Dr Arvind KapurCEO, VEG.DIV.RASI SEEDS (P) LTD.

AGRICULTURE BIOTECHNOLOGY

IP LAWS TO PROTECT INNOVATION

AND NOT TO RESTRICT FUTURE RESEARCH

DEC,16th,2010

Agriculture And Climate Will Continuously Change Without Waiting For The Copenhagen Debate To Be Conclusive

INDIAINDIA-- AN AGRICULTURAL COUNTRYAN AGRICULTURAL COUNTRY

26%

15%

6%6%4%

13%

3%

11%

16%

Rice WheatSorghum MilletCorn PulsesRapeseed & Mustard Other OilseedsOther Crops

Arable land area: 142 million hectares; 11% of world total (2nd to USA)

Population: 1,065 million (17%); Growth Rate 1.5 % (+ 16 million annually)

620 million (58%) rural Indians depend upon agriculture

Agricultural sector represents 21% of GDP

Challenges: 1. Growth rate stagnating (total

production and productivity)2. Major concerns on sustainability3. Challenge of free markets4. Erratic monsoons (60% rain-fed)5. Abiotic & biotic stresses6. Insufficient post harvest facilities

Food production targets and issues to achieve these by 2020 India needs to produce more than 320 mn Ton of food

ISSUES AND CHALLENGES Land and water resources are shrinking

Productivity is still low in many crops

Productive agricultural land is still under less productive seed

Heavy dependence on Monsoon and optimum weather conditions

Comprehensive agricultural policies are inadequate

Combined effort of public and private sector in agriculture is still lacking

THE WORLD SEED MARKET(billions $)

Total Seed

Field SeedsVegetable

Flower15

15

33%

05

101520253035404550

50 Billion

Including Farmers Saved SeedTotal SeedField SeedsVegetableFlower

Commercial seed market6.8 b$ Vegetable Seed27.2 b $ Cereal Seed(20.3 non GM+6.9 GM)

20% vegetable seed

80% Field & other seed

34 Billion

Global Seed Market Split

Cotton 3%

Canola 5%

Vegetables 18%

Corn 32%

Rice 10%

Other 6%

Potato 4% Sunflower 2%

Barley 2%

Sugar Beet 2%

Wheat 4%

Soybean 12%Tomato fresh indet. 11%

Cabbage 7%

Sweet pepper 7%

Lettuce 7%

Watermelon 5 %

Onion 5%

Seed Vegetable seed

Melon 5 %Chinese cabbage 5 %

Hot pepper 5%Carrot 4%

Tomato fresh set. 3%

Internal assessment

Uses of Cereal demand by developing countries in 1997 and 2020

INDIAN SEED INDUSTRY

Total Seed Industry is worth about $ 2 bn

Cereal industry is worth $1.3 bn approximately

About 1/3rd is contributed by cotton worth $ 450 mn

Rice OP and hybrids contribute about $225 mn

Millet hybrids contribute $ 110 mn

corn contributes around $ 180 mn

Vegetable seed industry is worth $ 400 mn

General/Specied of Crops notified for plant variety protection in IndiaDate of Notification Number of crops/Species Crop groups/Crops

21 May 2007 12 crops/12 species

Cereals: Bread wheat, Maize, peral millet, rice, sorghum; Pulses: Black gram, Green gram, Chick pea, field pea, Kidney bean, Lentil, Pigeon pea

31 Dec 2007 2 crops/6 species

Commerical crops: Cotton(4 species-tetraploid and diploid), Jute(2 species)

27 July 2009 3 crops/3 speciesCommercial crops: Sugarcane, Turmeric, Ginger

10 April 2010 11 crops/13 species

Spices: Black pepper, small cardamom; Oilseeds: Indian Mustard, Karan Rai, Rapeseed, Gobhi sarson, Sunflower, Safflower, Castor, Sesame, Linseed, Groundnut, Soybean

Details of extant variety registration process as on 30th Sep 2009Particulars Numbers of VarietiesApplications received 1003Registration certificates issued 66Recommended by Extant variety Registration Committee(EVRC) for registration 88Conditionally recommended by EVRC* 68Not recommeded for registration by EVRC 8To be examined as extant varieties of common knowledge 31*provided the demomination of the variety shall remain same as in Gazette notification under Section 5 of the Seeds Act, 1966

CROP IMPROVEMENT

EVOLUTION vs. REVOLUTIONSlow RandomStability ?Focus ?Environment

GERMPLASM BASE

VARIETAL BREEDING

PEDIGREE BREEDING

G x E INTERACTION

ACCESSION OF GENES

GENETIC TRANSFORMATION

ACCELERATED INTROGRESSION

THROUGH MAB

Fast SpecificStableFocused

Benefits of biotechnology

More foodBetter

food

Better for the environment

Genetic Genetic ErosionErosion

domestication selectionselection professional professional breedingbreeding

large (untapped) genetic resources availablelarge (untapped) genetic resources available

10,000 Breeding Lines

(a) (b)

500

100

20

500

20

Comparison of (a) Traditional and(b) Molecular breeding methods for variety development

Field Testing

Molecular Marker analysis

Field Testing

— Year 2 —

— Year 1 —

— Year 3 —

—Year 4—— Year 5 —

Seed Increase

Seed Increase

Commercial release

Commercial release

MAB MAB -- Markers to traits of interest (STS/Scars)Markers to traits of interest (STS/Scars)

-- Recurrent parent selectionRecurrent parent selection

-- QTL analysisQTL analysis

-- Hybrid purityHybrid purity

-- MappingMapping-- Advanced BackcrossingAdvanced Backcrossing

•Transcriptional changes•Post Transcriptional Changes

•Translational changes•Post Translational Changes

External Environment

COMPLEXITY IN THE EXPRESSION OF TRANSGENES

Nuclear Environment

Cytoplasmic Environment

•Temperature, Light, etc.

1996 2006

S.No. Company Name Million US $ Company Name Million US $

1 Pioneer 1500 Monsanto 4028

2 Novartis 900 DuPont-Pioneer 2781

3 Limagrain 650 Syngenta 1743

4 Adventa 460 Limagrain 1475

5 Seminis 375 KWS Saat 615

6 Takii 320 Land O’Lakes 550

7 Sakata 300 Bayer bioscience 465

8 KWS 255 Delta Pine land 417

9 Dekalb 250 Sakata 410

10 Cargill 250 DLF Trifolium 365

Global seed Market 30,000 Global Seed Market

34000

PROTECTION OF INNOVATORS IN AGRICULTURE

• INNOVATORS WITH THEIR INTELLECT AND FINANCIAL INVESTMENTS DEVELOP EITHER A NEW PROCESS OR A PRODUCT WHICH IS NOVEL AND NON-OBVIOUS AND HAVE THE RIGHT TO PROTECT BY

• PLANT BREEDERS RIGHTS

• PATENT RIGHTS

PLANT BREEDER’S RIGHTS

• BASED ON DUS AND NOVELTY

• RESEARCH EXEMPTIONS

• BREEDING EXEMPTIONS

• FARMER’S PRIVILEGE

ESSENTIALLY DERIVED VARIETIES (EDV)

• EDV IS A VARIETY DERIVED FROM INITIALLY PROTECTED

VARIETY MAINTAINING ALL IMPORTANT TRAITS AND

HAVE SUBSTANTIALLY SIMILAR TO THE INITIAL VARIETY

ISSUES- HOW TO CATAGORIES IT

WHETHER EDV SHOULD BE BASED ON THE IMPORTANT

TRAITS OR PHENOTYPIC SIMILARITY OF MORE THAN 80 OR 85%

PATENT RIGHTSUTILITY PATENTS BASED ON SPECIFIC CREDIBLE AND SUBSTANTIALE

UTILITY OF THE INNOVATION ALSO MEETS THE CRITERIA OF

PATENTABILITY OF NOVELTY AND NON-OBVIOUSNESS

IN US PATENT LAW ,THE PLANT PATENT ISSUED FOR NEW AND DISTINCT, INVENTED OR DISCOVERED,ASSEXUALLY REPRODUCED PLANTS INCLUDING CULTIVATED MUTANTS, HYBRIDS AND NEWLY FOUND SEEDLINGS OTHER THAN TUBER PROPAGATED PLANTS OR PLANTS FOUND IN AN UNCULTIVATED STATE. THE PROTECTION IS AVAILABLE FOR TWENTY YEARS

EU BIOTECHNOLOGY DIRECTIVE

• PLANT VARIETIES ARE NOT PATENTABLE IN MANY COUNTRIES INCLUDING EU

• CERTAIN BIOTECHNOLOGICAL INVENTIONS WERE NOT PROTECTABLE UNDER PBR A NEW BIOTECHNOLOGY DIRECTIVE ISSUED IN EU IN 1998

• NO SPECIFIC RULE OF PATENTABILITY OF PLANT GENES OR GENE SEQUENCE BUT MUST MEET THE REQUIREMENT OF PATENTABILITY ; NOVELTY INVENTIVENESS AND COMMERCIAL USE OF GENE SEQUENCE

• THIS DIRECTIVE ALLOWS INVENTIONS CONCERNING PLANTS TO BE PATENTABLE IF THE TECHNICAL FEASIBILITY OF THE INVENTION IS NOT CONFINED TO A PARTICULAR VARIETY

EXEMPTIONS UNDER PATENT RIGHT• UNLIKE PBR’S THERE IS NO EXEMPTION IN PATENT

RIGHTS LIKE BREEDING EXEMPTION• LIMITED PRIVATE EXEMPTION IS ALLOWED LIKE FARMER

CAN REUSE THE PATENTED MATERIAL FOR HIS OWN USE• IN USA, THE EXEMPTION UNDER PATENT LAWS ARE

STRONGLY RESTRICTED• THE GM PLANTS CAN’T BE USED FOR FURTHER

RESEARCH OR IN A CROSSING PROGRAM

THE ISSUE IS

PLANTS ARE SELF REPRODUCING HOW LONG AND TILL WHAT GENERATION THE PATENT PROTECTION SHOULD REMAIN

ESSENTIAL BREEDING PROCESSES

• ESSENTIAL BIOLOGICAL PROCESSES ARE NOT WELL DEFINED

• IN EU BIOTECHNOLOGY DIRECTIVE THESE ARE DEFINED AS ENTIRELY NATURAL PHENOMENON OF CROSSING AND SELECTION

• A TECHNOLOGY STEP IN BREEDING IS SUFFICIENT TO MAKE IT ENTIRELY NOT A NATURAL PHENOMENON AND THUS PATENTABLE

• UNDER THAT MANY BROAD BASED PATENTS ALLOWED INCLUDING ESSENTIAL BREEDING PROCESSES

ISOLATED DNA BELONG TO NATURE

• DEBATE ON PATENTING LAWS OF NATURE, NATURAL PHENOMENON AND NATURAL VARIABILITY IS GOING ON

• RECENT USA RULING ON A CASE OF “MYRIAD GENETICS” ON BRCA1 AND BRCA 2 PATENT, REJECTED THE CLAIM SAYING “ THESE ARE LAW OF NATURE AND WERE IMPROPERLY GRANTED

• THE RULING ALSO CLARIFIED THAT THE CHEMICAL STRUCTURE OF THE GENE IS PRODUCT OF NATURE AND IS NO LESS A PRODUCT OF NATURE WHEN A STRUCTURE IS ISOLATED FROM THE NATURAL ENVIRONMENT LIKE COTTON FIBER ISOLATED FROM COTTON SEED

THE ISSUES……• ARE PATENT LAWS ENECTED TO COMPENSATE THE

INNOVATORS OR RESTRICTING OTHER’S FOR FURTHER RESEARCH ?

• WILL IPR LAWS HELP TO REVOLUTIONALIZE PLANT BREEDING ?

• WILL PATENTS BECOME THE PROPERTY OF RICH COMPANIES OR RICH COUNTRIES ?

• WILL PATENT LAWS ALLOW ALL NATURAL VARIATIONS AND DIVERSITY TO BE PATENTABLE

WE MUST OF “RESTRICTIVE PATENT LIST” IN ALL PATENT LAWS