* Accord first step, more work needed, parties say
* GEMAA will be a contractually binding agreement
By Carey Gillam
Oct 31 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
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
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
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
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
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.