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BIO, ASTA reach initial off-patent agreement

The Biotechnology Industry Organization and the American Seed Trade Association announced Wednesday that they had reached an agreement on how to handle biotech seeds when their patents expire that may — or may not — resolve issues between companies and between companies and farmers.

BIO and ASTA signed off on the Generic Event Marketability and Access Agreement (GEMAA) and invited companies to sign it, but also acknowledged that this agreement was only the first of two steps in “The Accord,” as it is known in biotechnology circles.

The accord is being developed because Monsanto’s Roundup Ready 1 patent expires in 2015 and other companies want to make use of the technology and farmers want cheap biotech seeds. The issue is further complicated by the need to maintain foreign regulatory authorizations and stewardship obligations following the expiration of patents for biotechnology used in seed varieties.

It is unclear whether other seed companies will cooperate and whether agreement on the second stage on data use and compensation will be reached by December, as planned.
Paul Schickler

Paul Schickler
DuPont Pioneer was the first company to signal intent to sign the agreement, but DuPont Pioneer President Paul Schickler noted in a statement that is is only “an important first step.”

“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,” Schickler said.

“We have the opportunity as an industry to implement post-patent solutions similar to those in the pharmaceutical and crop protection sectors that have ensured there is no gap between when patents expire and new innovations reach the market,” he said.

“Collaboration and cooperation is key in our industry to meeting the needs of growers,” Schickler said. “With both agreements in place, we will maximize product choice for growers and foster a competitive market making the best seed technology available to farmers.”

A lobbyist with knowledge of the situation noted that “DuPont and Monsanto have been at each other’s throats over patent infringement regarding DuPont’s plans to stack RR1 and its OGAT glyphosate-resistant trait.”

DuPont wants to be able to stack these and its other proprietary traits when the RR1 patent expires in 2015, the lobbyist said, but Monsanto has developed a successor trait known as RR2Y and does not want to enhance DuPont Pioneer’s competitiveness with the old traits.

The first part of the accord “only reflects agreement on being able to access data and commercialize generic traits, like RR1, but not in stacks with proprietary traits,” the lobbyist said. If advances in technology do not make the expiring generic trait non-competitive, the first part of the accord will not viable on its own.

Both BIO and ASTA officials expressed confidence in the accord.
Cathleen Enright

Cathleen Enright
“The clear message we heard from our stakeholders was the importance of a reliable plan to maintain U.S. export markets,” said BIO Executive Vice President for Food and Agriculture Cathleen Enright.

“The GEMAA provides a predictable and transparent process that ensures global regulatory authorizations are maintained during and after these transitions so that farmers can continue to realize the benefits of these products,” Enright said.
Andrew LaVigne

Andrew LaVigne
“Innovation is the basis upon which the seed industry can provide farmers with a wide array of high quality seed,” said ASTA President and CEO Andrew LaVigne.

“Providing business opportunities is one of the principles behind the accord,” he said. “It assures access to off-patent, biotech events and a path by which these events can be confidently utilized by the broader seed industry.”

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, Reuters reported.

Such an agreement, Larson said, needs to provide access to genetic traits two to four 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 Accord