As a leader in biotech trait development, we are often the first company to wrestle with the complicated issues presented by this important technology. Transitioning proprietary biotechnology traits to generic status is a key industry issue, and the discussion has been generated in part by Monsanto’s first-generation Roundup Ready^® (“RR1”) soybean trait, as the last U.S. patent will expire in early 2015.

THE LAST U.S. PATENT WILL EXPIRE IN EARLY 2015 AS WE CONVERT TO THE GENUITY ROUNDUP READY 2 YIELD SOYBEAN TRAIT

Even after U.S. patents have expired, seeds that contain biotech traits, like RR1, will still be regulated in many countries to which U.S. soybeans are exported. These seeds must be authorized for import into major trading partner countries. Prior to patents expiring, the seed company that developed the biotechnology trait is responsible for obtaining and maintaining these export authorizations. After patents expire, the original seed company may or may not remain in the market, but any seed company can use the biotech event in the development of new seed products. However, the extensive data and regulatory intellectual property necessary to sustain the regulatory approvals for the biotechnology event remains the property of the original producer.  Therefore, industry stakeholders across the value chain agreed that there should be a process to continue the maintenance of regulatory authorizations and the proper stewardship of seed products containing the generic event.

Beginning in 2010, the Biotechnology Industry Organization (BIO), the American Seed Trade Association (ASTA) and their members, including Monsanto, worked to develop a private contractual mechanism for a smooth transition to a post-patent or generic marketplace, named The Accord. The Accord describes the rights and obligations of the parties to the Accord to access the generic biotech event and the regulatory data supporting that event to enable commercialization of seed products containing off-patent biotechnology. Additionally, it assures that international regulatory and stewardship responsibilities will be maintained by those parties. The Accord consists of two agreements: The Generic Event Marketability and Access Agreement (GEMAA) and the Data Use and Compensation Agreement (DUCA). Both of these are voluntary, but they are binding contracts among the signatories.

The GEMAA provides access to the generic event, and requires that regulatory approvals necessary to enable U.S. exports are maintained while parties to the GEMAA market seed products containing that single generic biotech event.  The DUCA accomplishes both of those objectives, while also providing access to the regulatory data to enable the commercialization of multiple-event seed products containing the generic event.

WE PLAN TO SUPPORT KEY IMPORT APPROVALS FOR THE RR1 EVENT THROUGH 2021, OR PURSUANT TO THE DUCA

Although Monsanto is discontinuing the use of the RR1 event and converting to the new and superior Genuity Roundup Ready 2 Yield soybean event, we plan to support key import approvals for the RR1 event through 2021, or pursuant to the DUCA. For seed companies that want to use the RR1 trait, that provides at least ten years (six of them post-patent) either bilaterally or through the DUCA to make arrangements to provide ongoing regulatory support for the RR1 trait. Under the Accord, possible arrangements include Monsanto supporting RR1 past 2021, sharing regulatory responsibility in a joint agreement, or transferring the existing RR1 regulatory data package to other seed companies that would provide continued support.

Together, the two Accord agreements facilitate continued grower access to seed products containing a generic biotech event (e.g. the RR1 event in 2015), protect trade in U.S. commodity crops containing the generic event, and facilitate product development and competition in the post-patent marketplace.

For more information on the Accord, visit: www.agaccord.org.