The American Seed Trade Association (ASTA) and the Biotechnology Industry Organization (BIO) announced they have completed the first phase of an industry framework for addressing off-patent, single-trait seed biotechnology.
How to handle genetically modified seed technology after patents expire is a looming concern for the industry. ASTA and BIO hope to develop the framework to help protect regulatory approvals of U.S. GMO seed in other countries. The new framework has been called the Generic Event Marketability and Access Agreement. It would be a contractually binding agreement that once companies sign, they are committed to the terms.
Despite the progress made so far, the groups have not completed a final solution to the agreement. One of the challenges is getting larger seed companies like Monsanto, DuPont and Syngenta to agree with smaller seed companies on obligations and opportunities as the first patented biotech trait comes off patent in 2014.
The Roundup Ready trait for corn, soybeans, cotton and other crops is the first. It was originally launched in 1996 by Monsanto Company.
The industry is challenged by how to handle this trait coming off patent not just in the United States but abroad as well. One concern mentioned is who should bear the costs and responsibilities of maintaining regulatory approvals after the patent expires. Then there’s the concern over submitting data to foreign countries to maintain approvals for the sale of those seeds in foreign countries.
Reuters reported that under the accord announced this week, “those companies that sign on will be required to provide notice of patent expiration three years before the last patent on the biotechnology event expires, and they will be required to provide access to the genetic event at patent expiration. The company then must maintain the regulatory data for at least four years or transition that with other users.”
“This agreement is an important first step, but the industry must continue moving forward on the second half of the accord, which will ensure seed companies are able to stack with generic traits to create innovative products for farmers,” Paul Schickler, president of DuPont’s Pioneer agricultural unit, told Reuters.