The transition from patented seed trait technology to generic technology is about to become a better-defined process with a positive outcome for U.S. farmers, thanks to a new accord that went into effect last week, the Generic Event Marketability and Access Agreement (GEMAA).
The accord will help ensure that post-patent products continue to meet global regulatory and stewardship obligations. It was developed over the course of the past two years in cooperation by the Biotechnology Industry Organization (BIO), the American Seed Trade Association (ASTA) and various stakeholders. Five stakeholders, including BASF Plant Science, Bayer CropScience, Dow Agro Sciences, DuPont Pioneer and Monsanto Company, have already signed the agreement.
The GEMAA is good news for farmers, notes Mathias Kremer, global head of seeds, Bayer CropScience.
"The GEMAA ensures the integrity of the regulation and stewardship of GM seeds will be maintained as events come off patent," Kremer says. "This is one way we can reassure the seed industry and farmers that we believe in responsible use of technology for its entire life cycle. It is exciting that we came together as an industry to proactively address this situation."
DuPont Pioneer President Paul Schickler adds, "Alignment across seed companies on this agreement is an important step for farmers and the agriculture industry."
During the next decade, nearly a dozen biotech seed traits will reach patent expiration, among them the Monsanto Roundup Ready 1 (RR1) soybean trait in 2015.
"There’s nothing from a patent expiration now that will get in the way of farmers who want to use these products," reports Jerry Steiner, executive vice president of sustainability and corporate affairs for Monsanto.
Steiner adds: "This has been a pleasantly unusual process that is broad across the industry and involves the entire value chain—a level of cooperation that’s pretty unusual. I think it’s a really healthy thing that will enable the marketplace to benefit, including farmers and innovators."
The GEMAA—in conjunction with the Data Use and Compensation Agreement (DUCA)—will provide a framework for dealing with the transition of regulatory and stewardship responsibilities for genetically modified seed technology after patents expire.
Having a "predictable mechanism" in place to maintain current global regulatory authorizations is imperative to keep U.S. agriculture export markets open, report Cathleen Enright, executive vice president, food and agriculture for BIO, and Andrew LaVigne, president of ASTA.
The GEMAA will be overseen by a committee of the signatories, which will be formed by next March.
The ultimate benefit of GEMAA, says Monsanto’s Steiner, is that when companies develop new technology, the resulting products will provide another choice for farmers, in addition to those products that have gone off patent.
Notes Monsanto’s Steiner: "We’re a company focused on innovation and developing new products that will provide additional choices for farmers. Now, there is a clear framework for post-patent technologies, too. This means that new products will have to compete with the old products—that’s our commitment to farmers."