About the Accord
Beginning in 2010, the Biotechnology Industry Organization (BIO) and the American Seed Trade Association (ASTA) and their members engaged key stakeholders to address the opportunities and the challenges associated with patent expiration. The result of this dialogue was the development of a framework, called the Accord, a private-sector driven mechanism that provides for the transition of regulatory and stewardship responsibilities for biotechnology events, after patent expiration.
The first genetically engineered row crop was commercialized in 1996. Currently, nearly ninety-percent of cotton, corn and soybean acreage in the United States is planted with seed varieties containing biotechnology events. Grain from these crops is traded globally, accounting for over $40 billion annually, making the United States the largest producer and exporter of crops and grain derived from biotechnology globally.
The first of the commercial biotechnology events will be going off-patent and becoming "generic" in 2015. The expiration of patents for biotechnology events creates opportunities for growers and the seed industry, but also creates challenges that must be addressed. The most pressing challenge presented by patent expiration of biotechnology events is the maintenance of global regulatory authorizations for these events as well as associated stewardship obligations so that farmers can continue to cultivate seed varieties containing off-patent events without jeopardizing U.S. export markets.
The Accord sets out rights and obligations for signatories involved in commercializing biotechnology seed products containing off-patent biotechnology events to ensure international regulatory and stewardship responsibilities are maintained. The Accord will contain two agreements: The Generic Event Marketability and Access Agreement (GEMAA) and the Data Use and Compensation Agreement (DUCA). While both of these agreements are voluntary, they are binding contracts among signatories. They promote continued innovation in the seed industry, preserve strong protection for intellectual property rights and potentially provide for new business opportunities.
The GEMAA is complete and is now open for signatures. The DUCA is targeted to be open for signatures the first quarter of 2013.