Benefits of Crop Protection Products on Society and Agriculture

Douglas Nelson

Executive Vice President, General Counsel

and Secretary

CropLife America

Before the Use of Insecticides and Fungicides (1850s)

• 50% of U.S. crop production consumed by

insects.

• 75% of fruit crops rotted in orchards.

• Fields were abandoned.

• Fruits and vegetables in the markets were

diseased and insect-damaged.

Apple: Codling Moth

By 1904, all commercial apples sprayed

Blueberry Maggot

In the 1920s the FDA seized cans

because of maggots

Without Insecticides, U.S. Crop Production Would be Much Lower

Crop % Reduction Billion Pounds

Apples - 93 9.2

Oranges - 61 9.0

Peaches - 54 1.0

Peanuts - 50 1.9

Potatoes - 29 11.9

Tomatoes - 52 13.4

Grower Income Benefits: Fungicide Use

• Growers gain $15 in income for every $1 spent on

Fungicides

For the past 10 years, one of the big

agricultural “stories” has been the rise of

organic farms. The press often refers to

organic foods as having been grown

without the use of pesticides but the

reality is …

Organic farmers use insecticides and

fungicides too.

Rise of Organic Agriculture

Organic Apple Production: Northeastern U.S.

Lime Sulfur

• 10 gallons/acre

Wettable Sulfur

• 12 pounds/acre

Rutgers

Apple Scab

Herbicide use has

contributed substantially

to increased crop

production in the US.

The Buried Menace

Each acre of U.S. cropland contains 50 to 300

million buried weed seeds.

Millions of people killed weeds in U.S. fields into the 1950’s.

Carrot Yields Reduced 70%

Season Long Weed Competition

Zero Weed Competition

U.S. Corn Yields

0

20

40

60

80

1880 1910 1940 1970

Bushels/

Acres

Herbicides

Introduced

U.S. Rice Yields

0

2000

4000

6000

1899 1914 1929 1944 1959 1974 1989

Lbs./

Acre Herbicides

Introduced

Herbicide Adoption Complete

Rice Yields and Herbicides: Land Conservation

• Rice yields doubled with herbicides.

• To maintain rice production without herbicides,

twice as many acres would need to be

planted.

U.S. Crop Acreage

0

20

40

60

80

100

1994 1996 1998 2000 2002 2004

Million

Acres

Source: USDA

Herbicide

Tolerant

Biotech

Organic

Pesticide Use in Africa:

• Subsistence farmers benefit from the use of

herbicides, insecticides and fungicides.

• These products support economic and social

development

• Meaning that these products are important and

worthy of rigorous data / IP protection

Removing Weeds Before Planting with Hand Hoes

126 hours/hectare

Enete, Nweke, & Tollens, 2002

Handweeding is the Predominant Weed Control Practice in Sub-Saharan Africa

• 50-70% of the labor in crop

production is spent weeding.

Chikoye, et al, 2007

Weeds Killed Before Planting With Herbicides

-124 hours/hectare Handweeding

+2 hours/hectare Herbicide Spray Gressel, Piesse

& Thirtle, 2006

Cotton Experiment: 4 Weeks After Herbicide Spray

Herbicide

Treated

Untreated

-254 hours/hectare Handweeding

+1.5 kg/hectare of Chemical Lagoke, et al, 1992

Intellectual Property in Crop Protection

• Patents Provide protection for molecules identified for

possible use as active ingredients in pesticides.

• Protection of Regulatory Data Prevents unauthorized commercial use of health and

efficacy data submitted for regulatory purposes.

• Trademarks Brand names, logos and trade dress to identify

manufacturer and build brand equity.

• Copyright Protects application instructions and other

informational data developed for consumers.

Innovative Product Life Cycle

1. Discovery – Researchers identify candidate

molecule for use in product development.

Patent Protection sought.

2. Development – Researchers establish

effectiveness and safety of various

formulations including the patented active

ingredient.

3. Registration – Companies seek approval to

sell the new compound from government

regulators. Protection of Regulatory Data

sought.

Discovery – Patent Protection

• Application filed when a

candidate molecule is

identified.

• Exclusive use in

production and research

for the patent term.

• Minimum term in TRIPS

Agreement is 20 years.

• Not all molecules which

are patented become

final products!

Innovative Product Life Cycle

1. Discovery – Researchers identify candidate

molecule for use in product development.

Patent Protection sought.

2. Development – Researchers establish

effectiveness and safety of various

formulations including the patented active

ingredient.

3. Registration – Companies seek approval to

sell the new compound from government

regulators. Protection of Regulatory Data

sought.

Development – Considerable Effort

• Development of a new

agricultural chemical

costs in excess of $200

million.

• Development time

exceeds 9 years.

• 1 out of 140,000

molecules makes it from

laboratory to field.

• Over 120 tests are

performed on each new

product to ensure safety

and efficacy.

Innovative Product Life Cycle

1. Discovery – Researchers identify candidate

molecule for use in product development.

Patent Protection sought.

2. Development – Researchers establish

effectiveness and safety of various

formulations including the patented active

ingredient.

3. Registration – Companies seek approval to

sell the new compound from government

regulators. Protection of Regulatory Data

sought.

Registration – Protection of Reg. Data

• Regulatory data are tests

and studies generated by

companies to prove the

safety and efficacy of a

product.

• Government regulatory

approval needed to

sell/make a pesticide.

• Protection of Regulatory

Data starts on the day of

registration.

New Product

Discovery

Development

Registration

Commercialization

Expiration of IPR

Generic Competition

Patents to protect

Novel inventions

Protection of

Regulatory Data

Generic competition

Spurs invention of

New products

Feeds generic

industry

Continuous flow of new products

Increasing productivity

Higher standards for food quality

With IPR: Sustainable Product Life Cycle

New Product

Discovery

Development

Registration

Commercialization

Expiration of IPR

Generic Competition

Patents to protect

Novel inventions

Protection of

Regulatory Data

Generic competition

Spurs invention of

New products

Feeds generic

industry

Lack of IPR: Stagnation of Innovation

No new products introduced

Static productivity

Potential problems with food exports

New Product

Discovery

Development

Registration

Commercialization

Expiration of IPR

Generic Competition

Patents to protect

Novel inventions

Protection of

Regulatory Data

Generic competition

Spurs invention of

New products

Feeds generic

industry

Continuous flow of new products

Increasing productivity

Higher standards for food quality

No new products introduced

Static productivity

Potential problems with food exports

Commercialization

Lack of IPR: further separates developed and developing economies

Protection of Regulatory Data

• Non-reliance for commercial use

Data submitted for registration may only be used by,

or with the permission of, the original submitter during

the exclusivity period.

Copy products – which are equivalent – may rely on

the data for registering after the expiration of the

exclusivity period.

• Non-disclosure

Data submitted for registration does not enter the

public domain, even after the expiration of the

exclusivity period.

Confidential business information must not be

released by regulators.

TRIPS Obligations

• TRIPS Article 39.2

• Natural and legal persons shall have the possibility of

preventing information lawfully within their control from

being disclosed to, acquired by, or used by others

without their consent in a manner contrary to honest

commercial practices so long as such information:

a.Is secret …

b.Has commercial value because it is secret; and

c.Has been subject to reasonable steps under the

circumstances, by the person lawfully in control of

the information, to keep it secret.

TRIPS Obligations

• TRIPS Article 39.3

• Members, when requiring, as a condition of approving

the marketing of pharmaceutical or of agricultural

chemical products which utilize new chemical entities,

the submission of undisclosed test or other data, the

origination of which involves a considerable effort,

shall protect such data against unfair commercial use.

In addition, Members shall protect such data against

disclosure, except when necessary to protect the

public, or unless steps are taken to ensure that the

data are protected against unfair commercial use.

US/EU PRD Practices

• United States

10 year protection from registration date

3 years of additional protection just for minor use

15 years data compensation

• EU

10 year protection from registration date

5 years of additional protection for new data

15 years total in Supplemental Protection Certificate

Global Protection of Regulatory Data

Country # of Years

Chile 10

China 6-10

Singapore 10

Australia 8 + 3

New Zealand 5

Korea 15

Japan 15+

Mexico 5

Colombia 10

EU Members 6-10

US FTAs 10

CAFTA 10

Brazil 10

Global Protection of Regulatory Data

Minimum Years of Data Exclusivity for a New Active Substance

Brazil and India, PRD Matters

• Brazil has effective 10-year protection of regulatory data in place.

• India has no protection of regulatory data rules presently.

• There are 410 more agricultural chemicals available to the farmers in Brazil than to the farmers in India.

• Case study comparing the availability of chemicals, and the yields of soybean harvests in Brazil and India.

Brazil and India - Soybean Study

• India

For soybean production there are only 12 herbicides,

8 insecticides and 4 fungicides registered.

The yield of soybean in India was 1.05million

tones/hectare in 2007.

• Brazil

For soybean production there are 171 herbicides,

159 insecticides and 104 fungicides registered.

The yield of soybean in Brazil was 2.71million

tones/hectare in 2007