Landmark agreement will offer various farmer benefits
Key seed companies agreed this past fall to a seed patent accord for biotech products that offers potentially big benefits to farmers of all major crops.
"It’s extremely important to international trade for U.S. corn growers. That’s why we are involved," says Sarah Gallo, National Corn Growers Association (NCGA) director of public policy for biotechnology and trade.
The Generic Event Marketability and Access Agreement (GEMAA) makes trade disruption far less likely when a seed product comes off patent. GEMAA ensures that international regulatory and stewardship responsibilities are maintained, she says.
Since the agreement was launched Oct. 31, 2012, no company has used it yet. In 2010, Monsanto Company announced that it was committed to maintaining foreign approvals for its first generation Roundup Ready soybeans coming off patent through 2021.
"GEMAA does for all traits what Monsanto has already committed to for the first generation Roundup Ready trait," explains Jim Tobin of Monsanto’s industry affairs. "Since the accord didn’t exist when we made those commitments, we didn’t technically use it. The spirit of the agreement, however, aligns with the commitments Monsanto made in 2010 to maintain foreign approvals."
It’s impossible to predict how future expiring seed patents will be handled, but GEMAA provides a framework. Signatories besides Monsanto are BASF Plant Science, Bayer CropScience, Dow AgroSciences, DuPont Pioneer and Gro Alliance. Organization signatories include NCGA, American Soybean Association, American Farm Bureau Federation and American Seed Trade Association.
In Gallo’s view, for GEMAA to operate as designed, all biotech seed companies need to sign the accord, which has not yet occurred. One such company is Syngenta. Until Syngenta has the opportunity to review both GEMAA and a separate post-patent agreement, the Data Use and Compensation Agreement (DUCA), the company says it cannot complete its analysis of this post-patent approach. DUCA was still being finalized at press time. Syngenta will not have an "event" go off patent until 2017.
"We will be clear with our approach to post-patent events well before that time arrives," notes Paul Minehart, Syngenta spokesperson.
What the accord will not do. While some farmers are hoping GEMAA could result in less expensive biotech seeds for post-patent products, the agreement does not address price, which will be solely determined by the marketplace, say both signatory companies and producer groups.
"GEMAA is most beneficial to farmers because it provides a framework to ensure they can sell their products to key global markets," Tobin says. "The added benefit for companies like Monsanto is this framework provides consistency in the industry."
The goal behind GEMAA is to preserve a global marketplace for biotech seed products, adds Scott Kohne, market acceptance manager, NAFTA countries, Bayer CropScience, and GEMAA vice chair. "Signatories commit to global support for these ‘events’ (products and traits)."
One key behind GEMAA is that, while voluntary, it puts a system in place for handling registrations worldwide—for companies that have introduced them, as well as how registrations and product traits can be traded and transferred to other companies, explains Mark Krieger, global leader biotechnology registration and operations manager for Dow AgroSciences and GEMAA chair.
When companies negotiating the sale of traits disagree on terms, the accord triggers an arbitration process. Signatory companies agree to notify the public three years in advance of patent expirations.
Product registrations are handled differently in other countries, Krieger adds, and global registration rules are a moving target. As a result, it’s not cheap to maintain global product registrations—in the range of $1.5 million to $3 million per product annually.
GEMAA obligates companies who extend registrations, or new companies who take them over, to maintain registrations globally for seven years.
Simply put, with GEMAA, farmers will know they can use a biotech product with an expiring patent and that there is a company responsible for maintaining authorizations.
You can e-mail Ed Clark at email@example.com.