Article

by Carey Gillam

The U.S. seed industry said Wednesday it was a step closer to establishing a broad framework for the handling of genetically modified seed technology as product patents expire.

The American Seed Trade Association (ASTA) and the Biotechnology Industry Organization (BIO) said they have completed the first phase of an industry accord that addresses post-patent, single-trait seed biotechnology.

When implemented, the groups said, the deal will safeguard foreign regulatory approvals of U.S. GMO seed and help spur seed innovation.

The announcement marks progress but not a final solution in an ongoing, sometimes contentious, effort by major seed industry players like Monsanto, DuPont, Syngenta, and smaller seed companies to agree on obligations and opportunities as the first patented biotech seed trait - the "Roundup Ready" herbicide resistance trait - comes off patent in 2014.

Monsanto has made billions of dollars off Roundup Ready soybeans, corn, cotton and other crops after first launching a Roundup Ready herbicide tolerant soybean in 1996. The company has licensed the trait technology to other companies over the years.

But with patent expiration approaching, the seed industry has had to grapple with an array of concerns, including who should bear the costs and responsibilities of maintaining regulatory approvals. That involves submitting data to foreign countries to maintain approval for sales of seeds in those countries.

Monsanto has said it will maintain the regulatory approvals globally through 2021. But the industry has been seeking a broad mechanism to protect international regulatory approvals and address product stewardship in ways that keep international trade from being disrupted and seed choice for farmers.

Under the accord announced Wednesday, those companies that sign on will be required to provide notice of patent expiration three years before the last patent on the biotechnology event expires, and they will be required to provide access to the genetic event at patent expiration. The company then must maintain the regulatory data for at least four years or transition that with other users.

Chuck Larson, executive director of Americans for Choice and Competition in Agriculture which has been advocating for an agreement, said he applauded the effort, but the accord falls short in many ways. Notably, he said, such an agreement needs to provide access to genetic traits 2 to 4 years in advance of patent expiration, not upon expiration. Otherwise developers will not be able to offer generics without a gap of several years for development.

The industry is continuing to wrestle with provisions for stacked trait technology, a "data use and compensation agreement" to provide for combinations of genetic traits as more come off patent.

"This agreement is an important first step, but the industry must continue moving forward on the second half of the accord, which will ensure seed companies are able to stack with generic traits to create innovative products for farmers," said Paul Schickler, president of DuPont's Pioneer agricultural unit.

The deal, called the Generic Event Marketability and Access Agreement (GEMAA), would be a contractually binding agreement, according to BIO and ASTA. Once companies sign on they will be committed to the terms.

"It assures access to off-patent, biotech events and a path by which these events can be confidently utilized by the broader seed industry," ASTA CEO Andrew LaVigne said of the accord.