The U.S. agricultural industry is on the verge of entering uncharted territory – as in 2014, when the first genetically engineered trait, Roundup Ready soybeans, will see its patent expire and more will follow with the first cotton trait expiring in 2016. These expirations raise questions about 1) a potential generic trait market and, more importantly, 2) whether the plethora of international regulatory approvals will be maintained so that trade is not disrupted.
The Biotechnology Industry Organization (BIO) and the American Seed Trade Assoc. (ASTA) announced and opened for signature their joint Generic Event Marketability and Access Agreement (GEMAA) to deal with biotech patent expiration issues.
GEMAA is a contractually binding agreement among signatories that aims to provide a clear set of procedures to manage patent expiration for the benefit of the entire value chain. Signatories to the agreement would be required to provide notice of patent expiration three years before the last patent on the biotechnology event expires and provide access to the generic event at patent expiration. In addition, the regulatory data owner (patent holder) must either maintain international regulatory responsibility on its own for at least four years after the last sale of the product or either share or transition this responsibility with other users. If no interest is expressed by other signatories for a trait, the owner could discontinue it.
Beginning in 2010, BIO and ASTA, along with their respective member companies, engaged a wide range of stakeholders on the patent expiration issue, including grower groups, grain handlers and government officials.
GEMAA is the first of two agreements that will make up “the Accord.” In addition to the GEMAA, the BIO-ASTA drafting group continues to work on a Data Use and Compensation Agreement (DUCA) that complements the GEMAA. DUCA will have additional provisions related to structured access to regulatory data and data compensation. DUCA is targeted to be open for signature early next year.
More information about the Accord and the GEMAA signature process is at www.AgAccord.org.