Monsanto is working with industry groups, in consultation with seed companies and farmer organizations, on mechanisms to transition proprietary biotech traits to so-called generic status to enable access to technology and farmer choice.
This is a key issue in our industry right now, and the discussion has been generated in part by Monsanto’s first-generation Roundup Ready (“RR 1”) soybean trait because the last U.S. patent on that trait will expire in early 2015. Farmers and seed companies that want to continue to work with the trait will have to address the regulatory implications of that decision.
Sustainability of Biotech Trait Use After Patent Expiry
Even after the patents have expired, seeds that contain RR 1 will still be highly regulated in many countries to which U.S. soybeans are exported. Industry stewardship guidelines, such as the Excellence Through Stewardship program, take the position that a trait should not be planted in a country unless that trait has been approved for import into all important export destinations for that crop.
Although Monsanto is discontinuing its use of the RR 1 trait and converting to the new Genuity® Roundup Ready 2 Yield® soybean trait, the company announced plans to support key import approvals for the RR 1 trait through year 2021. For seed companies that want to continue to use the RR 1 trait, that notice provided over ten years (six of them post-patent) to make arrangements to provide ongoing regulatory support for the RR 1 trait.
The six years of support that Monsanto is providing following patent expiry is considered to be ample time for interested parties to create an entirely new regulatory data package to provide ongoing support for the use of the RR 1 trait. That may not be necessary if the industry, working through the Biotechnology Industry Organization (BIO ) and the American Seed Trade Association (ASTA ), is successful in establishing a process that will enable interested companies to strike an alternative arrangement.
Under such an arrangement, Monsanto would either continue to support RR 1 past 2021 or would transfer the existing RR 1 regulatory data package to another entity that would provide continued support.
Being a leader in biotech trait development has benefitted Monsanto, but also means that Monsanto is the first company to have to wrestle with many difficult issues presented by this relatively new technology. By providing a long lead time for those interested in continued use of the RR 1 trait, Monsanto hopes that it provides a valuable model to the rest of the industry for the sustainable use of traits after patent expiry.
This article is excerpted from Monsanto’s 2011 Corporate Social Responsibility and sustainability Report. To see the entire report, please visit Monsanto.com.