Agricultural News
Biotechnology Data Use and Compensation Agreement is Open for Signature
Wed, 04 Dec 2013 11:20:14 CST
The Biotechnology Industry Organization (BIO) and the American Seed Trade Association (ASTA) announced today that the Data Use and Compensation Agreement (DUCA) is open for signature. This announcement marks the culmination of BIO and ASTA's work on the AgAccord®, a voluntary private sector mechanism to support a seamless transition to a marketplace that includes both proprietary and off-patent biotechnology events.
Creation of the AgAccord is a substantial milestone for the agricultural biotechnology and seed industry. Although the number of events coming off-patent in the next few years is expected to be small, it's likely to increase significantly after 2020. The AgAccord is in place in advance of the need and BIO and ASTA will now shift its focus to increasing awareness of the AgAccord agreements.
"These agreements are designed to provide confidence to the agricultural biotechnology value chain that off-patent events will be available to interested signatories and that U.S. exports will not be disrupted due to patent expiry. These two issues were critical to our stakeholders, and the AgAccord process is an example of how agriculture can come together to develop a voluntary, private-sector led solution to these challenges," stated Cathleen Enright, BIO Executive Vice President for Food and Agriculture.
Andy LaVigne, President and CEO of the American Seed Trade Association added, "BIO and ASTA have worked with the agricultural value chain to create a pathway for patent expiration that meets the needs of the biotechnology and seed industry and also the needs of our value chain customers."
The AgAccord consists of two separate but equally significant agreements: the Generic Event Marketability and Access Agreement (GEMAA) and the DUCA. The GEMAA was completed in 2012 and is fully operational. The DUCA has been approved by the leadership of both BIO and ASTA and is now open for signature.
The GEMAA and DUCA contain many shared principles and commitments. For example, when patents on events expire, signatories of both the GEMAA or DUCA voluntarily commit to provide access to their biotechnology events that are patented and commercialized in the United States and commit to a process for maintaining export authorizations and stewardship for these events. The GEMAA and DUCA offer alternative paths to address sharing and transitioning the proprietary regulatory information that support regulatory authorizations for the events. Each potential signatory will need to determine which agreement best suits their needs. Signing the GEMAA or DUCA or both will be an independent decision for technology developers, seed companies and other interested parties.
The DUCA will become operational once six parties sign, three that hold proprietary regulatory property or have petitioned the U.S. Department of Agriculture to deregulate an event, and three parties that do not hold proprietary regulatory property, such as a seed company or national farm organization.
Danny Murphy, Chairman of the American Soybean Association (ASA) applauded BIO and ASTA for finishing its work on the AgAccord, stating, "ASA was among the first to call on industry to address concerns related to patent expiration. Our members want confidence that off-patent events will be available and trade to our export markets will be facilitated. ASA looks forward to continuing to work with BIO and ASTA as the industry matures and we move closer to a marketplace that includes off-patent events."
Bob Stallman, President of the American Farm Bureau, added, "U.S. agriculture needs continued innovation in biotechnology to keep pace with increasing global demand. It's important that the private sector provides leadership by addressing patent expiration that preserves incentives for continued innovation in the U.S. seed and biotechnology industry."
Martin Barbre, President of the National Corn Growers Association stated "the AgAccord has been an inclusive process, providing grower groups many opportunities to communicate our concerns and interests with both BIO and ASTA."
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