• Intellectual Property tools for phytosanitary products
  • International Status of Protection of Safety and Efficacy Data
  • Benefits from Protection of Safety and Efficacy Data
  • CropLife Latin America Positions concerning of Safety and Efficacy Data
  • Myths & Realities of of Safety and Efficacy Data
  • World Intellectual Property Day

Agricultural innovation is key in promoting productivity and rural development in a sustainable manner. The improvement of seeds, fertilization, the adequate use of machinery and pest, weed and crop disease control are technologies that have registered development and great advancements in the last decades. The main benefit is a greater availability of food and supplies for a growing population. It is necessary to continue with technological and scientific developments, for which protection of inventions, brands, studies and copyrights becomes essential.

Intellectual Property Tools in the Industry associated to CropLife Latin America

As an innovating industry, the companies which make up CropLife Latin America utilize several tools offered by the intellectual property, in order to protect appropriately the innovative and scientific development efforts.

  • Patents: Provide exclusive rights to inventors for a fixed period of time in exchange for the disclosure of an invention. A patent provides the right to exclude others from making, using, selling, offering to sale or importing the patented invention for the term of the patent, which is usually 20 years from the date the patent is filed with the national patent office.
  • Trade Secret:  Is a formula, practice, process, design, instrument, pattern, or compilation of information which is not generally known or reasonably ascertainable, by which a business can obtain an economic advantage over competitors or customers. In some jurisdictions, such secrets are referred to as "confidential business information" or "classified information".
  • Plant Variety Rights: Also known as plant breeders’ rights, are rights granted to the breeder of a new variety of plant that give him exclusive control over the propagating material (including seed, cuttings, divisions, tissue culture) and harvested material (cut flowers, fruit, foliage) of a new variety for a number of years.
  • Copyright: Is a set of exclusive rights granted to the author or creator of an original work, including the right to copy, distribute and adapt the work. This protection is available to both published and unpublished works.
  • Trademark: Is granted to reduce confusion in the marketplace by preventing the unlicensed use of the registered mark, or one of a similar nature, on goods which are the same or similar to those for which the mark is registered.
  • Protection of Safety and Efficacy Data: Also known as test data protection, is the protection from unauthorized commercial use of health and efficacy data submitted for regulatory purposes. Besides It is a protection that prevents non authorized commercial use of safety and efficacy data submitted for obtaining the marketing approval or registration of a new pesticide or phytosanitary product in a country.
    It does not impede third parties from generating their own registration information. The Test Data protection is one of the priorities of CropLife Latin America and its members companies because it prevents unfair competition vis-à-vis the long and costly research and development effort demanded by each phytosanitary product. It is a topic that is treated in the field or unfair competition.

Benefics from Protection of Safety and Efficacy Data

  • It protects against unfair commercial use of research that implies investing millions, and many times without possibility of recouping it.
  • It ensures leverage of conditions for competitors.
  • Submitting the test data for each product guarantees the quality of these products; thus, benefitting health, environment and agriculture.
  • It permits continuing research for sustainable solutions against pests and diseases that attack crops.

CropLife Latin America Position concerning Protection of Safety and Efficacy Data

CropLife Latin America members companies consider that an adequate protection mechanism against the unfair use of the Test Data is a ten year period of exclusive use of the information, followed by five years of compensation to the studies’ titleholder counted from the date of commercial registration of the innovative product in each country. No person can use the test data to support a marketing approval or registration, neither directly nor indirectly, during the exclusivity period.

Once the ten year expired period has ended, any person may to use the test data of the innovative product as a support if, equivalence of the product to original one is demonstrated, according to the Food and Agriculture Organization (FAO) Manual of Specifications. The FAO proceedings will ensure that the safety and efficacy information of the new product is applicable to the second product.

International Status of Protection of Safety and Efficacy Data

Estatus Inter English

Myths an Realities about Protection of Safety and Efficacy Data

The absence of information and understanding about Test Data Protection has generated multiple myths. Here are some of the myths and realities that are raised in Latin America concerning this topic.

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World Intellectual Property Day

On the 26th of April of each year, the member States of the World Intellectual Property Organization (WIPO) realize varied hold various activities to make society conscious raise awareness about the function rol that intellectual property realizes in everyday life. They honor the innovators, inventors and artists that have contributed to the development of world societies.

The selected date was the 26th of April because that same date the 1970 Agreement which established WIPO came into effect.

Documents

Presentations

  • Legal Regulatory Environment in Latin America
    Author: Javier Fernández, CropLife Latin America Legal and Regulatory Matters Counsel, at the INFORMA Life Sciences Congress about Crop Protection: Off Patent Products and Generics, realized in Belgium, in November 2010.

Publications

Brochure “Intellectual Property Promotes the Service of Science for Agriculture"

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In this document you can find information about:
  • Science and Investment behind a New Phytosanitary Product.
  • Scientific Support of a Phytosanitary Product Permits its Evaluation.
  • How Must the Authorities Protect that Scientific Support?
  • How Can the Test Data of a Phytosanitary Product be Protected?
  • Myths and Realities about Test Data Protection of New Phytosanitary Products or Pesticides.

Recommended links

Organización Mundial de la Propiedad Intelectual, OMPI

CropLife International

Instituto Nacional de Propiedad Industrial INAPI (Chile) 

Instituto Mexicano de la Propiedad Industrial 

Instituto Nacional de defensa de la competencia y de la Protección de la Propiedad Intelectual (Perú)

Instituto Nacional de la Propiedad Industrial de Argentina

Asociación Argentina de Agentes de Agentes de la Propiedad

Instituto Nacional de la Propiedad Industrial (Brasil)

Servicio Nacional de la Propiedad Industrial (Bolivia)

Sistema Autónomo de la Propiedad Intelectual (Venezuela)

Dirección Nacional de la Propiedad Industrial (Uruguay)

Registro de la Propiedad Intelectual (Guatemala)

Registro Nacional (Costa Rica)

Asociación Colombiana de la Propiedad Intelectual

Superintendencia de industria y Comercio (Colombia)

Instituto Ecuatoriano de la Propiedad Intelectual