Benefits of Crop Protection Products on Society and Agriculture

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

Rise of Organic Agriculture 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.

Organic Apple Production: Northeastern U.S. Lime Sulfur 10 gallons/acre Wettable Sulfur 12 pounds/acre Apple Scab Rutgers

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% Zero Weed Competition Season Long Weed Competition

80 U.S. Corn Yields Herbicides Introduced Bushels/ Acres 60 40 20 0 1880 1910 1940 1970

U.S. Rice Yields Lbs./ Acre 6000 Herbicides Introduced Herbicide Adoption Complete 4000 2000 0 1899 1914 1929 1944 1959 1974 1989

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 Million Acres 100 80 60 40 Herbicide Tolerant Biotech 20 Organic 0 1994 1996 1998 2000 2002 2004 Source: USDA

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

Enete, Nweke, & Tollens, 2002 Removing Weeds Before Planting with Hand Hoes 126 hours/hectare

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

+2 hours/hectare Herbicide Spray Gressel, Piesse & Thirtle, 2006 Weeds Killed Before Planting With Herbicides -124 hours/hectare Handweeding

Cotton Experiment: 4 Weeks After Herbicide Spray Untreated Herbicide Treated -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.

Protection of Regulatory Data Patents to protect Novel inventions Development New Product Discovery Continuous flow of new products Increasing productivity Higher standards for food quality Generic competition Spurs invention of New products Generic Competition Registration Feeds generic industry Commercialization Expiration of IPR With IPR: Sustainable Product Life Cycle

Protection of Regulatory Data Patents to protect Novel inventions Development New Product Discovery No new products introduced Static productivity Potential problems with food exports Generic competition Spurs invention of New products Generic Competition Registration Feeds generic industry Commercialization Expiration of IPR Lack of IPR: Stagnation of Innovation

Patents to protect Novel inventions Development Protection of Regulatory Data Commercialization New Product Discovery Continuous flow of new products Increasing productivity Higher standards for food quality Generic competition Spurs invention of New products Generic Competition Registration No new products introduced Static productivity Potential problems with food exports Feeds generic industry Commercialization Expiration of IPR 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