999 Amendment passed by the parliament. New patent amendment bill referred to select committee

2003 Patents Act 1970 with second amendment comes into force

2005 Patent Act 1970 (2005 Amendment) comes in to force from 1-1-2005

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◦ Novelty.

◦ Inventiveness.

◦ Industrial application and usefulness.

◦ Patentability.

◦ Disclosure.

Exclude others from making, using or

selling the patented invention for up to 20

years.

may be licensed or sold.

does not prohibit non-commercial research.

In return for full public disclosure of

invention (when filed) and contribution to public

domain at expiry of patent term.

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Rewards time, money & effort associated withresearch.

Stimulates further research as competitors invent

alternatives.

Encourages innovation and research by permitting

companies to recover R&D costs during period of

exclusive rights.

Limited term encourages quick commercialization.

Patents allow early exchange of information between

research groups.

Avoiding duplicate efforts. Increasing general pool of

public information.

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Limitation of time

Limitation of space.

Usually the biotechnology applications comprise the claims

relating to the following subject matters:

(a) Polynucleotides or gene sequences (product and/or process),

(b) Polypeptides or protein sequences (product and/or process),

(c) Vectors (e.g., plasmids) (product and/or process),

(d) Gene constructs or cassettes and gene libraries,

(e) Host cells, microorganisms and stem cells (product and/or

process),

transgenic cells,

(f) Plants and animals tissue culture (product and/or process)

CLAIMS OF BIOTECHNOLOGICAL INVENTIONS

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(g) Pharmaceutical or vaccine compositions comprising microorganisms,

proteins, polynucleotides (product and/or process),

(h) Antibodies or antigen binding fragments thereof (monoclonal or polyclonal),

(i) Diagnostic kits and tests, and

(j) Diagnostic tests (products/process) such as a test for the detection of a

mutation in a gene/protein which might be associated with a particular

condition such as protein expression or a disease.

Are biotechnological inventions patentable ?

◦ New / novel

◦ Inventive step

◦ Industrial application

◦ Law of the land (non patentable inventions - Morality)

◦ Written Disclosure + Special disclosure requirement

◦ Deposit of Biological Materials

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◦ Biological material isolated from its

natural environment or human body or

produced by a technical process

◦ The industrial application / function of a

genetic material (eg : sequence or a partial

sequence of a gene) must be disclosed in

the patent application

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In US, there are three forms of protections for

plant related inventions. These are

◦Utility patents,

◦ Plant patent act(PPA),

◦ Plant variety protection act(PVPA)

Patenting of plant related inventions

• But under section 3(j) of Indian patents act 1970 plants are not considered patentable subject matter under section3(h) of the act, and method of agriculture and horticulture are not patentable. Similarly, essentially biological processes for the production or propagation of plants or not patentable under section 3(j)

• Plant varieties may be protected in India under PPVFRA which has recently came into force.

S.No PATENT

NUMBER

TITLE

1 US5,024,944 Transformation, somatic embryogenesis and

whole plant regeneration method for glycine

species

2 US5,986,181 Transformation and regeneration of fertile

cotton plants

3 EP910239 Transformation of cotton explant with

Agrobacterium

4 WO0042207 Transformation of a soybean germline with

Agrobacterium

Patents related to transformation of dicot plants

S.No PATENT

NUMBER

TITLE

1 US6,720,488 Transgenic maize seed and method for

controlling insect pests

2 WO05096806 Edible vaccine in the form of rice

3 AU3402897 Transformation of wheat with

Agrobacterium

4 AU7134298 Transformation of sorghum with

agrobacterium/pioneer hi-bred

Patents related to transformation of monocot plants

PATENT AWARDED TO SUBJECT OF PATENT

W.R. Grace and Co. All transgenic cotton

DNA plant Technology All transgenic pepper

Enzo Biochem, Inc. Antisense RNA

Technology

Mycogen Corp. Any method of modifying

the cry gene of

B.thuringiensis

r –DNA technology

Micro organisms

Vaccines

Polymerase chain reaction (PCR)

DNA/RNA and protein sequences

DNA sequencing methods

Hybridoma technology

Stem cell technology

Plant tissue culture

Genetically modified plants and animals

Cloning of animals, such as dolly and many more

Method of transforming cells or complete biological

entity such as microbes, plants are animals.

Methods of cloning and expression of desired genes

in the same or different cells.

Method of optimizing gene expression to produce

useful therapeutic proteins.

Method of producing transgenic plants or animals.

Method of screening and detection of specific DNA

sequnces.

Method of designing probes, primers, recombinant

vectors.

Different cloning vehicles (vectors) such as

plasmids, cosmids, phagemids, etc.

Probes, primers and oligonucleotides.

Vaccines and other useful proteins.

Transgenic / genetically modified organisms.

A gene is a structural unit of inheritance in living organisms.

For patenting of DNA/RNA sequences the following steps should be undertaken:

1.Identify novel genetic sequences.

2.Specify the resulting product from the sequence.

3.Specify how product functions in nature(use).

4.Enable one skilled in the field to use the sequence for its stated purpose.

◦ DNA sequence

◦ cDNA sequence

◦ Expressed sequence tag (EST)

◦ Single nucleotide polymorphism.

(note: meet the above mentioned criteria of

patentability)

The patenting of genes and/or DNA sequences is

popular in the US and EU.

In india , no product patent protection of DNA/RNA

or genes per se was allowed till January 2005.

This is an important area of research in plants.

Patentable things under this category are

◦ Transformation techniques

◦ Regeneration protocols

◦ Explants

◦ Transformation vectors

◦ Selectable marker genes

◦ Reporter genes

◦ Promoters and enhancers

◦ Genetically modified plants

Patents in the area of biotechnology have beciome very important in recent

years.

The basic criteria for patentability are three fold:

◦ Novelty

◦ Inventiveness

◦ Industrial appilication.

Patents of microorganisms , genes, genetically modified plants and animal

have generated a lot of debate in many countries.

The latest amendment has mandated india to grant product patents for

genes, drugs, and microorganisms, and most of the other biotechnological

inventions.

Regarding protection of plant varieties, India choose to opt for the sui

generis system for protection of plants and plant varieties by enacting the

protection of plant varieties and farmers right act 2001(PPVFRA).

PPVFRA may be granted for plant varieties which

have Novelty and exhibit the characteristics of

distinctiveness, uniformity, stability.(DUS)

This PPVFRA act recognizes farmers as

◦ Innovators

◦ Conservers

◦ Breeders

◦ Preservers

◦ cultivators of plants and plant varieties.

Headquarters : Geneva

UPOV : 54 Member countries

Conventions : 1961,1972,1978,1991

The concept of breeders rights, researchers

exemption and farmers privileges

Successive changes in UPOV made it more in

favour of breeders/ companies

Technical guidelines developed for 200 species

Passed by Lok Sabha on 9th August, 2001

Passed by Rajya Sabha on 28th October, 2001

Assented by the President of India on 30thOctober,2001

Act no. 53 of 2001The Protection of Plant PPV&FR Varieties and

Farmers’ Rights Rules, 2003

Major spheres of activity of PPV&FR Act, 2001

To provide for the establishment of an effective system

for the protection of plant varieties, the rights of

farmers and plant breeders and to encourage the

development of new varieties of plants;

Protection of farmers rights : With respect of their

contribution made at any time in conserving,

improving and making available plant genetic

resources for the development of new plant varieties;

Protection of Plant Breeders rights : To stimulate

investment for research and development both in

public and private sector for the development of new

plant varieties for accelerated agricultural

development.

Registration Voluntary & to be allowed for:Plant Breeder’s VarietyExtant VarietyFarmer’s Variety Plant Breeder’s Variety to satisfy the NDUS

conditions Extant Variety & Farmer’s Variety to satisfy only

DUS conditions Allows Researchers exemptions and Breeders rights Essentially Derived Varieties registration requires

specific approval Allows elaborate farmers’ rights Period of protection : 15 years for annuals, 18 years

for trees & vines

PPV&FR Authoritywww.plantauthority.gov.in

Gazette notification on 11th Nov. 2005Mandate1. Registration of plant varieties2. Characterization and documentation of registered

varieties3. Documentation, indexing and cataloguing of

farmer’s varieties4. Providing compulsory cataloguing facility for all

plant varieties5. Ensuring that seeds of all registered varieties are

made available to farmers6. Collection of comprehensive statistics on plant

varieties, Maintenance of National register of Plant variety.

Breeders rightsAct shall confer an exclusive right on thebreeder or his successor, his agent or licenseeto produce, sell, market, distribute, import orexport the variety.

Researchers exemptionsAny variety registered under this act will beallowed for conducting experiments orresearch and using it as an initial source forcreating other varieties.

Plant breeders rights are the rights

granted by the government to a plant

breeder, originator of a variety to exclude

others from producing or

commercializing the propagating material

of that variety for a minimum period of

15-20 years.

1.The opportunity to breeders of obtaining profits from

varieties developed by them will act as an incentive in

promoting plant breeder research.

2. It encourages private companies to invest in plant

breeding activities.

3.It will enable access to varieties developed in other

countries and protected by IPR laws.

4.Inceased competition among various organizations

engaged in plant breeding is likely to be beneficial to

both the farmers and the nation.

PBR will encourage monopolies in genetic material for specific traits.

It suppresses free exchange of genetic material and may encourage unhealthy practices.

The holder of PBR may produce less seed than the demand in order to increase prices for achieving more profit.

Farmers privilege to resow the seed produced by him may become diluted/eliminated.

PBR may increase cost of seed which will burden to the poor farmers of India and would limit the benefits from new varieties.

1.Right to register traditional varieties.2.Right to sell seed.

3.Right to reward and recognition.

4.Protection against innocent infringement.5.Right to information.

6.Benefit sharing for use of biodiversity conserved by farming community.

Trade secret is any information that gives a company

a competitive edge over competitors and which the

company maintains a secrete and away from public

knowledge

EXAMPLES:

1.Coco Cola company brand syrup formula.

2.polaroid company instant film chemical formula.

3.KFC.

They are for unlimited duration .

It is not necessary to satisfy the rather stringent

requirements for protection under patents.

The cost of filling, contesting and enforcing patents is

saved.

The risk of someone improving upon the product,

process, etc. is minimised.

Indications which could be used to recognize that a

good has originated in a particular locality where the

given quality reputation of the good are essentially

attribute to its geographical origin.

EXAMPLES:

1.Scotch whisky,

2.California wines,

3.Tuscany Olive oil,

4. Champagne.

The term “Geographical indications” signifies that a product

originates in a country or specific locality where it has been

traditionally produced

GIs are defined as

“a good originating in the territory of a member or a region or locality

in that territory where a given quality, reputation or other

characteristic of the good is essentially attributable to its geographical

origin”

Most GIs relate to agricultural products or those derived from them.

Handicraft products specific to a region are also registered under GI

Act, 1999.

S.no Name of the product State

1. Basmati Rice India

2. Darjeeling Tea (word and Logo) West Bengal

3. Kangra Tea Himachal Pradesh

4. Malabar Pepper Kerala

5. Alleppey Green cardamom Kerala

6. Pokkali Rice Kerala

7. Mango Malihabadi Dussheri Uttar Pradesh

8. Guntur Sannam Chilli Andhra Pradesh

9. Mahabaleshwar Strawberry Maharashtra

10. Madurai Malli Tamil Nadu

11. Udupi Mattu Gulla Brinjal Karnataka

S.No Name of the product State

1. Tirupathi Laddoo Andhra Pradesh

2. Bikaneri Bhujia Rajasthan

3. Pochampalli sarees Andhra Pradesh

4. Gadwal sarees Andhra Pradesh

5. Mysore sandal soap and oil Karnataka

6. Phulkari handicraft Punjab, Rajasthan and

Haryana

7. Champagne France

Basmati Rice

Muga silk -

Assam

Kolhapuri Chappals

- Maharashtra

Thanjavur Veena

– Tamil Nadu

Chambal Rumal – HP

and Jammu

Armagh Apples - Ireland

Kampot Pepper - Cambodia

Prior to 1999, there was no specific legislation to

regulate geographic indication.

In 1999, India in compliance with TRIPS (Trade

related aspects of Intellectual Property Rights)

enacted the GI Act

Geographical Indication of Goods (Registration and Protection) Act, 1999.

Registration of GIs is for a period of 10 years or for a

period till the date on which the registration of

geographical indication of authorized users expires,

whichever is earlier.

Provides for registration and better protection for

GIs relating to goods.

Provides for registration and better protection for

GIs relating to goods.

Provides for registration and better protectionfor GIs relating to goods.

In September 1997 a USA company RiceTec Inc. was

granted U.S. on "basmati rice lines and grains."

The company entered international basmati market

with brands like “Kasmati and Texmati”.

RiceTec Inc., owned by Prince Hans-

Adam of Liechtenstein, faced international outrage

over allegations of biopiracy.

Two Indian Non Governmental Oragnisations

(Centre for Food Safety and Research

Foundation for Science, Technology and Ecology

with support from Centre for Scientific and

Industrial Research (CSIR) filed a legal petition in

the United States.

The Indian Govt. challenged the patent officially

in June 2000.

The United States Patent and Trademark Office reviewed the situation.

RiceTec Inc. lost the case and withdrew most of the claims of the patent, including, most importantly, the right to call their rice lines "basmati.

A more limited varietal patent was granted to RiceTec in 2001 on claims dealing with three strains of the company’s rice lines.

Turmeric: The CSIR (Council of Scientific and

Industrial Research , India) asked for a re-

examination of the US Patent no. 5 401 504 which

was granted for the wound healing properties of

turmeric.

In a landmark decision, the United States Patent

and Trademark Office (USPTO) revoked this patent

after ascertaining that there was no novelty, the

innovation had been used in India for centuries

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1.IPR has encouraged monopolies; many take overs have been motivated by access to an IPR.

2.The IPR situations in many cases is quite complicated.

3.It is perceived by many as a threat to food security.

4.It may be detrimental to the livelihood of the poor in developing countries.

IP protection form Product Legislation

Patent Agrochemicals,

machinery, PHT ,novel

gene, processes

IPA,1970;1999;2002;2005

New variety/extant

variety/farmers variety

distinct, uniform, stable

plant grouping

PPVP&FR Act 2001

GI Products of specific

territorial origin

GI Act 1999

TD/TM/TS/copyright Agrochemicals,

machinery, PHT, software

All Acts in place

Community rights Genetic resources, TK Biodiversity Act, 2002

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