Health Canada's Pest Management Regulatory Agency has published final regulations with far-reaching implications for pesticide registration in Canada. The regulations focus on the intellectual property protections granted to companies that submit data to support registration of pesticides and how those data may be cited by other companies. They are likely to set off new rounds of negotiation and, probably, arbitration.
Among other things, the regulations ease generic registrants' access to Canadian markets and change how disputes over data compensation are to be resolved. They also expand the scope of test data subject to "exclusive use" protection, allow registrants to extend the length of the exclusive use protection period by adding minor crops uses to a pesticide's label, and change both the length and start date of the "compensable protection" period for test data.
A comprehensive White Paper describing the new regulations and their background is available at www.wileyrein.com/white_paper. The new regulations are intended to bring the Canadian pesticide registration system into closer harmony with the U.S. system. Nonetheless, there are many aspects of the new procedures that are notably different from those in place in the United States. Here is a quick overview of key differences:
- Generic applicants cannot obtain a registration simply by citing a prior registrant's data and offering to pay that company compensation. Instead, unless the prior registrant refuses to participate in mandated procedures, generic applicants generally must obtain a letter of access to the data before their registration will be issued.
- In most cases, the generic applicant will have to pay at least some compensation before it is able to obtain a registration. This payment will be made either to the prior registrant (because an agreement has been negotiated for a letter of access to the prior registrant's data) or to an escrow agent.
- If the registrant who submitted the data at issue and the generic applicant who relied on them cannot reach an agreement on the amount of compensation due, the dispute is to be resolved by binding, final-offer arbitration-that is, arbitration in which the arbitrator(s) must choose between the two parties' respective final offers.
The new regulations will require companies to employ registration and defensive strategies different from those that have developed under the data compensation system established by the U.S. Federal Insecticide, Fungicide and Rodenticide Act. This promises to bring new complexities to negotiations that already have been complicated by the separate data cost sharing provisions enacted by California in 2005.
For more information, review the White Paper at www.wileyrein.com/white_paper