The importance of regulatory data protection or exclusive use and other forms of intellectual property rights in the crop protection industry

In order for a chemical plant protection product to be authorised for sale a registration dossier has to be assembled to demonstrate safety and efficacy to the satisfaction of government regulators. These studies and tests are protected for a period of 10 years in Europe, North America and some other jurisdictions from the date of first product authorisation so that only the data owner can gain commercial benefit from the data. Subsequent regulatory reviews which require new studies should not result in further periods of regulatory data protection exclusive use for the new data but compensation should be payable to the data generator.