Since the introduction of genetically modified seeds into the global market during the 1990s, there has been little need to prepare for the expiration of the patents related to the technologies. That is, until the expiration of the pioneer Roundup Ready seed-trait patent drew near. Now that Monsanto’s Roundup Ready seed-trait patent is nearing expiration, seed-producing competitors, farmers, and the global food market have raised questions regarding how Monsanto will handle the unprecedented transition into a generic seed market. In response, Monsanto and other agricultural-biotechnology companies have created the Accord, comprised of two contractual agreements, which attempts to regulate the transition. However, this private-sector solution fails to address the needs of all interested parties in the same way that the Hatch- Waxman Act provides for the various parties in the pharmaceutical industry. For this reason, the legislature should act to provide a regime for the transition that ensures that the genetic traits with expiring patents stay available for public use and that crops grown with these seeds may continue to be exported. This Comment suggests a legislative solution that would meet these needs by delegating the regulation of the transition into the generic market to an administrative agency. The solution proposed in this Comment would provide for a regime similar to one enacted through the Hatch-Waxman Act that allows for competitors to develop products using the patented genetic trait prior to patent expiration to prepare for the generic market. At the same time, it provides a scheme to ensure the maintenance of the international regulation authorizations that are necessary for seeds and crops containing genetic modifications to be exported.
Brianna M. Schonenberg,
Twenty Years In the Making: Transitioning Patented Seed Traits Into the Generic Market,
97 Marq. L. Rev. 1039
Available at: http://scholarship.law.marquette.edu/mulr/vol97/iss4/7