Farmers from across the United States learned about the nuts and bolts of the transition from patented to generic biotech events at the recent 2012 Commodity Classic in Nashville, Tenn.

In 2014, the first widely grown plant biotechnology event will lose patent protection with more to follow in the coming years.

“This creates a challenge for the industry,” said Bernice Slutsky, American Seed Trade Association (ASTA) vice president of science and international affairs. “Even though an event comes off patent here in the United States, it’s still highly regulated around the world.”

 A mechanism needed to be developed to ensure that international regulatory approvals and proper product stewardship is maintained so that U.S. commodity exports are not impeded.

Working closely with its stakeholders, ASTA and the Biotechnology Industry Organization (BIO) decided to take a proactive approach to help address this challenge. 

The two organizations put together a joint working group comprised of seed companies big and small, trait providers and those who license traits. Stakeholders such as the North American Export Grain Association and American Soybean Association have regularly been invited to provide input to ensure their concerns could be addressed.

“While there is an immediate need to develop a framework to enable a clear and predictable transition to generics, the U.S. value chain needs a long-term and sustainable solution and we wanted to make sure everyone was on board with our efforts,” said Matt O’Mara, BIO Food and Agriculture Section director of international affairs.

O’Mara and Slutsky explained that a framework called the Accord Agreement is being developed to create a smooth transition from proprietary events to generic events in the seed industry.

“Our main goal is to make sure we protect the entire value chain from trade disruptions,” O’Mara said. “In addition, we needed to provide a clear path forward for the transition from proprietary to generic events, provide business opportunities and support innovation, which includes protecting intellectual property rights and providing fair compensation for intellectual property.

 “The Accord Agreement is intended to cast a wide-net to allow stakeholders to become signatories. Once a Signatory, stakeholders will be able to engage in a process with a series of steps and with each step comes increased responsibility,” O’Mara explained.

A few key elements of the Accord Agreement are:

  • It is a contractually binding process.
  • It is voluntary and open to any entity to become a signatory.
  • There is increasing responsibility dependent on whether the Accord signatory has a patented biotech event or intends to commercially utilize the event once its patent expires.

“The Accord Agreement provides transparency, predictability and all parties know what is expected,” Slutsky said. “For seed companies, it provides a clear means for them to take advantage of commercial opportunities of off-patent biotech traits while ensuring domestic and international regulatory approvals are maintained.

 “For farmers, this means that access to international markets will be unchanged, keeping trade doors open and helping to increase profitability for you, while creating economic activity in rural communities across the country.”

The Accord Agreement is still being drafted, but ASTA and BIO are working towards a completion date of early April.